Blood Safety Correspondence

Followup

DATE: February 8, 1999

TO: Interested Parties

FROM: Stephen D. Nightingale, M. D., Executive Secretary
Advisory Committee on Blood Safety and Availability

SUBJECT: Recommendations of Advisory Committee on January 28, 1999 - Followup 8/3/00

1. The Advisory Committee recommends that targeted lookback should be initiated based on a repeatedly reactive EIA-1 test result on a repeat donor unless

A. a supplemental test result was performed and did not indicate significant risk of HCV infection;

B. no supplemental test result is available, but the signal to cutoff ratio of the repeatedly reactive EIA-1 test was less than 2.5; or

C. followup testing is negative.

See at www.fda.gov/cber/guidelines.htm:

Draft Guidance to Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV): Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV) - June 17, 1999.

2. The Advisory Committee believes that, in light of the scope of the hepatitis C epidemic, current funding is inadequate for notification, testing, counseling, education, and therapy. We urge the Secretary to take immediate measures to increase funding to meet this major public health challenge. We further urge the Public Health Service to work with professional and private organizations to promulgate appropriate recommendations for testing, counseling, and therapy, and to secure additional resources for these purposes.

Discussions over reimbursement issues continue at many levels. Reimbursement for outpatient use of plasma derivatives is specified in the April 7, 2000 HCFA Final Rule on Hospital Outpatient Prospective Payment Systems. A conference titled "Identifying and Managing Transfused Patients with Hepatitis C in the 21^st Century" was held in Washington, D.C. on February 27 and 28, 2000 to discuss collaborative efforts with professional and private organizations on hepatitis C testing, counseling, and therapy.

3. The Advisory Committee urges the Secretary to consider providing appropriate support and resources for blood centers and hospitals, both public and private, to conduct HCV lookback activities.

SDN August 3, 2000

Last Revised: October 27, 2003

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