College of American Pathologists
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  New push to strengthen interim self-inspections


CAP Today




January 2013
Feature Story

Anne Ford

Unless you have a full-time custodial staff at home, you have the same small annoyances around the house that nearly everyone has. Perhaps it’s a patchy paint job in the upstairs hallway. A closet light that burned out long ago. A dishwasher that periodically leaks. All things that visitors might not know about, but you do. And all things you’ve likely learned to live with in lieu of fixing.

Left undone, some little jobs like those don’t have much of an effect beyond the aesthetic. But some—like a dead smoke-detector battery or a broken porch step—can have dangerous consequences. That goes double, of course, in the laboratory, where even a mildly malfunctioning piece of equipment can result in grave hazards down the line.

Unfortunately, despite one’s best intentions, it’s just as easy to get desensitized to potential risks in the laboratory as it is in the home. “Sometimes when you go to the same place every day, you may not see things,” says Kailash Sharma, MD, pathology department chief and laboratory director at University Hospital, Augusta, Ga., and chair of the CAP’s Inspection Process Committee.

That’s why CAP-accredited laboratories perform self-inspections: to guard against the all-too-human tendency to overlook or become desensitized to potentially troublesome issues. The College, of course, has long required its accredited laboratories to perform and document an annual internal inspection between biennial CAP inspections. The aim of a self-inspection isn’t just to “keep a list in the file for CAP inspectors to come and look at,” as Dr. Sharma says; it’s to identify and remedy potential noncompliances that might result in deficiencies during the external inspection.

As of October, the Inspection Process Committee and the Continuous Compliance Committee have joined forces to encourage more CAP-accredited laboratories to ramp up their self-inspection efforts. “We have felt that the interim self-inspection isn’t really providing us with the kind of assurance we would like to see that laboratories are doing this well and documenting their compliance,” says John Olson, MD, PhD, professor of pathology at the University of Texas Health Science Center, San Antonio, and a member of the Continuous Compliance Committee.

“Now, it’s unfair to paint all laboratories that way,” he adds. “There certainly are many laboratories that do this extremely well. But we would like to increase the quality and the value of the self-inspection in all laboratories.”

Part of the issue, in Dr. Olson’s view, is that not all CAP inspectors thoroughly review the documentation of a laboratory’s self-inspection at the time of the external inspection. “I’ve been here at UHS for 14 years and have gone through seven inspections, and I don’t think there has been a single instance of an inspector requesting to see the results of our interim inspection,” he says. “I’m not criticizing the inspectors; I think it just has not been a habit to check. I have to admit that in the past, I have not been consistent about doing this as an inspector myself.”

Some inspectors may simply verify that the documentation of the self-inspection exists, rather than take the time to go over it in detail. Says Dr. Sharma: “I think there are probably some inspectors who do not look at it as deeply and ask questions about what you found, how many deficiencies you found, how you corrected them, and whether you have documented the corrections process. They may be looking at the list and saying ‘Okay, you corrected these things, let’s move on.’”

The Inspection Process Committee, Dr. Olson says, plans to examine the inspection checklist wording “to be sure that it’s good in this regard” and to “re-emphasize to inspection team leaders that reviewing self-inspection information at the time of the on-site inspection is something that we want to have done more faithfully.”

For laboratories, CAP inspector and former Continuous Compliance Committee chair Renee R. Ellerbroek, MD, a pathologist with Iowa Pathology Associates, Des Moines, has one major piece of advice: “Treat a self-inspection like a real event.”

That is, do everything in your power to make the self-inspection as much like a CAP inspection as possible. “Formalize the inspection procedure,” she says. “Put a date on the calendar.” And avoid the piecemeal approach. “I would definitely recommend performing the inspection at one time,” she says. “It’s tempting to say, ‘We’ll do a couple questions today and a few more tomorrow,’ just kind of folding it into the normal workload. If at all possible, say, ‘Today is inspection day.’”

Begin the self-inspection process, Dr. Ellerbroek urges, by reviewing the deficiencies cited in the last CAP inspection. “Look at these and reconcile them with your deficiency responses to see if you’re really doing what you told the CAP you were going to be doing,” she says. “If you’ve neglected these, and the deficiency is cited again at the next live inspection, it’s a good indication that a serious self-inspection was not performed.”

She speaks from experience. “As a regional commissioner, I reviewed deficiency responses,” she says. “If there were recurring deficiencies over multiple inspection events, it would tell me that the laboratory wasn’t looking at itself very objectively during the interim self-inspections.”

To add to the air of authenticity—and to aid in ferreting out as many deficiencies as possible—sister facilities can perform each other’s inspections. “It’s a non-threatening way to get a fresh perspective on your laboratory,” Dr. Ellerbroek says. To return to the home-owner analogy, you might be so used to the patchy paint in the hallway that you don’t even see it anymore. But a visitor to your home is likely to.

Dr. Olson’s laboratory, which has a training program, puts its residents and fellows in charge of the self-inspection. “The team leaders for the inspection are the chief residents, and they team up with a supervisor or a manager from a different laboratory than the laboratory they’re inspecting,” he explains. “That way, you have knowledgeable people from a different discipline coming in to take a look at the operation.”

Whereas, he says, “if I’m the supervisor of a laboratory, at the time of my interim inspection I have been living with the checklist for several years, and I feel like I have this under control. I enter the self-inspection process, if I’m going to do it myself, with an understandable bias.”

Another tip from Dr. Ellerbroek: Have as many bench-level people as possible participate in the self-inspection. “They may have a different outlook because they’re not really immersed in a managerial mindset,” she says. “It also gives them greater confidence, should the real inspection team show up when the supervisor is absent.”

Along similar lines, she suggests having laboratory personnel attend CAP training. “Especially the bench techs who are unfamiliar with the CAP process should participate in an audioconference or an online course,” Dr. Ellerbroek says. “It will help them become familiar with the CAP checklists and allow them to participate meaningfully in the inspection process.”

To truly make your self-inspection feel like the real deal, consider making it unannounced, at least to a degree. In Dr. Olson’s laboratory, the residents who lead the self-inspection are told they can perform the inspection in any week they choose within a particular month, “so there is a little bit of an unannounced character to it,” he says.

Perhaps most important, steer clear of checking things off mentally rather than documenting them physically. “I think there’s kind of the temptation to just do a mental checklist: ‘Yeah, got it, got it, got that one too,’” Dr. Ellerbroek says. “If you are certain that a policy or written procedure exists, then insist on getting your hands on a physical copy of it. The live inspector will ask for that documentation. They won’t accept: ‘We have it here somewhere.’”

Dr. Sharma says: “Most laboratories do a very good job. But some of them do see a problem and don’t document it; they think it’s not significant or that it’s been corrected. They say, ‘Oh yeah, yeah, yeah, that’s a minor thing. Why put it on paper?’”

Space issues in particular tend to be glossed over. “When you’re doing your own self-inspection, you probably aren’t going to cite yourself for space concerns,” says Dr. Ellerbroek. “But a totally objective outsider may say, ‘This is really cramped.’”

Then, too, because citing space is often a political and cultural issue within a laboratory, Dr. Sharma says, “if a laboratory manager or chief tech does not have an office space or a conference room or a locker room [as the CAP checklist requires], because of the individual situation they may not bring that to their laboratory director’s attention. It’s a hierarchy issue, particularly in international laboratories.”

Equally at risk of being downplayed are issues involving the medical director. “Actually sitting down with the medical director and assessing that person’s authority and involvement in the laboratory is essential,” Dr. Ellerbroek says. “Medical directors may be busy and difficult to pin down, so I think that part of the self-inspection may be neglected. Managers tend to focus more on the technical aspect of the self-inspection process.”

Once the self-inspection is complete, don’t just walk away. Rather, hold a summation conference, just as you would after a CAP inspection. “We actually have a formal summation conference in which we gather everybody together,” Dr. Olson says. “We invite the administration of the hospital and other laboratories to attend, so that they have an opportunity to see the results of the inspection too. And then our quality and compliance manager takes all of the findings of the self-inspection, and we require that every laboratory respond to the deficiencies that are discovered in exactly the same way they would respond to an on-site inspection.” However, there’s more time to do so, he says: “We do allow 60 days to complete this, rather than the 30-day requirement for the on-site inspection.”

Dr. Olson has every faith that with enough encouragement, more laboratories will begin paying closer attention to their self-inspection procedures. “When laboratories undergo a CAP on-site inspection, they want inspectors to come in and look hard,” he says. “They prepare, and they want people to look very closely. And I think that the interim inspection needs to be raised to that same level. We want labs to feel: ‘I want the inspector to see that we’ve done a good job of inspecting ourselves.’”

Anne Ford is a writer in Evanston, Ill.