Major Canadian medical organizations and pathologists from the country's largest hospitals are calling for an immediate overhaul of the way laboratories handle medical tests to prevent more patients from dying unnecessarily.
Their urgent call for action is being issued in the wake of a breast cancer screening scandal in St. John's that is the subject of judicial inquiry set to begin this week.
Critical shortages of staff, inconsistent methods of interpretation and the absence of provincial or national standards are compromising the ability of some pathologists in labs across the country to catch mistakes or recognize incorrect diagnoses before it's too late, according to physicians leading the charge for change.
"Often, these things come to our attention because of individual transgressions or missteps, but in fact what they reflect is an underlying system issue," said Andrew Padmos, chief executive officer of the Royal College of Physicians and Surgeons of Canada.
"Both the number and the complexity of routine testing has increased exponentially, but the resources available in the institutions has not kept pace."
The college and the Canadian Association of Pathologists have become so concerned about quality control in hospital labs that they are launching national reviews to identify the biggest gaps and determine what steps are needed to fix the problems.
"Even one wrong report is a very serious issue," said Jagdish Butany, president of the Canadian Association of Pathologists. "It doesn't matter whose biopsy it is, we want it to be accurate. This is where we are coming from."
The issue has become an urgent priority for many physicians after the revelation that hundreds of breast cancer patients in Newfoundland received faulty results for hormone receptor tests over an eight-year period. The receptor tests are used to identify what course of treatment a woman might respond to best, and a faulty result could have altered that determination. More than 300 of the patients who received questionable test results have died, although it's unknown if another treatment would have helped them.
Two recently completed external reviews of the Newfoundland lab where the breast cancer tests were analyzed found major quality-control gaps, poor documentation and inconsistent methodology.
Pathologists worry, however, that the faults are not isolated to Newfoundland but reflect a serious lack of quality-control measures across Canada - weaknesses exacerbated by a massive shortage of pathologists.
"One of the big things it indicates is a systemic problem," Dr. Butany said. "Because there's a shortage, people work longer hours, people work longer years or more years than they're used to. It's almost a recipe for disaster."
The pathology association has just created a new committee to develop the first set of national standards for immunohistochemistry tests, the category being scrutinized in Newfoundland.
"There are no standards out there, either here in Canada or anywhere else in the world," Dr. Butany said. "We felt it was about time we did something to at least try to set standards or put standards out there and hope people would start using them."
The association plans to unveil the new standards at its annual meeting in Ottawa this July.
The Royal College of Physicians and Surgeons of Canada plans to begin a major review in the coming weeks with the help of other medical organizations and hospitals, to identify what help is needed and what steps can be taken to improve the system.
"I think it's exactly where things need to go," Dr. Padmos said.
Potential solutions the medical associations have identified include:
the creation of large laboratories where all medical tests in a region would be analyzed by specialists rather than general pathologists;
a mandatory requirement for a second pathologist to sign off on tests showing malignancies;
the creation of standardized terminology, interpretation measures and handling procedures to ensure all staff in a lab, and across the country, use the same thresholds to make a diagnosis;
requirements for all foreign pathologists to receive the same accreditation in Canada.
Pathologists must be certified to work in their field and laboratories are required to adhere to certain baseline operating principles. But quality-assurance procedures are typically left up to individual labs to create, a critical gap that many pathologists say has mistakenly been left unchecked, particularly as scientific advances make testing more complex and labs struggle with staff shortages.
"They're short of people, short of expertise. [Pathologists]don't have the opportunity even probably to go back and do their own reviews to evaluate their own performance on a regular basis," said Sylvia Asa, pathologist-in-chief at Toronto's University Health Network.
Another recent scandal involving medical tests is also fuelling concern over quality control in labs. Authorities in New Brunswick announced last month they would hold an inquiry and review about 24,000 pathology tests after an audit of pathologist Rajgopal Menon's work showed some were incomplete or misdiagnosed. Now, many residents in the Miramichi area of the province, where Dr. Menon worked, are concerned they may have been wrongly diagnosed, or that a diagnosis was missed.
Dr. Butany said the massive problems exposed in St. John's and Miramichi are tragic, but also speak to systemic problems across the country. The challenge facing pathologists is to make the changes necessary before the next tragedy occurs.
"I would like to say that no, these things probably never happen. I would probably be proven wrong very soon," Dr. Butany said.
"It's time to try and fix the problem."
Carly Weeks