Moderate complexity: technical consultant evaluates competency. Source: 42 CFR 493.1413(b)(8)-(9)
High complexity: technical supervisor evaluates competency. Source: 42 CFR 493.1451(b)(8)-(9)
CMS competency brochure. Source: CMS CLIA brochures
Competency assessment is one of the most frequently cited areas in CLIA surveys, mostly because labs confuse it with training or document it incompletely. This guide explains what 42 CFR Part 493 actually requires for moderate and high complexity testing personnel, how often assessments are due, and who is allowed to sign them.
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Training shows that a person was taught to perform a test. Competency assessment shows that, after training, the person is performing the test correctly on an ongoing basis. CLIA requires both: training must be documented before a person reports patient results, and competency must be assessed on a schedule afterward. A signed training checklist alone does not satisfy competency.
For moderate complexity testing the technical consultant is responsible for evaluating competency under §493.1413(b)(8); for high complexity testing the technical supervisor is responsible under §493.1451(b)(8). Both sections list the same six procedures:
Direct observation of routine patient test performance, including patient preparation if applicable, and specimen handling, processing and testing.
Monitoring the recording and reporting of test results, including critical result reporting where applicable.
Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records.
Direct observation 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, for example through written case scenarios or verbal questioning about troubleshooting.
CMS guidance (see the CMS brochure "What do I need to do to assess personnel competency?") states that all six elements must be assessed for each test system a person uses, unless an element genuinely doesn't apply to that test; when an element doesn't apply, document why.
Under §493.1413(b)(9) and §493.1451(b)(9):
At least semiannually (every six months) during the first year the individual tests patient specimens.
At least annually after the first year.
Before reporting patient results whenever there is a change in test methodology or instrumentation, the person's performance must be re-evaluated to include the new method or instrument.
A common survey finding is a new employee who received one "annual" assessment in their first year. The first year needs two.
Moderate complexity: the technical consultant (qualified under §493.1411) evaluates and documents competency.
High complexity: the technical supervisor (qualified under §493.1449) is responsible. The regulations allow a general supervisor who meets §493.1461 qualifications to perform assessments that have been delegated in writing (§493.1463).
Delegation must be in writing, and the delegate must meet the qualification requirements for the role. Peers who lack those qualifications cannot sign off competency, even if they are experienced.
Competency of the technical consultant, technical supervisor, clinical consultant and general supervisor is also expected, based on their regulatory responsibilities (CMS interpretive guidelines in State Operations Manual Appendix C).
CLIA does not apply the §493.1413/§493.1451 competency requirements to Certificate of Waiver laboratories. Waived labs must follow manufacturer instructions (§493.15(e)), and CMS and CDC recommend training and competency checks as good practice. Accrediting organizations and some states may require competency for waived testing, so check your accreditor's standards.
Keep one record per person per test system (or per group of tests using the same system), with:
Employee name, role and test system(s) covered
Assessment type: initial six-month, first-year, annual, or method/instrument change
Each of the six elements, with the date, the evidence reviewed (for example, sample IDs or the PT event) and the assessor's initials
Elements marked "not applicable" with a reason
Overall result, plus remedial training and reassessment if anything was unsatisfactory
The assessor's name, title, signature and date, and the written delegation if applicable
Store records where you can pull them quickly. Surveyors usually sample personnel files and ask to see competency for specific tests.
Treating PT participation as the full competency assessment (PT can satisfy element 5 only)
Missing the six-month assessment for new staff
Assessors who don't meet technical consultant or supervisor qualifications
No reassessment after a new analyzer goes live
Generic "all tests" sign-offs that don't identify the test systems
myLabCompliance.io tracks personnel competency assessments, training and certification expirations, so due dates don't slip. See mylabcompliance.io/features.
Do all six elements have to be done every time?
Each assessment should address all six elements for each test system the person performs. If an element doesn't apply to a test, document why it doesn't apply.
Does an annual assessment count during the first year?
No. During the first year of patient testing, competency must be assessed at least semiannually (§493.1413(b)(9), §493.1451(b)(9)). Annual assessments begin after that.
Is proficiency testing the same as competency assessment?
No. Testing PT samples can satisfy element 5, but PT alone doesn't cover the other five elements.
Who signs competency for high complexity testing?
The technical supervisor, or a qualified general supervisor to whom the duty has been delegated in writing (§493.1451, §493.1463).
Do waived-only labs have to do competency?
CLIA doesn't require it for Certificate of Waiver labs, but CMS recommends it, and accreditors or states may require it.
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