N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-6.8

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

Section 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 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, a 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 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 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 skin or other tissue intended for transplantation.

(c) If performed, skin processing for freeze-drying shall take place within seven 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 year afterwards.

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

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-6.8