The following is a list of common inspection citations due to inappropriate training and competency assessment of laboratory personnel:
- Initial Training Records -- Lack of initial training records for all test systems currently in use is not documented in individual personnel files, or documentation is incomplete.
- Competency Assessment -- Personnel records of moderate and high complexity testing personnel are not inclusive of required 6-month and 1-year post-hire competency assessments and annual assessments following the initial 1-year assessment. In addition, citations are often issued for lack of documentation of competency assessment corrective action, if required.
- Six Evaluation Types required by CLIA -- Competency assessment documentation is incomplete for the six required evaluation types:
- Direct observation of routine test performance
- Monitoring the recording and reporting of test results
- Review of intermediate test results or worksheets, quality control records, proficiency testing (PT) results, and preventive maintenance records
- Direct observation of the performance of instrument maintenance and function checks
- Assessment of test performance through testing previously analyzed samples, internal blind testing samples, or external PT samples
- Assessment of problem-solving skills
