As healthcare systems make patient safety a greater priority, the public reporting of pathology errors in Canada has no comparable track record in the United States
Errors in anatomic pathology testing in the Canadian provinces of Nova Scotia and Saskatchewan made media headlines this summer. In each case, it was just a limited number of cases where errors at pathology labs resulted in inaccurate diagnoses and, in at least one case, a needless mastectomy for a patient.
At a time when health systems in Canada, the United States, and other developed nations are giving great emphasis to patient safety, disclosure of life-changing diagnostic errors to patients is appropriate. Consumers are holding physicians—including surgical pathologists—to a higher standard of care.
Pathology Errors Disclosed in the Cities of Halifax and Regina
The first episode of pathology errors occurred in Halifax, Nova Scotia. Tissue specimens from across the Capital District Health Authority are sent to Queen Elizabeth II Health Sciences Centre for processing and diagnosis.
In April, “pathology results were switched on the charts for two patients, leaving one patient needlessly losing a breast and the other not being scheduled for the necessary treatment,” wrote the reporter for The Canadian Press in the story it published on this matter.
A second episode happened just one month later at the same hospital laboratory. Because the slides from two patients were mislabeled with wrong patient identification, one patient got a positive test result that was wrong and underwent needless treatment. The other patient got a negative test result that was wrong and did not receive appropriate treatment, according to a story published by The Globe and Mail about the pathology errors in Halifax.
Histology Laboratory Mishandled Tissue Specimens of 107 Patients
In August, provincial health officials in Regina, Saskatchewan, told reporters that the tissue specimens of 107 patients had been mishandled in the histology laboratory at Pasqua Hospital, part of the Regina Qu’Appelle Health Region. In its story about the incident, the Leader Post wrote, “The mix-up occurred when a lab worker put the wrong chemical—cytology clarifier, which was properly labeled—in a tissue processing machine instead of the correct product, xylene. Cytology clarifier, which contains acetic acid/vinegar and alcohol, damaged the tissue samples to varying degrees. The samples were processed overnight, and the error was identified the next morning, on Aug. 23.”
The health authority stated that, of the 107 patients involved, “29 were impacted to the point that a result could not be obtained,” said the Leader Post, noting that “for 53 patients, a proper pathology report couldn’t be issued.” Between 10 and 15 of those patients will need to undergo a second biopsy to acquire the tissue needed to complete their diagnosis.
More Pathology Errors Become Public in Canada Than in United States
Contrast this public disclosure of separate episodes of anatomic pathology testing errors in Canada to what typically does not happen in the United States. It is an interesting phenomenon that, within Canada, a nation of 35 million people, healthcare officials in two provinces have publicly acknowledged errors in anatomic pathology laboratories that resulted in patients getting a wrong diagnosis during the past six months.
Yet, within the United States, a nation of 314 million people, one must go back to a New York Times story, published July 19, 2010, to learn of a single case where a pathology laboratory made an error when diagnosing breast cancer in a woman who lived in Michigan.
Assume that quality of anatomic pathology testing in Canada and the United States is comparable. Given the lack of public reports about pathology errors in the United States, is it reasonable to then assume that the 15,000 pathologists in the United States make fewer diagnostic errors on patients in this country each year than the approximately 1,300 pathologists practicing in Canada?
Why Aren’t More Anatomic Pathology Errors Reported?
The level of public disclosure about anatomic pathology and other types of diagnostic errors in Canada is not matched here in the United States. Since the medical laboratories in both countries use similar methodology, similar instruments, similar workflow, and are directed by pathologists with similar training, one must ask: why is it that, in the United States, a nation with 10 times the population of Canada, there is no comparable or proportionate public record of errors in clinical laboratory testing and anatomic pathology diagnoses?
Certainly one reason why diagnostic errors by pathology labs and clinical laboratories in the United States seldom come to the attention of the public is that government agencies typically hold such information confidential. Malpractice cases are one source of public disclosure, but these cases often come to light months or years after a patient discovered that the laboratory had made an error that led to an inaccurate diagnosis and the wrong treatment for that patient.
One case now unfolding makes the point about the lack of timely public reporting of laboratory errors in the United States. It shows how the Food and Drug Administration (FDA) and in vitro diagnostics (IVD) manufacturers handle diagnostic errors that occur when lab test kits do not perform to specifications and generate inaccurate test results that can cause a physician to make the wrong diagnosis and negatively affect the patient’s care.
PSA Test Kit Recall Now Underway Because of Inaccurate Results
The example now unfolding probably involves tens of thousands of male patients. It involves a PSA test kit manufactured by Siemens Diagnostics. On August 26, 2013, ABC News Radio broadcasted a story that Pinnacle Health of Harrisburg, Pennsylvania was sending letters “to 7,500 patients to inform them of a faulty chemical in the [PSA] tests used to measure levels of the protein secreted by their prostate glands. It showed higher levels of the protein than were actually present.”
ABC News Radio reported that the PSA test kits were used at Pinnacle from May 2012 through June 26, 2013—almost an entire year! It went on to say that “…Pinnacle Health patients are likely the tip of the iceberg. The PSA test recall was ‘global,’ according to Siemens Healthcare Diagnostics, which produced the tests that went out to labs across the country just like Pinnacle.
According to ABC News Radio, “Siemens recalled all lots of the ‘IMMULITE’ PSA tests from June 27 because they had a 20 percent to 23 percent ‘positive bias,’” according to a company statement. It shipped bad tests to labs from February 2012 through May 2013.
Siemens Declined to Tell Reporter How Many Labs Were Affected by Recall
The ABC News Radio story went on to say: “Siemens spokeswoman Erin Brown told ABC News that all labs that used the tests were notified to discard them. But when asked how many labs were affected, she declined to answer, as did another Siemens representative, Gian Sachdev. The FDA, which posts recalls on its website, has not posted the nearly two-month-old Siemens recall yet because it is still assessing it.”
For its part, the FDA was reluctant to say much. ABC Radio News provided the following quote from the FDA. “The FDA takes any problem with a medical device very seriously and works with companies to ensure that the appropriate steps are taken to inform healthcare professionals and protect patients. The FDA is continuing to work with the company to identify the cause of false positive readings with the test. Siemens has contacted laboratory and health care facilities impacted by this recall.”
FDA Posts PSA Test Kit Recall Notice on September 4
Evidently, inquiries by the national media in August caused the FDA to reconsider its reticence to make public its recall notice about this issue. On September 4, 2013, the agency posted an Enforcement Report about the matter on its website. This enforcement report notes that Siemens voluntarily initiated a recall of the PSA test kits on June 26, 2013. However, as of this date, Dark Daily could not locate either a recall alert or a press release associated with the recall of the PSA test kits on websites operated by Siemens.
Meanwhile, the public is only now finding out about the problems with this particular PSA test kit, as individual laboratories begin to notify patients about the possibility of inaccurate PSA test results and local newspapers and media outlets learn of the retest letters. That includes Clear Point Diagnostic Laboratories of Lewisville, Texas; Regional Medical Laboratory of Bartlesville, Oklahoma; and Central Pennsylvania Alliance Laboratory of York, Pennsylvania. In Ireland, hospital labs have been sending out similar notices, according to a story published in the Irish Times.
Why Are U.S. Labs Reporting Fewer Errors Than Canadian Labs?
When the public record and media news accounts about pathology errors in Canada are compared to the public record and media accounts about pathology errors in the United States, it reinforces the impression that the Canadian system is more forthcoming about mistakes and errors in anatomic pathology testing that affect patients.
With few comparable episodes of pathology errors similar to those that occurred this year in Halifax and Regina known to the U.S. public, is that a sign that anatomic pathology laboratories in this country operate with a higher degree of accuracy than their counterparts north of the border? Or could it be that pathology laboratories in this country are failing to detect systemic problems in their labs that cause errors in specimen labeling and patient results?
In the United States, laboratory professionals have the opportunity to learn more about how to identify and permanently fix the sources of system errors in their laboratories–including issues that affect the integrity of the analytical stage.
On October 1-2, 2013, the seventh annual Lab Quality Confab in New Orleans, Louisiana, will tackle these subjects. Speakers on this topic include James W. Westgard, Ph.D., of Westgard QC; Luci Berte of Laboratories Made Better!; and Richard Zarbo, M.D., Ph.D. of Henry Ford Health. Visit www.labqualityconfab.com for the full agenda and to register.
In Canada, laboratory professionals will have their own opportunity to get information about the identification of systemic errors and how to fix them properly. On October 7-8, at the Marriott Bloor Yorkville Hotel in Toronto, Ontario, speakers at the sixth annual Executive Edge will speak to these issues, including Stephen Raab, M.D., Ph.D. of Eastern Health; and Rita D’Angelo of Henry Ford Health.
Visit www.exec-edge.com for information on the full program and to register.