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Clinical Laboratories and Pathology Groups

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Variability in the accuracy provided by pathologists at different hospital laboratories is highlighted…

Pathology misdiagnoses for selected types of breast cancer was the subject of a New York Times story this week. In recent days, Newsweek and several other newspapers across the nation picked up the theme and published their own stories centered on misdiagnoses of breast cancer.

Such extensive media coverage elevates public awareness of the role of pathologists in diagnosing disease—but, in this case, not in a positive way. However, media attention on these types of issues should not surprise pathologists and clinical laboratory managers. It is consistent with the trend of consumers becoming ever more educated and sophisticated in their knowledge of healthcare.

Registered nurse Monica Long’s case of breast cancer, involving ductal carcinoma in situ was misdiagnosed, according to a story in the New York Times. (photo by Michelle Litvin for The New York Times©)

The subject of the New York Times story was mammary ductal carcinoma in situ (DCIS). Surgical pathologists understand that, because this involves diagnosing breast cancer at a very early stage, it requires specific pathology skills and experience. Times reporter Stephanie Saul wrote that “As it turns out, diagnosing the earliest stage of breast cancer can be surprisingly difficult, prone to both outright error and case-by-case disagreement over whether a cluster of cells is benign or malignant, according to an examination of breast cancer cases by The New York Times.”

The Times reporter was objective in describing the difficulties pathologists face in rendering opinions about small breast lesions, often “the size of a few grains of salt.” At the same time, reporter Saul was alerting her readers to the fact that there is variability in the care provided by different pathology groups at different hospitals.

To that point, she wrote “There is an increasing recognition of the problems, and the federal government is now financing a nationwide study of variations in breast pathology, based on concerns that 17% of DCIS cases identified by a commonly-used needle biopsy may be misdiagnosed. Despite this, there are no mandated diagnostic standards or requirements that pathologists performing the work have any specialized expertise, meaning that the chances of getting an accurate diagnosis vary from hospital to hospital.

It was noted that the College of American Pathologists (CAP) was responding to this situation by preparing to start a voluntary certification program for pathologists who regularly read breast tissue. CAP is including a requirement that the pathologists should read at least 250 of these cases per year.

In the New York Times coverage, it profiled the case of Monica Long, a registered nurse. At the time of her diagnosis of DCIS, she was working as a nurse during the night shift at 46-bed Cheboygan Memorial Hospital in Cheboygan, Michigan. After a regular mammogram showed a one centimeter shadow on one breast, a biopsy was taken and sent to Linh Vi, M.D., the pathologist serving the hospital.

The New York Times explained that Dr. Vi was the only pathologist at the hospital and in this rural Michigan County. It also noted that “He ran the hospital’s pathology department even though he had not passed either part of the exam to become board certified until 2008, a year after he gave Ms. Long her diagnosis. In a deposition, Dr. Vi said he had taken one portion of the test ‘several times’ before passing, but he did not remember how many.”

Saul continued to track events in the Long’s case, noting that, before her decision to undergo surgery, her slides were sent to Northern Pathology Associates, PC, in Petosky, Michigan, for a second opinion. This three-pathologist group partially disagreed with Dr. Vi’s diagnosis of Long’s tissue.

In a deposition, Dr. Vi was asked why he did not send Long’s slides to “any number of known and notable breast pathology specialists for a second opinion.” As described by the New York Times, in this deposition, “Dr. Vi hinted at financial constraints. When a pathologist sends out a slide for consultation, the hospital, not the patient, is frequently billed. The Petoskey doctors had agreed to provide free consultations.”

The New York Times also printed a statement from lawyers representing the pathology group in Petrosky. These lawyers had “denied that there was any malpractice in Ms. Long’s treatment, citing reports in medical literature of a ‘wide array of variability’ in interpreting breast pathology. ‘It is not a breach of the standard of care for one pathologist to have one opinion and another competent pathologist to have another opinion,’ the lawyers said.”

In the balance of the story, the New York Times quotes a number of experts on the issues involved in the diagnosis of ductal carcinoma in situ. It also explained how, several years later, while working at a new hospital, Monica Long had her case reviewed by her current care team. That was when she was told that a review of her original pathology work had determined that she never had breast cancer.

The decision of the New York Times to investigate the problems in diagnosis of DCIS and publish a detailed story on this subject is just the latest example of how national media outlets are watching the successes and failures in clinical laboratory testing and anatomic pathology services. Since the majority of consumers assume that they can trust the quality and integrity of laboratory tests, it is disturbing when they learn otherwise.

Transparency in provider outcomes and greater publicity for medical errors is now a given. The publication of stories about breast cancer misdiagnoses by the New York Times, Newsweek, and other major news outlets has several messages for pathologists and clinical laboratory executives.

First, pathology laboratories and clinical laboratories may want to develop a public relations policy that anticipates the need to deal with media inquiries relating to the reporting of inaccurate laboratory test results. Second, growing media attention and interest in the quality of laboratory testing services is an early alert that pathology groups and medical laboratories would benefit from implementation of a continuous improvement management culture. The use of Lean, Six Sigma, and process improvement methods to steadily reduce and eliminate the source of errors in the laboratory is a timely management strategy.

Finally, in another example of how news reporting has gone viral, the New York Times has posted a video of this story, titled “Pathology of Errors.” Someone has already posted this same video, “Pathology of Errors”  on Either link will take you to this video.

Related Information:

Prone to Error: Earliest Steps to Find Cancer

Avoiding Breast-Cancer Mistakes: How to make sure your diagnosis of early cancer is correct.

Florida woman’s early breast cancer misdiagnosis serves as warning

Misdiagnosis of early breast cancer leads to many unnecessary treatments, story reports

Doctors encourage second opinions for breast cancer diagnoses

Pathology of Errors: video at New York Times

New York Times story about “Pathology of Errors” in breast cancer diagnosis: video clip on

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