SECTION G - LABELING
G3.000 LABELING INFORMATION
G3.200 Summary of Records and Package Insert
G3.210 Summary of Records Content
A Summary of Records is required when donor suitability determination has been completed and shall include:
1) A statement that the tissue was prepared from a donor determined to be suitable based on the results of screening and testing. All results of relevant communicable disease tests performed on specimens from the donor and used for release of tissue shall be listed Relevant tests include those tests that are required (see D4.354 Required Infectious Disease Tests). If a test for anti-HTLV I and/or anti-HTLV II was performed it must be reported. To clarify expectations and to offer an example, the CMV test result used must be listed for reproductive tissue; and
2) A statement that the communicable disease testing was performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS); and
3) The name and address of the establishment that made the donor suitability determination.
(R) A statement noting the reason for the determination of ineligibility in the case of a cell or tissue from a donor who is ineligible based on screening and/or testing.
Published date: November 11, 2009 (AATB News Release)
Effective date: At the discretion of the Tissue Bank