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Title: Section 52-3.7 - Reporting requirements

Effective Date


52-3.7 Reporting requirements.

(a) The tissue bank shall have a written procedure for documenting errors or accidents in retrieval, testing, processing, storage or distribution of tissue that may affect the safety of any product. If the error or accident is not detected prior to issuance of the tissue, specimens, or test results to a hospital or other tissue bank, transplantation facility or insemination/implantation site, the error or accident shall be reported immediately to the receiving facility. All such errors shall and accidents shall also be reported to the department's Wadsworth Center within seven (7) calendar days of discovery.
(b) All New York State-licensed tissue banks that directly perform or arrange for the performance of transmissible disease testing of donors shall: (1) make the results of such testing available, upon request, to other tissue banks receiving tissue from the same donor; and (2) report, within 24 hours, all positive test results that affect donor suitability to the comprehensive tissue procurement service, if a different facility, except that positive culture results need not be reported if contamination can be traced to a specific step in tissue processing not affecting other tissues processed from the same donor. (c) The comprehensive tissue procurement service shall report significant positive test results, as determined by the medical director, to facilities receiving tissues from the same donor so that decisions on quarantining and/or physician notification may be made in a timely and appropriate manner.
(d) When requested, a tissue bank shall submit reports to the department containing such information and data concerning its activities as may be required by this Part. Such reports shall be signed by the director of the tissue bank. (e) Comprehensive tissue procurement services that terminate operations shall submit, for approval by the department, a plan for the continued storage of donor records for the minimum time periods specified in this Part.


VOLUME A-1 (Title 10)