Competency is the ability of personnel to apply skill, knowledge, and experience to correctly perform their work duties. Competency assessment ensures that laboratory personnel are fulfilling job activities as required by federal regulation.
For testing personnel conducting moderate and/or high complexity testing, initial competency assessment is performed at the completion of orientation and training. Competency assessment will then occur at 6 months, 12 months, and annually thereafter. While competency assessment of testing personnel performing only waived testing is not required by CLIA, it represents good laboratory practice and is required by certain state regulations, as well as some accreditation agencies.
CLIA has defined six (6) procedures that encompass the minimal regulatory requirements for 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 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 competency of personnel who perform the testing.
Each of the six methods must be tagged with an appropriate assessment tool. Examples of tools include:
- Quizzes or exams
- Case studies
- Wet samples (eg, includes controls, calibrators, proficiency test samples)
Checklists are ideal for direct observation of test performance or instrument maintenance.
Review of previous test results or records, to include log sheets, test reports, and proficiency testing records may be utilized for review of previous test results or assessment of 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 or questions asking for synthesis of methods or problem-solving maps.
Wet samples are appropriate for evaluation of test performance. Basically, is the individual who is 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.