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The Six Elements of CLIA Competency Assessment
CLIA competency assessment has six required elements. They are direct observation of testing; monitoring result recording and reporting; review of worksheets and QC, PT and maintenance records; observation of maintenance and function checks; testing blind or previously analyzed samples; and assessing problem solving. Assess twice in the first year, then annually (42 CFR 493.1413, 493.1451).
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
Key facts and official sources
Moderate complexity: the technical consultant evaluates competency. Source: 42 CFR 493.1413(b)(8)-(9)
High complexity: the technical supervisor evaluates competency. Source: 42 CFR 493.1451(b)(8)-(9)
The lab must have written competency assessment policies. Source: 42 CFR 493.1235
What is the difference between training and competency assessment?
Training shows that a person was taught to perform a test. Competency assessment shows that the person continues to perform it correctly. CLIA requires both. A signed training checklist is not a competency assessment.
What are the six elements of CLIA competency assessment?
Both §493.1413(b)(8) and §493.1451(b)(8) list the same 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.
Review of intermediate results or worksheets, QC records, PT results and preventive maintenance records.
Direct observation of instrument maintenance and function checks.
Testing previously analyzed specimens, internal blind samples or external PT samples.
Assessment of problem-solving skills, for example through case scenarios or troubleshooting questions.
Assess all six for each test system the person uses. If an element genuinely doesn't apply to a test, document why.
How often is competency assessment required?
At least semiannually during the first year the person tests patient specimens.
At least annually after that.
Before reporting patient results after any change in test methodology or instrumentation.
A common survey finding is a new employee who received only one assessment in the first year.
Who can perform competency assessments?
Moderate complexity: the technical consultant.
High complexity: the technical supervisor. The director or technical supervisor may delegate evaluating and documenting competency to a qualified general supervisor (§493.1463(b)).
Delegation must be in writing, and the delegate must be qualified for the role. Experienced peers without those qualifications can't sign off competency.
Is competency required for waived testing?
CLIA's six-element requirements in §493.1413 and §493.1451 do not apply to Certificate of Waiver labs. Waived labs must follow the manufacturer's instructions (§493.15). Accreditors can require more. For example, The Joint Commission standard WT.03.01.01 requires waived-testing competency to be assessed using at least two of these four methods per person per test, at orientation and at least annually:
testing a blind specimen
observation of routine work
monitoring the person's QC performance
a written test specific to the test
What does a survey-ready competency record include?
The person, their role, and the test systems covered.
The assessment type: first 6-month, first-year, annual, or method change.
Each of the six elements, with the date, the evidence used (sample IDs, PT event) and the assessor's initials.
"Not applicable" entries, each with a reason.
The result, with any remedial training and reassessment.
The assessor's name, title, signature and date, and the written delegation if one applies.
What are common competency mistakes?
Treating PT as the whole competency assessment. PT only satisfies element 5.
Missing the 6-month assessment for new staff.
Assessors who don't meet the TC or TS qualifications.
No reassessment after a new analyzer goes live.
Generic "all tests" sign-offs.
Frequently asked questions
Do all six elements have to be done every time?
Yes. Each assessment should cover all six elements for each test system, with a documented reason for any element that doesn't apply.
Does an annual assessment count during the first year?
No. The first year needs at least two assessments.
Is proficiency testing the same as competency assessment?
No. Testing PT samples can satisfy element 5 only.
Who signs competency for high complexity testing?
The technical supervisor, or a qualified general supervisor with written delegation.
Do waived-only labs have to assess competency?
CLIA does not require it for Certificate of Waiver labs. Accreditors such as The Joint Commission, and some states, do.
Related guides
Need help with competency?
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