VOLUME A-1 (Title 10)

Chapter II - Administrative Rules And Regulations

CHAPTER II
Administrative Rules and Regulations
PART
VOLUME A
Subchapter A Vital Records and Personal Information 35
Subchapter B State Aid and Funding 39
Subchapter C Access to Records 50
Subchapter D Laboratories 55
VOLUME A-1
Subchapter E Food and Drug Products; Research 60
Subchapter F Disease Registry 62
Subchapter G Communicable Diseases and Poisoning 64
Subchapter H Maternal and Child Health 69
Subchapter I Environmental Health 70
Subchapter J Funeral Directing, Undertaking and Embalming 77
Subchapter K Controlled Substances 80
Subchapter L Hospitals and Related Facilities 81
Subchapter M X-ray Technology and Chiropractic Use of X-ray 89
Subchapter N Professional Medical and Dental Services 91
Subchapter O Physician's Assistants; Prohibited Discrimination in 94
Hospital Staff Appointments and Privileges
Subchapter P Licensure and Practice of Nursing Home Administration 96
Subchapter Q State Environmental Quality Review 97
Subchapter R Health Maintenance Organizations 98
Subchapter S Land Acquisition 99

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SubChapter A - Vital Records and Personal Information

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Complete

Part 34 - Health Care Practitioner Referrals and Laboratory Business Practices

Effective Date: 
Wednesday, November 22, 2017
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 238-a(10), 238-a(2)(g), 586(3) and 587(6)

SubPart 34-1 - Health Care Practitioner Referrals

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 238-a(2)(g) and 238-a(10)

Section 34-1.1 - Title

34-1.1 Title.

This Subpart shall be known and cited as the "Health Care Practitioner Referrals."

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-1.2 - Definitions

34-1.2 Definitions. Whenever used in this Subpart, unless the context of this Subpart clearly requires otherwise, the following terms shall have the following meanings:

(a) "Clinical laboratory services" shall mean the microbiological, immunological, chemical, hematological, biophysical, cytological, pathological, genetic or other examination of materials derived from the human body, for the purposes of obtaining information for the diagnosis, prevention, or treatment of disease, or the assessment of a health condition.

(b) "Fair market value" shall mean the value in arms length transactions, consistent with the general market value, and, with respect to rentals or leases, the value of rental property for general commercial purposes, not taking into account its intended use, and, in the case of a lease of space, not adjusted to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor where the lessor is a potential source of patient referrals to the lessee.

(c) "Financial relationship" shall mean an ownership interest, investment interest or compensation arrangement.

(d) "General hospital" shall mean a hospital engaged in providing medical or medical and surgical services primarily to in-patients by or under the supervision of a physician on a twenty-four hour basis with provisions for admission or treatment of persons in need of emergency care and with an organized medical staff and nursing service, including facilities providing services relating to particular diseases, injuries, conditions or deformities. The term general hospital shall not include a residential health care facility, public health center, diagnostic center, treatment center, out-patient lodge, dispensary and laboratory or central service facility serving more than one institution.

(e) "Group practice" shall mean a group of two or more practitioners organized as a partnership, professional corporation, foundation, not-for-profit corporation, faculty practice plan or similar association; and

(1) in which each practitioner who is a member of the group provides substantially the full range of services which the practitioner routinely provides, including medical care, consultation, diagnosis or treatment, through the joint use of shared office space, facilities, equipment and personnel; and

(2) for which substantially all of the services of the practitioners who are members of the group are provided through the group and are billed in the name of the group and amounts so received are treated as receipts of the group; and

(3) in which the overhead expenses of the income from the practice are distributed in accordance with methods previously determined by members of the group; and

(4) provided, however, in the case of a faculty practice plan associated with a hospital with an approved residency training program in which practitioner members may provide a variety of different specialty services and provide professional services both within and outside the group, as well as perform other tasks such as research, the provisions of paragraphs (1), (2) and (3) of this subdivision shall be applied only with respect to the services provided within the faculty practice plan.

(f) "Health care provider" shall mean a practitioner in an individual practice, group practice, partnership, professional corporation or other authorized form of association, a hospital or other health care institution issued an operating certificate pursuant to the public health law or the mental hygiene law, a certified home health agency or a licensed home care services agency, and any other purveyor of health or health related items or services including but not limited to a clinical laboratory, a physiological laboratory, a pharmacy, a purveyor of x-ray or imaging services, a purveyor of physical therapy services, a purveyor of health or health related supplies, appliances or equipment, or an ambulance service.

(g) "Health or health related items or services" shall include, but not be limited to, items and services available under the medical assistance program pursuant to title eleven of article five of the social services law.

(h) "Immediate family member" shall include spouse; natural and adoptive parents, children and siblings; stepparents, stepchildren and step-siblings; fathers-in-law, mothers-in-law, brothers-in-law, sisters-in-law, sons-in-law and daughters-in-law; and grandparents and grandchildren.

(i) "Interested investor" shall mean, with respect to a health care provider, an investor who is a practitioner in a position to make or to influence referrals or business to the health care provider, or who is an immediate family member of such an investor.

(j) "Investor" shall mean, with respect to a health care provider, a person with a financial relationship with the health care provider, subject to the exceptions provided in paragraph (b) of subdivision three, subdivision four and paragraph (b) of subdivision five of section 238(a) of the Public Health Law. (k) "Ownership interest" or "investment interest" shall mean an interest through equity, debt, or other means, but shall not include ownership of investment securities, including shares or bonds, debentures, notes or other debt instruments, which were purchased on terms generally available to the public and which are in a corporation that is listed for trading on the New York stock exchange or on the American stock exchange, or is a national market system security traded under an automated interdealer quotation system operated by the national association of securities dealers, and had, at the end of the corporation's most recent fiscal year, total assets exceeding one hundred million dollars.

(l) "Pharmacy services" shall mean the preparing, compounding, preserving or, the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions or other legal authority.

(m) "Practitioner" shall mean a licensed or registered physician, dentist, podiatrist, chiropractor, nurse, midwife, physician assistant or specialist assistant, physical therapist, or optometrist.

(n) "Rural" shall mean a county with population of two hundred thousand persons or less, or a town with a population density of one hundred fifty persons or less per square mile.

(o) "X-ray or imaging services" shall mean diagnostic imaging techniques which shall include but not be limited to the following:

(1) conventional x-ray or radiology;

(2) fluoroscopy;

(3) digital radiography;

(4) computed tomography;

(5) magnetic resonance imaging;

(6) nuclear imaging;

(7) ultrasonography; and

(8) angiography.

(p) "Radiation therapy services" shall mean the use of high-energy xrays, particles, or radiation materials for the treatment of cancer and other diseases or conditions. (q) Effective December 8, 2002, "physical therapy services" shall mean physical therapy as defined by section sixty-seven hundred thirty-one of the Education Law.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-1.3 - Referrals prohibited

34-1.3 Referrals prohibited.

Except as provided in this Part or in Public Health Law Article 2 Title II-D, a practitioner authorized to order clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services may not make a referral for such services to a health care provider authorized to provide such services where such practitioner or immediate family member of such practitioner has a financial relationship with such health care provider. A referral shall not be construed to include an arrangement whereby a treating practitioner makes arrangements with another covering practitioner for the treatment and/or care of the treating practitioner's patients for services routinely provided by the treating practitioner when the treating practitioner is unavailable to treat such patients. (a) Effective December 8, 2002, physical therapy services shall be subject to all applicable provisions of this Subpart governing designated health services to the same extent that clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services are subject to this Subpart, including, but not limited to, provisions governing prohibited referrals, disclosure requirements, disclosure forms and financial relationships.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-1.4 - Disclosure: Clinical laboratory services, pharmacy services or x-ray

34-1.4 Disclosure: Clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services.

(a) An ownership interest or investment interest shall not be subject to Public Health Law section 238-a(1)(a) or to section 34-1.3 of this Subpart if:

(1) the health care provider authorized to provide clinical laboratory services, pharmacy services, raditation therapy services, or x-ray or imaging services is in a rural area, and the referring practitioner or the patient is in such rural area; or

(2) the clinical laboratory services, pharmacy services, ratiation therapy services, or x-ray or imaging services are provided by a general hospital, the referring practitioner is authorized to perform services at such general hospital and the ownership or investment interest is in the general hospital itself and not merely in a subdivision thereof; or

(3) the clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services are provided by an ambulatory surgical center issued an operating certificate pursuant to Part 401 of this title in conjunction with a surgical procedure performed by the referring practitioner at the ambulatory surgical center; and

(4) if each practitioner who is an interested investor in a health care provider within a category specified in paragraph (1), (2) and (3) of this subdivision discloses to the patient the practitioner's, or family member's, ownership interest or investment interest in the health care provider and the patient's right to utilize a specifically identified alternative health care provider if any such alternative is reasonably available, in the disclosure form specified in section 34-1.6 of this Subpart. Such form shall also be posted prominently in the practitioner's office.

(b) A practitioner shall maintain documentation of each instance of disclosure to a patient pursuant to this section.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-1.5 - Disclosure: other health or health related items or services.

34-1.5 Disclosure: other health or health related items or services.

(a) With respect to referrals for health or health related items or services other than clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services, and except as provided in subdivision (c) of this section, a practitioner may not make a referral to a health care provider for the furnishing of health or health related items or services where such practitioner or immediate family member of such practitioner has any of the following financial relationships without disclosing to the patient such financial relationship:

(1) an ownership or investment interest with such health care provider; or

(2) a compensation arrangement with such health care provider which is in excess of fair market value, or which provides for compensation that varies directly or indirectly based on the volume or value of any referrals of business between the parties.

(b) The disclosure shall provide notice of any such financial relationship and shall also inform the patient of his or her right to utilize a specifically identified alternative health care provider if any such provider is reasonably available, and shall be in the form specified in section 34-1.6 of this Subpart. Such form shall also be posted prominently in the practitioner's office.

(c) Disclosure pursuant to this section shall not be required for a referral for the furnishing of any health or health related items or services under circumstances for which a referral for clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services would not be prohibited pursuant to section 238-a of the Public Health Law, provided that any disclosure required by section 34-1.4 of this Subpart for clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services remains applicable to referrals for other health, or health related items or services under comparable circumstances.

(d) A practitioner shall maintain documentation of each instance of disclosure to a patient pursuant to this section.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-1.6 - Disclosure form

34-1.6 Disclosure form.
NOTICE TO PATIENTS
Because of concerns that there may be a conflict of interest when a physician refers a patient to a health care facility in which the physician has a financial interest, New York State passed a law. The law prohibits me, with certain exceptions, from referring you for clinical laboratory services, pharmacy services, radiation therapy services, or x-ray or imaging services to a facility in which I or any of my immediate family members have a financial interest. If certain of the exceptions in the law apply, or if I am referring you for other than clinical laboratory, pharmacy, radiation therapy, or x-ray or imaging services, I can make the referral under one condition. The condition is that I disclose this financial interest and tell you about alternative providers where you may go to obtain these services. This disclosure is intended to help you make a fully informed decision about your health care.
I or my immediate family members have a financial relationship with the following providers: __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
For more information about alternative providers, please ask me or my staff. We will provide you with names and addresses of providers best suited to your individual needs that are nearest to your home or place of work.

Name of Physician

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-1.7 - Exceptions from compensation arrangement prohibitions.

34-1.7 Exceptions from compensation arrangement prohibitions.
The following shall not be considered to be compensation arrangements subject to Public Health Law section 238-a(1)(a) or to section 34-1.3 of this Subpart:

(a) Rental of equipment: Payments made by a lessee of equipment to the lessor of the equipment for the use of the equipment, if:

(1) the lease is set out in writing, signed by the parties, and specifies the equipment covered by the lease;

(2) the equipment rented or leased does not exceed that which is reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the lessee when being used by the lessee;

(3) the lease provides for a term of rental or lease of at least one year;

(4) the rental charges over the term of the lease are set in advance, are consistent with fair market value, and are not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties; and

(5) the lease would be commercially reasonable even if no referrals were made between the parties.

(b) Bona fide employment relationships: Any amount paid by an employer to a physician (or an immediate family member of such physician) who has a bona fide employment relationship with the employer for the provision of services, if:

(1) the employment is for identifiable services;

(2) the amount of the remuneration under the employment

(i) is consistent with the fair market value of the services; and

(ii) is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician; and

(3) the remuneration is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the employer. Subparagraph (2)(ii) shall not prohibit the payment of remuneration in the form of a productivity bonus based on services performed personally by the physician (or an immediate family member of such physician).

(c) Personal service arrangements: Remuneration from an entity under an arrangement if

(1) the arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement;

(2) the arrangement covers all of the services to be provided by the physician (or an immediate family member of such physician) to the entity;

(3) the aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement;

(4) the term of the arrangement is for at least one year;

(5) the compensation to be paid over the term for the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties;

(6) the services to be performed under the arrangement do not involve the counseling or promotion or a business arrangement or other activity that violates any state or federal law.

(d) Payments by a physician for items and services: Payment made by a physician

(1) to a laboratory in exchange for the provision of clinical laboratory services, or

(2) to an entity as compensation for other items or services if the items or services are furnished at a price that is consistent with fair market value.

(e) Remuneration consisting of any of the following:

(1) the forgiveness of amounts owed for inaccurate tests or procedures, mistakenly performed tests or procedures, or the correction of minor billing errors;

(2) the provision of items, devices, or supplies that do not have any generally accepted use in health care practices other than to, and are actually used solely to

(i) collect, transport, process, or store specimens for the entity providing the item, device or supply, or

(ii) order or communicate the results of tests or procedures for such entity;

(3) a payment made by an insurer or a self-insured plan to a practitioner to satisfy a claim, submitted on a fee for service basis, for the furnishing of health services by that practitioner to an individual who is covered by a policy with the insurer or by the self-insured plan, if

(i) the health services are not furnished, and the payment is not made, pursuant to a contract or other arrangement between the insurer or the plan and the practitioner,

(ii) the payment is made to the practitioner on behalf of the covered individual and would otherwise be made directly to such individual, and

(iii) the amount of the payment is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account directly or indirectly the volume or value of any referrals.

(f) Payments for services furnished in an ambulatory surgical center or a chronic renal dialysis center facility issued an operating certificate pursuant to Article 28 of the Public Health Law, if payment for those services is included in a rate that is substantially similar or equivalent to the ambulatory surgical center (ASC) rate reimbursable by the Medicare Program pursuant to 42 CFR Part 416 Subpart E, or a rate substantially similar to the End Stage Renal Disease composite rate reimbursable by the Medicare Program pursuant to 42 CFR Part 413 Subpart H, respectively.

(g) Payments for services provided by a hospice licensed pursuant to Article 40 of the Public Health Law, if payment for those services is included in a rate that is substantially similar or equivalent to the per-diem hospice charge reimbursable by the Medicare program set forth in 42 CFR Part 418 Subpart G.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

SubPart 34-2 - Laboratory Business Practices

Effective Date: 
Wednesday, November 22, 2017
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, sections 586(3) and 587(6)

Section 34-2.1 - Title

34-2.1 Title.

This Subpart shall be known and cited as "Laboratory Business Practices".

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.2 - Definitions

34-2.2 Definitions. Whenever used in this Subpart, the following terms shall have the following meanings:

(a) Agent means an individual who agrees, pursuant to a written agreement with another, the principal, to act on behalf of, instead of, and subject to the authority and control of, the principal with regard to acts described in the agreement and to perform such acts with individual good faith, loyalty and fidelity to the principal.

(b) Clinical laboratory means a facility for the microbiological, immunological, chemical, hematological, biophysical, cytological, pathological, genetic or other examination of materials derived from the human body, for the purpose of obtaining information for the diagnosis, prevention or treatment of disease, or the assessment of a health condition, or for identification purposes. Such examinations shall include procedures to determine, measure, or otherwise describe the presence or absence of various substances, components or organisms in the human body. Clinical laboratory does not mean any facility or activity specifically excluded by section 579 of the Public Health Law.

(c) Clinical laboratory services means examinations, tests and/or analyses performed by a clinical laboratory.

(d) Consideration means anything of value or benefit, in cash or in kind.

(e) Contract for laboratory management services means a legally enforceable written agreement between a clinical laboratory under department permit and a hospital or a health maintenance organization, whereby the contracting clinical laboratory:

(1) agrees to provide laboratory management services at fair market value at a facility of a contracting hospital; or

(2) agrees to provide laboratory management services at fair market value at a facility of a contracting health maintenance organization; or

(3) agrees to provide clinical laboratory services at the laboratory’s facility, and directly related services, all at fair market value, pursuant to a referral by the contracting hospital or health maintenance organization.

(f) Department means the New York State Department of Health.

(g) Directly related equipment and supplies means equipment and supplies provided by a clinical laboratory to a referring health services purveyor of a size, type and quantity reasonably related to the type and number of specimens being referred by the health services purveyor to the clinical laboratory, and which are used by the referring health services purveyor solely and exclusively for the collection, processing, storage, preservation, transport, or disposal of specimens, and which have no generally accepted use in health care practices other than solely for the collection, processing, storage, preservation, transport, or disposal of specimens.

(h) Directly related services means the following services, which are or can be performed by a clinical laboratory and are integral to the clinical laboratory services performed on referred specimens:

(1) the collection, processing, storage, preservation, transport, acceptance, or disposal of referred specimens;

(2) the reporting of test results to the referring health services purveyor; or

(3) the receipt, storage and transmittal of information between the clinical laboratory and the health services purveyor necessary for test ordering, requisitioning, reporting or billing.

(i) Fair market value means that value, calculated in monetary terms and not by bartering, in arms length transactions, consistent with general market value. The fair market value of clinical laboratory services is deemed to include the value of directly related equipment and supplies, and directly related services. With respect to rentals or leases of property and space, fair market value shall be:

(1) consistent with the value of rental property for general commercial purposes, not taking into account the property's intended use; and

(2) not adjusted to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor, where the lessor is a potential source of patient referrals to the lessee.

(j) Financial relationship means an ownership interest, investment interest or compensation arrangement, as those terms are defined or used in Public Health Law sections 238 and 238-a.

(k) Functions directly related to clinical laboratory operations means functions which are necessary and integral to, and have as their sole and exclusive purpose, the operation of a clinical laboratory, and may include clinical laboratory services and directly related services.

(l) Governmental agency means a department, board, bureau, division, office, agency, public benefit or other corporation, or any other unit, however described, of a state or of a political subdivision of a state, or the federal government.

(m) Health maintenance organization (HMO) means an organization operating in accordance with article 43 of the Insurance Law or article 44 of the Public Health Law, and includes an agent of the health maintenance organization.

(n) Health or health related services includes, but is not limited to, items and services available under the New York State Medical Assistance Program (Medicaid).

(o) Health services purveyor (HSP) means any person, firm, partnership, group, association, business corporation, not-for-profit corporation, professional corporation, limited liability company, or any agent, employee, fiduciary, employer or representative thereof, including, but not limited to, an entity that provides health related services, a physician, dentist, podiatrist, chiropractor, either in individual practice, group practice or employed in a facility owned by any person, group, association, firm, partnership, business corporation, not-for-profit corporation, professional corporation, limited liability company, hiring any one of the aforementioned practitioners who provides health or health related services.

(p) Hospital means a facility or institution defined in Public Health Law section 2801(1).

(q) Immediate family member means any of the following, whether natural or adoptive: spouse; parent; child and sibling; stepparent, stepchild and stepsibling; father-in-law, mother-in-law, brother-in-law, sister-in-law, son-in-law and daughter-in-law; or grandparent and grandchild.

(r) Industrial firm means any employer, including, but not limited to:

(1) an agent of an employer; or

(2) an employer or employers who establish(es) or maintain(s) a single-employer or multi-employer employee benefit plan under the Employee Retirement Income Security Act of 1974 as amended (ERISA); or

(3) or an agent of an employee benefit plan.

(s) Insurance carrier includes, but is not limited to:

(1) an insurance carrier used by an employer; or

(2) the agent of an insurance carrier.

(t) Laboratory management services means some or all services necessary for the operation of a clinical laboratory, including but not limited to:

(1) directly related services; or

(2) services performed by a clinical laboratory employee, provided the services are directly related to clinical laboratory operations, and, provided that phlebotomy services, if rendered, are accompanied by actual clinical laboratory services by the laboratory providing the employee.

(u) Legal relative means an individual with legal authority to act on behalf of the recipient of services.

(v) Patient service center (PSC) is synonymous with collecting station or collecting depot, and means a facility, fixed or mobile, operated by a clinical laboratory for the collection, drawing and temporary storage of materials derived from the human body until such material is forwarded to a clinical laboratory for clinical laboratory services.

(w) Purveyor, as used in section 586 of the Public Health Law, means a clinical laboratory that does not receive from any health care practitioner or private medical practice having an ownership interest in the clinical laboratory any referrals for clinical laboratory services for patients of such health care practitioner or private medical practice. Notwithstanding any provision to the contrary, the term purveyor shall include any clinical laboratory owned by a hospital licensed pursuant to Article 28 of the Public Health Law or any clinical laboratory that is owned and operated by a publicly traded corporation.

(x) Residence means the location at which a test subject resides, whether on a temporary or permanent basis, and whether or not the living arrangement is voluntary, and is not necessarily the subject’s legal residence.

(y) Trade union health facility means:

(1) a facility owned and operated by trade union to provide health or health related services to its members or their families; or

(2) an agent of a trade union health facility.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.3 - Prohibited business practices by health services purveyors -- general

34-2.3 Prohibited business practices by health services purveyors -- general.

(a) No health services purveyor shall solicit, receive, accept, or agree to receive or accept any payment or other consideration from a clinical laboratory, or its agent, employee or fiduciary for the referral of specimens for the performance of clinical laboratory services.

(b) No health services purveyor shall participate in the division, transference, assignment, rebate, or splitting of fees with any clinical laboratory, or its agent, employee or fiduciary, or with any other health services purveyor, in relation to clinical laboratory services.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.4 - Prohibited business practices by clinical laboratories

34-2.4 Prohibited business practices by clinical laboratories.

(a) No clinical laboratory, its agent, employee or fiduciary shall make, offer, give, or agree to make, offer or give, any payment or other consideration to a health services purveyor for the referral of specimens for the performance of clinical laboratory services.

(b) No clinical laboratory, its agent, employee or fiduciary, shall participate in the division, transference, assignment, rebate, or splitting of fees with any health services purveyor, or with another clinical laboratory, in relation to clinical laboratory services.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.5 - Equipment, supplies and services

34-2.5 Equipment, supplies and services.

(a) The provision at less than fair market value of equipment and supplies by a clinical laboratory to a health services purveyor is prohibited, except that a clinical laboratory may offer to provide, and a referring health services purveyor may accept, directly related equipment and supplies.

(b) A clinical laboratory may offer to perform, and a referring health services purveyor may accept, directly related services, unless prohibited by this Subpart.

(c) Any equipment and supplies provided to a health services purveyor by a clinical laboratory, which is used in a manner prohibited by this Subpart and which is in the possession of the health services purveyor at the time this Subpart becomes effective, shall be returned to the clinical laboratory by the health services purveyor or reclaimed by the clinical laboratory within sixty (60) days of the effective date of this Subpart.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.6 - Space

34-2.6 Space.

(a) The rental of space by a clinical laboratory from a referring health services purveyor, or an immediate family member of such purveyor, for more than fair market value, or under circumstances where the rental amount is affected by the volume or value of tests ordered by the health services purveyor shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(b) The rental of space by a clinical laboratory from a referring health services purveyor for storage of supplies provided by the laboratory to the health services purveyor shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(c) The location of a PSC by a clinical laboratory, within or sharing space in any part of the practice, administrative, office or waiting area of any health services purveyor that refers specimens to the clinical laboratory, shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(d) A PSC may be located in a building in which a health services purveyor that refers specimens to the clinical laboratory operating the PSC has a direct or indirect ownership, investment or leasehold interest, under the following circumstances:

(1) the PSC is the subject of a signed written lease, available to the department, which conforms to the requirements of Public Health Law section 238-a(5)(b)(i)(A) and implementing regulations; and

(2) the PSC is open to and actually serves the general public and operates independently from the health services purveyor, and meets all of the following criteria:

(i) the PSC actually collects a substantial number of specimens from patients of other health services purveyors which do not have a direct or indirect financial relationship with a referring health service purveyor who has an ownership, investment or leasehold interest in the building;

(ii) the PSC has its own entrance, exit, and waiting area, except that the PSC may use a waiting area that is generally shared by all tenants or occupants of the building or an entire floor of the building, provided there are two or more tenants renting separate office spaces who are not referring health services purveyors;

(iii) the PSC is identified on signs, consistent with signage of other tenants or occupants, on the outside of the building and within the building;

(iv) the PSC has its own telephone line, separate and distinct from that of any referring health services purveyor, and telephone listings for the clinical laboratory include the PSC's telephone number;

(v) advertisements and other public notices by the clinical laboratory list the address and telephone number of the PSC;

(vi) the hours the PSC is open are independent and not restricted to the hours of one or more referring health services purveyors in the building; and

(vii) the PSC patients of health services purveyors not located in the building have access to a restroom other than those of health services purveyors in the building.

(e) A clinical laboratory shall, within sixty (60) days from the effective date of this Subpart, bring any PSC which it operates at locations as described in subsection (d) of this section, into compliance with the requirements of paragraphs (d)(1) and (2) of this section, or shall cease operation of the PSC. However, a clinical laboratory may request in writing to the department an extension of time for complying with this Subpart with respect to a PSC. Such request shall be made within thirty (30) calendar days from the effective date of this Subpart, shall state the reason(s) that the PSC cannot be brought into compliance with the requirements of this Subpart, and shall document a plan of correction acceptable to the department. The department may extend the grace period granted pursuant to this subdivision for a period not to exceed one hundred eighty (180) days from the effective date of this Subpart.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.7 - Employees

34-2.7 Employees.

(a) Except as provided in subdivision (b) below, employees, agents or other fiduciaries of any clinical laboratory, when supplied by the clinical laboratory to a referring health services purveyor to perform functions and duties in the facility of the health services purveyor, shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(b) Nothing in Public Health Law section 587 or in this Subpart shall be construed as prohibiting a hospital or an HMO and a clinical laboratory from entering into a contract for laboratory management services, including provision of technical services and employees for the performance of functions directly related to clinical laboratory operations.

(c) Payment or reimbursement by a clinical laboratory to a health services purveyor for clinical laboratory services and/or directly related services, which had been rendered by the health services purveyor or such purveyor's employees, agents or fiduciaries, shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited. However, a clinical laboratory may enter into a written contract with a hospital, HMO or another clinical laboratory for the provision of phlebotomy services, clinical laboratory services, or directly related services to the contracting clinical laboratory, provided such services are rendered at fair market value and not in connection with individuals who are patients or clients of the hospital, HMO or other clinical laboratory.

(d) Nothing in this Subpart shall prohibit the employees, agents or fiduciaries of a clinical laboratory from visiting a residence for the purpose of drawing blood, or otherwise obtaining or collecting specimens, provided that:

(1) such visits shall not result in a substantially permanent presence and shall be established according to a schedule, available in the laboratory, or upon specific request of the health care provider or other authorized person responsible for care of the patient, and documented by the laboratory; and

(2) while at the residence, the employees, agents or fiduciaries of the laboratory do not provide any supplies, services or assistance, directly or indirectly, to the operators, nursing or medical staff or other individuals other than as stated in this Subpart; and

(3) during such visits, the activities of the employees, agents or fiduciaries of the laboratory are limited to:

(i) reviewing the orders for laboratory tests from the patient's health services purveyor, without reviewing the patient’s chart;

(ii) scheduling the collection of specimens for future tests, without reviewing the patient’s chart;

(iii) collecting specimens;

(iv) labeling the collected specimens;

(v) recording the number and kinds of specimens collected;

(vi) taking steps necessary to ensure that the test requisition forms are properly completed pursuant to orders from the patient's health care provider;

(vi) centrifuging blood specimens;

(vii) causing adequate and sanitary equipment and supplies to be maintained, when appropriate, at a residence, solely for the collection, preservation and transport of specimens; and

(viii) taking steps necessary to ensure the integrity of specimens which are stored, when appropriate, at a residence awaiting transport to the clinical laboratory; and

(4) no rent is paid by the clinical laboratory for the storage of equipment and supplies or specimens, or for any other purpose.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.8 - Professional courtesy

34-2.8 Professional courtesy.

The provision of clinical laboratory services by a clinical laboratory for health services purveyors, their families, or their employees, agents, or fiduciaries at a charge which is below the lower of the applicable Medicare fee schedule amount or the national limitation amount as defined by the Medicare program for such services is consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.9 - Computers

34-2.9 Computers.

(a) The provision, at less than fair market value, of computers, including hardware, hard drives, or monitors; or of computer equipment or supplies such as stands, tables, printers, printer stands, interfacing telephone lines, or modems; or of software, by a clinical laboratory to a health services purveyor, is prohibited, except as stated below.

(b) Nothing in Public Health Law section 587 or in this Subpart shall be construed to prohibit a clinical laboratory from providing a computer, computer equipment, computer supplies and/or software, and/or developing and providing software, to a health services purveyor, under the following circumstances:

(1) the computer, computer equipment, computer supplies and/or software are solely and exclusively used for, and are solely and exclusively dedicated to, enabling the health services purveyor to:

(i) make referrals of specimens for the performance of clinical laboratory services to the clinical laboratory; or

(ii) receive, access, print and/or store test results from the clinical laboratory, including cumulative test results concerning a particular patient, and including test related information stored by the clinical laboratory; or

(iii) transmit data to the clinical laboratory necessary for preparation of laboratory requisition forms and/or billing invoices; or

(iv) transfer laboratory related data from the clinical laboratory to any computer system maintained by the health services purveyor; and

(2) the clinical laboratory takes reasonable steps to ensure that the computer, computer equipment, computer supplies and/or software are solely and exclusively used as set forth in this Subpart; and

(3) the clinical laboratory reasonably monitors the use of the computer, computer equipment, computer supplies and/or software; and

(4) ownership of the computer, computer equipment, computer supplies and/or software remains in the clinical laboratory; and

(5) the clinical laboratory is responsible for all repair and maintenance of the computer, computer equipment and/or software; and

(6) the clinical laboratory maintains reasonable documentation that the computer, computer equipment, computer supplies and/or software is being used solely and exclusively as set forth in this Subpart.

(c) Nothing in Public Health Law section 587 or in this Subpart shall be construed to prohibit a general hospital licensed pursuant to Article 28 of the Public Health Law from providing a computer, computer equipment, computer supplies and/or software to a health services purveyor to facilitate the delivery of clinical laboratory services and health services to inpatients and outpatients of the general hospital, including, but not limited to, records access, patient admission, outpatient or inpatient service scheduling, and clinical laboratory service authorization, provided that the health services purveyor is a staff member or has professional privileges at the general hospital.

(d) Any computer, computer equipment, computer supplies and/or software provided to a health services purveyor in a manner prohibited by this Subpart, and which is in the possession of the health services purveyor at the time this Subpart becomes effective, shall be:

(1) returned to the clinical laboratory by the health services purveyor or reclaimed by the clinical laboratory within sixty (60) days of the effective date of this Subpart; or

(2) brought into compliance with this Subpart within sixty (60) days of the effective date of this Subpart.

Effective Date: 
Wednesday, December 26, 2001
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Section 34-2.10 - Waste disposal

34-2.10 Waste disposal.

The disposal or payment for disposal by a clinical laboratory for a health services purveyor of hazardous waste, radioactive waste and/or regulated medical waste shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.11 - Recall letters and reporting of test results

34-2.11 Recall letters and reporting of test results. 

(a) A clinical laboratory shall not communicate to a patient of a referring health services purveyor that a clinical laboratory test, including, but not limited to a Pap smear, is or will be due to be performed, or that a visit to the health services purveyor for diagnosis or treatment is or will be due. A clinical laboratory shall not prepare such communication for the health services purveyor to send, or otherwise facilitate the preparation or sending of such communication by the health services purveyor. Such communication or its facilitation shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(b) A clinical laboratory shall not communicate to a patient of a referring health services purveyor the results of a clinical laboratory test, including, but not limited to, a Pap smear. A clinical laboratory shall not prepare such communication for the health services purveyor to send, or otherwise facilitate the preparation or sending of such communication by the health services purveyor. Such communication or its facilitation shall be deemed consideration given for referral of specimens for performance of clinical laboratory services and is prohibited, except that:

(1) a clinical laboratory may communicate in writing to the patient (by mail or electronically) an accurate and complete account of the result of the laboratory test along with information required to be included in a report of test results pursuant to Subpart 58-1 of this Title under the following circumstances:

(i) the laboratory test results have already been, or are simultaneously being communicated to the referring health services purveyor authorized by law to order and use the results of laboratory tests;

(ii) the clinical laboratory advises the patient that the referring health services purveyor authorized by law to order and use the results of laboratory tests has received or is receiving the test results;

(iii) the clinical laboratory shall include, in the communication to the patient, a clear statement, presented in a prominent manner, to the effect that the communication should not be viewed as medical advice and is not meant to replace direct communication with a physician or other health service purveyor; 

(iv) the clinical laboratory directs the patient's inquiries regarding the meaning or interpretation of the test results to the referring health services purveyor; and

(v) the communication to the patient does not include any information which would be consideration given for referral of specimens, including, but not limited to, medical advice specifically directed at the patient concerning the patient’s condition, including diagnosis or treatment of the patient’s condition. 

(2) nothing in this subdivision shall prohibit a licensed physician from communicating with a patient:

(i) when requested by the referring health services purveyor;

(ii) when requested by the patient; or

(iii) when the referring health services purveyor, or other health services purveyor responsible for using the test results, cannot be reached and a critical value needs to be communicated to the patient.

Effective Date: 
Wednesday, November 22, 2017
Doc Status: 
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Section 34-2.12 - Waiver of co-payments, co-insurance, deductibles and fees

34-2.12 Waiver of co-payments, co-insurance, deductibles and fees.

(a) Routine waiver by a clinical laboratory of co-payments, co-insurance, or deductibles for clinical laboratory services performed for recipients of such services who are patients of a referring health services purveyor shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(b) Waiver of fees for clinical laboratory services for the patients of a referring health services purveyor who are enrolled in an HMO by a clinical laboratory which is not a participating laboratory of the HMO, where such waiver results in consideration being received by the referring health services purveyor, shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(c) Nothing in Public Health Law section 587 or in this Subpart shall be construed to prohibit a clinical laboratory from:

(1) waiving a co-payment, co-insurance, deductible, or fee for a particular patient based on the patient's inability to pay, in which case the clinical laboratory shall maintain a record documenting the patient's inability to pay; or

(2) waiving a co-payment, co-insurance, deductible or fee, if the cost of collection is greater than the amount to be collected.

(d) Nothing in Public Health Law section 587 or in this Subpart shall be construed to prohibit a clinical laboratory from offering a discount to a referring health services purveyor provided that:

(1) the health services purveyor appropriately reflects the discount on any costs or charges reported and/or claimed by the health services purveyor under any third party reimbursement program; and

(2) the discounted price is consistent with fair market value; or

(3) the discounted price reflects a volume discount, whereby the amount of the discount is reasonably related to costs saved by the clinical laboratory.

Effective Date: 
Wednesday, December 26, 2001
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Section 34-2.13 - Direct billing

34-2.13 Direct billing.

(a) Nothing contained in Public Health Law section 586 or this Subpart shall be construed to prohibit a clinical laboratory from sending a bill to or receiving payment for clinical laboratory services from the health services purveyor who ordered the clinical laboratory services, provided that:

(1) the clinical laboratory receives the name and/or other information relating to the test subject if the clinical laboratory is obligated to report such name and/or other information to the state or a local health department under state law or regulation;

(2) the bill for the clinical laboratory services shall be directed to the test subject or a payor expressly permitted by Public Health Law section 586 or this Subpart;

(3) the amount of the bill for clinical laboratory services shall be disclosed to the test subject or a payor expressly permitted by Public Health Law section 586 or this Subpart, and documentation of the disclosure shall be maintained by the health services purveyor who ordered the clinical laboratory services;

(4) if payment is made for the clinical laboratory services to the health services purveyor who ordered the clinical laboratory services, the payment amount must be equal to the amount stated in the clinical laboratory bill; and

(5) one of the following situations must apply:

(i) the cost of the clinical laboratory service is included in the usual and customary purchase price of a test kit that is approved by the federal Food and Drug Administration to be commercialized as a test kit that includes a collection device, specimen transport materials, and the clinical laboratory service; or

(ii) the clinical laboratory services are performed in relation to: a termination of pregnancy; testing for a sexually transmissible disease; HIV-related testing; drug abuse screening; or other tests specifically approved by the department where law or regulation recognizes the need for a heightened level of confidential protection of health information relating to the test subject.

Effective Date: 
Wednesday, December 26, 2001
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Section 34-2.14 - Financial relationship

34-2.14 Financial relationship. A financial relationship between any entity and a referring health services purveyor, or any immediate family member of a referring health services purveyor, which relationship was secured or facilitated either directly or indirectly by or through the efforts of a clinical laboratory, shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
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Section 34-2.15 - Loans

34-2.15 Loans. Any loan for the benefit of a referring health services purveyor or for the benefit of any immediate family member of such purveyor, which was secured or facilitated either directly or indirectly by or through the efforts of a clinical laboratory shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete

Section 34-2.16 - Compliance

34-2.16 Compliance. It is the responsibility of the clinical laboratory and the health services purveyor to establish, including by appropriate documentation, that any practice between the two entities complies with this Subpart. Upon request from the department, the health services purveyor and/or the clinical laboratory shall make such documentation available for inspection and copying. If requested by the clinical laboratory, such documentation shall be eligible for exemption from disclosure under the Freedom of Information Law (article 6 of the Public Officers Law), pursuant to the authority in section 89(5) of the Public Officers Law.

Effective Date: 
Wednesday, December 26, 2001
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Section 34-2.17 - Exclusions

34-2.17 Exclusions. Any payment or billing transaction authorized by the direct billing law (see Public Health Law section 586) shall not be rendered illegal by any provisions of Public Health Law section 587 or this Subpart.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
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Part 35 - Vital Records

Effective Date: 
Wednesday, October 23, 2013
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 413-b-c, 4173, 4174

Section 35.1 - Searches and certifications without fees

Section 35.1 Searches and certifications without fees. The New York State Department of Health shall make searches and issue certifications and certified copies of birth, death, and marriage records without charge to:

(a) local or State organizations of war veterans in connection with claims for soldiers' burial fees, markers for soldiers' graves, and securing relief for veterans or their families;

(b) applicants for enlistment in the U.S. armed services or the merchant marine:

(c) persons of any age filing applications with the State employment bureau;

(d) persons residing in Canada applying to Canadian authorities for public relief or veterans' claims, providing the province of Canada in which applicant resides furnishes similar information gratis to persons residing in the United States;

(e) children under the age of 16--limited to certifications of birth;

(f) persons who were either adopted or whose paternity was established by law, limited to a certification of birth or certificate of birth registration made out in the name by which the person is designated in the adoption or filiation papers at the time a new birth certificate is prepared pursuant to section 4138 of the Public Health Law;

(g) State or municipal departments for official purposes.
 

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Section 35.2 - Birth records; confidential information

35.2 Birth records; confidential information.

(a) A certified copy or a certified transcript of a birth certificate shall be issued only:

(1) upon order of a court of competent jurisdiction;

(2) upon specific request by the person, if 18 years of age or more, or by a parent or other lawful representative of the person to whom the record of birth relates; or

(3) upon specific request therefor to the Commissioner of Health of the State of New York by municipal, state or federal agencies when needed for official purposes.

(b) A certification of birth shall be issued when required for a proper purpose. A proper purpose shall not exist when the record is requested for commercial or profit-making purposes or to satisfy idle curiosity.

(c) The confidential information for medical and health use only furnished with a certificate of live birth shall not be copied and shall be detached except as herein provided. Data thereon, as determined by the State Commissioner of Health, shall be recorded on appropriate storage media for scientific research only. Following such recording the portion containing such confidential information shall be detached from the original certificate by the State Commissioner of Health or other person authorized by him who shall then destroy such portion. No copy of a certificate issued pursuant to sections 4173 and 4174 of the Public Health Law shall contain such information.

(d) The request for a certified copy of a birth certificate, a certified transcript of a birth certificate or a certification of birth shall include such documentation required by the State Health Commissioner to establish the stated need.
 

Effective Date: 
Wednesday, April 5, 1989
Doc Status: 
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Section 35.3 - Fetal death; confidential information

35.3 Fetal death; confidential information.

(a) The information contained on a fetal death certificate shall be disclosed by the State Commissioner of Health only to the mother,her lawful representative, and to authorized personnel of the Department.

(b) The confidential information for medical and health use only furnished with a fetal death certificate shall not be copied and shall not be detached except as herein provided. Data thereon, as determined by the State Commissioner of Health shall be recorded on appropriate storage media for scientific, medical and health research only. Following such recording, the portion containing such confidential information shall be detached from the original certificate by the State Commissioner of Health or other person authorized by him who shall then destroy such portion. No copy of a certificate issued pursuant to sections 4173 and 4174 of the Public Health Law shall contain such information.
 

Effective Date: 
Wednesday, April 5, 1989
Doc Status: 
Complete

Section 35.4 - Death records; disclosure

35.4 Death records; disclosure.

(a) No certified copy or certified transcript of a death certificate shall be subject to disclosure under article six of the Public Officers Law.

(b) A certified copy of a death certificate or a certified transcript of a death certificate shall be issued only:

(1) pursuant to the order of a court of competent jurisdiction on a showing of necessity, or

(2) upon specific request of the spouse, sibling, children, or parents of the deceased or the lawful representative of such persons, or

(3) when a documented need to establish a legal right or claim has been demonstrated, or

(4) when a documented medical need has been demonstrated, or

(5) upon specific request by municipal, state or federal agencies for statistical or official purposes, or

(6) when needed for medical or scientific research approved by the State Health Commissioner, and

(7) when needed for statistical or epidemiological purposes approved by the State Health Commissioner.

(c) Commencing on January 1, 1988 all death certificate forms shall contain a confidential section which shall list the cause and circumstances of the death. When a certified copy of a death certificate or a certified transcript of death certificate is issued, the confidential section shall be detached and no information from that section shall be disclosed in any other form or manner, except:

(1) pursuant to the order of a court of competent jurisdiction on a showing of necessity, or

(2) upon specific request for such information by the spouse, children, or parents of the deceased or the lawful representative of such persons, or

(3) when a documented medical need for such information has been demonstrated, or

(4) when a documented need for such information for the purpose of establishing a legal right or claim has been demonstrated, or

(5) upon specific request for such information by municipal, state or federal agencies for statistical or official purposes, or

(6) when such information is needed for medical or scientific research approved by the State Health Commissioner,

(7) when such information is needed for statistical or epidemiological purposes approved by the State Health Commissioner.

(d) A certification of death containing only the name, the date of death and the place of death of the person to whom it relates shall be issued when required for a proper purpose. A proper purpose shall not exist when the record is requested for commercial or profit-making purposes or to satisfy idle curiosity.

(e) The request for a certified copy of a death certificate, a certified transcript of a death certificate or a certification of death shall include such documentation required by the State Health Commissioner to establish the stated need.
 

Effective Date: 
Wednesday, October 23, 2013
Doc Status: 
Complete

Section 35.5 - Genealogical research; method of disclosure; searches

35.5 Genealogical research; method of disclosure; searches.

(a) Information from records of birth, death and marriage may be provided for genealogical research purposes, subject to the restrictions of this Part, in the form of an uncertified copy or abstract upon written application and payment of the applicable statutory fees, which are contained in Public Health Law, sections 4173 and 4174 and Domestic Relations Law, sections 19 and 20-a. If a search discloses no record, the applicant shall be required to pay the specified fee for the time spent for the search for the record and for a certification that the search disclosed no record. Information will not be released if it is to be used for commercial or profitmaking purposes.

(b) Records searches shall be conducted only by the following persons in the files maintained by their respective agencies:

(1) authorized employees of the Department of Health;

(2) a local registrar, deputy registrar, or an authorized employee of the registrar; and

(3) a town or city clerk, deputy clerk, or an authorized employee of the town of city clerk.

(c) Information may be released subject to the following limitations:

(1) no information shall be released from a record of birth which has been placed in a confidential file pursuant to Public Health Law, section 4138;

(2) no information shall be released from a record of birth unless the record has been on file for at least 75 years and the person to whom the record relates is known to the applicant to be deceased;

(3) no information shall be released from a record of death unless the record has been on file for at least 50 years; and

(4) no information shall be released from a record of marriage unless the record has been on file for at least 50 years and the parties to the marriage are known to the applicants to be deceased.

(d) The time periods specified in paragraphs (2), (3) and (4) of subdivision (c) of this section are waived if the applicant is a descendant or has been designated to act on behalf of a descendant of the person whose record is being requested. A descendant is a person in the direct line of descent such as a son, daughter, grandson or granddaughter. The applicant shall provide documentation of descendancy prior to the release of information in those instances where a waiver of the waiting period is requested. A party acting on behalf of a descendant shall further provide documentation that the descendant authorized the party to make such application.

(e) All uncertified copies, abstracts or information issued for genealogical research purposes shall be clearly marked with the statement "for genealogical purposes only."
 

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Section 35.6 - Adoption Information Registry

35.6 Adoption information registry.

(a) All registrations, records and information of the Adoption Information Registry, as established pursuant to section 4138-c of the Public Health Law, shall be filed and stored within the department with the Adoption Information Registry. Such filing and storage areas shall be clearly set off and physically separate from other areas and, except to the extent necessary for the proper function of the registry, access thereto shall be restricted to employees designated by the commissioner.

(b) The records and information of the Adoption Information Registry, except to the extent necessary for the proper function of the registry, shall not be transported or removed from the designated area within the Department of Health assigned for the operation of the Adoption Information Registry.

(c) Where an adoptee registrant registers directly with the department and requests the department to have nonidentifying information released either by the department or the authorized agency involved in the adoption, such agency shall be entitled to a service fee not exceeding $50 to be paid by the adoptee registrant directly to such agency for the review, compilation and forwarding of the nonidentifying information. The authorized agency, upon receipt of such request from the department and fee from the adoptee registrant, shall provide the nonidentifying information to either the department or the adoptee registrant as directed by the department.

(d) An authorized agency which maintains a mutual-consent voluntary adoption registry shall be entitled to a registration/a service fee for the registration, and a registration/a service fee for the services related to the processing of requests for information, according to the following schedule:

(1) Where an adoptee, a biological sibling of an adoptee or biological parent is registered directly with an agency, the agency shall be entitled to a registration fee not exceeding $20.

(2) Where the agency which was involved in the adoption provides nonidentifying information to an adoptee or the biological sibling of the adoptee, the agency shall be entitled to a service fee not exceeding $50, in addition to the registration fee.

(e) The verified registration by an adoptee, the adoptive parents of an adoptee under the age of 18 for the purpose of receiving medical information updates, the biological sibling of an adoptee or the biological parents of an adoptee whose consent to the adoption was required at the time of the adoption, or whose signature was required on an instrument of surrender to an authorized agency, as specified in sections 4138-c and 4138-d of the Public Health Law, shall be in the form that shall be prescribed by the commissioner.

(f) The recording and forwarding of the nonidentifying information to the Adoption Information Registry, as specified in section 4138-c of the Public Health Law, shall be in the form that shall be prescribed by the commissioner.

(g) Any person who discloses any information in the adoption registry unlawfully shall be guilty of a class A misdemeanor pursuant to section 4138-c(7)(b) of the Public Health Law.

(h) Any authorized agency which establishes a mutual-consent voluntary adoption registry shall inform the Department of Health, Adoption Information Registry, by certified mail, of the establishment of such registry on the form prescribed by the commissioner.

(i) Any authorized agency which maintains a mutual-consent voluntary adoption registry, upon registering a person and making a determination that the agency was involved in such adoption, shall promptly forward a copy of the registration form to the Adoption Information Registry of the Department of Health, indicating on the face of the form that such agency was involved in the adoption and shall provide other information as requested by the department. (j) Any authorized agency which maintains a mutual-consent voluntary adoption registry, upon registering a person and making a determination that the agency was not involved in the adoption, shall promptly forward a copy of the registration form to the Adoption Information Registry of the Department of Health, indicating on the face of the form that such agency was not involved in the adoption and shall provide other information as requested by the department.

(k) Any authorized agency which has not established a mutual-consent voluntary adoption registry, upon receipt of a request to register with such agency, shall refer such person to the Adoption Information Registry of the Department of Health.

(l) An authorized agency is an agency as defined by New York Social Services Law, sections 371(10)(a) and 371(10)(b).
 

Effective Date: 
Wednesday, July 12, 2000
Doc Status: 
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Section 35.7 Reserved

Section 35.8 - Birth and Death Certification; Form and Content

35.8 Birth and death certification; form and content.
(a) The signature of those persons executing, authenticating or filing such certificates may be constructed digitally for Certificates of Birth and Death prepared in the electronic format provided by the commissioner.
(b) A digital signature means the creation by the computer of an electronic identifier which the commissioner determines is:
(1) unique to the signer;
(2) capable of verification;
(3) under the signer's control; and
(4) linked to data in such a manner that if the data is changed, the signature is invalidated.

Effective Date: 
Wednesday, April 8, 1998
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Section 35.9 Reserved

Section 35.10 Reserved

Section 35.11 Reserved

Section 35.12 Reserved

Section 35.13 Reserved

Section 35.14 Reserved

Section 35.15 - Wallet-size certification of birth; fee

35.15 Wallet-size certification of birth; fee. Each applicant for a wallet-size certification of birth shall remit to the commissioner with such application a fee of fifteen dollars in payment for the search of the files and records and the furnishing of the wallet-size certification if such record is found or for a certification that a search discloses no record of a birth.

Effective Date: 
Wednesday, January 24, 1990
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Part 36 - Delayed Registration Of An Unrecorded Birth

Doc Status: 
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Statutory Authority: 
Public Health Law, Section 391

Section 36.1 - Definitions

GENERAL PROVISIONS

Section 36.1 Definitions.

(a) Delayed registration of birth is the registration of a birth one year or more after its occurrence.

(b) A supporting affidavit is a sworn statement substantiating the facts entered on the birth certificate.

(c) A written record is one which confirms the facts entered on the birth certificate.
 

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Section 36.5 - Certificate made by attendant at birth

MAKING OF CERTIFICATES

36.5 Certificate made by attendant at birth. If the physician or licensed midwife who attended the birth is alive and can be located, the certificate shall be made by such physician or licensed midwife.
 

Effective Date: 
Wednesday, May 31, 2000
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Section 36.6 - Certificate made by parent

36.6 Certificate made by parent.

If the physician or midwife who attended the birth has died or cannot be located, or if the birth was not attended professionally, the certificate of birth shall be made by one of the parents.
 

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Section 36.7 - Making of the certificate of birth in all other cases

36.7 Making of the certificate of birth in all other cases. If the physician or midwife who attended the birth has died or cannot be located and if neither of the parents can be conveniently reached or if both parents have died, the following procedure should apply:

(a) If the person whose birth it is desired to register is under 18 years of age, the certificate shall be made by the guardian of such person.

(b) If the person whose birth it is desired to register is 18 years of age or over, the certificate shall be made by that person.
 

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Section 36.10 - Official certification that record of birth is not on file required

SUPPORTING DOCUMENTS
36.10 Official certification that record of birth is not on file required. Each application for the delayed registration on an unrecorded birth shall be accompanied by a statement issued either by the local registrar of the community where the birth is believed to have occurred or by the State Department of Health to the effect that a search of the records has been made and that no record bearing the name of the person whose birth is to be recorded was found.

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Section 36.11 - Proof required in support of application for delayed registration of an unrecorded birth

36.11 Proof required in support of application for delayed registration of an unrecorded birth. The following supporting proof, or such proof as may in the opinion of the commissioner be considered the equivalent thereof, shall be submitted by an applicant for delayed registration of birth:

(a) Persons under 12 years of age. If the person whose birth it is desired to register is under 12 years of age, the supporting proof shall consist of one document, such as a hospital record of the birth, a baptismal certificate, a church or synagogue record, a school entrance certificate, or a census record, provided that such document shows the name of the person whose birth is to be registered, the date of birth, place of birth and the names of the parents. In the event that such document is not available, the supporting proof may consist of an affidavit by a competent person who has personal knowledge of the date and place of birth and the names of the parents of the person whose birth it is desired to record. If the certificate of birth submitted for delayed registration is signed by a parent, and an affidavit is submitted as supporting proof, such affidavit shall be made by some person outside the immediate family of the person whose birth is desired to register.

(b) Persons over 12 but under 18 years of age. If the person whose birth it is desired to register is over 12 but under 18 years of age, the application for such delayed registration shall be supported by two written records or certified copies thereof, other than affidavits, made at least five years prior to the date of application, showing the name, date and place of birth and the names of the parents of such person.

(c) Persons over 18 years of age; certificate signed by parent. If the person whose birth it is desired to register is 18 years of age or over, and if the certificate of birth submitted for delayed registration is signed by one of the parents, the application shall be supported by two written records or certified copies thereof, as follows:

(1) At least one of these records shall show the name, date of birth, place of birth, and names of the parents of such person, which record shall have been originally made when the person was a minor upon information furnished by a person other than the person whose birth it is desired to register.

(2) The other written record, not an affidavit, shall have been made at least five years prior to the date of application and shall show the name, the place of birth, the date of birth, and the names of the parents of such person.

(d) Persons over 18 years of age; certificate signed by such person. If the person whose birth it is desired to register is 18 years of age or over, and if the certificate of birth submitted for delayed registration is signed by such person, the application shall be supported by three written records, or certified copies thereof, as follows:

(1) At least one written record shall show the name, date of birth, place of birth, and names of the parents of such person, which record shall have been originally made when the person was a minor upon information furnished by a person other than the person whose birth it is desired to register.

(2) The other two written records shall have been made at least five years prior to the date of application and shall show the name, the place of birth, the date of birth, and the names of the parents of such person; only one of these may be an affidavit by a competent person who was old enough at the time the birth occurred to have personal knowledge of the date and place of birth and the names of the parents.
 

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Part 37 - Handling Of Bodies Of Persons Dying On Common Carriers

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Statutory Authority: 
Public Health Law, Section 375

Section 37.1 - Removal of body

Section 37.1 Removal of body.

A special stop may be made by a common carrier for the purpose of removing a body, but, in any event, it shall be removed at the first regular stop where an attendant is on duty and where there are known to be facilities for handling the corpse.
 

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Section 37.2 - Investigation of death; preparation of death certificate

37.2 Investigation of death; preparation of death certificate. A physician accompanying a person who dies on a common carrier, or a physician who is traveling on the same carrier who is called to give medical aid, may certify to the cause of death and sign the certificate as the physician last in attendance on the deceased. If death occurs without medical attendance, the coroner of the county or, if there be more than one, the coroner having jurisdiction of the district in which the body is removed, or the medical examiner or, in the County of Erie, the medical director, shall be notified and shall certify to the cause of death and sign the certificate.

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Section 37.3 - Registration district

37.3 Registration district.

The name of the registration district in which a body is removed from a common carrier shall be entered on the certificate of death as the place of death.
 

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Section 37.4 - Burial or transit permit

37.4 Burial or transit permit.

Upon receipt of a certificate of death, which shall be filed by the undertaker engaged, or the person in charge of the body, the registrar of vital statistics of the district in which the body has been removed from a common carrier shall issue a burial or transit permit.
 

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Part 38 - Information Obtained Under Provisions Of State Or Federal Laws

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Statutory Authority: 
Public Health Law, Section 19-d

Section 38.1 - Confidential information

Section 38.1 Confidential information.

(a) Definition; restricted use. All information as to personal facts and circumstances in the Maternal and Child Health and Crippled Children's Programs shall be considered privileged communications and shall be held confidential, and:

(1) except only in summary, statistical or other form which does not identify particular individuals; and

(2) except as may be necessary to provide services to individual mothers and children; such records shall not be divulged without the consent of the patient, parent or guardian.

(b) Application; limitation. This section shall apply to State, municipal, private and voluntary agencies. Information divulged to such agencies shall be confined to that necessary to achieve the specific purpose involved and shall be released only after appropriate assurances are received that the information will be held confidential in accordance with the provisions of this section.
 

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SubChapter B - State Aid and Funding

Effective Date: 
Wednesday, November 23, 2016
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Complete

Part 39 REPEALED

Effective Date: 
Wednesday, December 31, 2014

Part 40 - State Aid For Public Health Services: Counties And Cities

Effective Date: 
Wednesday, November 23, 2016
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, art. 6

SubPart 40-1 - Application and Payment

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.0 - Applications for State aid

Section 40-1.0 Applications for State Aid

(a) To be eligible for State Aid, local health departments shall annually submit to the department a detailed application for State Aid in a form specified by the commissioner.

(b) Each local health department shall submit its application for State Aid to the department no later than two months after the commencement of the fiscal year for which it is seeking State Aid.

(c) The application for State Aid shall include:
(1) an organizational chart of the local health agency and a list of the number of employees by job title providing public health services;

(2) a budget of proposed expenditures; (3) a description of how the local health department will provide public health services in a form determined by the commissioner;

(4) an attestation by the chief executive officer of the municipality that sufficient local funds have been appropriated to provide the public health services for which the local health department is seeking State Aid; (5) an attestation by the public health commissioner or director that the local health department has exercised due diligence in reviewing the State Aid application and that the application seeks State Aid only for eligible public health services; (6) a list of public health services provided by the local health department that are not eligible for State Aid, and the cost of each service; (7) a projection of the fees and revenues to be collected for public health services eligible for State Aid; and (8) any other information or documents required by the commissioner.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.10 - Performance and accountability; reporting

Section 40-1.10 Performance and accountability; reporting

(a) The commissioner shall establish, in consultation with the local health departments and the New York State Association of County Health Officials, uniform statewide performance standards for the services funded pursuant to Article 6 of the Public Health Law; provided, however, that upon request the commissioner may approve a modification of a specific standard for a local health department if such local health department demonstrates adequate justification. The commissioner shall recognize the particular needs and capabilities of the various local health departments. The commissioner shall monitor the performance and expenditures of each local health department to ensure that each one satisfies the performance standards.

(b) The commissioner shall establish, in consultation with the local health departments and the New York State Association of County Health Officials, a uniform accounting system for monitoring the expenditures for services of each local health department to which aid is granted and the amount of state aid received including any performance payments pursuant to section six hundred nineteen-a of Article 6 of the Public Health Law. Such reporting system shall require information on the amount of public health moneys received from the federal government, the private sector, grants, and fees.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.20 - Personnel

Section 40-1.20 Personnel

(a) Local health department personnel must meet the entry and supervisory level qualifications established by Part 11 of the State Sanitary Code (10 NYCRR Part 11), as applicable.

(b) All public health services shall be supervised by a local commissioner of health or public health director, to ensure that such services are provided in accordance with the approved State Aid application. Such supervising official shall devote his or her entire time to public health duties, provided that:

(1) such official may serve as the head of a merged agency or multiple agencies if the approval of the commissioner is obtained; or

(2) such official may serve as the local commissioner of health or public health director of additional counties when authorized pursuant to section 351 of the public health law.

(c) All local health departments referred to herein shall not be in violation of the Civil Rights Act of 1964 (42 USCA 2000 et seq.) and the regulations promulgated by the United States Department of Health and Human Services (45 CFR part 80). The purpose of such statute and regulations is to assure that no person in the United States shall, on the ground of race, color or national origin, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any program activity receiving Federal financial assistance from the Department of Health and Human Services. The local health department shall submit to the commissioner, in triplicate, the Assurance of Compliance form required by the Department of Health and Human Services. Such form must be submitted by present recipients of State Aid as well as by all future applicants.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.30 - Maintenance of effort

Section 40-1.30 Maintenance of effort

(a) A local health department shall maintain public health programs and services and gross expenditures for those services at “base year” levels, as defined below.

(b) The base year shall be the most recent local health department fiscal year for which the local health department has filed all quarterly claim forms with the department.

(c) Maintenance of effort shall be monitored by the department throughout the fiscal year.

(d) Adjustment to State Aid reimbursement shall be made when a local health department reduces its expenditures beneath the amount expended in its base year. State Aid shall be reduced by the percentage reduction in expenditures between the base year and the current fiscal year. When calculating the amount by which a local health department has reduced its expenditure, the Commissioner shall exclude extraordinary expenditures of a temporary nature, such as disaster relief; unavoidable or justifiable program reductions, such as a program being subsumed by another agency; or expenditures for which the local health department can demonstrate to the Commissioner’s satisfaction that the need for the expenditure no longer exists.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.40 - Limitation on State Aid

Section 40-1.40 Limitation on State Aid

(a) State Aid may be limited, in whole in or part, if the commissioner determines, upon review of a local health department’s State Aid application, that the local health department will not deliver a core public health service required by Subpart 40-2 of this title. In that event, the Commissioner may use the proportionate share that is not granted to the local health department to contract with agencies, associations, or organizations to provide such services, or expend such share to provide such services upon approval of the director of the division of budget, as authorized by section 605 of the Public Health Law.

(b) Partial service counties.The commissioner may approve a State Aid application that seeks funding for fewer than all core public health services required pursuant to Subpart 40-2 of this Part, provided that:

(1) a community health assessment is completed by the municipality pursuant to section 40-2.40 of this Part;

(2) the selected core services meet all standards for those services set forth in this Part; and

(3) the State Aid application identifies the availability of core public health services not provided by the local health department, who will provide those services and the manner in which the services will be provided and financed.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.41 - Withholding of State Aid

Section 40-1.41 Withholding of State Aid

(a) State Aid may be withheld, in whole or in part, if the commissioner determines, upon program review, that:

(1) core public health services were not performed in accordance with this Part, Article 6 of the Public Health Law, or the approved application for State Aid; or

(2) the local health department has not made every reasonable effort to collect fees for services set forth in section 40-1.51 of this Part.

(b) If, after notification that State Aid will be withheld pursuant this section, the local health department provides written justification within 60 days why such action is not warranted that is satisfactory to the commissioner, the commissioner may, within his or her discretion, adjust or cancel the withholding of State Aid.

(c) If the commissioner withholds funds pursuant to this section, the amount withheld shall be based on the cost of providing the missing or inadequate services by another agency or by the State.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.50 - Fees and revenue; quarterly reporting

Section 40-1.50 Fees and revenue; quarterly reporting

Each local health department shall:

(a) make every reasonable effort to collect fees and third-party billings revenue;

(b) maintain a written protocol for third-party billing and for assessment and collection of fees, including follow-up procedures for unpaid claims; and

(c) report quarterly to the commissioner, with its State Aid claim, each category of revenue collected.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.51 - Fees and revenue; services for which fees are charged

Section 40-1.51 Fees and revenue; services for which fees are charged

(a) Environmental health services. Each local health department must charge a fee for the granting of a permit, inspections and other services prerequisite to the issuance of a permit:
X-ray and radioactive materials (authorized programs only)Food service establishments (all types)Camps and recreation facilitiesIndividual water and sewerageRealty subdivisionsMobile home parksCommunity and noncommunity water systemsTanning facilities
Bathing beaches
Swimming pools
Recreational aquatic spray grounds
Temporary residences (hotels/motels/bungalow colonies/cottage colonies, cabins)
Mass gatherings and public functions
Children’s camps
Agricultural fairgrounds
Migrant farm worker housing
Multipurpose recreational facility
Plan review

(b) Clinic health services. Where third-party reimbursement is not available, the local health department shall charge a fee for the following clinic health services, regardless of whether such services are provided directly or by contract. Subject to subdivision (b) of section 40-1.52 of this Part, where third-party reimbursement is available, the local health department shall ensure that every reasonable effort is made to collect such reimbursement and any relevant co-payments.

Sexually transmitted diseases, consistent with Public Health Law § 2304
HIV counseling, testing, diagnosis and prevention
Family planning
Prenatal and postpartum care
Primary care for children less than 21 years of age;
Immunization

(c) Tuberculosis control. Fees for clinical health services related to tuberculosis control shall be governed by Part 43 of this Title.

(d) Rabies control. Local health departments shall make every reasonable effort to collect third-party reimbursement for the clinical health services for rabies control, when such services are provided by the local health department.

(e) Nothing in this section shall be deemed as prohibiting local health departments from charging fees for other public health services.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.52 - Fees and revenue; calculation

Section 40-1.52 Fees and revenue; calculation

(a) For all fees, the calculation of fees shall be based on the cost to the municipality of providing the service and shall not exceed the cost to the local health department of providing the service for which the fee is to be charged.

(b) For those clinic health services for which a fee is authorized, the fee to the individual shall be based upon the ability of the recipient to pay. A sliding fee schedule shall be established for this purpose and made available to all recipients of service.

(c) The local health department may request the commissioner’s approval to waive fee assessments, based on documentation that charging a fee would create a substantial barrier to obtaining the public health service. The commissioner's decision on whether or not to grant such waivers shall be conclusive.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.53 - Fees and revenue; deduction and offset

Section 40-1.53 Fees and revenue; deduction and offset

(a) All revenues collected by the local health department or the contractor shall be deducted from eligible expenditures to produce a net amount of expenditures eligible for State Aid, except that municipalities may provide accounting documentation for the withholding from deduction any earned revenue attributable to projects and services ineligible for State Aid reimbursement, as enumerated in 40-2.3. The commissioner may exclude such revenue from deduction limited to documentation submitted.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.60 - Submission of claims

Section 40-1.60 Submission of claims

(a) Quarterly claims for State Aid reimbursement must be accompanied by supporting documentation to enable calculation of State Aid amounts as shall be determined by the commissioner or his or her designee. Such documentation shall include, but not be limited to:

(1) a duly certified State Aid claim form;

(2) a clear statement of expenditures for each service included in the State Aid application; and

(3) a clear statement of each item of revenue earned during the reporting period.

(b) All expenses for which a claim is submitted shall be accounted for and reported using the cash basis method of accounting.

(c) Claims shall be prepared in accordance with 2 CFR Part 200 – “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.”

(d) A claim shall be deemed complete if it complies with subdivisions (a), (b) and (c) of this section.

(e) Complete claims for the first three quarters of a program year must be submitted by the local health department for State Aid no later than two months after the end of the quarter in which the expenditures claimed occurred. Complete fourth quarter claims must be submitted no later than three months from the end of the program year in which expenditures claimed occurred. Claims received later than such prescribed time limits may be returned unpaid by the commissioner. Returned claims may not be resubmitted.

(f) In the event that a local health department submits any quarterly claim later than six months after the end of the program year in which the expenditures claimed occurred, the commissioner may accept such claim only if the local health department has submitted a written statement which, in the commissioner’s discretion, adequately explains the extraordinary circumstances justifying the delay.

(g) Claims for State Aid reimbursement must be supported by expenditure and revenue records, to be retained and made available to facilitate concurrent or post audit, until concurrent or post audit is completed. Records supporting actual revenues and costs incurred shall be maintained by the municipality for the period of six years after the close of the fiscal year to which they pertain and are subject to audit and review by the State.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.61 - Method of payment

Section 40-1.61 Method of payment

Expenditures by local health departments shall be reimbursed as follows, provided all requirements of this Part are met:

(a) Base grant:

(1) For local health departments providing all of the core services set forth in Subpart 40-2 of this Part, the State Aid base grant shall be 100 percent of net eligible expenditures for performance of these services to a maximum of $650,000 or the amount representing 65 cents per capita, whichever is greater.

(2) For local health departments that the commissioner has approved to provide fewer than all of the core services set forth in Subpart 40-2 of this Part, the State Aid base grant shall be 100 percent of net eligible expenditures for performance of approved core services to a maximum amount determined by the commissioner that reflects the reduced scope of services.

(3) For the purposes of this section, population shall be determined by the local population data published as of January 1 of each calendar year by the New York State Department of Health.

(b) A local health department’s net eligible expenses for performance of core public health services, in excess of the base grant, shall be reimbursed at a rate consistent with section 616 of the Public Health Law, after review and approval of all State Aid applications.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-1.62 - Claims and method of payment; State Aid for physically handicapped children

Section 40-1.62 Claims and method of payment; State Aid for physically handicapped children

(a) For local health departments, State Aid for authorized medical services for physically handicapped children shall be paid at 50% of net expenses, where net expenses means total expenses less revenues received for such services. State Aid may be withheld if, on post-audit and review, the Commissioner finds that a medical service rendered was not in conformance with a plan submitted by the municipality or that the recipient of the medical service was not a physically handicapped child as defined in section 2581 of the Public Health Law.

(b) For American Indian children residing on a reservation, State Aid for authorized medical services for physically handicapped children shall be paid at 100% of net expenses for such services.

(c) To receive State Aid, the clerk of the board of supervisors or other similar governing body of each county, or chief fiscal officer of the city of New York, shall quarterly transmit to the Commissioner a certified statement stating the amount expended for the purposes specified herein, the date of each expenditure and date of service, and the purpose for which it was made.

(d) To receive State Aid, complete claims for physically handicapped children must be received by the Commissioner within two years of the date of service.

Effective Date: 
Wednesday, December 31, 2014
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SubPart 40-2 - Performance Standards and Minimum Requirements for Core Public Health Services

Effective Date: 
Wednesday, November 23, 2016
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Statutory Authority: 
Public Health Law, art. 6, Sections 602, 603

GENERAL PROVISIONS

Section 40-2.0 - Scope of Subpart 40-2

GENERAL PROVISIONS
Section 40-2.0 Scope of Subpart 40-2. In accordance with applicable provisions of article 6 of the Public Health Law, this Subpart establishes standards of performance and minimum requirements for core public health services relating to Family Health, Communicable Disease Control, Chronic Disease Prevention, Community Health Assessment, Environmental Health, and Emergency Preparedness and Response.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.1 - General provisions concerning State Aid eligibility

Section 40-2.1 General provisions concerning State Aid eligibility

(a) Core public health services are eligible for State Aid reimbursement only if such services are included in an approved State Aid application and only if performed in accordance with this Subpart.

(b) Local health departments may contract for core public health services provided, however, that:

(1) to remain eligible for State Aid, any contract for core public health services must require that:

(i) core public health services shall be performed under the general supervision and control of the local health department commissioner or public health director;

(ii) if a contract relates to a core public health service for which a fee must be collected pursuant to section 40-1.51 of this Part, the contractor shall make every reasonable effort to collect such fee and, for clinic health services, the contractor shall make every reasonable effort to collect third-party reimbursement and any relevant co-payments; and

(iii) the contractor shall report to the local health department all fees, co-payments, and third-party reimbursement collected;

(2) pursuant to section 616 of the Public Health Law, the local health department shall not claim as State Aid eligible expenses any portion of the contract cost relating to indirect costs or fringe benefits, including but not limited to retirement funds, health insurance and federal old age and survivors insurance; and

(3) when the local health department provides clinic services pursuant to section 40-2.2 of this Part through a contract with another provider, the Commissioner has discretion to review and approve or disapprove the contract. When exercising such discretion, the Commissioner shall examine factors including, but not limited to, the quality of the proposed contractor’s services, the ability the local health department to oversee the contracted services, and the contractor’s efficiency in delivering services.

(c) The following costs related to the facility space used by the local health department are eligible for State Aid:

(1) Rent paid to a person, a private entity, or a public entity other than the municipality that operates the local health department.

(2) For space owned by the municipality that operates the local health department, the cost of maintenance of space in lieu of rent (MILOR).

Effective Date: 
Wednesday, March 16, 2016
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Section 40-2.2 - State Aid eligibility; clinic services

Section 40-2.2 State Aid eligibility; clinic services

The cost of public health clinic services is allowable for only the following:

(a) clinic health services identified in subdivision (b) of section 40-1.51 of this Part, including clinics for sexually transmitted diseases, consistent with Public Health Law § 2304; HIV counseling, testing, diagnosis and prevention; family planning; immunization; primary care for children less than 21 years of age, provided that such services are only eligible for State Aid to the extent that the local health department makes good faith efforts to assist such persons with Medicaid or insurance enrollment, as applicable, and only until such time as insurance coverage becomes effective; and prenatal and postpartum care, provided that such services are only eligible for State Aid to the extent that the local health department makes good faith efforts to assist such women with Medicaid or insurance enrollment, as applicable, and only until such time as insurance coverage becomes effective;

(b) tuberculosis control;

(c) rabies control;

(d) dispensing countermeasures in the event of an actual or threatened public health emergency;

(e) other services consistent with section 602 of the Public Health Law and approved by the commissioner for State Aid reimbursement.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.3 - Projects and services ineligible for State Aid

Section 40-2.3 Projects and services ineligible for State Aid

Activities, services, and costs that are ineligible for State Aid include, but are not limited to, the following:

(a) activities and services involving other agencies:

(1) Joint activities. If joint State-local or Federal-local activities have been approved in the State Aid Application, the portion financed from State funds, other than State Aid under this section, and Federal funds will be excluded from consideration for reimbursement.

(2) Activities carried out by any other agency. The cost of activities for which any other government agency has been given legal responsibility.

(b) health care programs and services:

(1) Primary care and medical treatment, except as specified in this Subpart.

(2) Hospitals and other health facilities. The construction, establishment, maintenance and operation of hospitals, clinics, laboratories, dispensaries or similar facilities, except for the costs of providing eligible public health services in public health clinics as specified in section 40-2.2 of this Part.

(3) The cost of inpatient hospital care of patients with communicable disease, except tuberculosis and syphilis patients.

(4) Home health services provided by a local health department, except for public health home visiting as described in this Subpart.

(5) Laboratory services unrelated to eligible services. The cost of laboratory services related to public health services that are ineligible for State Aid are also ineligible for State Aid.

(6) Emergency Medical Service or Ambulance service. The maintenance and operation of Emergency Medical Service and ambulance service or the dispatching of ambulances.

(7) Medical examiner programs, services or activities.

(8) Jail medical services. The cost of providing routine medical treatment to inmates of jails operated by the local health department or in the municipality, including routine admission screenings and primary care to inmates older than 21 years of age.

(9) Any and all health care services for the screening or treatment of chronic diseases.

(c) environmental health programs and services:

(1) The cost of abatement, remediation, management in place or any action that removes a public health nuisance from a property, or the cost of relocating persons exposed to public health nuisances, consistent with section 40-2.55 of this Part.

(2) The cost of removal or covering lead paint or of relocating persons exposed to lead paint, consistent with section 40-2.58 of this Part.

(d) infrastructure and administration costs:

(1) Treatment plants and other facilities. The construction, maintenance and operation of water or waste water treatment plants, swimming pools and bathing beaches, and public bathhouses.
(2) Treatment of water supplies. The cost of treatment of public water supplies, including costs of chemicals for fluoridation.
(3) Garbage and refuse disposal facilities. The cost of construction, maintenance and operation of facilities for garbage and refuse collection, incineration or disposal and air cleaning facilities.

(4) Plumbing inspection. Plumbing inspection for the purpose of checking conformity with building code provisions.

(5) Boards of examiners. Compensation or expenses paid to boards of examiners (e.g., boards of examiners for plumbers and barbers).

(6) Insurance coverage of local health department employees. The cost of personal liability or malpractice insurance purchased by the local health department or the cost of funded self-insurance for such liability when such expense is related to protection against personal liability or malpractice of its employees.

(7) Real property. The cost of acquisition or development of real property.

(8) Depreciation and interest on funding, including:

(i) The cost of depreciation of the space utilized by a health agency in a building owned by the same municipality that operates the health agency.

(ii) The cost of interest on the funding of buildings utilized by a health agency and owned by the same municipality that operates the health agency.

(9) Rent paid to city or county. All rent for space utilized for health agency purposes, if such rent is payable to the same municipality that operates the health agency.
(10) Indirect costs and fringe benefits. Contributions by the local health department for indirect costs and fringe benefits, including but not limited to contractor fringe and indirect costs, employee retirement funds, health insurance, workers' compensation, and Federal old age and survivor's insurance.

(e) other programs and services that the commissioner reasonably determines are not eligible under this Part.

Effective Date: 
Wednesday, December 31, 2014
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Complete

FAMILY HEALTH

Section 40-2.10 - Family health; performance standards

Section 40-2.10 Family health; performance standards

(a) The local health department shall maintain a family health program designed to achieve the following goals:

(1) improve the health of persons under the age of 21, including children with special health care needs;

(2) increase the proportion of persons under the age of 21 who receive comprehensive well child primary and preventive care, including oral health care;

(3) improve birth outcomes, decrease maternal and infant mortality and morbidity, and increase the number of pregnant and postpartum women who receive early, continuous and comprehensive prenatal and postpartum care, including oral health care, and other supportive services to address risks and needs; and

(4) decrease the rate of unintended pregnancies, increase optimal spacing of pregnancies, decrease the prevalence and morbidity of sexually transmitted disease, and improve availability and accessibility of comprehensive reproductive health care and family planning services to men and women of reproductive age.

(b) To be eligible for State Aid, the local health department shall conduct public health activities in the following areas:

(1) Child Health;

(2) Maternal and Infant Health; and

(3) Reproductive Health.

(c) The activities required under this subdivision (b) of this section shall include, at a minimum:

(1) utilization of available public health data and information to shape strategies related to child health, maternal and infant health and reproductive health, including:

(i) using available data from

the community health assessment, other local assessments, and local knowledge;

(ii) identifying communities and/or neighborhoods where children, women and families are potentially in need of services;

(iii) identifying any specific local factors that influence children's health status, health care needs, maternal and infant birth outcomes, unintended pregnancy, and use of reproductive health care services; and

(iv) assess currently available services;

(2) public health marketing and communication, including developing or adapting public education materials or campaigns, and promoting and disseminating such materials or campaigns, to:

(i) promote the use of comprehensive health care services for children, women and families;

(ii) promote healthy behaviors, including the preconception, prenatal, postpartum and interconception periods; and

(iii) reduce risk factors associated with poor maternal and infant outcomes, unintended pregnancy, and sexually transmitted diseases and related health disparities;

(3) information, referral and assistance to women and families in accessing and effectively utilizing available services;

(4) outreach, education, training and technical assistance for health and human service providers, designed to improve the delivery of comprehensive primary and preventive care to women and families, including, at least one annual communication to health care providers on health data and interventions related to family health;

(5) efforts with multiple sectors in the community to promote policy, environmental and systems change to address population and community level factors that influence child health outcomes and use of health care services, birth outcomes, and reproductive health outcomes and services; and

(6) activities to identify uninsured women and families and to provide such persons, either directly or through referral, with assistance with enrollment in health insurance coverage and comprehensive prenatal care, child health care, primary care services, and reproductive health services.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.11 - Family health; services eligible, but not required, for State Aid

Section 40-2.11

Family health; services eligible, but not required, for State Aid

The following public health services are eligible for State Aid but not required as a condition of State Aid eligibility:

(a) primary care services to uninsured persons under 21 years of age, in a clinic setting, provided that such services shall be eligible for State Aid only to the extent that the local health department makes good faith efforts to assist such persons with Medicaid or other insurance enrollment, as applicable, and only until such time as insurance coverage becomes effective;

(b) provision of public health home visits associated with eligible services. Such public health home visits may include visits only for the following purposes: assessing women’s preconception, prenatal, postpartum and interconception health and social support needs; assessing child and family health and social support needs; providing information to promote positive birth outcomes and child health; and referring persons to needed services. Activities undertaken in relation to the Child Find System under the Early Intervention Program, as required pursuant to 10 NYCRR 69-4.1(c) and 69-4.2, shall not be eligible for State Aid;

(c) provision of reproductive health care and family planning services for men and women of reproductive age, in a clinic setting; and

(d) prenatal and postpartum care, in a clinic setting, provided that such services shall be eligible for State Aid only to the extent that the local health department makes good faith efforts to assist such women with Medicaid or insurance enrollment, as applicable, and only until such time as insurance coverage becomes effective.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

COMMUNICABLE DISEASE CONTROL

Section 40-2.20 - Sexually Transmitted Diseases (STDs) and Human Immunodeficiency Virus (HIV); performance standards

Section 40-2.20 Sexually Transmitted Diseases (STDs) and Human Immunodeficiency Virus (HIV); performance standards

The local health department shall maintain a program designed to minimize the incidence of STDs and HIV. The program shall include, at a minimum, activities to ensure:
(a) epidemiologic case finding, timely disease surveillance and reporting, in accordance with Part 2 of this Title;

(b) availability of accessible laboratory testing for STDs and HIV;

(c) provision of adequate facilities for diagnosis and treatment of STDs, directly or by contract, pursuant to Article 23 of the Public Health Law;

(d) provision of partner notification and referral services for priority patients, as determined in an investigation undertaken pursuant to 10 NYCRR 2.6;

(e) provision of prophylactic treatment to exposed partners for STDs;

(f) information, referral and assistance in utilizing appropriate community service programs;

(g) public health marketing and communication, including developing or adapting public education materials or campaigns, and promoting and disseminating such materials and campaigns, to promote healthy behaviors and reduce risk factors associated with STDs, HIV and related health disparities; and

(h) distribution of at least one communication per year to health care providers, clinics and laboratories on local and regional morbidity rates, CDC guidelines, diagnostic and treatment modalities and Department reporting requirements for STDs and HIV.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.21 - Tuberculosis; performance standards

Section 40-2.21 Tuberculosis; performance standards

The local health department shall maintain a program designed to minimize the incidence of tuberculosis. The program shall include, at a minimum, activities to ensure:

(a) timely tuberculosis surveillance and reporting;

(b) detection and follow-up with individuals identified as infected with tuberculosis, including contact investigations performed in close collaboration with healthcare facilities, schools, workplaces, and other settings;

(c) provision of clinical services for tuberculosis disease or infection, either directly,

through referral, or by contract;

(d) provision, or activities to ensure provision, of directly observed therapy for persons with tuberculosis, regardless of whether the local health department is the primary medical provider; and

(e) distribution of at least one communication per year to healthcare providers, clinics and laboratories regarding local and regional morbidity rates, CDC guidelines, diagnostic and treatment modalities, and Department reporting requirements for tuberculosis.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.22 - Communicable disease control; performance standards

Section 40-2.22 Communicable disease control; performance standards

The local health department shall maintain a program designed to minimize the incidence of communicable disease. The program shall include, at a minimum, activities to ensure:

(a) compliance with disease specific protocols, as established by the Department or, for New York City, the Department of Health and Mental Hygiene, for:

(1) disease surveillance;

(2) timely disease investigation;

(3) reporting of diseases to the commissioner, pursuant to Part 2 of this Title;

(b) verification and diagnosis of infections in a timely manner, ascertainment of the sources of infections, and follow up with infected persons as needed;

(c) minimization of the spread of disease, through the identification and, when appropriate, prophylaxis of persons possibly exposed to disease;

(d) performance of multiple, simultaneous investigations of communicable diseases, and maintenance of capacity to do so; and

(e) distribution of at least one communication per year to healthcare providers, clinics and laboratories regarding local and regional morbidity rates, CDC guidelines, diagnostic and treatment modalities, and Department reporting requirements for reportable diseases.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.23 - Immunization; performance standards

Section 40-2.23 Immunization; performance standards

The local health department shall maintain a program designed to minimize the occurrence and transmission of vaccine-preventable diseases. The program shall include, at a minimum, activities to ensure:
(a) compliance with all statutes and regulations concerning immunization applicable to local health departments, including but not limited to:

(1) Public Health Law § 613, concerning programs of immunization for children;

(2) Public Health Law § 2164, concerning vaccination of school children against certain diseases;

(3) Public Health Law § 2165, concerning vaccination of post-secondary students against certain diseases;

(4) Public Health Law § 2168 concerning the New York Statewide Immunization Information System (NYSIIS);

(5) Subpart 69-3 of this Title, concerning pregnant women, testing for Hepatitis B, and follow-up care;

(b) disease surveillance for vaccine preventable diseases, in accordance with Part 2 of this Title;

(c) assistance with and follow-up on school immunization surveys;

(d) educational efforts in the community, including:

(1) collaboration and communication with healthcare providers and schools to maintain required immunization levels in schools; and

(2) public health marketing and communication, including developing or adapting public education materials or campaigns, and promoting and disseminating such materials or campaigns, to increase awareness of diseases and the control measures required to prevent the spread of disease;

(e) coordination with medical providers and laboratories to encourage and advise them to conduct recommended diagnostic testing in the event of a disease outbreak; and

(f) engagement in quality assurance activities with providers in the community to improve immunization practices, including but not limited to, improving compliance with the NYSIIS reporting requirements, as applicable.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.24 - Zika Action Plan; performance standards

40-2.24 Zika Action Plan; performance standards. 

(a) By April 15, 2016, the local health department shall adopt and implement a Zika Action Plan (ZAP), in accordance with guidance to be issued by the Department, and which shall include, but not be limited to, the following activities: 

(1) for all local health departments: 

(i) human disease monitoring, response and control; and 

(ii) education about Zika virus and its prevention; and 

(2) in addition, for those local health departments identified by the Department as jurisdictions where mosquitoes capable of transmitting the Zika virus are currently located or may be located in the future: 

(i) enhanced human disease monitoring, response, control;  

(ii) enhanced education about Zika virus and its prevention;  

(iii) mosquito trapping, testing and habitat inspections specific to Aedes albopictus, and for such other species as the Department may deem appropriate; 

(iv) mosquito control; and 

(v) identification and commitment of appropriate staff available to join State-coordinated rapid response teams, which may be deployed to those areas where the Department determines that there is the potential for transmission of Zika virus by mosquitoes. 

(b) Local health departments shall update their ZAPs annually, or as directed by the Department, to include activities identified by the Department in guidance issued pursuant to subdivision (a) of this section.

(c) Local health departments shall submit such plans to the Department as part of the annual Application for State Aid made pursuant to section 40-1.0 of this Part.  State Aid shall only be available for activities within ZAPs determined by the Department to be necessary and appropriate to control the spread of the Zika virus in guidance issued pursuant to subdivision (a) of this section.

 

Effective Date: 
Wednesday, November 23, 2016
Statutory Authority: 
Public Health Law, Sections 602, 603, 619

CHRONIC DISEASE PREVENTION

Section 40-2.30 - Chronic disease prevention; performance standards

Section 40-2.30 Chronic disease prevention; performance standards

(a) The local health department shall maintain a program designed to reduce the prevalence or incidence of chronic diseases and conditions such as

cancer, cardiovascular diseases, diabetes, asthma, arthritis and obesity, and the underlying risk factors of tobacco use, physical inactivity and poor nutrition. The activities required in this program shall include, at a minimum:

(1) Analysis and utilization of public health data and information to shape objectives and strategies related to chronic disease prevention. This analysis shall:

(i) use available data from the community health assessment and other local assessments;

(ii) identify communities and/or neighborhoods where the population is at increased risk of chronic diseases and conditions and underlying risk factors;

(iii) identify the specific local factors and available policies, practices, underlying risk factors, and interventions that influence chronic disease;

(2) leadership of, or participation in, efforts with multiple sectors in the community to improve social and physical environments to support healthy behaviors;

(3) public health marketing and communication, including developing or adapting public education materials or campaigns, and promoting or disseminating such materials or campaigns, to reduce risk factors for chronic disease morbidity, mortality and related health disparities; and

(4) activities to promote the delivery of early detection and guideline-concordant health care by health care providers.

(b) Any and all health care services for the screening or treatment of chronic diseases are ineligible for State Aid.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

COMMUNITY HEALTH ASSESSMENT

Section 40-2.40 - Community health assessment; performance standards

Section 40-2.40 Community health assessment; performance standards

Local health departments shall work with community partners to conduct a Community Health Assessment (“Assessment”) and a Community Health Improvement Plan (“Plan”). Together, the Assessment and Plan shall include, at a minimum:

(a) an analysis of secondary data and, where available, primary data on health status and demographics;

(b) a description of the demographics of the population of the jurisdiction served by the local health department,

(c) a description of the health issues of the population, the distribution of health issues, and the contributing causes of the health challenges based on the data analyzed,

(d) the identification of priority areas for health improvement based on valid criteria;

(e) a description of public health services in the community and other resources that can be mobilized to improve population health, particularly in the priority areas;

(f) improvement strategies and measurable objectives through which the municipality and its community partners will address areas for health improvement and performance targets that will be used to track progress toward improvement of public health outcomes;

(g) methods by which access to the reports is to be provided to interested stakeholders including hospitals, nursing homes, medical societies, libraries, schools, government facilities, or other agencies and other organizations; and

(h) a description of the community partners that participated in the development of the community health assessment and improvement plan and their roles in the plan.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

ENVIRONMENTAL HEALTH

Section 40-2.50 - Public water supply protection; performance standards

Section 40-2.50 Public water supply protection; performance standards

The local health department shall maintain a program that ensures public water systems are operated pursuant to the New York State Public Health Law, Part 5 of the State Sanitary Code (10 NYCRR Part 5), and applicable federal Safe Drinking Water Act (SDWA) requirements.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.51 - Environmental radiation protection; performance standards

Section 40-2.51 Environmental radiation protection; performance standards

The local health department shall maintain a program to conduct environmental radiation surveillance activities, if the Department has authorized the local health department to conduct such a program. Such program shall, at a minimum, maintain appropriate equipment and supplies, ensure that personnel are properly trained, and collect environmental samples for radiological analysis.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.52 - Community environmental health and food protection; performance standards

Section 40-2.52 Community environmental health and food protection; performance standards

The local health department shall maintain a program that ensures that facilities operated pursuant to Parts 6, 7, 14, 15 and 17 of the State Sanitary Code comply with all relevant provisions of the State Sanitary Code and the Public Health Law.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.53 - Realty subdivisions; performance standards

Section 40-2.53 Realty subdivisions; performance standards

The local health department shall maintain a program for approving realty subdivisions and assuring construction is in accordance with approved plans; provided that this provision shall not apply to New York City. The program shall include, at a minimum:

(a) procedures for approval of all realty subdivisions in accordance with the Public Health Law, Environmental Conservation Law, Education Law, and applicable State regulations prior to the start of construction activities; and

(b) provisions for site evaluation and construction inspections as necessary to assure that approved plans are followed.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.54 - Individual water and sewage systems; performance standards

Section 40-2.54 Individual water and sewage systems; performance standards

The local health department shall, at a minimum, maintain a program for providing technical assistance to property owners regarding the installation, maintenance and operation of individual water supplies and individual sewage systems.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.55 - Public health nuisances; performance standards

Section 40-2.55 Public health nuisances; performance standards

The local health department shall:

(a) respond to all reported nuisances which may affect public health and safety; and

(b) maintain a program, consistent with Part 8 of the State Sanitary Code, as applicable, for responding to public health nuisances and ensuring abatement of such public health nuisances; provided, however, that abatement, remediation, management in place or any action that removes the public health nuisance from a property or relocating persons exposed to public health nuisances shall not be eligible for State Aid.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.56 - Injury prevention and control; performance standards

Section 40-2.56 Injury prevention and control; performance standards

The local health department shall maintain a program designed to reduce morbidity and mortality associated with injuries, utilizing reasonably available data. The program shall include, at a minimum, development and implementation of education programs to inform the public and providers of measures to avoid intentional and unintentional injury.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.57 - Environmental health exposure investigation, assessment and response; performance standards

Section 40-2.57 Environmental health exposure investigation, assessment and response; performance standards

The local health department shall maintain and conduct a program that includes, at a minimum:

(a) responding to reports of exposure to chemical and non-infectious biological hazards attributable to environmental and occupational settings. Such responses shall include, at a minimum, preliminary evaluation and exposure investigation; appropriate environmental, biological, clinical or epidemiological monitoring; appropriate public health interventions to reduce and/or eliminate exposures; public or professional information and education; and consultation and referral as needed; and

(b) maintaining a log of reported exposures and alleged health effects, including a timeline and description of the response provided.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.58 - Lead poisoning prevention; performance standards

Section 40-2.58 Lead poisoning prevention; performance standards

(a) The local health department shall maintain a lead poisoning prevention program, which shall include, at a minimum:

(1) activities to identify risk factors for childhood lead poisoning, including locations in the municipality where exposure of children to lead is likely;

(2) activities to educate the community as to the dangers of lead toxicity;

(3) for all children aged one and two years old, and other children at risk of exposure to lead, ensuring provision of:

(i) access to blood lead testing services;

(ii) appropriate case coordination; and

(iii) environmental intervention;

(4) reporting of pertinent blood lead testing information and follow up activities in a manner acceptable to the Commissioner, provided that this provision shall not be interpreted to limit the jurisdiction of the local health department to require additional reporting in accordance with local law.

(b) The cost of removal or covering lead paint or of relocating persons exposed to lead paint shall not be eligible for State Aid.

Effective Date: 
Wednesday, December 31, 2014
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ENVIRONMENTAL HEALTH – ONLY WHERE AUTHORIZED

Section 40-2.60 - Authorized radioactive materials licensing and inspection program; performance standards

Section 40-2.60 Authorized radioactive materials licensing and inspection program; performance standards

Where a local health department has received authorization to maintain a radioactive materials licensing and inspection program pursuant to Part 16 of this Title, the municipality shall conduct such program consistent with that Part.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 40-2.61 - Authorized radiation-producing equipment inspection program; performance standards

Section 40-2.61 Authorized radiation-producing equipment inspection program; performance standards

Where a local health department has been certified to maintain a radiation producing equipment inspection program pursuant to Part 16 of this Title, the municipality shall conduct such program consistent with that Part.

Effective Date: 
Wednesday, December 31, 2014
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Section 40-2.62 - Authorized tanning facilities licensing and inspection program; performance standards

Section 40-2.62 Authorized tanning facilities licensing and inspection program; performance standards

Where a local health department’s health officer has received authorization to act as a permit-issuing official for the licensing and inspection of tanning facilities pursuant to Subpart 72-1 of this Title, the municipality shall conduct such program consistent with that Subpart or, if applicable, local regulations issued pursuant to 10 NYCRR 72-1.2.

Effective Date: 
Wednesday, December 31, 2014
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Complete

EMERGENCY PREPAREDNESS AND RESPONSE

Section 40-2.70 - Emergency preparedness and response; performance standards

Section 40-2.70 Emergency preparedness and response; performance standards

The local health department shall conduct a program designed to ensure readiness to respond to health emergencies, whether naturally occurring or deliberate, to protect the health of its residents. The program shall include at a minimum:

(a) development and maintenance of an All Hazards Health Emergency Preparedness and Response Plan;

(b) activities designed to maintain readiness to provide appropriate medical countermeasures to the public in response to an emergency;

(c) ensure training and health education to local health department staff, health care providers and the community on health emergency preparedness;

(d) participation and implementation of exercises and drills that include appropriate response partners; and

(e) responding to emergencies as described in the All Hazards Health Emergency Preparedness and Response Plan.

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
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SubPart 40-3 - REPEALED

Effective Date: 
Wednesday, July 7, 2010

SubPart 40-4 - Fee and Revenue Plan for Departmental Services

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Statutory Authority: 
Public Health Law, art. 6, Section 606

Section 40-4.0 - Fee and revenue plan

Section 40-4.0 Fee and revenue plan.

(a) Fees and revenues received by the department pursuant to section 606 of the Public Health Law shall be deposited in a local public health services program account, and distributed to municipalities as supplemental health services grants.

(b) Such revenues shall include fees for services provided by the department, fines levied and collected by the department from enforcement actions associated with these services, and monies received or recovered as a result of State aid audit exceptions.
 

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Section 40-4.1 - Fees for departmental services

40-4.1 Fees for departmental services.

(a) The department must charge a fee for the granting of a permit, inspections, or other services prerequisite to the issuance of a permit, or for other environmental health services. Such fee shall be nonrefundable.

(b) Annual fees for facility inspection and permit issuance services, where such services are provided by the department and not directly by the municipality, are based on the costs of providing such services and shall be revised periodically.

(c) Cumulative fees for a single operator at a single location shall not exceed $1,000 per year.

(d) Definitions. (1) As used in this Subpart, "multipurpose recreational facilities," are defined as large tracts of land upon which a recreational facility owned and operated by a single person, partnership or corporation is located. Such facilities may encompass multiple food, swimming or recreational facilities permittable under the State Sanitary Code. In completing a Fee Determination Schedule, the facility operator may exercise an option to pay either a registration fee as provided for in paragraph (10) of subdivision (e) of this section or fees separately calculated for each individual activity.

(2) "Primary service" is defined as the principal or major function of such multipurpose recreational facilities (e.g. water slides). All such primary services are covered by the base fee. Other services, (e.g. food,) are chargeable as add-ons for each individual facility (e.g., 10 food booths x $50. = $500.00 additional fee).

(3) "Seasonal facility," for the purpose of determining the annual fee levels for such facility, is defined as a facility permittable under the provisions of the State Sanitary Code which operates 26 weeks or less in a calendar year. Such seasonal facility must be designated as such on any permit issued to it, which shall also state the starting and ending dates of the seasonal operating period. Such seasonal facility shall be entitled to a 10% reduction from the normal annual fee.

(e) Fees for departmental environmental services, excluding plan review unless otherwise stated, are established as follows:

(1) Food service establishments, taverns, bars (includes $25 frozen dessert fee except for free-standing soft ice cream and slush machine units, etc.).

Seating Capacity 100 or less, including takeout or stand up service $ 75.00 101 or more 150.00

(2) Caterers and Commissaries. 200.00

(3) Temporary Food Service Mobile 30.00 Vendors.

(4) Hotels, Motels, Bungalow Colonies, Cabins, Cottage Colonies. (Base fee (i) and added fees (ii-iv))

(i) Number of rental units 1-20 units 50.00 21-50 100.00 51-100 150.00 101-200 200.00 201+ 400.00

(ii) Food service dining areas (which may include a cocktail lounge, night club, etc.)

Capacity 1 - 100 add 50.00 for each separate area/facility

Capacity 101 or more add 100.00 for each separate area/facility

(iii) Pool add 30.00 for each separate pool

(iv) Beach add 20.00 for each separate beach

(5) Campgrounds and Travel Trailer Parks. (Base fee (i) and added fees (ii-iv))

(i) Number of Sites

50 or less 50.00 51 - 200 75.00 201 - 500 100.00 501 - 750 150.00 751 or more 250.00

(ii) Food service dining areas (which may include a cocktail lounge, night club, etc.)

Capacity 1 - 100 add 50.00 for each separate area/facility

Capacity 101 or more add 100.00 for each sep area/facility

(iii) Pool add 30.00 for each separate pool

(iv) Beach add 20.00 for each beach

(6) Mobile Home Parks. Base fee (i) and added fees (ii-iv))

(i) Number of Sites

Less than 50 50.00 50-100 100.00 101 or more 200.00

(ii) Food service dining areas (which may include a cocktail lounge, night club, etc.) Capacity 1-100 add 50.00 for each separate area/facility

Capacity 101 or more add 100.00 for each separate area/facility

(iii) Pool add 30.00 for each separate pool

(iv) Beach add 20.00 for each separate beach

(7) Migrant Labor Camps.

Occupancy 5 - 50 50.00 51 or more 100.00

(8) Swimming Pools and Common Use Spa Pools.

Maximum number of Bathers (25 sq. ft./bather) 1 - 100 50.00 101 or more plus wave pools and slides 100.00

(9) Bathing Beaches.

Less than 5000 sq. ft. 30.00 5000 sq. ft. or more 70.00

(10) Multipurpose Recreational Facilities.

(i) Base fee for primary service 500.00 (food, pool, beach, etc. as as designated by operator)

(ii) Additional services (other than primary)

Food service add 50.00 for each separate area/facility

Pool add 30.00 for each separate area/facility

Beach add 20.00 for each separate area/facility

(11) Community Water Supplies.

Population Served: Less than 1000 100.00 1000 - 9999 500.00 10,000 or more 1000.00

(12) Unpermitted Noncommunity Water Supplies. 100.00

(13) Mass Gatherings, Including Plan Review. 500.00

(14) Public Functions of Over 5000 People Not Constituting Mass Gatherings.

Number of emergency health care units Less than 3 100.00 3 or more 200.00

(15) Children's Camps. 100.00

(16) Frozen Desserts. (soft ice cream) 25.00

(f) Plan review fee (per project):

(1) Food Service Establishments, 75.00 Caterers, Commissaries, etc.

(2) Hotels, Motels, Bungalow Colonies, Cabins, Cottage Colonies.

Number of stories or structures 1 or 2 50.00 3 or more 200.00

(3) Campgrounds and Travel Trailer Parks. 100.00

(4) Mobile Home Parks. 100.00

(5) Migrant Labor Camps. 50.00

(6) Swimming Pools and Bathing Beaches.

100 - 5000 sq. ft. 100.00 5001 sq. ft. or more 150.00 Wavepools, slides, spa pools 150.00

(7) Realty Subdivisions (as prescribed by Public Health Law, section 1119) 25.00/lot

(8) Community and Noncommunity Water Supply.

Cost of Project Less than $10,000 50.00 10,000 - 100,000 100.00 More than 100,000 200.00

(9) Individual Sewage System. (alternative design) 50.00
 

Effective Date: 
Wednesday, January 25, 1989
Doc Status: 
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Section 40-4.2 - Applicability

40-4.2 Applicability. (a) It shall be the responsibility of each facility rendering to the public services covered by the fee schedule provided in section 40-4.1 of this Subpart to remit the annual fee in the form and by the date required by the department, except that no fee shall be charged in the case of a facility operated by a person, firm or corporation or association for charitable, philanthropic or religious purposes or by a municipality.
(b) Failure to pay the prescribed fee shall result in nonissuance of a permit to operate or summary suspension of any existing permit until such fee is paid.

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Part 41 - Grants For School Health Projects

PART 41
GRANTS FOR SCHOOL HEALTH PROJECTS
(Statutory authority: L. 1981, ch. 50)
Sec.
41.1 Applicability
41.2 Grant applications
41.3 Grant contracts
41.4 Waivers

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Section 41.1 - Applicability

Section 41.1 Applicability.

This Part shall apply to State grants paid for school health projects funded under chapter 50 of the Laws of 1981 or any subsequent State law providing funding through the State Department of Health for similar school health projects.
 

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Section 41.2 - Grant applications

41.2 Grant applications.

(a) State grants shall be based on the prior approval of specific school health project proposals after application by the governing authority of not-for-profit or publicly operated facilities licensed pursuant to article 28 of the Public Health Law. Review and approval of such applications shall be by the State Commissioner of Health with the consent of the State Commissioners of Education and Social Services.

(b) The submission of a memorandum of understanding and support between the governing authority of the school district serving the area in which the schools proposing to participate in the facility's project are located and the applicant-article 28 facility shall be a condition of eligibility for a grant under this Part. For those projects to be located in any nonpublic school, the submission of a memorandum of understanding and support between the governing authority of such nonpublic school and the applicant-article 28 facility shall also be a condition of eligibility for a grant under this Part. Services funded by these State grants shall be available to all pupils enrolled in participating schools regardless of ability to pay. Only article 28 facilities proposing projects based in schools located in cities exempt from the requirements of State mandated public school pupil medical inspections and examinations under article 19 of the Education Law will be eligible to receive grant funds. Grant funds received pursuant to this Part must be used solely for a school health project approved pursuant to this Part. Selection of applications for grants shall be based upon criteria which, at a minimum, shall include:

(1) the extent of need and high risk in the community to be served based upon health indicators relating to children;

(2) the degree of participation by, and the commitment of, the schools and school districts proposing to participate in the project;

(3) the quality, scope and feasibility of the project proposal; and

(4) the qualifications, experience and commitment to the proposal of the applicant.
 

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Section 41.3 - Grant contracts

41.3 Grant contracts. The Commissioner of Health shall, with the consent of the Commissioners of Education and Social Services, enter into contracts with the selected applicants with respect to the distribution and administration of grant funds, and the management, operation and evaluation of the school health projects. Such contracts shall contain provisions relating to, among other matters:

(a) those provisions of the Public Health Law and regulations that are waived;

(b) services to be provided;

(c) use of grant funds;

(d) staffing;

(e) submission of claims for grant funds and distribution of grant funds; and

(f) recordkeeping and reporting requirements.
 

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Section 41.4 - Waivers

41.4 Waivers.

The Commissioner of Health may waive any provision of the Public Health Law and regulations promulgated pursuant thereto in order to implement school health projects under this Part. Any such waivers shall only be effective for the duration of the grant contract entered into under this Part.
 

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Part 42 - State Aid For Public Health Laboratory Services: Counties And Cities

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Statutory Authority: 
Public Health Law, Section 620

GENERAL PROVISIONS

Section 42.1 - Application for State aid

GENERAL PROVISIONS

Section 42.1 Application for State aid.

(a) All counties and cities performing or contracting for laboratory tests related to the municipal health department's performance of eligible services described in this Part, must submit to the New York State Department of Health an application for State aid for laboratory services, on an annual basis, no later than on the date specified by the State Commissioner of Health.

(b) The application shall contain a detailed budget of proposed expenditures, estimated revenues, a copy of the latest schedule of laboratory fees, and other information that may be required by the Commissioner of Health.

(c) When a city or county contracts with a laboratory for public health laboratory services, in addition to the State aid application, a list of tests and the rate to be paid by the municipality for each test must be filed with the State Department of Health no later than on the date specified by the State Commissioner of Health.

Effective Date: 
Wednesday, July 7, 2010
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Section 42.2 - Approval of application

42.2 Approval of application.

Each application shall be reviewed by the State Department of Health. The application may be approved in whole or in part and the municipality shall be informed of the amount approved by the State Department of Health.
 

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Section 42.3 - Board of managers

42.3 Board of managers.

All laboratories shall be under the supervision, direction and control of either a board of managers or the board of health appointed in accordance with section 523 of the Public Health Law.
 

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Section 42.4 - Director of laboratories

42.4 Director of laboratories.

All laboratories shall have a director whose qualifications are in accordance with section 19.2 of this Title.
 

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Section 42.5 - Cost per laboratory test

42.5 Cost per laboratory test.

All laboratories must determine, at least every three years, the cost of each procedure done by the laboratory.
 

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STATE AID LIMITATIONS

Section 42.10 - Laboratory services eligible for reimbursement

STATE AID LIMITATIONS

42.10 Laboratory services eligible for reimbursement. State aid will be granted to a municipality performing or contracting for laboratory tests related to the municipal health department's performance of eligible services described in this Part for, the cost of laboratory services required for:

(a) the detection and control of disease as prescribed by the Public Health Law, the State Sanitary Code or the State Commissioner of Health;

(b) the maintenance of a safe and healthful environment; and

(c) the conduct of health research approved by the State Commissioner of Health.
 

Effective Date: 
Wednesday, July 7, 2010
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Section 42.11 - Laboratory Services ineligible for reimbursement

42.11 Laboratory services ineligible for reimbursement. State aid will not be provided on the cost of:

(a) laboratory services eligible for reimbursement by Medicaid, Medicare and other third-party payors; and laboratory services unrelated to the eligible services described in this Part; or those provided to private practitioners or others where the municipal laboratory is providing services available from a private, commercial laboratory;

(b) laboratory services of a blood bank;

(c) laboratory services of a medical examiner when the medical examiner's office is not eligible for State aid reimbursement;

(d) laboratory services not included within the scope of subdivision (a), (b) or (c) of section 42.10 of this Part;

(e) construction or purchase of a building;

(f) rental of space utilized by a laboratory if such rentals are payable to the same municipality as operates the laboratory. Expenditures for non-capital maintenance and operation of costs for space utilized by a laboratory may be included if such facility is owned by the same city or county as operates the laboratory;

(g) depreciation and interest on funding of the space utilized by a laboratory in a building owned by the same city or county as operates the laboratory;

(h) malpractice or personal liability insurance purchased by counties or cities for protection of laboratory employees;

(i) direct or apportioned cost of services provided by other agencies of the county or city to the laboratory;

(j) other costs that the State Commissioner of Health may deem inappropriate.
 

Effective Date: 
Wednesday, July 7, 2010
Doc Status: 
Complete

Part 43 - State Aid For Tuberculosis

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 2201, 2202(1), (2), (3), (4); Laws of 1981, ch. 623, Sec. 4

SubPart 43-1 - STATE AID FOR TUBERCULOSIS

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, sections 2201, 2202(1),(2), (3) and (4), section 4 of Chapter 623 of the Laws of 1981

STATE AID FOR TUBERCULOSIS

Section 43-1.1 - Definitions

Section 43-1.1 Definitions.

(a) A tuberculosis case shall mean a person diagnosed as having disease caused by M. tuberculosis determined by bacteriological evidence of tuberculous disease or a significant reaction to a mantoux tuberculin test and clinical or roentgenographic evidence of current disease.

(b) A person with tuberculosis infection shall mean a person diagnosed as having a significant reaction to the mantoux tuberculin test in the absence of clinical, roentgenographic or bacteriological evidence of tuberculous disease.

(c) A suspect shall mean a person suspected of having either tuberculosis infection or disease, (including a person who has been in close contact with a tuberculosis case) for whom diagnostic procedures have not been completed and who may or may not be receiving treatment. A person shall not be classified as a tuberculosis suspect for longer than 60 days.

(d) A tuberculosis contact shall mean a person who has been in close association with a suspect or tuberculosis case for a length of time sufficient to become infected with M. tuberculosis by breathing contaminated droplets.

(e) A provider shall mean any facility, agency or organization authorized to furnish tuberculosis health care services under Article 3, 28, 36 or 44 of the Public Health Law, or a licensed and registered physician.

(f) A tuberculosis patient shall mean a person who is a tuberculosis case; a tuberculosis suspect; or has a tuberculosis infection; and who has been accepted or admitted into care by a provider.

(g) Tuberculosis health care services shall mean diagnostic procedures, care, and treatment for tuberculosis patients furnished by a provider.

(h) Local health official shall mean the Commissioner of Health or public health administrator of a county or part county health district, the Commissioner of Health of the City of New York, the county health director or other appropriate health officer designated by the legislative body of each county or the corresponding authority of the City of New York to be responsible for providing or securing tuberculosis care and treatment, pursuant to section 2202 (1) of the Public Health Law.

(i) A state or local charge shall mean those persons defined as such in section 2200 (4) and (5) of the Public Health Law.

(j) Third-party payer shall mean Medicare, workers' compensation, medical assistance in accordance with the Social Services Law, the Veterans Administration, health and other insurers and indemnitors or other third parties by whom diagnosis, care and treatment hereunder is payable.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.2 - Responsibility for tuberculosis care and treatment

43-1.2 Responsibility for tuberculosis care and treatment. The local health official, where a tuberculosis patient or contact resides or is found, shall provide or secure tuberculosis health care services needed by such person. Upon notification of a tuberculosis case or suspect, the appropriate local health official shall be responsible for immediately determining if other persons may have become infected with tuberculosis by the case or suspect, and shall perform those duties and responsibilities identified in Part 2 of the State Sanitary Code. The local health official shall provide or secure health care services needed for all cases or suspects found.

The local health official shall initiate preventive measures, to prevent the spread of infection or development of disease.

If a case or contact resides outside of the geographic jurisdiction of the local health official to which he or she has been reported, the local health official shall transfer copies of all materials concerning that case or contact to the local health official with jurisdiction.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.3 - Nonresidents, aliens, refugees and staff members of legations

43-1.3 Nonresidents, aliens, refugees and staff members of legations.

(a) There shall be no discrimination against tuberculosis patients or contacts because of lack of United States citizenship or lack of New York State or local residence.

(b) Tuberculosis health care services for the following aliens are not eligible for payment by local health officials or the State or for payment of State aid reimbursement:

(1) officials, representatives or employees of foreign governments;

(2) officers and employees of international organizations;

(3) attendants, servants, personal employees of those listed in paragraphs (1) and (2) of this subdivision; or

(4) members of immediate families of those listed in paragraphs (1) through (3) of this subdivision.

Payment for tuberculosis health care services for these persons is the responsibility of the individual or foreign country through its appropriate representative in the United States.

(c) Refugees eligible for medical assistance in accordance with the Social Services Law and the rules and regulations thereunder shall also be eligible for tuberculosis health care services hereunder.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

REQUIREMENTS APPLYING TO PROVIDERS AS A CONDITION TO BEING ENTITLED TO PAYMENT FOR TUBERCULOSIS HEALTH CARE SERVICES

Section 43-1.4 - Standards for tuberculosis care and services

REQUIREMENTS APPLYING TO PROVIDERS AS A CONDITION TO BEING ENTITLED TO PAYMENT FOR TUBERCULOSIS HEALTH CARE SERVICES

43-1.4 Standards for tuberculosis care and services.

The care and treatment by providers of tuberculosis patients shall include health care services which meet prevailing standards of professional practice, including the following:

(a) a licensed and currently registered physician shall be responsible for the tuberculosis health care services furnished to a patient;

(b) tuberculosis suspects shall be confirmed as being or not being tuberculosis cases within 60 days from the date accepted into care by a provider. On or before the 60th day, the provider shall report findings in writing to the local health officials where the patient resides and where the provider is located;

(c) providers shall comply with applicable utilization review requirements.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.5 - Hospital inpatient admissions

43-1.5 Hospital inpatient admissions.

(a) Tuberculosis health care services provided in a hospital shall be based on prevailing standards of professional practice for the care of tuberculosis.

(b) An inpatient admission of a tuberculosis patient to a hospital for treatment of tuberculosis may be made when a person has severe symptoms attributed to tuberculosis, presents diagnostic problems or presents difficulties in drug treatment selection.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.6 - Reporting by providers

43-1.6 Reporting by providers.

(a) When a tuberculosis case or suspect is accepted for care by a provider, the provider shall notify by telephone within 24 hours the local health official where the provider is located, and also the local health official where the person resides. The provider shall then submit a written case report within 5 working days to the same local health official or officials. The written report shall include the person's name, date accepted for care, age, address, telephone number, name and address of employer, county of residence, diagnosis, clinical evidence of disease and diagnostic procedures completed. If the person has been admitted as an inpatient, a written statement shall also be submitted by the hospital indicating the reasons for inpatient admission, rather than ambulatory care.

(b) When a tuberculosis case or suspect accepted into care by a provider is or may be a local charge, as defined by Article 22, Section 2200 of the Public Health Law, the provider shall, within 5 working days, notify the local health official where the person resides of the person's name, address, potential status as a local charge, and the names and addresses of any third-party payers, along with all other information stated in part (a) of this section.

(c) When a tuberculosis case or suspect accepted for care by a provider is or may be a State charge, as defined by Article 22, Section 2200 of the Public Health Law, the provider shall, within 5 working days, notify the local health official where the provider is located of the person's name, address, potential status as a State charge, and the names and addresses of any third-party payers, along with all information stated in part (a) of this section. The health official will immediately inform the person designated by the State Health Commissioner for such purpose.

(d) A monthly patient status report on each person with tuberculosis disease shall be submitted by each provider to the local health officials where the person resides and where the provider is located, which shall include a medical and social history and, if applicable, a discharge summary. Reports shall be submitted within two weeks of the end of each month.

(e) Providers shall submit to such health official additional reports as the State Commissioner of Health may provide.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

AUTHORIZATION

Section 43-1.7 - Authorization of reimbursement for tuberculosis health care and services

AUTHORIZATION

43-1.7 Authorization of reimbursement for tuberculosis health care and services.

(a) Tuberculosis health care services shall be paid by the local health official with jurisdiction or the State only as authorized. Authorization for local charges shall be made by the local health official where the patient resides. Authorization for State charges shall be made by the designee of the State Health Commissioner.

(b) Providers shall be deemed authorized to collect reimbursement for tuberculosis health care services when they are so notified by the local health official or designee of the State Health Commissioner, if they comply with the requirements of this Subpart.

(c) Reimbursement for inpatient hospital services for a patient hospitalized for a period in excess of six weeks during a calendar year are not authorized unless approved in writing before expiration of the six weeks. Authorization for local charges may only be made by the local health official where the patient resides. If the patient is a potential State charge, the provider shall request authorization for care beyond six weeks by writing to the local health official where the patient resides. Such health official shall recommend whether such care is justified or not to the designee of the State Health Commissioner. Authorization for State charges may only be made by the designee of the State Health Commissioner.

(d) In determining which tuberculosis health care services to authorize for a tuberculosis patient, the local health official or designee of the State Health Commissioner shall consider available alternative tuberculosis health care services and determine the most appropriate source to meet the patient's needs.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

PROVIDER CLAIM FOR PAYMENT AND EFFORTS TO DETERMINE AVAILABILITY OF THIRD-PARTY PAYERS

Section 43-1.8 - Provider claim

PROVIDER CLAIM FOR PAYMENT AND EFFORTS TO DETERMINE AVAILABILITY OF THIRD-PARTY PAYERS

43-1.8 Provider claim.

(a) Providers of tuberculosis health care services may not claim payment from local health officials or the State for amounts which are eligible for payment from any other third-party payer or payers.

(b) For a tuberculosis patient who is a local charge, a provider shall submit to the local health official where the patient resides an itemized claim form for payment for tuberculosis health care services furnished to the patient who does not have full third-party coverage of the claim.

(c) For a State charge who does not have full third-party coverage, a provider shall submit an itemized claim form to the local health official where the patient resides. The health official shall verify the information on the claim form and shall forward the claim to the designee of the State Health Commissioner.

(d) The claim form shall show the charges for each of the services provided and shall deduct all amounts eligible for reimbursement or indemnification by the third-party payers.

(e) The claim form shall include the names of third-party payers or indemnitors who have paid, or are or may be responsible for making payments for part or all of the claim, and the amounts each has paid or is or may be responsible for paying.

(f) A form shall be submitted with a copy maintained by the provider, together with the claim form stating in detail the efforts made to determine whether there is third-party coverage or indemnification available for the claim. The form shall also state the efforts made to claim such reimbursements. If the provider's efforts to determine or obtain third-party reimbursement, as reported in the form are found unsatisfactory by the local health official, the provider shall make additional efforts and shall submit a supplemental form.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

RESPONSIBILITY FOR PAYMENT FOR SERVICES

Section 43-1.10 - No patient obligation to pay

43-1.10 No patient obligation to pay.

(a) No tuberculosis patient or his legally responsible relatives shall be requested or required by a provider, local health official, the State, or any other party to pay personally for any portion of tuberculosis health care services received, as provided in section 2202 of the Public Health Law.

(b) No provider, local health official, the State or any other person shall inquire into the financial ability of a tuberculosis patient or his legally responsible relatives to pay for tuberculosis health care services except to determine third-party coverage.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.9 - Extent of responsibility for payment

RESPONSIBILITY FOR PAYMENT FOR SERVICES

43-1.9 Extent of responsibility for payment.

(a) The local health official of the jurisdiction where a tuberculosis patient resides shall be responsible to pay providers for health care services rendered to a local charge tuberculosis patient when such services are authorized and provided in accordance with this Subpart, except:

(1) The maximum charges which the local health official shall be responsible for are the rates for the Medical Assistance Program established in accordance with the provisions of section 2807 of the Public Health Law and fees for services established in the State medical fee schedule for medical assistance.

(2) Amounts eligible for reimbursement or indemnification from any third-party payer shall not be paid by the local health official. Such amounts shall be deducted by the local health official from the charges billed by the provider or the established rates and/or fees in the State medical fee schedule for the health care services rendered, whichever are less.

(3) When a person has been admitted as an inpatient to a hospital for the treatment of a nontuberculous disease or condition and is subsequently found to have tuberculosis which requires inpatient care and treatment, a local health official has no responsibility to pay for care and treatment prior to the date of diagnosis of tuberculosis. If the person requires tuberculosis care and treatment, but hospitalization is not justified, the local health official shall not be responsible for hospitalization costs.

(4) If, upon review of a claim, the local health official determines that a tuberculosis patient had or was eligible for third-party coverage or indemnification and that the provider failed to make a good faith effort to determine whether there was such coverage or indemnification, the local health official may deny payment of claim.

(5) A person who volunteers to assume and pay for the cost of tuberculosis health care services hereunder shall be liable therefor.

(b) The State of New York shall be responsible to pay providers for health care services rendered to a State charge tuberculosis patient in accordance with the terms of this Subpart, with the same exceptions as described in subdivision (a) of this section.

(c) Subsequent to paying a provider for services, if a local health official or the State determines that a provider did not make a good faith effort to obtain third-party payer coverage or indemnification that was available, the local health official or the State shall require the provider to repay an amount equivalent to the amount of such third-party payer coverage or indemnification.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

REQUIREMENTS APPLYING TO LOCAL HEALTH OFFICIALS FOR RECEIVING STATE AID FOR TUBERCULOSIS HEALTH CARE SERVICES

Section 43-1.11 - State aid for tuberculosis

REQUIREMENTS APPLYING TO LOCAL HEALTH OFFICIALS FOR RECEIVING STATE AID FOR TUBERCULOSIS HEALTH CARE SERVICES

43-1.11 State aid for tuberculosis.

(a) Expenses incurred by a local health official for health care services rendered to tuberculosis patients in accordance with the terms of this Subpart shall be eligible for State aid reimbursement.

(b) Such aid shall be provided to local health officials through the same procedures and at the same rate as State aid for general public health work, pursuant to Part 40 of this Subchapter.
 

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 43-1.12 - Limitations on State aid

43-1.12 Limitations on State aid.

(a) No State aid is available to local health officials or providers for tuberculosis health care services which do not meet the terms of this Subpart or:

(1) if payment of a claim is available from any other third-party payer which equals or exceeds the per diem rate or fee for services;

(2) for tuberculosis health care services for persons listed in subdivision (b) of section 43-1.3 of this Subpart; or

(3) for services for which payment by a local health official is not required under this Subpart.

(b) If a local health official pays a provider more than it was responsible to pay under section 43-1.9 of this Subpart, State aid shall not exceed the amount that would have been due if the local health official had so limited payment in accordance with said section.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.13 - Audits by local health officials

43-1.13 Audits by local health officials.

Local health officials shall audit a sufficient number of provider reports, medical records, and if necessary, interview physicians and other personnel to determine whether a provider has furnished or is furnishing tuberculosis health care services in accordance with the requirements of this Subpart.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.14 - Recovery

43-1.14 Recovery.

Local health officials shall oversee all provider efforts to identify third-party coverage and to be able to demonstrate on audit that such third-party coverage was identified and fully utilized and that the providers adhered to the terms of this Subpart. Upon receipt of audit information by the State Health Department showing State aid overpayment, the Commissioner shall deduct from the next State aid voucher the amount previously overpaid.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

LOCAL HEALTH UNIT RECORDS AND REPORTS TO STATE HEALTH DEPARTMENT

Section 43-1.15 - Records and reports

LOCAL HEALTH OFFICIAL RECORDS AND REPORTS TO STATE HEALTH DEPARTMENT

43-1.15 Records and reports.

The local health officials shall submit all reports as required by the Department.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.16 - Return of a tuberculosis patient to location of residence

43-1.16 Return of a tuberculosis patient to location of residence.

(a) A New York State resident who is receiving tuberculosis health care services in another state and desires to return to New York State shall be referred to the local health official where the patient resides. The information requested of the other state by the local health official regarding the patient, shall include at least the following:

(1) medical history including sufficient clinical data to indicate need for further care and treatment of tuberculosis;

(2) a statement that the patient is physically able to travel without harm to himself or others, and arrangements have been made for his transfer to New York State;

(3) information for residence verification;

(4) a statement indicating the patient's willingness to return to New York State for further care and treatment of tuberculosis; and

(5) names and addresses of individuals who will assume responsibility for the patient.

(b) Once residence is established and the patient is able and willing to return, final arrangements for transfer shall be made by the local health official directly with the authorities of the other state.

(c) When a non-resident tuberculosis patient is willing and able to return to the political subdivision in which the patient resides in another state or country, the local health official where the patient's provider is located, or the Commissioner's designee, shall make arrangements with the health official of the political subdivision in which the patient resides so that the patient can be met on return and be provided the health care services needed. Copies of provider reports shall also be forwarded to said health official.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.17 - Commissioner's orders

43-1.17 Commissioner's orders.

If a local health official fails to provide or secure tuberculosis health care services or to pay providers for such services rendered under the terms of this Subpart, the State Health Commissioner upon notice and opportunity to be heard may order the local health official to provide or secure the services or to make such payment.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

Section 43-1.18 - Violations by a provider

43-1.18 Violations by a provider.

A violation of any provision of this Subpart as applied to a specific patient, shall be punishable by a denial of payment of State aid reimbursement to a local health official or a provider or the repayment thereof for tuberculosis health care services for such patient.
 

Effective Date: 
Wednesday, February 8, 1989
Doc Status: 
Complete

SubPart 43-2 - HIV Uninsured Care Programs

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 201(1)(j), (q), 2776(1)(e)

Section 43-2.1 - Scope

Section 43-2.1 Scope.

These regulations govern the application and eligibility determination process for the HIV Uninsured Care Programs and establish the rights and responsibilities of applicants, participants, providers, and contractors in that process.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.2 - Definitions

43-2.2 Definitions.

(a) An applicant is a person who has directly or by a representative, applied in writing to the New York State Department of Health.

(b) An application is the process by which a person indicates, in writing on a Department of Health-approved form, his/her desire to receive assistance.

(c) Resident means a person domiciled within the State.

(d) Authorized representative means any person authorized by an applicant or participant to act on his/her behalf.

(e) Period of coverage. Coverage for assistance for each individual program component is effective as specified in the individual's notification of eligibility. Coverage will terminate under the following circumstances:

(1) the applicant indicates in writing that he/she no longer needs or desires assistance;

(2) the department determines that a change in the participant's circumstances or residence has affected his/her eligibility.

(3) the participant has died or cannot be located; and

(4) funding for the HIV Uninsured Care Programs is exhausted.

(f) Program means the HIV Uninsured Care Programs, including the following service components: (1) AIDS Drug Assistance Program, which provides coverage of medications; (2) ADAP Plus, which provides coverage for ambulatory care services; (3) ADAP Plus Insurance Continuation, which pays for insurance premiums for eligible individuals who have cost effective insurance policies; and (4) the HIV Home Care Program, which provides coverage for home care services.

(g) Household. The applicant, persons legally responsible for the applicant, and persons for whom the applicant is legally responsible, shall be considered part of the household.

(h) Income means total gross income of the household. Income shall include: monetary compensation for services, including wages, salary, commissions or fees; net income from self-employment; unemployment insurance compensation; government civilian employee or military retirement or pension, including veterans' payments; pensions or annuities; alimony or child support payments; regular contributions from persons not living in the household; net royalties; social security benefits; dividends or interest on savings or bonds; income from estates or trusts; net rental income; public assistance or welfare payments; cash or any other income resource.

(i) Available household income means the applicant's household income after deducting the amount paid by the applicant under the Federal Insurance Contributions Act for Social Security and Medicare and the cost of health care coverage paid by the applicant. (j) Provider means a medical provider, including a pharmacy, hospital, clinic, physician, laboratory or home health care agency.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.3 - Confidentiality

43-2.3 Confidentiality.

All information which may identify an applicant which is received by the program will be confidential and can only be used when necessary for supervision, monitoring or administration of the program. Information received by any contractor, his agents, employees, or by any other person or agency concerning applicants or participants in the program is confidential and may not be disclosed without the written approval of the HIV Uninsured Care Program Director, who shall approve disclosure only in conformance with Article 27-F of the Public Health Law and the federal standards with respect to the privacy and security of individually identifiable health information contained in Part 164 of Title 45 of the Code of Federal Regulations.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.4 - Use of the application form

43-2.4 Use of the application form.

(a) The State-approved application form must be completed:

(1) for each applicant upon initial application and recertification, if required; and

(2) documentation may be required when there is a change in status affecting eligibility.

(b) The signature of the individual applying for assistance is required on the State-approved application form. In any case where the applicant is incapable of signing the application because of physical incapability, or mental incompetency, application shall be signed on behalf of such a person by his/her authorized representative.

(c) The State-approved form shall contain the following information, in addition to any other information which the Department of Health may require for the proper administration of the program:

(1) name, sex, date of birth, social security number, marital status, address and telephone number of the applicant;

(2) name and relationship to applicant for applicant's household members;

(3) income information for the applicant and members of the applicant's household; and

(4) information regarding any other health benefits or insurance coverage that is available to the applicant.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.5 - Eligibility for coverage

43-2.5 Eligibility for coverage.

(a) An applicant must be confirmed as medically eligible to participate in the program. The Department of Health will confirm medical eligibility based upon information received from the applicant or the applicant's physician or the physician's designee. The applicant's physician or the physician's designee will be required to submit information regarding an applicant's medical condition on a State-approved form.

(b) Financial eligibility will be based upon the available household income.

(1) In order to be eligible, an applicant's available household income must be equal to or less than 435% of the amount under the annual United States Department of Health and Human Services poverty guidelines for the applicant's family size. Federal poverty guidelines are published annually by the Department of Health and Human Services in the Federal Register.

(2) Applicants must provide income information for a reasonable period prior to application. Applicants who are self-employed must provide business records for the three months prior to application indicating type of business, gross income and net income.

(c) Liquid resources shall be reviewed to determine their availability in determining eligibility for the program. In order to be eligible, an applicant's liquid resources must be less than $25,000. Liquid resources are cash or those assets which can be readily converted to cash such as bank accounts, lump sum payments, i.e., stocks, bonds and mutual fund shares.

(d) Full and proper use shall be made of existing public and private medical and health services and facilities for obtaining therapeutic drugs, medical services, and related supplies and equipment for the treatment of HIV or AIDS.

(e) An applicant or recipient of assistance may be required as a condition of eligibility or continued eligibility to assign any rights he/she may have for coverage benefits under any health insurance policy or group health plan to the department.

(f) In order to be eligible for ADAP Plus Insurance Continuation, an applicant must have: (1) a health insurance policy that is determined to be cost effective by the department, based on the cost of premiums, limitations of coverage (i.e., deductible, caps, co-payments) and estimates of the monetary value of projected utilization and reimbursement under the insurance policy, and (2) a premium cost that is more than 4% of the applicants available household income, if the applicants available household income is greater than 200% of the amount under the annual United States Department of Health and Human Services poverty guidelines for the applicant's family size, and (3) an employer contribution of 50% or more of the total cost of the health insurance premium, if the applicant is employed full time and eligible for employer sponsored health insurance.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.6 - Decision on eligibility

43-2.6 Decision on eligibility.

(a) The department shall make one of the following decisions, based upon the application information:

(1) Accepted for coverage. This means that eligibility has been established through review and verification to the satisfaction of the department.

(2) Not accepted for coverage. Applications are denied when the information given by the applicant establishes that the applicant is ineligible, or when the applicant refuses to comply with any requirement essential to the determination of eligibility.

(b) No decision is required when:

(1) an application is withdrawn by the applicant; or

(2) the department documents that the applicant has died, cannot be located, or has left the State prior to the completion of the review and verification.
 

Effective Date: 
Friday, September 9, 1988
Doc Status: 
Complete

Section 43-2.7 - Responsibility for prompt determination of eligibility

43-2.7 Responsibility for prompt determination of eligibility.

The decision to accept or deny the application shall be made as soon as sufficient information to make a determination about eligibility is obtained.
 

Effective Date: 
Friday, September 9, 1988
Doc Status: 
Complete

Section 43-2.8 - Notification

43-2.8 Notification.

Written notification shall be given of the decision to accept or deny an application. Notification of denial shall clearly set forth the specific reason why the application was denied.
 

Effective Date: 
Friday, September 9, 1988
Doc Status: 
Complete

Section 43-2.9 - RESERVED

43-2.9 RESERVED

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.10 - Investigation

43-2.10 Investigation.

The department official shall review and verify information received on applications, as required. Documents, personal observation, personal and collateral interviews and contacts, reports, correspondence and conferences are means of verification of information supplied. When information is sought from collateral sources, other than public records or sources designated by the applicant on the application form, the department will inform the applicant/participant or his/her representative of what information is desired, why it is needed and how it will be used.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.11 - Fraud and abuse

43-2.11 Fraud and abuse.

(a) The commissioner, his agents or designees, shall investigate and refer for prosecution any violations of State laws pertaining to fraud or abuse in the program.

(b) Where review indicates substantial evidence of abuse of the program, the participant may be removed from the program or restricted to a single provider.

(c) If the recipient did not provide accurate information regarding his income and expenses, the commissioner may summarily suspend an enrollee's participation in the program, and the department can recover the amount of assistance granted, to which the recipient is not entitled.
 

Effective Date: 
Wednesday, September 18, 1991
Doc Status: 
Complete

Section 43-2.12 - Appeals

43-2.12 Appeals.

(a) An applicant may request a reconsideration of an adverse decision within 60 days of a decision.

(b) The department shall review any additional submissions and issue a written decision within 30 days of an applicant's request and submission of additional documents.
 

Effective Date: 
Friday, September 9, 1988
Doc Status: 
Complete

Section 43-2.13 - Continuing eligibility

43-2.13 Continuing eligibility.

(a) Participants may be required to establish periodically that they remain eligible for the program.

(b) The applicant/participant must notify the department immediately of any changes in circumstances that may affect eligibility.
 

Effective Date: 
Friday, September 9, 1988
Doc Status: 
Complete

Section 43-2.14 - Enrollment of providers.

43-2.14 Enrollment of providers.

The department will contract with or enter into provider agreements with providers, including providers of related laboratory and ancillary services, which demonstrate that they are qualified to provide program services.
 

Effective Date: 
Wednesday, June 2, 2010
Doc Status: 
Complete

Section 43-2.15 - Audit and claim review

43-2.15 Audit and review.

(a) Providers shall be subject to audit and reviews for quality assurance and proper utilization by the commissioner, his agents or designees. With respect to such audits and reviews, the provider may be required:

(1) to reimburse the department for overpayments discovered by audits; and

(2) to pay restitution for any direct or indirect monetary damage to the program resulting from their improperly or inappropriately furnishing covered drugs, services, supplies or equipment.

(b) The commissioner, his agents or designees, may conduct audits and reviews, and investigate potential fraud or abuse in a provider's conduct.

(c) The commissioner, his agents or designees, may pay or deny claims, or delay claims for audit review.

(d) When audit findings indicate that a provider has provided covered drugs, services, supplies or equipment in a manner which may be inconsistent with regulations governing the program, or with established standards for quality, or in an otherwise unauthorized manner, the commissioner may summarily suspend a provider's participation in the program and/or payment of all claims submitted and of all future claims may be delayed or suspended. When claims are delayed or suspended, a notice of the withholding payment or recoupment shall be sent to the provider by the department. This notice shall inform the provider that within 30 days he/she may request in writing an administrative review of the audit determination before a designee of the commissioner. The review must occur and a decision rendered within a reasonable time after a request for review. If the designee of the commissioner decides withholding or recoupment is warranted, or if no request for review is made by the provider within the 30 days provided, the department shall continue to recoup or withhold funds pursuant to the audit determination.

(e) Where investigation indicates evidence of abuse by a provider, the provider may be fined, suspended, restricted or terminated from the program.
 

Effective Date: 
Wednesday, June 2, 2010
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Section 43-2.16 - Audits and recovery of overpayments

43-2.16 Audits and recovery of overpayments.

(a) Recovery of overpayments shall be made only upon a determination by the commissioner, his agents or designees, that such overpayments have been made, and recovery shall be made of all money paid to the provider to which it has no lawful right or entitlement.

(b) Recovery of overpayments pursuant to this subject shall not preclude the commissioner or any other authorized governmental body or agency from taking any other action with respect to the provider, including auditing or reviewing other payments or claims for payment for the same or similar periods, imposing program sanctions, or taking any other action authorized by law.

(c) The commissioner may utilize any lawful means to recover overpayments, including civil lawsuit, participation in a proceeding in bankruptcy, common law set-off, or such other actions or proceedings authorized or recognized by law.

(d) All fiscal and statistical records and reports of providers and prescriptions filled or refilled which are used for the purpose of establishing the provider's right to payment under the program, and any underlying books, records and documentation which formed the basis for such fiscal and statistical records and reports, shall be subject to audit. All underlying books, records and documentation, including all prescriptions filled or refilled, shall be kept and maintained by the provider for a period of not less than three years from the date of completion of such reports, or the date upon which the fiscal and statistical records were required to be filed, whichever is later, or the date the prescription was filled or refilled.

(e) All claims made under the program shall be subject to audit by the commissioner, his agents or designees, for a period of six years from the date of their filing, or as required by state law, regulation or funding source. This limitation shall not apply to situations in which fraud may be involved or where the provider or an agent thereof prevents or obstructs the performance of an audit pursuant to this Part.
 

Effective Date: 
Wednesday, June 2, 2010
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Section 43-2.17 - Recoupment of overpayments

43-2.17 Recoupment of overpayments.

Overpayments determined to have been made pursuant to this section and section 43-2.16 of this Subpart shall be recovered by billing the provider for reimbursement, withholding the provider's current or withholding future payments on claims submitted or a percentage of payments otherwise payable on such claims, or such other remedies as may be available through a court of law.
 

Effective Date: 
Wednesday, June 2, 2010
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Section 43-2.18 - Claims submission

43-2.18 Claims submission.

(a) Providers shall submit claims for drugs or services within ninety days of the date of service in the manner and form proscribed by the program in order to receive reimbursement.

(b) The department will not be obligated to pay claims submitted more than ninety days after the date of service. Claims submitted later than 90 days with written justification may be considered for payment if funds are available.

Effective Date: 
Wednesday, June 2, 2010
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Part 44 - State Aid For Approved Vector Surveillance And Control Programs

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 611 and 619

Section 44.10 - Purpose

44.10 Purpose.

Pursuant to Public Health Law, section 611, the New York State Department of Health (NYSDH) is authorized to pay State aid for approved vector surveillance and control programs. These rules and regulations are promulgated to define the conditions under which the NYSDH will approve vector surveillance and control activities for State aid.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.20 - Definitions

44.20 Definitions.

For the purposes of these rules and regulations, the following definitions shall apply:

(a) Arthropod shall mean a member of the phylum Arthropoda, animals with jointed appendages.

(b) Presumptive human case shall mean the occurrence of one or more of the following:

(1) California Encephalitis: Central nervous system (CNS) symptoms plus serum titers consistent with the illness for example, HI >= 1:40, CF >= 1:8 or Neut >= 3 logs.

(2) Eastern Equine Encephalitis (EEE): CNS symptoms and single serum titers consistent with the illness, for example, HI >= 1:80, CF >= 1:16.

(3) Rocky Mountain Spotted Fever: headache, fever, rash, history of tick exposure and positive serologies.

(4) St. Louis Encephalitis: CNS symptoms plus single serum titers consistent with the illness, for example, HI >= 1:80, CF >= 1:16.

(c) Confirmed human case shall mean the occurrence of one or more of the following:

(1) California Encephalitis: virus isolation and/or CNS symptoms plus four-fold or greater rise or fall in antibody titers.

(2) Eastern Equine Encephalitis (EEE): virus isolation and/or four-fold or greater rise or fall in antibody titers or 1.3 log rise or fall in neutralization index.

(3) Rocky Mountain Spotted Fever: Rickettsial isolation and/or four-fold or greater rise in antibody titers.

(4) St. Louis Encephalitis: virus isolation and/or CNS symptoms plus four-fold or greater rise or fall in antibody titers.

(d) Clustering shall mean multiple human cases of disease which may be considered related to each other by proximity, source or simultaneity of occurrence.

(e) Control shall mean any measure taken to reduce or eliminate a vector arthropod species or related disease threat. Control measures may include water management, use of biological agents, chemical ground application, chemical air application, or any other method used to reduce or eliminate vector arthropods.

(f) Endemic shall mean the continued presence of a disease in an area, or the cyclic reintroduction of a disease into the same area.

(g) Epidemic shall mean the occurrence of recognizable disease or illness in the human or animal host outside the endemic area or an excess incidence of the disease beyond that usual in an endemic area.

(h) Etiologic agent shall mean the pathogen responsible for causing a disease or illness.

(i) Host shall mean a man or other living animal, including birds and arthropods, which affords subsistence or lodgement to an infectious agent under natural conditions.

(j) Reservoir shall mean a human, animal or arthropod in which an infectious agent normally lives and multiplies and on which it depends primarily for survival and serves as a source of infection for a susceptible host.

(k) Response protocols shall mean the procedure followed by the NYSDH in response to a documented public health threat or emergency.

(l) Surveillance shall mean the epidemiologic study of a disease as a dynamic process involving the ecology of the infectious agent, the host, the reservoirs and the vectors as well as the complex mechanisms concerned in the spread of infections and the extent to which this spread occurs.

(m) Vector shall mean an arthropod species capable of carrying and transmitting a disease agent.

(n) Vector surveillance program shall mean the activities of any agency designed to accomplish any or all of the following:

(1) location of vector breeding areas;

(2) collection and identification of vector species;

(3) determination of vector population densities;

(4) determination of vector species distribution;

(5) determination of physiologic or chronologic age composition of vector population;

(6) submission of site specific groups of vector species for etiologic agent isolation attempts;

(7) assessment of the vector population to determine the effectiveness of control measures; and

(8) compilation of data generated by any or all of the above.

(o) Commissioner shall mean the Commissioner of the New York State Department of Health.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.30 - Eligibility for State aid

44.30 Eligibility for State aid.

State aid shall be paid for approved vector surveillance and vector surveillance and control programs that:

(a) have been approved in advance of implementation by the commissioner or his designee and operated in accordance with that approval;

(b) have been conducted by county or part-county departments of health or county boards of health or municipal agencies which have been designated by the county or part-county health department or county board of health for vector surveillance or vector surveillance and control programs;

(c) have operated vector surveillance programs only or have had vector surveillance and vector control activities concurrently; and

(d) have been the subject of a determination of significance pursuant to the State Environmental Quality Review Act, Article 8 of the Environmental Conservation Law and the implementing regultions issued thereunder.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.40 - Procedure for applying for State aid

44.40 Procedure for applying for State aid.

Applications for State aid for vector surveillance and vector control activities shall be on a form prescribed by the commissioner and shall be accompanied by a detailed, proposed plan of activity which shall include the following:

(a) an historical and chronological review of arthropod-borne disease activity in the area with evidence of any substantive endemic disease which has occurred during the past decade and to include the number of human cases (confirmed and presumptive), clustering of human cases; and/or isolations of the agents from vector species as well as the presence of vectors with a potential risk to human health;

(b) a detailed description of the geographic area where vector populations have occurred previously or where they could occur; a map of the county identifying these risk areas must be included; and

(c) methods by which vector populations or areas will be monitored.
 

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Section 44.41 - Additional requirements for localities applying for State aid

44.41 Additional requirements for localities applying for State aid.

(a) Nonchemical control measures. Localities applying for nonchemical control of insect vectors must include in the plan a discussion of methods of habitat modification and biological control in terms of feasibility, manpower, equipment and target species in conjunction with a comprehensive delineation of the target area and anticipated short and long-term benefits.

(b) Chemical control measures. Localities which anticipate a need for chemical control measures must submit detailed plans for such measures. Plans for pesticide application must discuss the target vector, its anticipated geographic location, manpower/equipment required, chemicals/application procedures, and pertinent safeguards which will be followed.

(c) Miscellaneous responsibilities. (1) Localities anticipating the submission of vector surveillance or vector surveillance and control activities should review the response protocols available from the New York State Department of Health.

(2) Approval of a vector control program for the purpose of State aid shall not relieve any locality of its obligation to comply with all applicable laws or regulations, including Article 8 of the Environmental Conservation Law and implementing regulations. Each application for State aid for vector control shall include a statement indicating the applicant's acknowledgement of the obligation.

(3) Counties shall submit proposals directly to the New York State Department of Health. Other municipalities shall submit plans through their respective counties. Plans must be submitted to the Department of Health by January 15th of the calendar year for which State aid will be requested. Exceptions to this deadline may be allowed by the State Department of Health if a public health threat occurs and/or in other compelling unanticipated circumstances.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.50 - Public health threat; determination

44.50 Public health threat; determination.

(a) Public health threat of an arthropod vector-borne disease based on historical risk shall be determined by the documentation of a public health threat as described in subdivision (b) of this section, once in the previous three years, or two or more times in the previous ten years, and by a finding, based upon the risk assessment considerations set forth in section 44.51 of this Part, that current conditions pose a substantial risk to human health.

(b) A public health threat of an arthropod vector-borne disease based on current activity shall be determined by the presence of human vector-borne disease or the presence of disease-specific etiologic agents in a known or suspected vector as specified below, and substantiated by information required by the risk assessment activities described in section 44.51.

(1) The presence of human vector-borne disease includes, but is not limited to:

(i) a single human or equine case of EEE;

(ii) a single human case of St. Louis Encephalitis (SLE); or

(iii) epidemiologic evidence of clustering of human cases of:

(a) California Encephalitis (CE);

(b) Rocky Mountain Spotted Fever (RMSF);

(c) Lyme disease;

(d) Babesiosis; or

(e) The occurrence of indigenous cases of other arthropod-borne etiologic agents which include, but are not limited to:

(1) dog heartworm;

(2) malaria;

(3) tularemia;

(4) powassan; or

(5) dengue.

(2) The presence of disease specific etiologic agents in a known or suspected vector includes, but is not limited to:

(i) isolation of EEE virus or SLE virus from mosquitoes or an avian host;

(ii) demonstration of vector infectivity rates in excess of 5% in known or suspected tick vectors of the rickettsia of the spotted fever group, or in excess of 30% in known or suspected tick vectors of the Lyme disease spirochete in association with documented human cases;

(iii) site specific, multiple isolations of the related alpha virus, the Highlands J (HJ) virus, from known or suspected mosquito vectors, indicative of potential EEE virus activity;

(iv) demonstration of an imminent potential for the transfer of the etiologic agent from the endemic cycle to the epidemic disease cycle, including but not limited to:

(a) the demonstration of a significant rise in antibody levels or significant IgM antibody levels in avian hosts of EEE virus or SLE virus during the recognized period of disease activity; or

(b) the demonstration of high levels of parasitemia (>20%) in the mammalian reservoirs for human babesia; or

(c) in the case of established clustering of human cases of dog heartworm, malaria, powassan, dengue or tularemia, the demonstration of infective forms or etiologic agent isolation from known or suspected arthropod vectors.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.51 - Public health threat; risk assessment and declaration

44.51 Public health threat; risk assessment and declaration.

(a) In evaluating the existence of a public health threat, the commissioner shall assess the risk to human health by taking into account the etiologic agent, the vector species, the size of the specific and secondary vector populations, the vectors' physiological age, density and proximity of human population, the time of year and weather conditions.

(b) When a locality believes that an arthropod-borne disease should be designated as a public health threat, localities should document the information and immediately notify the county health commissioner or responsible regional health director who shall information the commissioner. The person notifying the Commissioner of Health shall also send a copy of the notification to the Commissioner of Environmental Conservation.

(c) Only the commissioner may make a declaration of public health threat for state aid eligibility.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.60 - Standards for review and approval

44.60 Standards for review and approval.

(a) State aid applications for vector control activities in the absence of a concurrent arthropod vector surveillance program shall not be approved. However, there will be State aid for vector surveillance programs in the absence of control activities where the surveillance activities are directed to the detection of arthropod vector-borne diseases which may constitute a public health threat.

(b) Plans for surveillance activities must be described within the State aid application for vector surveillance (form DOH 0627-2377) and be approved in advance by the designee of the commissioner.

(c) Localities implementing nonchemical control measures should take steps that do not create any risks to public health, that minimize any risks to the environment, that can be accomplished in a cost effective manner, and produce long-term benefits to the community by permanent vector control. Each control effort must be approved by the designee of the commissioner.

(d) Requests for state aid reimbursement for pesticide spray application for vector control shall meet the following requirements:

(1) Pesticide spray applications conducted by the municipality must be in response to a public health threat determined pursuant to section 44.50 of this Part.

(2) Reserved.

(3) When pesticide control measures are found necessary, ground application of pesticides shall be the preferred method of control. No aerial pesticide application shall be approved for State aid reimbursement except under conditions involving specific arboviruses such as Eastern Equine Encephalitis or St. Louis Encephalitis and the commissioner concludes, because of the inaccessibility of the target areas by land, that aerial spraying is the only practical way in which vector control activities can be carried out. The department, in its review of each application, will consider physiography, accessibility to the area where the vector is located, rapidity of response required as determined by the seriousness of the public health threat, and the likelihood that vectors in nearby areas not subject to control measures will migrate from the area if not subject to control.

(4) If a public health threat warranting control measures is found to exist, control measures must be limited to the immediate area where the vector population has been determined to exist through vector surveillance and may include adjacent areas considered at risk for imminent disease transmissions as documented through vector surveillance activities.

(5) The pesticides to be applied and the manner of application must be approved on a timely basis in advance of use by the department and must be conditionally approved by the Department of Environmental Conservation subject to a further timely review and opportunity, pursuant to paragraph (8) of subdivision (d) of this section, for the Department of Environmental Conservation to request a modification of an order of the Commissioner of Health declaring a public health threat. Such approval will be based upon, among other things, an assessment of effectiveness of the proposed pesticides applied to control the vector in the target area including pesticide type and timing in the vector's life cycle, the potential impact of the pesticide on people and the potential adverse ecosystem effects on any proposed pesticide based on its toxicity, persistence and target organism specificity, and potential for no-target impacts.

(6) Sources for public water supplies will not be subjected to direct pesticide applications nor to the drift of such activities. Surface water shall not be subjected to mosquito larvicide application without a NYSDEC aquatic pesticide permit, when required, and any such application shall comply with the label restrictions of the pesticide used.

(7) Under conditions of a current public health threat as declared by the commissioner, the applicant shall announce to the general public, via the print and broadcast news media, the use of vector control activities in the target area at least 24 hours in advance of such use. The time period for advance notice may be shortened by the commissioner or designee in the event that 24-hour advance notice is not possible or that delay would endanger the public health. Vector control activities taken under conditions supported only by historical evidence shall be announced similarly to the general public at least 72 hours in advance of such activities.

(8) The Commissioner of Environmental Conservation shall have an opportunity to consult with the Commissioner of Health and request such modification of orders declaring public health threats as are deemed necessary to implement the purposes of the Environmental Conservation Law.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.61 - State aid reimbursement; vector surveillance and control

44.61 State aid reimbursement; vector surveillance and control.

The municipality must document within the state aid application, as a precondition for reimbursable vector surveillance and control (form DOH-0627-2378), conditions supporting a public health threat.
 

Effective Date: 
Wednesday, August 19, 1992
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Section 44.70 - Monitoring

44.70 Monitoring.

(a) Localities receiving State aid for vector surveillance and/or control will be subject to unannounced, onsite monitoring by New York State Department of Health personnel. Localities applying pesticide will be monitored more actively than those areas only engaging in surveillance.

(b) Localities conducting vector control activities shall provide to the department information used to monitor and evaluate the effectiveness of each control activity. Such information shall be submitted to the department as part of the locality's monthly report in the format described in the response protocols.
 

Effective Date: 
Wednesday, August 19, 1992
Doc Status: 
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Section 44.80 - Claiming State aid

44.80 Claiming State aid.

Counties with State aid applications approved in advance of implementation shall submit vouchers for vector surveillance and/or vector control activities through the same procedure and at the same rate as State aid for general public health work, pursuant to Part 40 of this Title.
 

Effective Date: 
Wednesday, December 31, 2014
Doc Status: 
Complete

Section 44.90 - State aid reimbursement amounts

44.90 State aid reimbursement amounts.

Under emergency situations, the department shall reimburse counties or municipalities for 50 percent of the cost for emergency vector control measures as approved by the department. Emergency funds will only be available after the county or municipality has expended all other forms of State aid for vector surveillance and vector control programs.
 

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Part 45 - Cystic Fibrosis Health Care Program Adult Cystic Fibrosis Assistance Program

Doc Status: 
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Statutory Authority: 
Public Health Law, art. 27-G

Section 45.1 - Medical care and/or insurance premium reimbursement

Section 45.1 Medical care and/or insurance premium reimbursement.

Reimbursement for medical care for the treatment of cystic fibrosis patients and/or medical insurance premiums for cystic fibrosis patients will be made on behalf of patients enrolled in the Adult Cystic Fibrosis Assistance Program.
 

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Section 45.2 - Definitions

45.2 Definitions.

(a) Medical care for cystic fibrosis means such diagnostic, therapeutic and rehabilitative care by medical and paramedical personnel, including hospital and related care, drugs, prostheses, appliances, procedures, equipment and devices, as necessary for the treatment of cystic fibrosis and any conditions demonstrated to result from the progress or treatment of cystic fibrosis.

(b) Net annual income means gross income of the patient and/or patient's spouse, less State, local and Federal income taxes, and social security deductions.
 

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Section 45.3 - Eligibility criteria

45.3 Eligibility criteria.

(a) To be eligible for medical care reimbursement for cystic fibrosis and/or medical insurance premium payment through this program, such individual:

(1) shall be at least 21 years old;

(2) shall have been diagnosed as having cystic fibrosis;

(3) shall have resided in New York State for a minimum of 12 continuous months immediately prior to application for services from the Adult Cystic Fibrosis Assistance Program;

(4) shall not be eligible for medical benefits under any group or individual health insurance policy;

(5) shall not be eligible for medical assistance (Medicaid) pursuant to title 11 of article five of the Social Services Law solely due to earned income;

(6) shall submit an application and provide such other information, including documentation of net annual income, as required by the commissioner; and

(7) shall pay annually seven percent of his or her net annual income toward the cost of medical care related to cystic fibrosis and/or the cost of annual health insurance premiums at such intervals as are agreed upon by an authorized representative of the commissioner.

(b) To be a partially eligible individual for whom medical care reimbursement for cystic fibrosis and/or medical insurance premium payment will be provided through this program on a supplemental basis, such individual shall meet all criteria of a fully eligible individual except that a partially eligible individual shall have medical care reimbursement benefits available under a group or individual health insurance policy which does not provide full coverage for the care and treatment of cystic fibrosis.
 

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Section 45.4 - Qualified consultants

45.4 Qualified consultants.

Professional services rendered by medical specialists or consultants will be approved for reimbursement only if rendered by personnel listed in the department's file of clinical consultants and, when in-hospital care is required, if the hospital meets standards set forth in section 45.8 of this Part.
 

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Section 45.5 - Hospital and related medical care

45.5 Hospital and related medical care.

Reimbursement for inpatient and outpatient care rendered by hospitals and other facilities established pursuant to article 28 shall be made at rates not to exceed those established for patients eligible for medical assistance (Medicaid).
 

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Section 45.6 - Payment for outpatient and related medical care

45.6 Payment for outpatient and related medical care.

Fees for outpatient and related medical care may not exceed those established pursuant to title 11 of article five (Medicaid) of the Social Services Law.
 

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Section 45.7 - Out-of-state care

45.7 Out-of-state care.

Out-of-state care will not be approved for State aid reimbursement unless specific exception is made by an authorized representative of the commissioner for just cause.
 

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Section 45.8 - Accredited hospital

45.8 Accredited hospital.

Payment for care in hospitals will be made only if the hospital possesses a valid operating certificate from the commissioner if it is located within the State or appears on the Joint Commission on Accreditation of Hospitals list of approved hospitals if it is located out-of-state.
 

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Section 45.10 - Confidentiality

45.10 Confidentiality.

Medical, financial and personal information provided to the Adult Cystic Fibrosis Assistance Program to establish and maintain eligibility shall be kept confidential in accordance with Public Health Law, section 206(1)(j).

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Section 45.11 - Payor of last resort

45.11 Payor of last resort.

In all cases, the Adult Cystic Fibrosis Assistance Program shall be the payor of last resort.
 

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Section 45.9 - Foreign diplomatic personnel

45.9 Foreign diplomatic personnel.

No medical services shall be approved for State aid reimbursement under this program for any staff member of a foreign legation, consulate, embassy or mission, or for any child of such staff member who resides with such staff member. Provision of medical services shall be the responsibility of the foreign country through its appropriate representative in the United States.
 

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Part 46 - State Aid For Physically Handicapped Children

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Statutory Authority: 
Public Health Law, Sections 2500-a, 2583

Section 46.1 - Definition of medical service

Section 46.1 Definition of medical service.

Medical service, as it relates to physically handicapped children, means such diagnostic, therapeutic and rehabilitative care by medical and paramedical personnel, including hospital and related care, and drugs, prostheses, appliances, equipment and devices, as necessary.
 

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Section 46.2 - Conditions eligible

46.2 Conditions eligible.

Conditions for which medical service is reimbursable under State aid to counties or the City of New York under the physically handicapped children program shall be only those approved by the Bureau of Medical Rehabilitation, the Bureau of Dental Health, or the Bureau of Maternal and Child Health of the State Department of Health.
 

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Section 46.3 - Qualified consultants

46.3 Qualified consultants.

Professional services rendered by medical and dental specialists or consultants will be approved for reimbursement only if rendered by personnel listed in the department's file of clinical consultants and, when in-hospital care is required, if the hospital meets standards set forth in section 46.4 of this Part.
 

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Section 46.4 - Accredited hospitals

46.4 Accredited hospitals.

Payment for care in hospitals will be made only if the hospital appears on the department's list of accredited hospitals, and the care is supervised by a consultant listed in the department's file of clinical consultants as set forth in section 46.3 of this Part.
 

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Section 46.5 - Maximum fees

46.5 Maximum fees.

State aid for service rendered will not be paid in excess of the fees included in the schedule of maximum fees established by the State Department of Health.
 

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Section 46.6 - Inpatient hospital and related care

46.6 Inpatient hospital and related care.

Reimbursement for inpatient care rendered by hospitals shall be made at all-inclusive per diem rates not to exceed those established by the State of New York Joint Committee on Hospital Rates.
 

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Section 46.7 - Payment for outpatient and related service

46.7 Payment for outpatient and related service.

Fees for outpatient and related service may not exceed those established in the department's schedule of maximum fees.
 

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Section 46.8 - Out-of-state care

46.8 Out-of-state care.

Out-of-state care will not be approved for State-aid reimbursement unless specific exception is made by the Commissioner of Health.
 

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Section 46.9 - Procedures and treatment at approved centers

46.9 Procedures and treatment at approved centers.

(a) Heart surgery. Definitive diagnoses and surgical procedures by open or closed techniques will be approved for State-aid reimbursement by the Bureau of Medical Rehabilitation only when such services are performed at centers specifically approved by the department for the type of heart surgery involved.

(b) Other specific conditions. Unless specific exception is made by the Commissioner of Health, State-aid reimbursement shall be made for the initial evaluation and recommendations for a treatment program for children with the following conditions only when such services are performed at centers approved by the Commissioner of Health for such care:

(1) amputation;

(2) chronic asthma;

(3) blood dyscrasias;

(4) cancer;

(5) convulsive disorders;

(6) cystic fibrosis;

(7) diabetes mellitus;

(8) impaired hearing;

(9) complicated injuries, particularly to head and back, and mutilating injuries of the face and extremities;

(10) prematurity;

(11) chronic renal disease;

(12) phenylketonuria;

(13) branched-chain ketonuria;

(14) galactosemia;

(15) homocystinuria;

(16) histidinemia;

(17) congenital hypothyroidism.
 

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Section 46.10 - Financial investigators

46.10 Financial investigators.

(a) Definition. A financial investigator is a person employed under a county physically handicapped children's program for the purpose of:

(1) conducting financial investigations of families of children for whom care has been requested under the program; and

(2) detecting problems in families which may have a bearing on the utilization or outcome of services provided under the program, and referring families to appropriate agencies for help regarding these problems.

(b) Qualifications. The financial investigator shall meet one of the following qualifications:

(1) graduation from a recognized college or university with a bachelor's degree;

(2) satisfactory completion of training leading to nursing registration, and one year of satisfactory full-time experience as a registered professional nurse;

(3) four years of satisfactory full-time paid experience either in financial investigations or in casework with a social work agency adhering to acceptable standards or in supervised teaching in an accredited school;

(4) a satisfactory combination of the training and experience described in paragraphs (1)-(3) of this subdivision; or

(5) full-time employment specifically in the performance of financial investigations under the physically handicapped children's program as of April 1, 1964.
 

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Section 46.11 - Foreign diplomatic personnel

46.11 Foreign diplomatic personnel.

No medical services shall be approved for State-aid reimbursement under this program for any staff member of a foreign legation, consulate, embassy or mission, or for any child of such staff member who resides with such staff member. Provision of medical services shall be the responsibility of the foreign country through its appropriate representative in the United States.
 

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Part 47 - New York State Health Service Corps/Obstetric And Pediatric Practitioner Incentive Demonstration Program

Effective Date: 
Wednesday, October 13, 1993
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Statutory Authority: 
Public Health Law, Secs. 231, 232, 233 2506

SubPart 47-1 - New York State Health Service Corps

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
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Statutory Authority: 
Public Health Law, Secs. 231, 232, 233

Section 47-1.1 - Definitions

Section 47-1.1 Definitions

(a) State Health Service Corps professional shall mean a health professional in any one of the professions listed below or any other health professional, excluding physician or dentist, determined by the Commissioner of Health, in consultation with the State Health Service Corps advisory committee to be needed in designated facilities or agencies:

(1) A registered professional nurse;

(2) A registered physician's assistant;

(3) A dental hygienist;

(4) An occupational therapist;

(5) A physical therapist;

(6) A speech-language pathologist;

(7) An audiologist;

(8) A pharmacist;

(9) A midwife; and

(10) Any other health profession identified by participating agencies as being difficult to recruit. Scholarships in these occupations will be offered on a limited basis for no more than two years.

(b) State Health Service Corps advisory committee shall mean a committee composed of the Commissioners of the Departments of Health, Education and Correctional Services, the Commissioners of the Office of Mental Health and the Office of Mental Retardation and Developmental Disabilities and the Presidents of the Civil Service Commission and the Higher Education Services Corporation or their designees, established to advise the Commissioner of Health on issues related to the State Health Service Corps.

(c) Designated facility or agency shall mean a facility or institution designated by the Commissioner of Health, in consultation with the State Health Service Corps advisory committee that is:

(1) operated by:

(i) the Office of Mental Health;

(ii) the Office of Mental Retardation and Developmental Disabilities;

(iii) the Department of Correctional Services; or

(2) not-for-profit and licensed by the Office of Mental Retardation and Developmental Disabilities or the Office of Mental Health or under contract with the Commission for the Blind and Visually Handicapped;

(3) a not-for-profit diagnostic and treatment center, with an operating certificate issued pursuant to section 401.1 of this title, which has a critical shortage of health personnel, as determined by the commissioner, and which serves the medically indigent and Medicaid- eligible persons;

(4) a health care facility or non-profit or public agency which provides care or treatment to persons infected with the human immunodeficiency virus or who have acquired immunodeficiency syndrome and which are currently experiencing a shortage of health personnel to specifically serve such persons, or

(5) in the case of midwives, a not-for-profit facility with an operating certificate issued pursuant to section 401.1 of this title, which serves the medically indigent and Medicaid-eligible women.

(d) Licensure shall mean possession of a license, registration or certificate to practice in one of the professions listed in subsection (a) of this section issued by the appropriate governing agency.

(e) Academic year shall mean the period between July 1 and June 30 of the following year.

(f) Full-time enrollment shall mean matriculation as a college or university student taking at least 12 credits or their equivalent, except that in the final semester of study in which the student must take sufficient credits or their equivalent in order to complete training, but not fewer than six credits.

(g) Scholarship or fellowship award shall mean the sum of the State Health Service Corps funds paid to or on behalf of a State Health Service Corps recipient during one academic year. The award shall not exceed the cost of attendance which shall mean tuition, required fees, books, transportation, and room and board.

(h) Effective date of award shall mean the beginning date of the first semester for which the scholarship or fellowship recipient has received a State Health Service Corps award.

(i) Service obligation shall mean the period of time a State Health Service Corps scholarship or fellowship recipient is required to work a basic work-week as an employee of a designated facility or agency.

(j) Alternative service shall mean working a basic work week as a paraprofessional or in a profession other than the one for which the award was given in fulfillment of the service obligation.

(k) State Health Service Corps recipient shall mean an individual who has signed a service agreement to receive a scholarship or fellowship award under the State Health Service Corps program in return for a service obligation.

(l) Service agreement shall mean the written agreement to be signed by a State Health Service Corps recipient specifying the terms of the award and the service obligation required prior to issuance of an award.

(m) Reporting date shall mean the date upon which a State Health Service Corps recipient is required to begin employment in fulfillment of his/her service obligation.

(n) Rescission shall mean the withdrawal of an award after the signing of the service agreement but before full payment for an award is made to an educational institution. (o) Waiver shall mean full or partial release by the Commissioner of Health, of the service obligation and/or any financial obligation for repayment of scholarship or fellowship award monies incurred by a State Health Service Corps award recipient.

(p) Deferral shall mean a delay or temporary suspension of the award payment and/or service obligation and/or any financial obligation for repayment of award monies incurred by the State Health Service Corps award recipient, with no resulting reduction in service or financial obligation.

(q) Default shall mean the failure to complete program of study, or the failure to begin the service obligation on the reporting date, or the failure of a State Health Service Corps recipient to complete his/her service obligation within the time prescribed by the Commissioner of Health.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.2 - Eligibility for an award

47-1.2 Eligibility for an award.

(a) To be eligible for a State Health Service Corps award, an individual must:

(1) show evidence of enrollment or acceptance for full-time study in a professional study program in an institution approved by the Board of Regents. The Commissioner of Health may permit individuals who are not enrolled or who have not been accepted for enrollment to apply for an award, but an award will not be made until the individual provides evidence of acceptance into an institution approved by the Department of Health pursuant to standards established in this Title, or the Board of Regents. The Commissioner of Health may permit individuals who submit satisfactory medical statements substantiating a serious illness or disability that precludes full-time attendance to attend part-time;

(2) be pursuing a program of continuous undergraduate or graduate education in a health care profession as defined in section 47.1(a) of this Part;

(3) be within 24 months of completing the program of study and being eligible to apply for licensure, registration or certification in the profession of study;

(4) be a United States citizen or resident alien who is holding a valid I-551 card or a valid I-151 card issued by the U.S. Immigration and Naturalization Service;

(5) meet the character and moral standards required for licensure under section 6524, subsection 7 of the State Education Law; and

(6) complete, sign and file an application using prescribed forms which must be filed within specified time frames. All required supplementary documents must be filed as directed. Incomplete, illegible or vague applications may be rejected. Applications filed after the deadlines specified may be rejected.

(b) An individual may be determined to be ineligible to receive a State Health Service Corps scholarship or fellowship award if:

(1) the individual is already receiving any other scholarship or fellowship award that requires the fulfillment of a service obligation;

(2) the individual is employed by the State of New York and is granted educational leave with pay from the position held except in the instance of extreme hardship as determined by the Commissioner of Health;

(3) the individual is identified by Higher Education Services Corporation as having defaulted on the repayment of a guaranteed student loan; or

(4) the individual is not a resident of New York State and plans to attend or attends an educational institution located out of state.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.3 - Selection of award recipients

47-1.3 Selection of award recipients.

(a) Process. The Commissioner of Health in consultation with the State Health Service Corps advisory committee shall select award recipients based on the criteria and preferences described in subdivisions (b) and (c) of this section; however, no award shall be given to an applicant unless a designated facility or agency has expressed a willingness to employ the applicant upon completion of the applicant's education.

(b) Preference. Preference shall be given to persons in the following categories, in the order of priority stated:

(1) holders of a prior State Health Service Corps award who have maintained an acceptable academic performance, provided they meet all requirements of chapter 355 of the Laws of 1985 and regulations of the Commissioner of Health. Recipients are limited to one award annually and are eligible for annual awards for two consecutive academic years. Holders of awards may be required to submit such supplemental data as required by the department;

(2) a New York State resident attending or planning to attend a New York State educational institution;

(3) a New York State resident attending or planning to attend an educational institution located out of state; and

(4) persons who are not residents of New York State attending or planning to attend a New York State educational institution.

(c) Selection criteria. All eligible applications will be reviewed competitively using the following criteria:

(1) the need, as determined the Commissioner of Health and the State Health Service Corps advisory committee, for the profession for which a scholarship is being sought in the designated facilities or agencies and region(s) where the applicant is willing to work;

(2) academic performance and academic awards or honors;

(3) special training and education relevant to the needs of the population to be served;

(4) work experience in the chosen health profession;

(5) work or volunteer experience with the population to be served;

(6) demonstrated commitment to working with the population to be served;

(7) civic or community awards and honors; and

(8) special skills or abilities or background or experience which will facilitate working with the population to be served.

(d) Number of awards. The Commissioner of Health shall make as many awards as permitted by statute and for which there is available funding. The Commissioner of Health may make fewer awards than permitted by statute if, in consultation with the State Health Service Corps advisory committee, it is determined that no eligible applicants meet minimum qualifications, based on such criteria as those listed in the selection criteria in subdivision (c) of this section.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.4 - Maintaining eligibility for awards

47-1.4 Maintaining eligibility for awards.

(a) Full-time continuous enrollment. Award recipients must be enrolled full-time except as permitted by section 47.2 (a)(1) and in good standing in accordance with the standards and regulations established by the New York State Higher Education Services Corporation and the institution where the award recipient is receiving training. The recipient who receives awards for completing two years of education must do so in two consecutive academic years.

(b) Transfers. An award recipient may receive permission from the Commissioner of Health to transfer to another institution provided:

(1) the recipient continues training in the profession for which the award was granted;

(2) the transfer does not increase the total period of training; and

(3) the school to which the recipient transfers has a program approved by the New York State Department of Health pursuant to standards established in this Title, or the New York State Board of Regents.

(c) Reporting requirements. Award recipients must report semiannually to the Department of Health and the Higher Education Services Corporation on forms and at such times as required by these agencies.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.5 - Award rescission and deferrals

47-1.5 Award rescission and deferrals.

(a) Award rescission. An award may be rescinded by the Commissioner of Health if:

(1) the recipient fails to execute a student payment application (form HE8030) with the Higher Education Services Corporation or fails to follow the Higher Education Services Corporation or Department of Health reporting requirements;

(2) the recipient withdraws from school or otherwise fails to maintain full-time enrollment;

(3) the recipient is convicted of any felony;

(4) the recipient fails to maintain good academic standing; or

(5) the recipient is found to have provided fraudulent or willfully misrepresented information in the application or supporting documents.

(b) Award deferral. An award may be postponed or deferred temporarily by the Commissioner of Health because of one or more of the conditions described in subdivision (a) of this section if it is determined that the condition will be corrected in a reasonable time or if the circumstances warrant a deferral rather than a rescission.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.6 - Service obligation

47-1.6 Service obligation.

(a) Service obligation. A State Health Service Corps award recipient is required to work full-time in a designated facility or agency for 18 months in the profession he/she has received an award. A recipient will be required to complete his/her service obligation by working from the reporting date to completion of his/her service obligation without interruption.

(b) Reporting date. A State Health Service Corps recipient is required to begin his/her service obligation within 60 days of either completing the education for which he/she has received a State Health Service Corps award, or receiving a license in that profession whichever comes later, except that the reporting date shall not exceed:

(1) 30 months from the effective date of the first scholarship award if the recipient has received two awards; and

(2) 18 months if the recipient has received one award.

(i) In the case of a recipient whose award has been deferred, the period of time of the approved deferral shall not be included in the calculation of the reporting date described in this section.

(ii) If no appropriate position exists in any designated facilities or agencies for the recipient, the reporting date shall be extended until such a position becomes available.

(c) Alternative service. In the event a recipient fails to qualify for licensure or is unable to fulfill the service obligation in the profession for which the State Health Service Corps scholarship award is given, the Commissioner of Health, in consultation with the State Health Service Corps advisory committee, may permit the individual to provide alternative service which would meet the intent of the public service obligation.

(d) Service performance. Each recipient while employed in a designated facility or agency shall abide by all of the performance rules or requirements of that agency. Loss of employment due to unsatisfactory performance will result in default.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.7 - Service obligation: deferrals and waivers

47-1.7 Service obligation: deferrals and waivers.

(a) Service deferral. The Commissioner of Health may delay or defer the reporting date, the service obligation or the repayment obligation incurred by a State Health Service Corps recipient due to extreme hardship. Extreme hardship includes, but is not limited to: serious illness or injury of the recipient or an immediate family member and other circumstances beyond the control of the recipient that would make it difficult or impossible for the recipient to fulfill the service obligation or repay the State of New York.

(b) Waiver. The Commissioner of Health may waive all or part of the service obligation and/or any repayment obligation incurred by an award recipient for reasons described in subdivision (a) of this section.

(c) Evidence of hardship. The recipient must submit, in writing, ample evidence of hardship when requesting a deferral or waiver. Applications for deferral or waiver shall be submitted on forms prescribed by the Department of Health and may include sworn statements and appropriate documentation of the recipient's claim.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.8 - Default

47-1.8 Default.

(a) A recipient of an award will be considered in default if the recipient has not been granted a waiver or deferral by the Commissioner of Health and:

(1) the scholarship award is rescinded after disbursal of scholarship monies on the recipient's behalf; or

(2) the recipient is not available to fulfill his/her service obligation on the reporting date; or

(3) the recipient fails to complete a training program; or

(4) the recipient resigns, is dismissed from employment or otherwise fails, refuses or is unable to fulfill the service obligation.

(b) An individual found to be in default will be required to pay the State, within five years from the date of default, all monies received, plus interest, plus liquidated damages as determined by the following formula:

A = 2B (T-S) ________

T

"A" is the amount the State is entitled to recover; "B" is the sum of all payments made to the recipient and the interest on such amount which would be payable if at the time such awards were paid they were loans bearing interest at the maximum prevailing rate determined by the Higher Education Services Corporation; "T" is the total number of months in the recipient's period of obligated service; and "S" is the number of months of service actually rendered by the recipient.

(c) Department of Health shall advise the Higher Education Services Corporation of any default, and the Higher Education Services Corporation shall collect repayments and, where indicated, initiate action for prosecution to recover monies owed the State.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-1.9 - Administration

47-1.9 Administration.

(a) Acceptance and service agreement. Prior to being certified for payment, successful applicants must sign a written acceptance of the award and a service agreement describing the conditions of the award, the service obligation, and the terms of repayment.

(b) Disbursements and collections. The Higher Education Services Corporation will be responsible for disbursements to or on behalf of the scholarship recipient. A State Health Service Corps recipient is required to comply with all administrative and reporting requirements established by the Higher Education Services Corporation.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

SubPart 47-2 - Obstetric and Pediatric Practitioner Incentive Demonstration Program

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Secs. 231, 232, 233, 2506

Section 47-2.1 - Definitions.

Section 47-2.1 Definitions.

(a) "Program" means the Obstetric and Pediatric Practitioner Incentive Demonstration Program, also known as the Obstetric and Pediatric Malpractice Insurance Subsidy Program, as administered by the New York State Department of Health.

(b) "Obstetric practitioner" means:

(1) a New York State licensed physician who is board certified or an active candidate for board certification in obstetrics;

(2) a New York State licensed physician who is board certified or eligible for board certification in family practice and who provides obstetrical services;

(3) a New York State Education Department licensed midwife or person certified to practice midwifery by the Department of Health; or

(4) a licensed registered nurse certified as an obstetric nurse practitioner by the New York State Education Department.

(c) "Pediatric practitioner" means:

(1) a New York State licensed physician who is board certified or eligible for board certification in Pediatrics; or

(2) a licensed registered nurse certified as a pediatric nurse practitioner by the New York State Education Department.

(d) "Obstetric Group Practice" means an obstetric practitioner with an arrangement to practice with one or more other obstetric practitioners whether by partnership agreement or by forming a professional corporation.

(e) "Covered services" means prenatal, delivery and post-partum services provided by an obstetric practitioner or pediatric services provided by a pediatric practitioner for children under the age of one in a private individual or group practice, or in a comprehensive diagnostic and treatment center (1) through the Prenatal Care Assistance Program, or the Medical Assistance Program under the Social Services Law; or (2) to women and children who are not covered for obstetric or pediatric services by the programs set forth in paragraph (1) of this subdivision, or by private health insurance; or (3) through a program approved by the commissioner pursuant to section 2506(4) of the Public Health Law, under which the services are provided as part of a program provided by a general hospital or a city or a county health department and without remuneration to the practitioner.

(f) "Target population" means pregnant women and children up to the age of one who (1) are eligible for the Prenatal Care Assistance Program or the Medical Assistance Program under the Social Services Law; or (2) are not covered for obstetric or pediatric services by the programs set forth in paragraph (1) of this subdivision or by private health insurance; or (3) are eligible for a program approved by the commissioner pursuant to Section 2506(4) of the Public Health Law under which the services are provided as part of a program provided by a general hospital or a city or a county health department and without remuneration to the practitioner.

(g) "Malpractice insurance premium" means the cost of professional liability insurance coverage for the contract period.

(h) "Contractor" means an eligible obstetric or pediatric practitioner or group practice who has contracted with the Department of Health for a subsidy.

(i) "Subsidy" means the amount of remuneration a contractor may receive through this Program for his/her malpractice insurance premium.

(j) "Designated pediatric area" means a Federally designated Health Professional Shortage Area or an area designated by New York State Board of Regents as a Regents Physician Loan Forgiveness Area.

(k) "New pediatric practitioner" means a pediatric practitioner who is proposing to begin practice, or began practice, six months before or after filing an application for a subsidy, in a designated pediatric area.

(l) "Additional service obstetric practitioner" means an obstetric practitioner or obstetric group practice that agrees to increase the number of the target population provided covered services.

(m) "Disproportionate share obstetric practitioner" means an obstetric practitioner or obstetric group practice that has in the past provided and agrees to continue to provide covered services to a high number of the target population.

(n) "High-number" means 1/3 the average number of deliveries performed per year per obstetrician, family practitioner, or nurse midwife, as determined by the Department of Health.

(o) "Full-time pediatric practice" means providing patient care services at least 37.5 hours per week during at least 46 weeks per year in a designated pediatric area. Up to 8 hours per week providing services to residents from the designated pediatric area in a hospital located outside the designated area may be counted towards those hours.

(p) "General pediatric services" means ambulatory health care services provided to children under the age of one.

(q) "Comprehensive obstetrical services" means prenatal, delivery and post-partum services.

(r) "Application" means an application for a contract submitted by an obstetric practitioner, obstetric group practice, or pediatric practitioner on forms prescribed by the Department. (s) "Average obstetrical malpractice premium (AOMP)" means the amount determined by the commissioner to reflect the average malpractice insurance premium per delivery for obstetricians in a geographic region.
 

Doc Status: 
Complete

Section 47-2.2 - Practice requirements/eligibility

47-2.2 Practice requirements/eligibility.

(a) A new pediatric practitioner may be eligible to contract with the Program if the practitioner:

(1) agrees to provide pediatric services full-time in a designated pediatric area;

(2) agrees that the ratio of the practice's target patient population to the total patient population will be equal to or greater than the ratio of the target population in the designated area to the total population in that designated area;

(3) agrees to provide medical care in accordance with accepted medical standards (for example, standards accepted by the American College of Pediatricians);

(4) has the education, training and access to health care facilities to provide pediatric services to the eligible population (or, for a pediatric nurse practitioner, a practice arrangement with a pediatric practitioner who meets such requirements) including:

(i) hospital admitting privileges;

(ii) arrangements for twenty-four hour backup coverage; and

(iii) has purchased medical malpractice insurance from a medical liability insurer; and

(5) is responsible for paying his/her own malpractice insurance premiums or is a member of a partnership or professional corporation which is responsible for paying his/her malpractice insurance premiums.

(b) An additional service obstetric practitioner may be eligible to contract with the Program if the practitioner:

(1) agrees to increase the number of the target population provided comprehensive obstetrical services over the number served preceding the application;

(2) agrees to provide medical care in accordance with accepted medical standards (for example, standards accepted by the American College of Obstetricians and Gynecologists, the American Academy of Family Practitioners, or the American College of Nurse- Midwives);

(3) has the education, training and access to health care facilities to provide obstetric services to the eligible population (or, for obstetric nurse practitioners, a practice arrangement with an obstetric practitioner who meets such requirements) including:

(i) hospital admitting and delivery privileges in a hospital with maternity services or practice privileges in a birth center; and

(ii) arrangements for twenty-four hour backup coverage; and

(iii) has purchased medical malpractice insurance from a medical liability insurer; and

(4) is responsible for paying his/her/their own malpractice insurance premiums or is a member of a partnership or professional corporation which is responsible for paying his/her malpractice insurance premiums.

(c) A disproportionate share obstetric practitioner may be eligible to contract with the Program if the practitioner:

(1) agrees to maintain his/her/their current high number of the target population provided comprehensive obstetrical services: the number of deliveries required to be performed to be considered a group providing a disproportionate share of services is the sum of those required for each individual to be a disproportionate share provider;

(2) agrees to provide medical care in accordance with accepted medical standards (for example, standards accepted by the American College of Obstetricians and Gynecologists, the American Academy of Family Practitioners, or the American College of Nurse- Midwives);

(3) has the education, training and access to health care facilities to provide obstetric services to the eligible population (or for obstetric nurse practitioners, a practice arrangement with an obstetric practitioner who meets such requirements) including:

(i) hospital admitting and delivery privileges in a hospital with maternity services or practice privileges in a birth center;

(ii) arrangements for twenty-four hour backup coverage; and

(iii) has purchased medical malpractice insurance from a medical liability insurer; and

(4) is responsible for paying his/her/their own malpractice insurance premiums or is a member of a partnership or professional corporation which is responsible for paying his/her/their malpractice insurance premiums.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-2.3 - Amount of subsidy

47-2.3 Amount of subsidy.

(a) A new pediatric practitioner may receive a subsidy in an amount equal to his/her malpractice insurance premium for the contract period up to a maximum of $10,000.

(b) An additional service obstetric practitioner may receive a subsidy equal to the AOMP for each delivery to a member of the target population during the contract period above the number of deliveries of the target population performed during the calendar year prior to the date of original application, proportioned to the contract period. A maximum of $30,000 per year is allowed per obstetric practitioner in a solo or group practice who qualifies under section 47-2.2(b) which will be prorated for shorter contract periods. The number of deliveries performed by a group practice will be based on the total number performed by all practitioners in the group.

(c) A disproportionate share obstetric practitioner may receive a subsidy equal to the AOMP for each member of the target population delivered during the contract period over the minimum number of deliveries of the target population considered a disproportionate share, proportioned to the contract period. A maximum subsidy of $10,000 per year will be allowed per obstetric practitioner in a solo or group practice who qualifies under section 47-1.2(c) which will be prorated for shorter contract periods. The number of deliveries performed by a group practice will be based on the total number performed by all practitioners in the group.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-2.4 - Payment of subsidy

47-2.4 Payment of subsidy.

If a practitioner is a solo practitioner responsible for payment of his/her malpractice insurance premium, such subsidy will be paid directly to the practitioner. If the practitioner is a member of a partnership or professional corporation which is responsible for payment of his/her malpractice insurance premiums, such subsidy will be paid to the partnership or professional corporation.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

Section 47-2.5 - Selection of contractors

47-2.5 Selection of contractors.

(a) Process. Contractors shall be selected based on the criteria described in subdivisions (b) and (c) of this section to the extent funds are available for contracts; however, a practitioner who is not eligible to enroll in the medical assistance program as a Medicaid provider or who is under suspension, exclusion or involuntary withdrawal from participation in the medical assistance program shall not be eligible for a contract under this Part.

(b) Preference. Preference shall be given to practitioners in the following categories in the order of listing:

(1) An additional service obstetric practitioner who has had a contract, satisfactorily met the contract's terms and conditions, and is requesting a second contract.

(2) A new pediatric practitioner who has a new pediatric practitioner contract, satisfactorily met the contract's terms and conditions, and is requesting a second contract.

(3) An additional service obstetric practitioner applying for an initial contract.

(4) A new pediatric practitioner applying for an initial contract.

(5) A disproportionate share obstetric practitioner applying for an initial or additional contract.

(c) Selection criteria. If funds available for the program are not sufficient to cover all eligible applicants within a category listed in subdivision (b) above, then applicants within that category shall be reviewed competitively using the following criteria:

(1) the extent of the practitioner's potential contribution towards increasing covered services available to the target population;

(2) the need for covered services to the target population in the designated area or location;

(3) in the case of an obstetric practitioner, the extent of participation in the New York State Department of Health Prenatal Care Assistance Program;

(4) the extent of participation in a Medicaid managed care program if there is a New York State Department of Social Services approved program in the social services district; and

(5) the demonstrated commitment of the applicant to serve the target population and the education, training or other experience of the applicant to provide obstetric or pediatric services to the target population.
 

Doc Status: 
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Section 47-2.6 - Program administration and process.

47-2.6 Program administration and process.

(a) Applicants shall apply to the New York State Department of Health on such forms and provide such information as the Department determines is necessary to administer the program.

(b) Applicants who are practitioners in an obstetric group practice must submit an application as a group.

(c) To obtain a subsidy, applicants who are selected and approved must enter into a contract with the Department. The contract will include the minimum level of services to be provided, recording requirements, payment schedule and other requirements.
 

Effective Date: 
Wednesday, October 13, 1993
Doc Status: 
Complete

SubPart 47-3 - DESIGNATION OF UNDERSERVED AREAS

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, sections 901, 903 and 904

Section 47-3.1 - Underserved areas

Section 47-3.1 Underserved areas.

For purposes of Section 903(2)(a) of the Public Health Law, the Resident Loan Repayment Program; Section 903(2)(b) of the Public Health Law, the Physician Loan Repayment Program; and, Section 904 of the Public Health Law, the Primary Care Practitioner Scholarship Program, underserved areas shall be located in New York State and shall include the following:

(a) areas designated by the federal government as a Health Professional Shortage Area;

(b) not-for-profit diagnostic and treatment centers, with an operating certificate issued pursuant to section 401.1 of this Title which serve the medically indigent and Medicaid-eligible persons;

(c) facilities participating in state-supported rural health networks;

(d) programs receiving federal Title 10 funding;

(e) Department of Health approved Prenatal Care Assistance Programs;

(f) facilities or programs supported by the Department of Health Primary Care Services Grant program, pursuant to Section 2807 of the Public Health Law;

(g) school-based clinics providing primary care services;

(h) Department of Health designated AIDS service sites;

(i) state operated facilities;

(j) facilities and service sites operated by county health departments;

(k) sites serving the homeless or Native Americans;

(l) facilities licensed by the Office of Alcoholism and Substance Abuse Services;

(m) managed care plans approved by the Commissioner;

(n) other sites, areas and facilities determined by the Commissioner to have a significant need for additional primary care physicians and primary care practitioners.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

SubPart 47-4 - Resident Loan Repayment Program.

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 901 and 903

Section 47-4.1 - Definitions

Section 47-4.1 Definitions.

(a) "Council" shall mean the New York State Council on Graduate Medical Education.

(b) "Primary Care Medical Training Program" or "Primary Care Residency Program" shall mean a residency program approved by the Council for up weighting of 1.5 under Section 2807-c of the Public Health Law.

(c) "Resident Loan Repayment Recipient" and "Recipient" shall mean an individual who has signed a service agreement to receive a loan repayment award under this Subpart.

(d) "Service Agreement" shall mean the written agreement prepared by the Department of Health and signed by the Resident Loan Repayment Recipient prior to the issuance of an award specifying the terms of the award and the service obligation required.

(e) "Award" shall mean the funds provided under this Subpart during one residency year, for the purpose of repaying some or all of the qualifying debt of the Resident Loan Repayment Recipient.

(f) "Qualifying debt" shall mean any outstanding, unpaid debt incurred by the recipient from loans to cover tuition and other related educational expenses made by, or guaranteed by, the federal or state government, or made by a lending or educational institution approved under Title IV of the Federal Higher Education Act.

(g) "Underserved Area" shall mean a site, area, or facility designated pursuant to section 47-3.1 of this Part.

(h) "License" shall mean a license to practice medicine in New York State issued by the State Education Department.

(i) "Residency year" shall mean the period between July 1 and June 30 of the following year.

(j) "Service Obligation" shall mean the period of time a Resident Loan Repayment Recipient must practice primary care in an underserved area after completion of his/her residency training.

(k) "Service Obligation Start Date" shall mean the date upon which a Resident Loan Repayment Recipient is required to begin practicing primary care in fulfillment of his/her service obligation.

(l) "Rescission" shall mean the withdrawal, cancellation or revocation of an award in accordance with the provisions of section 47-4.4 of this Subpart, after the signing of the service agreement.

(m) "Waiver" shall mean full or partial release by the commissioner of the service obligation and/or financial obligation for repayment of an award incurred or owed by a recipient.

(n) "Deferral" shall mean a delay or temporary suspension of an award payment, service obligation, or any financial obligation for repayment of an award by the recipient, which is granted by the commissioner with no resulting reduction in service or financial obligation.

(o) "Default" shall occur if a recipient has not obtained an approved waiver or deferral and the recipient fails to complete the primary care residency program on which the award is based, or the recipient fails to begin or complete the service obligation within the timeframes prescribed by this Subpart, or an award is rescinded after payment of award monies to the recipient.

(p) "Program Default Rate" shall be equal to the number of residents that have completed residency training in a specific program and have defaulted on their service obligation divided by the total number of recipients that completed training in that program.

(q) "President" shall mean the president of the New York State Higher Education Services Corporation.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.2 - Eligibility for an award

47-4.2 Eligibility for an award.

(a) To be eligible to receive a Resident Loan Repayment Program award, an individual must:

(1) be a resident in good standing in the second or third year of residency training in a program that is designated as a Primary Care Residency Program by the Council and which was so designated prior to July 1 of the year in which the individual began such residency training;

(2) have begun his/her Primary Care Residency Program as a first or second year student after January 1, 1994;

(3) be eligible to apply for licensure upon satisfactory completion of his/her residency training, and meet the character and moral standards required for licensure as a physician;

(4) agree to seek licensure in New York State at least four months prior to the anticipated completion of his/her Primary Care Residency Program;

(5) agree to practice primary care in an underserved area for one year for each annual award received;

(6) agree to apply award monies toward repaying all or part of a recipient's qualifying debt; and,

(7) complete, sign, and file an application with the Department of Health on forms specified by the department at least six months prior to the beginning of the residency year for which an award is requested or by a later date specified by the commissioner. All required supplementary documentation shall be filed as directed. Incomplete or illegible applications may be rejected.

(b) An individual will be ineligible to become a Resident Loan Repayment Recipient if:

(1) the individual has received a scholarship or loan for his/her medical education which includes a service obligation that may require service outside of New York State;

(2) the individual is identified by the New York State Higher Education Services Corporation as being in default on the repayment of a guaranteed student loan or as being in default under the terms of any other governmentally administered scholarship or financial aid program and the individual refuses to allow the New York State Higher Education Services Corporation to directly apply the award to the defaulted account(s); or

(3) the individual is in a residency program with a program default rate higher than five percent. However, the Commissioner may waive this provision if less than 30 recipients have completed their training in the program.

(c) To maintain eligibility for an award, the Resident Loan Repayment Recipient must:

(1) be a participant in good standing in the Primary Care Residency Program;

(2) report to the Department of Health and the Higher Education Services Corporation annually and as may be necessary to implement the program on such forms and at such times as required by the Commissioner and the President; and,

(3) provide required documentation regarding qualifying debt.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.3 - Awards

47-4.3 Awards.

(a) Award Schedule. Awards shall be made during the second and third year of residency training in a Primary Care Residency Program.

(b) Award. The award shall be up to $15,000 per residency year.

(c) Award payments. Awards shall be paid directly to the recipients who will be required to apply the funding to reduce their qualifying debt.

(d) Payment of awards. Payment of awards shall be subject to the availability of funds.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.4 - Award rescissions and deferrals

47-4.4 Award rescissions and deferrals.

(a) An award may be rescinded by the commissioner if:

(1) prior to the full payment of an award, the recipient withdraws from or fails to continue in his/her primary care residency program;

(2) the recipient is convicted of a felony or a lesser offense related to professional activity;

(3) the recipient is found to have provided fraudulent or willfully misrepresented information in the application or supporting documents; or

(4) the recipient fails to apply award monies received toward repayment of all or part of a recipient's qualifying debt.

(b) An award may be postponed or deferred temporarily by the commissioner because of one or more of the conditions described in subdivision (a) of this section if the commissioner determines that the condition will be corrected within a reasonable time or that the circumstances warrant a deferral rather than a rescission.

(c) The commissioner will notify the President of any award rescissions or deferrals.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.5 - Service obligation

47-4.5 Service obligation.

(a) Service obligation start date. A recipient is required to begin providing primary care in an underserved area in New York State no later than 60 days after completion of his/her Primary Care Residency Program or obtaining his/her medical license, which ever is later, except that such date shall not exceed four months from completion of residency training.

(b) Practice requirements. A recipient must provide at least 35 hours per week of primary care services for at least 48 weeks per year for each annual award received. If the recipient receives two awards under this Subpart, the service obligations shall run consecutively.

(c) Alternate service. If a recipient fails to satisfactory complete the Primary Care Residency Program or fails to obtain a New York State license to practice medicine, the commissioner may permit the recipient to provide alternate service which involves the provision of health or human services in an underserved area and which is consistent with the intent of the Resident Loan Repayment Program.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.6 - Deferral and waiver

47-4.6 Deferral and waiver.

(a) Deferrals. The commissioner may delay or defer the service obligation start date, the service obligation and/or the repayment obligation of a recipient due to extreme hardship, or to permit the recipient to continue training in primary care specifically approved by the commissioner. Extreme hardship includes, but is not limited to, serious illness or injury of the recipient or a member of the recipient s immediate family or other circumstances beyond the control of the recipient that would make it extremely difficult or impossible for the recipient to fulfill the service obligation or repayment requirements.

(b) Waiver. The commissioner may waive all or part of the service obligation and/or any repayment obligation incurred by a recipient due to extreme hardship.

(c) Evidence of hardship. A request for a deferral or waiver of a service or repayment obligation must be submitted in writing on forms prescribed by the Commissioner. The commissioner may request sworn statements and appropriate documentation to support the recipient's request.

(d) Notice. The commissioner will notify the President of any service or repayment obligation deferrals or waivers.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.7 - Default

47-4.7 Default.

(a) A recipient shall be placed in default if he/she has not been granted a deferral or waiver by the Commissioner, and:

(1) the recipient fails to complete the primary care residency program, or

(2) the recipient is not available to fulfill his or her service obligation on the service obligation start date; or

(3) the recipient resigns, is dismissed from employment, or otherwise fails, refuses, or is unable to fulfill the service obligation; or

(4) an award is rescinded after dispersal of monies to a recipient.

(b) Calculation of financial obligation. A recipient found to be in default will be required to pay the President, within five years from the date of default, all monies received, plus interest, plus liquidated damages, as determined by the following formula:

A = 2B (T-S) _______ T

where "A" is the amount the President is entitled to receive; "B" is the sum of all payments made to the recipient and the interest on such amount which would be payable if, at the time such awards were paid, they were loans bearing interest at the maximum prevailing rate determined by the Higher Education Services Corporation; "T" is the total number of months in the recipient's period of obligated service; and "S" is the number of months of service actually rendered by the recipient. The total number of months in the recipient's period of obligated service is calculated by multiplying by twelve the number of annual awards received by the recipient.

(c) The Department of Health shall advise the Higher Education Services Corporation of any default, and the Higher Education Services Corporation shall collect repayments and, where indicated, initiate action for prosecution to recover monies owed the State.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-4.8 - Administration

47-4.8 Administration.

(a) Acceptance and service agreement. Prior to being certified for payment, a recipient must sign a written acceptance of the award and a service agreement describing the conditions of the award, the service obligation, and the terms of repayment in the event of rescission or default.

(b) A recipient is required to comply with all administrative and reporting requirements of the Department of Health and the Higher Education Services Corporation.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

SubPart 47-5 - Physican Loan Repayment Program

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 901 and 903

Section 47-5.1 - Definitions

Section 47-5.1 Definitions.

(a) "Underserved area" shall mean a site, area or facility designated under section 47-3.1 of this Part.

(b) "Recipient" shall mean a physician who has signed a service agreement pursuant to this Subpart agreeing to practice medicine in an underserved area.

(c) "Service agreement" shall mean the written agreement prepared by the Department of Health and signed by a recipient specifying the terms of the award and service obligation. Each agreement will require a minimum two-year service obligation.

(d) "Award" shall mean the funds, provided under this Subpart on an annual basis, for the purpose of repaying some or all of the qualifying debt of the recipient.

(e) "Qualifying debt" shall mean any outstanding, unpaid debt incurred by the recipient for loans to cover tuition and other related educational expenses made by, or guaranteed by, the federal or state government, or made by a lending or educational institution approved under Title IV of the federal higher education act;

(f) "License" shall mean a license to practice medicine in New York State issued by the State Education Department.

(g) "Service obligation" shall mean the period of time a recipient must practice in an underserved area.

(h) "Rescission" shall mean the withdrawal, cancellation or revocation of an award in accordance with the provisions of section 47-5.4 of this Subpart, after the signing of a service agreement.

(i) "Waiver" shall mean full or partial release by the Commissioner of the service obligation and/or financial obligation for repayment of an award incurred or owed by a recipient;

(j) "Deferral" shall mean a delay or temporary suspension granted by the Commissioner of an award payment, service obligation, or any financial obligation for repayment of an award by the recipient, with no resulting reduction in service or financial obligation;

(k) "Default" shall occur if the recipient has not received an approved deferral or waiver and the recipient is not available to fulfill his/her service obligation on the start date, the recipient fails to complete the service obligation, or the award is rescinded after payment of monies to the recipient.

(l) "President" shall mean the President of the New York State Higher Education Services Corporation.

(m) "Primary care physician" means a physician specialist in the field of family practice, general pediatrics, primary care internal medicine, or primary care obstetrics and gynecology who provides or arranges for coordinated primary care services.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.2 - Physician eligibility

47-5.2 Physician eligibility.

(a) Eligibility. To be eligible to receive a Physician Loan Repayment Program award, a physician must:

(1) be a primary care physician, emergency medicine physician or other physician specialist determined by the Commissioner to be in short supply;

(2) be licensed in New York;

(3) agree to practice in an underserved area for a minimum of two years;

(4) agree to apply award monies received toward repaying all or part of recipient's qualifying debt; and,

(5) complete, sign, and file an application with the Department on such forms and within such timeframes specified by the Department. All required supplementary documentation shall be filed as directed. Incomplete or illegible applications may be rejected.

(b) A physician may be eligible for a maximum of four annual awards.

(c) Ineligibility. A physician will be ineligible for an award if:

(1) the physician has a service obligation to the federal government or other entity which could require service outside of New York State;

(2) the physician is fulfilling a service obligation under the Regents Physician Loan Forgiveness Program or a federally-funded loan repayment program for the period for which a Physician Loan Repayment Program Award is requested; or

(3) the physician is in default on the repayment of a guaranteed student loan or in default under the terms of any other governmentally administered scholarship or financial aid program and the individual refuses to allow the New York State Higher Education Services Corporation to directly apply the award to the defaulted account(s).

(d) Selection criteria. The Department of Health shall consider the following factors in selecting recipients:

(1) the need for a physician specializing in the same specialty as the applicant in the underserved area where the applicant proposes to fulfil his/her service obligation;

(2) prior experience in serving the medically indigent or other underserved populations; and

(3) appropriateness of the applicant s education and training to meet the needs of the underserved area in which the applicant proposes to fulfil his/her service obligation.

(e) Number. The Department of Health shall award up to 100 new awards per year.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.3 - Awards

47-5.3 Awards.

(a) Award Amount. Physicians who agree to practice in an underserved area for two years and meet the other eligibility requirements under this Subpart shall be eligible for awards of up to $15,000 per year during their first and second year of practice in such area. Recipients who agree to practice in an underserved area for an additional two years and meet the other eligibility requirements under this Subpart shall be eligible for awards of up to $20,000 per year in their third and fourth years of practice in such area.

(b) Award Payments. Awards shall be paid directly to the recipient who will be required to apply the funds to pay off qualifying debt.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.4 - Award rescissions and deferrals

47-5.4 Award rescissions and deferrals.

(a) An award may be rescinded by the Commissioner if:

(1) prior to payment of an award, the recipient withdraws from the program or fails to begin his/her service obligation in an underserved area;

(2) the recipient is convicted of a felony or a lesser offense related to professional activity;

(3) the recipient is found to have provided fraudulent or willfully misrepresented information in the application or supporting documents; or

(4) the recipient fails to apply award monies received toward repayment of all or part of his/her qualifying debt.

(b) An award may be postponed or deferred temporarily by the Commissioner because of one or more of the conditions described in subdivision (a) of this section if the Commissioner determines that the condition will be corrected within a reasonable time or that the circumstances warrant a deferral rather that a rescission.

(c) The Commissioner will notify the President of any award rescissions or deferrals.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.5 - Service obligation

47-5.5 Service obligation.

(a) Period. A recipient shall agree to practice for a minimum of two consecutive years in an underserved area. A recipient shall provide at least 40 hours of service per week for at least 48 weeks per year.

(b) Start date. A recipient is required to begin practice in an underserved area within 90 days of signing a service agreement.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.6 - Deferrals and waivers

47-5.6 Deferrals and waivers.

(a) Deferral. The Commissioner may delay or defer the service obligation start date, the service obligation, and/or the repayment obligation of a recipient due to extreme hardship. Extreme hardship includes, but is not limited to, serious illness or injury of the recipient or a member of the recipient s immediate family or other circumstances beyond the control of the recipient that would make it extremely difficult or impossible for the recipient to fulfill the service obligation or repayment requirements.

(b) Waiver. The Commissioner may waive all or part of the service obligation and/or any repayment obligation incurred by a recipient due to extreme hardship.

(c) Prescribed forms. A request for a deferral or waiver of a service obligation and/or repayment obligation must be submitted in writing on forms prescribed by the Commissioner. The commissioner may request sworn statements andappropriate documentation to support the recipient's request.

(d) The commissioner shall notify the President of any service and/or repayment obligation deferrals or waivers.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.7 - Default

47-5.7 Default.

(a) Default. A recipient shall be placed in default if he/she has not been granted a waiver or deferral by the Commissioner and:

(1) the recipient is not available to fulfill his/her service obligation on the start date; or

(2) the recipient fails, refuses or is unable to fulfill his/her service obligation; or

(3) an award is rescinded after dispersal of award monies to the recipient.

(b) Dismissal. A recipient who is dismissed from employment or discontinues practice at the location of his/her service obligation, shall contact the Department of Health within 30 days of dismissal or discontinuance. The Commissioner may reassign the recipient to an alternate underserved area. A recipient who is reassigned shall resume his/her service obligation at the alternate location within 90 days of the dismissal or discontinuance. A recipient who is reassigned and who fails to resume his/her service obligation at the alternate location within 90 days of dismissal or discontinuance shall be placed in default.

(c) Calculation of financial obligation. An individual found to be in default will be required to pay the President, within five years from the date of default, all monies received, plus interest, plus liquidated damages, as determined by the following formula:

A =2B (T-S) ________ T

where "A" is the amount the President is entitled to receive; "B" is the sum of all payments made to the recipient and the interest on such amount which would be payable if at the time such awards were paid they were loans bearing interest at the maximum prevailing rate determined by the Higher Education Services Corporation; "T" is the total number of months in the recipient's period of obligated service; and "S" is the number of months of service actually rendered by the recipient. The minimum number of months in the recipient's period of obligated service shall be 24 months.

(d) The Department of Health shall advise the Higher Education Services Corporation of any default, and the Higher Education Services Corporation shall collect repayments and, where indicated, initiate action for prosecution to recover monies owed the State.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-5.8 - Administration

47-5.8 Administration.

(a) Prior to being certified for an award payment, a recipient must sign a written acceptance of the award and a service agreement describing the conditions of the award, the service obligation, and the terms of repayment in the event of rescission or default.

(b) A recipient is required to comply with all administrative and reporting requirements of the Department of Health and the Higher Education Services Corporation.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

SubPart 47-6 - Primary Care Practitioner Scholarship Program

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 901 and 904

Section 47-6.1 - Definitions

Section 47-6.1 Definitions.

(a) "Primary Care Practitioner Scholarship Program" shall be known as the Primary Care Service Corps.

(b) "Primary care practitioner" shall mean a midwife, nurse practitioner, or physician assistant who is licensed, registered or certified by the appropriate governing agency to practice in New York State and who provides or arranges for coordinated primary care services.

(c) "Underserved area" shall mean an area, site or facility designated pursuant to section 47-3.1 of this Subpart.

(d) "Primary care practitioner program" shall mean a full or part-time graduate, undergraduate or certificate course of study, approved or registered by the regents or a program registered by the Department of Education or determined by the Department of Education to be equivalent, and which an individual is required to complete in order to become licensed, registered, or certified as a primary care practitioner.

(e) "Academic year" shall mean the period between July 1 and June 30 of the following year.

(f) "Full-time enrollment" shall mean matriculation as a student taking at least 12 credits or their equivalent, except that in the final semester of study the student must take sufficient credits or their equivalent in order to complete training, but not fewer than six credits.

(g) "Part-time enrollment" shall mean matriculation as a student taking at least six credits but fewer than twelve or their equivalent per semester, except if the student is enrolled full time and in the final semester.

(h) "Recipient" shall mean an individual who has signed a service agreement to receive a scholarship award under the Primary Care Service Corps program in return for a service obligation.

(i) "Service agreement" shall mean the written agreement prepared by the Department of Health to be signed by a recipient, prior to issuance of an award, specifying the terms of the award and the service obligation required.

(j) "Scholarship award" shall mean the sum of the Primary Care Service Corps funds paid to, or on behalf of, a recipient under this Subpart during one academic year. An award shall not exceed the cost of attendance which shall mean tuition, required fees, books, transportation, and room and board; nor shall it exceed $15,000 for full-time study or $7,500 for part-time study; nor shall any combination exceed $15,000 annually.

(k) "Effective date" shall mean the beginning date of the first semester for which the recipient has received a Primary Care Service Corps scholarship.

(l) "Service obligation" shall mean the period of time a Recipient is required to provide primary care in an underserved area designated pursuant to section 47-3.1 of this Subpart.

(m) "Alternative service" shall mean work in a health facility in an underserved area as a paraprofessional or in a profession other than the one for which the award was given in fulfillment of the service obligation.

(n) "Reporting date" shall mean the date upon which a recipient is required to begin employment in fulfillment of the service obligation.

(o) "Rescission" shall mean the withdrawal, cancellation or revocation of an award in accordance with the provisions of section 47-6.5 of this Subpart, after the signing of the service agreement.

(p) "Waiver" shall mean full or partial release granted by the Commissioner of Health of the service obligation and/or any financial obligation for repayment of scholarship award monies incurred or owed by a recipient.

(q) "Deferral" shall mean a delay or temporary suspension granted by the Commissioner of an award payment and/or a service obligation and/or any financial obligation for repayment of award monies incurred by a recipient, with no resulting reduction in service obligation or financial obligation.

(r) "Default" shall occur if a recipient has not received a waiver or deferral from the Commissioner and the recipient fails to complete the program of study, the recipient is not available to fulfill his/her service obligation on the reporting date, the recipient fails to complete his/her service obligation within the time prescribed by the Commissioner of Health, or a scholarship award is rescinded pursuant to section 47-6.5(a) of this Subpart, after dispersal of scholarship monies to, or on behalf of, the recipient.

(s) "President" shall mean the president of the New York State Higher Education Services Corporation.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-6.2 - Eligibility for an award

47-6.2 Eligibility for an award.

(a) To be eligible for Primary Care Service Corps scholarship award, an individual must:

(1) show evidence of enrollment or acceptance for full- time study or part-time study in a primary care practitioner program. The Commissioner of Health may permit individuals who are not enrolled or who have not been accepted for enrollment to apply for an award, but an award will not be made until the individual provides evidence of enrollment or acceptance into a primary care practitioner program.

(2) be within 24 months of completing the program of study on a full-time basis or be within 48 months of completing the program of study on a part-time basis;

(3) be eligible to apply for licensure, registration or certification, as appropriate, in the profession of study after completion of the primary care practitioner program;

(4) be a United States citizen or resident alien who is holding a valid I-551 card or a valid I-151 card issued by the U.S. Immigration and Naturalization Service;

(5) be a New York State resident;

(6) meet the character and moral standards required for licensure registration or certification, as appropriate; and

(7) complete, sign and file an application with the Department of Health on such forms as are specified by the Department at least 90 days prior to the beginning of the semester for which an award is sought or by a later date specified by the Commissioner. All required supplementary documentation shall be filed as directed. Incomplete, illegible or vague applications may be rejected. Applications filed after the deadlines specified may be rejected.

(b) An individual may be determined to be ineligible to receive a Primary Care Service Corps scholarship award if:

(1) the individual is already receiving any other scholarship or fellowship award that requires the fulfillment of a service obligation;

(2) the individual is identified by Higher Education Services Corporation as having defaulted on the repayment of a guaranteed student loan or as being in default under the terms of any other governmentally administered scholarship or financial aid program.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-6.3 - Selection of recipients

47-6.3 Selection of recipients.

(a) Process. The Commissioner of Health shall select recipients based on the criteria and preferences described in subdivisions (b) and of this section.

(b) Preference. Preference shall be given to persons in the following categories, in the order of priority stated:

(1) holders of a prior Primary Care Service Corps scholarship award who have maintained an acceptable academic performance;

(2) a New York State resident attending or planning to attend a New York State primary care practitioner program;

(3) a New York State resident attending or planning to attend a primary care practitioner program located out- of-state.

(c) Selection criteria. All eligible applications will be reviewed competitively using the following criteria:

(1) the need, as determined the Commissioner of Health, for an individual(s) qualified to practice the profession for which a scholarship is being sought in the underserved areas of the region(s) where the applicant is willing to work;

(2) academic performance and academic awards or honors;

(3) special training and education relevant to the needs of underserved populations;

(4) work experience relevant to the chosen health profession;

(5) work or volunteer experience with underserved populations or in underserved areas;

(6) demonstrated interest or commitment to working with underserved populations or in underserved areas;

(7) civic or community awards and honors; and

(8) special skills or abilities, background or experience which will facilitate working with underserved populations or in underserved areas.

(d) Number of awards. The Commissioner of Health shall make as many awards as available funding permits. The Commissioner of Health may make fewer awards than available funding permits if it is determined that there are not a sufficient number of eligible applicants who meet minimum qualifications, based on such criteria as those listed in subdivision (c) of this section.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-6.4 - Maintaining eligibility for an award

47-6.4 Maintaining eligibility for an award.

(a) Continuous enrollment. Award recipients must be continuously enrolled either part-time or full-time in consecutive academic years and be in good standing in accordance with the standards and regulations established by the New York State Higher Education Services Corporation and the institution where the award recipient is receiving training.

(b) Transfers. An award recipient who transfers to another primary care practitioner program may continue to be eligible for an award if:

(1) the recipient notifies the Commissioner prior to the transfer;

(2) the recipient continues training in a primary care practitioner program in the profession for which the award was granted; and

(3) the transfer does not increase the total period of training beyond that which is allowed by this Subpart.

(c) Reporting requirements. Award recipients must report to the Department of Health and the Higher Education Services Corporation at least annually and as may be necessary to implement the program on such forms and at such times as required by the Commissioner and the President.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-6.5 - Award rescission and deferrals

47-6.5 Award rescission and deferrals.

(a) Award rescission. An award may be rescinded by the Commissioner if:

(1) prior to full payment of an award, the recipient withdraws from the primary care practitioner program or otherwise fails to maintain enrollment;

(2) prior to full payment of an award, the recipient fails to maintain good academic standing;

(3) the recipient is convicted of any felony or a lesser offense related to professional activity; or

(4) the recipient is found to have provided fraudulent or willfully misrepresented information in the application or supporting documents.

(b) If, prior to full payment of an award, the recipient fails to complete and return a payment application and any required supplementary documentation as required by the Higher Education Services Corporation or fails to report to the Higher Education Services Corporation and the Department of Health at least annually and as may be necessary to implement the program on such forms and at such times as required by the President and the Commissioner, the Commissioner may deny full or partial payment of an award.

(c) Award deferral. An award may be postponed or deferred temporarily by the Commissioner because of one or more of the conditions described in subdivisions (a) and (b) of this section if the Commissioner determines that the condition will be corrected within a reasonable time or that the circumstances warrant a deferral rather than a rescission.

(d) The Commissioner will notify the President of any award rescissions or deferrals.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-6.6 - Service obligation

47-6.6 Service obligation.

(a) Service obligation. A recipient is required to practice in an underserved area in the profession for which he/she received an award for a period of 18 months for each annual award received for full-time study. A recipient is required to practice in an underserved area in the profession for which he/she received an award for a period of 9 months for each annual award received for part-time study. However, in no case shall the total number of months of service be less than 18. If a recipient receives more than one award, the service obligations for such awards shall run consecutively.

(b) Practice requirements. A recipient must agree to the following practice requirements:

(1) provide primary care services in an underserved area;

(2) work in a practice site that accepts payment on behalf of beneficiaries of Title XVIII of the federal Social Security Act (Medicare) and individuals eligible for medical assistance pursuant to Title 11 of article five of the Social Services law; and

(3) provide thirty-five hours per week of direct patient care in the underserved area.

(c) Reporting date. A recipient is required to begin his/her service obligation within 60 days of either completing the education for which he/she has received a Primary Care Service Corps scholarship award, or receiving a license or becoming registered or certified, as appropriate, in that profession, whichever occurs later, except that the reporting date shall not exceed:

The number of months from the effective date as determined by the following formula:

M = (Y x 12) + 6

where "M" is the maximum number of months from the effective date of the award by which a recipient must begin the service obligation; "Y" is the number of years in which funding is received.

(1) In the case of a recipient whose award has been deferred, the period of time of the approved deferral shall not be included in the calculation of the reporting date described in this section.

(d) Alternative service. In the event a recipient fails to qualify for licensure, registration or certification, as appropriate, or is unable to fulfill the service obligation in the profession for which the Primary Care Service Corps scholarship award is given, the Commissioner may permit the individual to provide alternative service which would meet the intent of the public service obligation.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 47-6.7 - Service obligation: deferrals and waivers

47-6.7 Service obligation: deferrals and waivers.

(a) Service deferral. The Commissioner may delay or defer the reporting date, the service obligation and/or the repayment obligation incurred by a recipient due to extreme hardship, or the Commissioner may defer the reporting date for a recipient who is unavailable because the recipient is completing the program of study for which a scholarship award was given. Extreme hardship includes, but is not limited to: serious illness or injury of the recipient or a member of the recipient s immediate family and other circumstances beyond the control of the recipient that would make it extremely difficult or impossible for the recipient to fulfill the service obligation or repayment requirements.

(b) Waiver. The Commissioner may waive all or part of the service obligation and/or any repayment obligation incurred by a recipient because of extreme hardship.

(c) Evidence of hardship. A request for deferral or waiver shall be submitted on forms prescribed by the Department of Health. The Commissioner may require that sworn statements and appropriate documentation be submitted to support the recipient's claim.

(d) The Commissioner will notify the President of any service and/or repayment obligation deferrals or waivers.
 

Effective Date: 
Wednesday, October 22, 1997
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Section 47-6.8 - Default

47-6.8 Default.

(a) Causes. A recipient of an award will be placed in default if the recipient has not been granted a waiver or deferral by the Commissioner and:

(1) the recipient fails to complete a primary care practitioner program;

(2) the recipient is not available to begin the service obligation on the reporting date;

(3) the recipient resigns, is dismissed from employment, or otherwise fails, refuses or is unable to fulfill the service obligation; or,

(4) the scholarship award is rescinded pursuant to section 47-6.5(a) of this Subpart, after dispersal of scholarship monies to, or on behalf of, the recipient.

(b) Calculation of financial obligation. An individual found to be in default will be required to pay the President, within five years from the date of default, all monies received, plus interest, plus liquidated damages, as determined by the following formula:

A = 2B (T-S) _______ T

where "A" is the amount the President is entitled to recover; "B" is the sum of all payments made to, or on behalf of, the recipient and the interest on such amount which would be payable if, at the time such awards were paid, they were loans bearing interest at the maximum prevailing rate determined by the Higher Education Services Corporation; "T" is the total number of months in the recipient's period of obligated service; and "S" is the number of months of service actually rendered by the recipient.

(c) The Department of Health shall advise the Higher Education Services Corporation of any default, and the Higher Education Services Corporation shall collect repayments and, where indicated, initiate action for prosecution to recover monies owed the State.
 

Effective Date: 
Wednesday, October 22, 1997
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Section 47-6.9 - Administration

47-6.9 Administration.

(a) Acceptance and service agreement. Prior to being certified for payment, successful applicants must sign a written acceptance of the award and a service agreement describing the conditions of the award, the service obligation, and the terms of repayment in the event of rescission or default.

(b) A recipient is required to comply with all administrative and reporting requirements established by the Department of Health and the Higher Education Services Corporation.
 

Effective Date: 
Wednesday, October 22, 1997
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Part 48 - Palliative Care Certified Medical Schools and Residency Programs

Effective Date: 
Wednesday, June 23, 2010
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Statutory Authority: 
Public Health Law, Section 2807-n

Section 48.10 - Definitions

48.10 Definitions

(a)
Palliative careshall mean the active, interdisciplinary care of patients with serious, life-threatening, advanced, or life limiting illness, focusing on relief of distressing physical and psychosocial symptoms and meeting spiritual needs. Its goal is achievement of the best quality of life for patients and families.

(b)
Palliative care certified medical schoolshall be a Liaison Committee on Medical Education (LCME) or American Osteopathic Association (AOA) accredited medical school in New York State which is an institution granting a degree of doctor of medicine or of osteopathic medicine in accordance with regulations by the Commissioner of Education under subdivision two of section sixty-five hundred twenty-four of the education law, and which meets the following criteria:

(1) one or more faculty does clinical work or teaching relevant to palliative care; and/or

(2) contains an element of the preclinical or clinical curriculum relevant to palliative care; and

(3) is certified by the Commissioner or his or her designee in conformance with Subdivision (a) of Section 48.20 of this Part.

Relevant work, teaching, or curriculum may include, but is not limited to, didactic coursework or training related to one of the following eight domains of quality palliative care relating to populations with serious or life-threatening illnesses: (1) structure and process of care, (2) physical aspects of care, (3) psychological and psychiatric aspects of care, (4) social aspects of care, (5) spiritual, religious, and existential aspects of care, (6) cultural aspects of care, (7) care of the imminently dying patient, and (8) ethical and legal aspects of care.

(c)
Palliative care certified residency programshall be a graduate medical education program in New York State accredited and in good standing by the Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA), and which meets the following criteria:

(1) is sponsored by one of the following specialties that have incorporated Hospice and Palliative Medicine (HPM) as a subspecialty:

(i) anesthesiology;
(ii) emergency medicine;
(iii) family medicine;
(iv) internal medicine;
(v) pediatrics;
(vi) physical medicine and rehabilitation;
(vii) psychiatry and neurology;
(viii) radiology;
(ix) surgery; or
(x) obstetrics and gynecology; and

(2) contains an element of the teaching curriculum is identified as relevant to palliative care; and

(3) is certified by the Commissioner or his or her designee in conformance with Subdivision (b) of Section 48.20 of this Part.

Relevant work, teaching, or curriculum may include, but is not limited to, didactic coursework or training related to one of the following eight domains of quality palliative care, relating to populations with serious or life-threatening illnesses: (1) structure and process of care, (2) physical aspects of care, (3) psychological and psychiatric aspects of care, (4) social aspects of care, (5) spiritual, religious, and existential aspects of care, (6) cultural aspects of care, (7) care of the imminently dying patient, and (8) ethical and legal aspects of care.

Effective Date: 
Wednesday, June 23, 2010
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Section 48.20 - Certification

48.20 Certification

(a) Any medical school which has submitted an application with documentation acceptable to the department and which has been determined by the Commissioner or his or her designee to have met the definition of a palliative care certified medical school as set forth in subdivision (b) of Section 48.10 of this Part shall be certified until such time as the medical school receives written notice of termination from the Commissioner of Health, who, in his/she sole discretion, may terminate when continuation of such certification no longer benefits public health or satisfies the definitional requirements. Medical schools are eligible during the period of certification to apply for grants for undergraduate medical education in palliative care within amounts appropriated for such purpose to enhance the study of palliative care, increase the opportunities for undergraduate medical education in palliative care and encourage the education of physicians in palliative care.

(b) Any residency program which has submitted an application with documentation acceptable to the department and which has been determined by the Commissioner or his or her designee to have met the definition of a palliative care certified residency program as set forth in subdivision (c) of Section 48.10 shall be certified until such time as the residency program receives written notice of termination from the Commissioner of Health, who, in his/she sole discretion, may terminate when continuation of such certification no longer benefits public health or satisfies the definitional requirements. Residency programs are eligible during the period of certification to apply for grants for graduate medical education in palliative care, within amounts appropriated for such purpose.

Effective Date: 
Wednesday, June 23, 2010
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Part 49 - Funding For Family Practice Residency Training Programs

Effective Date: 
Wednesday, December 27, 1989
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Statutory Authority: 
L. 1988, ch.482

Section 49.1 - Purpose

Section 49.1 Purpose.

Funds allocated will be for the continuation and expansion of approved family practice residency training programs and will not be paid directly to individual family practice residents.
 

Effective Date: 
Wednesday, December 27, 1989
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Section 49.2 - Definitions

49.2 Definitions. As used in this Part, the following terms shall have the meanings indicated:

(a) "Family practice residency training program" means a family practice residency program accredited by the Liaison Committee on Graduate Medical Education (LCGME) for three years of postgraduate medical education (PGY-1, PGY-2, PGY-3) in the specialty of family practice, or accredited by the American Osteopathic Association for two years of postgraduate training in family practice (PGY-2, PGY-3).

(b) "Resident" means a physician employed in a training position in a family practice residency training program.

(c) "Commissioner" means the State Commissioner of Health.

(d) "Approved plan" means a funding application submitted by the director of a family practice residency training program, providing the information specified in section 49.3 of this Part and approved by the commissioner.

(e) "Program" means family practice residency training program.
 

Effective Date: 
Wednesday, December 27, 1989
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Section 49.3 - Funding application

49.3 Funding application.

A plan submitted to the commissioner by the program director for approval shall consist of the following:

(a) A copy of the application for program approval which was submitted to the Residency Review Committee of the American Medical Association or the American Osteopathic Association.

(b) A copy of the current program review report and letter of approval received from the Liaison Committee on Graduate Medical Education or the American Osteopathic Association.

(c) The budget for operation of the program for the current 12-month period, showing:

(1) with respect to the total cost of the program:

(i) compensation of each of the following personnel categories, both full-time and part-time: physician (excluding residents), other professional and administrative-clerical;

(ii) total salaries paid residents in the program;

(iii) fringe benefits of all personnel including residents;

(iv) rent;

(v) equipment;

(vi) medical and other supplies;

(vii) all other expense items.

(2) with respect to total revenues of the program, receipts or other financial support from the following resources:

(i) hospital(s);

(ii) third-party payors;

(iii) self-pay patients;

(iv) grants and contracts;

(v) gifts and endowments;

(vi) other.

(3) the proposed allocation of State funding to continuation of the program and to current or future expansion thereof.

(d) An acknowledgement that funding is contingent upon the residents' practicing medicine in New York State for at least two years following completion of their residency.

(e) With respect to all residents in the program:

(1) the salary paid a resident in each year of the program;

(2) a list of residents indicating name, medical school or osteopathic college of graduation, year in residency program, New York State medical license or limited permit number, or ECFMG number, and Social Security number ;

(3) (i) a copy of the agreement between the program and resident wherein the resident agrees to practice medicine in New York State for at least two years following completion of the residency (hereafter the "two year service obligation agreement".)

(ii) Such written agreement shall state whether the resident agrees to practice medicine in the State of New York for at least two years immediately following the completion of the family practice residency training program or immediately following completion of another medical training program or immediately following some other service obligation which the resident is legally committed to undertake. If such a commitment prevents the resident from fulfilling the two year service obligation immediately following the completion of the family practice residency training program, the agreement shall specify the date the resident expects to satisfy that commitment.
 

Effective Date: 
Wednesday, December 27, 1989
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Section 49.4 - Utilization of funds

49.4 Utilization of funds.

Funds received by a program may be used to pay the costs necessary to the conduct and operation of a program, including its expansion, provided that State funds allocated to a program shall not be used to pay capital construction costs taken into consideration in the determination and certification of rates by the commissioner pursuant to section 2807 of the Public Health Law.
 

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Section 49.5 - Funding

49.5 Funding.

(a) Funds will be distributed among eligible programs in the same ratio as the number of full-time residents who have two year service obligation agreements on file with the commissioner in each program is to the total number of residents in all programs who have two year service agreements on file with the commissioner. Funds allocated shall not exceed fifteen thousand dollars per family practice resident.

(b) Funds will be recouped for any residents who have not complied with their two year service obligation agreement.

(c) Distributed funds which must be recouped because former residents have not complied with their two year service obligation agreement shall be recouped by withholding funds from future distributions to the program.

(d) The amount recouped from the amount originally funded shall be in the same ratio as the time left unfulfilled to the two year service obligation.
 

Effective Date: 
Wednesday, December 27, 1989
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Section 49.6 - Records and reports

49.6 Records and reports.

The director of the program shall maintain such records and submit such reports, including an annual report, as may be required by the commissioner. The annual report shall include the status of all former residents who have not complied with their two year service obligation agreement.
 

Effective Date: 
Wednesday, December 27, 1989
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SubChapter C - Access to Records

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Part 50 - Funding For Family Practice Residency Training Programs

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Statutory Authority: 
Public Health Law, Section 206; Public Officers Law, art.6, Section 87(1)

SubPart 50-1 - Access to Records

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Section 50-1.1 - Statement of purpose

Section 50-1.1 Statement of purpose.

The purpose of this Subpart is to set forth the methods and procedures governing the availability, location and nature of those records of the New York State Department of Health subject to the provisions of article 6 of the Public Officers Law, known as the Freedom of Information Law, and the rules of the Committee on Open Government.
 

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Section 50-1.2 - Definitions

50-1.2 Definitions. As used in this Subpart, the following words and terms shall have the indicated meanings:

(a) Statistical tabulation means a collection or orderly presentation of numerical data logically arranged in columns, rows or graphic representation. Opinions, policy options and recommendations do not constitute statistical tabulations.

(b) Factual tabulation means a collection of statements of objective information logically arranged and reflecting objective reality, actual existence or an actual occurrence. Opinions, policy options and recommendations do not constitute factual tabulations.

(c) Records access officer means the person designated as responsible for ensuring that the department complies with provisions of the Freedom of Information Law and the regulations herein and coordinates the department's response to requests for access to or copies of records.

(d) Records access appeals officer means the Director, Department of Health, Public Affairs Group, whose business address is: Empire State Plaza, Corning Tower, Albany, NY 12237.

(e) Record means any information kept, held, filed, produced or reproduced by, with or for the department, in any physical form whatsoever, including, but not limited to reports, statements, examinations, memoranda, opinions, folders, files, books, manuals, pamphlets, forms, papers, designs, drawings, maps, photos, letters, microfilms, computer tapes or discs, rules, regulations or codes.

(f) Trade secret means information which, if disclosed, would cause substantial injury to the competitive position of the subject enterprise.
 

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Section 50-1.3 - Times and places for inspecting records

50-1.3 Times and places for inspecting records.

(a) Records shall be available for inspection and copying by members of the public and members of the news media on every day that the offices of the department are open for the transaction of business between the hours of 8:30 a.m. and 4:45 p.m.

(b) Records may be inspected at locations designated by the appropriate records access officer, whose titles and business addresses are as set forth in section 50-1.4 of this Subpart.
 

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Section 50-1.4 - Persons from whom records may be obtained

50-1.4 Persons from whom records may be obtained.

All requests from the public or members of the news media, to inspect and/or copy records subject to public disclosure as provided by this Subpart are to be made to the appropriate records access officer as follows:

(a) With respect to records maintained in the central offices of the department in Albany, he/she shall be the department records access officer whose business address is: Empire State Plaza, Corning Tower, Albany, NY 12237.

(b) With respect to records maintained in the area offices of the Office of Health Systems Management, he/she shall be the area administrator whose business addresses are:

(1) New York City Area Office

Office of Health Systems Management

116 West 32nd Street

New York, NY 10001

(2) Albany Area Office

Office of Health Systems Management

Building No. 7A, State Campus

Albany, NY 12226

(3) Buffalo Area Office

Office of Health Systems Management

584 Delaware Avenue

Buffalo, NY 14202

(4) Rochester Area Office

Office of Health Systems Management

Bevier Building

42 South Washington Street

Rochester, NY 14608

(5) Syracuse Area Office

Office of Health Systems Management

677 South Salina Street

Syracuse, NY 13202

(6) New Rochelle Area Office

Office of Health Systems Management

145 Huguenot Street

New Rochelle, NY 10801

(c) With respect to records maintained in the regional or area offices of the Office of Public Health, he/she shall be the regional health director or area public health director whose business addresses are:

(1) New York City Regional Office

Office of Public Health

8-10 East 40th Street

New York, NY 10016

(2) Northern Regional Office

Office of Public Health

Building No. 7A, State Campus

Albany, NY 12226

(3) Southern Regional Office

Office of Public Health

145 Huguenot Street

New Rochelle, NY 10801

(4) Western Regional Office

Office of Public Health

584 Delaware Avenue

Buffalo, NY 14202

(5) Rochester Area Office

Office of Public Health

Bevier Building

42 South Washington Street

Rochester, NY 14609

(6) Syracuse Area Office

Office of Public Health

351 South Warren Street

Syracuse, NY 13202

(d) With respect to records maintained in the State institutions in the department, he/she shall be the director of such facility whose business address is as follows:

(1) Helen Hayes Hospital

West Haverstraw, NY 10993

(2) New York State Veterans' Home

Oxford, NY 13830

(3) Roswell Park Memorial Institute

666 Elm Street

Buffalo, NY 14263
 

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Section 50-1.5 - Fees for copying records

50-1.5 Fees for copying records.

(a) Fees for certification of copies and supplying transcripts of all documents and records under the seal of the State Commissioner of Health shall be the fees as prescribed by the Public Health Law or applicable regulation of the department.

(b) Fees for photocopies or data printouts of records available pursuant to this Subpart shall be 25 cents per page and $60 for transfer of computer files to a requestor's computer tape.

(c) Except where fees are established by law, rule or regulation, no fee shall be charged for:

(1) inspection of a record;

(2) record searches;

(3) certification pursuant to this Subpart; and

(4) publications of the department provided free to residents of the State of New York.

(d) Fees shall be paid in full or a valid offer made to pay established fees prior to issuance of copies, transcripts or certification of records.

(e) Payment shall be made in the form of a check, bank draft, or money order payable to the New York State Department of Health, or if personally delivered may be made in cash for which a receipt shall be given.
 

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Section 50-1.6 - Availability of department records

50-1.6 Availability of department records.

(a) All records of the department are available for public inspection and copying, except that access may be denied to records or portions thereof that:

(1) are specifically exempted from disclosure by State or Federal statute;

(2) if disclosed would constitute an unwarranted invasion of personal privacy;

(i) an unwarranted invasion of personal privacy includes, but is not limited to:

(a) disclosure of employment, medical or credit histories or personal references of applicants for employment;

(b) disclosure of items involving the medical or personal records of a client or patient in a medical facility;

(c) sale or release of lists of names and addresses if such lists would be used for commercial or fund-raising purposes;

(d) disclosure of information of a personal nature when disclosure would result in economic or personal hardship to the subject party and such information is not relevant to the work of the department or the agency requesting it; or

(e) disclosure of information of a personal nature reported in confidence to the department and not relevant to the ordinary work of the department;

(ii) disclosure is not construed to constitute an unwarranted invasion of personal privacy when:

(a) identifying details are deleted;

(b) the person to whom a record pertains consents in writing to disclosure;

(c) upon presenting reasonable proof of identity, a person seeks access to records pertaining to him/her;

(3) if disclosed would impair present or imminent contract awards or collective bargaining negotiations;

(4) are trade secrets or are maintained for the regulation of commercial enterprise which, if disclosed, would cause substantial injury to the competitive position of the subject enterprise;

(5) are compiled for law enforcement purposes and which, if disclosed, would: (i) interfere with law enforcement investigations or judicial proceedings;

(ii) deprive a person of a right to a fair trial or impartial adjudication;

(iii) identify a confidential source or disclose confidential information relating to a criminal investigation; or

(iv) reveal criminal investigative techniques or procedures, except routine techniques or procedures;

(6) if disclosed would endanger life or safety of any person;

(7) are inter-agency or intra-agency material which are not:

(i) statistical or factual tabulations or data;

(ii) instructions to staff that affect the public; or

(iii) final agency policy or determination; or

(8) are examination questions or answers which are requested prior to the final administration of such questions.

(b) Nothing in this Subpart shall permit disclosure which constitutes an unwarranted invasion of personal privacy, if such disclosure is prohibited under article 6-A (Personal Privacy Protection Law) of the Public Officers Law.
 

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Section 50-1.7 - Procedures governing inspection and copying of records

50-1.7 Procedures governing inspection and copying of records. Inspection and copying of records shall be made in the following manner:

(a) Records access requests must be reasonably described and in writing.

(b) The records access officer shall, within five business days after receipt of a request:

(1) make requested records available;

(2) deny the request in writing. Such denial should:

(i) explain the reason for the denial;

(ii) set forth the right of appeal to the records access appeals officer; and

(iii) provide the name, title, business address and telephone number of the records access appeals officer; or

(3) furnish written acknowledgment of the request and the approximate date when the request will be granted or denied.

(c) If access to records is neither granted nor denied within 10 business days after the date of acknowledgment of receipt of request, the request may be construed as a denial of access that may be appealed.

(d) If access is approved, the records access officer shall cause a search for the records requested.

(e) If the record cannot be found after diligent search, the records access officer shall so notify the requestor.

(f) Upon request, the records access officer will certify that the record is a true copy.

(g) Where applicable, nondisclosable information will be deleted from a record as authorized by the Freedom of Information Law.

(h) The original or file copies of records will not be released from departmental files.

(i) Persons requesting records in the possession of the department but which records originated in any other State or Federal agency, shall be referred to the originating agency when there is a question concerning confidentiality requirements.

(j) Persons inspecting a record shall be allowed to copy it by any means which will not damage the record.

(k) A reasonably detailed current list of any records subject to the Freedom of Information Law, shall be maintained by the department and updated semiannually.

(l) The locations where public records are available for inspection or copying pursuant to this Subpart shall be posted in conspicuous places.
 

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Section 50-1.8 - Trade secrets

50-1.8 Trade secrets.

Trade secrets regulated under article 48, Toxic Substances, of the Public Health Law are registered under, and subject to, Part 72 of this Title. Documents which contain trade secrets or are maintained for the regulation of commercial enterprise which, if disclosed, would cause substantial injury to the competitive position of an enterprise may be withheld from public disclosure.

(a) Requests of exceptions from disclosure shall:

(1) be in writing to the records access officer;

(2) be submitted at the time the trade secret information is submitted;

(3) include the name, address and telephone number of the manufacturer, producer, formulator, employer or person desiring to register a trade secret;

(4) include the name and title of an individual who may be contacted concerning the request;

(5) include the name or other identification of the trade secret; and

(6) state reasons why the information should be excepted from disclosure.

(b) Information submitted as a trade secret is excepted from disclosure until 15 days after a determination regarding entitlement status has been finally determined or, when entitlement to an exception from disclosure has been granted, until such entitlement has expired, or until such further time as ordered by a court of competent jurisdiction.

(c) Documents pending or granted trade secret status will be assigned a control number by the records access officer.

(d) Department units responsible for collecting trade secret information are responsible for determining trade secret entitlement and safeguarding the information during the review process and until trade secret entitlement no longer exists.

(e) Documents granted trade secret status or pending a trade secret status determination will be filed in envelopes with flaps, or other containers which will effectively maintain the integrity of the documents and which can be marked so as to clearly limit access to the contents. The container is to be marked with the following:

(1) "contains trade secrets";

(2) the trade secret control number;

(3) bureau identification; and

(4) "access to or use of contents only with bureau director authorization."

(f) Trade secrets are to be maintained apart from other documents in a locked file cabinet, locked desk drawer or other place secure from general access. Bureau directors assigned custody are responsible for establishing control of trade secret documents and establishing a system of limited access which identifies persons within the department for whose inspection and study the record will be made available so as to prevent intentional or unintentional disclosure of the information.

(g) On the initiative of the department at any time, or upon the request of any person for a record excepted from disclosure, the department will:

(1) inform the person who requested the exception of the department's intention to determine whether such exception should be granted or continued;

(2) permit the person who requested the exception, within 10 business days of receipt of notification from the department, to submit a written statement of the need for continuation of such exception;

(3) within seven business days of receipt of such written statement, or within seven business days of the expiration of the period prescribed for submission of such statement, issue a written determination granting, continuing or terminating such exception and stating the reasons therefor; copies of such determination shall be served upon the person, if any, requesting the record, the person who requested the exception, and the Committee on Open Government.

(h) A denial of exception from disclosure or a denial of access to excepted information may, within seven business days of receipt of written notice of the denial, be appealed to the records access appeals officer. The appeal determination shall be made within 10 business days of the receipt of the appeal. A written notice of the determination shall be served upon the person, if any, requesting access, the person who requested exception and the Committee on Open Government. The notice shall contain a statement of the reasons for the determination.
 

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Section 50-1.9 - Appeals of denial of access to records

50-1.9 Appeals of denial of access to records.

(a) Except as provided for in section 50-1.8 of this Subpart, any person who has been denied access to records by the records access officer may appeal such denial in writing within 30 days to the records access appeals officer.

(b) The time for deciding on an appeal by the records access appeals officer shall commence upon receipt of the written appeal, which shall identify:

(1) the date and location of request for records;

(2) the records to which the requester was denied access; and

(3) the name and return address of the requester.

(c) The records access appeals officer shall, on receipt, forward a copy of the appeal to the Committee on Open Government and within 10 business days review the matter and affirm, modify or reverse the denial.

(d) If the records access appeals officer determines that the denial of access was erroneous, he/she shall instruct the records access officer to allow prompt inspection or copying of the record as requested.

(e) If the records access appeals officer affirms or modifies the denial, he/she shall communicate the determination and reasons in writing to the person making the appeal and inform such person of the right of judicial appeal with a copy to the Committee on Open Government.
 

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SubPart 50-2 - Access to or Correction/Amendment of Records of the Department of Health Subject to the Personal Privacy Protection Law

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Statutory Authority: 
Public Health Law, Section 206; Public Officers Law, Section 94

Section 50-2.1 - Statement of purpose

Section 50-2.1 Statement of purpose.

The purpose of this Subpart is to set forth the methods and procedures governing the availability, location and nature of those records of the New York State Department of Health subject to the provisions of article 6-A of the Public Officers Law, known as the Personal Privacy Protection Law and the rules of the Committee on Open Government.

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Section 50-2.2 - Definitions

50-2.2 Definitions.

As used in this Subpart, the following words and terms shall have the indicated meanings:

(a) Data subject means any natural person about whom personal information has been collected by an agency.

(b) Personal information means any data concerning a data subject which, because of name, number, symbol, mark or other identifier, can be used to identify that data subject.

(c) Records access officer means the records access officer or his/her authorized representative and shall be the person from whom records may be obtained, as listed in section 50-1.4 of this Part.

(d) Records access appeals officer means the Director, Department of Health, Public Affairs Group, whose business address is: Empire State Plaza, Corning Tower, Albany, NY 12237.

(e) Records means any item, collection or grouping of personal information about a data subject which is maintained and is retrievable by use of name or other identifier of the data subject. The term record shall not include personal information not used to make a determination about a data subject, such as:

(1) a telephone book or directory;

(2) a card catalog, book or other resource material in any library;

(3) a compilation of information containing names and addresses used exclusively for mailing agency information;

(4) personal information required by law to be maintained, and required by law to be used only for statistical research or reporting purposes;

(5) correspondence files; or

(6) information requested by the Department of Health which is necessary to answer unsolicited requests by the data subject for information.

(f) System of records means any group of records under the actual or constructive control of the department pertaining to one or more data subject from which personal information is retrievable by use of the name or other identifier of a data subject.
 

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Section 50-2.3 - Times, places for inspecting records and means for verifying the identity of a data subject

50-2.3 Times, places for inspecting records and means for verifying the identity of a data subject.

(a) Records shall be available for inspection and copying by data subjects/authorized representatives on every day that the offices of the department are open for the transaction of business between the hours of 8:30 a.m. and 4:45 p.m.

(b) Records may be inspected at locations designated by the appropriate records access officer, whose titles and business addresses are as set forth in section 50-1.4 of this Part.

(c) The identity of a data subject who requests access to his/her record may require verification as follows:

(1) Prior to being given access to personal information, an individual may be required to provide reasonable verification of his/her identity. No verification of identity, however, shall be required of an individual seeking access to records which are otherwise available to any member of the public under the Freedom of Information Law.

(2) In the case of an individual who seeks access or amendment in person, verification of identity will normally be made from those documents that an individual is likely to have readily available, such as an employee identification card, driver license, etc.

(3) When access or amendment is requested by mail, verification of identity may be obtained by requiring the individual to provide certain minimum identifying data, such as date of birth and some item of information in the record that only the concerned individual would likely know. If the sensitivity of the information in the record warrants, a signed and notarized statement of identity may be required.
 

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Section 50-2.4 - Persons from whom records may be obtained

50-2.4 Persons from whom records may be obtained.

All requests to inspect and/or copy records subject to disclosure as provided by this Subpart are to be made to the appropriate records access officer.
 

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Section 50-2.5 - Fees for copying records

50-2.5 Fees for copying records.

(a) Fees for certification of copies and supplying transcripts of all documents and records under the seal of the State Commissioner of Health shall be the fees as prescribed by the Public Health Law or applicable regulation of the department.

(b) Fees for photocopies or data printouts of records available pursuant to this Subpart shall be 25 cents per page or $60 for transfer of a computer file to a requestor's computer tape.

(c) Except where fees are established by law, rule or regulation, no fee shall be charged for:

(1) inspection of a record;

(2) record searches;

(3) certification pursuant to this Subpart; and

(4) amendment or correction of an agency record found to be in error.

(d) Fees shall be paid in full or a valid offer made to pay established fees prior to issuance of copies, transcripts or certification of records.

(e) Payment shall be made in the form of a check, bank draft, or money order payable to the New York State Department of Health, or if personally delivered, may be made in cash for which a receipt shall be given.
 

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Section 50-2.6 - Procedures governing the inspection and copying of records

50-2.6 Procedures governing inspection and copying of records. Inspection and copying of records shall be made in the following manner:

(a) Records access requests must be reasonably described and in writing.

(b) The records access officer shall, within five business days after receipt of a request:

(1) make requested records available;

(2) deny the request in writing. Such denial should:

(i) explain the reason for the denial;

(ii) set forth the right of appeal to the records access appeals officer; and

(iii) provide the name, title, business address and telephone number of the records access appeals officer;

(3) furnish written acknowledgment of the request and the approximate date when the request will be granted or denied, which date shall not exceed 30 days from the date of acknowledgment.

(c) If access is approved, the records access officer shall cause a search for the records requested.

(d) If the record cannot be found after diligent search, the records access officer shall so notify the requestor.

(e) Upon request, the records access officer will certify that the record is a true copy.

(f) The original or file copies of records will not be released from departmental files.

(g) Persons requesting records in the possession of the department but which records originated in any other State or Federal agency shall be referred to the originating agency when there is a question concerning confidentiality requirements.

(h) Persons inspecting a record shall be allowed to copy it by any means which will not damage the record.

(i) The locations where records are available for inspection or copying pursuant to this Subpart shall be posted in conspicuous places.
 

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Section 50-2.7 - Appeals of denial of access to records

50-2.7 Appeals of denial of access to records.

(a) Any person who has been denied access to records by the records access officer may appeal such denial in writing within 30 business days to the records access appeals officer.

(b) The time for deciding on an appeal by the records access appeals officer shall commence upon receipt of the written appeal, which shall identify:

(1) the date and location of request for records;

(2) the records to which the requestor was denied access; and

(3) the name and return address of the requestor.

(c) The records access appeals officer shall, within seven business days of the receipt of a written appeal, review the matter and affirm, modify or reverse the denial.

(d) If the records access appeals officer determines that the denial of access was erroneous, he/she shall instruct the records access officer to allow prompt inspection or copying of the record as requested.

(e) If the records access appeals officer affirms or modifies the denial, he/she shall communicate the reasons in writing by either first class mail or certified mail, return receipt requested, to the person making the appeal and inform such person of the right of judicial appeal.

(f) The records access appeals officer shall immediately forward to the Committee on Open Government a copy of such appeal and the determination thereon.
 

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Section 50-2.8 - Procedures governing the correction or amendment of records

50-2.8 Procedures governing the correction or amendment of records. The correction or amendment of records shall be made in the following manner:

(a) Records to be corrected or amended shall be reasonably described and must be made in writing.

(b) The records access officer shall, within 30 business days after receipt of a request:

(1) make requested correction or amendment in whole or part and advise the individual that, upon request, parties to which such data has been disclosed will be advised if such data was disclosed in accordance with section 94 (3)(c) of the Public Officers Law;

(2) deny the request in writing. Such denial should:

(i) explain the reason for the denial;

(ii) set forth the right of appeal to the records access appeals officer; and

(iii) provide the name, title, business address and telephone number of the records access appeals officer.
 

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Section 50-2.9 - Appeals of denial of correction or amendment of records

50-2.9 Appeals of denial of correction or amendment of records.

(a) Any person who has been denied correction or amendment of records by the records access officer may appeal such denial in writing within 30 business days to the records access appeals officer.

(b) The time for deciding on an appeal by the records access appeals officer shall commence upon receipt of the written appeal, which shall identify:

(1) the date and location of request for records;

(2) the records to which the requestor was denied correction or amendment to and the requestor's justification for correction; and

(3) the name and return address of the requestor.

(c) The records access appeals officer shall, within 30 business days of the receipt of a written appeal, review the matter and affirm, modify or reverse the denial.

(d) If the records access appeals officer determines that the denial was erroneous, he/she shall instruct the records access officer to allow correction or amendment of the record as requested and notify appropriate parties, if requested, by the requestor.

(e) If the records access appeals officer affirms or modifies the denial, he/she shall communicate the reasons in writing by either first class mail or certified mail, return receipt requested, to the person making the appeal and inform such person of the right of judicial appeal. In addition, the records appeals officer will notify the requestor of right to file with the agency a statement of reasons for disagreement with the agency's determination. This agency will note any portions of the record which are disputed and attach requestor's statement as part of the record. Upon an individual's request, such statement will be provided to parties to which such data has been disclosed in accordance with section 94 (3)(c) of the Public Officers Law together, if appropriate, with a concise statement of the agency's reasons for not making the requested amendment.

(f) The records access appeals officer shall immediately forward to the Committee on Open Government a copy of such appeal and the determination thereon.

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SubPart 50-3 - Access to Patient Information

Effective Date: 
Wednesday, September 30, 2015
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Statutory Authority: 
Public Health Law, Section 18(4)

Section 50-3.1 - Application

Section 50-3.1 Application.

This regulation shall govern the functioning of medical access review committees established pursuant to Public Health Law, section 18 to hear appeals from the denial of access to patient information.
 

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Section 50-3.2 - Definitions

50-3.2 Definitions. For the purpose of this section:

(a) Committee means a medical record access review committee appointed by the Commissioner of Health to hear appeals from the denial of access to patient information as provided in Public Health Law, section 18.

(b) Health care provider or provider means a health care facility or a health care practitioner as defined in subdivisions (c) and (d) of this section.

(c) Health care facility or facility means a hospital as defined in Public Health Law, article 28; a home care services agency, as defined in Public Health Law, article 36; a hospice, as defined in Public Health Law, article 40; a health maintenance organization, as defined in Public Health Law, article 44; and a shared health facility, as defined in Public Health Law, article 47.

(d) Health care practitioner or practitioner means a person licensed under Education Law, article 131, 131-B, 132, 133, 136, 139, 141, 143, 144, 153, 154, 156 or 159 or a person certified under Public Health Law, section 2560.

(e) Patient information or information means any information as defined in Public Health Law, section 18(1)(e).

(f) API coordinator means the Department of Health employee responsible for administration, coordination and operation of the access to patient information program within the Department of Health.

(g) Qualified person means any properly identified subject, committee for an incompetent appointment pursuant to article 78 of the Mental Hygiene Law, or a parent of an infant, a guardian of an infant appointed pursuant to article 17 of the Surrogate's Court Procedure Act or other legally appointed guardian of an infant who may be entitled to request access to a clinical record pursuant to Public Health Law, section 18.

(h) Personal notes and observations shall mean a practitioner's speculations, impressions (other than tentative or actual diagnosis) and reminders, provided such data is maintained by a practitioner. Handwritten notes and observations shall not be presumed to be personal notes and observations.
 

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Section 50-3.3 - Medical record access review committee

50-3.3 Medical record access review committee.

(a) Appointment.

(1) A medical record access review committee shall consist of three to five licensed professionals appointed by the commissioner. The commissioner shall designate a chairperson and a vice-chairperson.

(2) The commissioner may appoint new members to the committee when vacancies arise.

(3) The commissioner may remove members of a committee for cause. Cause for removal includes, but is not limited to, absence from three consecutive meetings or criminal conviction or findings of professional misconduct against the member.

(4) The commissioner shall appoint alternates who shall serve on the committee when a standing committee member is absent. The API coordinator shall determine when a standing member is absent and which alternate shall serve in place of the absent member. The alternate chosen shall have the same duties and responsibilities as a member.

(b) Term. Initial members shall be appointed for a one- or two-year term. Thereafter, the term shall be for two years.

(c) Quorum. A majority of the members of a committee constitutes a quorum.

(d) Meetings. A committee shall meet as frequently as its business may require. The API coordinator shall schedule meetings in consultation with the committee chairperson.

(e) Voting. Each member of the committee shall have one vote. No proxy voting is allowed. A majority vote of the members on the committee is required for committee action.
 

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Section 50-3.4 - Notification of patient rights

50-3.4 Notification of patient rights.

(a) If a provider denies access to patient information the provider shall inform, in writing, the qualified person of the reasons for denial and the qualified person's right to obtain a review of the denial. The provider shall furnish the qualified person a form, approved by the Department of Health, which can be used for requesting such a review.

(b) If a qualified person decides to request a review, he or she shall do so by forwarding the request to the API coordinator for review. The coordinator shall notify the provider of the request for review and of the name and address of the chairperson of the appropriate committee where the patient information shall be sent. A copy of the patient information, and a statement of the reasons for denial must be sent by the provider to the chairperson within 10 days of notification of the request.
 

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Section 50-3.5 - Notification of meetings

50-3.5 Notification of meetings.

(a) A committee meeting shall be held within 90 days of the chairperson's receipt of the patient information.

(b) The API coordinator shall inform the provider and the qualified persons in writing of the date, place and time of the meeting at least 15 days prior to the meeting. This notice shall state the nature of the meeting and describe the records in issue.
 

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Section 50-3.6 - Meetings

50-3.6 Meetings.

(a) The parties shall be given a reasonable opportunity to present information and oral and written statements.

(b) Only the provider(s), the qualified person, their representatives and the API coordinator may attend the committee meetings.
 

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Section 50-3.7 - Disqualification of committee members

50-3.7 Disqualification of committee members.

Meetings shall be conducted in an impartial manner. A committee member must disqualify himself/herself if a conflict of interest or bias exists.
 

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Section 50-3.8 - Decisions and determinations

50-3.8 Decisions and determinations.

(a) Committee decisions shall be in writing and issued promptly. The decision shall include the specific reasons for which access was denied or granted.

(b) A copy of the decision shall be mailed to the provider and qualified person by certified mail. When the committee's decision does not involve a finding of personal notes and observations, the qualified person shall also be notified in writing of the right to appeal the decision. A copy of the decision and record of the meeting shall be provided to the API coordinator.

(c) Copies of all patient records shall be returned to the provider within 10 days following the committee meeting.
 

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Section 50-3.9 - Records

50-3.9 Records.

(a) The record of a meeting will include notices, written statements, a transcript of the meeting if requested, any other information submitted, and a copy of the decision. The API coordinator shall retain the records of all meetings.

(b) Meetings may be mechanically, electronically or otherwise recorded under the supervision of the chairperson, and the original recording or an official transcript thereof shall be part of the record.

(c) Upon prior request made by the provider or qualified person, the API coordinator will prepare a transcript of proceedings within a reasonable time and shall furnish a copy to the requester. Except when any statute authorizes otherwise, the department is authorized to charge the cost for preparation and furnishing of such record or transcript or any part thereof.
 

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Section 50-3.10 - Confidentiality

50-3.10 Confidentiality.

All patient information is confidential as provided for in New York State law and regulations. Any patient information, committee records, committee deliberations, or correspondence sent to the committee or API coordinator will be treated confidentially and all records will be stored in a secure place.
 

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SubPart 50-4 - Intra-Agency Access to and Disclosure of Personal Health-Related Information

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Statutory Authority: 
Public Health Law 2786, 206

Section 50-4.1 - Statement of purpose

Section 50-4.1 Statement of purpose.

The purpose of this Subpart is to set forth methods and controls to restrict dissemination and maintain control of confidential personal health-related information within the Department of Health.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.2 - Definition

50-4.2 Definition.

For the purpose of this Subpart, Personal Health Related Information means any information concerning the health of a person which identifies or could reasonably be used to identify a person.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.3 - Access

50-4.3 Access.

(a) Employees or agents of the Department of Health are not to have access to personal health-related information except as part of their official duties.

(b) Access to personal health-related information by an employee is to be authorized by supervisors only after such employee has been trained in the responsibilities associated with access to the information, and has read this Subpart and Public Officers Law Section 74(3)(c).

(c) Agents of the Department may be authorized to have access to specific personal health-related information only when reasonably necessary to perform the specific activities for which they have been designated as agents of the Department of Health.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.4 - Disclosure

50-4.4 Disclosure.

No employee or agent of the Department who has knowledge of personal health-related information in the course of employment shall disclose such information to any other person unless such person is officially authorized access to the information and requires the information to perform an officially designated function.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.5 - Disposition

50-4.5 Disposition.

Documents containing personal health-related information shall be disposed of in a manner in which the confidentiality will not be compromised. Supervisors of units are responsible for control and security of documents until destroyed or control is transferred to an appropriate disposal service.

Records scheduled for long term storage by the Department of Education shall be subject to special provisions in the inter-agency records disposition document for security during storage and ultimate transfer to the archives or destruction.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.6 - Department and operational unit protocols

50-4.6 Department and operational unit protocols.

(a) The Department will promulgate, for use and implementation by all its operational units, standard confidentiality protocols which meet the requirements of this section.

(b) The supervisor of each operational unit in which employees have access to personal health-related information shall prepare protocol s for ensuring confidentiality of such information. The protocols shall include as necessary:

(1) measures to ensure that letters, memoranda and other documents containing personal health-related information are accessible only by authorized personnel;

(2) measures to ensure that personal health-related information stored electronically is protected from access by unauthorized persons;

(3) measures to ensure that only personal health-related information necessary to fulfill authorized functions is maintained in the unit;

(4) measures to ensure that staff working with personal health-related information secure such information from casual observance or loss and that such documents or files are returned to confidential storage on termination of use;

(5) measures to ensure that personal health-related information is not inappropriately copied or removed from control of the Department;

(6) measures to provide safeguards to prevent discrimination, abuse or other adverse actions directed toward persons to whom personal health related information applies;

(7) measures to ensure that personal health-related information is adequately secured after working hours;

(8) measures to ensure that transmittal of personal health-related information outside of the unit is authorized only by the director of the unit, other persons designated by the director or in accordance with such protocol;

(9) measures to protect the confidentiality of personal health-related information being transferred within the unit and to other units in the Department;

(10) measures to ensure that documents or files that contain personal health-related information that are obsolete or no longer needed are promptly disposed of in such a manner so as to not compromise the confidentiality of the documents.

(c) Unit protocols for ensuring confidentiality of personal health-related information are to be updated whenever a program activity change renders the established protocol obsolete or inadequate.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.7 - Employee training

50-4.7 Employee training.

(a) Department employees are to be trained with respect to responsibilities and authorization to access personal health related information.

(b) Employees authorized by supervisors to access personal health-related information are to be advised in writing that they shall not:

(1) examine documents or computer data containing personal health related information unless required in the course of official duties and responsibilities;

(2) remove from the unit or copy such documents or computer data unless acting within the scope of assigned duties;

(3) discuss the content of such documents or computer data with any person unless that person has authorized access and the need to know the information discussed;

(4) illegally discriminate, abuse or harass a person to whom personal health-related information applies.
 

Effective Date: 
Tuesday, July 4, 1989
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Section 50-4.8 - Employee attestation

50-4.8 Employee attestation.

Each employee, upon receiving training, in conformance with 50-4.7 of this section, shall sign a statement acknowledging receipt of sections 50-4.3(b) and 50-4.7(b) and acknowledging that violation of confidentiality statutes and rules may lead to disciplinary action, including suspension or dismissal from employment and criminal prosecution. Each employee's signed attestation is to be centrally maintained in the employee's personal history file.
 

Effective Date: 
Tuesday, July 4, 1989
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Part 51 - Uniform Hearing Procedures

Effective Date: 
Wednesday, September 6, 1989
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Statutory Authority: 
Public Health Law Sections 12-a, 206-a, 230, 577, 2801-a, 2803-d, 2806, 2897-a, 3393, 3511; State Administrative Procedure Act, Sections 301, 401

Section 51.1 - Applicability

Section 51.1 Applicability.

This Part shall apply to all adjudicatory proceedings to which the Department of Health is a party brought pursuant to the Public Health Law, unless there is a specific statute or regulation to the contrary. This Part shall not apply to proceedings brought pursuant to Part 76, Public Health Administrative Tribunal, of this Title.
 

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Section 51.2 - Definitions

51.2 Definitions.

Whenever used in this Part:

(a) Commissioner means the Commissioner of Health of the State of New York, or his duly authorized representative.

(b) CPLR means the Civil Practice Law and Rules.

(c) Department means the Department of Health of the State of New York.

(d) Hearing officer means the person duly designated for the purpose of conducting or participating in a hearing pursuant to the Public Health Law, including an administrative officer or an administrative law judge assigned by the department to the hearing.

(e) Party means the department and all persons designated as petitioner, respondent, or intervenor in any adjudicatory proceeding subject to this Part.

(f) Report means the hearing officer's summary of the hearing record, including his findings of fact, conclusions and recommendation or the findings, conclusions and recommendation of the hearing committee or hearing panel pursuant to Public Health Law, section 230.
 

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Section 51.3 - Notice of hearing and statement of charges

51.3 Notice of hearing and statement of charges.

(a) The notice of hearing shall contain a statement of the legal authority and jurisdiction under which the proceeding is to be held, a reference to the particular sections of the statutes and regulations violated, if any, and a short and plain statement of the matters asserted, or at issue, and/or a statement of charges.

(b) The notice of hearing shall specify the time, place and date for a hearing.

(c) Service of the notice of hearing and statement of charges, if any, shall be served at least 15 days prior to the date of the hearing and shall be by certified or registered mail, or by service consistent with article 3 of the CPLR. Where service is by mail, service shall be deemed complete three days after mailing.
 

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Section 51.4 - Adjournment

51.4 Adjournment.

A request for an adjournment of the hearing should be in writing and submitted to the hearing officer and other parties prior to the hearing. Adjournments shall be granted only by the hearing officer, and only after the hearing officer has consulted with both parties. When granted, adjournments should be to a specified time, day and place.
 

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Section 51.5 - Answer or responsive pleading

51.5 Answer or responsive pleading.

(a) A party may serve on the department an answer, or responsive pleading, signed by the party or the party's attorney. The answer or responsive pleading shall specify which allegations are admitted, which allegations are denied and which allegations a party has insufficient information upon which to form an opinion.

(b) The answer or responsive pleading shall be served no later than three days before the initial hearing date.

(c) An answer or responsive pleading is required if there are affirmative defenses.
 

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Section 51.6 - Amendment of pleadings

51.6 Amendment of pleadings.

Any party may amend or supplement a pleading at any time prior to the submission of the hearing officer's report to the commissioner, or to the appropriate board or council, by leave of the hearing officer, if there is no substantial prejudice to any other party. Any party may amend or supplement a pleading at any time prior to a hearing committee's final determination and order pursuant to Public Health Law, section 230(10), by leave of the hearing officer, if there is no substantial prejudice to any other party.
 

Effective Date: 
Wednesday, February 2, 1994
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Section 51.7 - Service of papers

51.7 Service of papers.

All notices and papers connected with a hearing, other than the notice of hearing and statement of charges, if any, may be served by ordinary mail. Except where otherwise provided, service by mail shall be deemed complete three days after mailing.
 

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Section 51.8 - Disclosure

51.8 Disclosure.

(a) Except as provided in subdivision (b) of this section or as otherwise agreed to by all parties, there shall be no disclosure, including but not limited to bills of particulars, exchanges of documents and witness lists, depositions, interrogatories, discovery and requests for documents. A hearing officer may not require disclosure. When the parties agree to any form of disclosure, the hearing officer shall ensure that all parties proceed in accordance with the agreement of the parties.

(b) (1) If the department in a notice of hearing states its intent to seek, or states the possibility of, the revocation of a license or permit, upon the service of such notice, any party to the proceeding may demand in writing from any other party disclosure of any of the following which such other party intends to introduce at the hearing:

(i) names of witnesses; however, a summary of the testimony to be given by the witnesses shall not be required to be disclosed;

(ii) a list of documentary evidence;

(iii) photocopies of documentary evidence listed in subparagraph (ii) of this paragraph in the possession of the party upon whom the demand has been made; and

(iv) a brief description of physical or other evidence which cannot be photocopied.

(2) The demand for disclosure shall be made at least 10 days prior to the first scheduled date of hearing. At least seven days prior to the first scheduled date of hearing, the party upon whom the demand has been made shall make the disclosure described in subparagraphs (1)(i) through (iv) of this subdivision or a statement that the party does not have anything to disclose. If, after such disclosure or statement, a party determines to present witnesses or evidence not previously disclosed, the party shall disclose as soon as practicable.

(3) Upon application of any party, the hearing officer:

(i) upon good cause shown, may allow demands and responses within time periods other than those described in paragraph (2) of this subdivision;

(ii) shall allow a party not to disclose information or material protected by statutory or case law from disclosure, including information and material protected because of privilege or confidentiality;

(iii) upon good cause shown, may limit, condition or regulate the use by the party to whom disclosure is made of information or material disclosed; and

(iv) may preclude a party that unreasonably fails to respond to a timely demand for disclosure or to supplement its disclosure from introducing evidence or witnesses not disclosed.
 

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Section 51.9 - Hearing officer

51.9 Hearing officer.

(a) No hearing officer shall preside who has any bias with respect to the matter involved in the proceeding. Any party may file with the department a request, together with a supporting affidavit, that a hearing officer be removed on the basis of personal bias or other good cause.

(b) The hearing officer shall conduct the hearing in a fair and impartial manner.

(c) The hearing officer shall have the power to:

(1) rule upon requests, including all requests for adjournments;

(2) set the time and place of hearing;

(3) administer oaths and affirmations;

(4) issue subpoenas requiring the attendance and testimony of witnesses and the production of books, records, contracts, papers and other evidence;

(5) summon and examine witnesses, including the authority to direct a party, without necessity of subpoena, to appear and to testify;

(6) admit or exclude evidence;

(7) limit the number of times any witness may testify, repetitious examination or cross-examination, and the amount of corroborative or cumulative testimony;

(8) hear argument on facts or law;

(9) order the parties to appear for a prehearing conference to consider matters which may simplify the issues or expedite the proceeding;

(10) order that opening statements be made; and

(11) do all acts and take all measures necessary, but not otherwise prohibited by this Part, for the maintenance of order and the efficient conduct of the hearing.

(d) The hearing officer shall not have the power to:

(1) remove testimony from the transcript by deletion, expungement or otherwise; and

(2) dismiss the charges unless otherwise authorized by designation.

(e) Upon being notified that a hearing officer declines or fails to serve, or in the case of death, resignation or removal of the hearing officer, or upon the initiative of the commissioner, or the appropriate board or council, a successor hearing officer shall be designated to continue the proceeding.

(f) The designation of a hearing officer shall be in writing and filed with the department.
 

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Section 51.10 - Stipulations and consent orders

51.10 Stipulations and consent orders.

(a) At any time prior to issuance of the final order or determination, parties may enter into a stipulation for the resolution of any or all issues.

(b) The commissioner, or the appropriate board or council, may issue a consent order upon agreement or stipulation of the parties. A consent order shall have the same force and effect as an order issued after a hearing.

(c) In matters governed by Public Health Law, sections 230, 230-B and 230-C, a licensee, who is under investigation or against whom a determination has been made that a hearing is warranted, as a condition for the satisfaction of all charges and potential charges, shall admit guilt to at least one of the acts of misconduct alleged, or shall agree not to contest the allegations, or shall assert that he or she cannot successfully defend against at least one of the acts of misconduct alleged, and shall either surrender his or her license or agree to a penalty. The signators to such an agreement shall be the licensee, his or her counsel, if the licensee is represented, the attorney for the department, the director of the office of professional medical conduct and the chairperson of the state board for professional medical conduct. The chairperson of the state board for professional medical conduct shall issue a surrender or consent order based upon said agreement. The order shall have the same force and effect as an order issued after a hearing.
 

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Wednesday, January 15, 1992
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Section 51.11 - The hearing

51.11 The hearing.

(a) Appearances.

(1) A party may appear in person or by an attorney. If a party appears by an attorney, service of papers shall be made upon the attorney.

(2) Any person appearing on behalf of a party in a representative capacity may be required to show his authority to act in such capacity.

(3) If a party fails to appear at the hearing, issues on which the absent party has the burden of proof may be resolved against that party.

(4) At any time before a report is submitted to the commissioner, or to the appropriate board or council, the hearing officer may open a default or relieve any party of the consequences of any default upon good cause shown.

(b) Consolidation and severance. (1) In proceedings which involve common questions of fact, the hearing officer, upon his own initiative or upon motion of any party, may order a consolidation of actions or a joint hearing of any or all issues to avoid unnecessary delay and cost.

(2) The hearing officer, to avoid prejudice or inconvenience, may order a severance of the hearing and hear separately any issue in the proceeding.

(c) Intervention. (1) At any time after the institution of a proceeding, the hearing officer may, upon a verified petition and for good cause shown, and upon notice to the parties, permit a person to intervene as a party, except in proceedings brought pursuant to Public Health Law, section 230.

(2) The petition of any person desiring to intervene as a party shall state with precision and particularity:

(i) the petitioner's interest in the matter at issue;

(ii) the nature of the evidence petitioner intends to present and the names of witnesses, if any;

(iii) the nature of the argument petitioner intends to make; and

(iv) any other reason that petitioner should be allowed to intervene.

(d) Conduct of hearing and evidence. (1) Each witness shall be sworn or given an affirmation.

(2) The rules of evidence need not be observed.

(3) Each party shall have the right to present evidence and to cross-examine witnesses.

(4) Official notice may be taken of all facts of which judicial notice could be taken and of other facts within the specialized knowledge of the department.

(5) All evidence, including records, documents and memoranda in the possession of the department of which it desires to avail itself, shall be offered and made a part of the record. All such documentary evidence may be received in the form of copies or excerpts, or by incorporation by reference. In case of incorporation by reference, the materials so incorporated shall be available for examination by the parties before being received in evidence.

(6) The department has the burden of proof and of going forward in all enforcement cases. The petitioner/applicant has the burden of proof and of going forward in all other cases.

(7) In administration proceedings relating to violation of Public Health Law, section 2803-d, the hearing officer may not compel the disclosure of the identity of the person who made the report or any person who provided information in an investigation of any such report.

(8) Complaints relating to matters governed by Public Health Law, section 230 may not be introduced into evidence by either party and their production may not be required by the hearing officer even if the complainant is a witness.

(9) In matters governed by Public Health Law, section 230, a hearing may proceed if at least two members of the hearing committee are present. At the conclusion of the hearing each member shall affirm that he or she has read and considered evidence introduced at and transcripts of any hearing days at which he or she was not present.

(10) Claims that an administrative hearing has been unreasonably delayed shall be raised only pursuant to this section and claims of unreasonable delay not permitted by this section shall not be entertained in a hearing.

(i) Claims of unreasonable delay occurring after hearing is requested or noticed.

Any claim that a hearing has been delayed unreasonably shall be treated as an affirmative defense pursuant to section 51.5 or otherwise as part of the claimant's case and shall be argued as part of the claimant's case. The burden of proving and the burden of going forward on the issue of unreasonable delay shall be on the claimant.

(a) In reviewing a claim of unreasonable delay, the hearing officer shall first calculate the time period that has elapsed between the date the hearing was requested or noticed, whichever is earlier, and the first day of hearing (the "time period"). For purposes of this section, the time period for cases brought pursuant to Public Health Law Section 2803-d or 230, or Subpart 60-1 of this Title, shall be from the date the hearing was noticed to the first day of hearing. (b) If the time period is one year or less, the claim of unreasonable delay shall be denied.

(c) If the time period is more than one year, the claimant shall then have the burden of showing that the claimant has been handicapped significantly and irreparably in mounting a case or defense by the time period. A mere assertion of handicap shall not suffice.

(d) If the claimant meets such burden, the hearing officer must then determine whether the time period is unreasonable under the circumstances. In making that determination, the hearing officer shall weigh at least the following factors:

(1) whether there is a causal relationship between the conduct of the Department and the time period, and whether the conduct of the claimant was responsible in whole or in part for the time period;

(2) the public policy sought to be effected through the administrative action which is the subject of the administrative hearing;

(3) the availability of Department resources to pursue the case consistent with other Department responsibilities.

(e) The hearing officer shall include in the report to the decision-maker any findings, conclusions and recommendations with respect to unreasonable delay. The report shall also include findings, conclusions and recommendations that will allow the decision-maker to dispose of the case if the decision-maker does not follow the recommendation for dismissal on the basis of unreasonable delay.

(ii) Claims of unreasonable delay occurring before hearing is requested or noticed.

(a) Claimant may make a record in connection with a claim of an unreasonable delay by the department occurring prior to a request for, or notice of, a hearing that has resulted in substantial prejudice to the claimant's defense due to the passage of time. The department may make a record in opposition to such a claim. A separate hearing on this issue shall not be provided.

(b) Neither a hearing officer nor, in a case of alleged professional misconduct, a hearing committee, shall consider, sustain or reject a claim of unreasonable delay occurring before a hearing is requested or noticed. After a final determination has been rendered, in the event that such determination is adverse to the claimant, and the claimant wishes to pursue the claim of an unreasonable delay occurring prior to a hearing request or notice, the claimant may do so in a proceeding pursuant to Article 78 of the CPLR.

(e) Record. (1) A verbatim record of the proceedings shall be made by whatever means the department deems appropriate.

(2) The record of the hearing shall include: the notice of hearing, statement of charges, if any, answer and any other responsive pleadings; motions and requests submitted, and rulings thereon; the transcript or recording of the testimony taken at the hearing; exhibits; stipulations, if any; a statement of matters officially noticed, except matters so obvious that a statement of them would serve no useful purpose; briefs or objections as may have been submitted and filed in connection with the hearing and any decision, determination, opinion, order or report rendered.
 

Effective Date: 
Wednesday, February 2, 1994
Doc Status: 
Complete

Section 51.12 - Hearing officer's report

51.12 Hearing officer's report.

For matters governed by Public Health Law section 230, 230-a and 230-b, the hearing officer shall submit the hearing panel's signed final report not more than fifty-two (52) days after the last day of hearing if service will be effectuated by mail and not more than fifty-eight (58) days after the last day of hearing if service will be effectuated personally. In all other matters, within 60 days of the close of the records, including receipt of the transcript, if any, the hearing officer should prepare his report and submit it to the commissioner or to the appropriate board or council, and to all parties.
 

Effective Date: 
Wednesday, January 15, 1992
Doc Status: 
Complete

Section 51.13 - Filing of exceptions

51.13 Filing of exceptions.

(a) Within 30 days of the date a copy of the report of the hearing officer and proposed order or, in hearings governed by Public Health Law section 230, within 15 days of the date a report of the hearing committee and proposed recommendation is sent to the parties, any party may submit exceptions to the report and order or recommendation to the Supervising Administrative Law Judge.

(b) The exceptions may include:

(1) the particular findings of fact, conclusions of law, or disposition with which the party disagrees, the reasons for disagreement and a substitute finding, conclusion or disposition;

(2) general comments on the suitability of the report and order or recommendation; and

(3) an alternative proposed order or recommendation for consideration and adoption by the Commissioner, his designee, or other decision-maker.

(c) The party shall send a copy of its exceptions to all other parties or their attorneys and the hearing officer.

(d) The opportunity to submit exceptions may be waived by such party.

(e) On notice to all parties, the party may request the Supervising Administrative Law Judge to extend the exception period. The Supervising Administrative Law Judge shall only address a request for an extension that has been made prior to the expiration of the exception period and after giving all other parties an opportunity to state their position on the request. The exception period may be extended by the Supervising Administrative Law Judge at the request of either party, for the good cause shown, and on notice to both parties. Extensions of time shall not be granted to allow a party to respond to exceptions already filed by another party.

(f) All exceptions shall be submitted to the commissioner, his designee, or other decision-maker with the record of the hearing.
 

Effective Date: 
Wednesday, September 6, 1989
Doc Status: 
Complete

Section 51.14 - Final determination and order

51.14 Final determination and order.

(a) After receipt of the hearing officer's report, the commissioner, or the appropriate board or council, shall make a final determination.

(b) The final determination shall be embodied in a written order which shall contain findings of fact and conclusions of law or reasons for the final determination.

(c) A copy of the order shall be served upon the parties.
 

Effective Date: 
Wednesday, September 6, 1989
Doc Status: 
Complete

Section 51.15 - Waiver of rules

51.15 Waiver of rules.

Any of the foregoing rules may be waived by agreement of the parties or, if a hearing has convened, by agreement of the parties and with consent of the hearing officer.
 

Effective Date: 
Wednesday, September 6, 1989
Doc Status: 
Complete

Section 51.16 - Administrative hearings (one-year time frame)

51.16 Administrative hearings (one-year time frame).

For hearings requested by applicants proposed for disapproval for establishment pursuant to Public Health Law, section 2801-a(2), or for construction pursuant to Public Health Law, section 2802(5), a notice of hearing shall be issued within 365 days of the receipt by the department of the written request for hearing. For hearings requested by applicants seeking increases in reimbursement rates pursuant to Part 86 of this Title, a notice of hearing shall be issued within 365 days of the rate review officer's determination that there are issues of fact which entitle the applicant to a hearing. Failure to comply with this section shall not affect the validity of the action taken.
 

Effective Date: 
Wednesday, September 6, 1989
Doc Status: 
Complete

Section 51.17 - Disqualification for bias

Section 51.17 Disqualification for bias.

(a) A hearing officer and, in hearings governed by Public Health Law section 230, a committee member, shall be disqualified for bias. For purposes of this section, bias shall exist only when there is an expectation of pecuniary or other personal benefit from a particular outcome of the case or when there is a substantial likelihood that the outcome of the case will be affected by a person's prior knowledge of the case, prior acquaintance with the parties, witnesses, representatives, or other participants in the hearing, or other predisposition with regard to the case. The appearance of impropriety shall not constitute bias and shall not be a grounds for disqualification. Hearing officers and committee members are presumed to be free from bias.

(b) A hearing officer or committee member may disqualify himself/herself for bias on his/her own motion. A party seeking disqualification for bias has the burden of demonstrating bias. The party seeking disqualification shall submit to the hearing officer an affidavit pursuant to SAPA section 303 setting forth the facts establishing bias. Mere allegations of bias shall be insufficient to establish bias.

(c) The hearing officer shall rule on the request for disqualification.
 

Effective Date: 
Wednesday, September 6, 1989
Doc Status: 
Complete

Part 52 - Tissue Banks And Nontransplant Anatomic Banks

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete
Statutory Authority: 
Public Health, Section 4365

SubPart 52-1 - Definitions

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4365

DEFINITIONS

Section 52-1.1 - Definitions

Section 52-1.1 Definitions.

For purposes of this Part, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Acquisitionmeans any activity, including solicitation, retrieval and donor selection and testing, which is necessary to obtain tissue for transplantation, transfer, artificial insemination or implantation, or to obtain nontransplant anatomic parts for research or education. (b) Allogeneic tissue collectionmeans the retrieval of tissue from a donor for the purpose of transplantation or transfer into another individual, including tissue provided by a donor for transplantation, artificial insemination, implantation or transfer into a designated recipient.

(c) Aseptic processingmeans the handling, preservation and packaging of tissue not intended for viral inactivation, using methods designed to prevent contamination with pathogenic organisms.

(d) Aseptic retrievalmeans the recovery of tissue in a clean, surgical field, using standard operating room techniques. (e) Autogeneic tissue collectionmeans the retrieval of tissue from a donor for subsequent reimplantation into that same donor.

(f) Clinical laboratorymeans a laboratory operating under a permit issued pursuant to Article V, Title 5 of the Public Health Law and/or which meets the requirements of the state in which it is located and of the Federal government (see Clinical Laboratory Improvement Amendments of 1988), and is acceptable to the Commissioner as specified herein. (g) Clinical usemeans the use of tissue for allogeneic or autogeneic transplantation, transfer, artificial insemination or implantation.

(h) Commissionermeans the Commissioner of the New York State Department of Health.

(i) Controlling interestmeans the ability to direct or control the operation or management of a tissue bank, tissue processing facility or tissue storage facility (herein referred to as a facility), including, but not limited to, the ability or authority, expressed or reserved, to:

(1) amend or change the corporate or operating identity (e.g., joint venture agreement or unincorporated business status) of the facility;

(2) approve operating and capital budgets of the facility;

(3) adopt, approve or direct facility fiscal operating policies and procedures;

(4) approve debt necessary to finance the facility's costs of compliance with operational or plant standards required by law;

(5) approve contracts for management of facility services;

(6) hire or dismiss the medical director or tissue bank director and non-technical personnel;

(7) maintain and control the books and financial records of the facility;

(8) control any of the assets of the facility;

(9) encumber the assets of the facility by way of mortgage or other indebtedness; and

(10) dissolve the facility or arrange for the sale or transfer of the facility to new ownership or control.

(j) Departmentmeans the New York State Department of Health.

(k) Direct ownership interestmeans the possession of stock, equity in the capital, or any interest in the profits of the facility.

(l) Distributionmeans any activity necessary to distribute tissue for transplantation, transfer, artificial insemination or implantation from the tissue bank to the transplantation facility, or insemination/implantation site, including allocation and transportation, but shall not include transportation within the transplantation facility. Distribution shall also include distribution of nontransplant anatomic parts from the bank to the research or education facility.

(m) Donormeans, except as otherwise defined in this Part, a human being, living or dead, who is the source of tissue or nontransplant anatomic parts, for transplantation, transfer, artificial insemination, implantation, education or research purposes.

(n) FDAmeans the Food and Drug Administration of the United States Department of Health and Human Services.

(o) Indirect ownership interestmeans the possession of stock, equity in the capital or any interest in the profits of an entity with a direct or indirect ownership interest in the facility. For example, if an entity owns ten percent of the stock in a corporation that owns 80 percent of the stock in a facility, that entity's interest equates to an eight percent indirect ownership interest.

(p) Medical advisory committeemeans a panel composed of at least five members with experience and expertise in the fields specified in the Subpart specific to the category or categories of tissue services provided, who are responsible for monitoring the medical efficacy of the tissue bank, and setting operating policies and procedures. At least one member of the medical advisory committee shall possess expertise in microbiology, clinical pathology or infectious disease.

(q) Medical directormeans a physician who meets the requirements of section 52-2.5(a)(3) of this Part.

(r) Nontransplant anatomic bankmeans any person or facility that solicits, retrieves, performs donor selection and/or testing, preserves, transports, allocates, distributes, acquires, processes, stores or arranges for the storage of nontransplant anatomic parts, including whole bodies, body segments, organs or tissues from living or deceased donors, for education and/or research purposes specifically authorized by the Public Health Law section 4302. The following shall not constitute a nontransplant anatomic bank: (1) Any person or entity that stores nontransplant anatomic parts, except whole bodies and body segments, solely for purposes of research and/or education conducted by such person, provided the person or entity maintains on its premises a properly executed anatomical gift consent document consistent with section 52-11.3 of this Subpart, and: (i) such person or entity is a legal donee pursuant to Public Health Law section 4302 and obtains all organs/tissues from a tissue bank or nontransplant anatomic bank licensed by the department; or (ii) is a general hospital conducting pathology services or research on nontransplant anatomic parts including whole bodies, recovered from within the facility from a living or deceased source; (2) Any person or entity whose activities within the State of New York are limited to distribution of nontransplant anatomic parts to a tissue bank or nontransplant anatomic bank licensed by the department; (3) Any person or entity that used prepared slides and/or human-derived cell lines for purposes of education and/or research; and (4) An employee of the federal government, provided an anatomical gift consent document has been executed in accordance with Public Health Law section 4301 and section 52-11.3(d).

(s) Ownermeans a person, persons or an entity with direct or indirect ownership interest in a facility.

(t) Personmeans an individual, corporation, government or governmental subdivision or agency, business trust, estate trust, partnership or association, or any other legal entity, other than the Office of Mental Health. (u) Principal stockholdermeans any person who owns (whether of record or as beneficiary), holds or has the power to vote, ten percent or more of any class of securities issued by a corporation.

(v) Processingmeans any activity necessary to prepare, preserve for storage, remove from storage and/or conduct laboratory testing to assure the potency, quality and/or sterility of bodies, body parts, organs or tissue for research or education purposes, or tissue for transplantation, transfer, artificial insemination or implementation.

(w) Procuremeans to perform any activity which is necessary for the procurement of organs or tissue for transplantation, artificial insemination, implantation, research, education, therapy, fertilization or autogeneic purposes, including solicitation, retrieval, donor selection and testing, clinical laboratory testing, including typing, preservation, transportation, allocation, distribution, storage and payment activities.

(x) Recipientmeans a patient who receives tissue through transplantation, artificial insemination, transfer or implantation.

(y) Service areameans a geographic area for acquisition and/or distribution services approved by the United States Secretary of Health and Human Services or, in the absence of such approval, by the department pursuant to the standards established in this Subpart.

(z) Storagemeans any activity necessary to store tissue for transplantation, transfer, artificial insemination or implantation, or nontransplant anatomic parts for research and/or education purposes.

(aa)(1) Tissue bankmeans any person or facility which solicits, retrieves, performs donor selection and/or testing, preserves, transports, allocates, distributes, acquires, processes, stores or arranges for the storage of human tissues for transplantation, transfer, therapy, artificial insemination or implantation, including autogeneic procedures. Tissue banks shall be issued a license in the specific category of tissue and type of tissue services provided as described in subdivision (ad) of this section, and shall be required to comply with the standards applicable to the category or categories of tissue acquired, processed, stored and/or distributed. Categories of tissue and their definitions are:

(i) Cardiovascular tissuemeans human heart valves, aorta, great vessels, pericardium, saphenous vein, umbilical vein, or any other cardiovascular tissue for transplantation.

(ii) Musculoskeletal tissuemeans human bone, tendon, ligament, muscle, fascia, cartilage, dura, or any other musculoskeletal tissue for transplantation.

(iii) Skinmeans any human skin tissue for transplantation.

(iv) Eyemeans a human cornea or any other ocular tissue for transplantation.

(v) Reproductive tissuemeans any tissue from the reproductive tract intended for use in artificial insemination or any other assisted reproductive procedure. This includes, but is not limited to, semen, oocytes, embryos, spermatozoa, spermatids, ovarian tissue, testicular tissue and epididymal aspirates.

(vi) Human milkmeans human milk for ingestion by a child other than the mother's own.

(vii) Hematopoietic progenitor cellsmeans human precursor or progenitor hematopoietic cells derived from bone marrow, peripheral blood or other tissue sources (see Subpart 58-5 of this Title). (2) The following exceptions shall apply to the definition of tissue bank in this subdivision: (i) An organ procurement organization shall not constitute a tissue bank solely by virtue of storing or arranging for the storage of heart valves. (ii) An entity that uses tissue or fluids exclusively for diagnostic purposes, after removal or withdrawal of these materials in the course of standard medical practice, shall not constitute a tissue bank. (iii) A hospital whose tissue banking activities are limited to requesting organs and/or tissue donations, or referring potential donors or next of kin to licensed comprehensive tissue procurement services pursuant to Public Health Law article 43-A, shall not constitute a tissue bank.
(ab) Tissue bank compliance officermeans an employee of a tissue transplantation facility who is responsible for communicating all department requirements pertinent to transplantation services to each transplantation service director in the facility and for responding to inquiries from the department regarding compliance with this Part.

(ac) Tissue bank directormeans a person who is appointed by the owner of a tissue bank and meets the requirements of section 52-2.5(a)(2) of this Part, who may be the medical director, and has responsibility for the operation of the tissue bank.

(ad) Tissue servicesmeans the type and extent of services provided by tissue banks acquiring, processing, storing and/or distributing tissues for transplantation, transfer, artificial insemination or implantation. Categories of tissue services and their definitions are:

(1) Comprehensive tissue procurement servicemeans a facility or organization that engages in donor selection, solicitation and retrieval activities related to tissues from living and/or cadaveric donors.

(2) Limited tissue procurement servicemeans a facility or organization whose tissue acquisition activities are limited to donor selection and solicitation by its own staff or the provision of staff, training or equipment for tissue acquisition activities to assist a comprehensive tissue procurement service in retrieving tissue. Retrieval of tissues on the premises of a limited tissue procurement service shall be performed by the staff or agents of a comprehensive tissue procurement service. Hospitals whose tissue banking activities are limited to requesting organ and/or tissue donations, or referring potential donors or next of kin to licensed comprehensive tissue procurement services are not subject to the licensure requirements in Subpart 52-2.

(3) Tissue processing facilitymeans a facility or organization that engages in any or all activities associated with processing, storage and/or distribution of human tissues for transplantation, transfer, artificial insemination or implantation. (4) Tissue storage facilitymeans a facility that engages in any or all activities associates with storage and distribution of human tissues for transplantation, transfer, artificial insemination and/or implantation, except insemination/implantation sites storing, for less than six months, semen collected and processed by a semen bank appropriately licensed by the department.

(5) Tissue transplantation facilitymeans a facility which temporarily stores and transplants tissue, except for tissue intended for autogeneic transplantation, provided such tissue does not leave the operating room for processing and/or storage.

(6) Tissue transplantation servicemeans a unit within a tissue transplantation facility that is independently supervised and transplants one or more types of tissue.

(7) Insemination/implantation sitemeans a location at which artificial insemination or assisted reproductive procedures are performed, using reproductive tissue from anonymous donors, directed donors and/or client-depositors. Semen processing, limited to washing, concentrating and storing semen from patients of physicians associated with the licensed insemination/implantation site or from the patients' regular sexual partners, and limited storage (less than six months' duration) may be undertaken without additional licensure.

(ae) Transplantation service directormeans a physician who directs a tissue transplantation service. (af) Viral inactivationmeans a process that subjects tissue to sterilization using ethylene oxide gas, gamma irradiation, or other sterilization method generally accepted by leading authorities in transplant medicine.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

SubPart 52-2 - Tissue Banks and NonTransplant Anatomic Banks-Licensure

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4365

Section 52-2.1 - Licensure

Section 52-2.1 Licensure.

(a) Any person who plans to operate a tissue bank or non-transplant anatomic bank or distribute tissue or non-transplant anatomic parts in New York State shall submit a completed, signed application to the department and obtain a license from the department prior to the operation of such a tissue bank or non-transplant anatomic bank, or conduct of such activity, unless otherwise specified in this Part.

(b) The department shall provide, upon request, an application for licensure as a tissue bank which may require information including, but not limited to, the following:

(1) the name, address and telephone number of the bank;

(2) the days and hours of bank operation;

(3) the type of organization sponsoring the bank, i.e., proprietary, municipal or non-profit;

(4) the type of ownership, i.e., individual, partnership, corporation or government;

(5) if ownership is individual, corporation or partnership: the name and principal office address of the entity, and the name, title, home address and Social Security number and Federal employer identification number, if any, of the owner, officers of the corporation or the partners;

(6) if government-operated: the name, principal office address of the government entity, and the name(s), title(s) and addresses of the administrator responsible for the operation of the bank in conjunction with the director;

(7) except for facilities established pursuant to Public Health Law, Article 28, for any person or entity with a direct or indirect ownership interest in the tissue bank of five percent or more, or any owner who is a licensed health professional and is authorized by law to prescribe tissue services and/or perform transplantation services, or principal stockholder or any person or entity with a controlling interest:

(i) name, home address and Social Security number and employer identification number, if any, of such persons, or for a corporation, the corporate name, principal place of business, corporate executive office address and employer identification number;

(ii) the manner in which the person or entity has an ownership interest or a controlling interest, and the percentage of such ownership interest;

(iii) any existing or prior direct or indirect ownership interest or status as a person or entity with a controlling interest in any other tissue bank, laboratory, funeral firm or health care facility holding a New York State or New York City license, permit or certificate of operation, and the name and address of such bank, laboratory, firm or facility, and whether such bank, laboratory, firm or facility has had its permit or license denied, revoked, suspended, limited or annulled, or currently has an enforcement proceeding pending against it; and

(iv) whether the person or entity has been convicted of, or pled guilty to, a criminal offense related to the operation of a bank, laboratory or health care facility, or of any programs established pursuant to Titles XVIII, XIX, or XX of the Federal Social Security Act; and

(8) the category or categories of tissue, and the type or types of tissue services to be provided;

(9) a description of the tissue bank premises and equipment;

(10) any other employment of the tissue bank director and/or medical director, including the position and number of hours worked;

(11) the name, position, qualifications, duties and work schedule of all technical personnel;

(12) a copy of all existing tissue acquisition and/or processing agreements;

(13) a description of the tissue bank's proposed or existing service area for acquisition and/or distribution of tissue;

(14) a description of educational programs, including those programs designed to encourage tissue donation;

(15) donor and recipient selection and testing criteria;

(16) a copy of each protocol or procedure required in this Subpart and in the Subpart for each category of tissue;

(17) any information required in the Subpart for each category of tissue;

(18) for a corporation: a copy of the existing certificate of incorporation, by-laws and any certificates of doing business under an assumed name, or for a partnership: a copy of the partnership agreement and any certificates of doing business under an assumed name;
(19) for the tissue bank director and medical director, if applicable, the following information:

(i) name;

(ii) work and home addresses and work telephone number;

(iii) educational background; and

(iv) work experience, including all places of employment and positions held for the ten years immediately preceding the date of the application; and

(20) the name, title, work address and telephone number of the tissue bank compliance officer and tissue transplantation service director(s), if such personnel are required pursuant to this Part. (c) An application for licensure as a limited tissue procurement service shall require the information specified in paragraphs (1) through (8) of subdivision (b) above, and:

(1) a list of all tissue banks performing tissue acquisition activities on the premises of a limited tissue procurement service; and

(2) the name, title and business telephone number of the person with primary responsibility for compliance with Public Health Law Article 43-B.

(d) An application for licensure as a nontransplant anatomic bank shall require the information specified in paragraphs (b) (1) through (8) of this section, and: (1) a list of all the types of nontransplant anatomic parts banked; (2) a list of all facilities that provide nontransplant anatomic parts to the nontransplant anatomic bank; (3) a list of all facilities in New York State to which nontransplant anatomic parts are distributed; (4) the name, title and business telephone number of the person with primary responsibility for compliance with Public Health Law article 43-B; and (5) an affirmation that the tissue will be distributed only to a legal donee as designated in Public Health Law section 4302 and will only be used by the bank for the purposes authorized by Public Health Law section 4302. (e) Any dentist or physician whose use of tissue is limited to virally inactivated tissue shall not be required to be separately licensed pursuant to this Part, provided he or she is licensed by, and currently registered with, the State Education Department.

(f) Shipping of any tissue from an out-of-state facility shall constitute distribution and shall require a license, unless the tissue is: (1) avascular eye tissue or hematopoietic progenitor cells shipped to a licensed comprehensive tissue procurement service, provided the licensed comprehensive tissue procurement service shall be responsible for: (i) the safety and appropriateness of the imported tissue as specified in Subparts 52-3 and 52-7 of this Part, and Subpart 58-5 of this Title; and (ii) obtaining documentation that valuable consideration has not been paid to the out-of-state facility transferring the tissue. Documentation that the transferring out-of-state facility is a nonprofit organization shall create a presumption that valuable consideration has not been paid. (2) subjected to viral inactivation by a process accepted by leading authorities in the field of transplantation medicine and a written exception to the requirements of this subdivision has been granted by the department on the basis of documentation submitted by the applicant, including a detailed description of the viral inactivation methodology and procedure, and data showing the amount of virus introduced and the effectiveness of the method in destroying the virus; or (3) from fully screened and tested donors; has been extensively processed and altered by such means as culturing over many generations, and combined with nontissue components, so that the original human tissue constitutes a small percentage of the final product; and a written exception to the requirements of this section has been granted by the department on the basis of documentation submitted by the applicant. Such documentation shall include a detailed description of the processing and donor screening performed to ensure that the tissue is free of pathogens listed in sections 52-3.4(c)(4), 52-4.7(a), 52-5.7(a), 52-6.7(a) and 52-7.7(a), as applicable to the type of tissue procured.
(g) All changes in the tissue bank director, medical director, owner or persons with a controlling interest shall be reported as specified in section 52-2.3(a) and (b) of this Subpart.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.2 - Provisional licensure

52-2.2 Provisional licensure.

(a) The department may issue a provisional license which shall be valid for a period determined by the department to be sufficient to enable the department to assess the compliance of the tissue bank or nontransplant anatomic bank with this Part. The provisional license may be renewed pending issuance or denial of a license.

(b) Except for a limited tissue procurement service, a tissue bank initially applying for a license may be issued a provisional license provided it meets the following conditions:

(1) a valid and complete license application has been filed;

(2) unless the site is a tissue transplantation facility or insemination/implantation site or a tissue storage facility whose tissue storage activity is limited to virally inactivated tissue, a medical advisory committee, consisting of at least five individuals with experience in tissue banking and/or transplantation medicine, including at least one member with expertise in infectious diseases, has been designated;

(3) if the tissue bank has been inspected by the department, the tissue bank has provided satisfactory evidence of correction of any deficiencies found; and

(4) the owners and/or persons with a controlling interest, tissue bank director, medical director, tissue bank compliance officer and transplantation service director, as required, meet the requirements of this Part and possess the education and experience necessary to ensure that the bank is operated in substantial compliance with this Part.

(c) A nontransplant anatomic bank or a limited tissue procurement service initially applying for a license may be issued a provisional license provided it submits a complete application.

(d) A provisional license may be withheld if the director, medical director, tissue bank compliance officer, any owner, or any person with a controlling interest applying for a provisional license has ever directed, owned or controlled a health care facility, laboratory, tissue bank, funeral directing firm, or nontransplant anatomic bank which has had its permit or license denied, revoked, suspended, limited or annulled, or which has an enforcement proceeding against it pending at the time of application for a provisional license.

(e) A provisional license may be denied or terminated, without a hearing, if the department finds that the tissue bank or nontransplant anatomic bank is not operated in substantial compliance with the applicable provisions of section 52-2.5 of this Subpart.

(f) The valid provisional license shall be conspicuously posted within the facility.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.3 - Ownership or controlling interest reporting requirements

52-2.3 Ownership or controlling interest reporting requirements.

(a) Except for a tissue bank owned and operated by a facility established pursuant to Public Health Law, Article 28, any change in the direct or indirect ownership status of five percent or more or in a controlling interest in a tissue bank or nontransplant anatomic bank, shall be reported to the department on a new application within thirty (30) days of the change. Such application shall be reviewed in accordance with section 52-2.5 of this Subpart. Any change in the direct or indirect ownership status or of a person with a controlling interest which requires Public Health Council approval pursuant to Public Health Law, Article 28, shall be reported to the department within thirty (30) days of the change.

(b) All changes in tissue bank director, medical director, nontransplant anatomic bank director, or tissue bank compliance officer shall be reported to the department in writing within five (5) days of the change, and a new application reflecting all changes since the prior application must be submitted within thirty (30) days of the change. Such application shall be reviewed in accordance with section 52-2.5 of this Subpart.

(c) If any person or corporation with an ownership or controlling interest in a tissue bank or nontransplant anatomic bank of five percent or more has been convicted of a criminal offense related to the operation of such a bank, a laboratory or of any programs established by Titles XVIII, XIX or XX of the Federal Social Security Act, such conviction shall be disclosed within thirty (30) days of its occurrence. Conviction does not necessarily bar ownership; the department shall review the conviction under the requirements of the Public Health Law to determine whether the conviction may affect the ability of the bank to operate in compliance with Public Health Law, Article 5, Title V and Article 43-B, and applicable state and federal regulations regarding the operation of tissue banks.

(d) Ownership of or controlling interest in any other tissue bank, nontransplant anatomic bank, laboratory or health care facility holding a New York State or New York City license shall be disclosed within thirty (30) days of any change in such status.

(e) Failure to comply with the reporting and application requirements of this section shall result in termination of the license.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.4 - Special criteria for tissue bank licensure

52-2.4 Special criteria for tissue bank licensure.

(a) Prior to approving an application for a license to operate a tissue bank, other than a limited tissue procurement service or a tissue transplantation facility, which acquires, processes, stores and/or distributes tissue for transplantation, transfer, artificial insemination or implementation, the department shall consider:

(1) the applicant's ability and intent to arrange for the acquisition, processing, storage and/or distribution of usable donated tissue within the designated geographic area of service;

(2) the applicant's ability to establish and maintain effective agreements for tissue acquisition with hospitals;

(3) the applicant's ability to engage and participate in systematic efforts, including professional and public education, to acquire usable tissue;

(4) the applicant's ability to establish and meet quality standards for the acquisition, processing, storage and/or distribution of tissue;

(5) the applicant's ability to arrange for the selection and testing of donors, and/or testing and processing of donated tissue;

(6) the character and competence of the tissue bank operator, the bank's officers, directors, principal stockholders and any persons with a controlling interest, including the quality of care or professional services provided by themselves or through any health care entity or business operated or controlled by such persons; and

(7) with respect to tissue banks created after June 1, 1991, the existence and activities of other tissue banks in the geographic area to be served by the applicant, and the statewide need for tissue to be distributed by the applicant, as determined by a review of the following factors, as applicable:

(i) the current and projected population characteristics of the service area, including relevant health status indicators;

(ii) normative criteria for age-specific and sex-specific rates of tissue utilization;

(iii) procedures to assure that tissues are distributed based on medical need and not preferentially distributed according to the donor or recipient's membership in a category based on race, color, creed, national origin, marital status, social organization or income, except if medically indicated; and

(iv) the need of the population served or to be served for the types of tissue services proposed for each category of tissue, and the extent to which all residents in the service area will have access to those services. The population need analysis for each proposal shall include a determination of the appropriate service area for distribution of tissues. After reviewing the evidence, the commissioner may determine that the proposed service area is not acceptable and may direct, as a condition of licensure, that additional, fewer or different areas be served.

(b) Prior to approving an application for a license to operate a tissue transplantation facility, the department shall consider the special criteria listed in subdivision (a) of this section except for paragraphs (1), (2), (3), (5) and (7).

(c) Prior to approving an application for a license to operate a limited tissue procurement service, the department shall consider the special criteria listed in subdivision (a) of this section except for paragraphs (1), (2), (5) and (7).

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.5 - License issuance and denial

52-2.5 License issuance and denial.

(a) A tissue bank, other than a tissue transplantation facility, tissue storage facility, or a limited tissue procurement service, shall be issued a license for one or more tissue categories, provided that:

(1) the owner(s) and/or an authorized representative have submitted a license application pursuant to this Subpart;

(2) a tissue bank director has been appointed who:

(i) is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices, and has at least two years' training or experience in the category or categories of tissue, or in a related field, as determined by the department; or

(ii) is a person with a doctoral degree in an appropriate biological science, and has a minimum of two years' tissue banking experience in the category or categories of tissue, or in a closely related field, as determined by the department; or

(iii) is a person with a master's degree in an appropriate biological science, and has a minimum of four years' tissue banking experience in the category or categories of tissue, or in a closely related field, as determined by the department; or

(iv) is a person with a bachelor's degree in an appropriate biological science, and has a minimum of six years' tissue banking experience in the category or categories of tissue, or in a closely related field, as determined by the department; and
(v) holds a current certificate of qualification from the department, in the category or categories of testing, if laboratory testing is performed by the tissue bank;

(3) the medical director is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices. The tissue bank director may serve as the medical director if he or she is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices;

(4) for tissue banks other than insemination/implantation sites, the medical advisory committee is found acceptable by the department;

(5) the department has found that the tissue bank owners, any parties with a controlling interest, medical director and tissue bank director have the character and competence to ensure that the tissue bank is competently staffed, properly equipped, and operated in accordance with the law, and that such tissue bank will be so operated. In making such a determination, the department shall consider the factors listed in subdivision (e) of this section with respect to the tissue bank, the director, medical director and owner(s) of the tissue bank, and any affiliated person, including parties with a controlling interest; and

(6) the tissue bank has corrected deficiencies found on any inspection conducted by the department and any deficiencies noted by the department in the standard operating procedures manual submitted with the application.

(b) A tissue transplantation facility shall be issued a license for one or more tissue categories, provided that:

(1) the owner(s) and/or authorized representative have submitted a license application pursuant to this Subpart;

(2) a tissue bank compliance officer has been appointed;

(3) a director who is a physician licensed and currently registered to practice medicine in New York State is appointed for each tissue transplantation service within the tissue transplantation facility;

(4) the tissue transplantation facility is established pursuant to Public Health Law, Article 28, or is the private office of a physician licensed and currently registered to practice medicine in New York State;

(5) the department has found no evidence that the tissue bank compliance officer and director of each tissue transplantation service within the tissue transplantation facility lack the character and competence to ensure that the tissue transplantation facility is competently staffed, properly equipped and operated in accordance with the law, and that such tissue transplantation facility will be so operated. In making such a determination, the department shall consider the factors listed in subdivision (e) of this section with respect to the tissue transplantation facility, the tissue bank compliance officer and the director of each tissue transplantation service within the tissue transplantation facility; and

(6) the tissue transplantation facility has corrected any deficiencies noted by the department in the written standard operating procedure manual or records of tissue issuance and, if inspected, the tissue transplantation facility has corrected any deficiencies found. (c) A tissue storage facility shall be issued a license provided: (1) the owner(s) and/or authorized representative(s) have submitted a license application pursuant to this Subpart; (2) a director has been appointed who has at least two years' experience in the storage of tissue or in a related field, as determined by the department; (3) the medical director is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices. The tissue storage facility director may serve as the medical director only if he or she is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices; (4) if inspected, the facility has corrected any deficiencies found; and (5) the department has found that the tissue bank owners and any parties with a controlling interest, medical director and tissue bank director have the character and competence to ensure that the facility is competently staffed, properly equipped and operated in accordance with the law, and that such tissue bank will be so operated. In making such a determination, the department shall consider the factors listed in subdivision (e) of this section with respect to the facility, the director(s) and owner(s) of the facility, and any affiliated person, including parties with a controlling interest. (d) A nontransplant anatomic bank or limited tissue procurement service shall be issued a license provided:

(1) the owner(s) and/or authorized representative(s) have submitted a license application pursuant to this Subpart;

(2) if inspected, the bank has corrected any deficiencies found; and

(3) the bank is competently staffed, properly equipped and operated in accordance with the law. In making such a determination, the department may consider the factors listed in subdivision (e) of this section with respect to the bank, the director(s) and owner(s) of the bank, and any affiliated person, including parties with a controlling interest.

(e) In determining whether to deny a license, the department may consider the following factors with respect to the tissue bank or nontransplant anatomic bank director(s) and owner(s), and any affiliated person, including parties with a controlling interest:

(1) false representation or omission of a material fact in filing the license application or during inspection;

(2) failure to supply further information necessary to process the license application, within three months of the department's written request, without satisfactory explanation;

(3) conviction of any crime or sustained charges of administrative violations of state or federal laws, rules and regulations, related to the operation of a site performing health care services or a funeral directing firm, including, but not limited to, the Public Health Law or related statutes;

(4) the employment of unqualified technical personnel or an insufficient number of such personnel or support personnel;

(5) a pattern of deficiencies on onsite inspection, especially in areas of quality assurance, management and handling of regulated medical waste and radioactive materials, including:

(i) refusal or inability to produce records or reports as requested by department employees;

(ii) failure to correct deficiencies from inspection to inspection;

(iii) deviation from regulations and/or accepted standards so as to jeopardize the quality of tissue services provided or pose a hazard to employees, donors, recipients or the public; and (iv) refusal to provide department employees with access to the premises;

(6) knowing acceptance of tissue requisitions from or provision of tissue services or tissue to a person or persons not authorized by law to provide such services, or possess or use such tissue;

(7) failure of the director to be on the premises for an adequate amount of time and adequately supervise technical personnel to ensure the proper performance of all tissue services provided;

(8) failure to establish and follow procedures for disposal or handling of tissue or infectious or radioactive medical waste, as determined by the governing state and federal agencies, or disposal in a manner which endangers the public, the employees or the environment; and

(9) whether the bank is in compliance with the technical requirements specified in this Subpart, Subpart 52-3 of this Part and/or the Subpart specific to each category of tissue.

(f) License denial. (1) If the department proposes to deny a license to a tissue bank or nontransplant anatomic bank, the bank shall be given written notice of the proposed denial, stating the reason or reasons for the denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice unless reconsideration is requested pursuant to paragraphs (3), (4) and (5) of this subdivision.

(2) Denial of a license shall preclude the applicant from operating a tissue bank or nontransplant anatomic bank in New York State, either directly or indirectly through any other person.
(3) If the department gives notice of proposed denial of a license, the applicant may request reconsideration of the proposed denial by submitting a written request for reconsideration to the department within thirty (30) days of the date of the notice. Submission of a request for reconsideration within thirty (30) days shall stay any action to deny a license, pending the department's decision regarding such reconsideration.

(4) The written request for reconsideration shall include all information the applicant wishes to be considered, including any written documentation which would controvert the reason for the denial or disclose that the denial was based upon a mistake of fact.

(5) Within ninety (90) days of receipt of the request for reconsideration, the department shall review its initial determination to deny a license and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke, or modify the proposed denial, allow issuance of a license conditional on maintenance of corrective action, or require that the applicant take corrective action. Such determination shall be the final decision of the department.

(6) No license application shall be considered for any applicant who is substantially the same as an applicant who has been denied a license within six (6) months of the final determination of the department denying such application. In the event an applicant has received two successive license denials, no license application shall be considered for that applicant within two (2) years of the last final determination of the department denying a previous application. (7) In addition to any penalties provided under the Public Health Law and Penal Law, falsification or failure to make full disclosure on a license application shall be deemed to constitute, in itself, a bar to obtaining a tissue bank or nontransplant anatomic bank license in New York State.

(g) A tissue bank license shall list the categories of tissue and types of tissue services offered, as defined in section 52-1.1(aa) and (ad) of this Subpart, respectively. Such license shall be conspicuously posted on the premises of the bank.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.6 - Financial disclosure and fees for services

52-2.6 Financial disclosure and fees for services.

(a) Each tissue bank and nontransplant anatomic bank shall establish and maintain complete and accurate books, financial records, documents and accounts, which shall be kept for a period of at least seven years. The department shall have access to all such records and any financial statements and audits of the bank, during normal business hours at an office of the bank located within the State of New York or, if no such office is available, at a mutually agreeable and reasonable venue for the purpose of inspection, auditing and copying.

(b) Upon request, a tissue bank or nontransplant anatomic bank shall provide the department with:

(1) a statement of the expenses of the bank, including, but not limited to, salaries, rents, equipment, utilities and travel;

(2) a statement of the revenues of the bank, including fees, grants, endowment funds and any other revenues; and

(3) a list of fees charged for all tissue services, tissues, and nontransplatnt anatomic parts provided by the bank.

(c) No tissue bank or nontransplant anatomic bank shall sell or otherwise transfer tissue for valuable consideration. Fees charged shall reflect only reasonable costs incurred in the provision of specific services, which shall include the fair market value of the overhead and salaries directly related to the provision of such services, actual transportation costs when transportation is provided, and other documented expenses directly related to the provision of services.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.7 - Administration and direction

52-2.7 Administration and direction.

(a) Every tissue bank other than a tissue transplantation facility or limited tissue procurement service shall have a tissue bank director. The tissue bank director shall develop and implement policies and procedures for the operation of the bank, consistent with this Subpart and the Subparts for each category of tissue. If the tissue bank director is not a physician, a medical director who is a physician shall be retained.

(b) Except for transplantation facilities, insemination/implantation sites, and limited tissue procurement services, every tissue bank shall have a medical advisory committee, composed of persons with training and experience in tissue banking or a closely related field,as well as at least one member with infectious disease expertise, and with the qualifications specified in the Subpart(s) for each category of tissue, if any.

(c) Medical direction of a tissue bank, other than a tissue transplantation facility or limited tissue procurement service, shall be provided by a physician, designated as the medical director, in consultation with the medical advisory committee, if applicable.

(d) The tissue bank director, if one is required, in consultation with the medical director, if not the same person, and the medical advisory committee, if one is required, shall monitor the medical efficacy of the tissue banking program and shall, as a minimum, develop:

(1) medical criteria for allogeneic donor participation;

(2) quality control and quality assurance standards; and

(3) procedures to assure that tissues from allogeneic donors are distributed based on medical need and not preferentially distributed according to the donor's or recipient's membership in a category based on race, color, creed, national origin, marital status, social organization or income, except if medically indicated.

(e) The tissue bank director shall be responsible for donor selection and the technical/scientific operation of the bank, including recruitment of sufficient numbers, training, and supervision of all personnel performing acquisition, processing, storage or distribution activities.

(f) The tissue bank director shall be responsible for ensuring that the tissue transplantation facility or insemination/implantation site performing each transplant, artificial insemination, transfer or implantation is advised of the donor's applicable medical history and tissue processing methods used, so that recipient counseling may be provided if indicated.

(g) The medical director of each insemination/implantation site shall be responsible for ensuring that the individual performing each artificial insemination, transfer or implantation is advised of the donor's significant medical history.

(h) The tissue bank director, medical director and owner(s) shall be responsible for compliance with this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.8 - Administration of a tissue transplantation facility

52-2.8 Administration of a tissue transplantation facility.

(a) Each tissue transplantation service director shall develop and implement policies and procedures for operation of the tissue transplantation service consistent with this Subpart and the Subparts for each category of tissue.

(b) The tissue transplantation service director shall, at a minimum, develop:

(1) quality assurance procedures and standards; and

(2) procedures to assure that tissues are issued for transplantation based on medical need and not preferentially distributed according to the donor's or recipient's membership in a category based on race, color, creed, national origin, marital status, social organization or income, except if medically indicated.

(c) The tissue transplantation service director shall be responsible for ensuring that the physician performing each transplant or transfer is advised of the donor's significant medical history if provided by the tissue bank supplying the tissue, and the processing methods used, so that recipient counseling may be provided if indicated.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.9 - Required records

52-2.9 Required records.

(a) Complete and accurate records of tissue and nontransplant anatomic parts released shall be kept by the tissue banks or nontransplant anatomic banks distributing the tissue. Such records shall be open to inspection by the department. For all donated tissue and nontransplant anatomic parts, the donor's name, address and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the bank to any person or entity, except upon the written consent of the donor or the person authorized by law to make the donation, or to authorized employees of the department, or as permitted by law. The recipient's name, address and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the tissue bank to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(b) Complete and accurate records of tissue and nontransplant anatomic parts released for transplantation, transfer, artificial insemination, implantation, research and education shall be kept by the tissue transplantation facility or insemination/implantation site. Such records shall be open to inspection by the department and shall be kept for at least seven (7) years after transplantation or six (6) months after the expiration date of the tissue, whichever is longer. In cases of reproductive tissue transfer/artificial insemination/implantation, records shall be kept for at least seven (7) years after the release of tissue not resulting in live births and twenty-five (25) years for tissue resulting in live births. Nontransplant anatomic banks shall retain records for five (5) years after release of nontransplant anatomic parts for research or education purposes. The recipient's name, address, and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the tissue transplantation facility or insemination/implantation site to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(c) The following donation records shall be kept by each comprehensive tissue procurement service:

(1) donor's full name, address at time of donation, identification code, date of birth or age, and date and time of death, if a cadaveric donor;

(2) documentation of evaluations of physical condition, if a cadaveric donor;

(3) pertinent donor medical history, including, but not limited to, autopsy reports, donation questionnaires and other donor solicitation materials;

(4) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address, unless this record is retained by a limited tissue procurement service;

(5) date and time of collection, and description and quantity of tissue retrieved;

(6) any reported changes in donor health status, if applicable;

(7) outcome of transplantation, transfer, artificial insemination and implantation procedures, if known, and any reports from facilities using the tissue, which would affect the donor's acceptability;

(8) records specified in the Subpart specific to each category of tissue; and

(9) documentation of staff training, certification and continuing education.

(d) The following records shall be kept by each limited tissue procurement service:

(1) a record of each referral to a comprehensive tissue procurement service, including the donor's name or other identification, the date and time of referral, the name of the person making the referral, the name of the comprehensive tissue procurement service, and whether the records specified in paragraphs (2) and (3) of this subdivision have been transferred to the comprehensive tissue procurement service;

(2) medical and social history information obtained from the donor, donor's family, and other individuals, including the names of the persons obtaining and giving the information, unless this record is transferred to a comprehensive tissue procurement service; and

(3) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address, unless the record is transferred to a comprehensive tissue procurement service.

(e) The following records shall be kept by each tissue processing facility:

(1) an acquisition log or other similar record indicating:

(i) donor's identification code and/or unique tissue product number;

(ii) name and address of the tissue bank from which the tissue was acquired;

(iii) date of receipt of the tissue; and

(iv) tissue location in the storage chamber;

(2) description of tissue received for processing;

(3) methods used for acquisition, processing, distribution and storage of the tissue;
(4) air quality measurements for critical and controlled work areas, if applicable;
(5) disposition of the tissue, including, but not limited to, distribution records, destruction logs, and autoclaving or incineration records; (6) results of all laboratory tests performed on donors and donated tissue, including documentation of review of test results prior to release of the tissue;

(7) documentation of labeling and packaging inspection prior to tissue transport to a tissue transplantation facility or release for transplantation, transfer, artificial insemination or implantation;

(8) records specified in the Subpart specific to each category of tissue; and

(9) documentation of staff training, certification and continuing education.

(f) The following records shall be kept by each tissue storage facility:

(1) an acquisition log or other similar record indicating:

(i) donor's identification code and/or unique tissue product number;

(ii) date of receipt of tissue;

(iii) name and address of tissue bank providing the tissue; and

(iv) location of the tissue in the storage chamber; and

(2) a record of the disposition of the tissue, including, but not limited to, distribution records, destruction logs, and autoclave or incineration records.

(g) The following records shall be kept by each tissue transplantation facility or insemination/implantation site:

(1) the name of the tissue bank providing the tissue, and unique tissue product number;

(2) a description of the tissue;

(3) results of any laboratory tests performed;

(4) a log of the disposition of the tissue, including, but not limited to, name or identification code of recipient, tissue product return records, destruction logs and autoclaving or incineration records;

(5) condition of the tissue upon receipt, including any loss noted of liquid nitrogen, dry ice, or other coolant;

(6) date of transplant, transfer, artificial insemination or implantation;

(7) quantity of tissue used;

(8) outcome of the tranplantation, artificial insemination, transfer or implantation procedure, including, but not limited to, any adverse outcome or infectious disease in the recipient, which shall be reported to the tissue bank from which the tissue was obtained; and

(9) record specified in the Subpart specific to each category of tissue.

(h) Records shall be kept in insemination/implantation sites as specified in Subpart 52-8.

(i) Nontransplant anatomic banks which solicit, retrieve, release or store nontransplant anatomic parts shall keep the following information: (1) if known, donor's full name, address at the time of donation, identification code, date of birth or age, and date and time of death if a cadaveric donor; (2) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address; (3) records of distribution of all nontransplant anatomic parts; (4) if applicable, name and address of the nontransplant anatomic bank from which the nontransplant anatomic part was acquired; (5) if applicable, date of receipt of the nontransplant anatomic part from the nontransplant anatomic bank; (6) location of nontransplant parts in storage, including documentation tracing nontransplant anatomic parts to specific donors; and (7) if known, disposition of the nontransplant anatomic parts once their use in education or research is ended, including the names of the funeral directors, cemeteries or crematories involved in disposition.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-2.10 - Compliance with standards

52-2.10 Compliance with standards.

Tissue banks, including tissue transplantation facilities, insemination/implantation sites, human milk transfer stations and nontransplant anatomic banks, shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating the operating procedures, equipment and records, including financial records and lists of physicians or facilities to whom or to which human tissue is released, to determine compliance with the standards in this Part. No tissue bank or nontransplant anatomic bank may acquire, process, store or distribute tissue or nontransplant anatomic parts in New York State unless the bank has been issued a license by the department, or as otherwise specified in this Part. If the commissioner determines that a bank's failure to comply with the standards set forth in this Part creates a significant likelihood that the health, safety and welfare of potential patients and other persons in contact with tissue or nontransplant anatomic parts from the bank is in jeopardy, the department may require that tissue not be released pending a hearing. The hearing shall commence within fifteen (15) days of any suspension pursuant to this section.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

SubPart 52-3 - General Technical Standards for Tissue Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-3.1 - Compliance with FDA regulations and manufacturers' instructions

Section 52-3.1 Compliance with FDA regulations and manufacturers' instructions.

(a) All antisera, reagents, devices, methods and procedures for tissue processing or transplantation-related testing shall be approved by the FDA, if such approval is available for the particular class or type of antiserum, reagent, device, method or procedure.

(b) All reagents shall be stored in labeled containers under conditions appropriate for each reagent as directed by the manufacturer and shall be removed from use after the expiration date. The reactivity, specificity and potency of each reagent shall be determined whenever a new lot is employed. All methods shall conform to manufacturers' instructions unless otherwise approved by the department upon submission of evidence that another method is equal or superior to the method described in the manufacturer's instructions.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-3.2 - Sterilization of instruments

52-3.2 Sterilization of instruments.

All instruments, including collection containers, used for both sterile and clean, non-sterile retrieval of tissues shall be either licensed by the FDA for single use or be sterilized prior to each use. Heat sterilization shall be by autoclaving at 121.5 degrees Celsius for 15 minutes after the chamber of the autoclave has been evacuated and has reached that temperature, or by dry heat for two hours at 170 degrees Celsius, or by such other procedures as may be approved by the department upon submission of evidence that such other procedures are at least equally effective.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-3.3 - Qualifications of donors

52-3.3 Qualifications of donors.

(a) A comprehensive or limited tissue procurement service shall obtain a signed informed consent from the living donor of tissue for clinical use.

(b) For potential cadaveric donors who have not left a signed, witnessed organ/tissue donor card (see section 4303 of the Public Health Law) or a will, the procurement service shall obtain informed consent to an anatomical gift from the next of kin or guardian of the decedent, as required by section 405.25 of this Title, before retrieving tissue. Informed consent forms shall clearly specify the tissues and/or nontransplant anatomic parts to be retrieved. Consent obtained by telephone shall be recorded or documented in writing by the tissue procurement service requesting the donation.

(c) The acceptability of a cadaveric donation shall be determined by medical history information obtained from medical records, attending physicians or other health care professionals, and from interviewing a family member and/or other person close to the decedent. In the event that no family member or other person close to the decedent is available, eye tissue may be accepted, provided that the final tissue container or accompanying paperwork is clearly labeled to alert the transplanting surgeon that such interview was not conducted. An evaluation of the donor's condition shall be made by a qualified tissue retrieval team member, including an examination for signs of injected drug abuse, infection or trauma at the site of donation that may affect the quality of the donated tissue.

(d) The acceptability of a donation from a living donor shall be determined by a physical examination of and health history interview with the donor.

(e) A trained, qualified supervisor shall determine whether a donor is suitable for tissue retrieval on the day of the retrieval, according to criteria developed by the medical director in consultation with the medical advisory committee. The medical director, as defined in Subpart 52-1 of this Part, shall be responsible for determining whether: (1) the living donor and his/her donated tissue are acceptable, prior to the retrieval of the tissue, according to criteria developed by the medical director in consultation with the medical advisory committee; and (2) the cadaveric donor and his/her donated tissue are acceptable, prior to the release of tissue, according to criteria developed by the medical director in consultation with the medical advisory committee.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-3.4 - Selection and testing requirements for tissue donors

52-3.4 Selection and testing requirements for tissue donors.

(a) Except as specifically approved by the medical director of the comprehensive tissue procurement service and in conformance with generally accepted standards of practice, allogeneic tissue for clinical use shall not be released from donors with any of the following conditions:

(1) evidence of infection at the site or donation or generalized sepsis on physical examination, by history or by autopsy;

(2) except for donors of eye tissue, evidence of autoimmune disease or malignant disease;

(3) history of hepatitis B or C, or hepatitis of unknown etiology; (4) history of a confirmed positive test or treatment for syphilis within the past 12 months;

(5) degenerative or infectious neurological disease, such as Creutzfeldt-Jacob disease, multiple sclerosis and Alzheimer's disease, or encephalitis of unknown etiology;

(6) history of receipt of pituitary-derived human growth hormone;

(7) transfusion within 48 hours, with four or more units of blood or blood components, in adults, or any transfusions within 48 hours in children under 12 years of age, unless:

(i) a pre-transfusion blood sample is available for testing;

(ii) a testing technology unaffected by plasma dilution and approved by the department is used for all analytes; or

(iii) plasma dilution is determined to be insufficient to alter test results, according to an algorithm submitted to and approved by the department.

(8) history of behavior or factors which place the donor at high risk for human immunodeficiency virus (HIV) infection, including:

(i) nontherapeutic injected drug use within the preceding five (5) years;

(ii) men who have engaged in anal intercourse or oral sex with another man at any time within the preceding five (5) years;

(iii) recipients of factor VIII or factor IX concentrate which was not heat-treated or otherwise virally inactivated;

(iv) individuals with evidence of HIV infection;

(v) individuals who have engaged in other behavior determined as high risk for HIV infection by the United States Public Health Service (USPHS); (vi) individuals who have been inmates of correctional facilities for seventy-two (72) consecutive hours or longer within the preceding twelve (12) months;

(vii) individuals who, within the preceding twelve (12) months, have been heterosexual partners of HIV-positive individuals or of individuals who fit within any of the above categories; and

(viii) men and women who have engaged in prostitution at any time within the preceding five (5) years, and individuals who have been their heterosexual partners within the past twelve (12) months;

(9) except for donors of eye tissue, significant exposure to a substance that may be transferred in toxic doses, such as lead, mercury and gold;
(10) acquisition, within the previous twelve (12) months, of a tattoo or other skin piercing in which shared instruments which were not sterilized between uses are known to have been used;
(11) within the proceding six (6) months, receipt of a bite from an animal suspect of rabies; and (12) for living donors, receipt of a blood transfusion within the preceding twelve (12) months. (b) Individuals with suspected rabies or evidence of HIV infection shall not be accepted as donors under any circumstances.
(c) All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state tissue acquisitions by New York State-licensed banks, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration or by the department.

(1) Blood samples from all allogeneic donors of tissue for clinical use, except oocyte donors tested in accordance with section 52-8.6(h) of this Part shall be tested for evidence of infection with HIV-1, HIV-2, hepatitis B virus (HBV), including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) and, except for donors of eye tissue or tissue to be virally inactivated, human T-lymphotropic virus type I (HTLV-I), for purposes of donor selection. If available, aliquots of residual serum or plasma shall be frozen for retrospective testing of donors in the event that new or improved tests become available prior to the distribution of donated tissue.

(2) All laboratory testing and donor medical history reports shall be reviewed and approved by the medical director or by the medical director's designee, according to criteria determined by the medical director, prior to release of tissue for distribution.

(3) Results of required testing shall be affixed to the final tissue product container or included in a product circular for tissue intended for clinical use.

(4) Except in a life-threatening emergency documented and approved by the medical director and the director of the tissue transplantation service using the tissue, tissue shall not be made available for clinical use unless the donor's blood reacts negatively to approved tests for HIV-1, HIV-2, HBsAg, HCV and, except for eye tissue or tissue to be subjected to viral inactivation, HTLV-I.

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Section 52-3.5 - Quality assurance and safety requirements

52-3.5 Quality assurance and safety requirements.

(a) Quality assurance. (1) Records shall document that the following quality control procedures are in place at the tissue bank, except for a limited tissue procurement service:

(i) preventive maintenance, periodic inspections and testing for proper operation of equipment, including annual calibration of thermometers used to monitor the temperature of tissue in storage, against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against and found to be in agreement with an NIST-certified thermometer;

(ii) monitoring of all temperature-controlled spaces and equipment to assure proper performance;

(iii) validation of computer systems, microprocessor-controlled equipment and associated software;

(iv) validation of processing and testing methodologies; and

(v) supervisory review of test results prior to labeling of tissue.

(2) Processing, laboratory and storage facilities shall be maintained in a clean and orderly manner, and shall be of suitable size, construction and location to assure tissue and personnel safety.

(3) All reagents and solutions shall be in-date, stored properly and labeled to indicate identity and, as appropriate, titer, strength or concentration, recommended storage requirements, preparation or expiration date, and other pertinent information. All such materials shall be removed from use on the expiration date. Materials of substandard reactivity and deteriorated materials shall be discarded regardless of expiration date.

(4) All specimens for testing accompanying the retrieved tissue shall be sufficiently stable to provide accurate and precise test results suitable for clinical interpretation. The tissue bank shall ensure that specimens are collected, preserved, and transported to the laboratory in such a manner as to meet this requirement. Specimens for analysis shall be identified fully and accessioned in a log book. The accessioning system shall be designed to trace the tissue to a specific donor and to identify the date and, if applicable, the time of retrieval.

(5) Control samples and standards shall be assayed regularly in order to validate test results on patient samples and to monitor reagents, operating characteristics of instruments and accuracy of volumetric equipment. The frequency required for such testing shall be determined by the nature of the testing. Records of test procedures, reagents, calibrations, and results with control samples and standards shall be maintained and be available at all times for use by processing laboratory personnel and inspection by the department. As appropriate, these records shall document the precision required for every method, automated or manual, and its restandardization schedule. Control limits for standards and reference samples shall be recorded and shall indicate when test results are outside acceptable limits. Values for quantitative assays shall be reported only if the analytical run of which they are a part is an acceptable run as determined by a protocol approved by the laboratory director. If the analytical error exceeds limits established by the laboratory' quality control program, remedial action shall be taken and documented, and the patient specimen, if available, retested. Whether or not the specimen is available for retesting, the initial result shall be reported as invalid.

(6) Current standard operating procedure manuals or other procedural guides specific to the facility shall be available at all times in the immediate work area of personnel engaged in tissue retrieval, processing, testing, storage and distribution activities. There shall be a written procedure for each tissue collection, processing, storage and distribution activity performed at the facility. Manuals shall contain a protocol for writing, maintaining and periodic review of standard operating procedures by user personnel and management staff. Procedure manuals shall have the following features:

(i) a standardized format;

(ii) a system of numbering and/or entitling individual procedures;

(iii) a clearly written description of purpose for each procedure;

(iv) a reference section listing appropriate scientific literature and industry and/or corporate standards espoused by the tissue bank;

(v) clearly defined areas of personnel responsibility by title;

(vi) documented approval of procedures and procedural modifications by the tissue bank director, and annual review by the tissue bank director or authorized supervisor;

(vii) instructions for the completion of reports and forms, including examples;

(viii) authorship and effective date, and date of review for each procedure; and

(ix) a system of archiving earlier versions of procedures and forms.
(7) The policies and procedures specified in the current standard operating procedures manual shall be followed at all times. If deviations or deficiences are identified, appropriate corrective action shall be taken and documented.
(8) The tissue bank director shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of the banking activities conducted. Included in the program shall be a system for designing and implementing corrective action for any problems identified. Quality assurance deficiencies shall be documented, and evidence shall be available that problems are reported to supervisory personnel in a timely manner and that corrective action is implemented, documented and subsequently followed-up. (b) Safety. The tissue bank shall implement written safety and infection control policies and procedures to ensure protection from unnecessary physical, chemical and biological hazards.

(1) Decontamination and disposal techniques for regulated medical waste shall be utilized. All hazardous and regulated waste materials shall be handled, stored and discarded pursuant to Part 70 of this Title, or in the case of out-of-state banks, in accordance with the hazardous waste disposal requirements of the state in which the disposal occurs.

(2) If autoclave equipment is used for sterilization, the pressure, temperature and duration of each cycle shall be recorded, and such records maintained for one year. For each run, these parameters shall be within the manufacturer's recommended operating standards. If any one or more of these parameters fall outside the manufacturer's standards, all material shall be reautoclaved. Chemical, biological and physical detection systems should be used in conjunction with these other measurements of performance.

(3) Eating, drinking, smoking, or the application of cosmetics or contact lenses shall not be permitted in work areas. Refrigerators or freezers used for storing tissue, specimens or reagents shall not be used for any other purpose.

(4) Gloves and laboratory coats, gowns or other protective clothing shall be worn as necessary while handling specimens or tissues. Such protective clothing shall not be worn outside the work area and shall be disposed of in an appropriate receptacle.

(5) A tissue bank performing tissue processing or laboratory testing shall have written policies and procedures in the following areas:

(i) infection control;

(ii) biosafety;

(iii) chemical and radiological safety;

(iv) emergency response to worksite accidents; and

(v) waste disposal.

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Section 52-3.6 - HIV antibody testing and notification

52-3.6 HIV antibody testing and notification.

No tissue bank shall inform any tissue donor or consenting next-of-kin of the results of HIV antibody testing solely on the basis of the enzyme-linked immunosorbent assay (ELISA) or other screening test for HIV antibodies unless such results are negative. Any reactive screening test shall be repeated in duplicate. If two or more separate screening tests are reactive, the sample shall be considered repeatedly reactive. Notification that a donor is positive shall be made only if the results have been reactive or equivocal for more than one screening test and the confirmatory HIV test has been unequivocally reactive. HIV test results that are substantiated as positive shall be reported to living donors. Equivocal or negative results based on confirmatory testing may be reported to the donor, if living, or person legally authorized to consent on behalf of such donor, provided that the person is not informed that the donor is seropositive. Appropriate counselling of living donors or the consenting next of kin regarding the significance of all test results shall be made available or arranged for by the comprehensive tissue procurement facility. Reporting of any HIV results to living donors or consenting next of kin, other than results of negative screening tests, shall be conducted in person, unless repeated efforts to encourage the individual(s) to come in have failed, in which case notification may be made by certified restricted delivery mail.

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Section 52-3.7 - Reporting requirements

52-3.7 Reporting requirements.

(a) The tissue bank shall have a written procedure for documenting errors or accidents in retrieval, testing, processing, storage or distribution of tissue that may affect the safety of any product. If the error or accident is not detected prior to issuance of the tissue, specimens, or test results to a hospital or other tissue bank, transplantation facility or insemination/implantation site, the error or accident shall be reported immediately to the receiving facility. All such errors shall and accidents shall also be reported to the department's Wadsworth Center within seven (7) calendar days of discovery.
(b) All New York State-licensed tissue banks that directly perform or arrange for the performance of transmissible disease testing of donors shall: (1) make the results of such testing available, upon request, to other tissue banks receiving tissue from the same donor; and (2) report, within 24 hours, all positive test results that affect donor suitability to the comprehensive tissue procurement service, if a different facility, except that positive culture results need not be reported if contamination can be traced to a specific step in tissue processing not affecting other tissues processed from the same donor. (c) The comprehensive tissue procurement service shall report significant positive test results, as determined by the medical director, to facilities receiving tissues from the same donor so that decisions on quarantining and/or physician notification may be made in a timely and appropriate manner.
(d) When requested, a tissue bank shall submit reports to the department containing such information and data concerning its activities as may be required by this Part. Such reports shall be signed by the director of the tissue bank. (e) Comprehensive tissue procurement services that terminate operations shall submit, for approval by the department, a plan for the continued storage of donor records for the minimum time periods specified in this Part.

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Section 52-3.8 - Special circumstances

52-3.8 Special circumstances.

(a) The department may exempt a tissue bank from a specific standard contained in this Part, provided:

(1) the tissue bank has applied to the department for an exemption for limited circumstances prior to the noncompliance with the standard; and

(2) the tissue bank has demonstrated to the department that application of the standard to the bank under the limited circumstances for which an exemption is sought:

(i) is inconsistent with the provision of the particular service, as documented in properly conducted current medical or scientific research, or current scientific literature;

(ii) is incompatible with a requirement imposed by a Federal or other state's government unit which is similar to the standard for which an exemption is sought, and the department determines that the requirement imposed by the Federal or other state's governmental unit's requirement adequately protects the public health, safety and welfare, based upon commonly accepted medical standards, properly conducted medical or scientific research or current scientific literature; or

(iii) would prevent provision of services necessitated by a medical emergency or special medical conditions. Persons seeking an exemption pursuant to this subparagraph shall describe the nature of the emergency or special medical conditions and the exemption requested, for review on a case-by-case basis by the department. All such emergencies or special medical conditions shall be documented in the medical record and any action taken in response which is contrary to the requirements of this Part shall be approved by the director of the tissue transplantation service.

(b) A copy of the department's approval for an exemption shall be maintained by the tissue transplantation facility and the tissue bank releasing the tissue.

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SubPart 52-4 - Cardiovascular Tissue Banks

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Section 52-4.1 - Definition

Section 52-4.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Cardiovascular tissue donormeans a human being, living or dead, who is the source of cardiovascular tissue for transplantation, including autogeneic tissue.

(b) Critical work areameans an area where sterile tissue containers or aseptically retrieved tissue are exposed to the environment.

(c) Critical surfacemeans a surface which comes into contact with aseptically retrieved tissue, sterile tissue containers or sterile container covers.

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Section 52-4.2 - Construction

52-4.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Cardiovascular tissue banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of this Part.

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Section 52-4.3 - Tissue procurement services

52-4.3 Tissue procurement services.

(a) A facility that engages in donor selection and solicitation, and retrieval of cardiovascular tissue shall be licensed by the department as a comprehensive tissue procurement service.

(b) A facility whose tissue acquisition activities are limited to donor selection and solicitation by its own staff shall be licensed by the department as a limited tissue procurement service.

(c) Comprehensive tissue procurement services retrieving cardiovascular tissue from cadaveric donors shall maintain written standard operating procedures that assure that the retrieval environment, including, but not limited to, walls, floors and permanent equipment, is suitable for retrieval and adequate to prepare an aseptic field. A working sink shall be available.

(d) Cardiovascular tissue retrieval shall be performed only by trained retrieval technicians under the supervision of the director of a licensed comprehensive tissue procurement service. The director of the licensed comprehensive tissue procurement service shall be responsible for developing policies, procedures and standards for the educational background, training, certification and continuing education of retrieval technicians. Documentation of compliance with this requirement and the standards developed shall be maintained.

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Section 52-4.4 - Donor qualifications

52-4.4 Donor qualifications.

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part.

(b) Unless specifically authorized by the tissue bank medical director, cardiovascular tissue shall not be released for allogeneic transplant from donors with any of the following conditions:

(1) a disease of unknown etiology;

(2) malaria within the last three (3) years or travel to a malarially endemic area within the last six (6) months;

(3) active or untreated tuberculosis;

(4) history or presence of bacterial endocarditis or semilunar valvular heart disease, except for mitral valve prolapse;

(5) previous cardiac valvular surgery, if donation of the affected valve is considered;

(6) insulin-dependent diabetes mellitus;

(7) death due to drowning, if immersion was for longer than six (6) hours; or

(8) history of rheumatic fever.

(c) In addition to the exclusions outlined in subdivision (b) of this section, saphenous veins shall not be released from donors with any of the following conditions:

(1) varicose veins or other conditions of chronic venous stasis;

(2) trauma to saphenous veins; or

(3) significant phlebitis.

(d) Social history as recorded in the medical chart of the donor, or as provided by a friend or family member shall be considered in the donor selection process.

(e) The medical director of the comprehensive tissue procurement service shall be responsible for determining that the donor and the donated cardiovascular tissue are acceptable based on medical history information and established donor selection criteria as specified in this Part, and a physical examination.

(f) A written policy shall specify the range of acceptable donor age limits for allogeneic cardiovascular tissue donation. This policy shall be determined by the tissue bank medical director in consultation with the medical advisory committee of the comprehensive tissue procurement service.

(g) Written criteria for acceptance of donors of autogeneic tissue shall be specified by the transplantation service director of the tissue transplantation facility, unless such criteria have been specified already by the medical director of a comprehensive tissue procurement service.

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Section 52-4.5 - Retrieval of tissue

52-4.5 Retrieval of tissue.

(a) Cardiovascular tissue shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director.

(b) Retrieval of cardiovascular tissue from a cadaveric donor shall occur within a time limit after cessation of cardiac function specified in written policies approved by the medical director of the comprehensive tissue procurement service.

(c) Cardiovascular tissue shall be stored and transported to the tissue processing facility at a temperature between one and 10 degrees Celsius.

(d) Aseptic processing of cardiovascular tissue shall begin within 48 hours of cessation of cardiac function.

(e) If an ante mortem blood sample is not available from a cadaveric donor, a post mortem sample of sufficient quantity to perform required laboratory testing shall be drawn via a cardiac insertion or from a large vein or artery.

(f) Tissue specimen containers and packaging materials shall be sterile and non-toxic.

(g) Each tissue and blood specimen container shall be labeled legibly at the time of retrieval with the tissue bank identification, and donor identification code or unique tissue identification number. The date, time and anatomic site of retrieval shall be recorded on accompanying documents.

(h) Unless a sample for culture is to be collected at the tissue processing facility, a segment or sample of contiguous heart or vascular tissue shall be placed in a separate, appropriately labeled sterile container intended for culturing for aerobic and anaerobic contamination.

(i) Tissue and blood specimen containers shall be labeled so as to maintain cardiovascular tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to significant deterioration under conditions of transport and storage.
 

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Section 52-4.6 - Tissue processing facilities

52-4.6 Tissue processing facilities.

(a) A facility which processes cardiovascular tissue shall be licensed by the department as a tissue processing facility. Such facilities shall make available to the department a statement of the procedures used in the preparation, testing and preservation of the tissue or tissues distributed, or offered for use. The premises, equipment, procedures, records, circulars of instruction and tissues shall be available for inspection and/or testing by the department as required. Copies of all brochures and other informational materials and instructions, including descriptions of methods of tissue handling, shall be available to the department. Each container of tissue shall be clearly labeled with the donor identification code or a unique tissue identification number, unit size and expiration date, if applicable.

(b) Aseptic processing of cardiovascular tissue shall be performed in separately defined work areas with:

(1) floors, walls and ceilings with nonporous smooth surfaces that are easily cleaned;

(2) temperature and humidity controls;

(3) an air supply filtered through high efficiency particulate air filters with positive pressure differentials between rooms;

(4) a system for monitoring environmental conditions;

(5) a system for cleaning and disinfecting a room and equipment to produce aseptic conditions; and

(6) adequate space for staff, and storage of garments and equipment.

(c) Critical work areas in which sterile tissue containers or aseptically retrieved cardiovascular tissue are exposed to the environment shall have an air quality of no more than 100 particles (less than or equal to 0.5 micron) per cubic foot of air and no more than one bacterial colony forming unit per 10 cubic feet of air. Critical work areas shall have a positive pressure gradient greater than or equal to 0.05 inches of water relative to an adjacent less clean area. Critical surfaces shall be sterile and shall not interact with the tissue so as to affect the quality of the tissue adversely.

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Section 52-4.7 - Required laboratory tests on donor and donated tissue

52-4.7 Required laboratory tests on donors and donated tissue.

All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state cardiovascular tissue procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United State Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic cardiovascular tissue donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), human T-lymphotropic virus type I (HTLV-I), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, for purposes of donor selection.
(b) Testing of each cardiovascular tissue unit for aerobic and anaerobic contamination from each retrieval site shall be performed prior to final packaging, using standard laboratory procedures. Whenever fresh tissue is transplanted, the results of cultures shall be made available to the transplantation surgeon on a daily basis until the final reading has been completed.

(c) All cardiovascular tissue from living donors intended for allogeneic use shall be quarantined for six (6) months. After such time and prior to distribution of the tissue for transplantation, the donor shall be retested for HBsAg and antibodies to HCV, HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen (anti-HBc).

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Section 52-4.8 - Processing and storage of tissue

52-4.8 Processing and storage of tissue.

(a) Fresh cardiovascular tissue shall be stored in an isotonic storage medium demonstrated to maximize tissue viability in a sealed, sterile container at a temperature between one and 10 degrees Celsius for a period not to exceed 24 hours from retrieval. Storage shall take place in a refrigerator reserved for cardiovascular or other tissue intended for transplantation, equipped with a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. The temperature shall be visually monitored and recorded daily unless the refrigerator is equipped with a calibrated mechanical temperature monitor and alarm system to detect an increase in temperature to above 10 degrees Celsius or a decrease in temperature to below one degree Celsius.

(b) Cardiovascular tissue processing for cryopreservation shall be initiated under aseptic conditions within 24 hours of retrieval. Until processing, tissue shall be stored at between one and 10 degrees Celsius. Once processed, cardiovascular tissue shall be stored frozen at a target temperature of minus 100 degrees Celsius or lower with a suitable cryoprotectant in labeled containers until distributed or issued for use, in either:

(1) a freezer reserved for cardiovascular or other tissue intended for transplantation, equipped with an audible alarm to detect an increase in temperature to above the limit established by the director and a recording thermometer calibrated at least annually against an NIST-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer; or

(2) a liquid nitrogen tank reserved for cardiovascular or other tissue intended for transplantation.

(c) Storage equipment shall have clearly defined and labeled areas for all cardiovascular tissue stored, and untested tissue shall be maintained in a quarantine area segregated from tissue awaiting distribution.

(d) Thermometers shall be visually monitored daily or temperatures shall be continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations potentially affecting the quality of the cardiovascular tissue. Temperature records and, if applicable, liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one (1) year afterwards.

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Section 52-4.9 - Distribution of tissue products

52-4.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, cardiovascular tissue shall not be made available for allogeneic transplantation if: (1) the donor's blood tests repeatedly reactive in approved screening tests for HBsAg or antibodies to HIV-1, HIV-2, HTLV-I or HCV; or (2) the donor's blood reacts positively to approved tests for syphilis, unless conformatory testing is negative.

(b) Cardiovascular tissue shall be transported by the tissue bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the tissue bank documenting the identification of tissue distributed, including the names of both the person(s) releasing the tissue and the person(s) receiving the tissue.

(c) Frozen cardiovascular tissue in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at a temperature of minus 70 degrees Celsius or lower. Tissue stored at a tissue transplantation facility shall be maintained at the appropriate storage temperature until immediately prior to transplantation.

(d) Cardiovascular tissue and its labeling and packaging shall be visually inspected prior to its distribution by the tissue processing facility. The tissue shall be inspected by the tissue transplantation facility immediately upon receipt and again after thawing, if frozen. If the physical appearance is abnormal, or there is indication or suspicion of overt microbial contamination, the tissue shall not be utilized for transplantation. In the case of frozen tissue, the period of time between thawing and use shall not exceed 24 hours if tissue is refrigerated at between one and 10 degrees Celsius, or four (4) hours if not refrigerated.

(e) Cardiovascular tissue shall be issued by the tissue transplantation facility only upon a written order by a licensed physician, or person authorized by law to order such issuance pursuant to section 52-4.11(b) of this Subpart. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of cardiovascular tissue shall be recorded in a disposition log and shall allow accurate tracking of tissue to each recipient.

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Section 52-4.10 - Required records of tissue acquisition, testing, processing and storage

52-4.10 Required records of tissue acquisition, testing, processing and storage. Each cardiovascular tissue bank shall maintain donation records as required by Subpart 52-2 of this Part.

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Section 52-4.11 - Records to be kept by a tissue transplantation facility

52-4.11 Records to be kept by a tissue transplantation facility.

(a) The director of each tissue transplantation service shall be responsible for records kept by the tissue transplantation facility. In addition to the records specified in Subpart 52-2 of this Part, the following records shall be kept, separate from recipient records, by the tissue transplantation facility:

(1) if performed, results of testing for bacterial and fungal contamination after tissue thawing and prior to engraftment;

(2) a disposition log allowing accurate tracking of tissue to each recipient; and

(3) records of appropriate storage and temperature monitoring of cardiovascular tissue. (b) A copy of the order for issuance of the cardiovascular tissue, including the name and signature of the ordering physician or person authorized by law to order such issuance, shall be kept by the tissue transplantation facility. A record in the patient's chart shall be satisfactory documentation of such order for issuance.

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Section 52-4.12 - Disposition of unused tissue

52-4.12 Disposition of unused tissue.

(a) Thawed cardiovascular tissue that is not used by the tissue transplantation facility within 24 hours of thawing shall be used for education or research purposes authorized by Public Health Law section 4302, or discarded pursuant to Part 70 of this Title. Packaging of cardiovascular tissue for destruction shall be designed to obscure the contents.

(b) Cardiovascular tissue returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The cardiovascular tissue bank shall not reissue tissue returned by the tissue transplantation facility, unless written criteria approved by the tissue bank medical director are met.

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Section 52-4.13 - Tissue storage facilities

52-4.13 Tissue storage facilities.

(a) A facility which stores cardiovascular tissue shall be licensed by the department as a tissue storage facility. The cardiovascular tissue bank shall keep the department fully informed of the number and type of tissue storage facilities operating under its direction.

(b) All cardiovascular tissue shall be stored and monitored in accordance with the provisions of sections 52-4.8, and 52-4.9(b), (c) and (d) of this Subpart.

(c) Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of cardiovascular tissue storage and for one (1) year afterwards.

(d) Cardiovascular tissue products shall be distributed in accordance with the requirements of this Part, and all records related to the inspection, distribution and transport of tissues shall be open to inspection by the department and shall be kept for at least seven (7) years or six (6) months after the expiration date of the tissue, whichever is the longer time.

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SubPart 52-5 - Musculoskeletal Tissue Banks

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Section 52-5.1 - Definitions

Section 52-5.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Batchmeans a specific quantity of tissue that is intended to have uniform characteristics and quality within specific limits, and is produced according to the same processing protocol and during the same processing cycle.

(b) Musculoskeletal tissue donormeans a human being, living or dead, who is the source of musculoskeletal tissue, including autogeneic tissue, for transplantation. (c) Critical work areameans an area where sterile tissue containers or aseptically retrieved tissue are exposed to the environment.

(d) Critical surfacemeans a surface which comes into contact with aseptically retrieved tissue, sterile tissue containers or sterile container covers.

(f) Controlled work areameans an area where unsterilized tissue, in-process materials and tissue containers are handled.

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Section 52-5.2 - Construction

52-5.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Musculoskeletal tissue banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of this Part.

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Section 52-5.3 - Tissue procurement services

52-5.3 Tissue procurement services.

(a) A facility that engages in donor selection and solicitation, and retrieval of musculoskeletal tissue shall be licensed by the department as a comprehensive tissue procurement service.

(b) A facility whose tissue acquisition activities are limited to donor selection and solicitation by its own staff shall be licensed by the department as a limited tissue procurement service.

(c) Comprehensive tissue procurement services retrieving musculoskeletal tissue aseptically from cadaveric donors shall maintain written standard operating procedures that assure that the retrieval environment, including, but not limited to, walls, floors and permanent equipment, is suitable for retrieval and adequate to prepare an aseptic field. A working sink shall be available.

(d) Musculoskeletal tissue retrieval shall be performed only by trained retrieval technicians under the supervision of the director of a licensed comprehensive tissue procurement service. The director of the licensed comprehensive tissue procurement service shall be responsible for developing policies, procedures and standards for the educational background, training, certification and continuing education of retrieval technicians. Documentation of compliance with this requirement and the standards developed shall be maintained.

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Section 52-5.4 - Donor qualifications

52-5.4 Donor qualifications.

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part.

(b) Unless specifically authorized by the tissue bank medical director, musculoskeletal tissue shall not be released for allogeneic transplant from donors with any of the following conditions:

(1) evidence of rheumatoid arthritis;

(2) a disease of unknown etiology; or

(3) malaria within the last three (3) years or travel to a malarially endemic area within the last six (6) months.

(c) Social history as recorded in the medical chart of the donor, or as provided by a friend or family member shall be considered in the donor selection process.

(d) The medical director of the comprehensive tissue procurement service shall be responsible for determining that the donor and the donated musculoskeletal tissue are acceptable based on medical history information and established donor selection criteria as specified in this Part, and a physical examination. (e) A written policy shall specify the range of acceptable donor age limits for allogeneic musculoskeletal tissue donation. This policy shall be determined by the tissue bank medical director in consultation with the medical advisory committee of the comprehensive tissue procurement service.
(f) Written criteria for acceptance of donors of autogeneic tissue shall be specified by the transplantation service director of the tissue transplantation facility, unless such criteria have been specified already by the medical director of a comprehensive tissue procurement service.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.5 - Retrieval of tissue

52-5.5 Retrieval of tissue.

(a) Musculoskeletal tissue, including tissue for which assurance of sterility cannot be maintained, such as mandible, shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director.

(b) Retrieval of musculoskeletal tissue from cadaveric donors shall occur within a time limit after cessation of cardiac function specified in written policies approved by the medical director of the comprehensive tissue procurement service.

(c) Musculoskeletal tissue retrieved from cadaveric donors shall be transported to the tissue processing facility at a temperature of 10 degrees Celsius or lower.

(d) If an ante mortem blood sample is not available from a cadaveric donor, a post mortem sample of sufficient quantity to perform required laboratory testing shall be drawn via a cardiac insertion or from a large vein or artery.

(e) Tissue specimen containers and packaging materials shall be sterile and non-toxic.

(f) Each tissue and blood specimen container shall be labeled legibly at the time of retrieval with the tissue bank identification, and donor identification code or unique tissue identification number. The date, time and anatomic site of retrieval shall be recorded on accompanying documents. (g) A segment or sample of musculoskeletal tissue that is not intended for viral inactivation shall be placed in a separate, appropriately labeled sterile container intended for culturing for aerobic and anaerobic contamination.

(h) Tissue and blood specimen containers shall be labeled so as to maintain musculoskeletal tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to significant deterioration under conditions of transport and storage.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.6 - Tissue processing facilities

52-5.6 Tissue processing facilities.

(a) A facility which processes musculoskeletal tissue shall be licensed by the department as a tissue processing facility. Such facilities shall make available to the department a statement of the procedures used in the preparation, testing and preservation of the tissue or tissues distributed, or offered for use. The premises, equipment, procedures, records, circulars of instruction and tissues shall be available for inspection and/or testing by the department as required. Copies of all brochures and other informational materials and instructions, including descriptions of methods of tissue handling, shall be available to the department. Each container of tissue shall be clearly labeled with the donor identification code or a unique tissue identification number, unit size, and expiration date.

(b) Aseptic processing of musculoskeletal tissue shall be performed in separately defined work areas with:

(1) floors, walls and ceilings with nonporous smooth surfaces that are easily cleaned;

(2) temperature and humidity controls;

(3) an air supply filtered through high efficiency particulate air filters with positive pressure differentials between rooms;

(4) a system for monitoring environmental conditions;

(5) a system for cleaning and disinfecting a room and equipment to produce aseptic conditions; and

(6) adequate space for staff, and storage of garments and equipment.

(c) Processing of musculoskeletal tissue intended for viral inactivation shall occur in controlled work areas. These areas shall have an acceptable microbial and particulate quality to minimize contaminants in final tissue preparation prior to sterilization and to ensure effectiveness of sterilization. Air shall have a particulate (less than or equal to 0.05 micron) count of less than or equal to 100,000 per cubic foot in the vicinity of the exposed tissue during periods of processing activity, and no more than 25 bacterial colonies per ten cubic feet. Air flow shall achieve 20 air exchanges per hour and a pressure differential greater than or equal to 0.05 inches of water relative to an adjacent less clean area. Compressed air shall be free of demonstrable oil vapors.

(d) Critical work areas in which sterile tissue containers or aseptically retrieved musculoskeletal tissue are exposed to the environment shall have an air quality of no more than 100 particles (less than or equal to 0.5 micron) per cubic foot of air and no more than one bacterial colony forming unit per 10 cubic feet of air. Critical work areas shall have a positive pressure gradient greater than or equal to 0.05 inches of water relative to an adjacent less clean area. Critical surfaces shall be sterile and shall not interact with the tissue so as to affect the quality of the tissue adversely.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.7 - Required laboratory tests on donors and donated tissue

52-5.7 Required laboratory tests on donors and donated tissue.

All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state musculoskeletal tissue procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic musculoskeletal tissue donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, and, unless the tissue is to be virally inactivated, antibodies to human T-lymphotropic virus type I (HTLV-I), for purposes of donor selection.

(b) Testing of each musculoskeletal tissue unit for aerobic and anaerobic contamination shall be performed prior to final packaging, using standard laboratory procedures. Whenever fresh tissue is transplanted, the results of cultures shall be made available to the transplantation surgeon on a daily basis until the final reading has been completed.

(c) All musculoskeletal tissue from living donors intended for allogeneic use shall be quarantined for six (6) months. After such time and prior to distribution of the tissue for transplantation, the donor shall be retested for HBsAg and antibodies to HCV, HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen (anti-HBc).

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.8 - Processing and storage of tissue

52-5.8 Processing and storage of tissue.

(a) Fresh musculoskeletal tissue shall be stored in an isotonic storage medium demonstrated to maximize tissue viability in a sealed, sterile container at a temperature between one and 10 degrees Celsius for a period not to exceed 14 days from retrieval. Storage shall take place in a refrigerator reserved for musculoskeletal or other tissue intended for transplantation, or blood intended for transfustion, equipped with a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. The temperature shall be visually monitored and recorded daily unless the refrigerator is equipped with a calibrated mechanical temperature monitor and alarm system to detect an increase in temperature to above 10 degrees Celsius or a decrease in temperature to below one degree Celsius.

(b) Musculoskeletal tissue processing for freezing shall be performed under aseptic conditions within 48 hours of retrieval. Until processing, tissue shall be stored at between one and 10 degrees Celsius. Once processed, musculoskeletal tissue shall be stored frozen at a target temperature of minus 40 degrees Celsius or lower in labeled containers until released for use, in either:

(1) a freezer reserved for musculoskeletal or other tissue intended for transplantation, or blood intended for transfusion, equipped with an audible alarm to detect an increase in temperature to above the limit established by the director and a recording thermometer calibrated at least annually against an NIST-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer; or

(2) a liquid nitrogen tank reserved for musculoskeletal or other tissue intended for transplantation.

(c) Freeze-dried musculoskeletal tissue shall be processed in a manner that meets the minimum standards of the manufacturer of the freeze-drier. The freeze-drier shall be equipped with a temperature recording device unless another mechanism for recording temperature is in place, and documentation shall allow tracing of each tissue product to a specific batch. Sterility testing of each freeze-dried tissue unit shall be performed using a properly validated method of 100 percent nondestructive testing, or another method approved by the medical director of the tissue bank in consultation with the medical advisory committee and approved by the department. Testing for residual moisture shall be performed on one representative sample from each freeze-dried batch for each type of musculoskeletal tissue, such as cartilage, ligament and bone. Freeze-dried tissue shall be stored at room temperature or lower.

(d) If musculoskeletal tissue is sterilized by ethylene oxide, testing for ethylene oxide, ethylene glycol and ethylene chlorhydrin residue shall be performed on each type of tissue within a batch. Residue amounts shall not exceed:

PARTS PER MILLION

TISSUE ETHYLENE ETHYLENE ETHYLENE QUANTITY OXIDE CHLORHYDRIN GLYCOL

Small (<10 g) 250 250 5,000 Medium (10-100 g) 100 100 2,000 Large (>100 g) 25 25 500

(e) Storage equipment shall have clearly defined and labeled areas for all musculoskeletal tissue stored, and untested tissue shall be maintained in a quarantine area segregated from tissue awaiting distribution.

(f) Thermometers shall be visually monitored daily, or temperatures shall be continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations potentially affecting the quality of the musculoskeletal tissue. Storage shall be at a target temperature of minus 40 degrees Celsius or lower. Temperature records and, if applicable, liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one (1) year afterwards.

(g) Musculoskeletal tissue from two (2) or more donors shall not be pooled.

(h) The age and sex of the donor, and, if the musculoskeletal tissue is from a living donor, the patient's orthopedic diagnosis shall be made available to the transplanting surgeon, upon request.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.9 - Distribution of tissue products

52-5.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, musculoskeletal tissue shall not be made available for allogeneic transplantation if: (1) the donor's blood tests repeatedly reactive in approved screening tests for HBsAg, or antibodies to HIV-1, HIV-2, HCV or, unless the tissue is to be virally inactivated, antibodies to HTLV-I; or (2) the donor's blood reacts positively to approved tests for syphilis, unless confirmatory testing is negative.
(b) Freeze-dried processed musculoskeletal tissue distributed by a processing or storage facility shall be visually inspected for cracks, contamination, or extraneous material prior to distribution. If tissue container seals are broken or there is evidence that proper temperature has not been maintained, tissue shall not be distributed for transplantation. Container vacuums shall be determined to be satisfactory by testing with a spark generator.

(c) Musculoskeletal tissue shall be transported by the tissue bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the tissue bank documenting the identification of tissue distributed, including the names of both the person(s) releasing the tissue and the person(s) receiving the tissue.

(d) Musculoskeletal tissue in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at the applicable storage temperature specified in section 52-5.8. Tissue stored at a tissue transplantation facility shall be maintained, until immediately prior to transplantation, at minus 20 degrees Celsius or lower for a maximum of six (6) months, and minue 40 degrees Celsius for longer periods. Storage shall be in a freezer reserved for musculoskeletal or other tissue intended for transplantation, or blood intended for transfusion.

(e) Musculoskeletal tissue and its labeling and packaging shall be visually inspected prior to its distribution by the tissue processing facility. The tissue shall be inspected by the tissue transplantation facility immediately upon receipt and again after thawing, if frozen. If the physical appearance is abnormal, or there is indication or suspicion of overt microbial contamination, the tissue shall not be utilized for transplantation. In the case of frozen tissue, the period of time between thawing and use shall not exceed 24 hours if tissue is refrigerated at between one and 10 degrees Celsius, or four (4) hours if not refrigerated.

(f) Musculoskeletal tissue shall be issued by the tissue transplantation facility only upon a written order by a licensed physician or other person authorized by law to order tissue. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of musculoskeletal tissue shall be recorded in a disposition log and shall allow accurate tracking of tissue to each recipient.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.10 - Required records of tissue acquisition, testing, processing and storage

52-5.10 Required records of tissue acquisition, testing, processing and storage. In addition to the recordkeeping requirements of Subpart 52-2 of this Part, each musculoskeletal tissue bank shall maintain tissue records which include:

(a) spark testing for vacuum in the case of freeze-dried tissue; and

(b) if the tissue is sterilized by ethylene oxide, amount of ethylene oxide, ethylene glycol and ethylene chlorhydrin residue for each type of musculoskeletal tissue within a batch.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.11 - Records to be kept by the tissue transplantation facility

52-5.11 Records to be kept by a tissue transplantation facility.

(a) The director of each tissue transplantation service shall be responsible for records kept by the tissue transplantation facility. In addition to the records specified in Subpart 52-2 of this Part, the following records shall be kept, separate from recipient records, by the tissue transplantation facility:

(1) if performed, results of testing for bacterial and fungal contamination after tissue thawing and prior to engraftment;

(2) a disposition log allowing accurate tracking of tissue to each recipient; and

(3) records of appropriate storage and temperature monitoring of musculoskeletal tissue. (b) A copy of the order for issuance of the musculoskeletal tissue, including the name and signature of the ordering physician or person authorized by law to order such issuance, shall be kept by the tissue transplantation facility. A record in the patient's chart shall be satisfactory documentation of such order for issuance.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.12 - Disposition of unused tissue

52-5.12 Disposition of unused tissue.

(a) All musculoskeletal tissue determined to be unsuitable for transplantation, or education or research purposes authorized by Public Health Law section 4302 shall be discarded pursuant to Part 70 of this Title. Packaging of musculoskeletal tissue for destruction shall be designed to obscure the contents.

(b) Musculoskeletal tissue returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The musculoskeletal tissue bank shall not reissue tissue returned by the tissue transplantation facility, unless written criteria approved by the tissue bank medical director are met.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-5.13 - Tissue storage facilities

52-5.13 Tissue storage facilities.

(a) A facility which stores musculoskeletal tissue shall be licensed by the department as a tissue storage facility. The musculoskeletal tissue bank shall keep the department fully informed of the number and type of tissue storage facilities operating under its direction.

(b) All musculoskeletal tissue shall be stored and monitored in accordance with the provisions of sections 52-5.8, and 52-5.9(b), (c), (d) and (e) of this Subpart.

(c) Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of musculoskeletal tissue storage and for one (1) year afterwards.

(d) Musculoskeletal tissue products shall be distributed in accordance with the requirements of this Part, and all records related to the inspection, distribution and transport of tissues shall be open to inspection by the department and shall be kept for at least seven (7) years or six (6) months after the expiration date of the tissue, whichever is the longer time.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

SubPart 52-6 - Skin Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.1 - Definitions

Section 52-6.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Skin donormeans a human being, living or dead, who is the source of skin tissue, including autogeneic tissue, for transplantation.

(b) Transplantationmeans the grafting of skin from a donor to a recipient, including the grafting of skin that has been manipulated and integrated into an artificial skin substitute, and the grafting of skin from an autogeneic donor.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.2 - Construction

52-6.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Skin banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.3 - Tissue procurement services

52-6.3 Tissue procurement services.

(a) A facility that engages in donor selection and solicitation, and retrieval of skin shall be licensed by the department as a comprehensive tissue procurement service.

(b) A facility whose tissue acquisition activities are limited to donor selection and solicitation by its own staff shall be licensed by the department as a limited tissue procurement service.

(c) Comprehensive tissue procurement services retrieving skin from cadaveric donors shall maintain written standard operating procedures that assure that the retrieval environment, including, but not limited to, walls, floors and permanent equipment, is suitable for aseptic retrieval and adequate to prepare an aseptic field. A working sink shall be available.

(d) Skin retrieval shall be performed only by trained retrieval technicians under the supervision of the director of a licensed comprehensive tissue procurement service. The director of the licensed comprehensive tissue procurement service shall be responsible for developing policies, procedures and standards for the educational background, training, certification and continuing education of retrieval technicians. Documentation of compliance with this requirement and the standards developed shall be maintained.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.4 - Donor qualifications

52-6.4 Donor qualifications.

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part.

(b) Unless specifically authorized by the tissue bank medical director, skin shall not be released for allogeneic transplant from donors with any of the following conditions:

(1) a disease of unknown etiology;

(2) malaria within the last three (3) years or travel to a malarially endemic area within the last six (6) months; or

(3) drowning as a terminal event.

(c) Social history as recorded in the medical chart of the donor, or as provided by a friend or family member shall be considered in the donor selection process.

(d) The medical director of the comprehensive tissue procurement service shall be responsible for determining that the donor and the donated skin are acceptable based on medical history information and established donor selection criteria as specified in this Part, and a physical examination.

(e) A written policy shall specify the range of acceptable donor age and weight limits for allogeneic skin donation. This policy shall be determined by the tissue bank director in consultation with the medical director and medical advisory committee of the comprehensive tissue procurement service.

(f) Written criteria for acceptance of autogeneic tissue shall be specified by the transplantation service director of the tissue transplantation facility, unless such criteria have been specified already by the medical director of a comprehensive tissue procurement service.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.5 - Retrieval of tissue

52-6.5 Retrieval of tissue.

(a) Skin shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director. In all cases, a vigorous surgical scrub and disinfectant solution nontoxic to epithelial cells shall be used in preparing the donation site for skin retrieval in accordance with standard operating room practice.

(b) Retrieval of skin from cadaveric donors shall occur within a time limit after cessation of cardiac function specified in written policies approved by the medical director of the comprehensive tissue procurement service.

(c) If an ante mortem blood sample is not available from a cadaveric donor, a post mortem sample of sufficient quantity to perform required testing shall be drawn via a cardiac insertion or from a large vein or artery.

(d) Skin specimen containers and packaging materials shall be sterile and nontoxic.

(e) Each skin and blood specimen container shall be labeled legibly at the time of retrieval with the tissue bank identification, and donor identification code or unique tissue identification number. The date, time and anatomic site of retrieval shall be recorded on accompanying documents.

(f) Fresh-cut skin shall be maintained in a sterile, isotonic solution or other nutrient medium during the skin removal procedure, and transported to the tissue processing facility at the completion of the procedure.

(g) Skin samples for testing for microbial contamination shall be recovered from each anatomical site and placed in a separate, appropriately labeled container.

(h) Skin and blood specimen containers shall be labeled so as to maintain identification throughout all phases of processing, storage and distribution, in a manner not subject to significant deterioration under conditions of transport and storage.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.6 - Tissue processing facilities

52-6.6 Tissue processing facilities.

A facility which processes skin shall be licensed by the department as a tissue processing facility. Such facilities shall make available to the department a statement of the procedures used in the preparation, testing and storage of the tissue or tissues distributed, or offered for use. The premises, equipment, procedures, records, circulars of instruction and tissues shall be available for inspection and/or testing by the department as required. Copies of all brochures and other informational materials and instructions, including descriptions of methods of tissue handling, shall be available to the department. Each container of tissue shall be clearly labeled with the donor identification code or a unique tissue identification number, unit size and expiration date, if applicable.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.7 - Required laboratory tests on donors and donated tissue

52-6.7 Required laboratory tests on donors and donated tissue. All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state skin procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic skin donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, and, unless the tissue is to be virally inactivated, antibodies to human T-lymphotropic virus type I (HTLV-I), for purposes of donor selection.
(b) Microbial testing of skin from each anatomical site for aerobic and anaerobic contamination shall be performed using standard laboratory procedures. Whenever fresh skin is transplanted, the results of cultures shall be made available to the transplantation surgeon on a daily basis until the final reading has been completed.

(c) All skin tissue from living donors intended for allogeneic use shall be quarantined for at least six months. After such time and prior to the distribution of the tissue for transplantation, the donor shall be retested for HBsAg and antibodies to HCV, HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen (anti-HBc).

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.8 - Processing and storage of tissue

52-6.8 Processing and storage of tissue.

(a) Fresh skin shall be stored in a sealed, sterile container with an isotonic solution or nutrient medium demonstrated to maximize tissue viability, at a temperature between one and 10 degrees Celsius for a period not to exceed fourteen (14) days from retrieval. Storage shall take place in a refrigerator reserved for skin or other tissue intended for transplantation, or blood intended for transfusion, equipped with a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. The temperature shall be visually monitored daily unless the refrigerator is equipped with a calibrated mechanical temperature monitor and alarm system to detect an increase in temperature to above 10 degrees Celsius or a decrease in temperature to below one degree Celsius.

(b) If performed, skin processing for cryopreservation shall occur under aseptic conditions within three (3) days of retrieval. Until processing, skin shall be stored at between one and 10 degrees Celsius. Once processed, skin shall be stored frozen at a target temperature of minus 40 degrees Celsius or lower with a suitable cryoprotectant in labeled containers until released for use, in either:

(1) a freezer reserved for skin or other tissue intended for transplantation, or blood intended for transfusion, equipped with an audible alarm to detect an increase in temperature to above the limit established by the director and a thermometer calibrated at least annually against an NIST-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer; or

(2) a liquid nitrogen tank reserved for skin or other tissue intended for transplantation.

(c) If performed, skin processing for freeze-drying shall take place within seven (7) days of tissue procurement and in a manner that meets the minimum standards of the manufacturer of the freeze-drier. If sterilized by ethylene oxide, testing for ethylene oxide, ethylene glycol and ethylene chlorhydrin residue shall be performed on each batch of skin sterilized. Freeze-dried skin shall be stored at between one and 30 degrees Celsius.

(d) Storage devices shall have clearly defined and labeled areas for all skin stored, and untested tissue shall be maintained in a quarantine area segregated from tissue awaiting distribution.

(e) Thermometers shall be visually monitored daily, or temperatures shall be continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations potentially affecting the quality of the skin. Storage shall be at a target temperature of minus 40 degrees Celsius or lower. Temperature records and, if applicable, liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one (1) year afterwards.

(f) Skin from two (2) or more donors shall not be pooled.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.9 - Distribution of tissue products

52-6.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, skin shall not be made available for allogeneic transplantation if: (1) the donor's blood tests repeatedly reactive in approved screening tests for HBsAg, or antibodies to HIV-1, HIV-2, HCV or, unless the tissue is to be virally inactivated, antibodies to HTLV-I; or (2) the donor's blood reacts positively to approved tests for syphilis, unless confirmatory testing is negative.

(b) Skin shall be transported by the tissue bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the skin bank documenting the identification of tissue distributed, including the names of both the person(s) releasing the tissue and the person(s) receiving the tissue.

(c) Skin in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at the applicable storage temperature specified in section 52-6.8 of this Subpart. Tissue stored at a tissue transplantation facility shall be maintained at a target temperature of minus 40 degrees Celsius or lower until immediately prior to transplantation. Storage shall be in a freezer or liquid nitrogen tank reserved for skin or other tissue intended for transplantation, or blood reserved for transfusion.

(d) Skin and its labeling and packaging shall be visually inspected prior to its release by the tissue processing facility. The tissue shall be inspected by the tissue transplantation facility immediately upon receipt and again after thawing, if frozen. If the physical appearance is abnormal, or there is indication or suspicion of overt microbial contamination, the skin shall not be utilized for transplantation.

(e) Skin shall be issued by the tissue transplantation facility only upon a written order by a licensed physician or other person authorized by law to order tissue. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of skin shall be recorded in a disposition log and shall allow accurate tracking of tissue to each recipient.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.10 - Required records of tissue acquisition, testing, processing and storage

52-6.10 Required records of tissue acquisition, testing, processing and storage.

Each skin bank shall maintain donation records as required by Subpart 52-2 of this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.11 - Records to be kept by a tissue transplantation facility

52-6.11 Records to be kept by a tissue transplantation facility.

(a) The director of each tissue transplantation service shall be responsible for records kept by the tissue transplantation facility. In addition to the records specified in Subpart 52-2 of this Part, the following records shall be kept, separate from recipient records, by the tissue transplantation facility:

(1) a disposition log allowing accurate tracking of tissue to each recipient; and

(2) records of appropriate storage and temperature monitoring of skin.

(b) A copy of the order for issuance of the skin, including the name and signature of the ordering physician or person authorized by law to order such issuance, shall be kept by the tissue transplantation facility. A record in the patient's chart shall be satisfactory documentation of such order for issuance.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.12 - Disposition of unused tissue

52-6.12 Disposition of unused tissue.

(a) Skin that is not used by the tissue transplantation facility immediately after thawing may be refrigerated at between one and 10 degrees Celsius in isotonic or nutrient medium demonstrated to maximize tissue viability for a period of up to seven (7) days. Such skin may be issued for transplantation to the same patient to whom the skin was originally assigned, but shall not be refrozen. Thawed skin that is not used within seven (7) days shall be discarded, or used for education or research purposes authorized by Public Health Law section 4302.

(b) Skin determined to be unsuitable for transplantation, or education or research purposes shall be discarded pursuant to Part 70 of thisTitle. Packaging of skin for destruction shall be designed to obscure the contents.

(c) Skin returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The skin bank shall not reissue tissue returned by the tissue transplantation facility, unless written criteria approved by the tissue bank medical director are met.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-6.13 - Tissue storage facilities

52-6.13 Tissue storage facilities.

(a) A facility which stores skin shall be licensed by the department as a tissue storage facility. The skin bank shall keep the department fully informed of the number and type of tissue storage facilities operating under its direction.

(b) All skin shall be stored and monitored in accordance with the provisions of sections 52-6.8, and 52-6.9(b), (c) and (d) of this Subpart.

(c) Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of skin storage and for one (1) year afterwards.

(d) Skin products shall be distributed in accordance with the requirements of this Part, and all records related to the inspection, distribution and transport of skin shall be open to inspection by the department, and shall be kept for at least seven (7) years or six (6) months after the expiration date of the tissue, whichever is the longer time.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

SubPart 52-7 - Eye Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-7.1 - Definitions

Section 52-7.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Eye donormeans a human being, living or dead, who is the source of ocular tissue intended for transplantation.

(b) Enucleationmeans the removal of the whole eye globe.

(c) Corneal excisionmeans the in situor laboratory removal of the cornea or corneal-scleral rim.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-7.2 - Construction

52-7.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Eye banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-7.3 - Tissue procurement services

52-7.3 Tissue procurement services.

(a) A facility that engages in donor selection and solicitation, and retrieval of ocular tissue shall be licensed by the department as a comprehensive tissue procurement service.

(b) A facility whose tissue acquisition activities are limited to donor selection and solicitation by its own staff shall be licensed by the department as a limited tissue procurement service.

(c) Comprehensive tissue procurement services retrieving ocular tissue aseptically from cadaveric donors shall maintain written standard operating procedures that assure that the retrieval environment, including, but not limited to, walls, floors and permanent equipment, is suitable for enucleation or excision, and adequate to prepare a clean surgical field. A working sink shall be available.

(d) Ocular tissue retrieval shall be performed only by trained retrieval technicians under the supervision of the director of a licensed eye bank. The director of the licensed eye bank shall be responsible for developing policies, procedures and standards for the educational background, training, certification and continuing education of retrieval technicians. Documentation of compliance with this requirement and the standards developed shall be maintained.

Effective Date: 
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Section 52-7.4 - Donor qualifications

52-7.4 Donor qualifications.

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part.

(b) Unless specifically authorized by the tissue bank medical director, ocular tissue shall not be released for transplant from donors with any of the following conditions or factors:

(1) evidence of disseminated malignant disease, such as lymphoma or leukemia;

(2) malignant disease of the eye;

(3) active hepatitis B or C, or hepatitis of unknown etiology;

(4) syphilis within the past 12 months;

(5) any disease of unknown etiology;

(6) congenital rubella;

(7) subacute sclerosing panencephalitis;

(8) Reye's syndrome; or

(9) bacterial or fungal endocarditis.

(c) The medical director of the comprehensive tissue procurement service shall be responsible for determining that donors and donated ocular tissue are acceptable based on medical history information, the tissue bank's established donor selection criteria and the factors specified in this Part.

(d) A written policy shall specify the range of acceptable donor age limits for eye donation. This policy shall be determined by the tissue bank medical director in consultation with the medical advisory committee of the comprehensive tissue procurement service.

(e) Unless intended for lamellar grafts or epikeratoplasty, corneal tissue shall not be released from donors with prior intraocular or anterior segment surgery affecting the corneal endothelium or from donors with intrinsic eye disease affecting the corneal endothelium.

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Section 52-7.5 - Retrieval of tissue

52-7.5 Retrieval of tissue.

(a) Prior to enucleation, eyes shall be maintained in accordance with procedures approved by the tissue bank medical director. Eyes shall be kept moist during the interval between cessation of circulatory function and enucleation.

(b) Enucleation and corneal excision shall be performed in a clean surgical field using standard operating room technique.

(c) Enucleation and/or corneal excision shall occur within 12 hours after cessation of circulatory function unless otherwise specifically authorized by the tissue bank medical director.

(d) Eyes shall be stored and transported to the tissue processing facility at a temperature between two and six degrees Celsius.

(e) If an ante mortem blood sample is not available from a cadaveric donor, a post mortem sample of sufficient quantity to perform required laboratory testing shall be drawn via a cardiac insertion or from a large vein or artery.

(f) Tissue specimen containers and storage solutions shall be sterile and nontoxic.

(g) Each tissue and blood specimen container shall be labeled legibly at the time of retrieval with the tissue bank identification, and donor identification code or unique tissue identification number. The date, time and anatomic site of retrieval shall be recorded on accompanying documents.

(h) Tissue and blood specimen containers shall be labeled so as to maintain tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to significant deterioration under conditions of transport and storage.

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Section 52-7.6 - Tissue processing facilities

52-7.6 Tissue processing facilities.

A facility which processes ocular tissue shall be licensed by the department as a tissue processing facility. Such facilities shall make available to the department a statement of the procedures used in the preparation, testing and preservation of the tissue or tissues distributed, or offered for use. The premises, equipment, procedures, records, brochures and other informational materials, instructions, manufactured media and tissues shall be available for inspection and/or testing by the department as required. Copies of all general circulars of information and instructions, including descriptions of methods of tissue handling, shall be available to the department. Each container of tissue shall be clearly labeled with the donor identification code or a unique tissue identification number and collection date.

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Section 52-7.7 - Required laboratory tests on donors and donated tissue

52-7.7 Required laboratory tests on donors and donated tissue.

All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state tissue procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic ocular tissue donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2) and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg), for purposes of donor selection.
(b) All ocular tissue from living donors, except corneal tissue, shall be quarantined for six (6) months. After such time and prior to the distribution of the tissue for transplantation, the donor shall be retested for HBsAg and antibodies to HCV, HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen (anti-HBc).

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Section 52-7.8 - Processing and storage of tissue

52-7.8 Processing and storage of tissue.

(a) Until processing, eyes shall be stored at a temperature of between two and six degrees Celsius.

(b) The corneal-scleral segment shall be examined grossly for clarity, epithelial defects, foreign objects, contamination and scleral color for evidence of jaundice.

(c) Slit-lamp examination of whole eyes or the corneal-scleral rim of excised tissue shall be performed to detect epithelial and stromal pathology, including edema, cell density, opacities, scars and guttata. A system, as determined by the tissue bank medical director, shall be in place to categorize tissue adequacy for transplantation.

(d) Eyes and ocular tissue shall be preserved using aseptic technique, in:

(1) a moist chamber kept at a temperature of between two and six degrees Celsius;

(2) a short-term preservation medium stored and used in accordance with the manufacturer's instructions and/or with written procedures approved by the tissue bank director;

(3) a long-term culture medium used in accordance with written procedures approved by the tissue bank director;

(4) a frozen or dehydrated state, if corneal tissue is used for epikeratoplasty;

(5) the frozen state, as scleral grafts immersed in antibiotic solution; or

(6) any other method, in accordance with written procedures approved by the tissue bank medical director and currently accepted by leading authorities in eye transplant medicine.

(e) Thawed tissue that has been refrozen shall not be issued for transplantation.

(f) The duration of storage subsequent to application of each preservation method above shall be clearly specified in written procedures approved by the tissue bank medical director.

(g) Tissue shall be maintained aseptically at a temperature appropriate to the method of preservation utilized. The tissue bank director shall determine the appropriate temperature based upon the method of preservation utilized, manufacturers' instructions, standards set forth in this Part and standards in current scientific literature. The refrigeration device used for storage shall be reserved for ocular and other tissue and related supplies, with clearly defined and labeled areas for all tissues stored. Quarantined tissue awaiting test results shall be segregated from tissue ready for distribution. Unless an alternative mechanism is in place for immediate notification and action to be taken in the event of a power failure, the refrigeration device shall be equipped with an audible alarm to detect temperature deviations above and below the established limits of storage, and a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer.

(h) Thermometers shall be visually monitored daily or temperatures shall be continuously monitored mechanically for fluctuations potentially affecting the quality of the tissue. Temperature records shall be available for inspection by the department for the entire period of storage and for one (1) year afterwards.

(i) If a whole eye is stored in a moist chamber, corneal excision shall occur within twelve (12) hours, and tissue shall be transplanted within a time period established in written policy by the tissue bank medical director and the medical advisory committee.

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Section 52-7.9 - Distribution of tissue products

52-7.9 Distribution of tissue products.

(a) Except as specified in section 52-3.4 of this Part, ocular tissue shall not be made available for transplantation if the donor's blood tests repeatedly reactive in approved screening tests for HBsAg or antibodies to HIV-1, HIV-2 or HCV.

(b) The eye bank shall distribute tissue for transplantation only to another eye bank or to a licensed tissue transplantation facility in possession of a written order by a licensed physician.

(c) Tissue shall be transported by the eye bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the eye bank documenting the identification of tissue distributed, including the names of both the person(s) releasing the tissue and the person(s) receiving the tissue.

(d) Tissue in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at the appropriate storage temperature specified in section 52-7.8 of this Subpart. Tissue stored at a transplantation facility shall be maintained at the appropriate storage temperature until immediately prior to transplantation.

(e) Tissue shall be visually inspected prior to use by the transplant surgeon, who shall determine the suitability of the tissue for transplantation.

(f) Tissue shall be issued by the tissue transplantation facility only upon a written order by a licensed physician or other person authorized by law to order tissue for transplant. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Documentation shall allow accurate tracking of tissue to each recipient.

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Section 52-7.10 - Required records of tissue acquisition, testing, processing and

52-7.10 Required records of tissue acquisition, testing, processing and storage.

In addition to the recordkeeping requirements of Subpart 52-2 of this Part, each eye bank must maintain tissue records which include:

(a) documentation of gross ocular tissue evaluation; and

(b) documentation of slit-lamp examination.

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Section 52-7.11 - Laboratory tests to be performed prior to tissue transplantation.

52-7.11 Laboratory tests to be performed prior to tissue transplantation.

The tissue transplantation service shall culture the corneal-scleral rim at the time of tissue transplantation for aerobic and anaerobic bacterial contamination.

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Section 52-7.12 - Records to be kept by a tissue transplantation facility

52-7.12 Records to be kept by a tissue transplantation facility.

(a) The director of each tissue transplantation service shall be responsible for records kept by the tissue transplantation facility. In addition to the records specified in Subpart 52-2 of this Part, the following records shall be kept, separate from recipient records, by the tissue transplantation facility:

(1) results of bacterial culture;

(2) records of appropriate storage and temperature monitoring of ocular tissue; and

(3) a dedicated record allowing accurate tracking of tissue to each recipient.
(b) A copy of the order for issuance of the tissue, including the name and signature of the ordering physician or person authorized by law to order such issuance, shall be kept by the tissue transplantation facility. A record in the patient's chart shall be satisfactory documentation of such order for issuance.

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Section 52-7.13 - Disposition of unused tissue

52-7.13 Disposition of unused tissue.

(a) All tissue unsuitable for transplantation, education, or research purposes authorized by Public Health Law section 4302 shall be discarded pursuant to Part 70 of this Title. Packaging of tissue for destruction shall be designed to obscure the contents.
(b) If tamper-resistant seals are broken or proper temperature has not been maintained, tissue shall not be issued for transplantation.

(c) Tissue returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The tissue bank shall not reissue tissue returned by the tissue transplantation facility, unless written criteria approved by the tissue bank medical director are met.

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SubPart 52-8 - Reproductive Tissue Banks

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Section 52-8.1 - Definitions

52-8.1 Definitions. As used in this Part:

(a) Anonymous donormeans a donor whose identity is unknown to the recipient.

(b) Artificial inseminationmeans the placement of semen within the body of a recipient.

(c) Assisted reproductive proceduremeans a medical procedure intended to result in conception, including, but not limited to,
in vitrofertilization (including intracytoplasmic sperm injection), embryo transfer and gamete intrafallopian transfer.

(d) Client-depositormeans an individual who deposits reproductive tissue prior to intended or potential use in artificial insemination or assisted reproductive procedures performed on his regular sexual partner, or a woman who deposits reproductive tissue for processing into embryos and subsequent implantation into the same woman.

(e) Directed donormeans a donor who is known to the recipient and who directs his or her reproductive tissue for use by a particular recipient. This includes a man providing semen to a surrogate, but who is not the regular sexual partner of the recipient.

(f) Donormeans a person who provides reproductive tissue for use in artificial insemination or assisted reproductive procedures performed on recipients other than that person or that person's regular sexual partner, and includes directed donors.

(g) Reproductive tissue bankmeans a facility which acquires, processes, stores, distributes and/or releases reproductive tissue to an insemination/implantation site for use in artificial insemination or assisted reproductive procedures. Reproductive tissue banks include, but are not limited to semen banks, oocyte donation programs and embryo banks.

(h) Insemination/implantation sitemeans a location at which artificial insemination or assisted reproductive procedures are performed, using reproductive tissue from anonymous donors, directed donors and/or client-depositors. Licensed insemination/implantation sites may undertake, without additional licensure, semen processing, limited to washing, concentrating and storing of semen from patients of physicians associated with the licensed insemination/implantation sites or the patients' regular sexual partners, as well as limited semen storage (less than six months' duration).

(i) Recipientmeans a woman who receives reproductive tissue from a donor or client-depositor.

(j) Semen processing facilitymeans a tissue processing facility that processes semen for use by other licensed reproductive tissue banks and insemination/implantation sites.

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Section 52-8.2 - Licensure

52-8.2 Licensure. Reproductive tissue banks, insemination/implantation sites and semen processing facilities shall not operate unless licensed as tissue banks pursuant to Subpart 52-2 of this Part.

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Section 52-8.3 - Administrative responsibility

52-8.3 Administrative responsibility.

The reproductive tissue bank director shall assume overall responsibility for operation of the reproductive tissue bank. The reproductive tissue bank director shall meet the requirements of section 52-2.5(a)(2) of this Part. The training and/or experience requirements specified in section 52-2.5 of this Part shall be in the field of reproductive endocrinology, andrology, human fertility or a closely related field. The reproductive tissue bank director shall develop and implement policies and procedures consistent with this Subpart for the operation of the bank. If the reproductive tissue bank director is not a physician, a medical director who meets the requirements of section 52-2.5(a)(3) of this Part shall be retained. Except for insemination/implantation sites, reproductive tissue anks shall have a medical advisory committee, composed of at least five members with experience and expertise in the fielda of human fertility, infectious disease, clinical pathology or related fields, who shall be responsible for monitoring the medical efficacy of the reproductive tissue bank and reviewing operating policies and procedures. If the bank acquires reproductive tissue from donors, a qualified microbiologist, clinical pathologist or infectious disease specialist, and a geneticist shall serve either as members of or consultants to the committee.

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Section 52-8.4 - Direction and medical direction

52-8.4 Direction and medical direction.

(a) Medical direction of a reproductive tissue bank shall be provided by the medical director in consultation with the medical advisory committee, if applicable.

(b) Except for insemination/implantation sites, the reproductive tissue bank director, in consultation with the medical director, if not the same person, and the medical advisory committee shall monitor the efficacy of the reproductive tissue banking program and shall, as a minimum, develop:

(1) medical criteria for donor participation;

(2) quality standards for sperm, oocytes, embryos and other reproductive tissue, as applicable; and

(3) guidelines for determining a maximum number of offspring per donor to minimize the probability of consanguinity.

(c) The reproductive tissue bank director shall be responsible for selection of donors who meet the medical criteria and the technical/scientific operation of the reproductive tissue bank, and shall make available to the physician performing each artificial insemination or assisted reproductive procedure the donor's medical history and other pertinent nonidentifying characteristics of the donor, so that recipient counseling may be provided.

(d) Artificial insemination and all assisted reproductive procedures shall be ordered only by a licensed physician, physician's assistant or nurse practitioner. Artificial insemination procedures shall be performed only by:

(1) a licensed physician;

(2) a licensed physician's assistant; (3) a licensed nurse practitioner; or
(4) a licensed registered nurse who has been trained in the technical aspects of artificial insemination by a licensed physician, licensed physician's assistant or licensed nurse practitioner employed by the insemination/implantation site, and is supervised by such a physician, physician's assistant or nurse practitioner.

Effective Date: 
Wednesday, November 1, 2000
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Section 52-8.5 - Donor qualifications

52-8.5 Donor qualifications.

(a) The reproductive tissue bank shall initially screen and periodically assess donors for conditions that may adversely affect the quality of reproductive tissue or impair the recipient's and/or the offspring's health. Reproductive tissue donor screening shall, except as provided in Section 52-8.6(g), be performed prior to the initial collection of reproductive tissue for clinical use, and shall include a physical examination, as well as an examination for indications of sexually transmissable diseases.

(b) A complete medical history, both individual and family, including first-degree and second-degree relatives, shall be obtained from each reproductive tissue donor prior to any collection of tissue for clinical use, and shall include, but not be limited to, incidence of the following:

(1) major malformations of complex cause that result in serious functional or cosmetic defects, including, but not limited to spina bifida or heart malformations;

(2) major genetic disorders, including: (i) autosomal dominant or X-linked disorders for which age of onset extends beyond the age of the donor; (ii) autosomal dominant disorders with reduced penetrance; and (iii) autosomal recessive disorders;
(3) for semen donors, systemic disease which may affect the decision to use the semen;

(4) for semen donors, infectious skin disease that may create a risk of contamination of the semen;

(5) history of sexually transmissable disease, including herpes simplex virus type 2;

(6) more than one sexual partner within the last six months;

(7) previous exclusion from blood donation for reasons of infectious disease;

(8) receipt of a blood transfusion within the past year;

(9) for semen donors, known episodes of trichomoniasis in a sexual partner;

(10) history of an occupation with increased risk of radiation or chemical exposure, or known such exposure;

(11) known history of alcohol abuse; (12) history of behavior or factors which place the donor at increased risk for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, as determined by the United States Public Health Service (USPHS);
(13) all conditions listed in section 52-3.4(a) of this Part; and

(14) other conditions as determined by the reproductive tissue bank director, medical director and medical advisory committee.

(c) Except for those factors currently identified by the USPHS as posing an increased risk for HIV infection, the factors in subdivision (b) above need not necessarily exclude a donor, but the reproductive tissue bank medical director or the attending physician shall counsel the recipient about potential associated risks if such a donor's reproductive tissue is accepted. Persons with an HIV risk factor identified by the USPHS shall not be accepted as anonymous donors. (d) Recipients' physicians shall be notified if a semen donor's age at the time of donation is older than 44 years. Recipients' physicians shall be notified if an oocyte donor's age at the time of donation is older than 34 years. (e) Potential anonymous donors with a history of behavior or factors which place them at increased risk for HIV infection or other infectious diseases, pursuant to section 52-3.4(a)(8) of this Part, shall be excluded.

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Section 52-8.6 - Required laboratory tests

52-8.6 Required laboratory tests.

(a) For reproductive tissue banks located within New York State, all required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state reproductive tissue banks, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulating authority, the United State Health Care Financing Administration, or by the department. (b) The following laboratory tests shall be performed prior to donor acceptance and, except as specified in paragraph (g) of this section, initial collection of donor semen for clinical use:

(1) Blood shall be tested for:

(i) determination of ABO and Rh blood groups; and

(ii) antibodies to HIV-1, human immunodeficiency virus type 2 (HIV-2), human T-lymphotropic virus type I (HTLV-I), hepatitis B core antigen (HBc), and to hepatitis C virus (HCV), and for hepatitis B surface antigen (HBsAg) and syphilis.
(2) Semen or a urethral specimen shall be tested for infection with Neisseria gonorrhoeae,and urine or a urethral specimen shall be tested for infection with Chlamydia trachomatisusing a method that meets standards generally accepted by leading authorities in laboratory medicine.

(3) Semen shall be tested for sperm quality as measured against criteria set by the director in consultation with the medical director and medical advisory committee, including such parameters as ejaculate volume and sperm motility, concentration, morphology and cryosensitivity, including a post-thAw analysis. Sperm quality tests shall be repeated at a frequency determined by the director.

(c) All tests for infectious diseases shall be repeated at least every six months for as long as a donor is participating in the semen banking program, or whenever a donor reenters the program after an absence of longer than six months.

(d) Any semen stored from a donor testing repeatedly reactive for antibodies to HIV-1, HIV-2, HCV or HTLV-I, for syphilis infection or for HBsAg, shall be destroyed unless such semen is to be used for research studies authorized by section 4302 of the Public Health Law and approved by the appropriate institutional review board, in which case all semen samples from the donor shall be labeled, "For research use only," and immediately sequestered from other donor samples. Testing for antibody to hepatitis B core antigen (anti-HBc) shall be negative for donor acceptable. For semen donors testing positive for any indicator of HIV infection, the director shall advise the department and the attending physicians of all recipients who received semen that was collected any time after six months prior to the last negative test.

(e) Subsequent to testing as required in subdivision (b) of this section, all donated semen shall be frozen and quarantined for six months. After such time and prior to release of the semen for artificial insemination or assisted reproductive procedures, the donor shall be retested for HBsAg and antibodies to HIV-1, HIV-2, HCV and HBc. If the semen to be released originates from a directed donor, the recipient may be given the opportunity to waive the quarantine period in writing after being advised by the director, his/her designee, or the physician performing the insemination of the risks involved in doing so. In such cases, each of the tests required in paragraph (a)(1), (2) and (3) of this section, except tests for ABO and Rh blood groups, must have been performed after a date one month prior to the first donation and every three months thereafter, while the donor is engaged in donation.

(f) Semen shall not be made available for artificial insemination or assisted reproductive procedures if: (1) the donor's blood is repeatedly reactive in approved screening tests for HBsAg or antibodies to HIV-1, HTLV-I or HCV;
(2) the donor's blood is repeatedly reactive in approved screening tests for antibodies to HBc; (3) the donor's blood tests positively in approved tests for syphilis, unless a confirmatory test is negative; (4) the donor's semen or urethral specimen tests positive in approved tests for Neisseria gonorrhoeae; or (5) the donor's urine or urethral specimen reacts positively to approved tests for Chlamydia trachomatis. (g) A client-depositor who wishes to direct stored semen for use by a specific recipient, other than his current or active regular sexual partner, shall first be fully evaluated and tested in accordance with the requirements of sections 52-8.5, 52-8.6(b),(c),(d)and (f) of this Subpart. Tissue from such client-depositors shall not be released unless stored for at least six months prior to such testing. (h) Reproductive tissue donors who, based on their racial/ethnic background or family history, have been identified at increased risk of being carriers of Tay-Sachs disease, thalassemia, cystic fibrosis and/or sickle cell disease shall be tested for such carrier states. The reproductive tissue bank medical director, in consultation with the medical advisory committee, shall establish a policy specifying any other conditions that should be tested for, the testing to be performed on donors with particular racial/ethnic backgrounds and family histories, and the analytes to be tested for. (i) Testing requirements for oocyte donors shall be specified in a written policy approved by the reproductive tissue bank medical director in consultation with the medical advisory committee. At a minimum, donors shall, within one month of each donation, be tested and found negative for HBsAg, and for antibodies to HCV, HIV-1 and HIV-2. Oocytes and embryos stored from donors who test repeatedly reactive for antibodies to HIV-1, HIV-2, or HCV or for HBsAg, shall be destroyed, unless such tissue is to be used for research studies authorized by section 4302 of the Public Health Law and approved by the appropriate institutional review board, in which case all tissue samples from the donor shall be labeled, "For research use only," and immediately sequestered from the donor samples. For donors testing positive for any indicator of HIV infection, the director shall advise the department and the attending physicians of all recipients who received tissue that was collected at any time after six months prior to the last negative test. (j) Male and female contributors to donated embryos shall be tested as specified in section 52-8.6(i) of this Subpart prior to release of embryos for clinical use by others. (k) Results of all donor testing shall be made available, upon request, to the donors and to physicians using the donors' reproductive tissue in artificial insemination and assisted reproductive procedures. (l) Accurate, written donor profiles or other descriptions of pertinent donor characteristics shall be provided upon request to physicians ordering reproductive tissues.

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Section 52-8.7 - Collection, storage and disposition of reproductive tissue

52-8.7 Collection, storage and disposition of reproductive tissue.

(a) Semen collection containers shall be clean and non-toxic to sperm.

(b) Each semen collection container shall be labeled legibly prior to collection with the donor's or client-depositor's name or identification code, unless another system is used to ensure absolute identification, and shall also be labeled at the time of collection with the date and time of collection.

(c) Semen storage containers and support vehicles shall be labeled so as to maintain identification throughout all phases of processing, storage and distribution, in a manner not subject to deterioration at low temperatures. Such containers and/or vehicles shall be labeled with the reproductive tissue bank identification and semen specimen collection date, donor's identification code or, in the case of a client-depositor, his name and semen specimen collection date. Semen shall be frozen with a suitable cryopreservative and stored continuously until placed in either a freezer section reserved for semen, equipped with a thermometer, or a liquid nitrogen storage tank. The thermometer shall be calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. Thermometers shall be either visually monitored daily or continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations in temperature potentially affecting the quality of the semen. Storage shall be at a temperature of minus 130 degrees Celsius or lower. Semen from client-depositor shall be stored in freezer section or tank separate from that for donor semen, and shall not be exposed to ambient air unless absolutely necessary. Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one year afterward.

(d) Frozen semen in transit from a reproductive tissue bank to an insemination/implantation site shall be maintained in liquid nitrogen or vapor until immediately prior to the artificial insemination or assisted reproductive procedure. Frozen semen shall be transported by the bank or its agents, the staff of the insemination/implantation site, or the recipient with the written authorization of her physician.
(e) The insemination/implantation site shall inspect semen samples for proper labeling and appearance immediately after thawing. If the physical appearance is abnormal or there is indication or suspicion of overt microbial contamination, the semen shall not be utilized for artificial insemination or other assisted reproductive procedures.

(f) Reproductive tissue stored for a client-depositor shall not be destroyed or released for other purposes as a result of nonpayment of storage fees or for any other reasons, without documentation that the client-depositor was given at least 30 days' written notice by certified mail, return receipt requested.

(g) Oocytes shall be collected, processed and stored as oocytes or embryos according to written procedures approved by the reproductive tissue bank director in consultation with the medical director and the medical advisory committee. Storage containers and support vehicles shall be labeled or segregated so as to maintain tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to deterioration at low temperatures. Final embryo containers shall be labeled with the identification code or name of the source of both the component oocyte and spermatozoan. (h) Embryos shall not be created for donation by fertilizing donor oocytes with donor semen, except at the request of a specific patient who intends to use such embryos for her own treatment. (i) Embryos shall not be created using semen or oocytes of client-depositors or directed donors who are blood relatives of the other gamete provider to a degree that their sexual contact would constitute incest under New York State law.

Effective Date: 
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Section 52-8.8 - Informed consent

52-8.8 Informed consent.

(a) Reproductive tissue banks shall obtain written informed consent from the donor for participation in the donation program, after the director or a designee has provided information to the donor on the procedures for collection, storage and use of semen, oocytes or embryos, and the risks of any drugs, surgical procedures and/or anesthesia administered. The informed consent shall include:

(1) a statement that the donor has been informed that his or her name and address will be kept on file by the reproductive tissue bank, and advised of the restrictions on release of donor-identifying information specified in section 52-8.9 of this Subpart;

(2) authorization for performance of genetic and infectious disease marker testing, consistent with statutory requirements for genetic testing;

(3) notification of all currently known ways in which the donor's reproductive tissue and resulting embryos may be used. If the reproductive tissue bank accepts reproductive tissue with restrictions on the manner in which embryos created may be used, the consent also shall include a statement that the reproductive tissue bank has informed the donor that it will make a good faith effort to ensure that the donor's restrictions are respected, but that it cannot guarantee that the recipients of the reproductive tissue will abide by the donor's restrictions;

(4) authorization for disclosure of the donor's medical history information to potential recipients and their physicians, consistent with statutory requirements for the disclosure of genetic and other medical information;

(5) an explanation of the oocyte donor's extent of responsibility for any costs of any medical complications associated with oocyte donation; and

(6) a statement that the reproductive tissue donor has the right to withdraw his/her consent to donation up until such time that a specific recipient has begun an assisted reproduction cycle in reliance on the availability of tissue from that donor.

(b) Reproductive tissue banks shall obtain written informed consent from the client-depositor for participation in the semen, oocyte or embryo storage program, after the director or a designee has provided information to the client-depositor on the procedures for collection/storage and retrieval of semen, oocytes or embryos, and the risks of any drugs, surgical procedures and/or anesthesia administered, as well as procedures for payment for semen, oocyte or embryo storage. The informed consent shall include the male client-depositor's specific instructions for disposition of frozen semen upon his death. The reproductive tissue bank shall maintain and adhere to written procedures for ensuring that the client-depositor's instructions are followed.

(c) The insemination/implantation site shall obtain written informed consent from the recipient for receipt of donated reproductive tissue, after a physician has explained the risks and benefits of the procedure, made available details of the medical history of the donor or donors, and, if applicable, notified the recipient that reproductive tissue bank records are required to be kept for the periods of time specified in section 52-8.9(a) of this Subpart and that the outcome of the procedure is required to be reported to the reproductive tissue bank.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.9 - Required records

52-8.8 Required records.

(a) Reproductive tissue bank records shall be open to inspection by the department and shall be kept for at least seven years after release of reproductive tissue for artificial inseminations or assisted reproductive procedures not resulting in a live birth, and 25 years for inseminations or assisted reproductive procedures known to have resulted in a live birth. For all donated reproductive tissue, the donor's name, address and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the reproductive tissue bank to any person or entity, except upon written informed consent of the donor, or except to authorized employees of the department or as permitted by law. The recipient's name, address and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the insemination/implantation site to any person or entity, except upon written informed consent of the recipient, or except to authorized employees of the department or as permitted by law.

(b) In addition to the recordkeeping requirements of section 52-2.9(c) of this Part, each reproductive tissue bank shall maintain applicable donor/client depositor records which include:

(1) for donors, pertinent family history of any genetic disorders;

(2) documentation of donor and client-depositor written informed consent;

(3) for semen donors, outcome of any prior insemination or other assisted reproductive procedures, if known, including number of successful pregnancies, if any, and any reports from insemination/implantation sites which would affect the donor's acceptability; and (4) documented approval of the reproductive tissue bank director, or his/her designee, of the acceptability of the donor.

(c) In addition to the recordkeeping requirements of section 52-2.9(e) and (f) of this Part, each reproductive tissue bank shall maintain applicable records which include:

(1) donor's identification code or client-depositor's name;

(2) for semin donations, documentation of laboratory cryosensitivity testing, and, if performed, results of viability checks after thawing and during storage, if any;

(3) the name of the insemination/implantation site, the physician or other person authorized by law to perform artificial insemination or assisted reproductive procedures, and/or receive reproductive tissue, and the name of the person communicating the order for distribution of the tissue; (4) the recipient's name, if the name has been provided to the reproductive tissue bank with her informed consent, or the recipient's identification code, if used;
(5) documentation of training, certification, licensure, if required by law, and continuing education for each staff member; and (6) any adverse outcomes, including infectious diseases in recipients or their offspring and genetic defects in offspring, which shall be reported to the donors if there is any possibility that the donor's reproductive tissue contributed to the adverse outcome.
(d) The following records shall be kept, separate from the recipient's records, by an insemination/implementation site for each insemination or assisted reproductive procedure performed:

(1) donor's identification code or name, if the reproductive tissue originates from a client-depositor; (2) evidence that reproductive tissue from donors and/or client-depositors has been obtained from a reproductive tissue bank licensed pursuant to Subpart 52-2 of this Part; (3) disposition of the reproductive tissue, including, but not limited to, the name or identification code of the recipient, destruction logs, and autoclaving or incineration records;
(4) the name and signature of the ordering physician or other person authorized by law to order issuance of the reproductive tissue;

(5) results of sperm viability checks, if performed; and

(6) signature of the person receiving the sample and conditions of the sample upon receipt.

(e) The insemination/implantation shall document the outcome of the artificial insemination or assisted reproductive procedure, including, but not limited to, any known adverse outcome in the infant or infectious disease in the recipient, as well as any known successful pregnancies. This information shall also be reported to the reproductive tissue bank releasing the tissue, even if the reproductive tissue bank is the same entity as the insemination/implantation site.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.10 - Quality assurance and safety

52-8.10 Quality assurance and safety.

The requirements of section 52-3.5 of this Part shall be met.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.11 - Compliance with standards

52-8.10 Compliance with standards.

A reproductive tissue bank, shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating operating procedures, equipment, and records, including lists of physicians or facilities to whom or to which reproductive tissue has been released, to determine compliance with the standards in this Part. If the Commissioner determines that a significant likelihood exists that adequate safeguards are not implemented at a reproductive tissue bank, the department may require that reproductive tissue not be released pending a hearing. Such hearing shall commence within 15 days of any suspension pursuant to this section.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

SubPart 52-9 - Human Milk Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.1 - Definitions

Section 52-9.1 Definitions. As used in this Part:

(a) Human milk bankmeans an organized service for the selection of donors and the collection, processing, storage or distribution of human breast milk for infants or children other than the donor's own infant.

(b) Donormeans a lactating woman who voluntarily contributes milk to a human milk bank for use by an infant or child other than her own. A donor shall not receive remuneration for the donation of milk.

(c) Human milk transfer stationmeans the location at which containers of human breast milk are held temporarily between the donation site and the human milk bank.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.2 - Construction

52-9.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Human milk banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.3 - Administrative responsibility

52-9.3 Administrative responsibility.

The director of a human milk bank shall ensure the development and implementation of policies and procedures consistent with this Part for the operation of the bank, and the appointment of a medical director and a medical advisory committee composed of physicians with experience in pediatrics, neonatology, blood banking, nutrition and/or other appropriate fields, including at least one member with expertise in infectious diseases, as well as other allied health personnel.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.4 - Medical direction

52-9.4 Medical direction.

(a) Medical direction of a human milk bank shall be provided by a physician, who may also be the director of the bank, in consultation with the medical advisory committee. Such physician shall be licensed and currently registered with the New York State Education Department, and possess a minimum of four years' experience in neonatology, pediatrics, blood banking or a related field.

(b) The medical director and the medical advisory committee shall establish operating procedures and monitor the medical efficacy of milk banking services, and shall, consistent with this Part, develop:

(1) medical criteria for donor participation;

(2) quality standards for the milk, including methodologies and criteria for heat-processing; and

(3) policies for priority distribution of milk when demand exceeds the supply.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.5 - Donor qualifications

52-9.5 Donor qualifications.

(a) The human milk bank shall initially screen and periodically assess the donor for conditions and behavior that may affect the quality or nutritional value of milk, or impair the donor's health, including, but not limited to, the donor qualification requirements in Subpart 52-3 of this Part, and for:

(1) the use of medications, tobacco, alcohol and/or other substances in quantities likely to be harmful if transmitted through human milk to a recipient;

(2) systemic chronic diseases or nutritional deficiencies;

(3) acute and chronic infectious diseases;

(4) emotional conditions and/or behavioral disturbances;

(5) history of jaundice in the donor's own infant after one week of age;

(6) sources of exposures which may be associated with environmental contaminants;

(7) duration of breast feeding; and

(8) general ability to understand and follow directions regarding sanitary collection and storage of the milk, and contraindications to donation.

(b) Donors with a history or behavior which places them at high risk for human immunodeficiency virus (HIV) infection or other infectious diseases (see Subpart 52-3 of this Part) shall be permanently excluded from donation.

(c) The human milk bank shall have evidence available that the donor has been tested within one month prior to the first donation and found negative for hepatitis B virus, including hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc); hepatitis C virus; human immunodeficiency virus type 1 (HIV-1); human immunodeficiency virus type 2 (HIV-2); human T-lymphotropic virus type I (HTLV-I); and for syphilis and tuberculosis, and that the donor is immune to rubella. Testing for cytomegalovirus shall also be performed, unless donated milk is subjected to the Holder pasteurization method. All laboratory tests shall be performed by a laboratory operating under a permit issued by the department. For out-of-state milk donations, all required laboratory testing shall be performed by a laboratory which is approved by that state's regulating authority, the United States Health Care Financing Administration, or by the department. Except for rubella and tuberculosis, testing shall be repeated every six months while the donor is participating in the milk banking program, and the donor shall be found negative prior to any subsequent donations. Milk from a donor testing positive for anti-HBc shall not be made available for clinical use.

(d) The milk bank shall obtain the informed signed consent of the donor for participation in the milk banking program.

(e) The milk bank shall implement a donor education program, including, but not limited to:

(1) the purpose of milk banking and responsibilities of the donor;

(2) operating policies and procedures of the milk bank;

(3) guidelines for sanitary collection and storage of milk;

(4) medical conditions, diseases and medications or other substances contraindicating use of the milk;

(5) diet and nutrition;

(6) smoking and alcohol consumption; and

(7) breast care and common problems associated with breast feeding and milk donation.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.6 - Collection and storage of human milk

52-9.6 Collection and storage of human milk.

(a) The human milk bank shall supply presterilized, leak-proof containers and container seals to the donor.

(b) Containers shall be accompanied by an affixed tag which shall show the donor's identification number, and the date and time the milk was collected. When frozen milk is held at a transfer station, this tag shall also identify the station, and the date and time of receipt and transport of the milk.

(c) Milk shall be transported and stored so that it is protected from contamination, thawing and refreezing. Milk in liquid form shall be maintained at a temperature between one and six degrees Celsius, but shall be stored in liquid form for no longer than 48 hours. If milk is frozen, it shall be maintained at minus 20 degrees Celsius or below for a maximum storage period of six months, unless the medical advisory committee specifically approves a longer storage period. Household freezers with automatic defrost cycles shall not be used for such storage. Frozen milk shall be utilized within 48 hours of thawing and discarded thereafter if not utilized.

(d) The physical facilities of the human milk bank shall minimize the potential for contamination, as follows:

(1) the human milk bank shall be located in a distinct, identifiable area with a separate refrigerator and/or freezer provided for human milk; and

(2) refrigerators and freezers shall be equipped with a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or with a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. The thermometer shall be either visually or mechanically monitored daily for fluctuations in temperature affecting the quality of the milk. Temperature records shall be maintained and made available for inspection for at least one year after collection of the milk.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.7 - Maintenance of records

52-9.7 Maintenance of records.

(a) The human milk bank shall maintain an individual file on each milk donor. For all donated human milk, the donor's name, address and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the human milk bank to any person or entity except upon the written consent of the donor or except to the department. Records to be kept by the human milk bank shall include, but not be limited to, those required in Subpart 52-2of this Part and documentation of instructions given to the donor for collecting, storing and preserving the wholesomeness of donated milk.

(b) Records of milk donations shall be filed by donor identification number and shall include, but not be limited to:

(1) information from the identification tag affixed to the container at the time of collection, showing the date and time of collection, amount collected, and, if applicable, the identification of the transfer station with recorded date, and time of receipt and transport of the milk;

(2) results of all clinical laboratory tests performed on the donor preparatory to and during participation in the milk banking program;

(3) the date of pasteurization of the milk, if applicable; and

(4) the date the milk was distributed or used, and, if applicable, identifying information regarding milk pooled from multiple donors.

(c) Records shall be maintained on each recipient, including, but not limited to:

(1) the infant's or child's age, birth weight and/or weight history, and diagnosis indicating the medical need for human milk;

(2) the dates the milk banking service began and terminated;

(3) identification by donor identification number of the source of all milk given to the recipient;

(4) documentation that the risks of consumption by an infant or child of donated milk have been disclosed to the person(s) legally responsible for such infant or child;

(5) recipient health status at the time of discontinuation of milk banking service and reason for such discontinuation.

(d) Donor and recipient records shall be maintained for at least three (3) years after a recipient's age of majority (18 years) or for at least six (6) years after a recipient's death.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-9.8 - Distribution of human milk

52-9.8 Distribution of human milk.

Facilities shall distribute human milk only upon receipt of a written order from a licensed physician.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

SubPart 52-10 - Hematopoietic Progenitor Cell Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-10.1 - Definitions

Section 52-10.1 Definitions. As used in this Part.

(a) Bone marrowmeans the human tissue filling cavities of bone, consisting of fully mature and precursor hematopoietic cells intended for hematopoietic reconstitution.

(b) Hematopoietic progenitor cellsmeans human precursor hematopoietic cells derived from bone marrow, peripheral blood or other tissue sources.

(c) Hematopoietic progenitor cell bankmeans hematopoietic progenitor cell procurement service, hematopoietic progenitor cell processing facility, hematopoietic progenitor cell storage facility or hematopoietic progenitor cell transplantation facility.
(d) Bone marrow transplantation servicemeans a coordinated program of inpatient and outpatient care in a hospital approved by the commissioner as a provider of bone marrow transplantation services pursuant to section 709.8 of this Title. Such services may accept only stem cells collected in substantial compliance with the criteria established in this Part and Subpart 58-5 of thisTitle, except in documented emergencies.

(e Departmentmeans the New York State Department of Health.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-10.2 - Licensure and compliance with standards

52-10.2 Licensure and compliance with standards.

No hematopoietic progenitor cell bank shall operate in New York State unless licensed by the department under Subpart 52-2 of this Part. All of the provisions of Subparts 52-1 and 52-2 shall apply to a hematopoietic progenitor cell bank, except for the recordkeeping requirements contained in section 52-2.9. All hematopoietic progenitor cell banks shall comply with the standards and requirements set forth in Subpart 58-5 of this Title.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

SubPart 52-11 - Nontransplant Anatomic Banks

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.1 - Definitions

Section 52-11.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Whole body

means the intact corporeal remains of an individual after the time of death.

(b) Whole body acquisition service

means a nontransplant anatomic bank that solicits, retrieves, performs donor selection, preserves, transports, allocates, distributes, acquires, processes, stores, or arranges for the storage of whole bodies or body segments, solely for education and/or research purposes.

(c) Whole body user

means a nontransplant anatomic bank located in New York State that obtains whole bodies and/or body segments from a whole body acquisition service. A whole body user shall store and/or use whole bodies or body segments solely for education and/or research purposes, under the direct oversight of the legally authorized donee. A whole body user may not transfer whole bodies or body segments to any other entity, except as authorized in writing by the whole body acquisition service.

(d) Body segment

means a portion of a whole body detached for purposes of study, evaluation, education and/or research. Body segments consist of contiguous mixed tissues whose relationships have been altered only at the segment boundaries.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.2 - Construction

Section 52-11.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Nontransplant anatomic banks shall apply to the department for licensure and otherwise comply with all applicable provisions of Subpart 52-2 of this Part.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.3 - Informed Consent

Section 52-11.3 Informed consent.

(a) Nontransplant anatomic banks that recover bodies, body segments, organs or tissues from deceased donors, including whole body acquisition services, shall obtain documented informed consent to the donation from a person authorized to consent to such donation in accordance with Public Health Law section 4301, or, for recoveries outside New York State, applicable statutes in the state where the nontransplant anatomic parts were recovered.

(b) Nontransplant anatomic banks that recover body segments, organs or tissues from living donors shall obtain documented informed consent from the donors.

(c) If specific direction is not provided in the consent document, it shall be presumed that whole bodies, body segments, and other nontransplant anatomic parts have been donated to entities authorized to receive the bodies of deceased persons pursuant to subdivision (1) of Public Health Law section 4211 and in accordance with the priorities established therein. Such entities may transfer or authorize the transfer of whole bodies, body segments and other nontransplant anatomic parts to other donees specified in subdivisions (1) and (2) of Public Health Law section 4302 for purposes of:

(1) medical or dental education;

(2) medical or dental research; and/or

(3) the advancement of medical or dental science, therapy or transplantation.

(d) The documentation of informed consent to a donation shall identify the donee, indicate whether the gift is of the whole body or is limited to specified identifiable body segments, organs or tissues, and clearly specify the authorized uses of such donated body, body segments, organs, and/or tissues. Consent obtained by telephone shall be electronically recorded or documented in writing by the nontransplant anatomic bank. Electronically recorded telephone consent shall be put in the form of written documentation of consent for donation prior to using whole bodies, body segments, organs and tissues in education and/or research.

(e) Except as provided in subdivision (c) above, no nontransplant anatomic bank shall use or transfer bodies, body segments or other nontransplant anatomic parts for any purpose not specified in the consent.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.4 - Retrieval and acquisition of nontransplant anatomic parts

Section 52-11.4 Retrieval and acquisition of nontransplant anatomic parts.

(a) The retrieval of nontransplant anatomic parts shall only be performed on: (1) the premises of a general hospital; (2) the premises of a whole body acquisition service licensed in accordance with this Subpart; or (3) for nontransplant anatomic parts other than whole bodies and body segments, the premises of a comprehensive tissue procurement service licensed in accordance with Subpart 52-2 of this Part.

(b) No body, body segment, or other nontransplant anatomic part shall be retrieved, acquired, distributed, transported, or used for a purpose not authorized by Public Health Law section 4302. For the purposes of this Subpart, the term “research” as used in Public Health Law section 4302 shall be limited to research conducted in accordance with accepted research protocols designed to improve the public health, safety and welfare.

(c) Whole body acquisition services.

(1) A whole body acquisition service shall employ the following staff:

(i) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences, or who has been serving as director of a nontransplant anatomic bank licensed by the department prior to the adoption of this provision;

(ii) an appropriately trained technician, morgue attendant, diener, or licensed funeral director responsible for the preparation, care and maintenance of whole bodies and body segments; and

(iii) at least one support staff person, other than the nontransplant anatomic bank director, but who may be the technician, morgue attendant, diener, or licensed funeral director, who shall be responsible for record keeping.

(2) Facilities requirements. A whole body acquisition service shall have a dedicated, secure and restricted space for preparation of whole bodies and body segments for research and/or education purposes. Access to such space shall be limited to individuals directly associated with receipt and preparation of whole bodies or body segments. Preparation and storage space shall include:

(i) a working sink and adequate counter space for preparation of whole bodies or body segments;

(ii) suitable space for storage of chemicals/materials used in preparation of whole bodies or body segments, as applicable;

(iii) counters, tables, and cabinetry built of material that may be easily disinfected and cleaned;

(iv) a refrigerated storage room, walk-in cooler, or cadaver drawer cooler, dedicated solely to storage of whole bodies or body segments. Such storage areas shall have lockable access doors, and alarms to signal intrusion or unacceptable temperature deviation;

(v) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting, and internal transportation of whole bodies or body segments;

(vi) OSHA-approved eye wash stations;

(vii) if embalming is performed, a morgue compliant with federal and state standards; and

(viii) if cremation is performed, a crematory compliant with federal and state standards.

(3) Records. In addition to the records required in section 52-2.9(i) of this Subpart, a whole body acquisition service shall maintain complete and accurate records of all donations, including:

(i) identification of the whole body, and, in the case of a body segment, a description and source of the body segment;

(ii) documentation of unclaimed acquisitions, death certificates, and burial transit permits associated with receipt and use of whole bodies or body segments;

(iii) facilities/institutions to which the whole bodies or body segments are transferred, or documentation of any other disposition; and

(iv) a copy of any contract or letter of agreement between the whole body acquisition service and the whole body user, and documentation of the method of intended final disposition of the whole body or body segment.

(d) Transfer.

(1) Any transfer of whole bodies, body segments or other nontransplant anatomic parts shall be conducted in compliance with existing state standards for such transfer. The burial transit permit(s) issued by the registrar of vital statistics (in the case of a whole body transfer), or written documentation of the source and a description of the body segment(s) or anatomic parts, shall accompany whole bodies, body segments, or nontransplant anatomic parts.

(2) In the case of a whole body transfer, a copy of the properly executed burial transit permit shall be maintained by the whole body acquisition service.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.5 - Use of nontransplant anatomic parts

Section 52-11.5 Use of nontransplant anatomic parts.

(a) Whenever a whole body is donated for educational purposes, unless another lawful donee is specified in the donor consent, the whole body user shall be an entity authorized to receive the bodies of deceased persons pursuant Public Health Law section 4211 in accordance with the priorities established therein.

(b) A whole body user shall not transfer the whole body or body segment to any other entity, except as authorized in writing by the whole body acquisition service from which the whole body or body segment was obtained.

(c) A whole body user shall have at least one staff member with a graduate degree in the health sciences, and training specific to human dissection or to the activity to be performed.

(d) In addition to the records required in section 52-2.9(i) of this Subpart, a whole body user shall maintain complete and accurate records of receipt, use and disposition of whole bodies, body segments, organs and tissues. These records shall include, but not be limited to:

(1) identification of the whole body, or, in the case of a body segment, a description and source of the body segment;

(2) a copy of any contract or letter of agreement between the whole body acquisition service and whole body user, and documentation of the method of final disposition of whole bodies or body segments; and

(3) in the case of whole body transfers, a copy of a properly executed burial transit permit.

(e) The dissection and/or other authorized use of whole bodies and body segments shall occur only in dedicated rooms on the premises of the facility identified on the license or at an off-site location approved by the director of the whole body acquisition service from which whole bodies and/or body segments were obtained. Such rooms shall feature:

(1) lockable doors with access restricted to individuals directly associated with the dissection and/or other authorized use;

(2) isolation from public view;

(3) sufficient size, and construction and equipment suitable to ensure safe and respectful handling of whole bodies and body segments;

(4) tables designed for dissection of whole bodies or other work spaces appropriate for the specific authorized activity to be performed;

(5) a working sink and adequate counter space to ensure the safety of individuals involved in using whole bodies and body segments in dissection or other authorized use;

(6) surfaces constructed of nonporous materials;

(7) OSHA-approved eye wash stations; and

(8) facilities for storage of chemicals, if any, in accordance with OSHA guidelines.

(f) Other nontransplant anatomic banks.

(1) All other nontransplant anatomic banks shall conduct authorized activities in spaces that feature:

(i) lockable doors with access restricted to individuals directly associated with the education and/or research activities conducted;

(ii) isolation from public view;

(iii) sufficient size, and construction and equipment suitable to ensure safe and respectful handling of the organs and/or tissues;

(iv) a working sink and adequate work space to ensure the safety of individuals involved in using organs and/or tissues in education and/or research; and

(v) surfaces constructed of nonporous materials.

(2) Nontransplant anatomic banks using nontransplant anatomic parts that are not whole bodies or segments shall maintain complete and accurate records of receipt, use and disposition of organs and tissues. These records shall include the source and a full description of each organ or tissue.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.6 - Disposition of nontransplant anatomic parts

Section 52-11.6 Disposition of nontransplant anatomic parts.

(a) All users of nontransplant anatomic parts, including whole body users, shall dispose of whole body remains, body segments, organs and tissue in accordance with existing state standards for such disposition. Users may return whole bodies or body segments to the whole body acquisition service from which the material was originally obtained.

(b) Disposition of whole bodies and body segments shall be consistent with instructions provided in the consent document.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.7 - Safety

Section 52-11.7 Safety.

A nontransplant anatomic bank shall implement written safety and infection control policies and procedures to ensure protection from unnecessary physical, chemical and biological hazards.

(a) Decontamination and disposal techniques for regulated medical waste shall be utilized. All hazardous and regulated waste materials shall be handled, stored and discarded pursuant to Part 70 of this Title and/or Title 6 Subpart 360-10 as appropriate, or in the case of out-of-state banks, in accordance with the hazardous waste disposal requirements of the state in which the disposal occurs.

(b) If autoclave equipment is used for sterilization, the pressure, temperature, and duration of each cycle shall be recorded, and such records maintained for one year. For each run, these parameters shall be within the manufacturer’s recommended operating procedures. If any one or more of these parameters fall outside the manufacturer’s standards, all material shall be reautoclaved. Chemical, biological, and physical detection systems shall be used in conjunction with these other measurements of autoclave performance.

(c) Eating, drinking, smoking, and the application of cosmetics or contact lenses shall not be permitted in work areas. Refrigerators and freezers used for storing nontransplant anatomic parts, specimens, or reagents shall not be used for any other purpose.

(d) Gloves and laboratory coats, gowns or other protective clothing shall be worn while handling nontransplant anatomic parts or specimens, sufficient to protect against the transmission of disease and exposure to toxic substances. Such protective clothing shall not be worn outside the work area and shall be disposed of in an appropriate receptacle.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Section 52-11.8 - Reporting Requirements

52-11.8 Reporting requirements.

Whenever requested, a nontransplant anatomic bank shall submit reports to the department containing such information and data concerning its activities as may be required by this Part. Such reports shall be signed by the director of the nontransplant anatomic bank.

Effective Date: 
Saturday, February 24, 2007
Doc Status: 
Complete

Part 53 - Drinking Water State Revolving Fund

Effective Date: 
Wednesday, December 2, 2009
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, sections 1161, 1162

Section 53.1 - Purpose, scope and applicability

Section 53.1 Purpose, scope and applicability.

(a) The purpose of this Part is to provide rules and procedures for the New York State Department of Health to provide financial assistance to public water systems from the New York State Drinking Water State Revolving Fund created by Chapter 413 of the Laws of 1996 of the State of New York. This is a cooperative program in conjunction with the New York State Environmental Facilities Corporation. That agency's regulations can be found in 21 NYCRR, Part 2604.

(b) This Part applies to all public water systems in New York State seeking or receiving financing from the Fund and to the activities of the Department in the discharge of its duties related to the Fund.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 53.2 - Definitions

53.2 Definitions.

(a) Terms used in this Part or to be used in complying with this Part have the following meanings:

(1) Act means Title XIV of the Public Health Service Act (commonly known as the "Safe Drinking Water Act") 42 USC section 300-f et. seq; and as supplemented by the American Recovery and Reinvestment Act of 2009 (ARRA).

(2) Administrator means the administrator of the United States Environmental Protection Agency or the chief executive officer of such agency or any successor agency or department or any authorized representatives of the administrator.

(3) Allowable costs means all costs of a project which the Department and/or Corporation determines:

(i) are properly allocable to that project; and

(ii) are not annual facility operation costs, including, but not limited to, those for maintenance, or replacement and repair of minor equipment.

(4) Annual fund resources means the funds available for project assistance within an annual funding cycle.

(5) Annual funding cycle means the period of time covered by a single Intended Use Plan.

(6) Commissioner means the Commissioner of the New York State Department of Health.

(7) Comptroller means the Comptroller of New York State.

(8) Construction means the erection, building, acquisition, alteration, reconstruction, improvement, enlargement or extension of a project; the inspection and supervision thereof; and the engineering, architectural, legal, fiscal, and economic investigations and studies, surveys, designs, plans, working drawings, specifications, procedures, and other actions necessary thereto.

(9) CT disinfection means the product of the free residual disinfectant concentration (C) in milligrams per liter determined before or at the first customer, and corresponding disinfectant contact time (T) in minutes, expressed by the formula (C) x (T) = CT.

(10) Corporation means the New York State Environmental Facilities Corporation or its successor.

(11) Department means the New York State Department of Health.

(12) Design means necessary design calculations and decisions and the preparation of construction drawings and specifications.

(13) Disadvantaged system means a public water system which has been qualified by the Corporation as being eligible for financial hardship assistance.

(14) DWSRF or fund means the New York State Drinking Water State Revolving Fund, established pursuant to Chapter 413 of the Laws of 1996.

(15) DWSRF assistance or fund assistance means financial assistance from the DWSRF, or other available sources, provided by the corporation to a recipient for an eligible project, including, without limitation, loans or hardship assistance.

(16) E. coli means Escherichia coli, a species of coliform bacteria that is indicative of fecal pollution and the possible presence of enteric pathogens.

(17) Eligible project means a project for construction of a water supply facility which is intended to improve drinking water facilities, including a project that would be eligible for financing under or designed to comply with the requirements of the Act, which the Commissioner has certified, in writing:

(i) is necessary for the objectives and goals of the State Sanitary Code or the Act to assure safe public drinking water;

(ii) represents a reasonable effort to develop a viable water supply that can consistently meet drinking water standards;

(iii) takes into consideration the water resources management strategy pursuant to Title 29 of Article 15 of the Environmental Conservation Law; and

(iv) is a project for which financial assistance is available from the Fund.

(18) Emergency means a situation that results in an imminent threat to public health. Imminent threats to public health include situations that result in the unavailability of a source of potable drinking water for an extended period of time.

(19) Engineering report means the document or documents incorporating the results of preliminary project planning and technical and fiscal studies to determine the technical and economic feasibility of the project.

(20) Federal capitalization funds are funds deposited in the DWSRF pursuant to a Federal capitalization grant according to the provisions of the Act or any lesser amount which the administrator shall determine is subject to the limitations imposed by the Act.

(21) Hardship assistance or financial hardship assistance means DWSRF assistance, including, without limitation, an additional reduced interest rate loan, a principal subsidy, and/or State assistance payments, provided by the Corporation to a recipient in those instances where the Corporation, in its discretion, determines financial hardship exists.

(22) HUD means the United States Department of Housing and Urban Development.

(23) Intended Use Plan (IUP) means a plan identifying the intended uses of the amounts available in the Fund, including but not limited to: a list of potentially eligible projects; a description of the short-term and long-term goals and objectives of the Fund; and information on the activities to be supported including a description of project categories, terms of Fund assistance, recipients, and the criteria and methods established for the distribution of funds. (24) Median Household Income (MHI) means the MHI published by the U .S .Department of Commerce, Bureau of the Census, as adjusted to the most recent biennium for which income data is available from the Bureau of the Census. For special districts and other areas for which accurate census data is not available, other income data may be considered by the Corporation.

(25) Maximum Contaminant Level (MCL) means the maximum permissible level of a contaminant in water which is delivered to any user of a public water system as specified in Subpart 5-1 of this Title.

(26) Nephelometric Turbidity Unit (NTU) means the unit in which measured turbidity is reported.

(27) Planning means the orderly development of a project concept from the original statement of need or purpose through the evaluation of alternatives to a final recommendation on a course of action and measures to implement the selected alternative.

(28) Principal Organic Contaminant (POC) means any organic chemical compound belonging to specific chemical classes as described in Subpart 5-1 of this Title.

(29) Project Financing and Loan Agreement (PFLA) means an agreement, or agreements, between the Corporation and one or more recipients with respect to the financing of an eligible project or projects.

(30) Project plans and specifications means any technical data, information, designs, plans, analyses, engineering reports or other material required to be submitted by an applicant for approval by the Department prior to installation or construction of a public water system or any addition or deletion or modification of a public water system.

(31) Public water system means any water system as defined in Section 5-1.1 of this Title.

(32) Segment of a project, project component or project phase means one or more construction contracts and associated costs that the Department and Corporation determine constitute a discrete portion of a project which may be financed and constructed separately from other project segments.

(33) State Act means Chapter 413 of the Laws of 1996 of the State of New York.

(34) State Sanitary Code means Parts 1 through 24 of this Title.

(35) Surface Water Treatment Rule means Parts 141 and 142 of Title 40 of the Code of Federal Regulations which require that all surface water be treated in accordance with Section 5-1.30 of the State Sanitary Code.

(36) Unspecified Organic Contaminant (UOC) means any organic chemical compound not otherwise specified in Subpart 5-1 of this Title.
 

Effective Date: 
Wednesday, December 2, 2009
Doc Status: 
Complete

Section 53.3 - Pre-application procedure

53.3 Pre-application procedure.

(a) Prospective applicants seeking financial assistance from the Fund must first submit a pre-application to the Department in the format required by the Department. Information required for the pre-application includes:

(1) a written request from an individual with sufficient authority to act on behalf of the applicant that the project be listed in the Intended Use Plan;

(2) a description of the project, including a discussion of the existing deficiencies of the public water system and the corrective effect the proposed project will have on that system's drinking water quality;

(3) a project schedule and project cost estimate; and

(4) such other information and material as the pre-applicant deems necessary for the Department to determine a project's eligibility for assistance from the Fund.

(b) An applicant will receive written notification from the Department if it fails to submit sufficient information for the Department to process the pre-application. The Department will identify any such deficiency and the applicant may submit supplemental material to complete the pre-application.

(c) A project may not be eligible for Fund assistance in a given annual funding cycle if the applicant has failed to complete its pre-application within the time prescribed by the Department.
 

Effective Date: 
Wednesday, October 22, 1997
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Complete

Section 53.4 - Priority ranking system scoring criteria

53.4 Priority ranking system scoring criteria.

(a) The total numerical score for the project or project segment being scored shall be the sum of the scores for technical and non-technical criteria as well as any additional points awarded pursuant to subdivision (d) of this section.

(1) The technical criteria are:

(i) MCL/Treatment technique violations;

(ii) other sanitary code violations; and

(iii) system reliability and dependability issues.

(2) The non-technical criteria are:

(i) governmental needs; and

(ii) financial needs.

(b) Eligible projects or project segments shall be scored on the basis of the following: Community MHI x 100= Factor Statewide MHI* * 1990 STATEWIDE MHI IS $32,965

The MHI of the community which the water service area is located and the statewide MHI will be determined by the Department from the income data in the most recent United States census. If an applicant has reason to believe that the census data do not provide a sufficiently accurate representation of the MHI within the area to be served by that applicant's project, the applicant must so notify the Department in writing and specifically document the facts which form the basis of this belief. The applicant shall also furnish the Department with additional information which the Department may use in determining the MHI of the project service area. Information will consist of reliable data from local, regional, State or federal sources or from an income survey conducted by a reliable impartial source.

(3) Tie Breaking In the event of a tie score for projects, the higher total score under Technical Factors (paragraph 1) will be used as a tie breaker. If this still results in a tie score, the size of the population served by the system will be used as a tie breaker. The larger population will be given preference.

(c) The Department has the sole authority to determine the existence of an emergency. Projects designed to address emergencies shall receive the highest priority ranking.

(d) Additional points may be awarded to an eligible project in the following manner:

(1) A phased project for which additional Fund assistance has been conditionally committed in an executed Project Financing and Loan Agreement for long-term financing will be assigned 2,000 points in addition to its total project priority ranking system score.

(2) A project for which additional Fund assistance has been conditionally committed in an executed Project Financing and Loan Agreement for short-term financing will be assigned 1,000 points in addition to its total project priority ranking system score. (e) Notwithstanding the foregoing, an eligible project or portion thereof listed in Category G, as identified in section 53.5(c)(5), shall be evaluated based upon criteria set forth in section 53.5(c)(5) of this part.
 

Effective Date: 
Wednesday, December 2, 2009
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Section 53.5 - Priority ranking and Intended Use Plan

53.5 Priority ranking and Intended Use Plan.

(a) With the exception of Category G projects, all completed pre-applications received by the Department will be evaluated and assigned a score based on the priority ranking scoring system described in section 53.4 of this Part, provided, however, that:

(1) the Department will not assign a score to any project it has determined to be ineligible for assistance; and

(2) after review of a pre-application the Department may determine that one or more proposed project components are not essential to addressing critical public water system deficiencies. In that event, the Department will sever any non-essential components from the essential project component and score them as separate projects.

(b) Projects receiving scores will additionally be assigned to one of three categories:

(1) Category A: Public water systems serving a population of ten thousand (10,000) or fewer.

(2) Category B: Public water systems serving a population exceeding ten thousand (10,000).

(3) Category C: Public water systems which have been qualified by the Corporation for financial hardship assistance.

(c) The Department shall prepare annually an Intended Use Plan that describes how the Department and the Corporation intend to allocate Fund resources available for that annual funding cycle. The Intended Use Plan will list all potentially eligible projects for assistance from the Fund. A project must be listed in an Intended Use Plan to be eligible for Fund assistance. The Intended Use Plan will also include the following:

(1) Multi-Year List: The Multi-Year List shall include all proposed projects which have been reviewed by the Department and received a numerical score pursuant to subdivision (a) of this section. New projects may be added to this list on a continuous basis.

(2) Project Readiness List: The Project Readiness List shall include all projects from the Multi-Year List which the Department has determined are sufficiently developed to proceed with long-term Fund assistance during the funding cycle covered by the Intended Use Plan. Applicants for these projects are expected to make applications for Fund assistance to the Corporation during that annual funding cycle. Projects shall be listed in descending order of their priority ranking system score.

(3) Funding List: The Funding List shall include all projects from the Project Readiness List and all projects from the Hardship List expected to qualify for long-term loans within the annual funding cycle covered by the Intended Use Plan.

(4) Hardship List: Upon written confirmation from the Corporation that a project qualifies for financial hardship assistance, that project will be placed on the Hardship List. Such written confirmation shall remain valid for two consecutive annual funding cycles. If a project has not received funding during this period, it shall be removed from the Hardship List and re-listed on the Multi-Year List unless the project receives another written confirmation from the Corporation that the project qualifies for financial hardship. (5) Category G List: The Category G list shall include projects or portions thereof that address green infrastructure including, without limitation, water and energy efficiency improvements or other environmentally innovative activities or that qualify as a demonstration project of new green infrastructure technology as provided in the IUP. Such projects or portions thereof shall be determined based on an evaluation of benefits to the public and positive (or least negative) impacts on the environment and that shall include, without limitation: economic benefits generated; public health and safety; protection of water quality and the environment; demonstrated readiness; green energy production and/or reduction in energy consumption; regional distribution of projects, or water conservation as provided in the IUP.

(d) The Department and the Corporation will annually publish a Draft Intended Use Plan which contains the Department's initial plan for the allocation of annual Fund resources and the project priority ranking system scores of each eligible project. The Department will specify a period for review and comment after the publication of the Draft Intended Use Plan during which the public may submit written comments directly to the Department or provide oral statements at public hearings held jointly by the Department and the Corporation. Notice of the hearings and availability of the Draft Intended Use Plan will be published in the State Register. Project applicants may use this opportunity to address any concerns they have regarding project scores and advance any reasonable arguments in support of having their respective scores adjusted. Such plan may, after a public comment period, be amended After the close of the comment and review period the Department will issue the Intended Use Plan.

(e) The Department shall develop the Intended Use Plan subject to the following requirements:

(1) A minimum of fifteen percent (15%) of the annual federal capitalization funds credited to the Fund in any fixed year, shall be allocated to public water systems serving populations of ten thousand (10,000) or fewer. The actual Fund assistance rendered to such systems will occur to the extent there are sufficient allowable project costs to finance in a given annual funding cycle.

(2) No more than thirty percent (30%) of the annual federal capitalization funds shall be used to give loan subsidies to disadvantaged systems as determined by the Corporation, except a greater percent of the annual federal capitalization funds may be used to give additional subsidization to eligible recipients when required or authorized by federal laws or regulations. Such additional subsidization shall be provided in accordance with the Act and shall include forgiveness of principal, a negative interest loan or a grant.

(3) No more than fifty percent (50%) of Fund resources shall be received annually by a particular applicant. In addition, the Corporation may, on its own initiative or at the direction of the Department, limit Fund assistance to the demonstrated annual cash flow needs of any single applicant. (f) Projects shall be selected for placement on the Funding List in the following manner:

(1) Any Category C project which receives a score greater than or equal to the project with the lowest score (excluding additional points awarded pursuant to section 53.4 of this Part) receiving Fund assistance in the annual funding cycle in which the Category C project received its current financial hardship qualification shall be placed on the Funding List.

(2) Category A projects from the Project Readiness List shall be selected in priority order and placed on the Funding List until fifteen per cent (15%) of funds available for the period covered by the IUP have been allocated.

(3) All remaining projects on the Project Readiness List shall be selected in priority order and placed on the Funding List until all remaining annual Fund resources have been encumbered. Final project funding selection is subject to the restrictions and project by-pass criteria in subparagraph (g) of this section.

(g) Projects on the Project Readiness List may be by-passed, upon written notice to the applicant from the Department or the Corporation, if any of the following occurs:

(1) the Department or Corporation receives written notice from the applicant that the project is withdrawn;

(2) the applicant fails to fulfill expectations, perform duties, or conform to deadlines or conditions established in the project schedule or the applicant will not be able to satisfy any other conditions precedent to obtaining funding during the period specified in the IUP;

(3) the applicant has reached the fifty percent (50%) annual Fund resources cap for fundable projects on the Project Readiness List. All projects of an applicant that would cause the applicant to exceed the fifty percent cap will be by-passed for that annual funding cycle; or (4) the department determines that another project better addresses water savings/conservation, or energy efficiency improvements or other environmentally innovative activities that meet green infrastructure mandates of the ARRA.

(h) Projects must be placed on the Multi-Year List to be eligible for any available short-term loans made by the Fund. Short-term loan availability shall be limited to those projects listed on the Multi-Year List which have a numerical project priority ranking score greater than or equal to the project with the lowest score (excluding points awarded pursuant to section 53.4 of this Part) on the funding list.
 

Effective Date: 
Wednesday, December 2, 2009
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Section 53.6 - General project requirements

53.6 General project requirements.

(a) Each recipient shall ensure that any project for which it receives assistance from the Fund:

(1) achieves or maintains compliance with the requirements of Part 5 of this Title;

(2) employs sound and appropriate management practices; and

(3) otherwise complies with all applicable requirements of the Act, the State Act, this Part, the Project Financing and Loan Agreement and all instructions issued by the Department and the Corporation.

(b) The Department and the Corporation may conduct such reviews, inspections and investigations as each may determine necessary to ensure project compliance pursuant to subdivision (a) of this section.

(c) The Department or the Corporation may permit a recipient to certify in writing that specified project requirements have been fulfilled where the recipient can show that such certifications are permitted by State laws and regulations. Acceptance by the Department or the Corporation of such a certification shall not constitute a conclusive statement by either that such certification is accurate nor shall any such acceptance preclude the Department or the Corporation from conducting inspection and verification of the recipient's compliance with project requirements.

(d) All contracts between the recipient and parties carrying out construction and other Fund assisted activities shall provide that representatives of the Department, the Office of the State Comptroller, and the Corporation shall have access to the project worksite at any stage of preparation or progress and shall permit extracts and copies of project records to be made by them.

(e) All change orders shall be submitted to the Department within thirty (30) days following the date they are ordered. Any proposed change which deviates from the approved project plans and specifications for any treatment process shall require prior approval by the Department. The Department will notify the Corporation of any approved change orders at the same time it notifies the recipient.

(f) Each recipient shall arrange for inspection of project construction under the direction of a professional engineer licensed in New York State who shall be responsible for determining whether such work has been performed in accordance with the approved project plans and specifications. Following project completion, the professional engineer shall certify to the recipient, the Department, and the Corporation that the construction is in accordance with the approved project plans and specifications and any approved amendments thereto.

(g) The recipient shall have or acquire such title, estate or interest in the site of the project, including, without limitation, necessary easements and rights-of-way, to ensure undisturbed use and possession during construction of the project and for the estimated operational life thereof.

(h) A recipient shall take any appropriate corrective action necessary to bring its project into compliance with the project performance standards contained in the approved engineering report for the project. A recipient may receive Fund assistance, to the extent such assistance is available, for corrective action where such action is not required due to fraud, mismanagement or failure to comply with the requirements set forth in the Project Financing and Loan Agreement.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 53.7 - Remedies

53.7 Remedies.

(a) If the Department or the Corporation determines that the project or the recipient is not in compliance with the terms of the Project Financing and Loan Agreement, and, following written notice to the recipient, the project is not brought into compliance, the Corporation may, on its own or at the Department's direction, refuse to approve Fund disbursement requests until the project is brought into compliance.

(b) Nothing in this section shall be construed to limit the rights of the Department or the Corporation to take actions including, but not limited to, administrative enforcement actions and actions for breach of contract against a recipient which fails to carry out its obligations under this Part or the Project Financing and Loan Agreement.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

Section 53.8 - Severability

53.8 Severability.

If any provisions of this Part or the application thereof to any person or circumstance is adjudged invalid by a court of competent jurisdiction, such judgment shall not affect or impair the validity of the other provisions of this Part or the application thereof to other persons and circumstances.
 

Effective Date: 
Wednesday, October 22, 1997
Doc Status: 
Complete

SubChapter D - Laboratories

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Complete

Part 54 - Requirements For Self-Defense Spray Devices

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete
Statutory Authority: 
Penal Law, section 265.20(a)

Section 54.1 - Purpose.

Section 54.1 Purpose.

The purpose of this rule is to protect public health, safety and welfare by specifying the type of self-defense spray device that may lawfully be purchased, possessed or used in New York State.
 

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete

Section 54.2 - Definitions.

54.2 Definitions.

(a) Camouflaged means designed to have the appearance of an object other than a self-defense spray device.

(b) Net weight means the weight of the contents of a self- defense spray device.

(c) Oleoresin capsicum means the oleoresin extracted from fruits of plants of the genus Capsicum. The oleoresin contains the active ingredient capsaicin and related compounds classified as capsaicinoids.

(d) Safety device means a self-defense spray device feature that is designed to prevent unintentional discharges.

(e) Self-defense spray device means a pocket-sized spray device which contains and releases a chemical or organic substance which is intended to produce temporary physical discomfort or disability through being vaporized or otherwise dispensed in the air or any like device containing tear gas, pepper or similar disabling agent.
 

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete

Section 54.3 - Requirements.

54.3 Requirements.

Every self-defense spray device which is purchased, possessed or used in New York State shall satisfy all of the following requirements:

(a) Every self-defense spray device shall contain oleoresin capsicum, and no other substance, as the active ingredient.

(b) The contents of every self-defense spray device shall not contain more than 0.7% by weight total capsaicinoids.

(c) The net weight of every self-defense spray device shall not exceed 0.75 ounces.

(d) Every self-defense spray device shall have a safety device.

(e) Every self-defense spray device shall be sold in a sealed, tamper-proof package.

(f) Every self-defense spray device shall not be camouflaged.

(g) Every self-defense spray device shall be accompanied by an insert or inserts which include directions for use, first aid information, safety and storage information and which shall also contain a toll free telephone number for the purpose of allowing any purchaser to call and receive additional information regarding the availability of local courses in self-defense training and safety in the use of a self-defense spray device.

(h) Every self-defense spray device shall bear the following label: "Warning: The use of this substance or device for any purpose other than self-defense is a criminal offense under the law. The contents are dangerous - use with care. This device shall not be sold by anyone other than a licensed or authorized dealer. Possession of this device by a person under the age of eighteen or by anyone who has been convicted of a felony or assault is illegal. Violators may be prosecuted under the law." This label shall appear on the self-defense spray device if the self-defense spray device does not bear the labels required by the California Penal Code pursuant to Section 12403.7(a)(5)(B) and by the United States Consumer Product Safety Commission pursuant to 16 Code of Federal Regulations Section 1500. This label shall appear on self-defense spray device packaging materials or the self-defense spray device if the self-defense spray device bears the labels required by California Penal Code pursuant to Section 12403.7(a)(5)(B) and by the United States Consumer Product Safety Commission pursuant to 16 Code of Federal Regulations Section 1500.

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete

Part 55 - Approval Of Laboratories

Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 225, 502, 504, Agriculture and Markets Law, Sec. 353

SubPart 55-1 - Approval of Laboratories and Institutions for Use of Living Animals and for Requisition and Allocation of Animals From Pounds

Effective Date: 
Friday, August 21, 2009
Doc Status: 
Complete

Section 55-1.1 - Purposes for which approval may be granted

APPROVAL OF LABORATORIES

Section 55-1.1 Purposes for which approval may be granted.

(a) Approval may be granted laboratories and institutions for the use of living animals in properly performed or conducted scientific tests, experiments or investigations, including educational demonstrations. Living animals include living mammals and birds.

(b) Approval will not be granted to laboratories for the use of living animals unless evidence is presented that the general research or teaching program of the institution or laboratory will contribute to the understanding of the problems of human or animal health.
 

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Section 55-1.2 - Eligibility for approval

55-1.2 Eligibility for approval.

Only laboratories or institutions will be approved in which the use of living animals for the purposes set forth in section 55-1.1 of this Subpart will be under the immediate supervision of persons qualified by training and experience to conduct scientific work.
 

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Section 55-1.3 - Method of approval

55-1.3 Method of approval.

Application for approval shall be made on forms provided by the State Department of Health. Approval will be granted to a laboratory or institution in the name of the person who is the highest level administrator in that laboratory or institution. The certificate of approval is not transferable and the State Department of Health shall be advised promptly if the individual in whose name approval has been granted shall cease to be in charge.
 

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Section 55-1.4 - Responsibility

USE OF ANIMALS

55-1.4 Responsibility.

(a) The individual whose name appears on the certificate of approval shall be responsible for all of the experimentation that involves the use of living animals in the designated laboratory or institution. Such individual shall designate one person to be in charge of animal care. That person shall be responsible for the animals' care regardless of whether that person is physically within or away from the laboratory or institution.

(b) The laboratory or institution shall have an animal care committee which shall be responsible for the review of the propriety of the procedures used and the scientific justification for the use of animals in experiments, tests, and investigations, including educational demonstrations.
 

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Section 55-1.5 - Care and treatment of animals

55-1.5 Care and treatment of animals.

(a) The laboratory or institution shall give careful consideration to the humane treatment of animals wherever located. This includes any off-premises locations which are not considered part of the laboratory or institution. The food given to the animals shall be wholesome and in sufficient quantity for the type of animal and scientific tests. The animals' quarters shall be kept clean, well lighted and ventilated and be maintained at a proper temperature. Quarters or cages of suitable size shall be provided so that each animal may stand, sit and lie in a normal position and turn around with ease. All quarters and cages shall be kept clean, and after they are vacated and before they are reoccupied shall be cleaned by procedures suitable to prevent spread of communicable diseases.

(b) Laboratories and institutions providing transportation for animals must arrange for their humane handling during their transportation to and from the laboratory or institution.

(c) Pain and discomfort shall be minimized by proper use of tranquilizers, analgesics and anesthetics. Exceptions may be made when provisions for maximum comfort, including the use of tranquilizers, analgesics and anesthetics, would defeat the purpose of the experiment. Any exceptions are to be made only after having received the recommendations of the person in charge of animal care.

(d) If animals are to be killed, they must be killed humanely.

(e) Humane methods for killing animals shall include, but not be limited to, the following:

(1) inhalant agents such as carbon dioxide for small rodents;

(2) noninhalant pharmacological agents such as:

(i) barbituric acid derivatives; and

(ii) a combination of chloral hydrate, magnesium sulfate and sodium pentabarbital for large animals;

(3) physical methods such as decapitation for small animals.

(f) Inhumane methods which are prohibited shall include but not limited to the following:

(1) noninhalant pharmacological agents such as:

(i) chloral hydrate alone;

(ii) strychnine;

(iii) magnesium sulfate alone; or

(iv) curariform drugs or agents with curariform activity;

(2) physical methods such as:

(i) drowning; or

(ii) exsanguination without causing prior unconsciousness.
 

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Section 55-1.6 - Interpretation

55-1.6 Interpretation. In meeting the requirements of this Subpart for adequate sanitation, ventilation, food, temperature and space, the standards set out in the latest edition of the Guide for the Care and Use of Laboratory Animals, DHEW Publications No. (NIH) 78-23, published by the U.S. Department of Health and Human Services, shall be used as a guide.
 

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Section 55-1.7 - Applicability

55-1.7 Applicability. This Subpart shall not apply to elementary or secondary schools under the jurisdiction of the State Education Department.
 

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SubPart 55-2 - Approval of Laboratories Performing Environmental Analysis

Effective Date: 
Wednesday, December 27, 2017
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, section 502

Section 55-2.1 - Definitions

55-2.1 Definitions. For purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Environmental laboratory means any facility that examines, or is available for the examination of, samples or specimens, including, but not limited to: air, stack emissions, water, wastewater, surface water, ground water, recreational waters, swimming pools, leachate, land runoff, solid waste, hazardous waste, soil, sediments and vegetation, as well as any substance that could contribute to the pollution of or that could be contaminated by material contained in such samples or specimens. Such examinations shall be limited to qualitative or quantitative determinations of the biological, chemical, radiochemical or physical characteristics of such samples or specimens for the purposes of public or personal health protection, or the protection of the environment or natural resources. Environmental laboratories shall not include facilities or entities that perform non-laboratory chemical testing associated with residential water softeners and residential swimming pools. Environmental laboratories shall include mobile laboratories, as defined in subdivision (c) of this section. (b) Approved laboratory means an environmental laboratory that has demonstrated to the New York State Commissioner of Health that it has met the on-site assessment, technical direction and proficiency testing requirements of this Subpart, and therefore has been issued a certificate of approval. For purposes of this Subpart, accredited shall have the same meaning as approved.
(c) Mobile laboratory means a separate, self-contained mobile facility for the examination of environmental samples or specimens as described in subdivision (a) of this section. A mobile laboratory shall have a fixed address, provided to the department with each application for approval, to which proficiency test samples and other correspondence may be sent, and shall be managed by a responsible person authorized to receive service of process.

(d) Technical director means an individual responsible for the technical and scientific operation of an environmental laboratory,and who meets the minimum qualifications in section 55-2.10 of this Subpart. If an environmental laboratory employs more than one technical director, the laboratory owner(s) shall designate one such individual as the lead technical director.

(e) Approved method means an analytical method, including sample preparation, of proven reliability which has been approved, or given similar recognition by the United States Environmental Protection Agency (EPA) or a New York State regulatory program in environmental or public health protection, for the specific purpose for which the method is to be used. Methods approved by the department pursuant to section 55-2.5 of this Subpart shall be deemed approved methods. The department shall make available a list of approved methods to approved laboratories. (f) Quality system means a structured laboratory management system that meets the standards for a quality system as set forth in the department’s Environmental Laboratory Approval Program Quality System Standards 2002, July 1, 2002 revision, which is hereby incorporated by reference, with the same force and effect as if fully set forth herein. These standards are available for public inspection and copying at the New York State Department of Health, Records Access Office, Corning Tower, Empire State Plaza, Albany, New York 12237.

(g) Analyte means a chemical and/or physical property, element, compound, group of compounds, organism or group of organisms, to be determined in samples examined. Sample and specimen are synonymous terms, and are used interchangeably in this Subpart.

(h) Statistical mean means the arithmetic average of a data set after outlier rejection, or, if transformation is used, the central point of data set distribution after outlier rejection.

(i) Method detection limit means the minimum concentration of an analyte that can be measured and reported with 99-percent confidence that the analyte concentration is greater than zero, as defined or stated in the least sensitive approved method.

(j) Assigned value means the nominal concentration of an analyte, based on sample preparation.

(k) Relative standard deviation means the standard deviation of a data set divided by the statistical mean, expressed as a percentage. Predictive standard deviation means the standard deviation derived from a linear regression equation based on historical data.

(l) Synthetic blank means an artificial sample with contents of known purity and without added analytes.

(m) Natural blank means a sample derived from the environment, for which the concentration of a given analyte or analytes, after repeated analyses, has been determined to be below the method detection limit.

(n) Spiked sample means a sample to which a known amount of an analyte has been added.

(o) Natural sample means a sample collected from the environment, to which no analytes have been added.

(p) Contract Laboratory Protocol (CLP) means a protocol, issued by the New York State Department of Environmental Conservation, for performance of environmental analyses in accordance with specifications describing: the types of samples to be analyzed (such as soil or water); internal sample-handling procedures (such as chain-of-custody or holding times); instrumentation and method of analysis to be used for each analyte; calibration procedures to be implemented (such as numbers of standards, their concentrations and acceptance criteria); quality control samples to be analyzed and the frequency of such analysis; and organization and content of reports to be issued on analytical results obtained.

(q) CLP data package means a collection of documentation whose organization and content are specified by CLPs. A CLP data package shall consist of analytical reports, including, but not limited to, a narrative description of how the analysis was performed, any problems encountered, analytical results for all samples, results for all quality control samples analyzed, copies of instrument printouts, and all logbook pages and laboratory bench sheets.

(r) Department means the New York State Department of Health. (s) Denial means the department’s refusal to approve, in total or in part, an environmental laboratory’s application for approval, including resubmission of an initial or renewal application. (t) Suspension means the department’s temporary removal, in total or in part, of an environmental laboratory’s approval for a defined period of time not exceeding six (6) months, to allow such laboratory time to correct deficiencies or areas of non-compliance. (u) Revocation means the department’s withdrawal, in total or in part, of an environmental laboratory’s approval.

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Section 55-2.2 - Certificates of approval

55-2.2 Certificates of approval.

(a) Certificates of approval shall be issued to environmental laboratories in one or more categories, including, but not limited to:

(1) examination of potable water, including but not limited to the analytes listed in Part 5 of the New York State Sanitary Code;

(2) examination of nonpotable water, such as wastewater and samples for water quality monitoring of lakes, streams and rivers;

(3) examination of solid waste, soil and sediment, including but not limited to, hazardous wastes (see New York State Environmental Conservation Law Article 27);

(4) examination of air; (5) examination of medical marihuana (see New York State Public Health Law Article 33, Title 5-A); and (6) examination of any sample, specimen or substance listed or otherwise described in section 502 of the Public Health Law. Certificates of approval shall limit approval to specific analytes within one or more of the above categories.

(b) A certificate of approval issued to an environmental laboratory shall set forth: (1) the nature of the approval (interim or full); (2) the approved categories and analytes; (3) the name of the laboratory lead technical director as defined in section 55-2.1 of this Subpart; and (4) the expiration date of the approval, which date shall be no later than one year from the date the certificate of approval is issued, unless an earlier date is set forth on the certificate. (c) All examinations conducted by an environmental laboratory shall employ approved methods, and shall be within the categories listed on the laboratory’s current certificate of approval or on any appendices thereof. A laboratory shall employ only approved methods for which a demonstration of capability has been conducted at the same site where the method is employed. (d) Current certificates of approval and any appendices shall be posted conspicuously in the environmental laboratory, and a copy shall, upon request, be provided by the laboratory to any person or entity requesting the services of the laboratory.

Effective Date: 
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Section 55-2.3 - Application for approval

55-2.3 Application for approval.

(a)(1) An application for a certificate of approval shall be submitted to the department by the owner(s) and technical director(s) of an environmental laboratory on a form prescribed by the department. No certificate of approval shall be granted to any laboratory failing to supply all the information requested on the application form.

(2) For each category for which approval is sought, the application for approval shall specify the analytes to be determined, the types of sample(s) to be analyzed (such as soil or water), and the approved methods to be employed for each analyte/sample type.

(3) The department may require additional information regarding the laboratory, including, but not limited to, its ownership, organization, quality system, testing program, premises, qualification of personnel, equipment, method of reporting results of analyses, and number of analyses performed each calendar year.

(b) Upon receipt of such application, the department shall review the laboratory's performance in required proficiency testing, quality system documentation, technical director(s) credentials, previous performance in on-site assessments, if applicable, and any additional materials and/or information requested, and shall determine whether the applicant laboratory qualifies for a certificate of approval, the analytes by category for which approval is to be issued, and the approval fee to be paid. Prior to issuance or renewal of a certificate of approval, the approval fee shall be paid, unless otherwise expressly authorized by the department pursuant to Subpart 55-3 of this Part.

(c) For purposes of the application and approval process, testing facilities housed in separate buildings shall be considered separate environmental laboratories, unless such facilities obtain a waiver for this requisite from the department. The requirements of this subdivision shall not be waived unless the department determines that:

(1) effective supervision of the operation of all such facilities can be exercised by the same technical director(s);

(2) the facilities do not duplicate each other’s analytical, reporting and/or record keeping activities; and

(3) the facilities are owned by the same legal entity.

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Section 55-2.4 - Approval criteria

55-2.4 Approval criteria.

(a) In such form as may be prescribed by the department, the environmental laboratory owner(s) and technical director(s) shall attest to the following:

(1) the laboratory will be operated in accordance with section 502 of the Public Health Law, the provisions of this Title and/or section 3-0119 of the New York State Environmental Conservation Law;

(2) the laboratory will employ approved methods and will document information pertinent to the approval, demonstration of capability, and use of each method;

(3) records will be maintained for not fewer than five (5) years and shall identify precisely the samples collected, accepted and examined; and procedures used and personnel involved; and shall document test conditions, observations and results of analyses, except that records of chemical analyses related to potable water supplies shall be maintained for not fewer than ten (10) years and records of analyses related to critical agents shall be maintained as required in section 55-2.13 of this Subpart; (4) the technical director(s) will develop, implement and document a quality system as defined in this Subpart; and

(5) the owner shall notify the department if the laboratory is found to be in violation of any federal, state or local law related to the provision of environmental laboratory services or reimbursement for such services, by the federal, state or local agency enforcing that law.

(b) Approval shall be granted to an environmental laboratory for the analytes by categories sought in the application for approval, provided: (1) the laboratory submits a complete application, including the attestation specified in subdivision (a) above and any additional information required by the department to support the application, and remits to the department the approval fee pursuant to Subpart 55-3 of this Part, unless otherwise expressly authorized by the department; (2) each proposed technical director submits documentation of his or her qualifications for evaluation by the department, and the department finds such individual(s) qualified pursuant to section 55-2.10 of this Subpart;
(3) the laboratory provides documentation of a quality system in compliance with this Subpart; (4) pursuant to section 55-2.8, the laboratory participates and performs satisfactorily in proficiency testing for the analytes for which it seeks approval; (5) except as provided in subdivision (c) of this section, the laboratory undergoes an on-site assessment conducted by the department or by a state regulatory program recognized by the department pursuant to section 55-2.9; the findings of the on-site assessment(s) confirm compliance with the staffing, methodological and other requirements of this Subpart; and the laboratory demonstrates effective implementation of its quality system for planning and assessing the work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results; (6) the laboratory provides entry to representatives of the department and/or of a state regulatory program recognized by the department, for on-site assessments during normal business hours; and (7) the department finds the owner(s) and technical director(s) to be of good character and competence after evaluation of factors including, but not limited to:

(i) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the owner or a technical director listed on the application, individually or jointly, or against any laboratory owned or directed by an owner or a technical director listed on the application, or findings by a municipality that a laboratory owned or directed by an owner or technical director listed on the application has violated a local ordinance relating either to collection and analysis of samples, or to reporting of results for the examination and said samples;

(ii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;

(iii) consideration of whether any environmental laboratory directed by the a technical director listed on the application has demonstrated a pattern of repetitive unsatisfactory performance in required proficiency testing in one or more proficiency testing categories, excluding an unsatisfactory score for administrative reasons such as late result submission;

(iv) consideration of whether any laboratory owned or directed by an owner or a technical director listed on the application has misrepresented any material fact pertinent to obtaining or retaining approval including, but not limited to, falsification of any report on or related to laboratory analysis, or submission of any reports on laboratory work, including work both on samples and proficiency testing, actually performed in another laboratory, without disclosing the fact that the examinations or procedures were performed in another laboratory; (v) evidence of aiding and/or abetting in the violation of any of the provision of this Subpart; and

(vi) any other factor having a direct bearing on the ability of the owner(s) and technical director(s) listed on the application to provide, direct or supervise the provision of high quality environmental laboratory services, or to ensure compliance with applicable statutory and regulatory requirements.

(c) Interim approval. (1) A laboratory that has not undergone an on-site assessment may be granted interim approval, for a period not to exceed twelve (12) months, provided all other requirements for approval in subdivision (b) above are met. (2) A laboratory with interim approval shall be granted full approval in the categories and analytes for which it seeks aprpoval provided the findings of on-stie assessment(s) as described in section 55-2.7 of this Subpart confirm compliance with the staffing, methodological and other requirements of this Subpart, and the laboratory demonstrates effective implementation of its quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results.

Effective Date: 
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Section 55-2.5 - Department approval of methods

55-2.5 Department approval of methods. Department approval of methods.

(a) A laboratory shall obtain department approval prior to performing a laboratory-developed method, or other method not otherwise approved or given similar recognition as described in section 55-2.1(e) of this Subpart. The department may approve such a method, provided the laboratory submits data and other information as required supporting the technical merit of the method, and demonstrating that that the method’s precision and accuracy are equivalent or superior to that of an approved method. Such data and information shall include, but not be limited to:

(1) a description of the method, including analyte, sample type, working range, reagents and their preparation, equipment specifications, analytical procedures, precision, accuracy, related calculations, intended purpose and pertinent literature citations;

(2) the anticipated date of method implementation;

(3) comparative data, including: sample source(s), dates and times collected, and matrix; whether the sample was spiked, and, if so, the spiking procedure; the approved method used; and analytical results for both the approved method and the method submitted for approval;

(4) data from inter-laboratory comparisons, demonstrating the method’s reproducibility;

(5) demonstration of capability data; and

(6) any other information pertinent to the department’s determination of the method’s technical merit.

(b) Provided all other requirements of subdivision (a) above are met, the department may approve a method for which reproducibility has not been demonstrated by inter-laboratory comparisons if the laboratory demonstrates that its performance of the method is technically acceptable for the intended sample types and analytical purpose. Such approval shall be limited to the laboratory which applied for such approval.

(c) In addition to the requirements of subdivisions (a) and (b) above, the department may require successful completion of on-site demonstration analysis on samples designed to challenge the procedure.

(d) The department shall respond to a laboratory’s request for method approval, notifying the laboratory of method approval, method approval contingent upon approval by the EPA, proposed denial of the request, or the need for further information.\

(e) If the department proposes to deny a request for method approval, it shall advise the laboratory of such proposed denial and the reasons for the denial. A proposed denial shall become final thirty (30) calendar days from the date of notice of proposed denial, unless the laboratory submits, within thirty (30) calendar days of the date of such notice, a written request for reconsideration, including all documentation and rationale in support of such request. Within thirty (30) calendar days of the date the department receives a request for reconsideration, the department shall issue a final determination concerning the request for reconsideration.

(f) Notwithstanding the provisions of this Subpart, the department may conduct an independent review of any approved method to substantiate or refute its technical merit. If the method’s technical merit is found to be lacking, the department shall notify the affected laboratory(ies) of its proposed determination that the method may not be performed under a New York State environmental laboratory certificate of approval, giving the reasons for such determination. Such proposed determination shall become final thirty (30) calendar days from the date of the notice of proposed determination, unless the laboratory(ies) offering such method submits, within thirty (30) calendar days of the date of the notice, a written request for reconsideration, including all documentation and rationale in support of such request. Within thirty (30) calendar days of the date of department receives of a request for reconsideration, the department shall issue a final decision regarding the request for reconsideration.

(g) All information and data pertinent to method approval shall be documented, and be made available for department review upon on-site assessment or upon request for a minimum of two (2) years after the date of the method’s discontinuation.

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Section 55-2.6 - Denial, suspension and revocation of department approval

55-2.6 Denial, suspension and revocation of department approval.

(a) The department may deny an environmental laboratory’s application for a certificate of approval for the following reasons:

(1) except as provided in section 55-2.4(c), failure to undergo an on-site assessment conducted by the department or by a state program recognized by the department pursuant to section 55-2.9 of this Subpart or failure to demonstrate, during any on-site assessment so conducted: compliance with the staffing, methodological and other requirements of this Subpart; and effective implementation of a quality system for planning and assessing work performed by the laboratory and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(2) failure to participate or perform satisfactorily in proficiency testing pursuant to section 55-2.8 of this Subpart for the analytes for which the laboratory seeks approval;

(3) failure of the laboratory technical director(s) to meet the required qualifications in section 55-2.10 of this Subpart;

(4) misrepresentation of any material fact pertinent to obtaining or retaining approval for any laboratory owned or directed by an owner or technical director listed on the application including, but not limited to, falsification of any report on or related to a laboratory analysis or submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(5) failure to submit a complete approval application, including the attestation required in section 55-2.4(a) of this Subpart, or failure to provide documentation of a quality system as defined in this Subpart or any additional information required by the department to support the application;

(6) failure to remit the required fees;

(7) the owner(s) and/or technical director(s) listed on the application are determined by the department to lack the character and competence necessary to ensure compliance with the applicable laws, rules and regulations after consideration of factors including but not limited to:

(i) evidence of aiding and/or abetting in violation of any of the provisions of this Subpart;

(ii) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the owner or a technical director, individually or jointly, or against any laboratory owned or directed by an owner or technical director listed on the application, or a finding by a municipality that a laboratory has violated a local ordinance related to collection and analysis of samples or specimens, or to reporting of results for examination of said samples or specimens;

(iii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;

(iv) consideration of whether any environmental laboratory directed by a technical director listed on the application has demonstrated a pattern of repetitive unsatisfactory performance in required proficiency testing in one or more proficiency testing categories, excluding an unsatisfactory score for administrative reasons such as late result submission; and/or

(v) any other factor having a direct bearing on the ability of the owner(s) and technical director(s) listed on the application to provide, direct or supervise the provision of high quality environmental laboratory services, or to ensure compliance with applicable statutory and regulatory requirements;

(8) failure to respond to an on-site assessment report with a corrective action plan within the required thirty (30) calendar days after receipt of the report;

(9) failure to respond to an on-site assessment report with an acceptable corrective action plan within the specified timeframe;

(10) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe; and/or

(11) denial of entry to representatives of the department or of a state program recognized by the department pursuant to section 55-2.9 of this Subpart, for on-site assessment during normal business hours.

(b) (1) If the department proposes to deny an environmental laboratory’s application for a certificate of approval, the laboratory shall be given written notice of the proposed denial, stating the reason or reasons for such proposed denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice, unless reconsideration is requested;

(2) if the department gives notice of proposed denial, the laboratory may request reconsideration of the proposed denial by submitting a written request for reconsideration to the department within thirty (30) days of the date of the notice of proposed denial. Submission of a request for reconsideration within thirty (30) days shall stay any action to deny a laboratory's application for a certificate of approval, pending the department’s decision regarding such request for reconsideration;

(3) the written request for reconsideration shall be signed by the owner(s) and technical director(s), and shall include all information the owner(s) and technical director(s) wish to be considered, including any written documentation that would controvert the reason(s) for the denial or disclose that the denial was based upon a mistake of fact;

(4) if the laboratory properly seeks reconsideration of the proposed denial, the department shall review its proposed denial and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke or modify the proposed denial, allow issuance of a certificate of approval conditional on maintenance of corrective action, or require that the laboratory take corrective action. Such determination shall be the final decision of the department.

(c)(1) An environmental laboratory’s certificate of approval shall be suspended automatically upon a change in laboratory ownership, technical direction, or location. However, provided re-application has been made in writing to the department within thirty (30) calendar days of the change, the department may extend an environmental laboratory’s certificate of approval for a period not to exceed ninety (90) calendar days after any change in laboratory ownership, technical direction or location, in order to permit the department to evaluate, as applicable, the character and competence of the new technical director(s) and/or new owner(s) considering requirements in section 55-2.4(b) of this Subpart; the qualifications of the new technical director(s); and/or the effect of the change in location on the environmental laboratory’s ability to produce accurate and reliable analytical data.

(2) An environmental laboratory’s certificate of approval shall be suspended automatically upon failure to remit at least the quarterly payment of the annual approval fee pursuant to Subpart 55-3 of this Part, unless otherwise expressly authorized by the department.

(3) An environmental laboratory’s certificate of approval shall be suspended automatically, in affected analytes and/or categories, for failure to maintain a record of at least two (2) satisfactory proficiency testing (PT) events within the three (3) most recent PT events.

(4) (i) The department may suspend an environmental laboratory’s certificate of approval, in affected analytes and/or categories, for reasons including:

(a) a pattern of deficiencies on on-site assessment or other demonstration that the laboratory lacks an effective quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results; and

(b) failure to notify the department of any change in major analytical instrumentation within thirty (30) calendar days of the change;

(ii) if the department proposes to suspend a laboratory’s certificate of approval, the laboratory shall be given written notice of the proposed suspension, stating the reason or reasons for such proposed suspension. Such notice shall be sent by certified mail and shall be a final determination to be effective ten (10) days from the date of the notice, unless reconsideration is requested. A laboratory may request reconsideration of the proposed suspension by submitting a written request for reconsideration to the department within ten (10) days of the date of the notice of proposed suspension. Submission of a request for reconsideration within ten (10) days shall stay any action to suspend department approval, pending the department’s decision regarding such request for reconsideration. The written request for reconsideration shall be signed by the owner(s) and the technical director(s) designated responsible for the affected category(ies), and shall include all information the owner(s) and technical director(s) wish to be considered, including any written documentation that would controvert the reason(s) for the suspension or disclose that the suspension was based upon a mistake of fact. The department shall review its proposal to suspend approval and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke or modify the proposed suspension, allow retention of the certificate of approval conditional on maintenance of corrective action, or require that the laboratory take corrective action. Such determination shall be the final decision of the department.

(5) An environmental laboratory whose certificate of approval is suspended pursuant to paragraphs (3) or (4) above shall retain approval for the analytes and/or categories for which it continues to meet department requirements. A laboratory so suspended shall discontinue analysis of samples for the analytes and/or categories affected by the suspension, as of the date of the suspension.

(6) The department shall change a laboratory’s certification status from suspended to approved upon receipt of sufficient documentation to permit the department to determine that the conditions meriting suspension no longer exist, and the laboratory meets the criteria for a certificate of approval in section 55-2.4 of this Subpart.

(7) Notwithstanding any of the provisions of this subdivision, the Commissioner of Health may suspend a laboratory's certificate of approval pursuant to the summary action provisions of Public Health Law section 16.

(d)(1) The department may revoke an environmental laboratory’s certificate of approval in affected analytes and/or categories for reasons including:

(i) failure to respond to an on-site assessment report with an acceptable corrective action plan within the specified timeframe;

(ii) a pattern of deficiencies on on-site assessment, or other demonstration that the laboratory lacks an effective quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(iii) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe;

(iv) failure to correct the deficiencies meriting suspension within six (6) months of the effective date of the suspension; or

(v) for an environmental laboratory suspended pursuant to section 55-2.6(c)(3) of this Subpart, unsatisfactory performance in the next PT event results in three (3) consecutive failed PT events.

(2) An environmental laboratory whose certificate of approval is revoked pursuant to paragraph (1) above shall retain approval for the analytes and/or categories for which it continues to meet department requirements, and may reapply for approval once the deficiencies meriting revocation have been corrected.

(3) The department may revoke an environmental laboratory’s certificate of approval, in total, for reasons including:

(i) failure to respond to an on-site assessment report with a corrective action plan within the required thirty (30) calendar days after receipt of the report;

(ii) failure to participate in a PT program acceptable to the department;

(iii) falsification of any report on or related to a laboratory analysis, including, but not limited to, submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(iv) misrepresentation of any material fact pertinent to obtaining or maintaining approval;

(v) denial of laboratory entry to representatives of the department or of a state program recognized by the department pursuant to section 55-2.9 of this Subpart for on-site assessment during normal business hours;

(vi) sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services, or reimbursement for such services, against the owner(s) or technical director(s), individually or jointly, or against any laboratory owned or directed by such individuals;

(vii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;

(viii) failure to remit the annual approval fee, or, for partial fee payments, failure to remit such payments within the timeframes established by the department;

(ix) aiding and/or abetting in the violation of any of the provisions of this Subpart; and/or

(x) a finding by a municipality that the environmental laboratory has violated a local ordinance related either to collection and analysis of samples or specimens, or to reporting of results for examination of such samples or specimens.

(4) If an environmental laboratory’s certificate of approval has been revoked pursuant to paragraph (3) above and the department finds that the violation was willful, or due to recklessness or gross negligence, no application shall be accepted, for a period of time to be determined by the Commissioner of Health or his or her designee, from any person who was an owner or technical director of such laboratory on the date of notification of proposed approval revocation.

(e) No environmental laboratory’s certificate of approval may be revoked without a hearing or an opportunity for a hearing. The environmental laboratory shall be given written notice of proposed revocation, stating the reason(s) for the department’s proposed action. Such notice shall be sent by certified mail and shall be a final determination, to be effective thirty (30) calendar days from the date of the notice, unless a hearing is requested by the laboratory. The environmental laboratory may request a hearing by submitting a written request for a hearing, signed by both the owner(s) and the technical director(s) designated responsible for the affected category(ies), within ten (10) calendar days of the date of the department’s notice of proposed revocation. Approval shall be automatically suspended while any hearing requested is pending, provided the hearing is scheduled to begin within ninety (90) calendar days of the request for such hearing.

(f) An environmental laboratory whose certificate of approval has been revoked shall submit a new application for approval and shall meet all criteria for approval provided in section 55-2.4 of this Subpart to be issued a certificate of approval. The department may conduct an on-site assessment of the environmental laboratory before acting on such application.

Effective Date: 
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Section 55-2.7 - Laboratory on-site assessments

55-2.7 Laboratory on-site assessments.

(a) An environmental laboratory seeking or holding a certificate of approval under this Part shall, as a condition of approval, permit on-site assessments to be conducted by the department or by a state program recognized by the department pursuant to section 55-2.9 during the laboratory’s normal business hours.

(b) The factors to be considered during on-site assessments shall include, but not be limited to, the competence and qualifications of staff, adequacy of facilities and equipment, appropriateness of sampling protocols, use of approved methods, and the laboratory’s quality system, including, but not limited to, quality assurance and quality control procedures, and record keeping and reporting practices, as specified in this Subpart.

(c) Each environmental laboratory shall, following each on-site assessment, be furnished with an assessment report which shall set forth the findings of the on-site assessment and any deficiencies to be corrected.

(d) Environmental laboratories located outside of the State of New York shall be assessed the approval fee specified in Subpart 55-3 of this Part, as well as additional expenses incurred by the department in conducting on-site assessments of each laboratory. Such on-site assessments shall not be performed before the department receives payment for such additional costs.

(e) If deficiencies are found during an on-site assessment, the environmental laboratory may be granted a grace period not to exceed ninety (90) calendar days from the date of notification to correct the deficiencies, provided that, within thirty (30) calendar days of such notification, the laboratory submits to the department or recognized state program performing the assessment a written plan of correction to be implemented within ninety (90) calendar days. If, at the end of the grace period, any of the deficiencies found remain uncorrected, the certificate of approval shall be revoked in affected analytes and/or categories pursuant to section 55-2.6 of this Subpart. If the deficiencies found do not necessarily or immediately affect either the accuracy or reliability of results, and if the environmental laboratory demonstrates in writing that corrections of deficiencies have been delayed for reasons beyond its control, the grace period granted pursuant to this subdivision may be extended further for a period not to exceed ninety (90) calendar days. Such extension may not be renewed further.

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Section 55-2.8 - Proficiency testing

55-2.8 (a) Environmental laboratories shall examine proficiency test samples supplied by the department or by a proficiency testing provider recognized by the department pursuant to subdivision (i) of this section. Laboratories shall conduct the specified examinations and submit the results to the proficiency sample provider for all analytes for which the laboratories are approved or are seeking approval, and for which samples have been supplied.

(1) The department shall announce its schedule for mailed proficiency test sample distribution as soon as practicable after the first day of each approval year. Distribution frequency and dates shall be included in this announcement. The department shall specify, in letters distributed with samples, the department’s test result scoring criteria. Laboratories participating in the department’s proficiency testing program, shall report test results to the department no later than on the dates specified by the department for each manner of result submission (i.e., hardcopy or electronic). No extensions shall be granted. Laboratories whose results are received after the deadline shall be considered to have achieved unsatisfactory performance in the proficiency test event. Laboratories participating in a recognized proficiency testing provider(s)’ proficiency testing program, other than the department’s program, shall arrange with that provider to have test results forwarded to the department.

(2) To obtain or maintain approval for a given analyte, an environmental laboratory shall attain satisfactory performance in at least two (2) of three (3) consecutive scheduled or unscheduled proficiency test events in which it has participated. Such events shall take place at least thirty (30) calendar days apart.

(3) To obtain or maintain approval for the potable water - total coliforms analyte, for which proficiency testing requires qualitative analysis, an environmental laboratory shall maintain a score of at least ninety (90) percent, without reporting a false negative result for at least two (2) of three (3) consecutive scheduled or unscheduled proficiency test events in which it has participated. Such events shall take place at least thirty (30) calendar days apart.

(4) To obtain or maintain approval in contract laboratory protocol (CLP) analyses, an environmental laboratory shall be evaluated on both proficiency testing performance and conformity to the contract requirements of the CLP data package submitted.

(b) Performance in examining an individual chemical or physical analyte shall be evaluated as follows, for a natural blank test sample:

(1) Satisfactory performance shall be a result, reported with or without the term “less than,” and having a value less than or equal to the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(2) Unsatisfactory performance shall be a result, reported with or without the term “less than,” greater than

the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(c) Performance in examining an individual chemical or physical analyte shall be evaluated as follows, for a synthetic blank test sample:

(1) Satisfactory performance shall be a result reported with the term “less than,” and having a value less than or equal to the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(2) Unsatisfactory performance shall be a result reported with or without the term “less than,” and having a value greater than the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(d) Performance in examining an individual chemical or physical analyte shall be evaluated as follows, for a spiked or natural test sample:

(1) For data sets examined by the standard statistical procedures described in subdivision (g) of this section and having a relative standard deviation lower than 34 percent:

(i) Satisfactory performance shall be a result within the 99-percent confidence interval about the statistical mean.

(ii) Unsatisfactory performance shall be a result outside the 99-percent confidence interval about the statistical mean.

(2) For data sets examined by the standard statistical procedures described in subdivision (g) of this section but having a relative standard deviation of 34 percent or higher, the relative standard deviation of the data set used for determining the 99-percent confidence interval shall be set at 34 percent, or a value derived from the scientific literature. Satisfactory and unsatisfactory performance shall be as described in paragraph (1) of this subdivision.

(3) For data sets evaluated by using a reference laboratory panel, the statistical mean and 99-percent confidence interval shall be derived from the reference laboratory data set, after standard statistical analysis. Satisfactory and unsatisfactory performance shall be as described in paragraph (1) of this subdivision.

(4) For data sets evaluated using an interval about the assigned value and defined by a fixed percentage of the assigned value, fixed percentages shall be set based on the department’s determination of the reliability, precision and accuracy of the methods used, and:

(i) Satisfactory performance shall be a result within the fixed percentage interval about the assigned value.

(ii) Unsatisfactory performance shall be a result outside the fixed percentage interval about the assigned value.

(5) For data sets evaluated using published linear regression equations to predict the mean and standard deviations:

(i) Satisfactory performance shall be a result within the interval of the predictive mean, plus or minus two (2) predictive standard deviations for potable water analytes, or plus or minus three (3) predictive standard deviations for other matrices.

(ii) Unsatisfactory performance shall be a result outside the interval described in paragraph (i) above.

(e) Performance in examining an individual bacteriological analyte for which quantitation is required shall be evaluated as follows:

(1) For negative coliform and/or standard plate count test samples, including sterile samples, samples containing bacteria not detectable by the method and samples containing bacteria not producing positive reactions with the required verification procedures, satisfactory performance shall be a result reported as a value lower than the method detection limit. Unsatisfactory performance shall be any other result.
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(2) Performance in examining an individual bacteriological analyte for which quantitation is required shall be evaluated as follows, for a positive inoculated test sample:

(i) Satisfactory performance shall be a result within the 99-percent confidence interval about the statistical mean for Most Probable Number (MPN) and Membrane Filter (MF) coliform data, and within the 95-percent confidence interval about the statistical mean for

standard plate count data.

(ii) Unsatisfactory performance shall be a result outside the 99-percent confidence interval about the statistical mean for MPN or MF coliform data, and within the 95-percent confidence interval about the statistical mean for standard plate count data.

(f) The statistical mean and the confidence intervals used to determine satisfactory and unsatisfactory performance for spiked and natural chemical test samples and positive inoculated MF coliform and standard plate count test samples shall be established from statistical analysis of the data set after rejection or weighting of outliers, as described in subdivision (g) of this section. The value assigned to the statistical mean shall be the mean of the resulting data set.

(g) Rejection of outliers in a chemical data set shall be based on the three-standard deviation interval, after eliminating the extreme values in the data set and all values exceeding twice the theoretical value for the test sample. Rejection of outliers in an MF coliform or standard plate count data set shall be based on the three-standard deviation interval, after eliminating the extreme values in the data set. Weighting of outliers, if used in place of rejection of outliers, shall be accomplished using robust analysis. The statistical mean and confidence intervals used to determine satisfactory and unsatisfactory performance for positive inoculated MPN coliform test samples shall be based on the log normal distribution.

(h) Performance in examining potable water bacteriological samples qualitatively shall be evaluated based upon the known presence or absence of total coliform group members of Escherichia coli (E. coli). Satisfactory performance shall be a result correctly indicating the presence or absence of total coliform bacteria, and correctly identifying E. coli, if present. Unsatisfactory performance shall be a result incorrectly identifying the presence or absence of total coliform bacteria or E. coli.

(i) (1) The department may recognize a proficiency testing provider to offer and score results of proficiency testing samples for purposes of obtaining New York State environmental laboratory accreditation pursuant to this Subpart, provided:

(i) the proficiency testing provider has submitted sufficient documentation to enable the department to determine that the provider adheres to standards for design, production, testing, distribution, data analysis and quality assurance that are at least equivalent to, or more stringent than, the department proficiency testing program’s, and applies scoring systems identical to the department’s;

(ii) the proficiency testing provider demonstrates it has policies and procedures in place to protect the integrity of its proficiency testing program and prevent fraud in its administration;

(iii) for analytes and sample types with EPA proficiency testing participation standards, the proficiency testing provider possesses a certificate or other documented approval demonstrating compliance with such EPA standards; and

(iv) the proficiency testing provider agrees to supply the department with test scores, and any such other information and documentation requested to resolve any issues concerning compliance with this Subpart.

(2) The recognition granted to a proficiency testing provider pursuant to this subdivision may be withdrawn at any time if the department finds the provider no longer meets the criteria set forth herein, or has failed to provide the department with sufficient information and documentation to permit determination or demonstration of compliance or noncompliance with this Subpart.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
Complete

Section 55-2.9 - Recognition of other state regulatory programs

55-2.9 Recognition of other state regulatory programs.

(a) An environmental laboratory located in another state may request that the department recognize, for purposes of a New York State certificate of approval, that the requirements of this Subpart for on-site assessment, technical direction, quality systems and/or proficiency testing have been met by the laboratory’s participation in another state’s environmental laboratory approval program. The department may recognize one or more of such requirements as met by participation in another state’s program, provided:

(1) the legal, technical and record keeping requirements of the state regulatory program in which the laboratory is participating are determined by the department to meet or exceed New York State’s requirements;

(2) the laboratory demonstrates good standing in the other state’s program, including successful completion of an on-site assessment and satisfactory performance in required proficiency testing, and documents such good standing to the department;

(3) the laboratory submits to the department a completed application for approval;

(4) the laboratory pays all applicable fees required by Subpart 55-3 of this Part;

(5) the laboratory pays any costs incurred by department representatives traveling outside New York State to perform an on-site assessment pursuant to this Subpart; and

(6) the technical director(s) meet(s) the requirements of section 55-2.10 of this Subpart.

(b) The department may enter into agreements with other state agencies or programs to assist the department in assessing an environmental laboratory’s performance or in determining whether another state’s program meets or exceeds the department’s requirements.

(c) Notwithstanding another state program's equivalency to the department’s program, the department may require an environmental laboratory to participate in the department’s proficiency testing program, on-site assessment, and/or similar evaluations to ensure the laboratory’s full compliance with New York State statutes, regulations and standards for laboratories approved pursuant to this Subpart.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
Complete

Section 55-2.10 - Technical director: qualifications and responsibilities

55-2.10 Technical director: qualifications and responsibilities.

(a) (1) Each environmental laboratory shall appoint one or more technical directors, who shall be full-time members of the laboratory's staff, and who shall exercise actual day-to-day supervision of laboratory operations, including the reporting of results. The designation of a lead technical director shall be documented; and

(2) each technical director shall have the requisite credentials and experience for an area of analysis, such as microbiology, organic chemistry, inorganic chemistry and radiochemical analysis, and shall supervise only the areas of environmental analysis for which he or she meets the qualifications required by this section.

(b) A technical director's responsibilities shall include, but not be limited to, development and implementation of a quality system as defined in section 55-2.1 of this Subpart, including: monitoring standards of performance in quality control and quality assurance; monitoring the validity of analyses performed and data generated to ensure reliable data; ensuring that sufficient numbers of qualified personnel are employed to supervise and perform the work of the laboratory; and providing educational direction to laboratory staff.

(c) An individual meeting the requirements of this section may not be the technical director of more than one approved laboratory without authorization from the department. Circumstances to be considered in the department's decision to grant such authorization may include, but not be limited to, the extent to which the operating hours of the laboratories to be directed overlap, adequacy of supervision in each laboratory, and availability of environmental laboratory services in the area served.

(d) A technical director who is absent for a period of time exceeding fifteen (15) consecutive calendar days shall designate another full-time staff member meeting the qualifications of this Subpart to assume the responsibilities of technical director temporarily. Whenever the term of such temporary direction exceeds sixty-five (65) consecutive calendar days, the department shall be notified in writing.

(e) A technical director of an approved laboratory engaged in chemical analysis shall be:

(1) a person with an earned doctoral degree in the chemical, environmental, physical or biological sciences, or engineering, with at least twenty-four (24) college semester credit hours in chemistry, and at least one year of experience in environmental analysis of representative inorganic and organic analytes for which the laboratory is approved or seeking approval;

(2) a person with a master's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least twenty-four (24) college semester credit hours in chemistry and at least one year of experience in environmental analysis of representative inorganic and organic analytes for which the laboratory is approved or seeking approval; or

(3) a person with a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least twenty-four (24) college semester credit hours in chemistry and at least two (2) years of experience in environmental analysis of representative inorganic and organic analytes for which the laboratory is approved or seeking approval.

(f) A technical director of a laboratory holding or seeking approval for the contract laboratory protocol tier, in addition to meeting the requirements of subdivision (e) of this section, shall have at least three (3) years of experience, at least one year of which shall be in a supervisory capacity.

(g) A technical director of an approved laboratory engaged in, but limited to, inorganic chemical analysis, other than contract laboratory protocol or metals analysis, shall be a person with at least an associate's degree in the chemical, physical or environmental sciences, or two (2) years of equivalent and successful college education, with at least sixteen (16) college semester credit hours in chemistry. In addition, such a person shall have at least two (2) years of experience performing such analysis.

(h) A technical director of an approved laboratory engaged in microbiological and/or biological testing shall be:

(1) a person with an earned doctoral degree or master's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including, for microbiological testing, at least once course having microbiology as a major component, and at least one year of experience in environmental analysis of representative analytes for which the laboratory is approved or seeking approval;

(2) a person with a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including, for microbiological testing, at least one course having microbiology as a major component, and at least two (2) years of experience in environmental analysis of representative analytes for which the laboratory is approved or seeking approval; or

(3) notwithstanding the requirements of paragraphs (1) and (2) of subdivision (h) above, a person with an earned doctoral, master's, bachelor's, or associate's degree in an appropriate field of the sciences or applied sciences, with at least four (4) college semester hours in general microbiology or a biological science course with a major microbiological component, and one year of experience in environmental analysis of representative analytes, may be a technical director of an approved laboratory, provided the laboratory is engaged in microbiological analysis limited to fecal coliform, total coliform and standard plate counts. Two (2) years of equivalent and successful college education, including the microbiology requirement, may be substituted for an associate's degree.

(i) A technical director of an approved laboratory engaged in radiochemical analysis shall be:

(1) a person with an earned doctoral degree in chemistry, physics or engineering, with at least twenty-four (24) college semester hours in chemistry, and at least one year of experience in radiochemical analysis of environmental samples;

(2) a person with a master's degree in chemistry, physics or engineering, with at least twenty-four (24) college semester hours in chemistry, and at least one year of experience in radiochemical analysis of environmental samples; or

(3) a person with a bachelor's degree in chemistry, physics or engineering, with at least twenty-four (24) college semester credit hours in chemistry, and at least two (2) years of experience in radiochemical analysis of environmental samples.

(j) Notwithstanding any other provision of this section, a full-time employee of a drinking water or sewage treatment facility who holds a valid treatment plant operator's certificate appropriate to the nature and size of such facility shall be deemed to meet the educational and experience requirements for serving as the technical director of the approved laboratory devoted exclusively to analysis of environmental samples taken within such a facility. Such approval for a water treatment facility shall be limited to determination of total dissolved solids, pH, temperature, alkalinity, acidity, total coliform organisms and standard plate counts. Such approval for a sewage treatment facility shall be limited to determination of biochemical oxygen demand, total solids, suspended solids, pH, temperature, alkalinity, acidity and fecal coliform organisms. However, such approval for a sewage treatment facility shall be extended to include determination of ammonia, total Kjeldahl nitrogen, nitrate or total phosphorus, provided such full-time employee has successfully completed a specialized course of study in the analysis of these substances, generally recognized by leading authorities in the field.

(k) Notwithstanding any other provision of this section, a full-time employee of an industrial waste treatment facility with at least one year of experience in environmental analysis, under supervision, shall be deemed to meet the requirements for serving as the technical director of an approved laboratory devoted exclusively to analysis of environmental samples taken within such a facility for determination of biochemical oxygen demand, total solids, suspended solids, pH, temperature, alkalinity, acidity and fecal coliform organisms.

(l) A technical director of an approved laboratory engaged in microscopic examination of asbestos and/or airborne fibers shall meet the following requirements:

(1) For procedures requiring use of a transmission electron microscope, a bachelor's degree, successful completion of specialized courses in use of the instrument, and one year of experience, under supervision, in use of the instrument. Such experience shall include identification of minerals.

(2) For procedures requiring use of a polarized light microscope, an associate's degree or two (2) years of equivalent and successful college study, successful completion of formal coursework in polarized light microscopy, and one year of experience, under supervision, in use of the instrument. Such experience shall include identification of minerals.

(3) For procedures requiring use of a phase contrast microscope, as in determination of airborne fibers, an associate's degree or two (2) years of equivalent and successful college study, documentation of successful completion of formal coursework in phase contrast microscopy, and one year of experience, under supervision, in use of the instrument.

(m) A technical director of an approved laboratory engaged in determination of radon in air shall meet the following requirements:

(1) An associate's degree in the physical sciences, or two (2) years of equivalent and successful college education, and one year of experience in radiochemical measurements, including at least six (6) months of experience in measurement of radon and/or radon progeny.

(2) For radon determinations using a direct continuous monitoring device, as in on-site measurement of residential radon levels, at least a high school diploma or high school equivalency diploma, and certification of successful completion of a training course in operation of the instrument, as well as six (6) months of experience, under supervision, in use of the instrument.

(n) A person who meets the experience requirements but not the educational and/or credential requirements of this Subpart, and is functioning in a technical director's capacity on the date the laboratory becomes subject to these regulations, shall qualify as technical director of that laboratory, or any other laboratory approved by the department and performing similar analyses, provided such person can demonstrate the ability to comply with the proficiency testing and quality system requirements of this Subpart.

Effective Date: 
Wednesday, June 16, 2010
Doc Status: 
Complete

Section 55-2.11 - Quality assurance officer: qualifications and responsibilities

55-2.11 Quality assurance officer: qualifications and responsibilities.

(a) Each environmental laboratory shall appoint a quality assurance officer (however named), who shall exercise oversight of the laboratory’s quality system. The individual so appointed shall have documented training, and/or experience in quality assurance and quality control procedures; be knowledgeable in the required quality system; and possess a general knowledge of analytical methods for which he or she performs data review.

(b) The quality assurance officer (and/or his or her designees) shall:

(1) serve as the focal point for the environmental laboratory’s quality assurance and quality control, and be responsible for monitoring and/or review of quality control data;

(2) evaluate data objectively and perform independent assessments without outside (e.g., managerial) influence;

(3) arrange for or conduct annual internal audits of the laboratory’s entire technical operation; and

(4) notify laboratory management of any deficiencies in the quality system and monitor required corrective actions.

(c) The quality assurance officer shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources, as well as to the technical director(s). The quality assurance officer shall fulfill his or her functions independently from laboratory operat