N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-4.8

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

Section 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 year afterwards.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-4.8