College of American Pathologists
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  In producing ‘paper’ standards, all hands on deck


CAP Today




October 2009
Feature Story

Anne Ford

If you’ve ever planned, led, or facilitated anything, you’ve undoubtedly seen the Pareto principle at work. Named after Italian economist Vilfredo Pareto, it postulates that in just about any enterprise, 80 percent of the effects are produced by 20 percent of the causes. Hence its more widely used name, “the 80–20 rule.” It’s most often interpreted to mean that in almost any group effort you can think of—from a work-related project to a PTA bake sale—20 percent of the people do 80 percent of the work. So how can the 80–20 rule be overcome? For starters, by simply spreading the word that there’s work to be done.

At least, that’s the hope of Alfred E. Hartmann, MD, a pathologist with Physicians Laboratory, Ltd., in Sioux Falls, SD, and chair of the CAP’s Standards Committee. With the other committee members, Dr. Hartmann is trying to draw attention to one area where that infamous 80–20 balance could use some remedying: the creation and review of “paper standards,” a.k.a. the recommendations and standards for clinical laboratories produced by the Clinical and Laboratory Standards Institute (CLSI), ISO, and other bodies. (They are called “paper” standards to differentiate them from the “bottled” or “liquid” standards used to standardize a laboratory process.) At the moment, the volunteers for this task come almost exclusively from the resource committees that fall under the auspices of the CAP’s Council on Scientific Affairs. So what’s wrong with that?

“The College has maybe 30 resource committees,” Dr. Hartmann points out. “Each committee has, say, 15 people. So there’s roughly 400 people on the resource committees out of a College membership of 17,000 people. Those 400 people, or whatever it is, get the same requests [regarding paper standards] over and over again. It became obvious to us that we have to involve more of the membership.”

Involve members in what, exactly? In a nutshell, helping make sure that guidelines that affect clinical laboratories are developed with input from pathologists. “There are standards and guidelines being produced by standard-setting organizations throughout the world that potentially affect the practice of laboratory medicine in the United States,” says Dr. Hartmann, “and these standards and guidelines aren’t necessarily produced by pathologists.”

For example, ISO’s documents “are produced mainly by scientists and in vitro diagnostic manufacturers’ representatives, not pathologists,” he continues. “Pathologists are actually a rarity on those particular working groups. So it behooves us as pathologists to try to get our membership involved in these working groups at an early stage, when the document is actually produced. The people writing the document have an obvious advantage. It’s much easier to have your opinions and biases put into the document at the production stage rather than at the review stage.”

The Standards Committee itself was reformed in 2008 to address the issue of paper standards. “The whole thing started with the Standards Committee being reborn,” says committee member James D. Faix, MD, associate professor of pathology at Stanford University School of Medicine. “Its charge was to coordinate the ways in which paper standards were reviewed by the College.”

That is, adds Dr. Hartmann, “the committee was charged with being the repository of the reports of inbound and outbound CAP liaisons to groups such as ISO and CLSI. The CAP for years has had liaisons to other organizations who have reported back to mainly the resource committees, and that information then resided in that resource committee and never got disseminated. It was realized that we needed a central repository, and the Standards Committee was reformed with that in mind.”

“Repository” may not be the most accurate description, however, given how constantly and quickly proposed paper standards flow back and forth between the College and CLSI, ISO, and other bodies. “They kind of flash by,” says Standards Commit­tee vice chair William J. Castellani, MD, professor in the Division of Clinical Pathology and medical director of clinical chemistry at Penn State Milton S. Hershey Medical Center. “It’s such an ongoing and dynamic process. New standards come up, old standards become historic. The Standards Committee tries to keep its finger on these activities.” At the same time, the CAP’s Sharon Burr, MT(ASCP), MBA, technical manager of Surveys, keeps a log of active and completed standards activity and acts as a standards liaison between the standards bodies and the CAP.

“It’s not necessarily the committee’s role to be the providers of input to the standards bodies,” Dr. Castellani explains. “We are more the monitors of the process, to ensure that things don’t fall through the cracks. It’s the resource committees, as well as CAP members who have expressed an interest, who we rely on to actually provide the expertise.”

Anyone interested in providing his or her own expertise in this regard should contact Burr, Dr. Hartmann says, keeping in mind that “if the CAP nominates a person for a project, that doesn’t necessarily mean that nominee will be selected, because other organizations will be nominating people.” Bear in mind, too, that it’s not just ISO and CLSI that set standards that affect pathologists, but also organizations such as the American Joint Committee on Cancer and the Association for Molecular Pathology. “Almost any organization might produce a standard or a guideline that might affect the practice of laboratory medicine and the care of the patient,” he says.

That these guidelines and standards are voluntary, Dr. Hartmann adds, doesn’t make pathologists’ involvement any less crucial. “They have the ability to become laws,” he points out. “Even if they don’t become laws, they tend to become best-practice guidelines and could cause problems in the legal area if people are doing some sort of practice in a different manner, even if it’s just as scientifically valid. If there is a guideline or standard out there, then you would have the onus of proving that the way you’re doing it is just as acceptable, and that can be difficult.”

“What I really would like to convey,” he says, “is that pathologists by nature of their training have been exposed to all aspects of the laboratory, so that breadth of knowledge makes them uniquely qualified to contribute to standard-setting activities that might affect the entire laboratory, particularly in the area of quality assurance and management issues. That’s what makes a pathologist unique. Our focus is trying to find these individuals.”

Not only find them, but convince them to pitch in their effort and expertise so that the College helps shape the standards that affect the future of pathology. Says Dr. Faix: “We’re too passive if we just wait to hear what ISO or CLSI has to say.”

For more information on how you can become involved with the College’s standards activities, contact Sharon Burr at the CAP at 800-323-4040 ext. 7417.

Anne Ford is a writer in Chicago.