Web2. The laboratory must enroll in a proficiency testing program for CLIA regulated analytes. The laboratory must have a method to verify non-regulated analytes at least twice a year. 3. After approximately 90 days, a Lab Examiner will contact the laboratory to schedule an on-site inspection. 4. WebReferee laboratory means a laboratory currently in compliance with applicable CLIA requirements, that has had a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test, analyte, subspecialty, or specialty and has been designated by an HHS approved proficiency testing program as a ...

Clinical Laboratory Improvement Amendments (CLIA) CMS

WebThe Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory … WebCLIA. Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure … lsu happy new year

Provider-Performed Microscopy (PPM) Procedures CDC

WebWe refer to the tests listed in Subpart I as "regulated" analytes. Review the specialty, subspecialty, and analytes listed and determine which specialties, subspecialties, and analytes you perform in your laboratory. A list of "regulated" analytes is available on pages 10-11 of CLIA Brochure #8 - Proficiency Testing. WebCLIA-exempt and accredited laboratories must permit validation and complaint inspections. As part of the process, laboratories may be required to: Test samples, including … WebThe 2014 revised consensus recognized that some models are more appropriate for certain analytes than for others, and it emphasized the importance of having high quality studies or data behind each recommendation. ... (CLIA’88 in the United States) and PT/EQA organizers are easily available and understood. Evaluation criteria are denoted as ... lsu general surgery clinic