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Clinical Laboratories and Pathology Groups

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New National Pathology Council Will Tackle Quality Issues, But Pathologist Understaffing Remains in Some Regions

In Canada, anatomic pathology has a public black eye due to disclosures of pathology misdiagnoses occurring in multiple medical laboratories over the past six years. One big lesson from these events is that public trust in the integrity of clinical laboratory tests is a precious asset that must be protected.

Now comes news that pathologists in Canada will squarely address the issue of pathology test integrity in their nation. Following a series of meetings, pathologists last month announced the creation of the Canadian Pathology and Laboratory Medicine Leadership Council (CPLMLC). Its mission will be to implement a quality-assurance system to address issues that cause medical errors in pathology laboratory testing. Its goal is to reduce or eliminate these sources of medical errors.

Pictured here is Dr. Jagdish Butany, staff pathologist at the University Health Network at Toronto General Hospital. He has advocated for national quality assurance standards for pathology laboratories throughout Canada, as well as funding to resolve the shortage of pathologists in the nation. (Photograph by Sarah Dea of Postmedia News.)

In a press release, the Royal College of Physicians and Surgeons of Canada stated that “the council will develop and coordinate strategies and initiatives to strengthen the teaching of pathology and laboratory medicine, improve quality management in laboratories across the country, and support and enhance health human resource planning.”

Pathology Test Errors and Surgical Mistakes Prompt Government Scrutiny The string of surgical and medical errors linked to deficiencies in anatomic pathology testing is what prompted Canadian pathologists to form this council. Just last year, for example, 2,856 breast cancer pathology samples in Quebec had to be retested because of flawed hormone and protein markers in the tests. Eighty seven women were misdiagnosed, and since that time, five have died.

Over in neighboring Windsor, Ontario, in the past 18 months, two women had breasts removed that were later found to be cancer-free. Investigators discovered that the surgeons had operated even though the patients had received conflicting diagnoses in the laboratory test reports signed out by pathologists.

According to an article in the Vancouver Sun, studies show that “clinically significant errors—mistakes that harm patients—occur in about 1% of diagnosis by pathologists.” In the Six Sigma world, this translates into 10,000 patients getting a wrong result for every 1,000,000 tests performed, or a quality level of 3.84 Sigma.

Pathologists Worked Two Years to Define and Create the Council It took more than 2 years for pathologists and other participating healthcare experts to define and structure the new council. Participating in CPLMLC are a significant number of provincial and national organizations in pathology, laboratory medicine, accreditation, and healthcare. They include:
  • Accreditation Canada
  • Association of Faculties of Medicine of Canada
  • Association of Canadian Academic Health Care Organizations
  • Canadian Society for Medical Laboratory Sciences
  • Canadian Association of Pathologists and Provincial Pathology Associations
  • Canadian Association of Provincial Cancer Agencies
  • Canadian Healthcare Association, Canadian Medical Association
  • Canadian Medical Protective Association
  • Canadian Partnership Against Cancer
  • Canadian Patient Safety Institute
  • College of Family Physicians of Canada
  • Federation of Medical Regulatory Authorities of Canada
  • Royal College of Physicians and Surgeons of Canada

The council will address:

  • Chronic understaffing in clinical and pathology laboratories
  • Quality control in medical laboratories
  • Workloads in clinical and pathology laboratories
  • Working conditions
  • Second opinions
  • Continuing education of the medical staffs.

“There was a strong commitment to fairly rapid action to put standards in place where none have existed before,” said Andrew Padmos, M.D., CEO of the Royal College of Physicians and Surgeons in Canada, speaking to the Vancouver Sun reporter. “Of the billions and billions of tests that are done, the vast, vast majority are done accurately and consistently by an exceptionally well-trained cadre of pathologists.”

However, Dr. Laurette Geldenhuys, President of the Canadian Association of Pathologists (CAP) further noted that the “relative number of pathologists has consistently decreased, virtually all across Canada.”

Up to now, pathology laboratories across Canada have operated under different standards and investigators believe this situation might have contributed to the surgical errors and pathology misdiagnoses.

Geldenhuys feels that, from this point forward, the new Canadian Pathology and Laboratory Medicine Leadership council will at least ensure that Canadian clinical and pathology laboratories adhere to a minimum set of standards. “This way,” she said, “we can continuously raise the bar, so that that error rate—which is very low to start with—approaches as close as possible to zero.”

The initiative of pathologists in Canada to create a nationwide body to implement minimum quality standards across the nation only addresses one aspect of the factors contributing to the publicized episodes of pathology misdiagnoses. Canadian pathologists continue to call attention to the fact that there are shortages of qualified pathologists in several regions of the nation. Until the health systems in each province increase the amount of funding needed to train and employ adequate numbers of pathologists, pathology understaffing will continue to be an unresolved problem.

Related Information:
Pathologists hope national body will lead to fewer errors

Healthcare leaders move to strengthen pathology and laboratory services

Health care leaders move to strengthen pathology and laboratory services

Pathologists work the thin edge of between death and life