Originally published in CAP TODAY
The experiences of the half-dozen laboratories that have either undergone or undertaken the CAP’s new unannounced inspections can be summed up in three words: no big deal.
Probably the largest impact on the pilot labs—the vanguard of what will become standard practice starting with labs that have accreditation anniversaries after June 1, 2006 and reach all labs by mid-2008—has been a spike in their anxiety level beforehand, says Adrienne Malta, the CAP’s manager for inspection services.
“For the inspector, the process is not going to be that different,” she says. “The first hour, maybe hour and a half, is a little more hectic than it typically is when they’re expecting you to come. Beyond that, the process pretty much goes the same as what our inspectors are used to. The bigger impact is on the laboratories’ anxiety level. They’re thinking of all the ‘what-if’ circumstances.”
The laboratories that participated in the pilot project had a 45-day window during which inspectors would be arriving. For other laboratories, that window will be considerably wider—six months—but they will have the opportunity to choose 10 “blackout” dates when key personnel will be absent and inspectors definitely will not arrive.
The aim of the pilots, conducted during the fall and winter, was to identify ways to minimize disruptions and share findings with the larger CAP community, says Caroline Maurer, project management analyst for the College. They found, in general, that the unannounced inspections had little effect on laboratory operations.
“We challenged everything from a very small, reference-type laboratory with one technician to a large community hospital with approximately 500 beds, esoteric testing laboratories, the full gamut. From the initial findings, it seems promising that it will go smoothly. The reality is, the exception is always out there,” Maurer says.
Stuart Gunn, general manager at Pathnet, an esoteric lab in Van Nuys, Calif., that underwent an unannounced inspection in February, agrees that the anxiety that came with not knowing the exact day inspectors would arrive surpassed the rational reasons for feeling nervous.
“It’s a little bit more unsettling,” he says. “There’s a little bit different
mindset, like knowing that you have a test coming.... It’s kind of like the
Sword of Damocles hanging over your head for an extended period of time. You
try to keep it in perspective.”
Laboratory director Juan Felix, MD, was off-site the day of Pathnet’s inspection, but fortunately he was in town and did not have other critical commitments, he says.
“The mechanics and the functionality of it, in my opinion, was, I would say, indistinguishable from other inspections,” Dr. Felix says. “The inspectors were as thorough and certainly tried to find any potential deficiency as well as in other years. I don’t think that the process, from the point of view of the inspection team, was at all different. From the point of view of the laboratory, it was a scramble because, of course, we were not aware of when they were going to come.”
How did they handle that? “We gave the person in charge of the inspection a lot of warm milk to calm her down,” he says with a laugh.
Though unannounced inspections come with the risk of critical personnel being off site, Dr. Felix says he believes they present no deep-seated risks so long as laboratories are doing the right things day to day.
“We have a very good lab that complies with the rules and the spirit of the rules of CAP,” he says. “Those laboratories will fare well in a surprise inspection scenario. The fact that we all suspect that some labs basically put on some cosmetics for inspection and pass should really be either confirmed or dispelled by a surprise inspection. That’s the idea of doing these: to make sure laboratories are in compliance not just for the week of the inspection but all year round.”
Those thoughts are echoed by Philip Dutt, MD, a pathologist at Kern Medical Center, a mid-size community hospital in Bakersfield, Calif., that underwent an unannounced inspection on Jan. 3.
“A lot of labs and pathologists are afraid of these unannounced inspections, but it went surprisingly well,” he says. “Probably, these unannounced inspections are more likely to be effective. They’re closer to reflecting the day-to-day reality of what the lab is really doing.” He says it’s analogous to random drug testing versus scheduled drug testing for athletes. “If it’s random, you’re more likely to catch people.”
Dr. Dutt notes the Joint Commission on Accreditation of Healthcare Organizations has taken a similar approach. “The reasoning is the same,” he says: “You’re more likely to detect the ordinary working state of the hospital if it’s unannounced than if it’s planned.”
The shift toward unannounced inspections is part of a broader trend that gathered steam in 2000 when the Department of Health and Human Services sharply criticized the Joint Commission for prearranging inspections.
The drumbeat has grown louder over the past six years, nudging the CAP and other organizations to move to unannounced inspections.
“We want to increase the public’s confidence in our ability to assess laboratories effectively,” the CAP’s Malta says. “We want our labs to be in a constant state of readiness. They should always be doing the things that we expect of our accredited laboratories.”
R. Bruce Williams, MD, chair of the CAP’s Commission on Laboratory Accreditation, says unannounced laboratory inspections are an idea whose time has come. “The commission is continuously looking for ways to improve itself and is continuing to evolve,” he says. “The unfortunate incidents that occurred at Maryland General gave the College and the commission an opportunity to look at the activities of the accreditation process to see if there’s anything we can improve.” Maryland General Hospital was the subject of congressional hearings after testing problems related to faulty equipment were discovered.
The pilot laboratories provided overwhelmingly positive feedback, with the downsides related mostly to relatively minor issues like not having breakfast ready upon inspectors’ arrival, Dr. Williams says. “The labs were happy to show that they were in compliance continuously,” he says.
The College has assembled findings and recommendations based on the pilots;
they are available on the CAP’s Web site (www.cap.org)—in
the “What’s New” section under the Laboratory Accreditation Program—and
through audioconferences, Malta says.
But the short story is that the labs in the pilot performed well, the CAP’s Maurer says. Pre- and post-interviews revealed their concerns going in and to what extent the experience had met—or not met—labs’ expectations, she says.
Beforehand many concerns revolved around “logistical things, like having a conference room available, having lunch available, having timely access to their documentation when it was requested,” she says. “And then having available the day of the inspection the people primarily knowledgeable about the testing.”
Most of these concerns did not prove to be problems, Maurer says. “When [inspectors] first presented, obviously they needed to assemble their documents,” she says. “With most of the pilots, they had that done within approximately 20 to 30 minutes. In every [location], we had a conference room of some sort. Amazingly enough, we were able to find food.”
In a couple of cases, the medical director or other key management personnel were not present when inspectors arrived, but others were able to help out. The labs’ preparation for such contingencies proved beneficial, Maurer says.
“It encourages the bench-level technologist to be involved in preparing for a CAP inspection,” she says. “Most of the pilot laboratories have been conducting drills—CAP drills, like a fire drill. They pretend a CAP inspection team has presented at the door, and they go through the process of who’s going to assemble the documents, bring in food, secure interview time.” That process has lessened anxiety, she adds. “It’s sometimes better to always be prepared than to get prepared. You’re not scrambling at the end to get it all done.”
Inspection teams need to keep in mind that they’re not necessarily expected on that morning, Maurer says. “The message we’ve been sending out is to allow yourself, as a team, a little extra time to allow the laboratory time to assemble their documents, and not to have a very tight end-time for the day to allow for any document retrieval that’s necessary, maybe from an off-site location,” she says. “Plan to get something to eat before you arrive. And plan to arrive at the lab as a collective group.”
Posted on the Web site are tips for inspectors about “what they should do to prepare, how they should go about scheduling the inspection, what to do if they find they need additional resources for the team [such as] a specialty inspector that they don’t have, what to do if they’re having trouble getting enough people together,” Malta says.
The CAP sends copies of current checklists to labs when they reapply, which they should be sure to annotate, she says. “The policy related to proficiency testing, for example, is located in the administrative manual. The annotated checklists are a quick reference on where to find something specific if they’re in a nervous state and they can’t find it,” Malta says. “That does help the process if they can prepare that.”
C. Robert Baisden, MD, who chairs the Commission on Laboratory Accreditation’s
new Inspection Process Committee (Related article: CLA
revamp means speed, efficiency), agrees. “If
the laboratory can answer ‘yes’ to
each checklist question that applies to the laboratory, and documents the data
so that it is readily available at the time of the inspection, the unannounced
inspections will be a pleasure and a rewarding experience.”
The laboratories inspected during the pilot phase and those doing the inspections essentially agree they’ve been more rewarding than stressful.
“The inspection was very much the same,” Pathnet’s Gunn says, “with the exception
that in the past, knowing when someone was going to be here allowed us to have
things in a convenient area—our procedures, our QA records—to make
it easier for inspectors. We’re a little bit spread out, and things are in
“The thing that we have always valued about the CAP inspection is working together with the inspectors,” he adds. “There’s always an exchange of ideas and perspectives. It helps us to structure our programs. We do things beyond the scope of the surveys, but we always make sure we’re running the operation in a fashion that addresses each of those areas.”
To prepare, Pathnet made sure key staff would be around, Gunn says. “A six-month window is going to be much more difficult, to make sure that your usual team will all be present,” he says. “That was one of our concerns from an operational business standpoint, trying to make sure that all of your key staff members are going to be on-site. It means that you can’t maybe schedule some meetings away from the lab that you might need to, or a conference that you had planned on sending someone to.”
But altering staff schedules is precisely what the CAP is encouraging labs not to do. “Just as patient testing continues without key personnel on the premises, so can an unannounced inspection,” says the CAP’s market manager Kathy Cilia.
Dr. Felix says the basic questions would be answerable without him present but deeper inquiries might need to wait, which has prompted Pathnet to accelerate its cross-training of personnel.
“Our laboratory can function without me. It can function very well without anybody who’s not there at the time. Some questions will have to be deferred if critical personnel is not there,” he says. “The checklist questions won’t be a problem, but if there’s a deeper inquiry into something, that will be a problem.”
Pathnet already had been cross-training microbiology and molecular pathology staff given the natural crossover, and “the knowledge that the inspectors would be in, in surprise fashion, urged us to speed up that cross-training,” Dr. Felix adds.
The process also prompted Pathnet to update paperwork in real time, he says. “It forced us to make corrections to protocol that previously used to be handwritten in the local books for a week or maybe even a month,” he says. “We don’t want a handwritten protocol on a bench with a different protocol in the central system.”
Gary Ponto, MD, of Santa Barbara (Calif.) Pathology Lab, says his three-person team that inspected Pathnet had apprehensions of its own beforehand. “None of us had ever done an unannounced inspection before. In reality it went almost like an announced inspection,” he says. “The only thing really missing was the usual coffee and donuts, but they arrived within minutes of our arrival.”
Dr. Ponto agrees with Malta that inspectors need to account for confusion at the outset. “Conceptually we’ve all known that we should always be ready for an inspection on any given day. As a practical matter, you are never as prepared as you are the day you know the inspection is going to arrive,” he says.
Dr. Dutt says Kern Medical Center did not institute major changes before its unannounced inspection. “The main thing we had done was have a contingency plan in case supervisors were not scheduled to be in on that day. Other than that, it was pretty similar to a regular inspection,” he says. “We were making sure our manuals were up to date and our procedures and policies were up to date.”
Don Broadley, clinical lab scientist and assistant laboratory administrative director for compliance at Kaiser Foundation Hospital in Sacramento, Calif., says the six-person team that inspected Kern experienced no significant glitches.
“There were some people who were not on site. It was not a glitch. It was a glitch for them because they assumed they needed those people there,” he says.
Broadley advises laboratories to make sure they don’t have to scramble. “Pull together laboratory staff and supervisors so information is shared and you don’t have to call somebody in,” he says. “Everyone should know where all of the proficiency testing and all of your QC records are kept, so you don’t have to scramble and find your QC supervisor out in the woods where they’re camping when this happens.
“That’s what I have found most in the sections I have done,” he adds. “For example, the hematology section hasn’t got a clue where chemistry keeps their records and vice versa. That’s a big, essential part that needs to change.”
Laboratory Corporation of America in Delaware, where Michael Mahoney, MD, serves as lab director, sailed through smoothly last November, he says.
“I was not at the laboratory when the inspection team came in, but I received
a phone call and went there,” he says. “Our quality assurance program at LabCorp
is pretty extensive.... We did nothing special other than keeping up with new
material that was coming forth from the CAP.” He adds, “I don’t think unannounced
[inspections], at least with the bigger labs, is something that’s going to
impact them because of their extensive quality improvement programs that are
Dr. Ponto of Santa Barbara Pathology Lab believes smaller labs like his, particularly those in more rural areas, will face a greater challenge. “At my little lab, we may oftentimes only have a secretary. I may be out in the field; I may be at the main lab, which is 100 miles away,” he says. “So much of what you need at an inspection requires a minimum of management on site. An unannounced inspection at my little lab could be a disaster. It would take people driving 100 miles at a moment’s notice to come here.”
The CAP should probably take a cue from JCAHO, he suggests, which publishes that day’s agenda on its Web site at 5 AM. “A hospital even has two or three hours of warning. I think CAP will have to do that,” he says. Otherwise, “the team may show up and there may be no one there—or almost no one there, but one terribly frightened secretary.”
LabCorp’s Dr. Mahoney, who saw the other side of the process when he inspected a laboratory in Las Vegas on March 2, would like to see checklists better streamlined to eliminate redundancies between the general lab checklist and those of specific areas. He would also like to see repetitive review eliminated of multidisciplined platforms under several department-specific checklists.
“As an example, you’ll have more than one inspector looking at the same checklist item on multiple departmental checklists,” he says. “I’ll walk into the department, and under the departmental checklist, I’ll want to see a specific item cited under one of the checklist questions. Then, the person who’s doing the general lab checklist may come in a half-hour later and want to see the same item that had been just reviewed under the department checklist. Well, the other inspector just did that. That tends to slow up or confuse the process.”
Kaiser Foundation’s Broadley expects the process will not go quite as smoothly as with the pilots with a six-month window facing those who will be inspected henceforth. But that doesn’t mean lab staff should get butterflies in their stomachs, he adds.
“This was a pilot. They knew we were coming within a certain time frame,” he says. But, “if there were any words of wisdom, it would be that you’re probably going to panic more than you need to, and you’re probably in better shape than you think you are.”
Dr. Baisden of the CAP’s Inspection Process Committee advises that laboratory staff prepare a written procedure, unique to their own laboratory, titled “The Unannounced CAP Inspection.”
“The CAP inspection date will be a surprise,” he says, “but there will be no surprise questions from the CAP.”
Malta encourages those with questions or concerns to express them to the CAP by sending a note by e-mail to email@example.com or calling the College’s toll-free number (800-323-4040 option 2#).
“I would encourage them to make use of the tools we provide them,” she says. “If they have suggestions or feedback, we would love to hear it. This is a new process. The more we can hear from people, the better it will direct us to make improvements.”
Ed Finkel is a writer in Evanston, Ill.