69th Meeting - June 14-15, 2001

Briefing Information

June 14, 2001

Contents   pdf

I.  Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results

A.  Introduction, Background, Paul A. Mied, PhD, Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR, FDA

Reentry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results   pdf

Attachment 1, NAT Testing Algorithm for Whole Blood    pdf

Attachment 2, Reentry for Donors Deferred Because of HIV Test Results   pdf

Attachment 3, Reentry for Donors Deferred Because of HCV Test Results   pdf


B. Presentation - Michael Busch, MD, PhD, Blood Centers of the Pacific, CA   ppt   html

D. Presentation - Susan Galel, MD, Stanford University   pdf

II.  CLIA Criteria for In Vitro Diagnostic Tests:  Applicability of Waivers to HIV Rapid Tests

B.  Historical Overview of CLIA Waivers - Thomas Hearn, PhD, CDC   pdf

Clinical Laboratory Improvement Advisory Committee, June 14, 2001, Lee Richardson pdf   html

Public Health Service; CLIA Program; Categorization of Waived Tests, September 13, 1995, 60FR47534     pdf   txt

Guidance for Clnical Laboratory Improvement Amendmends of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA Applications   html

Overview of FDA Draft Guidance for CLIA Criteria for Waiver, Joseph Hackett, PhD, DCLD, ODE, CDRH   pdf

Requirements for Moderate Complexity Tests and HCFA Experience with CLIA Waived Tests in the Laboratory - Judith Yost, HCFA   pdf

III. Revision of the Uniform Donor History Questionnaire - Informational Presentation

Overview and Introduction - Alan Williams, PhD, Director, Division of Blood Applications   pdf

Update on AABB Task Force Programs - Joy Fridey, MD, AABB   pdf

May 8, 2001 Letter to Jay Epstein, MD, Director, Office of Blood Research and Review from Joy L Fridey MD   pdf

Attachment 1 to May 8, 2001 letter   pdf

Attachment 2 to May 8, 2001 letter   pdf


Presentation of Proposed Modifications to Uniform Donor History Questionnaire - Susan Orton, MD, ARC   pdf

Association Bulletin #99-10, New Uniform Donor History Questionnaire Issued, Dated December 2, 1999   pdf

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