Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...
Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...
Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...
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FDA Guideline<br />
� Intended to be used in conjunction with applicable<br />
federal standards in 21 CFR<br />
� P Parts 6 600 through h h 68 680<br />
� Parts 210 and 211<br />
�� Establishments performing laboratory testing must also<br />
comply with 42 CFR Part 493 (CLIA requirements)<br />
� Standards for laboratory personnel, quality control,<br />
proficiency f testing, patient test management and d QA
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