All competency assessments must be documented. The use of appropriate tools must be incorporated into the assessment process. Specific information related to the specific assessment, documented review, and approval by required staff members must be included on all documents to provide a complete document. All documentation is retained in the personnel file of each testing personnel.
Documentation of competency assessment is to be trackable and traceable. A checklist that merely checks off each test method is not sufficient. Each assessment requirement must be documented for each test method (refer to the six CLIA evaluation types). Direct observation checklists for specific methods/test kits may be incorporated into the evaluation process as additional documentation or a compiled evaluation form that includes the six evaluation types as applied to specific test methods may be used. (See an example of a combined evaluation form).
Assessment of competency for each testing personnel can be performed throughout the12 month evaluation period (or six months, if appropriate) or another period that the assessment covers. The competency assessment may also include a retrospective review from the inclusive evaluation period. Coordinating the competency assessment program in routine workflow and procedures will minimize the impact on workload. The final document will include all completed tasks with details and dates.
Each form should include testing personnel demographics and specific details, such as:
- Demographics:
- Name of testing personnel
- Completion date of competency assessment
- Name and title of assessor
- Date of assessment
- Form elements:
- Title
- Space for sample identification of split samples, proficiency testing, medical record numbers, or dates of review of records
- Determination of competency:
- Signature/date of supervisor
- Signature/date of individual performing competency assessment (if different from the supervisor)
- Signature/date of employee – Include a statement of competency by the supervisor and the employee (shown below)
- Supplemental documentation to be included with the form (eg, graded test/quiz, completed case study evaluation)
Example Competency Statement:
(Employee sign/date)___________ certify that I am fully trained and competent to perform the roles listed above. (Assessor sign/date)___________ attest that the staff member listed above is fully trained and competent to perform the roles listed above.
