CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Anne Ford
October 2015—No one plans to screw up.Take the worker carrying out maintenance duties at a Damascus, Ark., U.S. Air Force base one evening in 1980. Surely the only thing on his mind was doing a decent job and going home.
Unfortunately, his good intentions didn’t prevent him from accidentally dropping a socket from a socket wrench. Or the socket from falling 80 feet onto a missile tipped with a nuclear warhead, piercing its fuel tank. Or the fuel from exploding. Or the entire launch complex from being destroyed. Or one person dying and 21 being injured.
Fortunately, few of us will ever be in a position to nearly eradicate Arkansas. But the point remains: Even completely innocent mistakes can have severe repercussions.
That’s why Amy Daniels, MT(ASCP), senior manager of investigations for CAP accreditation programs, is determined to put an end to the problem of proficiency testing referrals. “These incidents of PT referral that are occurring—they’re not caused by people trying to cheat,” she says. “That is not at all what’s driving this. What’s driving it is misconceptions on how PT is handled within the laboratory. No one means to screw up. No one’s trying to cause problems in the lab. These are honest, innocent mistakes. But they have serious consequences,” such as laboratories being put on probation, Medicare payments being canceled, and CLIA certificates being revoked.
Daniels
Daniels says that laboratories have become better at identifying when PT referral has occurred. Then, too, the actual number of PT referral incidents is quite low. Says Beth Chmara, CT(ASCP), CAP technical director of proficiency testing: “The vast majority of our labs adhere to the CLIA recommendations and CLIA requirements, and we do not see this [PT referral] as being a pervasive issue. Overall, the CAP has observed extremely high compliance.”
Still, Daniels and Chmara are frustrated that the number of PT referral incidents they see persists in remaining any more than zero. “I think laboratories are aware they’re not supposed to do this,” Daniels says. “But the problem is, it’s still happening.”
To go back to basics briefly: Per the Centers for Medicare and Medicaid Services and the CAP, laboratories are not permitted to communicate about proficiency testing samples with each other, refer PT samples to each other, or accept PT samples from each other. In Daniels’ words, “A CLIA number is issued to a laboratory with a physical address, and all of the laboratory’s proficiency testing has to be done within those four walls. Once PT leaves that CLIA number, then you’ve broken the rules.”
This rule applies even if the main laboratory’s CLIA number differs from the CLIA number of one or more point-of-care testing sites elsewhere in the institution, such as in the ER or ICU. “And if you decide, ‘Well, I’m going to share my PT with them and have them do this one,’ you can’t do that. They have to order a PT under their own number, do their own testing, and report it. You can’t bring their results to the main lab and report it for them because you’re a different lab,” Daniels says.
It’s not complicated, but it’s worth reviewing given that some laboratory directors, in Daniels’ experience, aren’t aware of how seriously they should be taking the possibility of a PT referral: “Maybe they’ve been a lab director for a long time and this has never happened in their laboratory before, so they’re just not aware this could happen and what the effect of it is.”
Dr. Sharkey
Why, despite potentially severe sanctions, does PT referral continue to happen? CAP Accreditation Committee member and Laboratory Accreditation Program state commissioner Francis E. Sharkey, MD, says that more often than not, a laboratory that mistakenly refers a PT specimen does so because it knows it is supposed to process PT samples in exactly the same way it processes patient samples, which entails sending at least part of its testing to another laboratory for further exam.
For example, “If a small stat lab gets a CBC, they may normally refer the visual differential to the main laboratory for review, or if they identify something atypical in the cells, they’ll refer it to the pathologist in the main laboratory for further review,” says Dr. Sharkey, a professor of pathology at the University of Texas Health Science Center at San Antonio.
But that’s no excuse, given how clearly the CAP’s prohibition against PT referral is worded. “It does say, ‘This prohibition takes precedence over the requirement that proficiency testing specimens be handled in the same way as patient specimens,’” Dr. Sharkey points out. “I think that’s pretty clear.”
For her part, Daniels speculates that staff turnover and the need for testing efficiency may be contributing factors. “Maybe someone at the lab hired someone new, and they didn’t realize they couldn’t do this [PT referral],” she says. “Or they trained people, but didn’t retrain them, so someone forgot. And laboratory testing happens quickly. Specimens are moving from place to place, and you want to report things in a timely way. Proficiency testing samples go through that same process, so the testing and the reporting occur quickly, and then you realize, ‘Oh, that was proficiency testing.’ And then you have a problem.”
If there’s a bright spot in all this, it’s that laboratories appear to have gotten better at recognizing when PT referral has occurred and reporting it to the CAP, she says. Unfortunately, sometimes the offending laboratory doesn’t recognize that PT referral has taken place until after it’s received the report from the other laboratory. “At that point, it’s too late,” she says. “And now two labs are involved in this—the lab that sent them something and the lab that reported something. At that point, both labs are problems, because one referred the result for interpretation and the other one interpreted it and sent out the report.”
Of course, sometimes the laboratory that receives the PT sample realizes it before testing takes place. “That’s a key step, to realize that if anything looks suspicious, like it might be proficiency testing, you need to stop the process, do a time-out, and figure out: ‘Is this a PT sample? Is this not a PT sample?’” Daniels says.
“Let’s say you receive a sample labeled ‘Marilyn Monroe,’ and you have no idea it has been relabeled, and it’s proficiency testing. You would be innocent,” she continues. “But if it’s labeled ‘CAP Survey D PT Specimen 1,’ it’s pretty obvious that’s a CAP proficiency testing sample, and if you accept it into your lab and do testing on it and then report, you’re guilty too.”
Once a laboratory realizes that PT referral has happened and alerted the CAP, a complaint investigation is opened. “There’s a lot of information we ask for, because we need to understand: Was this the first occurrence? Has this happened at all within the past two years, during their accreditation cycle? We ask for their proficiency testing procedures, their policies. If it happened with a specific proficiency testing challenge, we will ask to see their worksheets for that challenge, what they reported to the College, how did they figure out what happened. We want to understand: How did this accident happen, and at what point in time did you realize it?”
Three of the PT-related incidents that have taken place within the past year may serve as warnings to other laboratories. The first represents the only instance of PT referral to date in which Daniels has seen evidence of deliberate cheating. “They took a PT sample, and someone in the laboratory took it upon themselves to put an identifier on the sample so it didn’t look like proficiency testing. They sent it to another lab for testing, and then when they received those results, that’s what they reported to the proficiency testing provider,” she explains. “It just looked suspicious. I hate that that happened, but it did. And that laboratory did end up on probation.”
The second outstanding instance of PT-related misconduct took place in a cytology laboratory and involved not referral but inappropriate consultation among cytotechnologists.