Competency is the ability of personnel to apply skill, knowledge, and experience to perform their work duties correctly. Competency assessment ensures that laboratory personnel fulfill job activities as federal regulation requires.
For testing personnel conducting moderate and/or high-complexity testing, an initial competency assessment is performed after orientation and training. It will occur at 6 months, 12 months, and annually after that. While competency assessment of testing personnel performing only waived testing is not required by CLIA, it represents good laboratory practice. Specific state regulations and some accreditation agencies require it.
CLIA has defined six (6) procedures that encompass the minimal regulatory requirements for the assessment of competency of all personnel performing moderate and high complexity laboratory testing:
- Direct observations of routine patient test performance, including patient preparation (if applicable), specimen handling, processing, and testing;
- Monitoring the recording and reporting of test results;
- Review of intermediate test results or worksheets, QC records, proficiency testing results, and preventive maintenance records;
- Direct observations of the performance of instrument maintenance and function checks;
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples; and
- Assessment of problem-solving skills.
If your laboratory is subject to the CLIA regulations, either directly or indirectly through your accrediting agency, all of these elements for each(moderate and/or high complexity) test system must be included when assessing the competency of personnel who perform the testing.
Each of the six methods must be tagged with an appropriate assessment tool. Examples of tools include:
- Checklists
- Quizzes or exams
- Case studies
- Wet samples (e.g., includes controls, calibrators, proficiency test samples)
- Blind testing of samples
Checklists are ideal for direct observation of test performance or instrument maintenance.
Previous test results or records, including log sheets, test reports, and proficiency testing records, may be reviewed to assess test performance.
Quizzes or exams may be appropriate for problem-solving skills. These written assessment tools may include higher-level question types, such as case studies, questions asking to synthesize methods or problem-solving maps.
Wet samples are appropriate for the evaluation of test performance. Is the individual performing the test “getting the right answer?”
What steps should be taken if the “right answers” are not obtained? The individuals who exhibited deficiencies should be remediated using the following steps:
- Remove the staff member(s) from testing.
- Retrain the staff.
- Observe that the retraining has been effective with an alternate competency activity
- Reinstate the end user to testing.
- Document the remediation process, and that success was achieved.
