College of American Pathologists
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Beyond the blame game—putting QA through its paces in AP laboratories

April 2002
Mark Uehling

Not long ago, a prestigious medical research center in the Midwest assessed the quality of its anatomic pathology. One unexpected finding popped up. Every morning, nurses in the operating room were prelabeling requisitions and specimen containers for all patients scheduled for surgery that day.

When news of this practice reached the laboratory, it was not well received. Prelabeling, of course, can set a few undetected errors in motion. Pathologists and surgeons halted the practice immediately.

How do other labs correct similar problems? How does any lab raise its standards when conscientious people are already doing their best?

Tackling quality quandaries can be tough, which is why the CAP recently published the Quality Improvement Manual in Anatomic Pathology. The second edition, all 115 pages of it, contains meticulously prepared guidance on how to avoid some of the tens of thousands of medical errors that occur annually. As the Institute of Medicine has documented, American medicine does not have the one-mistake-in-a-million quality record of, say, the semiconductor or airline industries.

Given the nuances and complexity of medicine, the rate of serious errors is probably always going to be higher than that for people who build computer chips or pilot jetliners. "We’re hoping to improve the status quo," says Raouf E. Nakhleh, MD, co-editor of the new volume and senior staff pathologist at Henry Ford Hospital, Detroit.

The first edition of the manual was published in 1993, and since then, Dr. Nakhleh says, there has been a profusion of academic research and CAP data to help pathologists and others determine where errors arise and how to prevent them.

"Prior to 1990," Dr. Nakhleh adds, "there was very little literature on errors in surgical pathology. Since then, there have been a number of studies that have seriously looked at it. With data, you can provide some answers. You need numbers to say, we’ve got a problem here. We tried to incorporate the data that’s out there."

Throughout the new manual, for example, Q-Probes data are cited frequently when such studies provide useful comparisons for other labs. An example of such data: the finding of identification and accessioning errors in six percent of more than a million cases from 417 institutions, with discrepant or missing information in 77 percent of the errant subset of specimens. The manual is filled with such facts, all placed to help labs understand what they’re doing right and what could be improved.

But quality is more than statistics, as Dr. Nakhleh points out. Like any diagnosis, quality has human and subjective components.

"Our customers are the physicians who send us the biopsies, the tissue samples," he says. "Unless you put information in a report that the surgeon can interpret, you haven’t done your job. They have to be satisfied that our product is good. You do some of the assessment of quality informally because you interact with your colleagues all the time. But it is also smart to do a formal survey every year or two because you’re not having lunch with everybody." To assist with that, the manual contains sample questions for surveying surgeons or gynecologists.

Equally practical: an easy-to-swallow but potent dose of the accreditation requirements and federal regulations pertaining to quality. The authors of each chapter were charged with condensing the pertinent rules that govern particular practices—for example, the CAP requirements for retaining immunostained slides.

"We incorporated, whenever we could, regulatory compliance elements," Dr. Nakhleh says. "We know we’ve got to meet CLIA standards; we know we’ve got to meet the laboratory accreditation process; we know we’ve got to meet JCAHO standards. We tried to blend those elements in with the data we had and put it in a useful way for our membership and our colleagues to use."

The creators of the CAP manual had another goal: to help laboratory professionals track their own efforts more systematically. "Part of this manual is helping people design monitors so that they can measure what they’re doing," Dr. Nakhleh says. "In the airline industry, they encourage the reporting of errors so they can collect as much data as possible and work on the problems."

In pathology, he notes, the regulatory climate is different. But Dr. Nakhleh suggests that the airline industry’s doggedness in identifying and eradicating opportunities for error is something the medical community could emulate.

"Certainly one of the charges of quality improvement is to improve the system rather than find and place blame," he says. "Look hard at the system, examine as much as you can, and try to prevent errors by modifying the system. It -shouldn’t be about placing blame on anybody."

Mahul B. Amin, MD, vice chair of the CAP Cancer Committee, considers the new CAP volume the best single source of information about quality issues in anatomic pathology. "Almost all physicians want to do quality right, as opposed to having a program just for the sake of having a program. This manual makes it easier to have a meaningful program," says Dr. Amin, associate professor of pathology and urology and director of surgical pathology at Emory University Hospital, Atlanta.

"There is no single pathology textbook that talks about quality assurance in such great detail," he says. "This is, to my knowledge, the only book entirely devoted to developing and carrying out a quality assurance plan in anatomic pathology."

The new manual, in Dr. Amin’s view, is suitable for labs embarking on quality improvement and for long-time quality mavens who need a few new ideas or reminders. Suppose, he says, a pathologist wonders, "What do I do for retention of blocks? Or what is the benchmark for turnaround time for complex specimens?" The answer is readily available.

Pathologists, he notes, typically are not as thoroughly trained in running labs as they are in making diagnoses. "What saves an institution," Dr. Amin says, "is not only the best practice for a given case but a best-practice environment. This manual gives the broad strokes for the entire QA operation."

That includes cytopathology. Theresa M. Voytek, MD, director of cytopathology at Hartford (Conn.) Hospital, says residents and fellows in her field are not likely to be inundated with quality improvement instruction during their training. "Most of our trainees, especially in cytopathology fellowships, will go on to be involved in quality assurance and improvement. This manual will be very useful to those going into practice," says Dr. Voytek, who helped edit the cytopathology chapter.

The manual contains extensive facts on, for example, the 2001 Bethesda system and the CAP Interlaboratory Comparison Program in Gynecologic Cytopathology. "It’s very current data based on the current practice of cytopathology," Dr. Voytek says.

Her colleagues provided 16 cytology-related tables, all of which can be photoduplicated or edited and used immediately. "We wrote the tables the way we did so that cytopathologists could copy them or modify them ever so slightly and adopt them," Dr. Voytek says.

The manual’s table 14, for instance, is a one-page form that divides into columns the conventional and liquid-based methodology statistics for a wide variety of gynecologic cases. "That will be helpful to labs that are trying to find a convenient way to tabulate these data," Dr. Voytek says.

The new manual, she adds, could help pathologists avoid mistakes. "Public expectations are higher than they have ever been," she says. "The cytology community is under greater scrutiny today. Implementing specific and complete quality assurance and improvement procedures can protect the laboratory and cytopathologists who are practicing in this difficult time."

The aim of the manual is to make higher quality possible for every laboratory and to offer a fresh way for anatomic pathology labs to design their quality programs. "Instead of revising parts of the old manual, we decided to take a new approach and totally rewrite it," says Patrick Fitzgibbons, MD, chair of the CAP Surgical Pathology Committee and co-director of pathology at Good Samaritan Hospital, Los Angeles.

"We wanted people in anatomic pathology to think in the same test cycle that people on the clinical side have been doing for years," he says. "Instead of focusing on a person who makes a mistake, let’s focus on the system. What can we do to minimize that?"

Part of the strategy, Dr. Fitzgibbons says, is to make it clear that quality is not some sort of Mt. Everest—dazzling and splendid to behold but unattainable by ordinary mortals.

"If quality becomes too much of a big deal, a big burden, if it requires a terrific number of additional resources, then it won’t work," he says. "Every lab has a certain amount of resources it can devote to quality improvement, and it has to make a decision—how can it most efficiently use those resources—i.e., pathologists’ time and staff time."

Referring to the guidelines in the manual, Dr. Fitzgibbons says: "We’re not saying you should implement them all. We’re saying you should implement various things that are appropriate for your situation and then change them from time to time."

"Let’s say you’re going to review all ultrasound-guided core biopsies of the breast for a period of time," he adds. "You’re going to do this by having a second pathologist review all of the slides within so many days of sign out. Then, after two to three months, you realize, you’re not finding any errors; everything seems to be fine. At that point, you’ve done a nice study, and it’s time to do something different."

Dr. Fitzgibbons is especially proud of the manual’s chapter four, which delves into how to define errors and what to do when they occur. But this doesn’t mean the manual contains a cut-and-dried set of marching orders for those who identify errors. "We didn’t want to just say, ’Do this, this, and this,’" he says. "It’s a very difficult area, partly because the response to finding an error varies based on the nature of the case, the specific discrepancy that has been found, and how much time has elapsed since the original pathology report was issued. We can’t mandate a specific response for each situation."

Like Dr. Nakhleh, Dr. Fitzgibbons hopes pathologists will focus on improving a system as much as a single diagnosis. "Someone did a study looking at axillary lymph nodes of micrometastases," he recalls as an example. This has an error rate of about two or three percent. Cutting that rate closer to zero is pretty simple: Have two pathologists examine the evidence.

"That’s a way of avoiding having to say Pathologist A screwed it up," he says. "What you’re saying is, we created a system that reduces the chance of a missed diagnosis or a major discrepancy to an acceptably low level." The new manual is filled with such insights and with the practical tools to achieve new quality heights.

Mark Uehling is a writer in Chicago.

To order the manual (publication No. 113, $45 for CAP members, $60 for nonmembers), call CAP customer service at 800-323-4040, option 1#.