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ASRM BULLETIN
Volume 9, Number 6
March 15, 2007
FDA Guidance On Donor Eligibility Testing
FDA has issued a Guidance concerning donor eligibility test methodology for Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens of Diagnostic Tests- effective February 24, 2007.
This Guidance relates to reproductive tissues and has implications donor eligibility determinations. Action may be required if your donor testing procedures have not been in compliance with the regulations in 21 CFR 1271. Please view the Guidance at
http://www.fda.gov/cber/gdlns/hctppool.htm
The following is a summary of some of the requirements described in the Guidance, intended to assist your understanding. It is not the Guidance document, itself, nor a substitute for the Guidance.
I. New donors:
Donors tested after February 24, 2007 must be tested using appropriate donor screening tests. If NAT (nucleic acid amplification technology) testing is used, specimens must NOT be pooled.
II. Donors previously tested, whose tissue has been transferred or remains in storage:
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If your practice or your testing lab used diagnostic tests or pooled NAT tests to conduct testing required under 21 CFR 1271 C on donor tissues collected on or after May 25, 2005, you will need to attempt to re-test the donors using appropriately cleared, licensed, or approved donor screening tests in accordance with the test manufacturer’s recommendations prior to distributing or transferring any of these tissues.
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If you conduct some or all of your donor-eligibility determination in-house, you must determine whether inappropriate testing using diagnostic tests or pooled NAT tests was performed to determine donor eligibility since May 25, 2005. If this did happen, you need to identify the donors affected, quarantine their tissue, and attempt to re-test the donors using appropriate tests. You will also need to identify any transfer of tissue from these donors.
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If you use an outside laboratory for your infectious disease testing, that laboratory is required to inform you if they used inappropriate testing methods. If the contract lab tells you that any of your donors are affected, you must identify the donors, quarantine their tissue, and attempt to retest the donors using appropriate tests. You will also need to identify any transfer of tissue from these donors. Even though your contract lab is required to notify you, it is recommended that you formally request this investigation from them.
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It is very important to fully document the investigations and the re-testing of donors. Tissue from directed and anonymous donors who were not properly tested must not be transferred to a recipient until after the donor has been re-tested according to the correct method and found negative for infectious disease.
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An exception to this, however, is made for embryos created for a sexually intimate couple using a third party gamete donor. If it is not feasible to re-test the donor in this situation, FDA will exercise enforcement discretion regarding distribution of these tissues. The establishment must include the reason re-testing could not be performed in the records accompanying the tissue and in related files. The HCT/P must be labeled “Warning: Advise patient of communicable disease risks” and qualifiers regarding the testing deficiencies must be included in the summary of records. The establishment must also document that the tissue recipient’s physician was notified of the results of the testing and screening and of the labeling requirements.
The ASRM Bulletin is published by ASRM's Office of Public Affairs to inform Society members of important recent developments. Republication or any other use of the contents of the Bulletin without permission is prohibited. To request permission to quote or excerpt material from the Bulletin, contact Sean Tipton at
stipton@asrm-dc.org.
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