CEO SUMMARY: In Canada, the story about inaccurate breast cancer testing just won’t go away. In March, the Cameron Report was made public with its assessment of lab testing failures in Newfoundland and Labrador. In April, the health system in those provinces admitted that it needed to review and possibly retest another 43 breast cancer patients. Calls for a uniform system of laboratory proficiency testing and accreditation have not yet motivate federal and provincial health officials to tackle this issue.
SERIOUS DEFICIENCIES IN BREAST CANCER TESTING continue to make national headlines in Canada. Three times in the past 90 days, media stories about laboratory problems have captured the attention of the public.
The first event to dominate the news cycle was release of the Cameron Report on March 3. This was a major review of failures in estrogen receptor (ER) and progresterone receptor (PR) tests performed in Newfoundland and Labrador from 1997 to 2005. It is believed that laboratory failures may have caused at least 396 patients to get inaccurate results during this time.
Inaccurate Cancer Tests
Exactly one month later, on April 3, another disclosure made national headlines. That was the day that officials of Eastern Health in Newfoundland and Labrador publicly admitted that the breast cancer tests of another 43 patients will undergo review. Potential problems with laboratory testing for these patients had apparently gone undetected, despite the health service’s earlier efforts to identify all breast cancer patients whose laboratory test results may have been inaccurate.
In the wake of these two developments, The Toronto Globe and Mail newspaper then published its assessment of events. Collectively, these issues have kept laboratory testing failures in the public eye across Canada. For lab managers and pathologists in the United States, these developments may speak to how funding cutbacks for laboratory test services over many years can quietly erode the quality and integrity of laboratory testing.
Taking each event in order, it was March 3 when the Cameron Report was released to the public. This is the most recent product of the Commission of Inquiry on Hormone Receptor Testing, which was organized in 2007 to investigate the problems with breast cancer testing in Newfoundland and Labrador between 1997 and 2005.
Author of the Cameron Report is Margaret Cameron, a judge in the Supreme Court of Newfoundland and Labrador, Court of Appeals. As authorized by the Commission on Inquiry, she heard testimony from 93 witnesses over 138 days. Judge Cameron’s findings were published in a 495-page report that focused on the problems with estrogen receptor (ER) and progresterone receptor (PR) tests performed in Newfoundland and Labrador from 1997 to 2005.
A Series of Problems Cited
The Cameron Report is a compilation of the testimony given by patients or relatives of patients during the hearings. Their stories illustrate the many different ways that problems with ER/PR testing affected patients.
In her report, Cameron explained that she was prohibited from expressing any conclusions or making recommendations regarding civil or criminal responsibility of any person or organization. Consequently, Cameron noted that she made no attempt to identify the specific reasons for the problems with breast cancer testing for the individual patients.
Following this disclaimer, Cameron’s report outlined a long list of problems that caused at least 386 breast cancer patients to get inaccurate test results. She described how, as a result of the inaccuracies, physicians used faulty laboratory test results to determine treatment.
Of the 386 breast cancer patients originally identified by Eastern Health as having received potentially inaccurate PR/ER test results, at least 108 have since died. Health officials concede that it is unlikely anyone will ever know how many patients died, if any, as a result of not getting appropriate breast cancer care.
Test Problems Discovered
Problems with breast cancer testing in Newfoundland and Labrador were first detected in 2005. That’s when doctors questioned the hormone receptor test results of a patient with invasive lobular carcinoma, a form of breast cancer.
“The [PR/ER] testing inaccuracies were the result of a failure of accountability and oversight at all levels of Newfoundland and Labrador’s healthcare system, Cameron wrote. “The whole of the health system, to varying degrees, can be said to have failed the ER/PR patients. There was a failure of both accountability and oversight at all levels.”
During her investigation, Cameron heard testimony about one laboratory in St. John’s that processed the botched tests. In testimony before Cameron, witnesses identified problems that included: 1) staff shortages in the laboratory; 2) lack of proper internal controls; and, 3) improperly trained staff in the laboratory. Witnesses also reported infighting among medical staff, communication lapses between the Newfoundland government and Eastern Health, and failed attempts at damage control.
The second event followed just one month later. On April 3, Eastern Health announced that test results from another 38 breast cancer patients were going to be reviewed to determine if they were accurate. A few days later, Eastern Health raised to 43 the number of patients whose laboratory tests would be reviewed. It also disclosed that 27 of these patients have died, although what role inaccurate lab tests may have played in these deaths is unknown.
Days after scathing criticism by Danny Wilson, Premier of Newfoundland and Labrador about how these patients have been handled, Pat Pilgrim, Chief Operating Officer for Cancer Care at Eastern Health conducted a press conference, where she said “To our patients, we realize how distressful this is to them—to be hearing from us now, almost four years later, that we missed you; you should’ve been on a list for retesting; and now we have identified you and we will be retesting you. We apologize to our patients for that. We wish that we could undo that, but we cannot undo it and we do have to give them the information that we have.”
While these problems were in the news, The Toronto Globe and Mail reported that little progress has been made to adopt national standards for clinical laboratories. For most clinical labs in Canada, proficiency testing (PT) is voluntary. But in British Columbia and Ontario, it is mandatory and the success of a program in British Columbia to standardize testing, called the Diagnostic Accreditation Program, was spurring calls for health regulators in all of the Canadian provinces to adopt mandatory PT. (See TDR, September 8, 2008.)
The Globe and Mail also reported on April 1 that dozens of breast cancer lab tests in British Columbia, done between May of 2005 and October of 2006, were being reviewed after Kirk Ready, M.D., a pathologist and former clinical director of the Okanagan Health Service Area Laboratories, in Penticton, British Columbia, wrote a letter to the provincial health authorities voicing concerns about how the lack of uniformity and other issues in breast cancer testing at the Okanagan laboratory may have resulted in misinterpretation. In the weeks since Dr. Ready’s letter was made public, health officials determined that there were no misdiagnoses of breast cancer patients whose specimens were handled by this laboratory.
Problems In Other Provinces
In its coverage of Canada’s problems with breast cancer testing, The Globe and Mail revisited the list of laboratory test problems that became public news in recent years. Once problems with pathology testing became public in Newfoundland and Labrador, other provinces uncovered inaccuracies in pathology testing. Inaccurate pathology diagnoses took place in these provinces:
- February 2008, Miramichi, New Brunswick: Pathologist Rajgopal Menon, M.D., left his position as head of pathology at Miramichi Regional Hospital following a review of 227 cases of prostate and breast cancer biopsies from 2004-2005. These independent reviews determined that: 1) 18% of the cases had incomplete results; 2) 3% were misdiagnosed; 4) 41 cases included incomplete protocols or examinations and or miscalculated the stage of the cancer; and, 5) compared to the original diagnosis, there were seven cases of undetected cancer, and four additional cases that were possibly cancerous. Health officials announced they would review as many as 24,000 cases. Menon characterized this review as “unjustified and unfair.” He filed a civil suit against the regional health authority.
- May, 2008, Winnipeg, Manitoba: Pathologist Robert Stark, M.D., was put on leave from his position as head of the pathology department at St. Boniface Hospital. The outside pathology review of this lab, including approximately 822 of the cases diagnosed from February 2008 and complex cancer cases dating back to March 2007, determined that errors were made in at least 42 cases and two patients received the wrong cancer diagnosis due to error.
- May, 2008, Owen Sound, Ontario:
After routine quality control testing identified an error by pathologist Barry Sawka, M.D., at Owen Sound Hospital, a more detailed review of 600 of his cases was launched. Grey Bruce Health Services, the local health authority, detemined that the error rate was 6%, which health officials stated was six times the “the normal error rate for pathologists.” These misdiagnoses lead to errors in treating patients.
Government Support Needed
One recommendation in the Cameron Report was that, “to prevent a public health disaster,” a government-backed national program for accreditation and quality testing at hospital labs should be established.
The Globe and Mail pointed out that, before such improvements in pathology testing could be made to local and provincial health systems in Canada, pathologists would need the authority and financial support of federal authorities and of each provincial government. The newspaper quoted Newfoundland Health Minister Ross Wiseman stating that federal intervention is required. Federal authorities said the government will not become involved because the regulation of pathologists and laboratories is a provincial and territorial responsibility.
For laboratory administrators in the United States, the problems with anatomic pathology testing surfaced to date in Canada are instructive. Back in the second half of the 1980s, Canada was one of the first developed nations in the world to begin consolidating laboratory testing services regionally. In several provinces, health officials were active and aggressive in eliminating excess laboratory capacity and driving down reimbursement paid for laboratory testing services.
Thus, could these instances of systemic breakdown in the accuracy, integrity, and reproducibility of anatomic pathology testing be the first symptoms of a pathology infrastructure that is ready to unravel at the seams in certain regions of Canada?
High Stress in Newfoundland
Take Newfoundland and Labrador as an example. In the wake of this lab testing scandal, experts noted that specimen volume increased in Eastern Health by 20% from 1999 to 2005. Yet low pay meant that the pathologist turnover rate during the years 2003-2007 was 32%.
Moreover, despite an additional stipend granted pathologists in Newfoundland and Labrador to encourage retention and recruitment, Eastern Health has failed to maintain adequate staffing of pathologists. Joseph Tumilty, M.D., President of the Newfoundland and Labrador Medical Association, stated in April 2008, that these two provinces were short by 12 to 15 pathologists. In fact, the laboratory at St. John’s, where the ER/PR testing problems happened, should be staffed at about 18 pathologists. Yet, at one point in 2008, it was down by six positions.
It is provincial health authorities which establish the budgets and physician reimbursement levels. Pathology staffing and quality problems in Newfoundland and Labrador may be the canary in the coal mine—reminding us that when funding for laboratory testing services falls to an inadequate level, it is patients who feel the brunt of the cost savings, in the form of inaccurate lab test results that lead to the wrong care.
Commission of Inquiry Issues ER/PR Report
It was 2007 when the Commission of Inquiry on Hormone Receptor Testing was established by the Government of Newfoundland and Labrador. Judge Margaret A. Cameron was appointed commissioner and asked to inquire into, and report on, problems with estrogen receptor (ER) and progesterone receptor (PR) tests conducted between 1997 and 2005 in the Newfoundland and Labrador health care system.
The inquiry was further tasked with determining the cause of problems in the laboratory, when these problems were discovered, and what laboratory protocols were in place during the time in question. Judge Cameron was also asked, as part of the inquiry, to examine whether the estrogen and progesterone hormone receptor testing systems and quality assurance processes currently in place are reflective of “best practices” in laboratory medicine.
As a point of interest, the commission was instructed not to express any conclusions or recommendations regarding the civil or criminal responsibility of any person or organization. Judge Cameron concluded the public hearings in October 2008. The Cameron Report is available as a three-part report in PDF format on-line at http://www.cihrt.nl.ca/default.htm.