GK CLIA Exam Study Guide

GK CLIA Exam Study Guide. CLIA does not apply - answerForensic testing, research, National Institutes on Drug Abuse certified drug testing Lab test categories - answerWaived, moderate complexity including provider-performed microscopy, high complexity CLIA categorized - answerBy FDA after approving marketing submission Test complexity - answerScored 1, 2 or 3 for seven criterion of knowledge to perform, training and experience, test preparation, operational steps, Cal/QC/PT, troubleshooting/maintenance, and interpretation FDA complexity test scores - answer<12 moderate, 12+ high complexity Certificate of registration - answerRequired for all mod and/or high complexity testing labs, valid 2 yrs Certificate of waiver - answerLab performing only waived tests Certificate for PPM - answerMod complexity PPM only Certificate of compliance - answerReplaces cert of registration when mod and/or high complexity lab meets reqs after passing CMS state inspection Certificate of accreditation - answerLab passes private accrediting agency inspection (CAP, COLA, JCAHO) Mobile labs - answerMay be covered by primary lab's certificate Local/State/Fed labs - answerLab performs limited <