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  Frequently Asked PT questions

 

May 2005
Originally published in CAP TODAY

Desiree A. Carlson, MD, Editor, Laboratory Accreditation News

Laboratory managers participating in the CAP’s teleconference had the chance to ask the questions that crop up often out in the field. Here are examples:

Does the PT sample have to be reviewed by the person performing the PT?
Do PT records have to be kept for five years on site?
Why does lack of consensus at the College about a particular challenge become an individual laboratory issue on a PT report?
If something happened on a five-level challenge so the laboratory was only able to get three levels, is it incumbent on the laboratory to find the additional PT to make up the missing challenges?
If the laboratory is meeting the CAP’s PT requirements, can CLIA overrule that and say, for example, “You have to have five testing levels”?

Does the PT sample have to be reviewed by the person performing the PT?

No, Dr. Hoeltge says. “Every PT result should be reviewed by somebody, but in CAP’s Surveys it doesn’t have to be the person doing the test. The overall evaluation should, of course, focus on things that need some kind of corrective action. But in CLIA regulations, part of quality assurance is feedback to the person in the laboratory who performed the test—so reviewing PT results would be one way to do that.”
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Do PT records have to be kept for five years on site?

“No. Most PT records must be retained for two years; blood bank records must be retained for five. For purposes of CAP inspection, make sure they’re readily available on the day of inspection,” Dr. Hoeltge recommends. “If your inspector asks for data that is not on site, the review can always be handled in post-inspection correspondence.”
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Why does lack of consensus at the College about a particular challenge become an individual laboratory issue on a PT report?

“If a particular challenge wasn’t graded because of lack of consensus among participants, you’re expected to make use of the data. Whether it’s ungraded because of lack of consensus or any other reason, get whatever you can from it. There may be something quite useful to your laboratory. If your review says this wouldn’t help us at all, that’s what you would document.”
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If something happened on a five-level challenge so the laboratory was only able to get three levels, is it incumbent on the laboratory to find the additional PT to make up the missing challenges?

While states differ in their regulation of PT, in CAP’s accreditation program, “if it’s a regulated analyte, and you were only able to test three to five samples because two were spoiled or broken or couldn’t be used, you don’t have a robust PT sample for that particular case.”

“We would expect review of the evaluation report to look at all the other things going on at that particular workstation and document that QC and other things are acceptable. I would not think that a CAP laboratory would have to purchase a special reinstatement module from another provider.”
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If the laboratory is meeting the CAP’s PT requirements, can CLIA overrule that and say, for example, “You have to have five testing levels”?

“CAP’s LAP has been deemed as a whole program to meet requirements for an approved certification agency. Can CLIA come in either as a federal agency or through a state agency and apply additional criteria? Of course they can; in their interpretation of the rules, that’s entirely permissible.”

“What I can tell you is that CAP’s LAP in its entirety is fully compliant with CLIA regulations, and it’s expected that if you meet the accreditation criteria, you won’t have any difficulty with a regulatory agency. If you do, let us know about it because it’s something we need to look into.”
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