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

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Blood Bank Growth � 1937 Cook County in Chicago established the first “blood bank” � M May 3, 1946 fi first li license iissued d to the h Phil Philadelphia d l hi Blood Bank �� 1947 AABB formed � 1947 start of early blood regulation �� Safety of the donor � Free from disease transmissible by blood � Donor history, physical and clinical tests
Court Cases 1960‐1970 � Violations included extending the expiration date and shipping unlicensed products �� Guilty of misbranding and false labeling � Blood is a drug under the FDC Act � Blood is a biologic g analogous g to therapeutic p serum � Court of Appeals ruled that Whole Blood citrated and Red Blood Cells are not analogous to a therapeutic serum – blood is a drug but not a biologic under the current definition � 1970 97 Congress g modified the definition of biologic g to include “blood, blood components or derivatives”
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: World at War � American Red Cross
Page 11 and 12: National Blood Policy � 1972 Pres
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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