CLIA Regulations Competency, Proficiency Testing PT and Inspections questions and answers 2024 with complete solution

2. Monitoring the recording and reporting of test results (post-analytical phase) - -can be accomplished by reviewing patient records in a lab information system (LIS), hard copy reports, or patient medical records -specific elements, such as critical value documentation, accurate RR, corrected reports, and accurate patient demographics are important to the quality of patient data and should be monitored 3. Review of intermediate test results or worksheets, QC records, PT results, and preventive maintenance (PM) records - -a method to document the review of the elements mentioned in the standard must be used to ensure that all staff are maintaining quality in the lab 4. Direct observation of performance of instrument maintenance and function checks - -in addition to the review of documentation, a specified individual is also responsible to watch staff perform instrument maintenance and function checks, which are critical to analyzer performance - ensures that all steps are performed according to the writing procedures 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external PT samples - -this requires the assessor to prepare unknown samples to be incorporated into the daily workload 6 requirements for competency - 1. direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing 6. Assessment of problem solving skills - -problems encountered include inadequate or mislabeled specimens, troubleshooting instrumentation or reagent performances, and customer complaints AABB inspection - -announced According to CLIA - -one (1) accrediting body (CMS or those approved by CMS) can inspect the lab and the lab would be in compliance with CLIA-If you are accredited by other accrediting bodies you are subject to additional inspections to meet the criteria the set for the laboratory Any non-waived test system must be addressed in a competency program - -this includes PPM and moderate- and high- complexity testing