PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Part 52 of Title 10 NYCRR.
Amended action:
This action amends the rule that was filed with the Secretary of State on December 12, 2006, to be effective December 27, 2006, File No. 1502. The notice of adoption, I.D. No. HLT-20-06-00003-A, was published in the December 27, 2006 issue of the State Register.
Statutory authority:
Public Health Law, section 4365(1)
Subject:
Establishment of minimum technical requirements for non-transplant anatomic banks.
Purpose:
To refine the definition of non-transplant anatomic banks; eliminate any regulatory confusion; and establish certain technical requirements that reflect current standards of practice at non-transplant anatomic banking facilities.
Substance of amended rule:
This amendment to Part 52 changes existing definitions and adds new definitions to reflect currently accepted nomenclature, and provide needed clarification and consistency specific to the regulation of nontransplant anatomic banks. In addition, the new Subpart 52-11 enables the Department to establish needed technical standards for nontransplant anatomic banks.
The amendment fine tunes the definition of nontransplant anatomic bank to eliminate any regulatory confusion, decrease the likelihood of misinterpretation by regulated parties, and clarify licensure requirements for nontransplant anatomic banks located outside New York State. Exclusion from licensure as a nontransplant anatomic bank are clarified.
The amendment includes a new Subpart 52-11, which establishes minimum technical standards for nontransplant anatomic banks. The terms whole body, whole body acquisition service, whole body user, and body segment are defined.
The amendment specifies informed consent requirements for nontransplant anatomic banks that recover nontransplant anatomic parts (whole bodies, body segments, organs and/or tissues) for use in research and education. Consent must be documented, and any restrictions on the use of the gift, specified by the donor or donating next of kin, must be honored by the nontransplant anatomic bank. Requirements for documenting the consent, including those consents obtained by telephone, are specified.
The amendment requires the retrieval or acquisition of nontransplant anatomic parts to be performed on the premises of a general hospital, a nontransplant anatomic bank licensed in the category of whole body acquisition service, or, for nontransplant anatomic parts other than whole bodies and body segments, a licensed comprehensive tissue procurement service. Whole bodies, body segments, or other nontransplant anatomic parts are to be retrieved, acquired, distributed, transported, or used for purposes authorized by Public Health Law Section 4302.
Minimum staffing requirements for whole body acquisition services and whole body users are set forth. Included is a provision that permits individuals who do not meet educational requirements, but who serve as director of a whole body acquisition service at the time of adoption of this amendment, to continue as director.
Facility requisites for whole body acquisition services and whole body users are specified. The amendment requires that whole body acquisition services and whole body users have dedicated, secure and restricted space, or approved offsite locations for preparation of whole bodies and body segments for research and/or education purposes. Access to such space must be limited to individuals directly associated with receipt and preparation of whole bodies or body segments. Minimum requirements for preparation and storage space include: a working sink; adequate counter space; suitable space for storage of chemicals; counters, tables and cabinetry built of material that may be easily disinfected and cleaned; a dedicated, refrigerated room, walk-in cooler, or cadaver drawer cooler for the storage of whole bodies and body segments; U.S. Occupational and Health Administration (OSHA)-approved eye wash stations and devices for handling, lifting and internal transporting of whole bodies and body segments; and a morgue and/or crematory compliant with federal and state standards for embalming and cremation, if embalming and/or cremation services are performed.
Recordkeeping requirements, supplemental to those already detailed in Section 52-2.9(i), are specified.
The amendment includes provisions for the appropriate transfer of whole bodies, body segments, or other nontransplant anatomic parts in compliance with existing State standards for such transfer.
The amendment outlines requirements for the disposition of nontransplant anatomic parts, including whole bodies and body segments, once their use in education and research is concluded.
The amendment requires nontransplant anatomic banks to implement written safety and infection control policies and procedures to ensure protection of employees from unnecessary physical, chemical and biological hazards. Requisites are detailed for decontamination and disposal techniques for regulated medical waste as well as use of autoclave equipment. Restrictions on eating, drinking, smoking, and the application of cosmetics in work areas, and the use of gloves, laboratory coats, gowns or other protective clothing are imposed.
Finally, reporting requirements are set forth, consistent with those already in effect for licensed tissue banks. The amendment requires nontransplant anatomic bank directors to report to the Department certain information and data regarding the bank's activities.
Amended rule as compared with adopted rule:
The effective date of the rule was changed.
Text of amended rule and any required statements and analyses may be obtained from:
William Johnson, Department of Health, Division of Legal Affairs, Office of Regulatory Reform, Corning Tower, Rm. 2415, Empire State Plaza, Albany, NY 12237, (518) 473-7488, fax: (518) 486-4834, e-mail: regsqna@health.state.ny.us
Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
Although the regulation has been changed since it was published in the State Register on May 17, 2006, the changes do not necessitate any changes to the Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.
