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CRI Lab Quality Advisor

Competency Assessment: The Changing Landscape

Published March 18, 2014 11:35 AM by Irwin Rothenberg

I know that this is not the first time that I have discussed competency assessment on this blog site, but I continue to find (as a quality advisor) a lack of knowledge about  changes to the required processes;  who is qualified to perform these  and when, and the reasons why these assessments are so important.  More and more, I’ve seen that as technological change accelerates, not only for how we test, but how we communicate these results and store data, that the old ways of performing routine annual assessments are not sufficient to guarantee the continuous quality that we all strive for.

We know by now, that your CLIA qualified technical consultant / supervisor has overall responsibility for the training and competency of the staff, but that there are many situations, such as in Point of Care (POC) and Physician Office labs (POLs) where this responsibility is carried out through the training of on-site competent individuals who then train the testing staff.  But, I reiterate, that the technical consultant /supervisor should always be monitoring this training and competency assessment to ensure all steps are followed and assessments are accurate.

Since change, represented by new instrumentation, new LIS, new kits, and new tests is an on-going process, assessing competency must go beyond set evaluation schedules arranged before these changes occurred.  Continuous quality is derived from , and dependent upon,  continuous  training, continuous feedback, and continuous competency assessment.  Feedback from patients, physicians, and staff provide important indicators of whether quality standards are being met.

The most important recent change is the mandate from CLIA that competency assessment must include (where and whenever relevant to the particular process under study) the following six components:

Direct observation of routine patient test performance;  monitoring and recording of test results; review of intermediate test results and worksheets;  direct observation of instrument maintenance; blind sample testing (such as proficiency testing); and problem solving skills.

Competency assessment is not only performed in response to changes going on in the lab, but must also be periodically performed for routine work as well;  you cannot assume that once competent , always competent;   personnel may experience changes to competency for any number of reasons, such as changes in work assignments.  Never assume that competency is a constant for any individual.

Think of competency assessment as the backbone of lab quality; and the backbone runs the length of the lab operations both in terms of time and structure.

posted by Irwin Rothenberg


Yes, competency assessment must be performed annually for all testing done by staff.  However, if you have instruments that perform and report panels of tests where all analytes are treated alike, then you can focus on instrument operation, troubleshooting and reporting; this will encompass all the analytes tested at the same time. An exception would be any analyte that must be handled or prepared in a specific way for testing, such as pre-treatment for cholesterols. The competency assessment must encompass any and all of the six components required where applicable.  However, you can spread the monitoring of these components throughout the year, such as PT performance, or taking corrective actions; or performing maintenance; or reporting results correctly.

Irwin Rothenberg April 11, 2014 4:03 PM

Do you have to assess all tests every year that an employee does by one of the abive methods?

kathy, hematology - supervisor April 10, 2014 10:24 PM

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