2024 - eCompliance Series - Preparing for the CLIA Inspection-CLIA: Getting Started with CLIA (Video)

Video Transcription

Video Summary

The video is a presentation on Getting Started with CLIA (Clinical Laboratory Improvement Amendments). The presenter, Bridget Smedrick, is the director of CLIA Compliance for Doctors Management. Doctors Management is a medical practice management and consulting firm. The objectives of this session are to understand the basic aspects of CLIA, the differences in CLIA certificates, how to obtain a CLIA certificate, and an overview of CLIA requirements. CLIA is a regulatory framework enforced by the Centers for Medicare and Medicaid Services to ensure quality patient care in laboratory testing. CLIA covers all laboratory testing on human specimens except forensic testing and skin testing. There are five types of CLIA certificates: Certificate of Waiver, Certificate of Provider Performed Microscopy Procedures, Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation. Each certificate has specific requirements and responsibilities. The presentation also discusses the personnel requirements for moderate and high complexity laboratories, state laboratory laws, confidentiality and security, specimen handling and collection, calibration and control procedures, proficiency testing, test request procedures, performance specifications, quality assessment, record retention, and surveys. The presenter emphasizes the importance of following manufacturer instructions and maintaining compliance with CLIA regulations.

Keywords

CLIA

Clinical Laboratory Improvement Amendments

Bridget Smedrick

Doctors Management

CLIA certificates

laboratory testing