SubPart 52-5 - Musculoskeletal Tissue Banks

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

Section 52-5.1 - Definitions

Section 52-5.1 Definitions.

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

(a) Batchmeans a specific quantity of tissue that is intended to have uniform characteristics and quality within specific limits, and is produced according to the same processing protocol and during the same processing cycle.

(b) Musculoskeletal tissue donormeans a human being, living or dead, who is the source of musculoskeletal tissue, including autogeneic tissue, for transplantation. (c) Critical work areameans an area where sterile tissue containers or aseptically retrieved tissue are exposed to the environment.

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

(f) Controlled work areameans an area where unsterilized tissue, in-process materials and tissue containers are handled.

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

Section 52-5.2 - Construction

52-5.2 Construction.

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 this Part.

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

Section 52-5.3 - Tissue procurement services

52-5.3 Tissue procurement services.

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

(c) Comprehensive tissue procurement services retrieving musculoskeletal tissue aseptically 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) Musculoskeletal 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 52-5.4 - Donor qualifications

52-5.4 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, musculoskeletal tissue shall not be released for allogeneic transplant from donors with any of the following conditions:

(1) evidence of rheumatoid arthritis;

(2) a disease of unknown etiology; or

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

(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 musculoskeletal tissue 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 limits for allogeneic musculoskeletal 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.
(f) 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 52-5.5 - Retrieval of tissue

52-5.5 Retrieval of tissue.

(a) Musculoskeletal tissue, including tissue for which assurance of sterility cannot be maintained, such as mandible, shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director.

(b) Retrieval of musculoskeletal tissue 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) Musculoskeletal tissue retrieved from cadaveric donors shall be transported to the tissue processing facility at a temperature of 10 degrees Celsius or lower.

(d) 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.

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

(f) 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. (g) A segment or sample of musculoskeletal tissue that is not intended for viral inactivation shall be placed in a separate, appropriately labeled sterile container intended for culturing for aerobic and anaerobic contamination.

(h) Tissue and blood specimen containers shall be labeled so as to maintain musculoskeletal 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 52-5.6 - Tissue processing facilities

52-5.6 Tissue processing facilities.

(a) A facility which processes musculoskeletal 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.

(b) Aseptic processing of musculoskeletal 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) Processing of musculoskeletal tissue intended for viral inactivation shall occur in controlled work areas. These areas shall have an acceptable microbial and particulate quality to minimize contaminants in final tissue preparation prior to sterilization and to ensure effectiveness of sterilization. Air shall have a particulate (less than or equal to 0.05 micron) count of less than or equal to 100,000 per cubic foot in the vicinity of the exposed tissue during periods of processing activity, and no more than 25 bacterial colonies per ten cubic feet. Air flow shall achieve 20 air exchanges per hour and a pressure differential greater than or equal to 0.05 inches of water relative to an adjacent less clean area. Compressed air shall be free of demonstrable oil vapors.

(d) Critical work areas in which sterile tissue containers or aseptically retrieved musculoskeletal 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 52-5.7 - Required laboratory tests on donors and donated tissue

52-5.7 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 musculoskeletal tissue 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 musculoskeletal tissue 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) Testing of each musculoskeletal tissue unit for aerobic and anaerobic contamination 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 musculoskeletal 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 52-5.8 - Processing and storage of tissue

52-5.8 Processing and storage of tissue.

(a) Fresh musculoskeletal 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 14 days from retrieval. Storage shall take place in a refrigerator reserved for musculoskeletal 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 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) Musculoskeletal tissue processing for freezing shall be performed under aseptic conditions within 48 hours of retrieval. Until processing, tissue shall be stored at between one and 10 degrees Celsius. Once processed, musculoskeletal tissue shall be stored frozen at a target temperature of minus 40 degrees Celsius or lower in labeled containers until released for use, in either:

(1) a freezer reserved for musculoskeletal 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 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 musculoskeletal or other tissue intended for transplantation.

(c) Freeze-dried musculoskeletal tissue shall be processed in a manner that meets the minimum standards of the manufacturer of the freeze-drier. The freeze-drier shall be equipped with a temperature recording device unless another mechanism for recording temperature is in place, and documentation shall allow tracing of each tissue product to a specific batch. Sterility testing of each freeze-dried tissue unit shall be performed using a properly validated method of 100 percent nondestructive testing, or another method approved by the medical director of the tissue bank in consultation with the medical advisory committee and approved by the department. Testing for residual moisture shall be performed on one representative sample from each freeze-dried batch for each type of musculoskeletal tissue, such as cartilage, ligament and bone. Freeze-dried tissue shall be stored at room temperature or lower.

(d) If musculoskeletal tissue is sterilized by ethylene oxide, testing for ethylene oxide, ethylene glycol and ethylene chlorhydrin residue shall be performed on each type of tissue within a batch. Residue amounts shall not exceed:

PARTS PER MILLION

 

TISSUE QUANTITY

 

ETHYLENE OXIDE

ETHYLENE CHLORHYDRIN

 

ETHYLENE GLYCOL

 

 

 

 

Small (<10 g)

250

250

5,000

Medium (10-100 g)

100

100

2,000

Large (>100 g)

   25

   25

   500

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

(f) 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 musculoskeletal tissue. 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.

(g) Musculoskeletal tissue from two (2) or more donors shall not be pooled.

(h) The age and sex of the donor, and, if the musculoskeletal tissue is from a living donor, the patient's orthopedic diagnosis shall be made available to the transplanting surgeon, upon request.

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

Section 52-5.9 - Distribution of tissue products

52-5.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, musculoskeletal 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, 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) Freeze-dried processed musculoskeletal tissue distributed by a processing or storage facility shall be visually inspected for cracks, contamination, or extraneous material prior to distribution. If tissue container seals are broken or there is evidence that proper temperature has not been maintained, tissue shall not be distributed for transplantation. Container vacuums shall be determined to be satisfactory by testing with a spark generator.

(c) Musculoskeletal 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.

(d) Musculoskeletal tissue 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 52-5.8. Tissue stored at a tissue transplantation facility shall be maintained, until immediately prior to transplantation, at minus 20 degrees Celsius or lower for a maximum of six (6) months, and minus 40 degrees Celsius for longer periods. Storage shall be in a freezer reserved for musculoskeletal or other tissue intended for transplantation, or blood intended for transfusion.

(e) Musculoskeletal 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.

(f) Musculoskeletal tissue 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 musculoskeletal 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 52-5.10 - Required records of tissue acquisition, testing, processing and storage

52-5.10 Required records of tissue acquisition, testing, processing and storage. 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 of ethylene oxide, ethylene glycol and ethylene chlorhydrin residue for each type of musculoskeletal tissue within a batch.

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

Section 52-5.11 - Records to be kept by the tissue transplantation facility

52-5.11 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 musculoskeletal tissue. (b) A copy of the order for issuance of the musculoskeletal 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 52-5.12 - Disposition of unused tissue

52-5.12 Disposition of unused tissue.

(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 designed to obscure the contents.

(b) Musculoskeletal tissue returned by the tissue transplantation facility for possible reissuance shall meet all storage and transport requirements of this Part. The musculoskeletal 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 52-5.13 - Tissue storage facilities

52-5.13 Tissue storage facilities.

(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 musculoskeletal tissue shall be stored and monitored in accordance with the provisions of sections 52-5.8, and 52-5.9(b), (c), (d) and (e) of this Subpart.

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

(d) Musculoskeletal 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