2024 - eCompliance Series - Preparing for the CLIA Inspection-CLIA: Performance Specs for Labs (Video)

Video Transcription

Video Summary

The video features Bridget Smedrick, the Director of CLIA Compliance for Doctors Management. She has a background in biology and chemistry and has over two decades of laboratory experience. Doctors Management is a medical practice management and consulting firm that offers services to large and small medical practices. The video focuses on the learning objectives of implementing new non-waved testing using precision, accuracy, reportable range, reference range, calibration, and calibration verification according to CLIA and COLA requirements. The importance of accuracy, precision, reportable range, and reference range in laboratory testing is discussed. Differences between CLIA and COLA regulations regarding accuracy, precision, and reportable range studies are explained. The process for introducing a new instrument into a test system is outlined. Calibration verification is defined, and its importance in maintaining accurate test results is emphasized. The video concludes by discussing the evaluation of performance specifications for qualitative tests and non-FDA approved tests.

Keywords

Bridget Smedrick

CLIA Compliance

Doctors Management

laboratory testing

calibration verification