Coming soon—unannounced lab
  inspections

October 2005
Feature Story

Anne Paxton

Laboratories accredited by the CAP are used to dealing with small changes in accreditation procedures, but there has been more buzz than usual about the package announced in September and slated to take effect in January.

For the first time, the Laboratory Accreditation Program will be conducting unannounced routine inspections. The question is, will this new policy bring a sea change to accreditation—or will it produce barely a ripple?

The conversion to unannounced inspections is “a big change,” says Ron Lepoff, MD, immediate past chair of the CAP Commission on Laboratory Accreditation, but not as big as it appears.

For one thing, unannounced inspections aren’t a new idea. “We’ve done unannounced inspections all along when we thought it was appropriate, for complaint investigations, at times for re-inspection or validation of a laboratory with a sanction. A laboratory under probation, and a number of laboratories are, almost always will have a re-inspection prior to being taken off probation, and it’s almost always unannounced,” he explains.

The difference for most laboratories accredited by the CAP is that now the routine inspections will be unannounced. Laboratories doing reproductive testing and forensic urine drug testing will be excluded. “Clinical laboratories nearly always operate 24 hours a day, seven days a week turning out patient results, and should always be ready to be inspected,” Dr. Lepoff says.

What’s behind the shift? Adoption of unannounced inspections is part of a trend in accreditation, Dr. Lepoff says, noting that the Joint Commission on Accreditation of Healthcare Organizations, which accepts the CAP’s program in lieu of its own, is simultaneously making unannounced inspections a routine policy.

The seeds of change were planted five years ago, when a report from the Department of Health and Human Services inspector general dealt severe criticism to the Joint Commission for prearranging inspections rather than dropping in unannounced.

That was followed by several highly visible laboratory scandals involving fraud or results being fabricated by laboratories. Maryland General Hospital in Baltimore was the first, and there have been a few additional incidents over the past year and half.

“Whether we’re simply uncovering more fraud or there really is more, that’s more than we’ve ever found before,” Dr. Lepoff says.

The CAP believes, too, there is a need to strengthen public confidence in the accreditation process. “There is the perception on the part of some government agencies, members of Congress, and members of the public that announced inspections are subject to manipulation, that they’re not as good somehow. This is a perception not based in fact.”

“My personal feeling,” he says, “is that there really isn’t that much of a difference in what you find when doing an unannounced inspection, unless there’s some kind of deception or misinformation or fraud on the part of the laboratory. It’s not possible to make up two years’ worth of data.”

Unannounced inspections will take place before the laboratory’s anniversary date. The laboratory can choose 10 “blackout dates,” a new policy that will not apply to initial inspections.
So if there were two weeks when the laboratory didn’t want to be inspected, the inspection team would agree not to appear on those days.

In Dr. Lepoff’s view, the unannounced inspections won’t bring much disruption to laboratories’ routine operations. “I think laboratories do try to pull all the information together that the inspection team is going to want prior to the inspection. For example, they might put all the policy manuals in one room for the team to look at, rather than running all over the laboratory.”

His own laboratory doesn’t jump to wax the floor before the CAP inspection team arrives. “But we do arrange a conference room. We’re a fairly big institution and we arrange for a lecture hall for the opening and summation conferences, we arrange for sack lunches for the team, and we pull together the manuals, the PT documents, the QC documents, all the things we know they’ll want, so they’re in one place and are easy to find.”

When the inspections are unannounced, “laboratories are going to have to think ahead of time. They’ll have to make sure everyone knows where everything is. Some laboratories are not comfortable being inspected unless everyone is there, but people take vacations or get sick, and have good reasons for not being there.”

“We certainly would never intend for the inspections to interfere with the routine functioning of the laboratory,” Dr. Lepoff says. “As long as the materials are there, we don’t need to have everybody there, including the laboratory director.”

Also part of the package of changes is a new team leader checklist. “In the past, the Laboratory General inspection checklist was sometimes completed by the team leader, but sometimes delegated to a member of the team, so we had people who were not qualified to be laboratory directors making judgments about laboratory directors.”

While there was no evidence that the delegation of responsibility was unacceptable, he says, “The intent is that the team leader, most often the pathologist, be the person filling out the inspection checklist.”

“We want to emphasize that aspect of laboratory inspection,” he adds. “Certainly one of the problems at a handful of our labs has been the apparent lack of involvement of the laboratory director in the lab’s quality management systems. We think it’s important that the laboratory director be involved.”

What the checklist does first is “pull together into one place a few overarching questions and ask the team leader to evaluate as a whole how effective the laboratory’s quality systems are,” Dr. Lepoff says. “The second objective is to evaluate the laboratory director not only in terms of qualifications but in terms of the involvement of the laboratory director in laboratory functions and quality management.”

In line with the new checklist, revised forms will be sent out soon for new laboratory directors, who will be required to attest that they personally perform each of the 14 responsibilities from LAP Standard No.1, or delegate some of those responsibilities and monitor them.

Inspector training will also get a shot in the arm from the new requirements. “We’ve always had training requirements. What we haven’t done is enforce them. We’ll now be enforcing them beginning next year.” There will be a fixed requirement that all inspectors complete training, then be retrained at least every two years. “They won’t be allowed to inspect if they haven’t been trained,” Dr. Lepoff says.

The College’s Education Department will track the fulfillment of the training requirements, he says. “We already document attendance at inspector training activities, but we’ll be offering more online training with interactive features and more audioconferences. Every training activity will have a knowledge assessment at the end to make sure people got something out of the training, and didn’t just sit there half asleep, but actually heard and will be able to use the knowledge.”

Another new checklist question addresses the CAP’s laboratory patient safety goals. “The goals are very simple and are related to what laboratories do every day. They are things laboratories tend to have the most problems with, like specimen labeling, patient identification, and communication of critical results,” Dr. Lepoff says.

The new question asks laboratories whether they are addressing the current goals. “The question will now require the laboratory not to necessarily monitor compliance with every one of the goals, but at least make an assessment as to whether the lab fulfills each goal as well as possible. If they don’t find any issues with a specific goal in their situation, they don’t have to do anything.”

To ease the transition to unannounced inspections, the College is preparing a series of free audioconferences. But the most important message the CAP wants to convey about its accreditation program is that unannounced inspections will not be fundamentally different from regular inspections. While they’re likely to generate concern for laboratories, Dr. Lepoff advises, “Don’t worry about it. Just be prepared.”

In fact, unannounced inspections may bring an unexpected reduction in the hassle factor, Dr. Lepoff suggests. “Laboratories may even find they like it after a while.”