CLIA citation regarding proficiency testing
During a recent CLIA inspection, one of our clinics was recently cited with D2007, which states that PT samples must be examined or tested with the lab's regular patient workload by personnel who routinely perform the testing in the laboratory, using the lab's routine methods. The citation says that the lab failed to rotate between all personnel who perform moderate complexity hematology testing on seven of seven surveys. That being said, we have one full time employee in the clinic lab, so she usually does the PT surveys. The other two employees listed as testing personnel are full-time nurses who have been trained to work in the event that the full-time lab employee has to be out unexpectedly and it's not a better option to send the samples to the hospital lab. I can see that this could be a recommendation, but it does not seem to me that we deserve a citation. How do most people interpret this and what is the process for challenging this? Is it worth it? I did discuss it with the inspector but she insisted on citing it.
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In my opinion, if the other two people are certified to do the testing when the regular person is not there then unfortunately they should also be included in the survey. My line of thought is this, unless the Lab employee never takes any time off, then it would be fine. But since that is highly unlikely, they do patients, then they should do the proficiency testing. I know it may sound crazy but it is the way the world works.
dave m
Rotating performance of PT samples is a standard that is why you are cited.
It is in CLIA regs.
All staff performing the tests should have a chance to do them.
I let the testers know the schedule when the PT samples are coming.
I also have a list of who already performed the test so
we made it a requirement that they have to do it at least once a year.
Yeah, that's a long-standing rule across all lab regulatory - PT has to be rotated among all staff that test patient samples. In fact, you could even reason that it's even more valuable to have the staff that rarely test patient samples to be sure to participate in PT just to make sure their skills actually are up to snuff.
It's a common citation in clinic lab circles because they tend to opt to always have their "best" person test the PT samples. They know the goal is to get correct answers but they're not appreciating the other (more important) purpose of PT, which is to make sure all operators actually are proficient.
Probably what also wasn't in your favor is you have such a small number of total staff, it was easy to see who wasn't doing PT. If you had 30 staff and 2 weren't ever doing PT it'd be much easier for an inspector to miss. So, unfortunately, the deck was sort of stacked against you this time around. Sorry
That makes sense, and I know this is standard that has to be met after having worked in a CAP accredited lab for so many years. I guess it was just somewhat of a gray area for me since we are working with such a small lab in that clinic and we do try to treat PT samples as we would treat actual patients. Thank you all for the feedback. It sounds as if it would be best to just write a corrective action to include the two back-up nurses on all subsequent PT testing.