Transcription of Q16 「治験における臨床検査等の精度管理に関す …
1 Q16 25 7 1 CAP CLIA A16 CAP College of American Pathologists CAP 1946 CAP CAP Laboratory Accreditation Program LAP CAP CAP LAP CAP CAP 21,500 2013 10 CAP LAP 2 1 CAP 700 200 CLIA Clinical Laboratory Improvement Amendments 1988 CLIA CLIA Centers for Medicare & Medicaid Services(CMS)
2 CLIA CMS 239,000 CLIA 2013 10 CLIA FDA 2 CLIA ( ) ISO15189 2003 ISO15189 - ISO15189 5,000 2005 68 ( JAB 2013 10 10 ) CLIA ISO15189 ISO15189 1. CAP 2.
3 Clinical Laboratory Improvement Amendments (CLIA) 3. JAB
