Waived Testing Annual Recertification

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Our health system used to require certified operators to run at least 1 QC and 1 patient test (real or fake test patient) to maintain annual certification on our waived tests. Now, we are only accepting real patient tests to count towards annual competencies. We have several clinics with low patient volumes or POC devices that are there just for emergencies (glucometer for rapid responses). These low volume locations may not have enough real patient tests to perform in a year for all of the operators to maintain certification. Any advice on how to handle this problem? If we let the low volume locations use a test patient, then everyone will want to use a test patient.

Thanks!

7 Replies

Jo Win

Wed Jan 07, 2026 at 11:50AM

Some glucometers can use other specimen types other than fingersticks. Maybe you can go down that route.

Have you voiced your concerns to upper management and explain the challenges.

Usually the regulation says that you can select the elements that you want to fulfill competencies.

Erika Deaton-Mohney BS, MT(ASCP), CPP

Wed Jan 07, 2026 at 11:56AM

I would push back and ask for the actual standard they are using, noting that your operator population will shrink drastically and the option to test at certain locations might need to be removed.

Good luck.
Erika

Julie Blasini

Wed Jan 07, 2026 at 12:12PM

Whether TJC or CAP or CLIA a quiz should count as one of the acceptable requirements for a Waived testing renewal. On some of our waived platforms we just use a quiz to document renewal. On others we use quiz and blind sample. I know TJC requires 2 out of 4 criteria for waived testing, so if that is the case you could just use QC and a quiz instead of a patient for those low volume areas.

Jamey Irvine

Wed Jan 07, 2026 at 12:17PM

Yes, we do require an online quiz and review of the procedure in addition to the QC and patient test. Our hospitals operate under CAP and clinics are CLIA. We have one POC department for both hospitals and clinics so we are trying to keep requirements the same for both. We talked about only requiring online education and no QC or test patients but came to the conclusion that may lead to poor testing practices for some operators. We have about 5,000 certified operators right now, and competency requirements are automatically tracked using Telcor QML.

Erika Deaton-Mohney BS, MT(ASCP), CPP

Wed Jan 07, 2026 at 12:27PM

EDIT: The requirement of only meeting 2 of the 6 elements is what our policy states, written off of standards long ago. You could review the specific requirements you are choosing. The difficulty comes in how do you prove the 2 requirements chosen were completed for all of your users. CAP has different expectations if you need to follow that: "For waived test systems, the laboratory may select which elements to assess. It is not necessary to assess all six elements listed below at each assessment event unless more stringent state and local regulation are in place. Elements of competency assessment include, but are not limited to:

1. Direct observations of routine test performance, including, as applicable, patient/sample identification and preparation; and specimen collection, handling, processing and testing

2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical 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, as applicable

5. Assessment of test performance through testing previously analyzed specimens, internal blind testing specimens (eg, de-identified patient specimens) or external proficiency testing specimens; and

6. Evaluation of problem-solving skills."

James Beck

Wed Jan 07, 2026 at 4:16PM

I would echo what Jo said. If the expectation is for all operators to maintain access, then I would say your system has adopted an unrealistic expectation that maybe should be reconsidered. I agree with the logic of having operators do an actual patient test because it is a better reflection of actual competency than doing QC, but the fact is all regulatory agencies allow any 2 competency elements to be completed for a waived test, so sometimes you do what you have to do to keep the program manageable. Not perfect, but necessary.

Peggy Mann

Wed Jan 07, 2026 at 5:29PM

Jamey, so many times in our 'one POC Program' program, I've seen us come up with solutions which were not in the least compromises from 'several sides' of the issue. Is it possible to ignore those who believe 'if they get to use fake test samples, we deserve to use fake test samples'? Consider drawing a line where 'low volume testing' meets 'not so low volume testing'. Then advocate with whomever makes the rules on competency compliance for only the low volume testing' clinics' operators to receive and use 'fake' test samples to demonstrate competency.

To acknowledge that 'staying competent' if rarely or never performing a patient test is a real concern for us in POCT, you could consider adjusting the new hire competency assessment schedule to 6 months and 12 months, then annually, along with the use of 'fake' test samples.

My opinion. I'd rather champion for an alternative competency than pull the glucose meters from clinics whose medical director previous met the justification for adding a glucose meter (no clin lab, no 'crash cart team', visitors accompanying patients go down and we can't just call 911).

Good Luck with this.

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Topic	Replies	Views	Participants	Last Reply
Laboratory Director Designee Statement Jennifer Gagne about 4 hours ago	0	82		Jennifer Gagne about 4 hours ago
Verifying Reportable Range using Controls and Calibrators Jo Win 1 day ago	5	231		Jo Win about 6 hours ago
Waived Testing Annual Recertification Jamey Irvine 1 day ago	7	355	+ 3 more	Peggy Mann 1 day ago

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Waived Testing Annual Recertification