Competency confirms the effectiveness of training. Assessment of competency is an evaluation of training and verifying that training is applied to test performance.
Competency assessment should include policies and procedures outlining the process for performing an evaluation of competency. As with all policies and procedures, the laboratory director must approve the process at the inception and following any major revision. All reviews and approvals are documented with signatures and dates. All policies and procedures must be periodically reviewed, annually or every two years (biennially), depending on regulatory and accrediting requirements, by the laboratory director or designee and this review documented with date of review.
As with initial training, each employee that performs non-waived POCT must have competency assessed and documented at the completion of training and prior to performing patient testing. It is good laboratory practice to also include waived POCT. To align with compliance, the documentation tool must include the six CLIA required procedures (shown in the table). The documentation must be retained for each procedure the employee performs. If there is a change in test method or a new test added, initial training and assessment of competency must be completed and documented. This documentation is signed by the laboratory director or designee and represents approval to perform the testing method(s) on which the competency assessment has been successfully completed.
For each employee performing non-waived testing, ongoing competency assessment must be completed at designated intervals for each test method that the employee performs. For CLIA compliance, competency must be assessed for each non-waived POCT at six months and 12 months following initial training and assessment annually thereafter. Ongoing competency assessment is not required for waived testing methods; however, as previously mentioned, good laboratory practice may include ongoing competency assessment for all test methods.
All competency assessment is documented and the documentation retained for a minimum of two years. Competency assessment of waived methods is not required for CLIA compliance, but may be required for compliance with state or accreditation agency regulations. Competency assessment for all test methods for all employees represents good laboratory practice.
Evaluation of competency should include pre-analytic, analytic, and post-analytic phases of testing. For minimum compliance with regulatory agencies, six procedures must be included within the competency assessment process for all employees performing non-waived POCT testing. These six procedures include:
- 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, quality control 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.
- Assessment of problem solving skills.
Each of the required procedures will not be appropriate for every activity in a comprehensive competency assessment program. The procedures are applied as appropriate, evaluated with an appropriate assessment tool, results evaluated, reviewed with the employee, and documentation is retained.
Tools employed for competency assessment may include items such as checklists (for direct observation), case studies (problem solving), quizzes (problem solving), unknown sample testing (test performance), review of retained records, proficiency testing results, and any other appropriate mechanism for assessment of competency. Refer to the table outlining possible competency tools for each required procedure.
If results of any assessment are unsatisfactory, the employee should cease testing, remediation must be completed, the activity reassessed, and competency demonstrated prior to returning to resumption of performing patient testing.
Remediation may include retraining, additional practice with the process or procedure, observation of other employees completing the unsuccessful activity, and any other appropriate remediation steps, followed by reassessment of competency. If the employee is unable to be remediated, a reassignment of job tasks may be warranted.
