According to CLIA (Clinical Laboratory Improvement Amendments) Sec. 493.1413(b)(8), the technical consultant is responsible for "evaluating the competency of testing personnel." There are a number of ways to do this: direct observation, review of records, analyzing previously tested samples, and so on. These have to be written procedures (493.1235). But what does this mean?
At first glance, more work! It means retesting samples, extra documentation, and being watched. This insults professionals otherwise trusted to perform lab work. Why do I have to prove I'm able to do the work I'm already doing? I understand and agree with these feelings.
But there is another way to view "competency." If you think of your laboratory as a quality system that defines how test results are produced, many competency checks are already built in. They have to be; it's the way that good bench techs feel confident to report results. Some examples:
- Commercial quality control
- Reflex criteria to repeat testing / perform confirmatory testing
- Calibration verification
- Blind samples i.e. proficiency testing
For example, the question How do you know this glucose result is accurate? is really answerable in most labs. Most lab tests are backed up by hard data. It's how good systems enable quality. Therefore, we can think of quality as rephrasing How do we prove our competence to How do we know these patient results are accurate?
This is a litmus test that each reportable result needs to pass. Ideally, the system should be designed to ensure results are accurate, including some way of knowing they are done correctly. In other words, "competency" should be built into our procedures. That way, assessing competency isn't busy work but an ongoing proof that patients are getting the best care.
The challenge is to check your lab menu for tests that don't have proficiency testing, quality control, a way to review how the test was performed, and so on. You might have a few. And while we may be able to spot-check a tech annually, we need to know that patient results reported throughout the year are accurate.