March 2012
Feature Story

Anne Ford

Nothing appeals to laboratorians more than data. And during this, the Laboratory Accreditation Program’s semicentennial year, there’s more than enough of it to go around.

Fifty years since the Laboratory Accreditation Program, or LAP, was established. Forty-eight since the first laboratory received CAP accreditation. Nineteen since CAP accreditation achieved Joint Commission equivalency; 18 since it obtained equivalency for CLIA ’88. More than 7,000 laboratories accredited in all, 318 of them outside the United States.

But there’s a less data-driven way to appreciate just how much progress the program has made in 50 years: by talking to the people on the frontlines of inspection and accreditation. Take the following tale from Jay Schamberg, MD, an advisor to and past chair of the CAP’s Council on Accreditation who has been involved with the program for more than 35 years.

In April 2010, Dr. Schamberg found himself inspecting a very small malaria research laboratory in Mali. “It was a room maybe 20 by 10 feet, and they had, maybe, eight employees,” he says. “For two years, I think, they had been preparing for this inspection. It was the first time they had seen a CAP inspector.”

Inadvertently, Dr. Schamberg strayed into the laboratory without discarding his gum. The lab’s response was polite but firm, he recalls: “One of the people, who wasn’t even a supervisor, walked up to me and said, ‘You’re chewing gum. We don’t allow anybody to chew gum in the laboratory.’”

Far from being offended, Dr. Sch-amberg says, “I was very impressed. He knew what the rules were, and he was not cowed by me being the inspector. That was the rule they had to follow, and he was going to make sure I followed it.”

That story perfectly illustrates the message that the CAP accreditation program has sent to laboratories everywhere for half a century: To achieve the highest standards of excellence, a lab must exercise vigilance at all times and in all ways. When a tiny laboratory half a world away from CAP headquarters is so dedicated to top-notch quality and safety that it refuses to overlook even a violation the size of a stick of Wrigley’s—well, that’s a pretty good indication the message has been received.

A quick refresher on the early days of the program: In the 1940s and 1950s, CAP leaders discussed creating a national laboratory performance evaluation program, but not until 1962 was the Inspection and Accreditation Program (as it was then known) created. That year also brought the formation of the Commission on Laboratory Inspection and Accreditation and the naming of the first 10 regional commissioners.

Two years later, the first facility—Medical Laboratory Associates of Birmingham, Ala.—received accreditation. But the program’s real growth spurt wouldn’t begin until the 1970s, under the guidance of commission chair Maj. Gen. Joseph M. Blumberg, MD. By the time General Blumberg retired as chair in 1979, no fewer than 2,000 laboratories had earned CAP accreditation. By 1987, that number had doubled; by 1996, it had reached 5,000; and by 2011, it had soared to more than 7,000.

General Blumberg is no longer with us, nor are many other pivotal early CAP accreditation leaders too numerous to name. Happily, several current program leaders who began doing inspections early in their careers, and who remain intimately involved with the program, can speak to its many strategic turns over the years, as well as to its future goals. The picture they paint is one of dedication, innovation, and hard work—and, as the decades have passed, ever-increasing structure and rigor.

“I was just a kid, you know?” says Gerald Hoeltge, MD, of his early days as an inspector. Dr. Hoeltge, who is a quality officer in the Pathology and Laboratory Medicine Institute of the Cleveland Clinic, a member of the Commission on Laboratory Accreditation, and chair of the commission’s Checklists Committee, has been involved with the program since 1977. “My first real inspection was at the University of Washington in Seattle. I got to participate in a very large, exciting inspection and meet people whom I had only read about in manuscripts. After that, I was hooked.”

Back then, “the management of the program was on a region-by-region, or sometimes state-by-state, basis,” he recalls. “There was no international activity. Inspectors were found by personal phone calls, and friendships were the infrastructure of getting the job done. Training consisted of being a member of an [inspection] team.”

“There was no formal training,” Dr. Schamberg agrees. “You saw one [inspection], you did one, you taught one.”

In the early days, Dr. Hoeltge adds, “the checklists were bound by a printer, and it was very difficult to change anything.” And when checklist changes were made, they were sometimes made in a hands-on fashion. “At my first commission meeting, Bill Hamlin [William B. Hamlin, MD, chair of the commission from 1993 to 2001] was vice chair,” he says. “He was a one-man checklist committee. He brought this cardboard box to the meeting with him with all this paper in it, and it was a computer printout of the draft of the next edition of the checklist. In between sessions, he had his red pen going, marking this thing up, doing it all by hand. At the time, there were over 4,000 questions.”

And although Dr. Hoeltge understandably retains a certain nostalgia for the old days (“I’ll never forget Bill Hamlin with that big cardboard box,” he says fondly), “now every one of the LAP’s processes has been systematized and standardized. Now we have online training very specific to the task at hand. And it’s a much better program.”

That’s not to imply that there was anything lax or loosey-goosey about the program in the old days. “I did my first major inspection around 1981,” says international commissioner C. Robert Baisden, MD, who is a former regional commissioner for the Gulf region and professor emeritus of pathology, Georgia Health Sciences University Hospital, Augusta. “It was in Miami, and the checklist was very different then. You had to complete every question and then send the checklist back to the CAP. If you didn’t complete it, the team leader had to answer every question over the phone the next week. So we got to the airport after the inspection, and the team leader said, ‘I have your boarding passes to get home, and I will give them to you when you complete your checklist.’ That was my introduction to CAP discipline.”

One of the most crucial turning points of the accreditation program in more recent times came in the early 1990s, when the CAP had to decide whether to seek deeming authority under CLIA ’88. “That was a very controversial issue,” says Paul Bachner, MD, a past CAP president and current member of the Accreditation Committee who is professor and chair of the Department of Pathology and Laboratory Medicine at the University of Kentucky, Lexington. “There were a lot of strategic considerations. I was on the Board of Governors at the time, and I remember it was a very close decision.”

Why? Because, as he remembers, some felt that by seeking this equivalency, “we would surrender much of our independence and our ability to set criteria that we thought were essential to patient care, and be put into the position of enforcing federal requirements, not all of which we agreed with.” On the other hand, “the people who felt differently felt that if we did not do this, the program [LAP] just would not do well and would be pre-empted by whoever was enforcing the federal law.”

The latter point of view prevailed, of course. And that, says Frank Rudy, MD, has given the accreditation program some very sharp teeth. In the view of Dr. Rudy, chair of the Commission on Laboratory Accreditation, member of the Council on Accreditation, and president of Pathology Associates of Central Pennsylvania, Harrisburg, “the program could not have grown the way it has if we had not been successful in getting deemed by CMS.” Had the College not succeeded in achieving deemed status, he says, “a laboratory accredited by the College would also need to be inspected by another accrediting body such as a state or CMS.” Deemed status does place requirements on the program. “Now if you are solely CAP accredited and that accreditation is revoked, we need to notify CMS, the state, and, as appropriate, the Joint Commission.”

Another major strategic shift came when the program began to focus on expanding overseas. Though international interest in CAP accreditation had emerged as early as 1969, and the first overseas commissioner (Robert R. Rickert, MD) was appointed in 1988, not until about 2000 did the program really begin to take off abroad, thanks in part to CAP members with ties to Brazil, South Korea, and the Middle East. “When you look at the list of countries now, it’s really quite long,” says Dr. Schamberg. The largest concentrations of CAP-accredited laboratories are in Brazil (12), China (16), Germany (14), India (37), Japan (20), Saudi Arabia (19), Singapore (18), South Korea (12), and Taiwan (25), but you’ll also find them in Barbados, Cyprus, Iceland, Kuwait, Qatar, and Tanzania, among many other countries.

Though accreditation program leaders are, of course, delighted to see the program succeed internationally, conducting inspections in other countries pre-sents a sometimes formidable set of challenges. “One of our greatest challenges in some countries is getting our PT material delivered,” Dr. Sch-amberg says. That’s particularly the case in China. “It seems to be arbitrary how PT specimens are handled when they go through Chinese customs. It’s hard to predict what’s going to be stopped and what is not. We are working with regulatory and government organizations to educate them as to the kinds of things we are shipping in—that they’re really quality control materials, they’re not in large quantities, and they don’t put China at any increased risk of biohazards.”

Inspectors who travel abroad must navigate potential cultural minefields. Not until very recently, for example, were female laboratory inspectors permitted in Saudi Arabia. “We have to be aware of cultural characteristics,” Dr. Baisden says. An American inspector must know not only how to inspect a laboratory but also that, for example, in Japan it’s impolite to take someone’s business card without pausing a moment to carefully study it.

Another challenge: The expense of sending an inspection team to another country. The laboratory to be inspected bears the costs of the inspection, which can become very high indeed when travel costs are factored in. “For a lab in India to come up with that money is a very meaningful statement,” says Ronald B. Lepoff, MD, chair of the Accreditation Committee and professor of pathology and medicine at the University of Colorado, Denver. Meaningful, yes, but no one wants it to be prohibitive.

“We want to keep the program affordable,” Dr. Baisden says, “which we think in turn will help it spread.” One way to do that is to use extremely experienced inspectors who are qualified to inspect multiple areas of a laboratory—people who are able to handle three checklists at one time, for example.

Developing international CAP communities will also help keep costs down. “We have already started recruiting pathologists who work in CAP-accredited laboratories in China to do lab inspections, so we’re not having to send the entire team from the United States,” Dr. Schamberg says. “We now have a program where we certify international inspectors. It’s a three-day face-to-face course; then they have to take an exam and do training inspections under supervision, and then they become a qualified laboratory inspector.” The first training session took place in Beijing last October.

If you’re getting the impression that a large portion of the program’s international efforts is focused on China, you’re correct. “China is a huge market. They have roughly 800 hospitals that have more than 1,000 beds and offer very complex services,” Dr. Schamberg explains. “There’s no other country in the world that has that many large hospitals. We think that’s a sweet spot for us.”

Then, too, the CAP’s competition in China is virtually nonexistent. Although a Chinese ISO program exists and has been adopted by about 80 laboratories there, says Dr. Schamberg, “the high-end laboratories really feel that CAP accreditation is necessary for them to distinguish themselves.”

Another country of focus: India, with its now nearly 40 CAP-accredited laboratories and rapid growth. Dr. Baisden points to a recent inspection in Calcutta as evidence of just how enthusiastically Indian laboratories are embracing CAP accreditation. “It was a lab that had been accredited by the Indian government, and they were very good,” he says. “But when one of our people went to the blood bank, he was there for a day and a half and found 22 deficiencies. We decided to re-inspect six months later.” On that trip, no deficiencies were found.

“And then, during the summation conference, the director of the lab came in and said, ‘The blood bank people want to speak with you separately,’” he continues. “They said, ‘We want to thank you for teaching us how to run a laboratory. We are now better than our own government, and we’re challenging our government to raise their standards.’ That’s when I learned the real value of a checklist.”

Even as the accreditation program’s international growth got underway, a highly unfortunate and widely publicized incident brought about major changes in the program’s structure. In 2004, at least 460 patients at the CAP-accredited Maryland General Hospital, Baltimore, were found to have been given potentially inaccurate HIV or HCV test results. In a May 3, 2004 statement, the CAP said: “After thorough investigation of the issues, the College has determined that what caused the errors appears to have been deliberate data manipulation by laboratory employees. The employees edited the quality control reports of the testing instrument used. This action caused unreliable patient results to be released and concealed MGH’s problem from the CAP and state of Maryland laboratory inspectors.”

“It’s the worst incident that I can remember since I started in this business anywhere in the country. Anywhere in the world, probably,” says Dr. Lepoff, who—as the chair of the Commission on Laboratory Accreditation at the time—testified in a congressional hearing on the matter. “No question that was the biggest turning point in the history of the program.”

But Dr. Hoeltge says it wasn’t a bad laboratory inspection. “The CAP team that went in there saw what looked like good records, but they were in fact bad records.” (He notes, too, that once Maryland General’s laboratory had rectified its issues, he helped perform the lab’s follow-up inspection and “was gratified to see that they were serving their patients very well.”)

As a result of the incident, the commission took a hard look at all of its processes. Dr. Bachner explains: “There had been some questions raised as to whether there was cronyism going on, whether accreditation had elements of the ‘good ol’ boys club.’ While that was not the case, in my opinion, you can see how an outside observer could question the process. So the process was considerably cleaned up, so that any potential conflict of interest was ruled out. It was a total re-do, if you will. Nothing quite stayed the same, other than the basic principle of a program based on peer review.”

Among the changes implemented: mandatory training for inspectors; a policy that requires accredited laboratories to post information explaining how workers can file reports of poor lab practices; and unannounced inspections. One of the most significant changes, in Dr. Rudy’s view, was the decision to separate the activities of the Commission on Laboratory Accreditation from the body making accreditation decisions. Thus was the Accreditation Committee established.

Says Dr. Rudy: “When I first joined the commission, it had the role both of a legislative body by virtue of deciding what the contents of the checklist would be and what we were going to inspect against, and the commission then also made accreditation decisions based on the outcome of the inspection, so it also served a judicial function. Now we split those functions, and I think that’s a very positive change.”

Not all of the changes that were implemented after the Maryland General incident have been as popular. The switch in June 2006 to unannounced inspections—a change mandated by the Joint Commission—has left some a bit disgruntled. “I never thought arranging for an inspection changed the objectivity of anything,” Dr. Hoeltge says. “You can walk into a lab and tell when they’ve done everything last-minute anyway.” One of his chief objections: “When you walk into a laboratory at eight o’clock in the morning and it’s unannounced, you’re never quite sure whether all the people who need to work with you have come to work that particular day.”

Dr. Rudy agrees. “I think it’s essential that key laboratory staff be on site when the College inspects,” he says. Not only that, but “for some laboratories, it would be helpful for them to adjust their staffing on the day of the inspection to ensure key staff will be available to spend a significant portion of their day with the inspection team without detracting from providing laboratory services. CMS will allow a two-week notification period, and we really feel it would be best if the LAP would be permitted to give a two-week notification period of the inspection date.”

Until then, there’s always the method Dr. Bachner uses: “I go to the laboratory in the afternoon after calling the director an hour before my arrival. I say, ‘How do you do? I’m the inspector and this is the start of the inspection. Please take me for a tour of your lab. I would like to meet briefly with you and your supervisors to discuss the inspection process, and then you and I can start discussing your role as director [team leader checklist]. My team and I will be here tomorrow morning to continue the inspection.’”

As for more recent shifts in strategy, one of the largest is the development last year of the voluntary Accreditation Program for Biorepositories. Biorepositories—banks of biological material stored for research purposes—are “a modality that’s growing,” says Dr. Bachner, “particularly as the ability to study, let’s say, cancers by molecular markers is going up.”

The CAP last year completed checklist, policy, operations, and other work to create the program and recruited biorepositories to participate. Inspector training began last month, and inspections will begin this spring.

More than 20 biorepositories are already on track to be inspected by the CAP this year. “Our early adopters are in the program now,” says David Booker, MD, chair of the Council on Accreditation, CAP governor, and chair of pathology at Trinity Hospital, Augusta, Ga. “The idea has been kicked around for a good while; it’s been in the last couple of years that the momentum has picked up on it. We’re in the process of finalizing the standards for that program. It’s a three-year instead of a two-year inspection cycle. It’s tailored to biorepositories, but culturally it’s clearly a CAP product.”

In Dr. Rudy’s view, the need for the biorepository program will only grow as the role of biorepositories does. “While at this point in time biorepositories tend to be focused on research activities, my own view is that that is likely to change over time,” he says. “In the future, if you or I have the misfortune of having a malignant tumor removed, I anticipate that some portion of that tumor will be placed in a biorepository—not for general research purposes, but in anticipation of the possibility that at some future date, there will be a need to go back to that specimen and analyze it for a molecular or genetic variation that may affect your future care.”

As the biorepository accreditation program launches, the CAP continues to offer another form of voluntary accreditation: CAP 15189, which accredits labs to the International Organization for Standardization’s 15189 standard for medical laboratories. While the ISO 15189 standard is mandatory in many countries, it remains optional in the United States. Introduced in 2008, CAP 15189 complements rather than replaces CAP laboratory accreditation. Thus, Dr. Schamberg, who chaired the Council on Accreditation at the time the program was introduced, calls it a “belt-and-suspenders” method of assuring laboratory quality.

“That decision [to offer CAP 15189] was made with the anticipation that ISO was going to gain additional traction in the United States,” Dr. Rudy says. “And while ISO has gained some traction outside the United States, thus far we have a relatively very small number of laboratories that are 15189-accredited in the U.S. While I think it was a strategically important initiative and has value for laboratories, it has not borne the fruit that was anticipated at its conception.”

“It has not grown as rapidly as we had hoped,” admits Dr. Schamberg. “But it is continuing to grow. And I think that it’s critical because 15189 is an international standard which is understood around the world. Had we not done this, our understanding [of the standard] would be very superficial.”

What else does the accreditation program’s future hold? For one thing, says Dr. Bachner, probably more so-called desk inspections. That is, “It may be that there are certain things that will be done in advance of the inspection by review of documentation at [CAP headquarters in] Northfield,” he explains. For example, “when you get into some of these more complex areas such as molecular testing, the ability of an inspector to make that assessment may be limited, in addition to which, it takes a lot of time. An on-site inspection may not be the best way to do that. So there’s some talk about having significant portions of the inspection done in advance.”

Then, too, the logistics of performing an inspection will change—in fact, are already changing—as the technology becomes more complex. “We’re in a time of history when the field of laboratory medicine is very volatile,” Dr. Bachner says. “It’s going to be harder to do inspections because some of the technology will be beyond the technical expertise of our current inspectors, and I include myself in that category. There are certain labs I’m comfortable inspecting, and there are other labs I’m not comfortable inspecting. I think this segmentation by discipline is going to be a challenge.”

But the accreditation program will assuredly incorporate what Dr. Rudy calls the “not just evolutionary, but almost revolutionary” changes taking place in laboratory medicine. “As an example, we are exploring what components we are going to need to place in our checklist that will address the quality of testing done for whole genome sequencing,” he says. “Only a few years ago, that was something we did not need to spend a great deal of effort on, because it was not readily available, and if it was available it was at such an exorbitant cost, it was not going to be adopted by very many, if any, of our accredited laboratories. It was more of a research tool. But that is no longer the case.”

One longstanding facet of the program that will not change: its strong emphasis on mentoring. “When I do lab inspections, I always take a couple of senior residents,” Dr. Bachner says. “I do it because it’s

a way of training young pathologists and getting them interested in serving as inspectors, and because I believe it’s a wonderful way for them to put together much of what they’ve learned about laboratories. When we come back, they always say to me that that was one of the most memorable parts of their residency. They went along because they thought it would be fun to go to a new city, but they find that all of a sudden, many of the things they’ve learned during their training, they begin to understand.”

Dr. Booker can attest to that. “When I was in my training program at the Medical College of Georgia, Dr. Baisden was head of clinical pathology, and he made a point of making sure that the residents participated in as many inspections as possible,” he recalls. “We had the opportunity to inspect pretty much every part of the lab, so we became familiar with every aspect from an accreditation standpoint. We also had the opportunity to meet many lab directors who we would then know professionally going forward.”

One of the most beneficial aspects of participating in an inspection as a resident under the guidance of a senior pathologist is the opportunity to learn things that just can’t be taught in other settings. “There are certain things you can learn in a course, and then there are certain things you don’t learn in a course,” Dr. Bachner says. “They’re just experiential.” For example, a few years ago, one of the inspectors on a team Dr. Bachner was leading came to him and revealed that she had witnessed the medical director of a microbiology laboratory drinking a cup of coffee in the lab. “This was a very senior pathologist who’d been a lab director for years and years, who clearly should have known better,” he says.

The inspector asked him, “Do I cite this? And how do I deal with it at the summation conference?” “Yes, you cite it,” Dr. Bachner told her. “And at the conference you say, ‘When I was inspecting one of the laboratories, one of the people was drinking coffee.’ Then you talk to her privately.”

“That’s the sort of thing that’s not written down anywhere,” he says. “That’s the kind of thing you learn how to deal with over the years.”