[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-27241] [[Page Unknown]] [Federal Register: November 3, 1994] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Consensus Development Conference on Effect of Indirect Markers of Infectious Diseases on Blood Transfusion Safety Notice is hereby given of the NIH Consensus Development Conference on ``Effect of Indirect Markers of Infectious Diseases on Blood Transfusion Safety,'' which will be held January 9-11, 1995, in the Masur Auditorium of the National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892. The conference begins at 8:30 a.m. on January 9 and 10 and at 9 a.m. on January 11. In the approximately 50 years since the U.S. has had an organized national blood collection and distribution system, an increasing number of tests have been mandated, recommended by regulatory authorities, or adopted voluntarily to minimize the transmission of infectious diseases and make blood transfusion as safe as possible. In the last 10 years alone, blood collection agencies have implemented five new tests on all donated blood--Human Immunodeficiency Virus (HIV) antibodies (later expanded from HIV-1 to HIV-1 and -2); hepatitis B core antibody (HBcAb); serum alanine aminotransferare (ALT); antibodies to Human T-cell Lymphotrophic Virus (HTLV) 1 and 2; and, most recently, antibodies to Hepatitis C Virus (HCV). And there are pressures to add tests for emerging diseases--most recently, for example, Chagas' Disease. Most of the newer tests have been improved since they were introduced, adding to transfusion safety and reducing false positive tests and the unnecessary loss of donors. However, several of the tests that are now performed are not specific for the diseases they are targeting. Some (ALT, HBcAb) were introduced as surrogates for diseases now subject to more specific testing. Another (Serological Test for Syphilis-STS) was introduced to protect against one disease, but is being retained as much as a sign of lifestyle as for evidence of disease. The contribution some of these tests make to transfusion safety is uncertain. This issue is important if they do not, in fact, improve safety. It has become increasingly difficult to locate donors to replace those lost to false positive tests, which results in more frequent and severe blood shortages. And the cost of the tests themselves needlessly makes blood processing and blood transfusions more expensive. The purpose of this consensus conference is to evaluate the continued use of the syphilis, hepatitis B core antibody, and alanine aminotransferase (ALT) tests, as well as to examine the process for adding new infectious disease screening tests to improve transfusion safety. This conference will bring together specialists from the fields of hematology, cardiology, transfusion medicine, infectious disease, and nursing as well as representatives from the public. After 1\1/2\ days of presentations and audience discussion, an independent, non-Federal consensus panel will weigh the scientific evidence and write a draft statement that it will present to the audience on the third day. The consensus statement will address the following key questions:What are the indications for the introduction of an infectious disease screening test to improve transfusion safety and what should be the requirements of such a test? To what extent do the following contribute to transfusion safety: tests for syphilis and for hepatitis B core antibody; should they continue to be used as now or should their use be modified? To what extent does the alanine aminotransferase (ALT) test contribute to transfusion safety; should it continue to be used as now or should its use be modified? What are the appropriate ways to manage potential threats to transfusion safety from emerging infectious diseases such as, for example, Chagas' disease? What are the highest priorities for research to improve transfusion safety by reducing the transmission of infectious disease? The primary sponsors for this conference are the National Heart, Lung, and Blood Institute and the NIH Office of Medical Applications of Research. The conference is cosponsored by the Transfusion Medicine Branch of the NIH Clinical Center. This is the 99th Consensus Development Conference held by NIH since the establishment of the Consensus Development Program in 1977. Advance information on the conference program and conference registration materials may be obtained from: Debra Steward, Technical Resources International, Inc., 3202 Tower Oaks Blvd., Suite 200, Rockville, Maryland 20852, (301) 770-3153. The consensus statement will be submitted for publication in professional journals and other publications. In addition, the consensus statement will be available beginning January 11, 1995, from the NIH Consensus Program Information Service, P.O. Box 2577, Kensington, Maryland 20891, phone 1-800-NIH-OMAR (1-800-644-6627). Dated: October 26, 1994. Ruth L. Kirschstein, Deputy Director, NIH. [FR Doc. 94-27241 Filed 11-2-94; 8:45 am] BILLING CODE 4140-01-M