Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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Hepatitis B � 1967, studies at NIH showed 50% of multiply transfused cardiac patients developed transfusion associated hepatitis primarily due to commercial blood (only 7% with blood from volunteer donors) � More that 100 100,000 000 cases of post‐transfusion post transfusion hepatitis per year � HBV test developed p and licensed � 1971 NIH issued regulation requiring testing of blood donations for HBV
National Blood Policy � 1972 President Nixon called for a study and recommendation to develop a safe, fast and efficient system for blood collection and distribution � 4 goals were recognized �� Supply – adequate supply to meet needs � Quality – attainment of highest standards � Accessibility y – access to the supply pp y of blood and blood products by everyone in need � Efficiency – Efficient collection, processing, storage and untilization ili i
Page 1 and 2: Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQ
Page 3 and 4: A Horse named Jim � In 1901 a ser
Page 5 and 6: Early Regulations ‐ 1903 � Issu
Page 7 and 8: World at War � American Red Cross
Page 9: Court Cases 1960‐1970 � Violati
Page 13 and 14: Bureau of Biologics Regulation �
Page 15 and 16: HIV and the Blood Supply � 1980
Page 18 and 19: FDA Guideline � Intended to be us
Page 20 and 21: Quality Control � Several dimensi
Page 22 and 23: Quality System Essentials � 1997
Page 24 and 25: AABB Accreditation � 1998 AABB In
Page 27: Questions

Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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