CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
CLIA (Clinical Laboratory Improvement Amendments) has updated its requirements for QC and QA. CLIA has replaced the term Quality Assurance with the term Quality Assessment the new guidelines regarding QA specifically stress measuring quality through all aspects of the testing process. This includes pre-analytical, analytical, and post-analytical parts of the process as a whole. QA is now focused on measuring outcomes and developing actions based on findings. The Quality Control process has guidelines in place for all three levels of testing; Waived, Moderately Complex and High Complexity. We will explore the differences and the proper methods to meet the guidelines.
Areas Covered in the seminar:
- Quality Assurance vs. Quality Assessment: Why the Change?
- The Three Phases of Testing.
- Quality Assessment Systems That Work.
- Quality Control: Principles and Practice.
- QC for Waived Testing: Is Minimum Enough?
- QC Formulas and Their Use.
Who will benefit:
This webinar will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.All automated non-waived systems fall under these regulations. Employees who would benefit include:- Chemistry and special chemistry supervisors and techs.
- Hematology and coagulation supervisors and techs.
- Blood bank supervisors and techs.
- Microbiology (automated) supervisors and techs
Instructor Profile:
Barry Craig, is the founder and CEO of Laboratory Consulting, LLC, a consulting firm dedicated to the clinical laboratory. The company works with medical laboratories, research facilities, and physician office laboratories. They currently manage over 35 POLs.