SubPart 52-6 - Skin Banks

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

Section 52-6.1 - Definitions

Section 52-6.1 Definitions.

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

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

(b) Transplantationmeans the grafting of skin from a donor to a recipient, including the grafting of skin that has been manipulated and integrated into an artificial skin substitute, and the grafting of skin from an autogeneic donor.

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

Section 52-6.2 - Construction

52-6.2 Construction.

Terms not defined in this Subpart are defined in Subpart 52-1 of this Part. Skin 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 52-6.3 - Tissue procurement services

52-6.3 Tissue procurement services.

(a) A facility that engages in donor selection and solicitation, and retrieval of skin 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 skin 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 aseptic retrieval and adequate to prepare an aseptic field. A working sink shall be available.

(d) Skin 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 52-6.4 - Donor qualifications

52-6.4 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, skin 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; or

(3) drowning as a terminal event.

(c) 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.

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

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

(f) Written criteria for acceptance 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 52-6.5 - Retrieval of tissue

52-6.5 Retrieval of tissue.

(a) Skin shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director. In all cases, a vigorous surgical scrub and disinfectant solution nontoxic to epithelial cells shall be used in preparing the donation site for skin retrieval in accordance with standard operating room practice.

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

(d) Skin specimen containers and packaging materials shall be sterile and nontoxic.

(e) Each skin 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.

(f) Fresh-cut skin shall be maintained in a sterile, isotonic solution or other nutrient medium during the skin removal procedure, and transported to the tissue processing facility at the completion of the procedure.

(g) Skin samples for testing for microbial contamination shall be recovered from each anatomical site and placed in a separate, appropriately labeled container.

(h) Skin and blood specimen containers shall be labeled so as to maintain 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 52-6.6 - Tissue processing facilities

52-6.6 Tissue processing facilities.

A facility which processes skin 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 storage 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.

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

Section 52-6.7 - Required laboratory tests on donors and donated tissue

52-6.7 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 skin procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic skin donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, and, unless the tissue is to be virally inactivated, antibodies to human T-lymphotropic virus type I (HTLV-I), for purposes of donor selection.
(b) Microbial testing of skin from each anatomical site for aerobic and anaerobic contamination shall be performed using standard laboratory procedures. Whenever fresh skin 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 skin tissue from living donors intended for allogeneic use shall be quarantined for at least six months. After such time and prior to the 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 52-6.8 - Processing and storage of tissue

52-6.8 Processing and storage of tissue.

(a) Fresh skin shall be stored in a sealed, sterile container with an isotonic solution or nutrient medium demonstrated to maximize tissue viability, at a temperature between one and 10 degrees Celsius for a period not to exceed fourteen (14) days from retrieval. Storage shall take place in a refrigerator reserved for skin or other tissue intended for transplantation, or blood intended for transfusion, 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 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) If performed, skin processing for cryopreservation shall occur under aseptic conditions within three (3) days of retrieval. Until processing, skin shall be stored at between one and 10 degrees Celsius. Once processed, skin shall be stored frozen at a target temperature of minus 40 degrees Celsius or lower with a suitable cryoprotectant in labeled containers until released for use, in either:

(1) a freezer reserved for skin or other tissue intended for transplantation, or blood intended for transfusion, equipped with an audible alarm to detect an increase in temperature to above the limit established by the director and a 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 skin or other tissue intended for transplantation.

(c) If performed, skin processing for freeze-drying shall take place within seven (7) days of tissue procurement and in a manner that meets the minimum standards of the manufacturer of the freeze-drier. If sterilized by ethylene oxide, testing for ethylene oxide, ethylene glycol and ethylene chlorhydrin residue shall be performed on each batch of skin sterilized. Freeze-dried skin shall be stored at between one and 30 degrees Celsius.

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

(e) 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 skin. Storage shall be at a target temperature of minus 40 degrees Celsius or lower. 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.

(f) Skin from two (2) or more donors shall not be pooled.

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

Section 52-6.9 - Distribution of tissue products

52-6.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, skin 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, HCV or, unless the tissue is to be virally inactivated, antibodies to HTLV-I; or (2) the donor's blood reacts positively to approved tests for syphilis, unless confirmatory testing is negative.

(b) Skin 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 skin 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) Skin in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at the applicable storage temperature specified in section 52-6.8 of this Subpart. Tissue stored at a tissue transplantation facility shall be maintained at a target temperature of minus 40 degrees Celsius or lower until immediately prior to transplantation. Storage shall be in a freezer or liquid nitrogen tank reserved for skin or other tissue intended for transplantation, or blood reserved for transfusion.

(d) Skin and its labeling and packaging shall be visually inspected prior to its release 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 skin shall not be utilized for transplantation.

(e) Skin shall be issued by the tissue transplantation facility only upon a written order by a licensed physician or other person authorized by law to order tissue. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of skin 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 52-6.10 - Required records of tissue acquisition, testing, processing and storage

52-6.10 Required records of tissue acquisition, testing, processing and storage.

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

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

Section 52-6.11 - Records to be kept by a tissue transplantation facility

52-6.11 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) a disposition log allowing accurate tracking of tissue to each recipient; and

(2) records of appropriate storage and temperature monitoring of skin.

(b) A copy of the order for issuance of the skin, 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 52-6.12 - Disposition of unused tissue

52-6.12 Disposition of unused tissue.

(a) Skin that is not used by the tissue transplantation facility immediately after thawing may be refrigerated at between one and 10 degrees Celsius in isotonic or nutrient medium demonstrated to maximize tissue viability for a period of up to seven (7) days. Such skin may be issued for transplantation to the same patient to whom the skin was originally assigned, but shall not be refrozen. Thawed skin that is not used within seven (7) days shall be discarded, or used for education or research purposes authorized by Public Health Law section 4302.

(b) Skin determined to be unsuitable for transplantation, or education or research purposes shall be discarded pursuant to Part 70 of thisTitle. Packaging of skin for destruction shall be designed to obscure the contents.

(c) Skin returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The skin 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 52-6.13 - Tissue storage facilities

52-6.13 Tissue storage facilities.

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

(b) All skin shall be stored and monitored in accordance with the provisions of sections 52-6.8, and 52-6.9(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 skin storage and for one (1) year afterwards.

(d) Skin products shall be distributed in accordance with the requirements of this Part, and all records related to the inspection, distribution and transport of skin 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