SubPart 52-4 - Cardiovascular Tissue Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.1 - Definition

Section 52-4.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Cardiovascular tissue donormeans a human being, living or dead, who is the source of cardiovascular tissue for transplantation, including autogeneic tissue.

(b) Critical work areameans an area where sterile tissue containers or aseptically retrieved tissue are exposed to the environment.

(c) Critical surfacemeans a surface which comes into contact with aseptically retrieved tissue, sterile tissue containers or sterile container covers.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.2 - Construction

52-4.2 Construction.

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 Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.3 - Tissue procurement services

52-4.3 Tissue procurement services.

(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 solicitation by its own staff shall be licensed by the department as a limited tissue procurement service.

(c) Comprehensive tissue procurement services retrieving cardiovascular tissue from cadaveric donors shall maintain written standard operating procedures that assure that the retrieval environment, including, but not limited to, walls, floors and permanent equipment, is suitable for retrieval and adequate to prepare an aseptic field. A working sink shall be available.

(d) Cardiovascular tissue retrieval shall be performed only by trained retrieval technicians under the supervision of the director of a licensed comprehensive tissue procurement service. The director of the licensed comprehensive tissue procurement service shall be responsible for developing policies, procedures and standards for the educational background, training, certification and continuing education of retrieval technicians. Documentation of compliance with this requirement and the standards developed shall be maintained.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.4 - Donor qualifications

52-4.4 Donor qualifications.

(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 medical director, cardiovascular tissue shall not be released for allogeneic transplant from donors with any of the following conditions:

(1) a disease of unknown etiology;

(2) malaria within the last three (3) years or travel to a malarially endemic area within the last six (6) months;

(3) active or untreated tuberculosis;

(4) history or presence of bacterial endocarditis or semilunar valvular heart disease, except for mitral valve prolapse;

(5) previous cardiac valvular surgery, if donation of the affected valve is considered;

(6) insulin-dependent diabetes mellitus;

(7) death due to drowning, if immersion was for longer than six (6) hours; or

(8) history of rheumatic fever.

(c) In addition to the exclusions outlined in subdivision (b) of this section, saphenous veins shall not be released from donors with any of the following conditions:

(1) varicose veins or other conditions of chronic venous stasis;

(2) trauma to saphenous veins; or

(3) significant phlebitis.

(d) Social history as recorded in the medical chart of the donor, or as provided by a friend or family member shall be considered in the donor selection process.

(e) The medical director of the comprehensive tissue procurement service shall be responsible for determining that the donor and the donated cardiovascular tissue are acceptable based on medical history information and established donor selection criteria as specified in this Part, and a physical examination.

(f) A written policy shall specify the range of acceptable donor age limits for allogeneic cardiovascular tissue donation. This policy shall be determined by the tissue bank medical director in consultation with the medical advisory committee of the comprehensive tissue procurement service.

(g) Written criteria for acceptance of donors of autogeneic tissue shall be specified by the transplantation service director of the tissue transplantation facility, unless such criteria have been specified already by the medical director of a comprehensive tissue procurement service.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.5 - Retrieval of tissue

52-4.5 Retrieval of tissue.

(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 cardiac function specified in written policies approved by the medical director of the comprehensive tissue procurement service.

(c) Cardiovascular tissue shall be stored and transported to the tissue processing facility at a temperature between one and 10 degrees Celsius.

(d) Aseptic processing of cardiovascular tissue shall begin within 48 hours of cessation of cardiac function.

(e) If an ante mortem blood sample is not available from a cadaveric donor, a post mortem sample of sufficient quantity to perform required laboratory testing shall be drawn via a cardiac insertion or from a large vein or artery.

(f) Tissue specimen containers and packaging materials shall be sterile and non-toxic.

(g) Each tissue and blood specimen container shall be labeled legibly at the time of retrieval with the tissue bank identification, and donor identification code or unique tissue identification number. The date, time and anatomic site of retrieval shall be recorded on accompanying documents.

(h) Unless a sample for culture is to be collected at the tissue processing facility, a segment or sample of contiguous heart or vascular tissue shall be placed in a separate, appropriately labeled sterile container intended for culturing for aerobic and anaerobic contamination.

(i) Tissue and blood specimen containers shall be labeled so as to maintain cardiovascular tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to significant deterioration under conditions of transport and storage.
 

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.6 - Tissue processing facilities

52-4.6 Tissue processing facilities.

(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 tissues distributed, or offered for use. The premises, equipment, procedures, records, circulars of instruction and tissues shall be available for inspection and/or testing by the department as required. Copies of all brochures and other informational materials and instructions, including descriptions of methods of tissue handling, shall be available to the department. Each container of tissue shall be clearly labeled with the donor identification code or a unique tissue identification number, unit size and expiration date, if applicable.

(b) Aseptic processing of cardiovascular tissue shall be performed in separately defined work areas with:

(1) floors, walls and ceilings with nonporous smooth surfaces that are easily cleaned;

(2) temperature and humidity controls;

(3) an air supply filtered through high efficiency particulate air filters with positive pressure differentials between rooms;

(4) a system for monitoring environmental conditions;

(5) a system for cleaning and disinfecting a room and equipment to produce aseptic conditions; and

(6) adequate space for staff, and storage of garments and equipment.

(c) Critical work areas in which sterile tissue containers or aseptically retrieved cardiovascular tissue are exposed to the environment shall have an air quality of no more than 100 particles (less than or equal to 0.5 micron) per cubic foot of air and no more than one bacterial colony forming unit per 10 cubic feet of air. Critical work areas shall have a positive pressure gradient greater than or equal to 0.05 inches of water relative to an adjacent less clean area. Critical surfaces shall be sterile and shall not interact with the tissue so as to affect the quality of the tissue adversely.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.7 - Required laboratory tests on donor and donated tissue

52-4.7 Required laboratory tests on donors and donated 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 that state's regulatory authority, the United State Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic cardiovascular tissue donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), human T-lymphotropic virus type I (HTLV-I), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, for purposes of donor selection.
(b) Testing of each cardiovascular tissue unit for aerobic and anaerobic contamination from each retrieval site shall be performed prior to final packaging, using standard laboratory procedures. Whenever fresh tissue is transplanted, the results of cultures shall be made available to the transplantation surgeon on a daily basis until the final reading has been completed.

(c) All cardiovascular tissue from living donors intended for allogeneic use shall be quarantined for six (6) months. After such time and prior to distribution of the tissue for transplantation, the donor shall be retested for HBsAg and antibodies to HCV, HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen (anti-HBc).

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.8 - Processing and storage of tissue

52-4.8 Processing and storage of tissue.

(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 in a refrigerator reserved for cardiovascular or other tissue intended for transplantation, equipped with a thermometer calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. The temperature shall be visually monitored and recorded daily unless the refrigerator is equipped with a calibrated mechanical temperature monitor and alarm system to detect an increase in temperature to above 10 degrees Celsius or a decrease in temperature to below one degree Celsius.

(b) Cardiovascular tissue processing for cryopreservation shall be initiated under aseptic conditions within 24 hours of retrieval. Until processing, tissue shall be stored at between one and 10 degrees Celsius. Once processed, cardiovascular tissue shall be stored frozen at a target temperature of minus 100 degrees Celsius or lower with a suitable cryoprotectant in labeled containers until distributed or issued for use, in either:

(1) a freezer reserved for cardiovascular or other tissue intended for transplantation, equipped with an audible alarm to detect an increase in temperature to above the limit established by the director and a recording thermometer calibrated at least annually against an NIST-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer; or

(2) a liquid nitrogen tank reserved for cardiovascular or other tissue intended for transplantation.

(c) Storage equipment shall have clearly defined and labeled areas for all cardiovascular tissue stored, and untested tissue shall be maintained in a quarantine area segregated from tissue awaiting distribution.

(d) Thermometers shall be visually monitored daily or temperatures shall be continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations potentially affecting the quality of the cardiovascular tissue. Temperature records and, if applicable, liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one (1) year afterwards.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.9 - Distribution of tissue products

52-4.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, 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

(2) the donor's blood reacts positively to approved tests for syphilis, unless confirmatory testing is negative.

(b) Cardiovascular tissue shall be transported by the tissue bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the tissue bank documenting the identification of tissue distributed, including the names of both the person(s) releasing the tissue and the person(s) receiving the tissue.

(c) Frozen cardiovascular tissue in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at a temperature of minus 70 degrees Celsius or lower. Tissue stored at a tissue transplantation facility shall be maintained at the appropriate storage temperature until immediately prior to transplantation.

(d) Cardiovascular tissue and its labeling and packaging shall be visually inspected prior to its distribution by the tissue processing facility. The tissue shall be inspected by the tissue transplantation facility immediately upon receipt and again after thawing, if frozen. If the physical appearance is abnormal, or there is indication or suspicion of overt microbial contamination, the tissue shall not be utilized for transplantation. In the case of frozen tissue, the period of time between thawing and use shall not exceed 24 hours if tissue is refrigerated at between one and 10 degrees Celsius, or four (4) hours if not refrigerated.

(e) Cardiovascular tissue shall be issued by the tissue transplantation facility only upon a written order by a licensed physician, or person authorized by law to order such issuance pursuant to section 52-4.11(b) of this Subpart. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of cardiovascular tissue shall be recorded in a disposition log and shall allow accurate tracking of tissue to each recipient.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.10 - Required records of tissue acquisition, testing, processing and storage

52-4.10 Required records of tissue acquisition, testing, processing and storage. Each cardiovascular tissue bank shall maintain donation records as required by Subpart 52-2 of this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.11 - Records to be kept by a tissue transplantation facility

52-4.11 Records to be kept by a tissue transplantation facility.

(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 tissue transplantation facility:

(1) if performed, results of testing for bacterial and fungal contamination after tissue thawing and prior to engraftment;

(2) a disposition log allowing accurate tracking of tissue to each recipient; and

(3) records of appropriate storage and temperature monitoring of cardiovascular tissue. (b) A copy of the order for issuance of the cardiovascular tissue, including the name and signature of the ordering physician or person authorized by law to order such issuance, shall be kept by the tissue transplantation facility. A record in the patient's chart shall be satisfactory documentation of such order for issuance.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.12 - Disposition of unused tissue

52-4.12 Disposition of unused tissue.

(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 cardiovascular tissue for destruction shall be designed to obscure the contents.

(b) Cardiovascular tissue returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The cardiovascular tissue bank shall not reissue tissue returned by the tissue transplantation facility, unless written criteria approved by the tissue bank medical director are met.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-4.13 - Tissue storage facilities

52-4.13 Tissue storage facilities.

(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 cardiovascular tissue shall be stored and monitored in accordance with the provisions of sections 52-4.8, and 52-4.9(b), (c) and (d) of this Subpart.

(c) Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of cardiovascular tissue storage and for one (1) year afterwards.

(d) Cardiovascular tissue products shall be distributed in accordance with the requirements of this Part, and all records related to the inspection, distribution and transport of tissues shall be open to inspection by the department and shall be kept for at least seven (7) years or six (6) months after the expiration date of the tissue, whichever is the longer time.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete