CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved quality assurance testing program and are unrelated to problems that plagued Eastern Health labs between 1997 and 2005 when 386 patients received wrong results for hormone receptor testing.
ERRORS IN BREAST CANCER TESTING at the Eastern Health pathology lab in St. John’s, Newfoundland, have generated news headlines in the province and nationally across Canada. This is the same health region that mishandled breast cancer testing between 1997 and 2005.
This situation is a reminder to all pathologists and lab executives that public trust in the accuracy of lab test results is essential for a lab organization to stay in operation.
The story has elements of both bad news and good news. The bad news is that, for breast cancer testing done at the St. John’s lab between April and December, 2013, discrepancies were discovered in the test results reported on some patients.
The good news is that the new procedures and improved quality control/quality assurance protocols instituted after the lab’s earlier problems were uncovered in 2005 had a role in the discovery of these recent test problems. As a result, the number of lab test errors was limited and notifications of the test problems were sent to both the patients who were affected and their physicians.
Because of the lab test errors, nine patients with breast cancer were treated with Herceptin, but a review of their test results by an outside laboratory suggested that they were in fact negative for overexpression of the Her2. Eight of the nine patients had begun treatment because of physicians believed these patients had aggressive cases of breast cancer, provincial health authorities stated.
Discrepancies Were Found
After discrepancies were found and retesting was done early this year, the health authorities changed the treatment for these nine patients and apologized for mischaracterizing their test results.
In a press conference on February 13, officials at Eastern Health said these cases were discovered as a result of quality assurance testing and are unrelated to problems that plagued Eastern Health labs between 1997 and 2005. That was when 386 patients received wrong results for hormone receptor testing. Some of those patients possibly died as a result of a lack of proper treatment.
Those 386 cases of wrong breast cancer test results led to an extensive investigation called the Cameron Inquiry in 2009. It was conducted by Margaret Cameron, a Supreme Court judge in the province.
The inquiry’s report cited numerous flaws in lab testing procedures in Eastern Health and resulted in extensive changes in Eastern Health’s pathology laboratory processes and administration. (See TDR, May 18, 2009.)
Although the recent cases involve breast cancer treatment just as the cases that led to the Cameron Inquiry did, the recent errors were different from those that occurred from 1997 to 2005, reported Barb Sweet in the St. John’s Telegram.
Here’s what unfolded: On December 9, the quality assurance initiative of the Laboratory Medicine Program at Eastern Health identified a discordant test result between a result produced by the Eastern Health lab and the result done by an outside quality assurance lab.
A quality assurance review of 68 cases done between April and December indicated the need for additional testing, and of these tests, 34 required additional testing at a lab in Miami, stated Eastern Health CEO Vickie Kaminski at the February 13 news conference.
On January 31, 34 of the 68 samples were sent to a Dual ISH expert in Miami for review. The name of the Miami lab has not been released, and, during an interview with THE DARK REPORT, Dr. Martin Trotter, President of the Canadian Association of Pathologists, said that he did not know the name of that lab.
Among the 34 results sent to Miami, Eastern Health had determined that 22 were HER2 negative and the Miami lab agreed. Among the 12 samples that tested positive, the Miami lab confirmed the findings for three results, but reported nine cases as discordant, the Telegram reported.
Quality Assurance Review
“The authority knew something was amiss in December due to a quality-assurance check, but said it did not have confirmation of the nine errors in the immunohistochemistry lab until Tuesday (February 12), after consulting an expert in Miami, Florida, and having further testing done in an outside lab,” reported the Telegram.
Provincial health officials stated that, while a quality assurance test identified the need for retesting and the retesting identified results that did not match, the source of the mismatched results remains unclear. The fact that the mismatched results were caught as a result of a quality assurance review indicated improvement from the problems uncovered between 1997 and 2005 when lab testing errors were common, officials said.
The Telegram reported that, as of mid February, health officials did not know the source of the error and that they would conduct a root cause analysis. Also, HER2 testing has been discontinued in the province until the results of the analysis are known. This will lengthen the time before patients know the results of their lab tests for breast cancer.
Kaminski admitted that while it was bad news that nine patients were affected negatively, the QA program caught the problem quickly, the newspaper reported. “This is a very distressing time for our patients and their families and we are offering whatever support they need at this time,” she said at the time.
Detecting Discordant Results
“However, this incident demonstrates that Eastern Health has a quality assurance program in place in its laboratory medicine program that is working,” Kaminski said, according to The Telegram. “It allows us to detect any discordant results early; that we put a process in place to determine whether there is an issue and, most importantly, that we can adjust treatments for our patients if required. That is what we have learned from the errors in estrogen and progesterone receptors.”
The regional and national news stories that appear in Canada following the disclosure of lab errors that may have negatively affected patient care, such as those described above, demonstrate the level of trust citizens place in their medical laboratories. That is why it is significant news whenever a respected laboratory organization must acknowledge to the public that, due to errors, it must notify the patients affected and provide additional testing.
President of Canadian Association of Pathologists Weighs in on the Issues at the St. John’s Lab
MUCH HAS CHANGED IN LAB TESTING at Eastern Health’s St. John’s laboratory since the Cameron Inquiry in 2009 identified extensive problems with breast cancer testing during the years 1999 through 2005. A more rigorous program of quality assurance (QA) and quality control was implemented.
“Changes have been made to the funding of pathologists and the testing system, along with the level of transparency in the system,” stated Martin J. Trotter, M.D., Ph.D., President of the Canadian Association of Pathologists and a Professor in the Department of Pathology and Laboratory Medicine at the University of Calgary. “In addition, a comprehensive quality-assurance program was added since the 2009 inquiry. Pathology quality programs in Newfoundland have improved at least 100%.
“What’s different in this most recent episode at the St. John’s laboratory is that these latest errors were discovered as part of a quality assurance process, as all labs do now,” Trotter explained. “The laboratory participates in several external quality assessment (EQA) programs and discrepancies were dis- covered on one of these external tests.
“That QA assessment was done specifically to assess performance of the Her2 Dual in situ Hybridization (DISH) tests that the Eastern Health lab has been running,” he said. “These chromogenic ISH slides are difficult to interpret, with considerable interobserver variation.
“The external quality assessment suggested that two cases that were interpreted by Eastern Health pathologists were discrepant with the reference lab result,” stated Trotter. “A review of testing protocols was recommended, and, on a subsequent EQA challenge, further retesting was advised.
“Eastern Health requires labs to participate in quality assessment, and the QA process quickly identified a potential issue,” noted Trotter. “A review of assay protocols demonstrated that there were no technical problems with tests. The issue seems to have been interpretative variability. These EQA cases are often very challenging and not straightforward.
Discrepant Test Results
“Our position at the Canadian Association of Pathologists (CAP-ACP) is that—when pathologists participate in quality assurance activities—policies and procedures need to be in place to define the actions to be taken if test results are discrepant,” added Trotter. “The CAP-ACP position is that a lab should make sure its processes are complete and accurate, then retest a subset of cases within a recognized EQA program.
“Unless a systemic problem is discovered after a root cause analysis, then retrospective review of patient cases is not the correct approach to EQA discrepancies,” observed Trotter. “I don’t know of any lab that would retrospectively review 100% of patient cases. The correct approach is to continue with all components of the Newfoundland quality assurance programs, including EQA testing, continuing medical education, and continuous improvement processes.”