N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-5.8

Current through Register Vol. 46, No. 45, November 2, 2024

Section 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, a 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 a NIST-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, a 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 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 year afterwards.

(g) Musculoskeletal tissue from two 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.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-5.8