As the CAP marches forward with
its newly inaugurated unannounced inspection process, which began June 1 and will roll out over the next two years, the Laboratory Accreditation Program is bringing online a new conflict-of-interest form, an automated matching system, and an earlier reapplication date for labs.
The new conflict-of-interest form will enable laboratories to identify institutional conflicts before assignment. The form will be on the CAP’s Web site and in the self-evaluation packets, says Denise Driscoll, director of laboratory accreditation.
“If inspectors and laboratories tell us ahead of time they have conflicts of interest, they can give us that way in advance and we will never match them for an inspection,” she says.
The assignment acceptance system will work like jury duty, Driscoll says. Rejecting an assignment just means a laboratory’s name goes back into the pool for consideration in the near future. “If they reject it, that’s fine,” she explains. “We will just put them back in the system and look for a good match. It could be that the anniversary date’s not good timing for them, or they don’t think they’re a good fit for that laboratory, or they have a conflict.”
C. Robert Baisden, MD, chair of the CAP’s Inspection Process Committee, cites several reasons why an assignment might be rejected. “Some of the reasons would be an existing business or professional relationship. If a large pathology group covered several hospitals, that would be a conflict for one of those hospitals to come in and inspect a sister lab,” he says. “And consultations—if you have someone consulting in a laboratory, the consultant must not inspect that laboratory. The thing that’s really not recognized, right off, is that people have a lot of part-time jobs. The team leader needs to know where the team members are moonlighting.”
A laboratory might also cite an existing personal relationship, Dr. Baisden says. “If your spouse is working at the lab to be inspected, it certainly would be a conflict of interest for you to inspect it. Or the time frame —you can’t do the inspection in the time frame needed. And then, there is the direct competitive relationship. That does cause problems. Sometimes they’re so competitive in small towns.” He adds: “We want the team leader to reveal this conflict of interest and turn down the assignment. We would find someone else to do the inspection at that point.”
The form does not allow laboratories to reject a match for just any reason, Driscoll says. “The laboratory won’t have an opportunity to say, ‘No, I don’t want that team. The director from that laboratory used to be married to my other pathologist,’” she says. “We need to do a good job of having the inspector tell us if there are any conflicts, [such as] if they’re working at the other institution that they’re [assigned to be] inspecting.”
The computerized matching system will assign laboratories based on factors like size, test volumes, disciplines, and geographic location, with the aim of providing better inspections and a more productive peer-to-peer educational experience for the inspected and the inspectors. In addition to these advantages, the system will enable the CAP to schedule inspections farther in advance and during a time outside inspectors’ own inspection window for their labs, under the new unannounced inspection process.
The matching system should reduce the burden on state commissioners’ offices and provide a team of appropriate size and composition. With help from the state commissioners, who have insider knowledge, the process should run smoothly, Dr. Baisden says.
“The state commissioners will be asked to review these assignments ahead of time to see if they know of any conflicts of interest. They often know little things no one else knows about laboratories,” he says. The computerized system will match appropriately sized laboratories and areas of expertise. “If a laboratory to be inspected has molecular pathology, the computer would not choose a small hospital that did not have molecular path on its menu to supply the inspection team.
“What we expect this program will accomplish is the fielding of a professional inspection team of appropriate size and composition with laboratory expertise. Probably the No. 1 complaint I have received from laboratories that have been inspected is that the inspection team was too big.”
Driscoll says the state commissioners’ offices will stay involved. “The computer will select the best match—not one that’s across the street, but not too far away,” she says. “The state commissioner will vet that match. We’re not taking the human part out entirely… [The new system] will look at things like the specific disciplines and the number of disciplines. We think the computer will give us better matches. If there has been a conflict identified and stored, it won’t select that one.”
Future use of the system guarantees that the assignments to inspect a laboratory will not conflict with inspectors’ own time to be inspected, Dr. Baisden says. “Right now, there’s a little overlap,” he says. “You might be scheduled to be inspected at the same time you’re doing an inspection because they’re unannounced. The CAP office currently uses manual methods to prevent this. The CAP, through the automation, will not make an assignment for that team during the six months they’re open for inspection. That’s one reason for automating it.”
The CAP will keep training records for inspectors to make sure teams are properly trained before heading into the field, Dr. Baisden says. “We only pick trained laboratory workers to do the inspections,” he adds. “This approach of using knowledgeable laboratory peers with special training in inspection techniques makes sure that the laboratory is being inspected by the best possible inspectors.” Dr. Baisden confirms that the state commissioners will remain involved. “Certainly, we’re still relying on the state commissioners and the regional commissioners to make sure this is a smooth process. The state commissioners will be called upon to vet any problems prior to the making of final assignments,” he says.
But leaving the system entirely up to humans would prove untenable under the new system that requires laboratories to be assigned well before their anniversary dates, Driscoll says. “Doing this manually, it’s just too many different parameters for our human brain to process at one time,” she says. “The computer can do it better. By our getting the assignments done earlier…they can accept their inspection sooner.”
This facilitates moving the reapplication date back to nine months before a laboratory’s anniversary date, where it has been five months, which gives the CAP time to assign the team and match it appropriately while being aware of blackout dates. This, in turn, gives laboratories time to update test menus and become familiar with the appropriate versions of checklists while granting inspectors-to-be enough time to become trained.
Driscoll says this move will happen gradually. “Every laboratory is on its own individual cycle,” she says. “We’re starting to send these out earlier. There’s a cycle to this transition process. I wish we could say a definitive date” when all will hit the nine-month lead time. But labs need not get too impatient, she adds.
“The advantages to the laboratory from moving the re-app date are not huge. It’s really so the inspector can use the whole six-month window. But labs are locked into the checklists earlier, which is a positive thing for them. They know which version will be used sooner, and they’ve got more time to become familiar with that specific edition.”