BLOOD PRODUCTS ADVISORY COMMITTEE
69th Meeting - June 14-15, 2001
Gaithersburg Hilton, 620 Perry Parkway
Gaithersburg, MD 20877
Thursday, June 14, 2001
8:30 a.m. Statement of Conflict of Interest
8:35 a.m. Welcome and Opening Remarks
8:40 a.m. Committee Updates
9:00 a.m. Open Committee Discussion
I. Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results
A. Introduction and Background - Paul A. Mied, Ph.D. Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR
B. Presentation - Michael Busch, M.D., Ph.D.,Blood Centers of the Pacific, CA
C. Presentation - Susan Stramer, Ph.D., American Red Cross
D. Presentation - Susan Galel, M.D., Stanford University
10:15 a.m. OPEN PUBLIC HEARING
10:45 a.m. BREAK
11:00 a.m. Open Committee Discussion
E. Questions for the Committee
F. Committee Discussion and Recommendations
12:30 NOON LUNCH
1:30 p.m. Open Committee Discussion
II. CLIA Criteria for In Vitro Diagnostic Tests: Applicability of Waivers to HIV Rapid Tests
A. Introduction and Background - Elliot Cowan, Ph.D. DETTD, OBRR, CBER
B. Historical Overview of CLIA Waivers - Thomas Hearn, Ph.D., CDC
C. Overview of FDA Draft Guidance for CLIA Criteria for Waiver - Joseph Hackett,Ph.D., DCLD, ODE, CDRH
D. Public Health Strategic Goals for HIV Testing - Ida Onorato, M.D., CDC
E. Requirements for Moderate Complexity Tests and HCFA Experience with CLIA Waived Tests in the Laboratory - Judith Yost, HCFA
F. FDA Perspectives on CLIA Waiver of Rapid HIV Tests and Questions for the Committee - Elliot Cowan, Ph.D., DETTD,OBRR, CBER
2:30 p.m. OPEN PUBLIC HEARING
3:00 p.m. Open Committee Discussion
G. Committee Discussion and Recommendations
4:00 p.m. BREAK
4:15 p.m. Open Committee Discussion
III. Revision of the Uniform Donor History Questionnaire - Informational Presentation
A. Overview and Introduction - Alan Williams, Ph.D. Director, Division of Blood Applications
B. Update on AABB Task Force Programs - Joy Fridey, M.D.,AABB
C. Presentation of Proposed Modifications to Uniform Donor History Questionnaire - Susan Orton, M.D. ARC
4:45 p.m. OPEN PUBLIC HEARING
5:00 P.M. Open Committee Discussion
D. Committee Discussion and Recommendations
5:30 p.m. RECESS (until 8:30 a.m., Friday, June 15, 2001)
Friday, June 15, 2001
8:30
a.m. Committee Updates9:00 a.m. Open Committee Discussion
IV. Transfusion-Related Acute Lung Injury - Informational Presentation
A. Introduction and Background - Leslie Holness, M.D., Medical Officer, Division of Blood Applications
B. Presentation - Mark Popovsky, M.D., Haemonetics Corp.
C. Presentation - Patricia Kopko, M.D., Sacramento Blood Center
D. Presentation - Lynn K. Boshkov, M.D., Oregon Health Sciences University
E. Presentation - John Finlayson, Ph.D., Associate Director for Science, OBRR
10:15 a.m. OPEN PUBLIC HEARING
10:45 a.m. BREAK
11:00 a.m. Open Committee Discussion
F. Committee Discussion and Recommendations
11:45 a.m. LUNCH
12:45 p.m. Open Committee Discussion
V. Studies on Leukoreduction Filtration Failures
A. Introduction and Background - Betsy Poindexter, Biologist, Lab. of Cellular Hematology, DH B. Presentation - Constance Noguchi,Ph.D., NIH
C. Presentaton - Thomas Walker, M.D., Canadian Blood Services
D. Presentation - Rebecca Haley, M.D., American Red Cross
E. Presentation - Cheri Jennings, Gulf Coast Blood Center
F. Presentation - Glenda Ford, Oklahoma Blood Institute
1:45 p.m. OPEN PUBLIC HEARING
2:15 p.m. Open Committee Discussion
G. Committee Discussion and Recommendations
2:45 p.m. VI. Report of the Intramural Site Visit of the Laboratory of Plasma Derivatives, Division of Hematology, OBRR
A. Introduction and Overview
- Neil Goldman, Ph.D., Associate Director for Research, CBER
- John Finlayson, Ph.D., Associate Director for Science, OBRR
- Basil Golding, M.D., Chief, Lab. of Plasma Derivatives, DH
3:15 p.m. Closed Committee Deliberations
B. Committee Discussion and Recommendations
3:45 p.m. Adjournment