Pathologists Respond to Criticism After Breast Cancer Testing Errors

Allison Gandey

July 19, 2008

July 19, 2008 (Ottawa, Ontario) — Experts say staffing and funding constraints are making it difficult for pathologists to do their jobs and it is more likely that testing errors will occur. It is a problem, some say, that should encourage oncologists to remain vigilant and verify results.

"If test results don't fit with the usual pattern of the clinical problem or clinicians suspect the diagnostic test might be faulty, they should retest," Andrew Padmos, MD, chief executive officer of the Royal College of Physicians and Surgeons of Canada, told Medscape Oncology.

Jared Schwartz, MD, president of the College of American Pathologists, has this question for oncologists: "Do you know who is examining and interpreting your pathology?" He suggests that doctors adopt a more collaborative approach and work more closely with one another. "You have to have a relationship with the person looking at that slide. And clinicians, like patients, should have the ability to request a second opinion."

Dr. Schwartz, who also works at the Presbyterian Healthcare System, in Charlotte, North Carolina, pointed out during an interview that pathology, like most areas of medicine, is an art as well as a science. "At the end of the day, it is an opinion. Our goal is always to provide the most scientifically accurate diagnosis that we can, but results can vary and we have to work with that."

Close to 400 Breast Cancer Patients Received Incorrect Test Results

Canadian pathologists have come under fire recently after a series of mistakes in the lab were made public. The most worrisome problem occurred in Newfoundland, where the breast tumors of nearly 400 breast cancer patients were assigned an incorrect estrogen-receptor status. At least 100 of these women have since died, leaving grieving families wondering if inaccurate test results cost their loved ones their lives.

Separate investigations are underway to review faulty forensic pathology and additional misdiagnoses in New Brunswick, in Owen Sound, Ontario, and in Winnipeg, Manitoba.

These problems took center stage at the Canadian Association of Pathologists' annual meeting this week in Ottawa, Ontario. The group wrapped up its meeting Wednesday with a press conference publicizing new recommendations to address the public outcry.

Association president Jagdish Butany, MD, from the University of Toronto, in Ontario, told reporters that Canadian laboratories are not unique in facing problems related to workload, human resources, and quality control. "We are unique in that we lack a national quality-assurance program to link laboratories, provide support, and administer national standards."

"This doesn't mean the federal government says you have to use this method, tool, or equipment to perform testing," Dr. Schwartz, who attended the Ottawa meeting, said during an interview. "What it does mean is that there is a national standard, so that anywhere you go, you have the same level of care."

Call for National Standards

Dr. Padmos told Medscape Oncology that most Canadian labs have kept up by providing state-of-the-art equipment, but have lagged when it comes to staffing. This has become increasingly problematic as the complexity of diagnostic testing has increased.

For example, Dr. Padmos pointed out, what could have been done in the 1980s on about 10 slides, now will often take 100 slides or more because testing methods have improved and are so much more detailed. Yet the head count in labs has not kept up in Canada, or in many other countries.

Dr. Schwartz pointed to similar problems in Ireland, Great Britain, New Zealand, and Australia. "Many pathologists feel as though their requirements and requests are falling on deaf ears," Dr. Padmos added.

To address these concerns, Canadian pathologists have issued recommendations.

The 5-Point Plan

  • Certify each prognostic and predictive test performed by a lab.

  • Start an external validation system, where test results from one lab are verified by an independent external lab.

  • Use the national checklist for diagnostic immunohistochemistry, which is a quality-assurance system that covers test validation, staff training and competency assessment, standardization of operating procedures, and equipment maintenance.

  • Create a national body — separate from government — to accredit all medical laboratories and ensure they meet quality and critical-mass standards

  • Obtain immediate and ongoing support from federal, provincial, and territorial governments to address the critical workforce and resource shortages undermining laboratory medicine.

"The plan is ready, we now look to our political leaders to step forward with the support needed to get it up and running," Dr. Butany said.

"The vast majority of pathologists do a fantastic job and work really hard to provide accurate diagnoses," Dr. Schwartz said. "But we can always do better."


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