Lab Competency Assessment Form (Six Elements)
One competency record per person and test system, built on the six procedures 42 CFR 493 lists for moderate and high complexity testing (five for provider-performed microscopy). Note how each was assessed, the date, the result and any retraining; see who may sign as assessor; and get the due dates for the first year and after. It prints as a form for the personnel file, filled in or blank.
Competency assessment form — assaydeck.com
Competency assessment record
Empty until you fill it in. Fill it on screen and print, or print it blank and fill it by hand.
Who and what
Laboratory
CLIA number
Employee
One record per test system. CMS: the six procedures apply to every test performed.
Test or test system
Test complexity
Waived testing only? CLIA does not require a competency assessment for waived testing personnel; CMS calls it good laboratory practice.
This assessment
Sets the schedule below. Left empty, no date is assumed.
Began testing patient specimens
Assessor
Assessor qualifies as
Pick the complexity above to see who may assess this person under subpart M.
Schedule
At least twice in the first year of patient testing, then at least once a year (§ 493.1413(b)(9),§ 493.1451(b)(9)). A new method or instrument means a reassessment before patient results are reported.
| Assessment | Months after start | Due by |
|---|---|---|
| First year, 1st semiannual | 6 | |
| First year, 2nd semiannual | 12 | |
| Annual, year 2 | 24 | |
| Annual, year 3 | 36 |
Enter the date this person began testing patient specimens.
The six procedures
Worded as 42 CFR 493 words them (§ 493.1413(b)(8), § 493.1451(b)(8)). Each one is documented for this person and this test system.
(i)Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing
OpenHow assessed
Date
Result
Remediation
(ii)Monitoring the recording and reporting of test results
OpenHow assessed
Date
Result
Remediation
(iii)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
OpenHow assessed
Date
Result
Remediation
(iv)Direct observation of performance of instrument maintenance and function checks
OpenHow assessed
Date
Result
Remediation
(v)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples
OpenHow assessed
Date
Result
Remediation
(vi)Assessment of problem solving skills
OpenHow assessed
Date
Result
Remediation
Outcome and sign-off
Outcome
Reassess by (if remediation)
Assessment completed
Assessor signature
Date
Employee signature
Date
Laboratory director review
Date
Procedures documented
0 of 6
Bench sheet
- Employee–
- Complexity–
- Assessor qualifies as–
- Procedures documented0 of 6
- Marked for remediation0
How to use the form
- Fill one record per person and test system: the analyzer or kit, and the tests on it that this person runs.
- Pick the complexity. It sets who may sign as assessor and, for provider-performed microscopy, drops procedure (iv), which CMS says does not apply to PPM.
- Enter the day the person began testing patient specimens. The schedule fills in the two first-year due dates and the annual ones after them.
- For each procedure, write how you assessed it (what you watched, which records you reviewed, which samples were run), the date, the result, and the retraining if it fell short.
- Print it for the personnel file and sign it, or print it blank and fill it in at the bench.
The six procedures are printed in the regulation's own words, so the record answers the surveyor's question directly. Nothing you type is sent anywhere; reload the page and it is gone, so print or copy first. To keep records for a whole staff in one place, see competency assessment software compared.
What it records and works out
The form keeps the facts a competency record has to show: who was assessed, on which test system, by whom, how each procedure was assessed, when, with what result, and what was done about a miss. The well beside each procedure fills once it has both a date and a result; the result tray counts them against six (five for PPM). The same records feed the testing personnel component of an IQCP risk assessment.
The schedule counts calendar months from the start date: the first-year assessments at 6 and 12 months, then one every 12 months. A start on the 31st lands on the last day of a shorter month. The “next due” line reads your device's date, so it appears only once your browser supplies it.
The 6- and 12-month marks are a common reading of the rule's “at least semiannually during the first year”. CMS's competency brochure puts it as “at least two times (semi-annually) during the first year”. If your written policy sets other dates inside that, follow your policy.
Worked example
A medical laboratory technician starts running patient glucose and BMP panels on 2 March 2026 in a moderate complexity lab. The worked example in the form uses her record: five procedures acceptable, problem solving marked for remediation, and a reassessment date a week out.
| Started testing | 1st semiannual | 2nd semiannual | First annual |
|---|---|---|---|
| A March start: 2 March 2026 | 2 September 2026 | 2 March 2027 | 2 March 2028 |
| A start on the 31st: 31 August 2025 | 28 February 2026 | 31 August 2026 | 31 August 2027 |
Takeaway
What 42 CFR 493 says
The six procedures sit in the technical consultant's duties for moderate complexity testing (§ 493.1413(b)(8)) and the technical supervisor's for high complexity testing (§ 493.1451(b)(8)). The high complexity duty may be delegated to a general supervisor (§ 493.1463(b)(4)). For PPM the laboratory director carries it, with five procedures (§ 493.1359(c)). CMS adds: “Personnel who don't meet the regulatory qualifications of a TC, TS, or GS cannot perform or be designated to perform competency assessments.”
Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.
Behind both sits the standard surveyors cite: the lab “must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency” (§ 493.1235, tag D5209). A form is evidence; the written policy is what it is checked against. The CLIA inspection checklist covers competency alongside the other areas a surveyor reviews.
Proposed, not in force
CMS's proposed rule CMS-3478-P (8 October 2026, comments due 7 December 2026) would remove the PPM competency duty in § 493.1359(c) and (d), and reword § 493.1463(b)(4) to cover “both moderate and high complexity” testing personnel. Until a final rule says otherwise, today's text applies.
Takeaway