The CLIA regulations require competency assessments. According to CMS, "competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. Competency assessments are used to ensure that laboratory personnel are fulfilling their duties as required by federal regulation."
A competency assessment involves:
- Directly observing routine patient test performance
- Monitoring the recording and reporting of test results
- Reviewing intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
- Directly observing the performance of instrument maintenance and function checks
- Assessing test performance through testing previously analyzed specimens or testing samples
- Assessing problem-solving skills
A technical supervisor assesses the competency of their laboratory staff. According to CLIA regulations, assessments must be completed twice in the first year of employment and once yearly afterward.
