The CMS defines a well-structured competency assessment program to be inclusive of six (6) evaluation types. These can be found in the CMS's Clinical Laboratory Improvement Amendments (CLIA) and include:
- Direct observation of routine patient testing -- Watch employees perform routine work processes and procedures. This observation should include patient preparation and, if applicable, specimen handling, processing, and testing. The direct observation should include the use of a recording device (eg, a checklist) as guidance for evaluation and to document that all required procedural steps are completed.
- Monitoring the recording and reporting of test results -- Review worksheets, computer printouts, or manual test logs for results or entries that are incorrect or incomplete. The worksheets, logs, and printouts should be compared to final test reports, evaluated turnaround times, and compliance with policies and procedures.
- Review of intermediate test results, records, and proficiency testing results -- Review testing documentation, including test results or worksheets, documentation forms, QC logs, proficiency testing documentation, and other applicable documentation for completion of proper policies and procedures. Documentation of review will include follow-up of corrective action related to problems in the laboratory.
- Direct observation of instrument maintenance and function checks -- Watch employees perform instrument maintenance and function checks as compared to documentation for completeness and correctness of process and expected outcome. Record observations on the checklist for documentation of inclusion and completion of all steps.
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples -- Assessment of previously tested samples; internal blind samples, or external proficiency testing samples. Rotate proficiency testing samples among all testing personnel. Assign appropriate sets of previously tested samples or blind samples to personnel to assess the performance of testing. See the sample checklist for documentation of blind sample performance.
- Assessment of problem-solving skills -- Include a review of problem logs, incident reports, and QC failures; determine if the root cause was determined. Review corrective actions employed to resolve the problem. Personnel interviews (staff narrative) may also be included for documentation.
Again, POCT may be waived or non-waived. CMS does not require competency testing on waived testing. However, some states and accreditation agencies do include this requirement in their regulations. If the POCT is waived, performing competency assessment is good laboratory practice. The POCT coordinator or evaluator may choose which evaluation types are to be included and should document all activities performed and evaluated. If the POCT is non-waived or moderately complex, a competency assessment must be performed and documented. All six CLIA evaluation types must be included in the assessment, for each employee, for each POC test performed. See the sample generic checklist for non-waived testing, inclusive of all six evaluation types.
