Blood Safety, Minimizing Plasma Product Risks: Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, Second Session, September 9, 1998U.S. Government Printing Office, 1999 - 174 pages |
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ABRA Alpha America's Blood Centers American Red Cross Applicant Donor ARCNET assurance Baxter blood and plasma blood donors blood products blood safety blood supply BOYLE BULT Centeon centers cGMP Chairman Christopher Shays committed Committee companies compliance consent decree continue disease donor pool donor screening Donor standard facilities Factor VIII FRIEDMAN GAO report hemophilia hepatitis IGIV immune deficiency immune globulin implementation improve infectious agents inspection inventory hold IPPIA Statement IPPIA Voluntary Initiatives issues IVIG manufacturing practices marker rate standard paid donors patients percent plasma collection plasma derivatives plasma donors plasma fractionation plasma industry plasma pool plasma safety potentially infectious problems Qualified Donor recombinant factor recommendations recovered plasma regulatory REILLY response risk safety of plasma SHAYS shortages SNOWBARGER source plasma Subcommittee testing transfusion viral inactivation viral marker rates virus viruses Voluntary Initiatives Presenation volunteer donors whole blood window period
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Page 42 - These activities are administered through the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the...
Page 75 - DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE ON GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES JUNE 4, 1992 FOR RELEASE ONLY UPON DELIVERY Good Morning Mr.
Page 34 - GAO evaluated this first step to determine the risk of infectious agents including human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis c virus (HCV) from unpaid versus paid donors being incorporated into the manufacturing process.
Page 24 - Thank you for the opportunity to appear before you today, and I look forward to answering your questions. [The prepared statement of Mr.
Page 35 - Available at www.cdc.gov/hiv/stats/ hasrl201.htm. 5. Kleinman S, Busch MP, Korelitz JJ, Schreiber GB. The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection. Transfusion Med Rev 1997; 11(3): 155-72.
Page 15 - ... another donation as being positive.5 Thus, potentially infectious units from these donors could be incorporated into a plasma pool for manufacturing. HIV incidence rates are 19 times higher for paid donors than for volunteer donors; HBV and HCV rates are 31 times and 4 times higher, respectively. 2 Antibody tests detect antibodies that the human body produces in its immune response to a virus; antigen tests detect a part of the actual virus. Because it takes time for the body to develop antibodies,...
Page 21 - This concludes my prepared statement, Mr. Chairman. I will be happy to respond to any questions that you or Members of the Subcommittee may have.
Page 5 - I ask unanimous consent that all members of the subcommittee be permitted to place any opening statement in the record and the record remain open for 3 days for that purpose.
Page 140 - Ms. FINLEY. I think the question that I am trying to get at is not necessarily the load in the pool but rather the confidence that you would have in the qualified donor program. Isn't that in fact a reflection of the improvement in the viral marker rate in qualified donors versus the applicant donors who have not been qualified? Mr. REILLY. We are looking at or we are in the middle of establishing a viral marker rate of qualified donors that each facility would be measured against so that the facility...
Page 162 - Chairman and members of the subcommittee, for this opportunity to present our views.