Part 400 - All Facilities--General Requirements

Effective Date: 
Wednesday, November 13, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 2800, 2803

Section 400.1 - Title and applicability

Section 400.1 Title and applicability.

This Subchapter shall be known and may be cited as "Medical Facilities--Minimum Standards," and shall apply to medical facilities defined as hospitals within article 28 of the Public Health Law. The standards within a particular article shall constitute the minimum standards for the identified medical facility in addition to those standards that may apply to such facilities as set forth in Articles 1 and 3 of this Subchapter as applicable.

Doc Status: 
Complete

Section 400.2 - Other laws, codes, rules and regulations

400.2 Other laws, codes, rules and regulations.

Medical facilities issued operating certificates or certificates of approval shall comply with all pertinent Federal laws and regulations enacted pursuant thereto, applicable State law, including the Public Health Law and the Mental Hygiene Law and codes, rules and regulations having general application.
 

Doc Status: 
Complete

Section 400.3 - Inspection, reproduction and reports

400.3 Inspection, reproduction and reports. (a) The commissioner or his authorized representative may inspect, reproduce, require reproduction of or require reports on:

(1) any medical facility record, report or other written document or report to or from an inspecting, accrediting or certifying body which he may require for the purpose of conducting cost analyses and studies of standards and procedures relating to operating certificates, or certificates of approval under the provisions of the Public Health Law; and

(2) any patient medical record, clinical log or other patient record which he may require for the purpose of conducting medical audits under the provisions of paragraph (j) of subdivision 1 of section 206 and article 28 of the Public Health Law; and

(3) the disclosure of any interest in the operation of a medical facility or any interest in the ownership of the property interests in a medical facility which he may require for the purpose of conducting an analysis of the operation of medical facilities and standards and procedures relating to operating certificates under the provisions of the Public Health Law; and

(4) such other medical facility records as may be required.

(b) The medical facility shall not charge the commissioner or his authorized representative for the cost of reproducing any records, reports or documents required by this section, but such reproduction costs shall be an allowable expense of the medical facility for the purposes of third-party reimbursement.
 

Doc Status: 
Complete

Section 400.4 - Contracts

400.4 Contracts. (a) Contracts to perform any services for a medical facility issued an operating certificate or certificate of approval shall:

(1) be in writing, signed by an authorized representative of the facility and the person or agency providing the service and dated;

(2) include each party's responsibilities, functions, objectives, financial arrangements and charges;

(3) require compliance with all pertinent provisions of this Chapter;

(4) include the following language: "Notwithstanding any other provision in this contract, the facility remains responsible for ensuring that any service provided pursuant to this contract complies with all pertinent provisions of Federal, State and local statutes, rules and regulations."

(b) Medical facilities are hereby authorized, subject to the provisions of this Chapter, to enter into contracts and make arrangements among themselves and among other municipal, State, Federal or privately owned hospitals, or any medical schools, or other health-related facilities having or utilizing hospital services or facilities, whether or not located in this State or elsewhere, for the:

(1) mutual use, or exchange of medical resources including, but not limited to, real or personal property or employment of personnel;

(2) joint purchases of goods, supplies and services; or

(3) development of medical information, techniques and facilities useful in the progress of the medical art; reduction of medical costs and promotion of a more efficient and effective approach to the delivery of health care services.
 

Effective Date: 
Tuesday, January 1, 1980
Doc Status: 
Complete

Section 400.5 - Statements or bills for health services

400.5 Statements or bills for health services. Statements or bills for patient health services rendered in a hospital or by a home health agency as defined in article 28 of the Public Health Law shall:

(a) indicate the nature of the service for which a charge is being made;

(b) indicate that professional or other services not provided by the hospital, or by the home health agency for which a charge is not included, may be billed independently; and

(c) be rendered to a patient or the patient's legal representative without charge.
 

Effective Date: 
Tuesday, April 18, 1978
Doc Status: 
Complete

Section 400.6 - Identification of personnel delivering health care services

400.6 Identification of personnel delivering health care services.

All employed personnel, including paraprofessionals and volunteers, who deliver health care services in a medical facility shall be clearly and readily identified as to professional function by means of an insignia or other device worn on his or her person.
 

Effective Date: 
Thursday, July 1, 1976
Doc Status: 
Complete

Section 400.7 - Facility participation in title XVIII program

400.7 Facility participation in title XVIII program.

Every facility that provides a service which is reimbursable under the provisions of title XVIII of the Social Security Act shall make application to be an approved provider of such services pursuant to such title. If approved, the facility shall participate in such program and make appropriate claims for payment in any instance in which a patient is eligible for benefits under such program.

Effective Date: 
Thursday, July 1, 1976
Doc Status: 
Complete

Section 400.8 - Exception, construction standards

400.8 Exception, construction standards.

The standards set forth in this Subchapter, to the extent they constitute construction standards, shall not apply. Medical facilities shall comply with the construction standards contained in Article 2 of Subchapter C of this Chapter (State Hospital Code).
 

Effective Date: 
Thursday, July 1, 1976
Doc Status: 
Complete

Section 400.9 - Transfer and affiliation agreements

400.9 Transfer and affiliation agreements. Effective January 1, 1970 the admission, discharge or transfer of any patient or resident from each facility having an operating certificate under the provisions of any Article of Subchapter C of this Chapter to a facility issued an operating certificate under any other Article of Subchapter C of this Chapter or to a certified home health agency shall conform to the following provisions:

(a) The governing authority or operator of each such facility shall have in effect a transfer and/or affiliation agreement acceptable to the department with:

(1) one or more facilities having a valid operating certificate under Articles 2, 4 and 5 of this Subchapter and located in or near the same community; and

(2) one or more home health agencies certified by the department and serving a geographic area of coverage appropriate to the area of coverage of this facility.

(b) The governing authority or operator of each such facility shall:

(1) maintain in the administrator's office and available to the department a written copy of each transfer or affiliation agreement;

(2) include in such agreement reasonable assurance that there will be transfer of the patient or resident whenever deemed medically appropriate and mutually agreed upon by the physician responsible for the medical care in the referring facility, or by the midwife responsible for the medical care in the case of a referring midwifery birth center, and by the physician who will become responsible for the medical care in the receiving facility, or, in the case of a certified home health agency, by the physician who will become responsible for the medical care when such patient or resident is to receive services from the certified home health agency;

(3) include in such agreement reasonable assurance that the originating facility will transfer promptly such medical and other information as is relevant to proper care by the receiving facility or home health agency including medical, social, nursing and other care plans; and

(4) include in the agreement reasonable assurance that there is sharing of diagnostic and other services when the department finds that such sharing is in the interest of efficiency, economy and quality of care.

(c) For each admission to or transfer or discharge from each such facility, the governing authority or operator shall assure that:

(1) the personal, alternate or staff physician requests or agrees to the admission, transfer or discharge unless the patient or resident signs out or is signed out against medical advice;

(2) admission information is obtained and transfer and discharge information is furnished as required by the provisions of this Chapter;

(3) the method of physically transporting the patient or resident is safe and medically approved by the responsible physician; and

(4) the patient's or resident's personal effects, especially his monies and valuables, are transported and stored safely in a place known and reasonably accessible to the patient or resident or to a person or agency legally authorized to act in his behalf and full information about same is on file and readily available in the administrator's office or other site acceptable to the department.

(d) If the personal, alternate or staff physician or the director or acting or assistant director of nursing approves an emergency or unusual admission, transfer or discharge, the requirements of paragraph (c)(1) of this section may be waived providing the circumstances and reasons are recorded in the medical record.

(e) The governing authority or operator of each facility having a valid operating certificate under the provisions of Article 6 of Subchapter C of this Chapter shall have an affiliation agreement with at least one facility having an operating certificate under the provisions of Article 2, 4 or 5 of this Subchapter which includes assurance that:

(1) the affiliating facility has the capability of providing strong backup support, including but not limited to medical, diagnostic, emergency and other services; and

(2) the affiliating facility furnishes such backup support by providing, as needed, medical, medically related and other supportive services to enhance the effectiveness of operation of the treatment center and diagnostic center.

(f) Where it is in the interest of the community and where it is essential to assure that inpatient or resident care will continue to be available for those requiring such care, the department may except the governing authority or operator from specific requirements of this section when the operator or governing authority provides documented verification acceptable to the department that all reasonable attempts have been made in good faith to make such an agreement.

Effective Date: 
Wednesday, November 13, 2019
Doc Status: 
Complete

Section 400.10 - Health Provider Network Access and Reporting Requirements

Section 400.10 Health Provider Network Access and Reporting Requirements

The operator of a facility shall obtain from the Department’s Health Provider Network (HPN), HPN accounts for each facility he or she operates and ensure that sufficient, knowledgeable staff will be available to and shall maintain and keep current such accounts. At a minimum, twenty-four hour, seven day a week contacts for emergency communication and alerts must be designated by each facility in the HPN Communications Directory. A policy defining the facility's HPN coverage consistent with the facility’s hours of operation, shall be created and reviewed by the facility no less than annually. Maintenance of each facility’s HPN accounts shall consist of, but not be limited to, the following:

(a) sufficient designation of the facility’s HPN coordinator(s) to allow for HPN individual user application;

(b) designation by the facility operator of sufficient staff users of the HPN accounts to ensure rapid response to requests for information by the State and/or local Department of Health;

(c) adherence to the requirements of the HPN user contract; and

(d) current and complete updates of the Communications Directory reflecting changes that include, but are not limited to, general information and personnel role changes as soon as they occur, and at a minimum, on a monthly basis.

Effective Date: 
Wednesday, November 2, 2005
Doc Status: 
Complete

Section 400.11 - Assessment of long-term care patients

400.11 Assessment of long-term care patients. (a) (1) For patients who require placement or continued stay in a nursing home or health-related facility, the Hospital/Community PRI or the PRI, as appropriate, shall be completed by a registered professional nurse who has successfully completed a training program in patient case mix assessment approved by the department to train individuals in the completion of the patient review form (PRI) as contained in section 86-2.30(i) of this Title, or the Hospital/Community patient review form (Hospital/Community PRI) as contained in section 400.13 of this Part, and for patients who require placement or continued stay in a nursing home or a health-related facility, the SCREEN shall be completed by a professional with demonstrated skills in assessing psychosocial situations, including but not limited to social work and discharge planning professionals, who has successfully completed a training program in patient case mix screening approved by the department to train individuals in the completion of the patient screening form (SCREEN), as contained in section 400.12 of this Part.

(2) Each general hospital shall have on staff trained and qualified screener(s) and assessor(s) in such numbers as specified in section 85.8(c)(1)(ii) of this Title, who shall be responsible for and attest to the accuracy of Hospital/Community PRIs, PRIs, and SCREENs, as contained in section 400.13, 86-2.30(i) and 400.12 of this Title, respectively. Each residential health care facility shall have on staff trained and qualified screener(s) and assessor(s) who shall be responsible for and attest to the accuracy of PRIs and SCREENs.

(b) The commissioner may waive the requirements of this section or any part thereof for recognized demonstration projects to effect the development of additional knowledge and experience in different types of assessments for long-term care patients.

(c) The patient, and/or the patient's designated representative shall be given an explanation of the information contained on the SCREEN, including the determination of setting for care for that particular patient.

(d) Residential health care facilities not participating in the Medicare and Medicaid programs (titles XVIII and XIX of the Federal Social Security Act) are required to complete the PRI and SCREEN forms for prior to admission and admission review purposes pursuant to sections 415.1(a), 420.1(a), 416.9(a) and 421.13(a) of this Title. The continued stay review requirements of sections 416.9(b), (f) and 421.13(b), (f) of this Title shall not apply. An alternate schedule for completion and submission of the forms may be established by the commissioner for such continued stay review requirements.
 

Doc Status: 
Complete

Section 400.12 - Level of care criteria

400.12 Level of care criteria

(a) New York State criteria for level of care. (1) Minimum qualification for residential health care facility care: The patient is qualified for residential health care facility care and such care is consistent with all applicable federal requirements as documented on the

patient screening instrument (SCREEN).

(2) Skilled nursing facility care. Patients in the following resource utilization groups meet the requirements for skilled nursing facility level of care:

Special Care A
Special Care B
Heavy Rehabilitation A
Heavy Rehabilitation B
Clinically Complex A
Clinically Complex B
Clinically Complex C
Clinically Complex D
Severe Behavioral A
Severe Behavioral B
Severe Behavioral C
Reduced Physical Functioning A
Reduced Physical Functioning B
Reduced Physical Functioning C
Reduced Physical Functioning D
Reduced Physical Functioning E

The SCREEN Form DOH 695 shall be maintained by the department, in such form and format as prescribed by the department in compliance with federal law, and shall be accessible at: http://www.health.state.ny.us/forms/

Effective Date: 
Wednesday, November 4, 2009
Doc Status: 
Complete

Section 400.13 - Forms (Hospital/Community Patient Review Instrument)

400.13 Forms (Hospital/Community Patient Review Instrument (PRI) Instrument).

Note: Item 1 on page 2 of the (Hospital/Community) Patient Review Instrument (PRI) instructions under "Administrative Data" has been amended.

To receive a copy of the forms, contact the NYS Department of Health,

Division of Health Care Standards and Surveillance, Hedley Building, 6th Floor, Troy, NY (518) 402-1068.

Effective Date: 
Tuesday, April 2, 1991
Doc Status: 
Complete

Section 400.14 - Request for patient review instrument (PRI) data

400.14 Request for patient review instrument (PRI) data. (a) For purposes of this section, PRI data shall mean the data submitted by a residential health care facility on the PRI forms submitted pursuant to section 86-2.30 of this Title.

(b) All requests for PRI data shall be processed pursuant to section 400.18 of this Title.
 

Effective Date: 
Wednesday, September 3, 2014
Doc Status: 
Complete

Section 400.15 - The role of the licensed practical nurse in intravenous therapy procedures

400.15 The role of the licensed practical nurse in intravenous therapy procedures.

(a) For purposes of this section, facility shall mean an entity licensed pursuant to Article 28 of the Public Health Law.

(b) A facility may allow specially trained licensed practical nurses, under the supervision of a qualified registered professional nurse or physician, to perform all intravenous therapy procedures except for the administration of blood and blood products, intravenous anti-neoplastic agents, and a bolus of medication by intravenous push unless administered for chronic hemodialysis treatment.

(c) The facility shall ensure that licensed practical nurses allowed to perform intravenous therapy procedures have satisfactorily completed a training program, received supervised clinical experiences and demonstrated competence in the performance of intravenous therapy procedures.

(d) The training program for intravenous therapy shall include as a minimum instruction in:

(1) the facility's policies and procedures related to intravenous therapy;

(2) the facility's quality assurance and risk management program;

(3) anatomy and physiology related to intravenous therapy;

(4) the solutions and drugs used in intravenous therapy, their pharmacological action and therapeutic effects;

(5) procedures used for mixing intravenous medications and solutions;

(6) the signs and symptoms of complications and adverse reactions to intravenous therapy;

(7) the functions, use and maintenance of intravenous devices and equipment; and

(8) infection control techniques.

(e) The facility shall ensure that all intravenous therapy procedures performed by the licensed practical nurse are provided in accordance with written policies and procedures which are reviewed and updated as needed, but at least annually.

(f) The facility shall ensure that there is documentation in the licensed practical nurse's personnel file which indicates the training program attended, number of hours and content of the program, supervised clinical experiences and approval to perform intravenous therapy procedures.

(g) Inservice education programs shall be conducted to update and inform the licensed practical nurse of new intravenous therapy procedures, equipment and medications. The programs shall be conducted as often as necessary but at least on an annual basis and be documented in the personnel file of the licensed practical nurse.
 

Effective Date: 
Wednesday, September 20, 1989
Doc Status: 
Complete

Section 400.16 - Determination of death

400.16 Determination of death. (a) An individual who has sustained either:

(1) irreversible cessation of circulatory and respiratory functions; or

(2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead.

(b) A determination of death must be made in accordance with accepted medical standards.

(c) Death, as determined in accordance with paragraph (a)(2) of this section, shall be deemed to have occurred as of the time of the completion of the determination of death.

(d) Prior to the completion of a determination of death of an individual in accordance with paragraph (a)(2) of this section, the hospital shall make reasonable efforts to notify the individual's next of kin or other person closest to the individual that such determination will soon be completed.

(e) Each hospital shall establish and implement a written policy regarding determinations of death in accordance with paragraph (a)(2) of this section. Such policy shall include:

(1) a description of the tests to be employed in making the determination;

(2) a procedure for the notification of the individual's next of kin or other person closest to the individual in accordance with subdivision (d) of this section; and

(3) a procedure for the reasonable accommodation of the individual's religious or moral objection to the determination as expressed by the individual, or by the next of kin or other person closest to the individual.
 

Doc Status: 
Complete

Section 400.17 - Compliance with application conditions

400.17 Compliance with application conditions.

The operator of a medical facility shall comply with all conditions, limitations or other requirements imposed by the Public Health Council or commissioner in conjunction with the approval of any application for establishment or construction for such medical facility pursuant to the provisions of sections 2801-a and 2802 of the Public Health Law and this Chapter.
 

Doc Status: 
Complete

Section 400.18 - Statewide Planning and Research Cooperative System (SPARCS)

400.18 Statewide Planning and Research Cooperative System (SPARCS).

(a) Definitions. For the purposes of this section, these terms shall have the following meanings:

(1) Health care facilities shall mean facilities licensed under Article 28 of the Public Health Law.

(2) Identifying data elements shall mean those SPARCS data elements that, if disclosed without any restrictions on use or re-disclosure would constitute an unwarranted invasion of personal privacy. A list of identifying data elements shall be specified by the Commissioner and will be made available publicly.

(3) Inpatient hospitalization data shall mean SPARCS data submitted by hospitals for patients receiving inpatient services at a general hospital that is licensed under Article 28 of the Public Health Law and that provides inpatient medical services.

(4) Outpatient data shall mean emergency department data, ambulatory surgery data, and outpatient services data.

(i) Emergency department data shall mean SPARCS data submitted by a facility licensed to provide emergency department services under Article 28 of the Public Health Law.

(ii) Ambulatory surgery data shall mean SPARCS data submitted by a facility licensed to provide ambulatory surgery services under Article 28 of the Public Health Law.

(iii) Outpatient services data shall mean all data submitted by licensed Article 28 facilities excluding inpatient hospitalization data, emergency department data, and ambulatory surgery data.

(5) SPARCS Administrator shall mean a person in the SPARCS program designated by the Commissioner to act as administrator for all SPARCS activities.

(6) SPARCS data shall mean the data collected by the Commissioner under section 2816 of the Public Health Law and this section, including inpatient hospitalization data and outpatient data.

(7) SPARCS program shall mean the program in the New York State Department of Health (NYSDOH) that collects and maintains SPARCS data and discloses SPARCS data.

(b) Reporting SPARCS data.

(1) Health care facilities shall report data as follows:

(i) Health care facilities shall submit, or cause to have submitted, SPARCS data in an electronic, computer-readable format through a secure electronic network designated by the Department according to specifications provided by the Commissioner.

(ii) All SPARCS data must be supported by documentation in the patient’s medical and billing records.

(iii) Health care facilities must submit on a monthly basis to the SPARCS program, or cause to have submitted on a monthly basis to the SPARCS program, data for all inpatient discharges and outpatient visits. Health care facilities must submit, or cause to have submitted, at least 95 percent of data for all inpatient discharges and outpatient visits within sixty (60) days from the end of the month of a patient’s discharge or visit.  Health care facilities must submit, or cause to have submitted, 100 percent of data for all inpatient discharges and outpatient visits within one hundred eighty (180) days from the end of the month of a patient’s discharge or visit.

(iv) The SPARCS program may conduct an audit evaluating the quality of submitted SPARCS data and issue an audit report to a health care facility listing any inadequacies or inconsistencies in the data. Any health care facility so audited must submit corrected data to the SPARCS program within 90 days of the receipt of the audit report.

(2) Content of the SPARCS data.

(i) Health care facilities shall submit, or cause to have submitted, uniform bill data elements as required by the Commissioner. The data elements required by the Commissioner shall be based on those approved by the National Uniform Billing Committee (NUBC) or required under national electronic data interchange (EDI) standards for health care transactions and shall be published on the NYSDOH website to the extent allowed by copyright law.

(ii) Health care facilities shall submit, or cause to have submitted, additional data elements as required by the Commissioner. Such additional data elements shall be from medical records or demographic information maintained by the health care facilities.

(iii) The list of specific SPARCS data elements and their definitions shall be maintained by the Commissioner, will be made available publicly, and may be modified by the Commissioner.

(c) Maintenance of SPARCS data.

The Commissioner shall be responsible for protecting the privacy and security of the health care information reported to the SPARCS program.

(d) Requests for SPARCS data.

(1) SPARCS data may be used for medical or scientific research or statistical or epidemiological purposes approved by the Commissioner.

(2) The Commissioner may determine that additional purposes are proper uses of SPARCS data.

(3) In determining the purpose of a request for SPARCS data, the SPARCS program shall not be limited to information contained in the data request form and may request supplemental information from the applicant.

(4) The Commissioner shall charge a reasonable fee to all persons and organizations receiving SPARCS data based upon costs incurred and recurring for data processing, platform/data center and software. The Commissioner may discount the base fee or waive the fee upon request to the SPARCS program. The fee may be waived in the following circumstances:

(i) Use by a health care facility of the data it submitted to the SPARCS program.

(ii) Use by a health care facility that is licensed under Article 28 of the Public Health Law for the purpose of rate determinations or rate appeals and for health care-related research.

(iii) Use by a Federal, New York State, county or local government agency for health care-related purposes.

(5) The SPARCS program shall follow applicable federal and state laws when determining whether SPARCS data contain identifying data elements may be shared and whether a disclosure of SPARCS data constitutes an unwarranted invasion of personal privacy.

(6) All entities seeking SPARCS data must submit a request to the SPARCS program using standard data request forms specified by the SPARCS program. Data users shall take all necessary precautions to prevent unwarranted invasions of personal privacy resulting from any data analysis or release. Data users may not release any information that could be used, alone or in combination with other reasonably available information, to identify an individual who is a subject of the information. Data users bear full responsibility for breaches or unauthorized disclosures of personal information resulting from use of SPARCS data. Applications for SPARCS data must provide an explicit plan for preventing breaches or unauthorized disclosures of personal information of any individual who is a subject of the information.

(7) Each data request form must include an executed data use agreement in a form prescribed by the SPARCS program. Data use agreements are required of: a representative of the requesting organization; a representative of each other organization associated with the project; and all individuals who will have access to any data including identifying data elements.

(8) The SPARCS program shall publish and make publicly available the name of the project director, the organization, and the title of approved projects.

(9) The SPARCS Administrator shall review and make recommendations on requests for SPARCS data containing identifying data elements to a data release committee established by the Commissioner. The data release committee shall have at least three members, including at least one member not otherwise affiliated with NYSDOH. The members of the data release committee shall be posted on the NYSDOH website. Requests will be granted only upon formal, written approval for access by a majority of the members of the data release committee. The Commissioner has the final authority over the approval, or disapproval, of all requests. Requests for identifying data elements shall be approved only if:

(i) The purpose of the request is consistent with the purposes for which SPARCS data may be used;

(ii) The applicant is qualified to undertake the project; and

(iii) The applicant requires such identifying data elements for the intended project and is able to ensure that patient privacy will be protected.

(10) The SPARCS Administrator may recommend approval of a request in which future SPARCS data is to be supplied on a periodic basis under the following conditions:

(i) SPARCS data may be requested for a predetermined time not to exceed three years beyond the current year provided that the organization and uses of the data remain as indicated in the data request form submitted to the SPARCS program.

(ii) During the period of retention of SPARCS data, no additional individuals may access SPARCS data without an executed data use agreement on file with the SPARCS program.

(11) The Commissioner may rescind for cause, at any time, approval of a data request.

(e) Penalties.

(1) Any person or entity that violates the provisions of this section or any data use agreement may be liable pursuant to the provisions of the Public Health Law, including, but not limited to, sections 12 and 12-d of the Public Health Law.

(2) Any person or entity that violates the provisions of this section or any data use agreement may be denied access to SPARCS data.

Effective Date: 
Wednesday, January 30, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2816

Section 400.19 - Withdrawal of equity or assets

400.19 Withdrawal of equity or assets. (a) Definitions. For purposes of this section, the following terms shall have the following meanings:

(1) The term equity means:

(i) any right or claim to assets;

(ii) any interest in property or in a business, subject to claims of creditors;

(iii) the difference between assets and liabilities;

(iv) net worth.

(2) The term asset means any owned physical object or any right having economic value to its owner or any item or source of wealth expressed, for accounting purposes, in terms of its cost, depreciated cost determined in accordance with the applicable provisions of Part 86 of this Title, or fair market value at date of donation.

(3) The term withdrawal shall include, but not be limited to, the following examples:

(i) any transfer of a facility's cash or other assets directly or indirectly to or for the benefit of its operator.

(ii) expenditures of the facility's assets or equity for personal items not recognized as reimbursable under the state's medical assistance program.

(iii) any liability incurred within any period of time required for financial reporting in accordance with Part 86 of this Title by a facility or its operator by reason of a mortgage, lease, borrowing or other transaction relating to such a facility that exceeds, in the aggregate, $50,000.

(iv) any non-arm's length or related party loans made by the facility or its operator, including loans to any individual, corporation, partnership, or other organization related to the facility within the meaning of "related organization", as that term is defined in section 451.229 of this Title.

(v) payment to the operator or owner of a salary in excess of the maximum amount allowed for reimbursement purposes by the Department of Health.

(b)(1) No medical facility operated for profit, or operator of such facility, may withdraw said facility's equity or assets, without the prior approval of the commissioner, if such a withdrawal would create or increase a negative net worth position for the facility or occur when the facility is in a negative net worth position.

(2) A withdrawal shall be considered to have taken place if it has occurred during any period of time required for financial reportingin accordance with Part 86 of this Title.

(3) Negative net worth shall be calculated without regard to any surplus created by revaluation of assets, or to receivables resulting from non-arm's length or related party loans.

(4) When calculating net worth under this section, only the equity or assets of the facility shall be considered, and not any other property owned by the facility's operator, nor any other business entities related to the facility. Appeals and audits made pursuant to Part 86 of this Title and Title 18 (Social Services) NYCRR, respectively, shall not be considered for purposes of calculating net worth unless finally determined.

(5) In any administrative hearing brought pursuant to section 2808(5) of the Public Health Law, this section and Part 51 of this Title it shall be prima facie evidence of a withdrawal of equity or assets in violation of section 2808(5) of the Public Health Law and this section if, at the close of the period of time required for financial reporting in accordance with Part 86 of this Title, a facility is in a negative equity or net worth position and the operator has withdrawn equity or assets from the facility during the period of time covered by the financial report.

(c)(1) An application for approval shall be submitted on forms provided by the Department of Health at least sixty days prior to the proposed withdrawal and shall specify the necessity, purpose, and impact on patient care of the withdrawal and the details concerning such withdrawal including, but not limited to, the principal amount, interest rate, repayment terms, conditions of default, remedies upon default and obligee of any transaction to be consummated in a proposed withdrawal, unless such items are inapplicable. The application shall contain a current interim balance sheet and a description of the facility's cash position, including as cash such cash equivalents as certificates of deposit and treasury bills. Requests shall be made by certified or registered mail. Nothing herein shall be construed to prohibit the commissioner from considering applications submitted less than sixty days prior to the proposed withdrawal in an emergency situation that directly affects the health, safety or welfare of patients.

(2) The commissioner or his designee shall approve or disapprove a request for withdrawal of equity or assets within sixty days of the date of receipt of such a request. Any request not approved or disapproved within sixty days shall be considered approved.

(3) In reviewing an application for withdrawal, the commissioner shall consider: (i) the necessity for the withdrawal;

(ii) whether such withdrawal would impair the facility's ability to render quality care;

(iii) any expense which such withdrawal would generate; and

(iv) the financial condition of the facility in general.

(d) If an analysis of a facility's financial reports indicates the violation of the provisions of this section, the commissioner may review all documents which may indicate a withdrawal of equity has occurred and the facility shall produce all data necessary for the completion of such review.

(e) In addition to any other remedy or penalty available, and after the operator has been granted the opportunity for an administrative hearing, the commissioner may require replacement of the withdrawn equity or assets and may impose a penalty for violation of this regulation in an amount not to exceed ten percent of any amount withdrawn without prior approval.
 

Effective Date: 
Wednesday, October 4, 1989
Doc Status: 
Complete

Section 400.20 - HIV infection control

400.20 HIV infection control. (a) All facilities regulated under this article shall:

(1) implement and enforce a program for the prevention of circumstances which could result in an employee or patient/client becoming exposed to significant risk body substances which could put them at significant risk of HIV infection during the provision of services, as defined in section 63.1 and 63.9 of this Title. Such a program shall include:

(i) use of scientifically accepted protective barriers during job-related activities which involve, or may involve, exposure to significant risk body substances. Such preventive action shall be taken by the employee with each patient/client as an essential element for the prevention of bi-directional spread of HIV;

(ii) use of scientifically accepted preventive practices during job-related activities which involve the use of contaminated instruments or equipment which may cause puncture injuries;

(iii) training at the time of employment and yearly staff development programs on the use of protective equipment, preventive practices, and circumstances which represent a significant risk for all employees whose job-related tasks involve, or may involve, exposure to significant risk body substances;

(iv) provision of personal protective equipment for employees which is appropriate to the tasks being performed;

(v) a system for monitoring preventive programs to assure compliance and safety.

(2) implement and enforce a policy/procedure for the management of individuals who are exposed to significant risk body substances under circumstances which constitute significant risk of transmitting or contracting HIV infection. The policy/procedure shall include:

(i) a system for reporting to a designated individual in the facility exposure thought to be a circumstance which constitutes significant risk of transmitting or contracting HIV infection;

(ii) Evaluation of the circumstances of a reporting exposure and services for providing follow-up of the exposed individual which includes:

(a) medical and epidemiological assessment of the individual who is the source of the exposure, where that individual is known and available;

(b) if indicated epidemiologically, HIV counseling and voluntary testing of the source individual. Disclosure of the HIV status of the source individual can be made with the express written consent of the protected individual, or a person authorized pursuant to law to consent to health care for the protected individual if such person lacks capacity to consent, or pursuant to court order, if the HIV status is not known to the exposed individual;

(c) appropriate medical follow-up of the exposed individual.

(iii) assurances for protection of confidentiality for those involved in reported exposures.
 

Effective Date: 
Tuesday, August 8, 1989
Doc Status: 
Complete

Section 400.21 - Advance directives

400.21 Advance directives. (a) Statement of purpose. The New York State Health Care Proxy Law allows an adult to designate another adult, such as a trusted friend or loved one who knows the person and his/her wishes, to make treatment decisions if the adult becomes incapacitated and is unable to do so. The Health Care Proxy Law guarantees an adult's right to self-determination and the expression of this right through another adult. Advance directives also allow an adult to express his or her preference regarding health care treatment, including a desire to continue or to refuse treatment and life supports. In the absence of a Health Care Proxy, the Family Health Care Decisions Act allows a surrogate (a family member or close friend) to make treatment decisions on behalf of a patient, in accordance with the patient’s wishes, if known, or if the patient’s wishes are not known, in accordance with the patient’s best interests. Facilities must ensure that all adult patients/residents are informed of their rights and are supported and protected as they exercise their right to formulate written or oral instructions regarding their health care in the event such adults become incapacitated and are unable to direct their own health care.

(b) Definitions. The following words or phrases shall have the following meanings:

(1) An advance directive means a type of written or oral instruction relating to the provision of health care when an adult becomes incapacitated, including, but not limited to a health care proxy, a consent to the issuance of an order not to resuscitate or other medical orders for life-sustaining treatment (MOLST) recorded in a patient's/resident's medical record, and a living will;

(2) A health care proxy means a document created pursuant to Article 29-C of the Public Health Law which delegates the authority to another adult known as a health care agent to make health care decisions on behalf of the adult when that adult is incapacitated.

(3) A living will means a document which contains specific instructions concerning an adult's wishes about the type of health care choices and treatments that an adult does or does not want to receive.

(4) A health care agent or agent means an adult to whom authority to make health care decisions is delegated under a health care proxy.

(5) An adult means any person who is 18 years of age or older, or is the parent of a child, or has married. (6) Medical orders for life-sustaining treatment (MOLST) means medical orders to provide, withhold or withdraw life-sustaining treatment. The MOLST form is an alternative form authorized by the Commissioner under subdivision six of section twenty-nine hundred ninety-four-dd of the public health law. The MOLST form and guidance and checklists for using the MOLST form for any patient in any setting are posted on the department’s website.

(c) Facility compliance. The facility shall ensure compliance with the requirements of law governing advance directives including but not limited to Articles 29-C, 29-CC and 29-CCC of the Public Health Law.

(d) Policies and procedures. The facility shall be responsible for developing, implementing and maintaining written policies and procedures addressing advance directives and shall:

(1) make the following material available to each adult patient/resident, or if the adult patient/resident lacks capacity, to the family member or other adult who speaks on the patient's/resident's behalf at or prior to the time of admission to the facility as an inpatient or an outpatient and to each member of the facility's staff who provides patient/resident care. A facility need not provide these items more than once to an outpatient receiving services on a recurring basis:

(i) the description of state law prepared by the Department entitled “Deciding About Health Care: A Guide for Patients and Families,” which summarizes the rights, duties and requirements of Articles 29-C, 29-CC and 29-CCC; and

(ii) the pamphlet prepared by the Department entitled "Health Care Proxy: Appointing your Health Care Agent in New York State," containing a sample health care proxy form

(2) ensure that there is documentation in each adult's medical record indicating whether or not the adult has executed a health care proxy under Article 29-C of the Public Health Law, or whether the adult has provided written or oral advance instructions about treatment to facility staff responsible for the patient's care or to facility employees upon admission; (3) assess advance directives other than those described in Articles 29-C, 29-CC and 29-CCC of the Public Health Law. Nothing herein shall be construed to require that a facility must or may not seek a court determination that any individual advance directive has been expressed in a clear and convincing manner;

(4) provide in-service education to staff involved in the provision of care including medical staff concerning the facility's policies and procedures concerned with advance directives;

(5) provide (individually or with others) education to the community on issues concerning advance directives;

(6) ensure that an adult is not discriminated against in the provision of care or otherwise discriminated against based on whether or not the adult has executed an advance directive; and

(7) in addition, a nursing home shall:

(i) educate adult residents about the authority delegated under a health care proxy, what a proxy may include or omit, and how a proxy is created, revoked, or changed as requested by the resident;

(ii) ensure that each resident who creates a proxy while residing at the facility does so voluntarily; and

(iii) designate one or more individuals to educate the residents, respond to questions and assist residents in creating, revoking or changing a proxy. (e) Medical orders for life-sustaining treatment (MOLST). To implement a patient’s wishes regarding cardiopulmonary resuscitation (CPR) and other life-sustaining treatment, facilities may, if appropriate, utilize the department approved MOLST form for patients with serious health conditions who: (1) want to avoid or receive any or all life-sustaining treatment; or (2) can reasonably be expected to die within one year. (f) Rights to be publicized. The facility shall post in a public place in the facility the rights, duties and requirements of this section. Such statement may be included in any other statement of patient's/resident's rights required to be posted.
 

Effective Date: 
Wednesday, March 26, 2014
Doc Status: 
Complete

Section 400.22 - Statewide perinatal data system

Section 400.22 Statewide perinatal data system. (a) All hospitals and freestanding birthing centers which provide care and services to parturient women and/or neonates shall participate in the Statewide Perinatal Data System by providing required information in accordance with this section. Facilities contributing data to the system may only access data from the system in accordance with this section and other applicable laws and regulations.

(b) As used in this section the following terms shall have the following meanings:

(1) The statewide perinatal data system (SPDS) shall mean the electronic

maternal and newborn data collection and analysis system established and maintained by the Department of Health which includes the data elements, organized in modules, which comprise the New York State Certificate of Live Birth for births occurring in New York State outside of New York City, or the New York City Certificate of Live Birth for births occurring in New York City, and other data elements which

relate to maternal and newborn health and care in hospitals and free-standing birthing centers.

(2) The core module shall be the New York State Certificate of Live Birth, a data set consisting of elements specified by the Commissioner of Health and collected for all parturient women and newborns in New York State outside of New York City; and for births occurring in New York City, the core module shall be the New York City Certificate of Live Birth, a data set consisting of elements specified by the New York City Commissioner of Health and Mental Hygiene and collected for all parturient women and newborns in New York City.

(3) The supplemental module shall mean a set of data supplied by the patient consisting of data elements specified by the Commissioner of Health in consultation with the Commissioner of the

New York City Department of Health and Mental Hygiene. Supplemental module data elements shall be related to quality of prenatal care and maternal factors that may be related to birth outcomes.

(4) The high risk obstetric module shall mean a data set consisting of data elements that provide clinically-relevant information on pregnant women who are referred to obstetricians for specialty care in the antepartum period or who are transported to a higher level facility for delivery or care in the antepartum, intrapartum or postpartum period. Elements will be as specified by the Commissioner of Health in consultation with the Commissioner of the New York City Department of Health and Mental Hygiene concerning all pregnant women identified as having high risk pregnancies, inclusive of maternal transports to higher levels of care. The data elements shall supplement core module data, providing additional data on clinical risk status and interventions for high risk births.

(5) The high risk neonatal module (NICU module) shall mean a data set consisting of data elements that provide clinically-relevant information on the neonate at the time of entry to the neonatal intensive care unit. The elements will be as specified by the Commissioner of Health in consultation with the Commissioner of the New York City Department of Health and Mental Hygiene and data will be collected on all neonates entering all special care and intensive care nurseries for longer than four hours. The high risk neonatal module shall also include information on all newborns who die in the delivery room, in transit to the neonatal special or intensive care unit, and in the neonatal special or intensive care units. The data elements shall supplement core module data, providing additional data on clinical risk status and interventions for high risk newborns.

(6) The newborn Medicaid eligibility module shall consist of the Medicaid Client Identification Number (CIN) and other Medicaid-specific information as specified by the Commissioner of Health, and shall be available solely to authorized Office of Medicaid Management staff and departmental staff authorized to help maintain the SPDS files and the programming required thereby.

(7) De-identified patient data shall mean data from which individual patient names have been expunged and other identifiers have been modified so that there is no reasonable basis to believe that individual patients can be identified by using such data except by the facility which provided the patient care and services.

(8) Quality improvement shall mean any use or analysis of SPDS data that identifies for further investigation any poor outcomes potentially amenable to intervention (sentinel events), trends by hospital, hospital level or region, potential problem areas or any issues with quality of care; and further, may lead to improvement of the care provided by the regional perinatal center, its affiliate hospitals or regional perinatal system providers through development of initiatives designed to address the potential problems identified, or to improve the quality of the data collected via the SPDS.

(9) Target area for a community-based organization under contract to the New York State Department of Health shall mean the organization’s specified area of operation and/or influence as noted in their current contract.

(c) Participation in the statewide perinatal data system (SPDS).

(1) All hospitals and freestanding birthing centers that provide perinatal health care services shall participate in the statewide perinatal data system. All live births shall be entered into the state perinatal data system. For births occurring in New York City, the core module shall be implemented on January 1, 2007.

(2) Each hospital and freestanding birthing center shall submit core module data to the agency responsible for collecting birth records. In addition, all hospitals shall submit data from the supplemental module, the high risk obstetric module, and the Medicaid eligibility module, and, if the hospital has a neonatal special or intensive care unit, from the high risk neonatal module as well, to the department in a form and manner prescribed by the department. The hospital shall be responsible for retaining signed consent forms, if any, for at least six years. The hospital will only transmit data as required under the regulations and any additional data for which it has consent, when consent is needed. Data elements in the system shall address the following:

(i) mother’s Medicaid information to be used only to determine newborns' Medicaid eligibility;

(ii) public health surveillance of birth outcomes; and

(iii) improvement of prenatal, obstetric, and newborn care for mothers and infants.

(3) New York City Department of Health and Mental Hygiene will continue to exercise oversight of the use and release of the New York City Birth Certificate and the information contained therein. Nothing contained herein shall abridge the authority of the New York City Department of Health and Mental Hygiene to maintain the New York City Vital Records System. Nothing contained herein shall abridge the authority of the New York State Department of Health to maintain the New York Vital Records System outside of New York City.

(4) Access to SPDS data shall be limited to staff authorized by the Department of Health, and in the case of core module data for births occurring in hospitals and freestanding birthing centers located in New York City, staff authorized by the New York City Department of Health and Mental Hygiene, in the following settings for the purposes specified. Identifying SPDS information may be disclosed to authorized staff when and to the extent the disclosure is consistent with the Public Health Law, and for core module data from New York City consistent with applicable New York City law and regulations, and

necessary to conform to an identified requirement of the Public Health Law or one of its implementing regulations and when that disclosure is not otherwise prohibited or restricted by or inconsistent with the Public Health Law or its implementing regulations.

(i) Authorized staff of a facility shall have access to data submitted to the SPDS by that facility, with the exclusion of the Medicaid eligibility module; use of data shall conform with facility policies regarding use of confidential data.

(ii) A regional perinatal center shall have access to de-identified data submitted to the SPDS by its perinatal affiliates, with the exclusion of the Medicaid eligibility module, with a unique identifier that can be linked to identifying information only by the originating hospital for reference in evaluation of patient outcomes as specified in section 721.9 of this Title. De-identified data may also be used to monitor regional trends.

(iii) A comprehensive prenatal/perinatal services network or other community-based organization under contract to the Department of Health may be given access to available selected aggregate core and supplemental module data about births within its target area with all patient and provider identifiers eliminated. The level of aggregation and/or the geographic area targeted must ensure that no patients or providers are able to be identified from the data provided. Data shall be used only in furtherance of the organization’s role in assessing and improving perinatal health in their target area, as specified in their contract with the Department.

(iv) Staff authorized by the Department of Health shall have access to individual-level perinatal data system data reported by hospitals and freestanding birthing centers except in the case of core module data for births occurring in hospitals and freestanding birthing centers located in New York City, where staff access to core module data will be authorized by the New York City Department of Health and Mental Hygiene. For births occurring in hospitals and freestanding birthing centers located in New York City, SPDS data, including core and supplemental modules, shall be available to the New York City Department of Health and Mental Hygiene.

(v) Regional perinatal centers, affiliate hospitals and freestanding birthing centers with access to the data in the statewide perinatal data system (“SPDS”) shall not use the data for purposes other than quality improvement as defined in these regulations. SPDS data is confidential and must be appropriately secured by the regional perinatal centers, affiliate hospitals and freestanding birthing centers and shall not be redisclosed, except to the department or its authorized agents or contractors.

(d) The Commissioner shall waive for up to one year, upon request from the New York City Department of Health and Mental Hygiene on behalf of the facilities

located within that vital records registration district, the data collection requirements of this section under the following circumstances:

(1) An application for a waiver must be submitted that:

(i) is received at least three months before the effective date of the SPDS in the registration district;

(ii) identifies the financial, administrative or other hardship which necessitates the request;

(iii) describes the measures to be taken to eliminate the hardship and the anticipated completion date of those measures; and

(iv) assures continued access by hospitals to data comparable to that required in this section prior to implementation of SPDS.

Effective Date: 
Wednesday, October 11, 2006
Doc Status: 
Complete

Section 400.23 Repealed

Effective Date: 
Wednesday, December 19, 2007

Section 400.24 - Charges in connection with certain health care facility financings

Section 400.24 Charges in connection with certain health care facility financings. (Public Health Law, Sections 2868, 2881, Public Authorities Law, Section 2976-a(3)). In connection with the issuance of bonds, notes, or other obligations issued by public benefit corporations (which for purposes of this section shall include the Dormitory Authority of the State of New York and industrial development agencies (IDAs) created pursuant to Title 1 of Article 18-A of the General Municipal Law or any other provision of law) for the financing of hospital projects approved by the Commissioner for which reimbursement is provided pursuant to Article 28 of the Public Health Law, the Commissioner shall charge for the operational period of such financing which shall be from occupancy date to mortgage discharge, an annual charge of three-tenths of one percent of the mortgage loan, for inspection, regulation, supervision and audit payable monthly to the State Department of Health by the owner or operator of the hospital project. Adjustments of charges for the operational period shall be made by adjusting future operational period payments. For purposes of this section, the term "hospital" shall have the same meaning as is set forth in Section 2801(1) of the Public Health Law.

Effective Date: 
Thursday, March 1, 2007
Doc Status: 
Complete

Section 400.25 - Disclosure of nursing quality indicators

Section 400.25 Disclosure of nursing quality indicators.

(a) Definitions. For purposes of this section, the following terms shall have the following meanings:

(1) Acuity means the nursing care requirements of patients or residents.

(2) Case mix means the differences in patients or residents within a population in terms of their physical and mental conditions, and the resources that are used in their care.

(3) Fall means:

(i) For general hospitals, an unplanned descent to the floor with or without injury to the patient including unassisted and assisted descents whether they result from physiological or environmental reasons.

(ii) For nursing homes, an unintentional change in position coming to rest on the ground, floor or onto the next lower surface with or without injury to the resident including intercepted falls.

(4) Fall injury level means:

(i) For general hospitals, the degree of injury resulting from a fall and designated as moderate, major or fatal. For purposes of this subparagraph: moderate injuries involve suturing, application of steri-strips/skin glue, splinting or muscle/joint strain; major injuries involve surgery, casting or traction, or require consultation to rule out neurological or internal injury or patients with coagulopathy that receive blood products as a result of the fall; and fatal falls involve injuries that cause the patient’s death but do not include falls caused by physiologic events.

(ii) For nursing homes, the degree of injury resulting from a fall designated as major involves bone fractures, joint dislocations, closed head injuries with altered consciousness or subdural hematoma.

(5) Healthcare setting associated infection means any localized or systemic patient condition that:

(i) resulted from the presence of an infectious agent or its toxin(s) as determined by clinical examination or by laboratory testing; and

(ii) was not found to be present or incubating at the time of admission unless the infection was related to a previous admission to the same setting.

(6) Licensed Practical Nurse means a person who is licensed and currently registered as a Licensed Practical Nurse pursuant to Article 139 of the New York State Education Law.

(7) Patient includes a resident of a nursing home.

(8) Patient care staff means unit-based Registered Nurses, Licensed Practical Nurses and unlicensed personnel providing direct patient care greater than 50% of their shift.

(9) Patient day is the average number of patients a unit has per shift during a 24 hour period.

(10) Pressure ulcer means a localized injury to the skin and/or underlying tissue as a result of pressure or pressure in combination with shear acquired after admission to a healthcare facility.

(11) Registered Nurse means a person who is licensed and currently registered as a Registered Professional Nurse pursuant to Article 139 of the New York State Education Law.

(12) Shift means a 24 hour period of time as a whole or divided into parts as appropriate to the reporting facility.

(13) Unit means a distinct location providing patient care in a general hospital or nursing home distinguished from other distinct locations by name, number or other patient-specific factors.

(14) Unlicensed personnel means individuals trained to function in an assistive role to nurses in the provision of patient care, as assigned by and under the supervision of the Registered Nurse.

(b) Nurse Staffing Indicators are:

(1) The total number of productive hours of care provided by patient care staff per patient day for each unit, and the number and percentage of productive hours of care provided by Registered Nurses, Licensed Practical Nurses and unlicensed personnel each; and

(2) the average Registered Nurse and Licensed Practical Nurse to patient ratio for each unit and on each shift.

(c) Nurse-sensitive patient outcome indicators for general hospitals are:

(1) Falls with injury rate as indicated by the frequency in which falls result in a fall injury level of moderate, major or fatal per applicable unit calculated no less often than quarterly.

(2) Health care acquired pressure ulcers as indicated by the percentage of patients with facility-acquired pressure ulcer(s) of the skin that are determined to be stages II, III, IV, unstageable and suspected deep tissue injury per applicable unit calculated no less often than quarterly.

(3) Healthcare setting associated infection rates per applicable unit calculated no less often than quarterly for the following:

(i) Central line associated blood stream infection;

(ii) Catheter associated urinary tract infection; and

(iii) Ventilator associated (pneumonia) event.

(d) Nurse-sensitive patient outcome indicators for nursing homes are:

(1) Percent of long-stay residents who experienced one or more falls with major injury.

(2) Percentage of short-stay residents who have medical conditions that predispose them to developing a facility-acquired pressure ulcer with new or worsening pressure ulcers Stage II-IV.

(3) Percentage of long-stay residents with urinary tract health care setting associated infections.

(e) Within 30 days of a written request, general hospitals and nursing homes shall provide to the requester in hard copy or an electronic copy such as a portable document format (pdf) file, the following information for a three to twelve month period of time that is not more than one year prior to the date of the request:

(1) nurse staffing indicators and nurse-sensitive patient outcome indicators specified in this section;

(2) the procedures and processes used for determining and adjusting staffing levels based on patient case mix and acuity;

(3) the final conclusions of any complaint investigations filed with any state or federal regulatory agency or accrediting agency and any citations resulting from surveys; and

(4) the sources and dates for data disclosed.

(f) Facilities shall have policies and procedures for documentation and management of requests and responses to requests under this section. Documentation of requests and responses to requests under this section shall be kept for a period of no less than two years from the date the request for information was received.

Effective Date: 
Wednesday, January 7, 2015
Doc Status: 
Complete