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 implantation, 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 transplantation, 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) records 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