CLIA competency assessment: who, when and what counts

What are the six procedures?

1. Direct observation of routine patient test performance, including patient preparation if applicable, specimen handling, processing and testing.
2. Monitoring the recording and reporting of test results.
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records.
4. Direct observation of performance of instrument maintenance and function checks.
5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
6. Assessment of problem solving skills.

All six apply to every test system a person is approved to perform. For provider-performed microscopy, the fourth does not apply. The record form is CA-02 Testing Personnel Assessment Form.

How often is competency assessed?

At least twice in the first year a person tests patient specimens, and at least once a year after that. The first-year assessments are semiannual, so the first falls no later than six months after the person began patient testing.

When a test method or instrument changes, the person is assessed on the new one before reporting patient results from it.

The due-date calculator works the dates out from a start date.

Who is allowed to perform the assessment?

Moderate complexity: the technical consultant. Someone else may do it only if they meet the technical consultant qualifications.

High complexity: the technical supervisor, who may delegate the task in writing to a general supervisor who meets the qualification requirements.

Provider-performed microscopy: the laboratory director.

A person who does not meet those qualifications should not perform or sign assessments, however experienced they are at the bench. The laboratory director remains responsible for seeing that assessments are done.

Does a delegation have to be in writing?

Yes. Keep a signed and dated delegation that names the person, the duties delegated and the test systems covered. Surveyors ask for it when an assessment is signed by anyone other than the technical consultant or technical supervisor. The form is CA-04 Delegation of Competency Assessment.

Is competency assessment required for waived tests?

Not by CLIA. The federal requirement applies to moderate and high complexity testing and to provider-performed microscopy. Many states and accreditation organizations do expect it for waived testing, and CMS describes training and periodic observation as good laboratory practice, so check the rules that apply to your site.

Is a signed checklist enough?

A signature alone does not show what was done. The record should show, for each of the six procedures, how it was assessed, the date, who assessed it and what was reviewed, for example the specimen or record identifiers looked at. One line that reads "competent" for the year is the pattern that gets cited.

Is it done per analyte or per test system?

Per test system. Where one platform runs many analytes, the platform is assessed, and any test on it with unique steps or known problems is assessed on its own. Write your definition of each test system into the policy so you can explain it to a surveyor.

Can proficiency testing count as the assessment?

In part. Proficiency testing samples can be used for the fifth procedure, test performance. They do not cover the other five, so proficiency testing alone is not a competency assessment.

Is training the same as competency assessment?

No. Training comes before a person starts testing and is documented separately. Competency assessment comes afterward and confirms the person follows the procedure and gets accurate results. An annual performance review is not a competency assessment either.

Do supervisors and consultants need to be assessed?

Yes. The laboratory must have written policies to assess employee and, where applicable, consultant competency. The technical consultant, technical supervisor, general supervisor and clinical consultant are assessed against the responsibilities of their role. If they also test patient specimens, they are assessed on the six procedures too. The forms are in CA-03 Role Assessment Forms.

What if the laboratory director is the only person testing?

The director documents a minimum level of proficiency, for example through proficiency testing performance or a review of the director's work by another qualified party.

What happens after an unsatisfactory assessment?

The person stops testing independently on the affected test system, is retrained and is reassessed. The director decides whether patient results reported since the last satisfactory assessment need review. Record it on CA-07 Remedial Training and Reassessment Record.

How long are the records kept?

Set the period in your policy. Two years is a sensible floor because it matches the general CLIA retention period, and many laboratories keep competency records for as long as the person is employed.