CLIA Competency Assessment: What the Rules Ask
Competency assessment policies were the second most cited standard-level CLIA deficiency in 2024. The rule itself is short: six procedures, a set schedule, and a named role who must do the assessing. Here it is in plain words, from 42 CFR 493 and CMS's own guidance, with what a surveyor expects to find in the file. The competency form puts it on paper.
What a competency assessment is, and is not
Quick reference
- Who is assessedModerate and high complexity testing staff
- Procedures per assessment6 (PPM: 5)
- First year of patient testingAt least semiannually
- After thatAt least annually
- Moderate complexity assessorTC, § 493.1413
- High complexity assessorTS or delegated GS, § 493.1451
- Waived testing onlyNot required
CMS defines it as checking a person's “ability to correctly apply their skill, knowledge, training, and experience to their laboratory duties.” It is a documented look at someone who already tests patients, on the tests they actually run.
Three things are often filed as competency and do not count on their own, per CMS's competency brochure:
- Training happens before someone tests. The assessment comes after and checks they follow the lab's procedures and test correctly.
- Personnel evaluations (the yearly HR review) rate behaviour and attributes in the job, not test performance.
- Proficiency testing. A PT result can feed procedure (v), but CMS says PT alone “is insufficient to meet all six procedures.”
Takeaway
Who must be assessed
CLIA requires a documented assessment for everyone who performs moderate or high complexity testing, “and for every test performed (even when multiple tests are part of a single testing platform).” CMS lists the roles:
- Testing personnel: the six procedures, on each test they perform.
- Clinical consultant, technical consultant, technical supervisor, general supervisor: an assessment of their own subpart M duties, plus the six procedures if they also test.
- A director who is the only person testing: CMS says they “must establish and document a minimum proficiency level”, for example through PT samples or having another entity review their work.
Waived testing is the exception: “For laboratories only performing waived testing, CLIA does not require a competency assessment for Testing Personnel (TP), however, it is good laboratory practice.” CMS gives the same answer for people who only draw blood, label or process samples, or accession, with one catch: a phlebotomist who performs bleeding times is running a moderate complexity test.
A lab with waived and nonwaived tests
The exemption is for staff in labs that only do waived testing. In a lab that also runs moderate complexity tests, the people running those tests need assessments on those tests. Use the certificate finder if you are unsure where your menu sits.
The six elements
The regulation lists the same six procedures for moderate (§ 493.1413(b)(8)) and high complexity testing (§ 493.1451(b)(8)). They are a floor: “include, but are not limited to”.
| Procedure, as written | What it looks like at the bench |
|---|---|
| (i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing | Watching real patient runs from specimen ID to release, not a staged demo. |
| (ii) Monitoring the recording and reporting of test results | Tracing results from the analyzer or worksheet to the report or LIS, including units and flags. |
| (iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records | Reading the person's own QC entries, worksheets, PT forms and maintenance logs. |
| (iv) Direct observation of performance of instrument maintenance and function checks | Watching the daily or weekly maintenance and the start-up checks the manufacturer requires. |
| (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples | Repeat samples or blind samples run and compared with the known result. |
| (vi) Assessment of problem solving skills | A QC failure, a short sample or a flagged result: what would you do, and why. |
For provider-performed microscopy the list is five: CMS says (iv) does not apply, and § 493.1359(c) words (iii) as “Review of test results or worksheets” and (v) as testing “internal blind testing samples or external proficiency testing samples”.
Takeaway
Who may assess whom
The duty sits with a named subpart M role, and the person doing it has to hold that role's qualifications.
| Testing | Who assesses | Where it is written |
|---|---|---|
| Moderate complexity | Technical consultant, or anyone who meets the TC qualifications | § 493.1413(b)(8); quals § 493.1411 |
| High complexity | Technical supervisor; may delegate in writing to a qualified general supervisor | § 493.1451(b)(8), § 493.1463(b)(4); quals § 493.1449, § 493.1461 |
| PPM | Laboratory director; individual procedures may be delegated in writing to qualified PPM testers | § 493.1359(c); quals § 493.1357 |
| Waived only | No assessment required; train staff and follow the manufacturer's instructions | CMS brochure |
CMS's brochure puts it bluntly: “Personnel who don't meet the regulatory qualifications of a TC, TS, or GS cannot perform or be designated to perform competency assessments.” (CMS, Assessing Personnel Competency, May 2025)
The director stays answerable either way. CMS: the director “is ultimately responsible for ensuring that the laboratory completes all competency assessments”, and a director who takes on TC, TS or GS duties takes on the assessments with them. In a Certificate of Accreditation lab, CMS sends the director to the accreditation organization for its rules.
Small labs without a qualified TC on staff often buy that cover. The lab director and consulting services comparison reads which firms offer technical consultant or supervisor duties.
How often
Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens.
The clock starts when the person first tests patient specimens in your lab (CMS: “in your laboratory”), not on the hire date and not at the end of training. Someone who starts testing on 2 March 2026 is due by 2 September 2026 and again by 2 March 2027, then yearly. CMS asks for “All six procedures” to be documented for each person each year, and suggests spreading them through the year alongside routine work.
A new analyzer or a method change is its own trigger: the person is reassessed on it “prior to reporting patient test results”, whatever the calendar says. An experienced hire still gets the first-year schedule in your lab.
Takeaway
Per test, per test system
One assessment per person per year is not the unit. CMS says the six procedures apply “for every test performed (even when multiple tests are part of a single testing platform).” A tech who runs a chemistry analyzer, a hematology analyzer and a coagulation analyzer has three test systems to cover.
Asked whether every analyte needs its own assessment, CMS answers that the assessment must “include the specific test procedures performed” and that the lab “should assess tests with unique aspects, problems, or procedures (e.g., ammonia received on ice or similar)”. Name those tests on the record; a line that just says “chemistry” invites the question.
Supervisors and consultants are assessed on their duties as well. For a technical consultant that means things like method selection, PT enrollment and review, the QC program and resolving test failures, the duties listed in § 493.1413(b).
Takeaway
What to document
As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency.
Two layers are checked: the written policy, and records that show you follow it. The policy names who is assessed on what, who assesses (by role and qualification), the schedule, how each procedure is done for each test system, and what happens when someone falls short. Each record then shows:
- the person, the test or test system, and the date they began testing patient specimens;
- each of the six procedures (five for PPM): how it was assessed, the date and the result;
- the assessor, by name and by the subpart M role they qualify under;
- remediation where needed, and the reassessment that closed it;
- a signature and date from the assessor, and the employee's acknowledgement if your policy asks for one.
Remediation is part of the director's duty, not an extra: policies must monitor competency and “whenever necessary, identify needs for remedial training or continuing education to improve skills” (§ 493.1407(e)(12), high complexity § 493.1445(e)(13)).
How long to keep them? § 493.1105 sets retention periods for requisitions, QC, PT and reports, but names no category for competency records. Set the period in your written policy, and check your accreditation organization's and state's rules.
Top inspection findings
818
labs cited under D5413, storage and operating conditions: the only finding ahead of it (5.0%)
CMS publishes the counts, not the reasons. Reading the rule against a personnel file, these are the gaps worth checking before a surveyor does:
- a new hire's second first-year assessment missing, or done at month 13;
- one assessment covering “all testing” with no test systems named;
- fewer than six procedures documented for a test system;
- PT results or a training checklist filed as the whole assessment;
- an assessor who does not meet TC, TS or GS qualifications, or a GS with no written delegation;
- no reassessment after a new analyzer went live;
- no written policy, only forms.
Takeaway
What the October 2026 proposal would change
Proposed, not law
CMS-3478-P was published on 8 October 2026; comments are due 7 December 2026. None of it applies until a final rule is published. Today's text, above, is what a surveyor cites.
The proposed rule touches competency in three places. It would rescind the PPM director's competency duty in § 493.1359(c)(1)–(5) and (d), citing the disruption of observing tests during a patient visit. It would reword § 493.1463(b)(4) so a general supervisor may be delegated assessments of “both moderate and high complexity” testing personnel. And it would widen who qualifies to assess moderate complexity blood gas testing.
For everyone else, CMS says the proposal “would not change CLIA regulatory requirements related to personnel training, annual competency assessment, quality systems, PT, and biennial on-site surveys”.
Paper, spreadsheet or software
CLIA asks for a written policy and records that follow it; it does not ask for software. A lab with a handful of testers and two or three test systems runs well on a printed form per person per system and a dated calendar. The work grows with people times test systems, twice over in each person's first year, and that is usually when labs start looking at tracking software.
Takeaway