N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-7.8

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

Section 52-7.8 - Processing and storage of tissue

(a) Until processing, eyes shall be stored at a temperature of between two and six degrees Celsius.

(b) The corneal-scleral segment shall be examined grossly for clarity, epithelial defects, foreign objects, contamination and scleral color for evidence of jaundice.

(c) Slit-lamp examination of whole eyes or the corneal-scleral rim of excised tissue shall be performed to detect epithelial and stromal pathology, including edema, cell density, opacities, scars and guttata. A system, as determined by the tissue bank medical director, shall be in place to categorize tissue adequacy for transplantation.

(d) Eyes and ocular tissue shall be preserved using aseptic technique, in:

(1) a moist chamber kept at a temperature of between two and six degrees Celsius;

(2) a short-term preservation medium stored and used in accordance with the manufacturer's instructions and/or with written procedures approved by the tissue bank director;

(3) a long-term culture medium used in accordance with written procedures approved by the tissue bank director;

(4) a frozen or dehydrated state, if corneal tissue is used for epikeratoplasty;

(5) the frozen state, as scleral grafts immersed in antibiotic solution; or

(6) any other method in accordance with written procedures approved by the tissue bank medical director and currently accepted by leading authorities in eye transplant medicine.

(e) Thawed tissue that has been refrozen shall not be issued for transplantation.

(f) The duration of storage subsequent to application of each preservation method above shall be clearly specified in written procedures approved by the tissue bank medical director.

(g) Tissue shall be maintained aseptically at a temperature appropriate to the method of preservation utilized. The tissue bank director shall determine the appropriate temperature based upon the method of preservation utilized, manufacturers' instructions, standards set forth in this Part and standards in current scientific literature. The refrigeration device used for storage shall be reserved for ocular and other tissue and related supplies, with clearly defined and labeled areas for all tissues stored. Quarantined tissue awaiting test results shall be segregated from tissue ready for distribution. Unless an alternative mechanism is in place for immediate notification and action to be taken in the event of a power failure, the refrigeration device shall be equipped with an audible alarm to detect temperature deviations above and below the established limits of storage, and 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.

(h) Thermometers shall be visually monitored daily or temperatures shall be continuously monitored mechanically for fluctuations potentially affecting the quality of the tissue. Temperature records shall be available for inspection by the department for the entire period of storage and for one year afterwards.

(i) If whole eye is stored in a moist chamber, corneal excision shall occur within 12 hours, and tissue shall be transplanted within a time period established in written policy by the tissue bank medical director and the medical advisory committee.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-7.8