Breast cancer testing in Quebec came under sudden and intense scrutiny in May 2008 when the Association des pathologistes du Quebec (APQ) reported that a re-examination of 25 pathology samples from 15 patients showed a variation of 15 to 30% from prior tests and diagnoses covering the period April 1, 2008-June 1, 2009. Despite the tiny size of the study, the story made front-page news in the wake of several pathology scandals and investigations in other provinces over the past few years.
Reaction from the Quebec government was swift: Dr. Yves Bolduc, Minister of Health and Social Services, appointed an expert committee to assess the APQ report and make recommendations. Within weeks, he announced that the government would undertake the re-testing of nearly 3,000 breast cancer pathology samples as a "precautionary measure" to ensure patient confidence.
As announced at a press conference in December, there were differences in 3% (87) of 2,856 samples, well below the 5% of "normal variability" anticipated for this type of hormone receptor testing. [Note: the 'false negative' rates reported in this study were 0.5% for HER2 (human epidermal growth factor receptor 2), 0.6% for PR (progesterone receptor) and 6.2% for ER (estrogen receptor). These results were better than the false negative rates of ~20% reported elsewhere.]
Treatment based on errors in diagnosis could neither be presumed nor excluded as cause of death.
Five of the 87 patients with altered results had died; in these cases, treatment based on errors in diagnosis could neither be presumed nor excluded as cause of death. Of the remaining 82 patients, 39 had their treatment protocols modified.
Comparing the re-testing results to accepted variability rates elsewhere, Dr. Bolduc called the results of the re-testing "world class," and a validation of the high quality of the province's medical laboratories. At the same time, he acknowledged that improvements were needed and announced that the government was implementing an external quality control program for labs effective June 2009.
On the heels of these statements, however, three provincial organizations called a joint press conference the following day to express their concerns. Representatives of the Fédération des médecins spécialistes du Québec, the Ordre professionnel des technologistes médicaux du Québec and the Coalition Priorité Cancer au Québec challenged the quality standard chosen for the re-testing, pointing out that it was less rigorous than in some Quebec laboratories and would therefore produce fewer hormone receptor-positive results. They urged the government to adopt a stricter hormone receptor threshold as mandatory standard for all laboratories and supported the minister's commitment to upgrade equipment and personnel training as rapidly as possible.
Adhopia, Vic. Anatomy of Newfoundland's cancer-testing scandal. CBC, April 28, 2008. (www.cbc.ca).
Canada lags in standardized protocols for medical labs (News). Canadian Medical Association Journal, July 15, 2008
Canadian Cancer Society. Special report: the controversy about Breast Cancer (www.cancer.ca/Quebec/About%20us/Media%20centre/Qc_nouvelle_diagnostics.aspx?sc_lang=en)
Chorneyko K. & Butany J. Canada's Pathology (editorial). Canadian Medical Association Journal, June 3, 2008.
Dougherty, K. Cancer tests called 'world class'. The Montreal Gazette, December 17, 2009.
Fidelman, C. Breast cancer: Anatomy of a scandal. The Montreal Gazette, June 9, 2009
--------------- No results for women who died. The Montreal Gazette, December 16, 2009.
--------------- Cancer survivors still wary. The Montreal Gazette, December 17, 2009.
Mathews, A.W. Bad Cancer Tests Drawing Scrutiny. Wall Street Journal, January 4, 2008.
Press release: Le ministre Yves Bolduc fait le point sur la reprise de certains tests de pathologie lies au traitement du cancer du sein, Quebec Ministry of Health and Social Services, July 9, 2009
Press release: Le ministre Yves Bolduc rend publics les resultats de la reevaluation des tests de pathologie lies au traitement du cancer du sein. Quebec Ministry of Health and Social Services, December 16, 2009
39 Quebecers with breast cancer wrongly treated. CBC News (www.cbc.ca) and The Canadian Press, December 16, 2009.
Pathology in the limelight
The practice of pathology has come under scrutiny lately as several provinces deal with high-profile stories of tumours left undetected or wrongly diagnosed (false negatives) or at the other end of the spectrum – false positives resulting in unnecessary treatment. Action plans to remedy this, both in terms of improving work conditions and restoring public confidence, are welcomed by those on the front lines.
The Canadian Association of Pathologists (CAP) issued a statement in March 2010 outlining its position, present and future needs, and some new work guidelines. Issues raised include:
- Funding: The Canadian Medical Association Journal reported that CAP and the Royal College of Physicians and Surgeons “believe inadequate investment in laboratory medicine has left the discipline overworked, understaffed and ultimately prone to errors and incomplete work.” Both organizations are working on protocols and quality improvements.
- Work load: A growing and aging population, an increase in the incidence of cancer, and an increase in screening have meant an increase in the number and complexity of cases seen by pathologists. In addition, new technologies, new quality control procedures and testing methods for new therapies all require extra training.
- Lack of human resources: The pathologist workforce is aging and many will retire in the next ten years while demand for this specialty continues to climb. The CAP estimates that 500 new pathologists will be needed during the next decade merely to maintain current levels. Also, the number of physicians generating pathology specimens (e.g., oncologists) is increasing more rapidly than the number of pathologists.
- Lack of laboratory accreditation: While some provinces have quality management systems and accreditation systems for laboratories, proficiency testing for labs varies and there is no technical organization at the national level. Some variants (e.g., handling or time delays in treating specimens) have been identified as contributing to testing errors and are targeted for standardization.
Pathology is under-recognized as the basis for many decisions related to health care. Examination of specimens is inherently labour-intensive, specialized, time-sensitive and subject to interpretation. Recognition of and support towards standardizing and addressing operational needs will strengthen the entire health-care system and ultimately the patients it serves.