Clinical Laboratory Improvement Amendments (CLIA) Exam Questions With Verified Answers.

Clinical Laboratory Improvement Amendments (CLIA) Exam Questions With Verified Answers. CLIA - answerstandards of quality, proficiency testing, and competency in the lab- 1967 CLIA standard - answeridentifies specific, essential requirements for materials, methods, or practices CLIA '88 - answerexpanded the scope of CLIA '67; labs are required to submit to routine periodic inspections; law requirements for staffing, management, procedures, and oversight of US labs that perform testing used in diagnosis, treatment, and prevention of disease in patients Government Roles in CLIA - answerSecretary of US Department of Health and Human Services - certifies labs performing non-research testing CMS administers the CLIA certification program for the Secretary along with the FDA and CDC CMS roles - answerapproves private accreditation organizations that performs inspections and approves State exemptions collects user fees conducts inspections enforces regulatory compliance issues lab certificates publishes CLIA rules/regulations monitors lab performance on proficiency testing and approves PT programs FDA roles - answerdevelops rules/guidance for CLIA complexity categorization categorizes tests based on complexity reviews requests for Wavier by Application CDC roles - answerconducts lab quality improvement studies develops/distributes professional information and educational resources