Part 52 Tissue Banks and Nontransplant Anatomic Banks

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 an…

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.

(a) Nontransplant anatomic banks that recover bodies, body segments, organs or tissues from deceased donors, including whole body acquisition services, shall obtain documented informed consent to the donation from a person authorized to consent to such donation in accordance with…

(a) The retrieval of nontransplant anatomic parts shall only be performed on: (1) the premises of a general hospital; (2) the premises of a whole body acquisition service licensed in accordance with this Subpart; or (3) for nontransplant anatomic parts other than whole bodies and…

(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 to Public Health Law, section 4211 in accordance with…

(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 acqu…

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. A…

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.

(a) Any person who plans to operate a tissue bank or nontransplant anatomic bank or distribute tissue or nontransplant anatomic parts in New York State shall submit a completed, signed application to the department and obtain a license from the department prior to the operation o…

Tissue banks, including tissue transplantation facilities, insemination/implantation sites, human milk transfer stations and nontransplant anatomic banks, shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating the oper…

(a) The department may issue a provisional license which shall be valid for a period determined by the department to be sufficient to enable the department to assess the compliance of the tissue bank or nontransplant anatomic bank with this Part. The provisional license may be re…

(a) Except for a tissue bank owned and operated by a facility established pursuant to Public Health Law, article 28, any change in the direct or indirect ownership status of five percent or more or in a controlling interest in a tissue bank or nontransplant anatomic bank, shall b…

(a) Prior to approving an application for a license to operate a tissue bank, other than a limited tissue procurement service or a tissue transplantation facility, which acquires, processes, stores and/or distributes tissue for transplantation, transfer, artificial insemination o…

(a) A tissue bank, other than a tissue transplantation facility, tissue storage facility or a limited procurement service, shall be issued a license for one or more tissue categories, provided that: (1) the owner(s) and/or an authorized representative have submitted a license app…

(a) Each tissue bank and nontransplant anatomic bank shall establish and maintain complete and accurate books, financial records, documents and accounts, which shall be kept for a period of at least seven years. The department shall have access to all such records and any financi…

(a) Every tissue bank other than a tissue transplantation facility or limited tissue procurement service shall have a tissue bank director. The tissue bank director shall develop and implement policies and procedures for the operation of the bank, consistent with this Subpart and…

(a) Each tissue transplantation service director shall develop and implement policies and procedures for operation of the tissue transplantation service consistent with this Subpart and the Subparts for each category of tissue. (b) The tissue transplantation service director shal…

(a) Complete and accurate records of tissue and nontransplant anatomic parts released shall be kept by the tissue banks or nontransplant anatomic banks distributing the tissue. Such records shall be open to inspection by the department. For all donated tissue and nontransplant an…

(a) All antisera, reagents, devices, methods and procedures for tissue processing or transplantation-related testing shall be approved by the FDA, if such approval is available for the particular class or type of antiserum, reagent, device, method or procedure. (b) All reagents s…

All instruments, including collection containers, used for both sterile and clean, nonsterile retrieval of tissues shall be either licensed by the FDA for single use or be sterilized prior to each use. Heat sterilization shall be by autoclaving at 121.5 degrees Celsius for 15 min…

(a) A comprehensive or limited tissue procurement service shall obtain a signed informed consent from the living donor of tissue for clinical use. (b) For potential cadaveric donors who have not left a signed, witnessed organ/tissue donor card (see section 4303 of the Public Heal…

(a) Except as specifically approved by the medical director of the comprehensive tissue procurement service and in conformance with generally accepted standards of practice, allogeneic tissue for clinical use shall not be released from donors with any of the following conditions:…

(1) Records shall document that the following quality control procedures are in place at the tissue bank, except for a limited tissue procurement service: (i) preventive maintenance, periodic inspections and testing for proper operation of equipment, including annual calibration …

No tissue bank shall inform any tissue donor or consenting next-of-kin of the results of HIV antibody testing solely on the basis of the enzyme-linked immunosorbent assay (ELISA) or other screening test for HIV antibodies unless such results are negative. Any reactive screening t…

(a) The tissue bank shall have a written procedure for documenting errors or accidents in retrieval, testing, processing, storage or distribution of tissue that may affect the safety of any product. If the error or accident is not detected prior to issuance of the tissue, specime…

(a) The department may exempt a tissue bank from a specific standard contained in this Part, provided: (1) the tissue bank has applied to the department for an exemption for limited circumstances prior to the noncompliance with the standard; and (2) the tissue bank has demonstrat…

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings: (a) Cardiovascular tissue donor means a human being, living or dead, who is the source of cardiovascular tissue for transplantation, including autogene…

Each cardiovascular tissue bank shall maintain donation records as required by Subpart 52-2 of this Part.

(a) The director of each tissue transplantation service shall be responsible for records kept by the tissue transplantation facility. In addition to the records specified in Subpart 52-2 of this Part, the following records shall be kept, separate from recipient records, by the ti…

(a) Thawed cardiovascular tissue that is not used by the tissue transplantation facility within 24 hours of thawing shall be used for education or research purposes authorized by Public Health Law section 4302, or discarded pursuant to Part 70 of this Title. Packaging of cardiova…

(a) A facility which stores cardiovascular tissue shall be licensed by the department as a tissue storage facility. The cardiovascular tissue bank shall keep the department fully informed of the number and type of tissue storage facilities operating under its direction. (b) All c…

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Cardiovascular tissue banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of this…

(a) A facility that engages in donor selection and solicitation, and retrieval of cardiovascular tissue shall be licensed by the department as a comprehensive tissue procurement service. (b) A facility whose tissue acquisition activities are limited to donor selection and solicit…

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part. (b) Unless specifically authorized by the tissue bank me…

(a) Cardiovascular tissue shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director. (b) Retrieval of cardiovascular tissue from a cadaveric donor shall occur within a time limit after cessation of cardi…

(a) A facility which processes cardiovascular tissue shall be licensed by the department as a tissue processing facility. Such facilities shall make available to the department a statement of the procedures used in the preparation, testing and preservation of the tissue or tissue…

All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state cardiovascular tissue procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by tha…

(a) Fresh cardiovascular tissue shall be stored in an isotonic storage medium demonstrated to maximize tissue viability in a sealed, sterile container at a temperature between one and 10 degrees Celsius for a period not to exceed 24 hours from retrieval. Storage shall take place …

(a) Except as provided in section 52-3.4 of this Part, a cardiovascular tissue shall not be made available for allogeneic transplantation if: (1) The donor's blood tests repeatedly reactive in approved screening tests for HBsAg, or antibodies to HIV-1, HIV-2, HTLV-I, or HCV; or (…

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings: (a) Batch means a specific quantity of tissue that is intended to have uniform characteristics and quality within specific limits, and is produced acco…

In addition to the recordkeeping requirements of Subpart 52-2 of this Part, each musculoskeletal tissue bank shall maintain tissue records which include: (a) spark testing for vacuum in the case of freeze-dried tissue; and (b) if the tissue is sterilized by ethylene oxide, amount…

(a) The director of each tissue transplantation service shall be responsible for records kept by the tissue transplantation facility. In addition to the records specified in Subpart 52-2 of this Part, the following records shall be kept, separate from recipient records, by the ti…

(a) All musculoskeletal tissue determined to be unsuitable for transplantation, or education or research purposes authorized by Public Health Law section 4302 shall be discarded pursuant to Part 70 of this Title. Packaging of musculoskeletal tissue for destruction shall be design…

(a) A facility which stores musculoskeletal tissue shall be licensed by the department as a tissue storage facility. The musculoskeletal tissue bank shall keep the department fully informed of the number and type of tissue storage facilities operating under its direction. (b) All…

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Musculoskeletal tissue banks shall apply for licensure and otherwise comply with Subpart 52-2 of this Part, and shall meet all general technical standards for tissue banks specified in Subpart 52-3 of thi…

(a) A facility that engages in donor selection and solicitation, and retrieval of musculoskeletal tissue shall be licensed by the department as a comprehensive tissue procurement service. (b) A facility whose tissue acquisition activities are limited to donor selection and solici…

(a) In addition to all the requirements of this Subpart, limited tissue procurement services and comprehensive tissue procurement services shall comply with the donor qualification requirements in Subpart 52-3 of this Part. (b) Unless specifically authorized by the tissue bank me…