New push to strengthen 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 home­owner 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.