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A CAP inspector’s guide to Competency Assessment

Author: Darryl E. Elzie, PsyD, MHA, MT(ASCP), CQA (ASQ)

CMS has updated the Federal Register with new regulations governing laboratory personnel qualifications impacting competency. Some rules went into effect on January 27, 2024, and some personnel rules will be effective on December 28, 2024. 

There is a lot of information on the internet about the new rules. However, I wanted to focus on the competency requirements of non-waived testing since that has not changed. CLIA and laboratory accrediting bodies still report that competency is the most commonly cited deficiency despite there being no significant change in the requirements in decades.

I have been performing CAP (College of American Pathologists) inspections for years and always get asked about competencies. I decided to write about some of those.

First, and most importantly, when considering competency, the laboratory has two employee pools:  New Employees and Everyone Else

New employees should be handled separately to meet the semi-annual competency requirement successfully. (I’ll talk about the nuances in getting the timing right in another post.)

Everyone else has the entire year to complete their annual competency. 

Now, some questions…

What are the six elements required for the competency of non-waived testing?

  1. Direct Observation of routine test performance
  2. Monitoring the recording and reporting of test results
  3. Review of immediate test results, worksheets, QC, and preventive maintenance records
  4. Direct Observation of instrument function or maintenance checks
  5. Proficiency testing or blind samples
  6. Problem-solving skills

For elements 1, 2, and 3, can proficiency or blind samples be used? 

Yes.  Blind samples are great as the tech can more closely mimic the true patient sample testing process.  The caveat is that they should only be used for low-volume tests.  Blind samples should not be used for high-volume tests such as CMP, UA, etc.

What if you have not had to do a critical specimen for a particular test system for the year? My laboratory supervisor said to put an asterisk and comment, “See (a critical listed for a different test system) for processing of criticals. No criticals performed for this test system this year.”  If so, what about criticals reported to the state lab (i.e., STS) that differ from those of the chemistry or hematology analyzer? 

The notation stated by your supervisor may be acceptable. However, be cautious about its use because inspectors know the tests that typically have criticals. The comment would be inappropriate for a CBC but is conceivable for AFB. 

The State lab notification process does not apply. COM.30000 states:

The laboratory immediately notifies physicians or other clinical personnel responsible for patient care when results of designated tests exceed established “critical” values. Records of notification are retained.

NOTE: Alert or critical results are those results that may require prompt clinical attention to avert significant patient morbidity or mortality. The laboratory director, in consultation with the clinicians served, must define the critical values and critical results that pertain to its patient population.

The laboratory may establish different critical results for specific patient subpopulations (for example, dialysis clinic patients). An appropriate notification includes a direct dialogue with the responsible individual or an electronic communication (eg, secure email or fax) with confirmation of receipt by the responsible individual.

The notification applies to patient caregivers for prompt patient management.  Though it is vital to ensure State Labs are notified appropriately, it is more for epidemiological issues and possible public health concerns rather than immediate patient care.  (There are standards addressing notification of state and local authorities.)

Can we just comment that no criticals were done during the year?

This may be acceptable, but only for rare tests, in addition to the comment mentioned earlier.  (As noted in the COM. 30000, your lab director should be heavily involved with the medical staff in developing the critical value list.) 

If your laboratory uses an LIS integrated with the hospital EMR system and the process is the same regardless of the reported test, an inspector may be okay with demonstrating one critical.  However, some inspectors may want to see multiple criticals documented even though the electronic process is the same.

Can we create “fake” patients in our EMR and use those to result a critical?

This is an acceptable option. However, remember to go through the entire readback process and note who was called (with first and last name) along with the time and date.

Does reporting internal QC (i.e., Bhcg, rhiv, occult blood card) count, or is it just external QC?  

Yes. QC used to evaluate the acceptability of a patient test is suitable.  This would include internal as well as external QC.

For analyzers such as urine analyzers, sed rates, etc., QC is the responsibility of another shift.  Is it okay for the techs just to show the competency assessor where they find the quality control results to verify QC is done, or should we just put N/A for that element since the techs working that shift are not responsible for running the QC?

Some inspectors accept the N/A notation for some tasks, such as maintenance. However, the question could be asked, “What if an instrument was down and QC needed to be run to bring it back up on an off-shift?”  Shouldn’t all techs be able to perform QC?  Techs may run additional QC to meet the competency requirement.  You should be aware that recording an N/A for the quality control element can be problematic for some inspectors.

For the tests that a tech may not have performed during the year, such as STS/PFA/Crypto/RHIV/LAP, can all elements be commented that “no specimen testing was done during the year”?

This is also a popular question. The simple answer is no. Continued competency must be demonstrated annually for all patient testing an individual is allowed to perform. Blind samples should be used. 

The reason? Suppose a tech did not perform competency on a patient sample for Crypto in all of 2023 and got their first sample in Dec of 2024. How can the laboratory confidently prove that the individual was competent to perform the test on the patient sample in December 2024? It may have been two years or more since the individual would have performed the test. (Competency could have last been done in Jan of 2022.)

However, specific test systems may be grouped if the sample handling and testing process are the same.  The lab director, laboratory supervisor, and manager can determine the groupings.

Can we use proficiency slides and samples for competency?

Yes, but there is one BIG CAVEAT.  PT samples and slides may be used for competency only after the submission due date.  If PT is used for competency before the submission due date has passed, it is considered duplicate testing. 

Though the competency requirements may seem onerous at times, training, competency, and personnel qualifications are the three primary documentation requested by regulatory and accrediting authorities during an inspection and in response to a reportable incident.  These are just a few of the popular questions I get about competency.  If you want to know more, refer to the CMS brochure What Do I Need to Do to Assess Personnel Competency?” or you can reach out to me at darryl.elzie@labsymplified.com

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