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Blood Safety Recommendations - August 1997

DATE: August 18, 1997

TO: Interested Parties

FROM: Stephen D. Nightingale, MD, Executive Secretary
Advisory Committee on Blood Safety and Availability
SNIGHTIN@OSOPHS.DHHS.GOV

SUBJECT: COMMITTEE RESOLUTION OF AUGUST 12, 1997

The resolution on the following page was approved by the Advisory Committee on Blood Safety and Availability on August 12, 1997 by a vote of 12 to 0, with one member abstaining and the Chairman not voting. As is documented in the transcript of the meeting of this Committee, the resolution was approved with the understanding of the members that it was subject to minor revision by the Committee Chairman and the Executive Secretary for grammar and clarity. There were two such revisions; each was submitted to each member of the Committee who voted on the resolution. The language on the following page is the second revision; this language was approved by 10 of the members of the Committee who voted on the resolution and by the Committee Chairman. Two of the members who voted were unable to respond to either revision within 48 hours after it was submitted to them.

Please note that this document is a recommendation by an independent committee whose mandate is to advise the Department of Health and Human Services; this document is not the official policy of the Department of Health and Human Services. This document is, however, under active review by the Department, and a response to it is currently being developed.

RESOLUTION

Hepatitis C virus (HCV) is a major cause of chronic liver disease which can progress to cirrhosis and liver failure in some infected persons, usually over the course of 20 or more years. An estimated 4 million Americans have been infected with HCV, of whom about 7% may have acquired their infection from blood transfusion, most before 1992. The first donor screening test for HCV infection was introduced in 1990, and an improved second generation screening test was introduced in 1992. Since 1992, the availability of a confirmatory test has made possible the more precise identification of persons who may have been infected with HCV, and it has become apparent that

1. Many HCV-infected persons are unaware of their infection because it may remain silent for many years;

2. Persons with HCV infection may benefit from treatment or behavioral interventions.

In view of these considerations and the Committee's belief that persons who may have received blood or blood components from an HCV-infectious donor should be notified of the risks associated with transfusion of the blood or blood components they received, we recommend to the Secretary of Health and Human Services the following:

1. a program to educate providers of medical care regarding the importance of identification of persons at risk for HCV infection, including those who received blood or blood components prior to 1992, and the appropriate measures for prevention, counseling, diagnosis, and treatment;

2. an aggressive and sensitive public education campaign to notify and test recipients transfused prior to 1992;

3. a targeted lookback program triggered by donors detected as HCV-confirmed positive by second generation screening and supplemental testing (1992 and after). This lookback should extend to January 1987 or 12 months prior to the donor's most recent negative second generation HCV test and should include tracing

a. recipients of blood or blood components from HCV-confirmed positive donors who had previously tested negative by a second generation test for HCV infection between 1992 and the present;

b. recipients of blood or blood components from HCV-confirmed positive donors who had previously tested negative by a first generation test for HCV infection between 1990 and1992; and

c. recipients of blood or blood components from HCV-confirmed positive donors who had no prior HCV test.

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