Transcription of Q16 「治験における臨床検査等の精度管理に関する基本的考 …
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.
3 CAP 2. clinical laboratory improvement Amendments ( clia ) 3. JAB
