CEO SUMMARY: Experts point out that widely publicized episodes of lab testing deficiencies in several provinces are signs that chronic underfunding of lab testing services is a key factor in these failures. To restore public confidence in breast cancer testing, the Canadian Association of Pathologists is developing a voluntary proficiency testing system for hospital labs to improve the accuracy and reproducibility of breast cancer markers, including estrogen receptor, progesterone receptor, and other clinical IHC tests.
LABORATORIES AND BANKS SHARE ONE BUSINESS ATTRIBUTE: both businesses will fail if they lose the confidence of the public. In Canada, high-profile testing deficiencies at several lab testing sites in recent years demonstrate the truth of this long-recognized principle.
Sustained cuts in laboratory funding in Canada are believed to be a major contributing factor in the handful of lab testing failures that have been widely covered by newspapers and the media in that country. Pathologists and lab directors in Canada argue that the deep funding cuts in laboratory testing, sustained over two full decades, leave the nation’s laboratories with inadequate resources to produce high-quality lab test results at all sites and at all times.
With the negative consequences of underfunding now visible to the public, Canadian pathologists themselves are taking steps to correct deficiencies in the system. However, this effort to guarantee the quality of laboratory testing faces a daunting obstacle: the lack of health system funding to support a newly-instituted laboratory proficiency testing program.
Widely publicized erroneous results for breast cancer estrogen receptor (ER) and progesterone receptor (PR) testing in Newfoundland Province recently triggered a judicial inquiry. Deficiencies and possibly inaccuracies in surgical pathology biopsy reporting in another Atlantic province, as well as in Ontario and Manitoba, triggered public alarm across Canada.
To improve the reliability of laboratory test results and to boost public confidence in the quality of laboratory test results, the Canadian Association of Pathologists (CAP) has endorsed a proficiency testing (PT) program for laboratories doing diagnostic immunohistochemistry, including estrogen receptor/progesterone receptor (ER/PR) tests for breast cancer.
In an interview with THE DARK REPORT, Jagdish Butany, MBBS, MS, FRCPC, and CAP President, discussed the new Canadian Immunohistochemistry Quality Control Program that is endorsed and supported by the CAP. Currently it is voluntary for laboratories in Canada and they may continue to participate in other external quality assurance programs.
“We set up the National Standards Committee/I mmunohistochemistry chaired by Dr. Emina Torlakovic from the Royal University Hospital, University of Saskatchewan,” noted Butany. “She and Blake Gilks, M.D., from Vancouver General Hospital, University of British Columbia, set up a Web-based program, the Canadian Immunohistochemistry Quality Control (cIQc), for proficiency testing in diagnostic immunohistochemistry that included breast cancer markers and other IHC tests. However, at this time, the entire service provided by the pathologists, technologists, and IT support are donated. We are seeking funding to sustain this PT program into the future.
“Participation in the program is voluntary at this time, but this may change in the future,” he said. “The CAP National Standards Committee/ Immunohistochemistry is calling for mandatory certification for all prognostic and predictive IHC tests. To obtain certifi- cation, the laboratories will need to demonstrate high levels of concordance with reference values by participation in external quality assurance (EQA) pro- grams which provide testing samples that enable calculations of the concordance, meaning that test samples would need to include large numbers of samples to provide meaningful results. One such program is the cIQc.”
In an article published in the June 3, 2008, issue of the Canadian Medical Association Journal (CMAJ), Butany and Kathy Chorneyko, M.D., Staff Pathologist and Assistant Medical Director for Laboratory Services at Brant Community Healthcare System, in Brantford, Ontario, called on provincial governments to remedy problems at overworked labs.
Inadequate Funding for PT
“Although there is some momentum for technical quality assurance programs, the Canadian healthcare system does not have a well resourced national approach to quality assurance of the analytical or professional component of anatomic pathology,” wrote the authors. Not waiting for provincial health systems to respond, Butany and other pathologists developed the voluntary ER/PR proficiency program and are having some preliminary success.
“Design of an ER/PR proficiency testing program was initiated in April 2007,” Butany said. “By the following July, CAP executives and the general body agreed that a committee of experts should set up a platform for the development of the national standards in diagnostic immunohistochemistry. The standards would call for mandatory certification in breast carcinoma markers IHC testing, which is facilitated by the development of the suitable national EQA.
“The ER/PR proficiency testing service is now available to any hospital willing to participate,” explained Butany. “Proficiency of a participating laboratory is checked against the proficiency of a central laboratory and expert pathologists who interpret the same section from the same tumor and the same patient.
“We offered this PT service at no charge because we wanted to encourage lots of participation and ensure good, reproducible, quality across the country,” Butany stated. “Dr. Torlakovic has done a tremendous amount of work to get this program running. So far, three rounds of slides have been sent to her from the participating hospitals and the results are recorded and evaluated.
“Because this PT program is so new, we are working on finding the best ways to do a quick evaluation of the results and their distribution,” he noted. “We are also working to provide direct interaction between experts and participants in information exchange as well as directly helping participants to improve their procedures whenever necessary.
“Until now, there were no protocols or standard operating procedures (SOPs) for ER/PR testing,” Butany said. “Every lab seemed to do things differently. There was no consensus as to the best way to handle these tissues and ER/PR testing requires more than 40 steps. Would it matter if the surgeon took the biopsy out and kept it in the OR for two hours? Would it make any difference if the biopsy specimen stayed in the lab overnight or over the weekend without being fixed?
“Of course, we now know that each of those steps makes a phenomenal difference,” he added. “National and international guidelines need to be developed, and we are supporting this movement by our own efforts. The existence of protocols will make a significant difference because all of the proper steps are bundled into the SOP. At the end, the results should be reasonably similar and reasonably reproducible. We are going one step further to establish that each pathologist interprets these slides the same way. We hope that these efforts will result in numerous new safeguards that will ensure quality reporting in prognostic and predictive IHC testing.
Regular Use of SOPs
“Pathologists recognize that SOPs are needed for every test,” Butany continued. “SOPs exist for routine staining. However, immunohistochemistry tests were not fully standardized because of their complexity and much work is needed to achieve this goal.
“For example, there are different types of IHC tests,” he explained. “ER/PR is a category 2 test, since the results are ‘stand- alone’ and reported independently of other evaluated parameters, but inform the oncologist whether the patient may be a suitable candidate to get a particular treatment, and what treatment is likely to be most appropriate.
“Because category 2 tests have a direct impact on the treatment choices, the quality of the testing procedures makes a tremendous difference,” he emphasized. “If the specimen is processed and the quality is not excellent and not reproducible, then that laboratory has a problem which can have a negative impact on patient care. After ensuring the quality of the ER/PR tests, plans are for Dr. Torlakovic’s committee to establish SOPs for all the other immunohistochemistry tests.
“In the end, it is worth noting that these highly publicized problems have been found in only one laboratory in the country, and that only a very small number of pathologists (three out of about 1,200) have had their diagnoses challenged,” Butany said. “All Canadian laboratories have a major commitment to quality assurance and pathologists continue to do excellent work, in spite of seemingly insurmountable odds.”
Lessons for United States
The events unfolding in the Canadian laboratory system are instructive and relevant for lab directors and pathologists in the United States. After all, underfunding of laboratory testing services in the United States has been a feature of both public and private payer policies for almost two full decades. At some point, under-reimbursement of laboratory services will trig- ger lab testing deficiencies that affect patient care in a noticable way.
Thus, as cracks in the performance of Canada’s laboratories become visible and are attributed to sustained underfunding for lab testing services, it helps healthcare policymakers in the United States understand how underfunding of lab services here in in this country could contribute to declines in the accuracy of laboratory testing, resulting in declines to both patient care and outcomes.