CLIA '88 Quizlet Based on Review Course slides questions with correct answers

Definition of a Laboratory under CLIA - Answer Facility for examination of human body for treatment, diagnosis, or prevention of disease or impairment Who does CLIA NOT apply to - Answer Labs regulated under NIDA, research labs, forensic labs Five types of certificates issued by CMS - Answer Waiver, PPM, Registration, Compliance, accreditation Three levels of complexity - Answer Waived, Moderate, High What changes must be reported to CMS within 30 days? - Answer Change in ownership, location, name, director, or technical supervisor What must be reported to CMA within 6 months - Answer addition, deletion, change in test. What two things must be met in addition to CLIA requirements? - Answer 1. Comply with all federal, state and local regs 2. If accredited, stay in compliance with accred agency