Make no mistake — PT referral not allowed

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Dr. Henry

Michael Ross Henry, MD, a member of the CAP Checklists Committee and director of cytopathology at the Mayo Clinic, explains how gynecologic cytology PT should be performed: “The slides are sent to the laboratory, and if your laboratory uses cytotechnologists to screen, then the slides are screened by a cytotechnologist and their answers are recorded on an answer sheet. They’re not allowed to ask any questions or get help with any of those slides from any individuals. Then the slides are also interpreted by the pathologists who sign out gyn cytology, and they get slides that have been screened by a cytotechnologist, and they have that cytotechnologist’s answers. Again, the pathologist is not allowed to show those slides to anybody else; they just have that cytotechnologist’s answers. And they’re not allowed to share. And then you’re not allowed to talk about any of the answers within the laboratory during the PT testing period.”

A proctor oversees the process, and here’s where the laboratory in question went wrong, says Daniels: “The person proctoring the test didn’t follow the rules. Unfortunately, a lot of laboratories will assign the proctoring role to someone who is in more of an administrative support role within the laboratory, someone who understands how the laboratory works but who may not understand how important it is to follow all the rules for the proctoring. In retrospect, I wonder if they should have brought in, say, a supervisor from chemistry to do the proctoring, because that person would have understood proficiency testing.

“What happened in this event was, the proctor let people collaborate about their results, and that’s what was submitted,” she continues. “It’s supposed to be an exercise completed independently by each person, and basically, it became a group project. The rules weren’t followed. Someone complained to the College, and there were serious problems. CMS also investigated it. Several people aren’t at that laboratory anymore, and there was a large fine, but it could have been worse. I mean, they didn’t close the lab.”

In Chmara’s view, the error may have stemmed from the fact that “in practice, a pathologist and a cytotechnologist will often consult each other on a challenging case,” she says. Still, “all the information that the CAP offers as guidance for labs, of which there’s plenty, indicates that consulting on PT cases is breaking those requirements, which are set up by the government. All of our documentation strongly indicates you cannot discuss cases.”

Daniels sees a clue in the fact that proctoring generally happens only annually. “The proctoring instructions aren’t excessively complicated, but you do it only once a year,” she says. “And if, let’s say, the proctor who’s been doing it for 10 years in your laboratory has retired, and now you have someone new doing it, you really need to make sure that person understands all the rules and instructions, so they handle the PT appropriately.”

The third instance, too, took place in a cytology laboratory. “Typically you have a cytology person who screens the slides, and they will mark suspicious-looking slides with a Sharpie marker, and that slide gets referred to a pathologist to take a look at,” Daniels explains. “Well, a lot of times the pathologist won’t screen that slide; the cytotech will screen it, and the pathologist will look at it. If both of those people are in the same building, that’s fine.”

You know what’s coming next: “We had an event where a laboratory screened the slides at one location, and then they sent the slides to a secondary location to have the pathologist look at them, and you can’t do that. You can’t send marked slides from one location to another, and that’s what this lab did, and that’s not allowed.”

That said, “CMS does allow for off-site courtesy screening, if approved by the CAP. Completing the alternative site courtesy screening form is required prior to off-site testing. If approved, the proctor from the main laboratory cleans the slide set between testing and secures the slide set for transport between labs. The main laboratory proctor and a randomly chosen cytotechnologist will travel to the alternative lab with the secured Pap PT material, where the cytotechnologist will perform a courtesy screen.”

In their ongoing efforts to prevent inappropriate PT-related incidents, Daniels and Chmara are making slight changes in the wording of the CAP’s instructions. For example, the PT-related requirements in the CAP’s All Common checklist have been revised slightly. Daniels reports, “We tried to add clarifying text just so that people are aware of what you can’t do and what you need to have procedures for. The goal is to try to figure out what the magic words are that we need to share with laboratories to get them to make sure that everyone in their lab really does understand the effect of referring a proficiency testing sample.”

Chmara

Chmara is rearranging content within the proctoring kit instructions for cytology PT. “A lot of times, if people are really familiar with PT, they may not be as diligent with reviewing the kit instructions,” she says. “So we’re revising the language and calling attention to it. The new language will also speak to the civil money penalties that laboratories are susceptible to if they don’t adhere to the regulations.”

Those penalties are no longer as severe as they once were for laboratories that unknowingly or unintentionally refer PT specimens. “Once the CAP saw that some of these penalties were quite draconian and varied from one region to another, it got together with CMS and came to an agreement about at least grading the penalties according to intent and things of that nature,” Dr. Sharkey says. “Previously, the penalties had been extremely severe, even for completely inadvertent referral or discussion of PT. They were over the top. And they were decidedly inconsistent from one CMS region to another, which also was not fair. I believe now there is greater consistency in this respect.”

But, of course, that doesn’t mean laboratories can relax their vigilance in this regard. Nor can Daniels. “CMS has made it a much improved process, and I think the laboratory community appreciates it,” she says. “The problem is that the way the regulations are written, the laboratory gets a break the first time, but if it has an accident a second time, the regulations are not as favorable. We don’t know what would happen with round two. We’re going to see some of those eventually. And I’m afraid of what could happen to the facility.”

Anne Ford is a writer in Evanston, Ill.