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Not backing off: CAP retains call for blinded review

Pap test litigation—
Not backing off: CAP retains call for blinded review

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Anne Paxton

March 2015—When the 11th Circuit U.S. Court of Appeals issued an opinion harshly criticizing the CAP’s guidelines on review of Pap tests last summer, many in the pathology community were stunned by the rebuke and wondered whether change was called for.

The CAP and the American Society of Cytopathology developed the guidelines in 1998 to ensure unbiased evaluation when cytopathologist and cytotechnologist Pap test findings are being litigated. The guidelines’ key recommendation is that pathologists conduct a blinded review, without knowing the result in advance, before testifying about a Pap test result in a malpractice case. Ruling in the case Adams v. Laboratory Corp. of America on July 29, 2014 (Laboratory Corp. of America, 760 F.3d 1322 [11th Cir.2014]), the Court of Appeals said the guidelines wrongly intruded into legal questions on expert witness testimony that should be left to the courts.

So far, College officials have decided to retain the guidelines. After reviewing the case, the CAP Cytopathology Committee, part of the Council on Scientific Affairs, decided in December that the “CAP Guidelines for Review of Pap Tests in the Context of Litigation or Potential Litigation” are more or less fine the way they are. The committee, which has conducted several other reviews of the guidelines over the years (in 2001, 2005, and 2012), has now recommended only minor edits.

The case began when Christina Adams and her husband filed suit against LabCorp, alleging that the company failed to properly identify abnormal cells on five Pap tests she had between 2006 and 2008; in 2009, Adams was diagnosed with cervical cancer that had already metastasized to her lymph nodes.

The Adamses retained the distinguished cytopathologist Dorothy Rosenthal, MD, as an expert witness to testify as to whether LabCorp’s employees had breached the standard of care for cytotechnologists in reviewing the slides. Dr. Rosenthal reviewed the slides at LabCorp’s laboratory in Atlanta, spending about 90 minutes examining them, and concluded that the LabCorp cytotechnologists’ review fell short of the applicable standard of care because it failed to identify abnormal cells that should have been identified.

LabCorp moved to exclude Dr. Rosenthal’s testimony, however, citing the CAP/ASC guidelines as evidence that a blinded review was the standard set by the profession. The U.S. District Court for the Northern District of Georgia agreed to exclude the testimony and granted LabCorp’s motion for summary judgment. The court expressed concern about the risk of bias in Dr. Rosenthal’s assessment and the general risk of review bias in non-blinded review. In fact, Dr. Rosenthal herself referred to “review bias” in her deposition, explaining that “any time you go to look at another case somebody else has looked at and rendered a diagnosis, you’re biased by what they called it, and you’re also biased if you have any additional information.”

The 11th Circuit Court of Appeals reversed the district court. The guidelines, the court said, “are not objective, scientific findings; they are not guidelines followed by laboratories to screen for pre-cancerous or cancerous cells; they are policy proposals to limit how the courts can find the members of the organizations liable for professional negligence when they are sued.” In its experience, the court added, the CAP guidelines are “the first time” that an industry group has attempted to define and limit the evidence courts should accept when the group’s members are sued.

Jack Bierig, who was general counsel for the CAP from 1980 to 2005 and helped develop the guidelines, disagrees with the 11th Circuit Court’s characterization of the guidelines. “The guidelines address the situation of a retrospective reviewer who knows that a plaintiff had cancer. Since the reviewer already has that knowledge when reviewing the slides, that knowledge has to affect his or her decision. By contrast, the original cytotechnologist or pathologist who reviewed them didn’t have that knowledge. The guidelines were designed to recommend a methodology designed to reduce the bias of hindsight. I personally don’t see anything wrong with that,” says Bierig, who is a partner with Sidley Austin LLP in Chicago.

Pathology had reason to be especially concerned about such bias because of a side effect of the passage of CLIA. In 1992, after CLIA ‘88 regulations were issued, “litigation really went up dramatically,” says Marshall Austin, MD, PhD, former member of and advisor to the CAP Cytopathology Committee and professor of pathology and director of cytopathology at the University of Pittsburgh Medical Center.

With the public attention and media hype about the pathologists and cytotechnologists behind the slides being linked to potential errors in diagnosis, “suddenly attorneys and patients were aware they could bring charges against someone for malpractice for missing cases,” says Barbara Crothers, DO, current chair of the Cytopathology Committee.

Cytology is different from any other screening test, Dr. Austin emphasizes. “Cytology slides have thousands of cells and in the screening process, where cytologists look at many, many cells per second over about five minutes, they typically don’t look individually at every cell, and they have to make a lot of interpretations based on variable morphology of the cells.” The closest analogy to reading a Pap test is viewing a mammogram, because it’s also based on visual interpretation, he says. Radiologists face some of the same issues because often, when it’s known that a patient has cancer, “they go back to the scan and say there must have been something not interpreted properly.”

While the history of CLIA is long and complicated, Dr. Austin says, Pap smears played a central role in the push for federal regulation of clinical laboratories. “CLIA was largely prompted because of concerns about what was going on in Pap smear labs. A few commercial labs figured out if you gave away Pap smears for almost nothing, akin to a ‘loss leader,’ and let the doctors’ offices bill the insurance company, the offices could get a markup and the labs retained other work.”

Dr. Crothers

Dr. Crothers

The problem was that those laboratories were driving the cytotechnologists to look at way too many slides, he says. “Since the Pap smear is not a perfect test, it wasn’t hard to go back and find errors that could have potentially been avoided if the cytotechnologists were looking at fewer slides.” Since that time, there have been tremendous advances with cytology testing, he hastens to add. “But it’s still not a perfect process; nothing is perfect when it involves visual evaluation.”

Laboratories themselves may have been the unintended cause of the surge in malpractice suits, says Dr. Crothers, cytopathology medical director for Walter Reed National Military Medical Center, Bethesda, Md. “CLIA actually stated that for good laboratory practice, laboratories should rescreen pathology past cases where the patient has a current diagnosis of high-grade epithelial lesion, and look retrospectively at negative cases from the last five years to see if there were cases where they might have missed some cells.”

That was intended as a quality assurance measure, she says. “It was to help laboratories better develop their diagnostic eye and start to learn to recognize patterns that might be subtle and that are frequently missed. Generally that’s what a good laboratory would do, say, in a five-year review.”

Often such reviews find a high percentage of cases that are atypical in some way. “It can be as high as 50 to 90 percent in some cases,” Dr. Crothers says. “But that’s really just a reflection of the process, because sometimes these lesions are high in the cervical canal. They may not shed many cells or the cells may be degenerated, or the potentially atypical cells may be overlapped with other normal cells that occur on the Pap. Very tiny high-grade cells can sometimes be mistaken for endometrial cells. Or there are other factors such as inflammation, blood, or other obscuring cells that make the slide difficult, if not impossible, to interpret.”

“But once you know the patient has developed something, the review process is very intensive, and you scrutinize the entire slide trying to find something you can learn from.” When laboratories were essentially required by law to review and report, they started to issue amendments to pathology reports, reclassifying some Pap tests called negative in the past as “atypical squamous cells.” Public attention followed—and extreme reactions in some cases.

In Rhode Island, for example, a hospital was told by the state health department to rescreen a whole series of its patient slides and issue an amended report in any case where a later opinion said a slide was abnormal. “As a result of that, patients filed 15 lawsuits—even patients without cervical cancer. That was the kind of environment we were in at the time,” Dr. Crothers says.

In 1996, the CAP convened a conference devoted to liability and quality issues in vaginal and cervical cytology. “It was from that breeding ground that there came this upswell for some kind of guidance for labs and patients and plaintiff and defendants to have a realistic idea of what constitutes a failure of standard of care,” Dr. Crothers says. “It was really to recognize that the Pap test is subjective, that there are factors making it extremely difficult to interpret. And zero error tolerance is really not possible.”

“Some failures are true diagnostic errors where every cytopathologist or cytotechnologist looking at that slide would say ‘that’s definitely there and should have been caught.’” But the other type of error is an error in the realm of subjective interpretation, she says. “Those are the ones that cause the most lawsuits.”

While there may not have been a causal relationship, after the guidelines were issued there was a drop in litigation, Dr. Austin says. Pathologist David B. Troxel, MD, reported in 2012 that The Doctors Company, the largest insurer of physician and surgeon liability in the U.S., had an average of 19.7 gynecologic cytology claims per year from 1995 to 1997. Then from 1998 to 2003 the number declined to seven per year, subsequently falling to 1.4 per year from 2004 to 2010.

According to the 2012 article written by Dr. Troxel, there had been a significant decline in the number of claims involving melanoma, breast, and gynecologic cytology. Pathology typically has a low frequency of claims or demands for payment, but claim severity trends high. From 1999 through 2010, the average severity for all closed pathology claims was $431,964, for melanoma it was $753,100, and for gynecologic cytology it was $596,455 (Troxel DB. Am J Surg Pathol. 2012;36[1]:e1–e5).

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