CEO SUMMARY: Facing a crisis due to several highly publicized deficiencies in lab testing, pathologists in Canada are using proficiency testing (PT) to improve standards. In British Columbia, PT is mandatory and every lab is evaluated every quarter. Pathologists in BC recommend that every province and territory adopt mandatory proficiency testing. Currently only British Columbia has such requirements. Labs in the rest of the nation can participate in a newly developed voluntary PT program.
FOR MOST CLINICAL LABS IN CANADA, proficiency testing (PT) is voluntary. But in British Columbia and Ontario, it is mandatory. Documented successes of the Diagnostic Accreditation Program in British Columbia are spurring calls for health regulators in all provinces in Canada to adopt a similar mandatory PT program.
In Canada, proficiency testing for clinical laboratories has been a high-profile issue. In recent years, serious deficiencies in several laboratories were discovered and attracted unfavorable media attention. In response to these events—and to restore public confidence in breast cancer testing—the Canadian Association of Pathologists (CAP) developed a voluntary PT system for hospital labs.
Dr. Emina Torlakovic at Royal University Hospital in Saskatoon, Saskatchewan, manages this program for CAP. It is well subscribed but does not cover all labs that perform these tests. It also has been successful in terms of compliance and reporting. The goal of the program is 100% participation and 100% accuracy by seeking to improve the accuracy and reproducibility of breast cancer markers including estrogen receptor (ER), progesterone receptor (PR), and other clinical immunohistochemistry tests. (See TDR, Aug. 18, 2008.)
One Canadian province which has avoided these problems is British Columbia. Not coincidentally, it has a rigorous, mandated program for laboratory proficiency testing. To get the inside story, THE DARK REPORT caught up with Robert Wolber, M.D., Medical Discipline Leader For Anatomic Pathology at Vancouver Coastal Health in Vancouver, British Columbia. Wolber said a program similar to the Diagnostic Accreditation Program (DAP) in British Columbia should be required in every lab in every province or territory.
Identifying Deficiencies Early
“If you want proficiency testing to work, you have to make it mandatory in each of the provinces,” observed Wolber, who is a member of the DAP’s Anatomic Pathology Advisory Committee. Wolber notes that one key to this proficiency testing program’s success is the provincial law that allows the Provincial College of Physicians to revoke the medical license of any physician who operates a lab that fails to meet the DAP’s standards.
“Under the DAP, we have proficiency testing for the important tissue biomarkers for breast carcinoma,” Wolber explained. “Significantly, as part of this program, all tissue specimens in the province used for testing are verified with what is considered to be the gold standard method, which is fluorescence in situ hybridization (FISH) testing. All 11 clinical laboratories in British Columbia that perform breast cancer testing for clinical purposes participate in this PT program.
Tissue Array-Based Survey
“Each quarter, we provide tissue array-based surveys to each of the 11 laboratories,” he added. “After we review the results, we send feedback to those laboratories within two weeks. In each array, we include between 40 and 50 tissue specimens. In effect, we have about 200 tests per immunohistochemical marker per year from each of the 11 laboratories. This is meaningful statistical analysis of each laboratory’s performance, allowing us to state, with a fair degree of certainty, whether or not any laboratory is reaching appropriate levels of sensitivity and specificity for that marker.
“That degree of certainty is very important,” continued Wolber. “For example, we can state, with a high degree of specificity, that every estrogen receptor (ER) test done in British Columbia is per- formed with a minimum accuracy rate of 95% or greater. In fact, as of the last survey that we did, I can also make this same statement about HER2 (human epidermal growth factor receptor 2) testing.
“Because of this comprehensive quality assurance program in British Columbia,” he noted, “if any lab is going off the rails, we can quickly identify the error. If a lab fails one test, then we make recommendations. If that lab fails to perform the second time, we report the results to the DAP and the lab is told to shut down the test until the problem is fixed. That’s the strength of the program. It is based on the very strong legislation in British Columbia that requires labs to participate in an external PT program for specific tissue biomarkers.
“These aspects of DAP grew out of a program we had here in our own health region—one of six health regions in British Columbia,” Wolber said. “Since about 2003, we have conducted this testing to monitor our own performance. DAP was made mandatory 37 years ago, but it wasn’t until the early 1990s that the provincial government put teeth into this legislation. The requirement for labs to participate in PT for specific tissue bio-markers was introduced last year, as a result of lobbying by pathologists.”
BC Pathologists Join in National PT Effort
IN ADDITION TO WORKING on the mandatory proficiency testing (PT) program in British Columbia, pathologists at Vancouver Coastal Hospital are also working with the Canadian Association of Pathologists (CAP) to improve the voluntary PT system being introduced nationwide for hospital labs.
Pathologist Dr. Robert Wolber and others are collaborating with Dr. Emina E. Torlakovic, who heads the CAP’s National Standards Committee. “We send Dr. Torlakovic tumor array specimens for evaluation and have participated in the national program on a voluntary basis,” Wolber said. “I’m very supportive of their program. I particularly like how they post the results on the Web so that the participating labs can access this information.
“However, I have also recommended that this national PT committee score the results from the various labs,” Wolber added. “When we get results from labs in British Columbia, the pathologists use a multiheaded microscope and score all the slides. Then, we send the labs their scores. That shows whether the results reported by each laboratory met the criteria.”