With the announcement that the Centers for Medicare
and Medicaid Services had approved a gynecologic cytology proficiency
testing program, a once-dormant provision of CLIA ’88 has become a central
concern for laboratories performing cytology testing.
The Midwest Institute for Medical Education, or MIME, a nonprofit company
based in Indiana, obtained CMS approval for its program and began enrollment
in November. But the College has also submitted an application to the
CMS for approval of its Interlaboratory Comparison Program in Cervicovaginal
Cytopathology—known as the Pap program—as a national PT program
College officials had requested that the CMS delay implementing the requirement
for at least one year. "Laboratories do not need to sign up by Jan. 1,
2005, as some advertising has claimed. That’s not what CMS has decided,"
says CAP president Mary Kass, MD.
The CMS posted a letter on its Web site (www.cms.hhs.gov/medicaid/survey-cert/sc0511.pdf)
in December listing the following compliance dates:
- Laboratories must ensure that individuals performing gynecologic
cytology testing are enrolled in a CMS-approved cytology PT program
by June 30, 2005.
- All individuals performing gynecologic cytology testing must be tested
at least once by a CMS-approved provider by April 2, 2006.
- Individuals who do not pass the first test will have the opportunity
to be retested. All individuals that perform gynecologic cytology testing
must pass a proficiency test by Dec. 31, 2006.
The gynecologic cytology PT requirement is a "sleeper" provision of CLIA
’88. When approved programs become available, all CLIA-certified laboratories
performing cytology testing "must ensure that each individual engaged
in the examination of gynecologic preparations is enrolled in a proficiency
testing program approved by CMS," according to the CLIA regulations.
The requirement that laboratories conduct cytology PT was not only included
in the law, but also viewed by some as one of its chief purposes because
of widespread media attention to Pap testing errors. Though the state
of Maryland has had a CMS-approved program for about 10 years, until now
no national gynecologic cytology PT program has been available.
CLIA ’67 was the genesis of cytology proficiency testing
because it set requirements for PT in a variety of laboratory areas, notes
R. Marshall Austin, MD, PhD, of Coastal Pathology Laboratories, Charleston,
SC. Dr. Austin is president of the American Society of Cytopathology.
"To the extent that cytology was considered to be like a laboratory test
rather than an interpretive professional medical service, it initially
was included in with the rest," he says. "The thought at that time about
doing PT in cytology was largely by analogy with other clinical laboratory
tests. However, there was never any serious discussion of extending this
to other parts of anatomic pathology, so far as I’m aware."
Two decades later, a 1987 Wall Street Journal article focused
on Pap testing. The article eventually led to CLIA ’88. "When this went
to Congress and elected officials were trying to address the political
issue of what to do," Dr. Austin recalls, "this concept of cytology PT
came back up and it seemed logically at first to some like a good idea,
because certainly, who can be against proficiency?"
"At the time," he adds, "some larger laboratories were really trying
to get cytotechnologists to look at too many slides, but that was largely
a matter of bad laboratory management and corporate practices rather than
people who were not qualified to review slides. But that’s how individual
PT eventually got into the law."
The effectiveness of gynecologic cytology proficiency testing has never
been evaluated officially, Dr. Kass points out. The state of Maryland,
with the only CMS-approved program, requires all pathologists and cytopathologists
to take gynecologic cytology PT. But Dr. Kass is skeptical of its value.
"I think what the tests do is drive people out of the field, pathologists
specifically," she says. "If you have only a small number of cytology
tests, and it’s not a mainstay of your practice, why would you subject
yourself to proficiency testing? The compensation pathologists receive
to look at cytology tests is so minuscule compared with the risks they
run every time they sign out gyn cytology, it just adds insult to injury."
The result in Maryland has been a marked consolidation of cytology to
a smaller number of laboratories, she adds. However, pathologists have
not failed the proficiency tests. "I know this is a fear, but it didn’t
turn out to be the case," she says. "The proficiency tests are fairly
straightforward. They use clear-cut cases and not complex issues with
shades of gray."
Unlike Maryland’s program, New York’s program is state-specific. "New
York comes in and gives a slide test to pathologists and cytotechnologists.
The mechanism of grading and how the test is performed are different from
what is being defined out there by CMS," says CAP president-elect Thomas
Sodeman, MD, who is chairman of laboratory medicine, North Shore Long
Island Jewish Health System, Lake Success, NY. In fact, when the CLIA
requirement kicks in, New York cytology laboratories will have to participate
in two proficiency testing programs.
Dr. Austin has studied the states that have had gynecologic cytology
PT in place for a long time. "New York has had it for the longest—since
the early 1960s—and I looked to see if their outcomes data had improved
relative to other states," he says. The data showed that New York not
only did not have consistently better outcomes than other states, but
had steadily fallen behind.
Later studies have confirmed that the results of these types of tests
"don’t really correspond to how people are actually doing on the job,"
he adds. For example, a large study funded by the Centers for Disease
Control and Prevention compared a rescreening of patient slides to results
on regulatory proficiency testing. As reported in the American Journal
of Clinical Pathology in 1999, there was little correlation between
how cytologists did on the proficiency test and their individual error
rate as determined by rescreening of their previously signed out cases.
"So the concept of cytology PT is probably misguided because there’s
really no solid evidence that it tests proficiency or correlates well
with real performance. It’s more of a political solution than a scientific
one," Dr. Austin says.
The cytology PT program under CLIA differs from PT for other laboratory
tests, he notes. "If you flunk PT, say, for a specific analyte or test,
then you have to show you’re doing something to remediate the situation.
Potentially, if you flunk enough you have to stop doing the test until
you document corrective action. But that kind of PT is directed at the
laboratory, not any individual. Cytology PT is the only one where the
individual professional is specifically involved."
The CAP’s Pap program has functioned until now strictly as an interlaboratory
comparison program. "Depending on the difficulty of a case, people like
to see how they are doing relative to the opinions of their peers," Dr.
Austin says. "So CAP’s program is an educational quality improvement program
rather than a testing program focused on weeding out ’bad apples.’" The
weeding-out concept is what you hear about in the political arena, he
adds. "But it’s really not the approach generally taken in modern quality
improvement theory, which focuses much more on the concept of improving
In cytology, it’s very hard to find what people call "classic examples"
of slides to review, he says, "because there are so many cells on every
slide, and cells in biology are not made on a cookie cutter. They tend
to be highly variable."
Comparisons using computer-assisted screening devices and liquid-based
cytology have shown that the error rates were more substantial than people
realized before CLIA, he notes. "The limitations on slide testing volume
were probably the most significant quality improvement in CLIA cytology
regulations, because there clearly had in the past been laboratories pushing
people to read too many slides. Even now, it’s a much more difficult interpretive
test than people realize."
A problem raised by the timespan since CLIA regulations
were written is outdated grading nomenclature for cytology PT, and the
College is in discussions with the CMS about this issue.
Under the CLIA specifications for the gyn PT program, "the pathologist
is penalized if they don’t consistently differentiate on a reliable basis
between low-grade and high-grade cases," Dr. Austin says. "This sounds
very clear-cut, but we know from the Pap program and other data that about
10 to 20 percent of high- and low-grade cases may be easily classified
in the other category. Again, this has to do with the variability of cells
and the fact that it’s very hard to get so-called classic examples."
"Since new clinical guidelines have gone into effect recommending universal
referral for colposcopy at any level of SIL [squamous intraepithelial
lesions], whether low or high, a major basis for separating these as supposedly
clear-cut different entities is less than when it was originally proposed,"
he continues. "All patients are now generally being referred for colposcopy,
so the followup on these cases is going to be the same 90 percent or more
of the time, and differentiating between them in a PT scoring format doesn’t
make good clinical sense."
Another major problem is going to be obtaining unsatisfactory cases that
perform consistently, he says. "Everyone involved in proficiency testing
knows how hard this is because the definition of unsatisfactory slides
involves estimating the number of cells on the slide, in part, and this
is just not a very straightforward task." The College has a considerable
amount of data on this variability, he adds, expressing concern that the
CMS may not be well informed about this.
"We feel the grading system is unfair to pathologists," Dr. Kass says.
"We also don’t agree with the classification system they’re using. It’s
not the weighted Bethesda system, which we’ve finally migrated all pathologists
to, so they’re kind of going back a step. We’d like them to give the test
using the latest medical terminology."
The impending requirement has also rekindled controversy
over pathologists having to take what is essentially a federal recertification
test. Dr. Sodeman considers the recertification aspect to be a disturbing
violation of states’ rights.
"I’m licensed to practice medicine in the state of New York, and the
restrictions on what I can practice are not set by the state; they are
limited in the hospitals I have credentials in by what I can prove to
be satisfactory experience to be given those credentials. But now enters
the federal government, saying that in order for me to practice cytopathology,
I must take their exam."
No other physician group in the country is required to take a federal
exam to practice medicine, he adds. "They don’t require radiologists to
look at 10 x-rays and pass reading those x-rays by 90 percent, or cardiologists
to read 10 EKGs. So why has the federal government stepped in and selectively
isolated the pathologist?"
"It’s the only federally required test for physicians, and I hope it
will be the last," Dr. Kass says. Since the American Board of Pathology
is now requiring recertification of pathologists who finish residency
after 2004, "pathologists are going to be re-examined every 10 years anyway.
But it will be by the American Board of Pathology, and it will be set
up by a nonprofit peer group that does the examinations—not by independent
Dr. Austin raises the question of whether the law is truly constitutional,
if it usurps the states’ traditional right to license professionals and
the right of professional organizations to control recertification programs.
"These threats to traditional authority structures are probably greatly
underestimated and have never been fully legally explored," he says.
There were problems in cytology testing that needed to be addressed,
but with CLIA the government created something that was not the right
approach, he says, citing H.L. Mencken’s dictum: "For every human problem
there’s a simple answer: easy, plausible wrong."
"I do think there were excesses in the field that largely had to do with
irresponsible corporate interests, and those needed to be dealt with,"
Dr. Austin says. "But when politicians get involved with a problem, the
solution often isn’t necessarily one that thoughtful reformers would have
The CMS has indicated that it is willing to discuss the CAP’s concerns
further and to work toward a smooth implementation for laboratories, says
Dr. Kass. "In the meantime," she adds, "the College is committed to supporting
laboratories in successfully meeting this new CLIA requirement."
Anne Paxton is a writer in Seattle.