Beyond the blame game—putting QA through its paces in AP laboratories
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
How do other labs correct similar problems? How does any lab raise
its standards when conscientious people are already doing their
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
"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
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
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#.