Improved diagnostic technologies and more sophisticated software tools allow innovative clinical lab managers to more precisely measure the accuracy of their lab’s analytical results
VANCOUVER, BRITISH COLUMBIA, CANADA—In this beautiful port city, a national gathering of clinical laboratory and anatomic pathology experts convened last week and tackled serious issues concerning the accuracy and integrity of the diagnostic test results produced by labs in Canada and other developed nations.
One big take-away from this meeting was that the bar is being raised for the quality of the lab test results produced by a medical laboratory. Issues of bias, variability, and inaccuracy that accompany the technologies and methods used by clinical laboratories and anatomic pathology groups were front and center during all three days of the meeting.
International Conference for Pathologists and Medical Lab Managers
What brought together this unique mix of Canadian and international speakers and attendees was the “Quality Management Conference for Medical Laboratories.” The meeting was produced by the Program Office for Laboratory Quality Management at the Department of Pathology and Laboratory Medicine at the University of British Columbia.
What was noteworthy about this program is the candor with which speakers addressed the limitations of diagnostic technologies, along with the uneven levels of quality that is observed from one lab organization to the next as revealed by various proficiency testing programs and regulatory requirements. Participants were keenly interested to understand why there is so much variability in the quality of the lab test results produced by different medical laboratories.
Identifying and Eliminating Sources of Errors in Anatomic Pathology
For example, one presentation discussed the source of errors in anatomic pathology. It was delivered by Gregory J. Flynn, M.D., a pathologist who is the Managing Director of the Institute for Quality Management in Healthcare in Toronto, Ontario. He explained how each phase—pre-analytical, analytical, and post-analytical—could be the source of systemic errors that would affect the accuracy of the patient’s diagnosis and negatively impact patient safety.
For the pathology profession to make progress on reducing errors, it is important for them to understand why the popular wisdom that says the pre-analytical phase is the source of the largest share of pathology errors is wrong. Flynn pointed out that surrogate indicators such as malpractice data from the United States and Canada show that the analytical phase is actually where the greatest proportion of errors occurs.
Some Data Indicate that 70% of Pathology Errors Occur in Analytic Phase
“Once they see this surrogate data, most pathologists are surprised to learn that—when you look at the entire pathology laboratory—the analytical phase is the source of as much as 70% of errors that happen in anatomic pathology!” explained Flynn. “These findings challenge the ‘Gold Standard’ thinking within the pathology profession.
“The problem of errors in the analytical phase has been compounded because we pathologists have kept this knowledge to ourselves,” he continued. “As a profession, pathology has not publicly shared its internal concerns about the true level of uncertainty that exists within pathology’s analytical phase.”
Flynn told his audience that work is ongoing to develop more precise assessment of risk management in anatomic pathology. “This is needed so we know where the dragons are,” he observed. “Armed with these insights, we can configure the architecture of quality management so it is adapted to purpose in anatomic pathology to the benefits of the profession and patients.
“For example, I would like to see the pathology profession bring intra-observer comparison into use,” continued Flynn. “This can be done through proficiency testing programs or external quality assessment.
Could Pathologists Benefit from More Simulation Training?
Flynn believes there is another opportunity for improving accuracy and reducing errors in anatomic pathology. “There are changes unfolding in diagnostic interpretive medicine, which includes radiology, cardiac imaging, and pathology,” he explained. “The opportunity is to expand simulation training for physicians in these specialties. In Canada, we are working with the Royal College of Physicians and Surgeons in Canada to introduce more simulation training in the specialties of laboratory medicine and pathology.
“All of these recommended actions would help pathologists reduce the source of errors in the analytical phase of anatomic pathology,” added Flynn. “Moreover, there is an untapped resource that would be of great value. Most medical labs and pathology labs have much undocumented quality management data. Were we better at capturing this data, it could be used most effectively to inform and refine the existing processes of risk mitigation.”
Comparable presentations about problems in the quality of lab testing in clinical laboratories were delivered by such well-known experts as James Westgard, Ph.D., Founder and Principal of Westgard QC and Emeritus Professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin Medical School, and Kent Dooley, Ph.D., Clinical and Associate Professor, Department of Pathology and Laboratory Medicine at the University of British Columbia. These presentations can be accessed on the Internet by visiting the conference website (or copy and paste this URL in your browser: http://polqm.ca/conference_2013/conference_2013/schedule.html).
No National Medical Laboratory Licensure Requirements in Canada
Dark Daily readers outside of Canada may find it helpful to know that there is no national regulation of medical laboratories and anatomic pathology laboratories. “Unlike the United States, which has federal laws that establish a uniform national standard for medical laboratory licensure, in Canada, this responsibility is handled by the each province,” explained Dr. Michael Noble, Chair, Program Office for Laboratory Quality Management at the University of British Columbia. “Therefore, within the Canadian healthcare system, there is no role for a federal law like the Clinical Laboratory Improvements Amendments (CLIA) in the United States.”
Noble is the organizer and Chair of the conference that took place in Vancouver last week. His goals for the meeting were quite specific. “Overall, laboratory medicine in Canada has gone beyond the beginning stage of quality management,” he stated. “It is developing in sophistication and the sessions at this conference were designed to specifically to give delegates a 360-degree view of quality management.
“In this way, it broadens their understanding of quality in medical laboratories and anatomic pathology labs and inspires the vision on how to raise our existing quality standards to further improve accuracy in lab test results and contribute to increased patient outcomes,” concluded Noble.
Your Dark Daily editor,
Robert L. Michel