Proposed Regulations
NEW YORK STATE DEPARTMENT OF HEALTH
Return to Public Health Forum



Proposed Rule Making:
Amendment of Section 52-1.1(r) and (aa)(2) and Addition of new Subpart 52-11 to Part 52 of Title 10
(Minimum Technical Requirements for Nontransplant Anatomic Banks)

Publication Date: 05/17/2006Comment Period Expiration: 07/01/2006
Proposed Text and Statements:
Summary of Express Terms

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 improves 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. Exclusions 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, bodies 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 individual body segments or other nontransplant anatomic parts to be performed on the premises of a general hospital or a nontransplant anatomic bank licensed in the category of whole body acquisition service. Whole bodies, body segments, or other nontransplant anatomic parts are to be retrieved, acquired, distributed, transported, or used only for purposes authorized by Public Health Law section 4302.
Minimum staffing requirements for whole body acquisition services and whole body users are specified. 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 the adoption of this amendment, to continue as director.
Facilities requirements 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 off-site 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.
Record keeping requirements, supplemental to those already required 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 completed.
The amendment includes a provision that requires the nontransplant anatomic bank to implement written safety and infection control policies and procedures to ensure protection of employees from unnecessary physical, chemical and biological hazards. Requirements are specified for decontamination and disposal techniques for regulated medical waste and 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 included, 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.

Pursuant to the authority vested in the Commissioner of Health by Public Health Law Section 4365 as added by Chapter 589 of the Laws of 1990, Part 52 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is hereby amended, to be effective within 60 (sixty) days of the date of publication of a Notice of Adoption in the State Register, as follows:

A new Subpart 52-11 is added to the table of contents for Part 52 to read as follows:
Subdivision (r) of Section 52-1.1 is amended as follows:
(r) Nontransplant anatomic bank means any person or facility that solicits, retrieves, performs donor selection and/or testing, preserves, transports, allocates, distributes, acquires, processes, stores or arranges for the storage of nontransplant anatomic parts, including whole bodies, body [parts] segments, organs or tissues from living or cadaveric donors, for education and/or research purposes specifically authorized by Public Health Law section 4302 [to be conducted at another facility]. The following shall not constitute a nontransplant anatomic bank:
(1) Any person [who] or entity that stores [bodies, body parts, organs or tissues] nontransplant anatomic parts, except whole bodies and body segments, solely for purposes of research and/or education conducted by such person [shall not be deemed a nontransplant anatomic bank], provided the person or entity maintains on its premises a properly executed anatomical gift consent document consistent with section 52-11.3 of this Part, and:
[(1)] (i) such person or entity is a legal donee pursuant to Public Health Law section 4302 and obtains all [tissue material] organs/tissues from a tissue bank or nontransplant anatomic bank licensed by the department[,]; or
(ii) is a general hospital conducting pathology services or research on nontransplant anatomic parts including whole bodies, recovered from within the facility from a living or deceased source; [and maintains a properly executed anatomical gift consent document on its premises; and]
(2) [such person is a physician, medical school or other legal donee entitled to receive anatomical parts pursuant to Public Health Law section 4302.] Any person or entity whose activities within the State of New York are limited to distribution of nontransplant anatomic parts to a tissue bank or nontransplant anatomic bank licensed by the department;
(3) Any person or entity that uses prepared slides and/or human-derived cell lines for purposes of education and/or research; and
(4) An employee of the federal government, provided an anatomical gift consent document has been executed in accordance with Public Health Law section 4301 and section 52-11.3(d) of this Part.

Paragraph (2) of subdivision (aa) of Section 52-1.1 is amended as follows:
(2) The following exceptions shall apply to the definition of tissue bank in this subdivision:
(i) An organ procurement organization shall not constitute a tissue bank solely by virtue of storing or arranging for the storage of heart valves.
(ii) An entity that uses tissue or fluids exclusively for diagnostic purposes, after removal or withdrawal of these materials in the course of standard medical practice, shall not constitute a tissue bank.
(iii) [An entity that uses prepared slides and/or human-derived cell lines for purposes of research or education shall not constitute a tissue bank.
(iv)] A hospital whose tissue banking activities are limited to requesting organs and/or tissue donations or referring potential donors or next of kin to licensed comprehensive tissue procurement services pursuant to Public Health Law article 43-A shall not constitute a tissue bank.

A new Subpart 52-11 is added to Part 52 to read as follows:

SUBPART 52-11
NONTRANSPLANT ANATOMIC BANKS
Section
52-11.1 Definitions
52-11.2 Construction
52-11.3 Informed consent
52-11.4 Retrieval and acquisition of nontransplant anatomic parts
52-11.5 Use of nontransplant anatomic parts
52-11.6 Disposition of nontransplant anatomic parts
52-11.7 Safety
52-11.8 Reporting requirements

Section 52-11.1 Definitions. For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:
(a) Whole body means the intact corporeal remains of an individual after the time of death.
(b) Whole body acquisition service means a nontransplant anatomic bank that solicits, retrieves, performs donor selection, preserves, transports, allocates, distributes, acquires, processes, stores, or arranges for the storage of whole bodies or body segments, solely for education and/or research purposes.
(c) Whole body user means a nontransplant anatomic bank located in New York State that obtains whole bodies and/or body segments from a whole body acquisition service. A whole body user shall store and/or use whole bodies or body segments solely for education and/or research purposes, under the direct oversight of the legally authorized donee. A whole body user may not transfer whole bodies or body segments to any other entity, except as authorized in writing by the whole body acquisition service.
(d) Body segment means a portion of a whole body detached for purposes of study, evaluation, education and/or research. Body segments consist of contiguous mixed tissues whose relationships have been altered only at the segment boundaries.

52-11.2 Construction. Terms not defined in this subpart are defined in subpart 52-1 of this Part. Nontransplant anatomic banks shall apply to the department for licensure and otherwise comply with all applicable provisions of subpart 52-2 of this Part.

52-11.3 Informed consent.
(a) Nontransplant anatomic banks that recover bodies, body segments, organs or tissues from cadaveric donors, including whole body acquisition services, shall obtain documented informed consent to the donation from a person authorized to consent to such donation in accordance with Public Health Law section 4301, or, for recoveries outside New York State, applicable statutes in the state where the nontransplant anatomic parts are recovered.
(b) Nontransplant anatomic banks that recover body segments, organs or tissues from living donors shall obtain documented informed consent from the donors.
(c) If specific direction is not provided in the consent document, it shall be presumed that whole bodies, body segments, and other nontransplant anatomic parts have been donated to entities authorized to receive the bodies of deceased persons pursuant to subdivision (1) of Public Health Law section 4211 and in accordance with the priorities established therein. Such entities may transfer or authorize the transfer of whole bodies, segments and other nontransplant anatomic parts to other donees specified in subdivisions (1) and (2) of Public Health Law section 4302 for purposes of:
(1) medical or dental education;
(2) medical or dental research; and/or
(3) the advancement of medical or dental science, therapy or transplantation.
(d) The documentation of informed consent to a donation shall identify the donee, indicate whether the gift is of the whole body or is limited to specified identifiable body segments, organs or tissues, and clearly specify the authorized uses of such donated body, body segments, organs, and/or tissues. Consent obtained by telephone shall be electronically recorded or documented in writing by the nontransplant anatomic bank. Telephone consent shall be followed by written documentation of consent for donation, which must be obtained prior to using whole bodies, body segments, organs and tissues in education and/or research.
(e) Except as provided in subdivision (c) above, no nontransplant anatomic bank shall use or transfer bodies, body segments or other nontransplant anatomic parts for any purpose not specified in the consent.

52-11.4 Retrieval and acquisition of nontransplant anatomic parts.
(a) The retrieval or acquisition of individual body segments or other nontransplant anatomic parts shall only be performed on the premises of a general hospital or the premises of a whole body acquisition service licensed in accordance with this subpart.
(b) No body, body segment, or other nontransplant anatomic part shall be retrieved, acquired, distributed, transported, or used for a purpose not authorized by Public Health Law section 4302. For the purposes of this subpart, the term “research” as used in Public Health Law section 4302 shall be limited to research conducted in accordance with accepted research protocols designed to improve the public health, safety and welfare.
(c) Whole body acquisition services.
(1) A whole body acquisition service shall employ the following staff:
(i) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences, or who has been serving as director of a nontransplant anatomic bank licensed by the department prior to the adoption of this provision;
(ii) an appropriately trained technician, morgue attendant, diener, or licensed funeral director responsible for the preparation, care and maintenance of whole bodies and body segments; and
(iii) at least one support staff person, other than the nontransplant anatomic bank director, but who may be the technician, morgue attendant, diener, or licensed funeral director, who shall be responsible for record keeping.
(2) Facilities requirements. A whole body acquisition service shall have a dedicated, secure and restricted space for preparation of whole bodies and body segments for research and/or education purposes. Access to such space shall be limited to individuals directly associated with receipt and preparation of whole bodies or body segments. Preparation and storage space shall include:
(i) a working sink and adequate counter space for preparation of whole bodies or body segments;
(ii) suitable space for storage of chemicals/materials used in preparation of whole bodies or body segments, as applicable;
(iii) counters, tables, and cabinetry built of material that may be easily disinfected and cleaned;
(iv) a refrigerated storage room, walk-in cooler, or cadaver drawer cooler, dedicated solely to storage of whole bodies or body segments. Such storage area shall have lockable access doors, and alarms to signal intrusion or unacceptable temperature deviation;
(v) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting, and internal transportation of whole bodies or body segments;
(vi) OSHA-approved eye wash stations;
(vii) if embalming is performed, a morgue compliant with federal and state standards; and
(viii) if cremation is performed, a crematory compliant with federal and state standards.
(3) Records. In addition to the records required in section 52-2.9(i) of this subpart, a whole body acquisition service shall maintain complete and accurate records of all donations, including:
(i) identification of the whole body, and, in the case of a body segment, a description and source of the body segment;
(ii) documentation of unclaimed acquisitions, death certificates, and burial transit permits associated with receipt and use of whole bodies or body segments;
(iii) facilities/institutions to which the whole bodies or body segments are transferred, or documentation of any other disposition; and
(iv) a copy of any contract or letter of agreement between the whole body acquisition service and the whole body user, and documentation of the method of intended final disposition of the whole body or body segments.
(d) Transfer.
(1) Any transfer of whole bodies, body segments or other nontransplant anatomic parts shall be conducted in compliance with existing state standards for such transfer. The burial transit permit(s) issued by the registrar of vital statistics (in the case of a whole body transfer), or written documentation of the source and a description of the body segment(s) or anatomic parts, shall accompany whole bodies, body segments, or nontransplant anatomic parts.
(2) In the case of a whole body transfer, a copy of the properly executed burial transit permit shall be maintained by the whole body acquisition service.

52-11.5 Use of nontransplant anatomic parts.
(a) Whenever a whole body is donated for educational purposes, unless another lawful donee is specified in the donor consent, the whole body user shall be an entity authorized to receive the bodies of deceased persons pursuant Public Health Law section 4211 in accordance with the priorities established therein.
(b) A whole body user shall not transfer the whole body or body segment to any other entity, except as authorized in writing by the whole body acquisition service from which the whole body or body segment was obtained.
(c) A whole body user shall have at least one staff member with a graduate degree in the health sciences, and training specific to human dissection or to the activity to be performed.
(d) In addition to the records required in section 52-2.9(i) of this subpart, a whole body user shall maintain complete and accurate records of receipt, use and disposition of whole bodies, body segments, organs and tissues. These records shall include, but not be limited to:
(1) identification of the whole body, or, in the case of a body segment, a description and source of the body segment;
(2) a copy of any contract or letter of agreement between the whole body acquisition service and whole body user, and documentation of the method of final disposition of whole bodies or body segments; and
(3) in the case of whole body transfers, a copy of a properly executed burial transit permit.
(e) The dissection and/or other authorized use of whole bodies and body segments shall occur only in dedicated rooms on the premises of the facility identified on the license or at an off-site location approved by the director of the whole body acquisition service from which whole bodies and/or body segments were obtained. Such rooms shall feature:
(1) lockable doors with access restricted to individuals directly associated with the dissection and/or other authorized use;
(2) isolation from public view;
(3) sufficient size, and construction and equipment suitable to ensure safe and respectful handling of whole bodies and body segments;
(4) tables designed for dissection of whole bodies or other work spaces appropriate for the specific authorized activity to be performed;
(5) a working sink and adequate counter space to ensure the safety of individuals involved in using whole bodies and body segments in dissection or other authorized use;
(6) surfaces constructed of nonporous materials;
(7) OSHA-approved eye wash stations; and
(8) facilities for storage of chemicals, if any, in accordance with OSHA guidelines.
(f) Other nontransplant anatomic banks.
(1) All other nontransplant anatomic banks shall conduct authorized activities in spaces that feature:
(i) lockable doors with access restricted to individuals directly associated with the education and/or research activities conducted; (iii) sufficient size, and construction and equipment suitable to ensure safe and respectful handling of the organs and/or tissues;
(iv) a working sink and adequate work space to ensure the safety of individuals involved in using organs and/or tissues in education and/or research; and (2) Nontransplant anatomic banks using nontransplant anatomic parts that are not whole bodies or segments shall maintain complete and accurate records of receipt, use and disposition of organs and tissues. These records shall include the source and a full description of each organ or tissue.

52-11.6 Disposition of nontransplant anatomic parts.
(a) All users of nontransplant anatomic parts, including whole body users, shall dispose of whole body remains, body segments, organs and tissue in accordance with existing state standards for such disposition. Users may return whole bodies or body segments to the whole body acquisition service from which the material was originally obtained.
(b) Disposition of whole bodies and body segments shall be consistent with instructions provided in the consent document.

52-11.7 Safety. A nontransplant anatomic bank shall implement written safety and infection control policies and procedures to ensure protection from unnecessary physical, chemical and biological hazards.
(a) Decontamination and disposal techniques for regulated medical waste shall be utilized. All hazardous and regulated waste materials shall be handled, stored and discarded pursuant to Part 70 of this Title and/or 6 N.Y.C.R.R. Subpart 360-10 as appropriate, or in the case of out-of-state banks, in accordance with the hazardous waste disposal requirements of the state in which the disposal occurs.
(b) If autoclave equipment is used for sterilization, the pressure, temperature, and duration of each cycle shall be recorded, and such records maintained for one year. For each run, these parameters shall be within the manufacturer’s recommended operating procedures. If any one or more of these parameters fall outside the manufacturer’s standards, all material shall be reautoclaved. Chemical, biological, and physical detection systems shall be used in conjunction with these other measurements of autoclave performance.
(c) Eating, drinking, smoking, and the application of cosmetics or contact lenses shall not be permitted in work areas. Refrigerators and freezers used for storing nontransplant anatomic parts, specimens, or reagents shall not be used for any other purpose.
(d) Gloves and laboratory coats, gowns or other protective clothing shall be worn while handling nontransplant anatomic parts or specimens, sufficient to protect against the transmission of disease and exposure to toxic substances. Such protective clothing shall not be worn outside the work area and shall be disposed of in an appropriate receptacle.

52-11.8 Reporting requirements. Whenever requested, a nontransplant anatomic bank shall submit reports to the department containing such information and data concerning its activities as may be required by this Part. Such reports shall be signed by the director of the nontransplant anatomic bank.

Regulatory Impact Statement
Statutory Authority
Article 43-B of the Public Health Law (PHL) establishes the Department’s authority over the operation of tissue banks and nontransplant anatomic banks in New York State. PHL Section 4365(1) expressly authorizes the Commissioner of Health, in consultation with the Transplant Council, to promulgate regulations to establish standards for tissue banks and storage facilities. PHL Section 4365(6) expressly authorizes the Commissioner of Health, in consultation with the Transplant Council, to establish subcategories of tissue bank licensure and develop standards specific to a subcategory. Nontransplant anatomic banks are licensed as tissue banks under 10 NYCRR Part 52, but technical standards for the operation of such facilities, except for minimal record keeping requirements, have not yet been adopted, and are proposed in this rule-making.

Legislative Objectives
The Legislature has directed the Department to ensure the highest quality of public health care by establishing regulations for licensing facilities engaged in tissue banking activities, including nontransplant anatomic banking, in New York State. Article 43-B requires the Commissioner of Health to promulgate regulations that establish standards for tissue banks and nontransplant anatomic banks; and to license and periodically inspect such facilities to evaluate operating procedures, equipment, and records to determine compliance with those standards. Such action is intended to prevent operation of substandard tissue banks and nontransplant anatomic banks.

Needs and Benefits
The demand for and use of whole bodies, body segments, organs, and tissues for medical research and health professional education have increased dramatically since the adoption of licensure requirements for tissue banks and nontransplant anatomic banks in 1991. Concerns about informed consent, and proper and respectful handling of donated human materials have been raised in the public media and in complaints received by the Department. To date, the Department has issued licenses to 70 nontransplant anatomic banks. Many facilities currently licensed to recover and/or process tissue for transplantation may redirect tissue deemed unsuitable for transplant to research and education use. Tissue banks and nontransplant anatomic banks perform a variety of banking activities, including recovery, processing, storage and distribution of nontransplant anatomic parts (whole bodies, body segments, organs, and tissues).
Anecdotal and lay press reports of body parts’ theft for personal profit have increased in recent years. Concerns have also arisen regarding anatomy educational workshops and seminars using body parts in public venues, such as hotel conference rooms. However, bodies, body segments, organs, and tissues are widely used for medical research and health professional education throughout the world scientific community. Nontransplant anatomic parts for legitimate purposes in New York State are procured from many areas of the country and, in some cases, from other countries.
The amendment imposes reasonable requirements intended to ensure that all nontransplant anatomic parts recovered, processed and used in New York State are obtained with documented informed consent, and handled respectfully and safely. At the same time, the proposed regulations reflect an awareness that restrictions on use of nontransplant anatomic parts must not be so constraining as to stifle research and education endeavors in New York. The amendment seeks to address areas of concern by requiring that donated nontransplant anatomic parts be acquired, processed and/or stored in New York State only by Department-licensed nontransplant anatomic banks, or under the supervision of a licensed bank.
Definitions of whole body, whole body acquisition service, whole body user, and body segment are added, thereby establishing subcategories of nontransplant anatomic parts and nontransplant anatomic banking services so that appropriate requirements may be specified for each.
These amendments refine 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. The new Subpart 52-11 would establish certain new technical requirements that reflect current standards of practice at nontransplant anatomic banking facilities. These requirements were developed in cooperation with the Anatomic Committee of the Associated Medical Schools of New York State and are based, in part, upon written standards prepared by that committee.
Reports of unauthorized removal and sale of body parts at several large medical educational institutions emphasized the need for oversight of whole body acquisition services, which include all anatomic gift programs operated by medical schools, and for-profit and not-for-profit independent facilities conducting business in New York State. Therefore, minimum staffing requirements for whole body acquisition services and whole body users are detailed. To assure proper handling and use of whole bodes, whole body acquisition services must employ a director with a graduate degree in either anatomy or the health sciences. Whole body users must employ at least one staff member with a graduate degree in the health sciences, or training in either human dissection or the specific activities performed.
Facility requirements for whole body acquisition services, whole body users, and users of other nontransplant anatomic parts are set forth to address concerns about the current lack of standards for safe and appropriate handling and disposition of nontransplant anatomic parts. A provision is included to require that dissection of whole bodies and body segments occur only in dedicated rooms or at off-site locations approved by the director. General safety requirements applicable to all nontransplant anatomic banks are also added.
Department surveyors have observed that nontransplant anatomic banks often create and maintain insufficient documentation of informed consent for donation of whole bodies. To ensure that donations of whole bodies and other anatomical gifts are used only for the purposes intended by the donor or the donor’s next of kin, informed consent requirements for all nontransplant anatomic banks would be expanded to identify those body segments, organs, or tissues intended for donation and their permitted uses. Provisions for documenting consent obtained by telephone are detailed.
Finally, a requirement for reporting nontransplant anatomic banking activities is added to notify the Department of changes in activities performed by the licensed nontransplant anatomic bank.

COSTS:
Costs for the Implementation of, and Continuing Compliance with, the Regulation to the Regulated Entity
Currently, staff members of all New York State medical schools that would be whole body acquisition services, meet all stipulated educational requirements. If a whole body acquisition service does not meet this proposal’s staffing requirements, it may incur expenses associated with employing: (1) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences; and (2) an appropriately trained morgue attendant, diener, or licensed funeral director responsible for preparation, care and maintenance of whole bodies and body segments. Full-time salaries for properly trained morgue attendants or dieners range from $24,000 to $46,200. Salaries for a director with the appropriate graduate degree would depend upon whether the director is full-time or part-time and other responsibilities within the institution. Full-time salaries for occupations requiring similar credentials range from $38,000 to $101,390. (See NYS Education Department website workforce wages.)
A whole body user may incur expenses associated with recruiting a staff member with a graduate degree in the health sciences, and training in human dissection or in the activity to be performed. Based upon information submitted in the application process, nontransplant anatomic banks currently licensed to use whole bodies and body segments in research and/or education are already likely to employ such an individual.
A whole body acquisition service not already in compliance with the proposal’s new facilities requirements could incur additional expenses, as follows:
(1) a working sink and adequate counter space for preparation of whole bodies and body segments (costs range from $5,000 to more than $10,000, depending on size and specifications);
(2) counters, tables, and cabinetry made of material easily disinfected and cleaned (modular-unit base cabinets cost from $800 to $1,400 each);
(3) a refrigerated storage room dedicated solely to storage of whole bodies or body segments, with lockable access doors and alarms to signal intrusion or unacceptable temperature deviation (cost varies depending on size and type, e.g., four-body crypt versus walk-in, or portable versus fixed-room, but ranges from $12,000 to $140,000);
(4) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting and internal transportation of whole bodies or body segments (a cadaver lift assembly costs approximately $4,000); and
(5) an OSHA-approved eye wash station (a fixed, plumbed station costs from $300 to $500).
A whole body user not already in compliance with the proposal’s facilities requirements could incur additional expenses, as follows:
(1) a dedicated room with lockable access doors and isolation from public view to ensure safe and respectful handling of whole bodies and body segments (costs associated with providing locks and a means to obscure the public’s view are minimal);
(2) dissection tables commercially designed for that purpose (commercial dissection tables cost $2,800 for a standard table and $4,400 for a hinged-hood table);
(3) a working sink and adequate counter space (costs range from $5,000 to more than $10,000, depending on size and specifications); and
(4) an OSHA-approved eye wash station (a fixed, plumbed station costs from $300 to $500).
Other nontransplant anatomic banks not already in compliance with the proposal’s facilities requirements could incur additional expenses, as follows:
(1) a room of sufficient size and construction with lockable doors to restrict access to individuals directly associated with the education or research conducted, and ensure isolation from public view (costs associated with providing locks and a means to obscure the public’s view are minimal); and
(2) a working sink and adequate counters constructed of nonporous materials (costs range from several hundred dollars to more than $1,000, depending on size and specifications).
Unless otherwise stated, cost estimates provided above are based upon information generally available in medical and laboratory supply catalogs and cost estimates provided by medical schools that would be required to comply with these standards.
Nontransplant anatomic banks could incur some minimal additional costs to revise written procedures, and forms/logs for recording specific information to document the donation process, informed consent, and storage and disposition of nontransplant anatomic parts. It is not possible to provide an estimate of the costs of implementing this amendment’s record keeping provisions, since costs would vary depending upon the volume of the nontransplant anatomic parts recovered and the amount of record keeping already in place. Most research and education facilities currently identify, track and dispose of nontransplant anatomic parts in a manner consistent with these requirements as part of good research techniques and inventory procedures. Moreover, it is expected that existing staff would be able to implement these requirements, thereby avoiding added labor costs.
The above-described costs would be easily offset by the benefits to be derived from assurance of safe, appropriate and respectful handling of human bodies, body segments, organs, and tissues used in research and/or education.
Costs to State and Local Governments
State and local government agencies that operate nontransplant anatomic banks would incur the same costs and benefits as private regulated parties.
Costs to the Department of Health
The Department operates several nontransplant anatomic banks, that are subject to these regulations. However, since existing staff and facilities fulfill most of the requirements, the Department expects to incur few costs, if any, in complying with these regulations. Similarly, since new licensure application processing and surveys of nontransplant banks for compliance with the increased technical requirements would not require additional Department staff, the Department does not expect to incur additional costs in implementing the proposed regulations.

Paperwork
Nontransplant anatomic banks that are whole body acquisition services and whole body users may be required to revise their procedures for handling nontransplant anatomic parts to comply with the new requirements.
Minimal additional paperwork and printing costs would be experienced by whole body acquisition services to revise informed consent documents. Assuming such forms are in word-processing files, revisions should require no more than 10 (ten) person-hours and would be expected to be completed by the tissue bank director and existing staff. Thus, no additional labor costs should be associated with these requirements.

Local Government Mandates
The regulation imposes no new program, service, duty, or responsibility on any county, city, town, village, school district, fire district, or other special district. A municipal government or district that operates a nontransplant anatomic bank would be affected as described herein to the same extent as other regulated parties.

Duplication
This amended regulation does not duplicate any other State or federal regulation.

Alternative Approaches
No alternatives were considered in developing these regulations, since no consistent or overriding regulations or current industry standards are in place in this area.

Federal Standards
Although the U.S. Food and Drug Administration (FDA) has published rules addressing banking of human tissue intended for transplantation, these rules do not include provisions for whole bodies, body segments, organs, and tissues used in research and/or education.

Compliance Schedule
Regulated parties should be able to comply with all provisions of these amended regulations within 60 (sixty) days of the date of publication of a Notice of Adoption in the New York State Register. Consequently, the effective date of these regulations has been set at 60 (sixty) days after publication of such a Notice of Adoption.
Contact Person William Johnson
NYS Department of Health
Division of Legal Affairs
Office of Regulatory Reform
Corning Tower, Rm. 2415
Empire State Plaza
Albany, NY 12237
(518) 473-7488
(518) 486-4834 FAX
REGSQNA@health.state.ny.us

___________________________________________________________________________________________

Regulatory Flexibility Analysis for
Small Business and Local Government

Effect of Rule
Small businesses to which these regulatory changes apply represent fewer than ten of the 70 nontransplant anatomic banks approved to operate in the State. The majority of nontransplant anatomic banks in New York State are affiliated with hospitals, medical schools or other not-for-profit organizations. The Department is aware of two retailers and one manufacturer of educational specimens which are licensed as nontransplant anatomic banks that would fall within the definition of a small business.
Five nontransplant anatomic banks are owned by or operate in local government-owned facilities, including two county mortuaries, one medical examiner’s office, and health professional programs at two community colleges.

Compliance Requirements
These amendments refine 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. Licensure requirements are detailed for entities that use whole bodies and body segments in medical research and/or health professional education. Minimum personnel, facilities, and record keeping standards are established for recovery, processing, storage and distribution of whole bodies and body segments. The proposed regulations include the following provisions:
· The terms body segment, whole body, whole body acquisition service, and whole body user are defined.
· Ownership and control requirements are specified for whole body acquisition services located in-State and for those located out of State.
· Minimum staffing requirements for whole body acquisition services and whole body users are established.
· Facility requirements for whole body acquisition services, whole body users, and users of other nontransplant anatomic parts are set forth.
· Donor/next-of-kin informed consent requirements for all nontransplant anatomic banks are expanded to ensure that donor families are given the opportunity to limit a gift to specified identifiable body segments, organs, or tissues. Provisions for documenting consent obtained by telephone are added.
· Record keeping requirements specifically applicable to whole body acquisition services and whole body users are included to supplement existing requirements for all nontransplant anatomic banks found in Section 52-2.9(i).
· Disposition and transfer requirements for whole bodies, body segments and other nontransplant anatomic parts are described.
· Safety requirements applicable to all nontransplant anatomic banks are detailed.
· A requirement for reporting nontransplant anatomic banking activities to the Department is specified.

Professional Services
Regulated parties are not likely to need additional professional services to comply with these regulations.

Compliance Costs
Currently, staff members of all New York State medical schools that would be whole body acquisition services, meet all stipulated educational requirements. If a whole body acquisition service does not meet this proposal’s staffing requirements, it may incur expenses associated with employing: (1) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences; and (2) an appropriately trained morgue attendant, diener, or licensed funeral director responsible for preparation, care and maintenance of whole bodies and body segments. Full-time salaries for properly trained morgue attendants or dieners range from $24,000 to $46,200. Salaries for a director with the appropriate graduate degree would depend upon whether the director is full-time or part-time and other responsibilities within the institution. Full-time salaries for occupations requiring similar credentials range from $38,000 to $101,390. (See NYS Education Department website workforce wages.)
A whole body user may incur expenses associated with recruiting a staff member with a graduate degree in the health sciences, and training in human dissection or in the activity to be performed. Based upon information submitted in the application process, nontransplant anatomic banks currently licensed to use whole bodies and body segments in research and/or education are already likely to employ such an individual.
A whole body acquisition service not already in compliance with the proposal’s new facilities requirements could incur additional expenses, as follows:
(1) a working sink and adequate counter space for preparation of whole bodies and body segments (costs range from $5,000 to more than $10,000, depending on size and specifications);
(2) counters, tables, and cabinetry made of material easily disinfected and cleaned (modular-unit base cabinets cost from $800 to $1,400 each);
(3) a refrigerated storage room dedicated solely to storage of whole bodies or body segments, with lockable access doors and alarms to signal intrusion or unacceptable temperature deviation (cost varies depending on size and type, e.g., four-body crypt versus walk-in, or portable versus fixed-room, but ranges from $12,000 to $140,000);
(4) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting and internal transportation of whole bodies or body segments (a cadaver lift assembly costs approximately $4,000); and
(5) an OSHA-approved eye wash station (a fixed, plumbed station costs from $300 to $500).
A whole body user not already in compliance with the proposal’s facilities requirements could incur additional expenses, as follows:
(1) a dedicated room with lockable access doors and isolation from public view to ensure safe and respectful handling of whole bodies and body segments (costs associated with providing locks and a means to obscure the public’s view are minimal);
(2) dissection tables commercially designed for that purpose (commercial dissection tables cost $2,800 for a standard table and $4,400 for a hinged-hood table);
(3) a working sink and adequate counter space (costs range from $5,000 to more than $10,000, depending on size and specifications); and
(4) an OSHA-approved eye wash station (a fixed, plumbed station costs from $300 to $500).
Other nontransplant anatomic banks not already in compliance with the proposal’s facilities requirements could incur additional expenses, as follows:
(1) a room of sufficient size and construction with lockable doors to restrict access to individuals directly associated with the education or research conducted, and ensure isolation from public view (costs associated with providing locks and a means to obscure the public’s view are minimal); and
(2) a working sink and adequate counters constructed of nonporous materials (costs range from several hundred dollars to more than $1,000, depending on size and specifications).
Unless otherwise stated, cost estimates provided above are based upon information generally available in medical and laboratory supply catalogs and cost estimates provided by medical schools that would be required to comply with these standards.
Nontransplant anatomic banks could incur some minimal additional costs to revise written procedures, and forms/logs for recording specific information to document the donation process, informed consent, and storage and disposition of nontransplant anatomic parts. It is not possible to provide an estimate of the costs of implementing this amendment’s record keeping provisions, since costs would vary depending upon the volume of the nontransplant anatomic parts recovered and the amount of record keeping already in place. Most research and education facilities currently identify, track and dispose of nontransplant anatomic parts in a manner consistent with these requirements as part of good research techniques and inventory procedures. Moreover, it is expected that existing staff would be able to implement these requirements, thereby avoiding added labor costs.
The above-described costs would be easily offset by the benefits to be derived from assurance of safe, appropriate and respectful handling of human bodies, body segments, organs, and tissues used in research and/or education.
All costs associated with modifying facilities to comply with the regulations would be one time costs. To the extent a bank does not currently comply with the staffing requirements, the labor costs noted above could be said to be the estimated annual cost of complying with this regulation.

Economic and Technical Feasibility
The proposed changes present no economic or technical difficulties to small businesses and local governments. Although some revisions to whole body recovery and processing facilities and record keeping practices are required, these requirements are straightforward and easily instituted by existing nontransplant anatomic bank staff.

Minimizing Adverse Impact
The proposed amendments would have no significant adverse impact on small businesses presently in compliance with established industry standards. The need to codify standards for appropriate handling of whole bodies and body segments outweighs any added costs some small businesses may incur to implement these changes fully. These amendments have been developed with an emphasis on minimizing burdens on regulated parties to the greatest extent possible, while maintaining adequate standards to ensure safe and respectful handling of whole bodies and body segments.

Small Business and Local Government Participation
The Department notified all regulated parties directly regarding the proposed regulation in order to solicit comments. Changes have been incorporated, as appropriate, based on comments and suggestions received as a result. No adverse comments were received from affected parties that are either government operated or small businesses.
More recently, the Department distributed copies of the modified proposal at the January 20, 2006 meeting of the Anatomical Committee of the Associated Medical Schools of New York State, and participated in discussion of specific changes made in response to informal comments. No adverse comments and no written comments were received as a result of this meeting.

Rural Area Flexibility Analysis

Types and Estimated Numbers of Rural Areas
The Department has identified three nontransplant anatomic banks located in rural New York State counties or towns with a population density of fewer than 150 persons per square mile: a chiropractic college, a university health professional education program, and a medical imaging equipment manufacturer. These facilities are all licensed by the Department as nontransplant anatomic banks. Two of these facilities are whole body users and would be subject to the facilities requirements imposed by the amended regulation. The medical imaging instrument manufacturer would be affected by the amendments minimally, since only human bone is used in its manufacturing process; this entity is not a whole body user according to the definition in the amendment.

Reporting, Record Keeping and other Compliance Requirements; and Professional Services
These amendments refine 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. Licensure requirements are detailed for entities that use whole bodies and body segments in medical research and/or health professional education. Minimum personnel, facilities, and record keeping standards are established for recovery, processing, storage and distribution of whole bodies and body segments. The proposed regulations include the following provisions:
· The terms body segment, whole body, whole body acquisition service, and whole body user are defined.
· Ownership and control requirements are specified for whole body acquisition services located in-State and for those located out of State.
· Minimum staffing requirements for whole body acquisition services and whole body users are established.
· Facility requirements for whole body acquisition services, whole body users, and users of other nontransplant anatomic parts are set forth.
· Donor/next-of-kin informed consent requirements for all nontransplant anatomic banks are expanded to ensure that donor families are given the opportunity to limit a gift to specified identifiable body segments, organs, or tissues. Provisions for documenting consent obtained by telephone are added.
· Record keeping requirements specifically applicable to whole body acquisition services and whole body users are included to supplement existing requirements for all nontransplant anatomic banks found in Section 52-2.9(i).
· Disposition and transfer requirements for whole bodies, body segments and other nontransplant anatomic parts are described.
· A requirement for reporting nontransplant anatomic banking activities to the Department is specified.

Costs
Currently, staff members of all New York State medical schools that would be whole body acquisition services, meet all stipulated educational requirements. If a whole body acquisition service does not meet this proposal’s staffing requirements, it may incur expenses associated with employing: (1) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences; and (2) an appropriately trained morgue attendant, diener, or licensed funeral director responsible for preparation, care and maintenance of whole bodies and body segments. Full-time salaries for properly trained morgue attendants or dieners range from $24,000 to $46,200. Salaries for a director with the appropriate graduate degree would depend upon whether the director is full-time or part-time and other responsibilities within the institution. Full-time salaries for occupations requiring similar credentials range from $38,000 to $101,390. (See NYS Education Department website workforce wages.)
A whole body user may incur expenses associated with recruiting a staff member with a graduate degree in the health sciences, and training in human dissection or in the activity to be performed. Based upon information submitted in the application process, nontransplant anatomic banks currently licensed to use whole bodies and body segments in research and/or education are already likely to employ such an individual.
A whole body acquisition service not already in compliance with the proposal’s new facilities requirements could incur additional expenses, as follows:
(1) a working sink and adequate counter space for preparation of whole bodies and body segments (costs range from $5,000 to more than $10,000, depending on size and specifications);
(2) counters, tables, and cabinetry made of material easily disinfected and cleaned (modular-unit base cabinets cost from $800 to $1,400 each);
(3) a refrigerated storage room dedicated solely to storage of whole bodies or body segments, with lockable access doors and alarms to signal intrusion or unacceptable temperature deviation (cost varies depending on size and type, e.g., four-body crypt versus walk-in, or portable versus fixed-room, but ranges from $12,000 to $140,000);
(4) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting and internal transportation of whole bodies or body segments (a cadaver lift assembly costs approximately $4,000); and
(5) an OSHA-approved eye wash station (a fixed, plumbed station costs from $300 to $500).
A whole body user not already in compliance with the proposal’s facilities requirements could incur additional expenses, as follows:
(1) a dedicated room with lockable access doors and isolation from public view to ensure safe and respectful handling of whole bodies and body segments (costs associated with providing locks and a means to obscure the public’s view are minimal);
(2) dissection tables commercially designed for that purpose (commercial dissection tables cost $2,800 for a standard table and $4,400 for a hinged-hood table);
(3) a working sink and adequate counter space (costs range from $5,000 to more than $10,000, depending on size and specifications); and
(4) an OSHA-approved eye wash station (a fixed, plumbed station costs from $300 to $500).
Other nontransplant anatomic banks not already in compliance with the proposal’s facilities requirements could incur additional expenses, as follows:
(1) a room of sufficient size and construction with lockable doors to restrict access to individuals directly associated with the education or research conducted, and ensure isolation from public view (costs associated with providing locks and a means to obscure the public’s view are minimal); and
(2) a working sink and adequate counters constructed of nonporous materials (costs range from several hundred dollars to more than $1,000, depending on size and specifications).
Unless otherwise stated, cost estimates provided above are based upon information generally available in medical and laboratory supply catalogs and cost estimates provided by medical schools that would be required to comply with these standards.
Nontransplant anatomic banks could incur some minimal additional costs to revise written procedures, and forms/logs for recording specific information to document the donation process, informed consent, and storage and disposition of nontransplant anatomic parts. It is not possible to provide an estimate of the costs of implementing this amendment’s record keeping provisions, since costs would vary depending upon the volume of the nontransplant anatomic parts recovered and the amount of record keeping already in place. Most research and education facilities currently identify, track and dispose of nontransplant anatomic parts in a manner consistent with these requirements as part of good research techniques and inventory procedures. Moreover, it is expected that existing staff would be able to implement these requirements, thereby avoiding added labor costs.
The above-described costs would be easily offset by the benefits to be derived from assurance of safe, appropriate and respectful handling of human bodies, body segments, organs, and tissues used in research and/or education.

Minimizing Adverse Impact
The proposed amendments would have no significant adverse impact on rural facilities presently in compliance with established industry standards. The need to codify standards for appropriate handling of whole bodies and body segments outweighs any added costs some facilities located in rural areas may incur in implementing these changes fully. These amendments have been developed with an emphasis on minimizing burdens on regulated parties to the greatest extent possible, while maintaining adequate standards to ensure safe and respectful handling of whole bodies and body segments.

Rural Area Participation
The Department notified all regulated parties directly regarding the proposed regulation in order to solicit comments. Changes have been incorporated, as appropriate, based on comments and suggestions received as a result. No adverse comments were received from affected parties that operate a tissue bank in an area designated as rural.
More recently, the Department distributed copies of the modified proposal at the January 20, 2006 meeting of the Anatomical Committee of the Associated Medical Schools of New York State, and participated in discussion of specific changes made in response to informal comments. No adverse comments and no written comments were received as a result of this meeting.

Job Impact Statement

A Job Impact Statement is not attached, because it is apparent, from the nature and purpose of the proposed rule, that it will not have a substantial adverse impact on jobs and employment opportunities.