Lab didn't appreciate complexity of using equipment, MD tells cancer inquiry
31.07.2008 16:01
Health
- Source: cbc.ca
 Dr. Diponkar Banerjee told the Cameron inquiry that there was much division in the Eastern Health pathology lab when he examined it in 2005. (CBC)St. John's health managers may have placed too much faith in new technology used to handle breast cancer tests, an expert has told a judicial inquiry. Dr. Diponkar Banerjee, a University of British Columbia pathologist, was recruited by Eastern Health in 2005 to review what had gone wrong with hormone receptor tests used to determine the course of treatment for hundreds of breast cancer patients. Banerjee told the Cameron inquiry in St. John's that he needed only to look at a handful of slides of stained breast cancer tissues to understand what the problems were. He saw poor preparation of tissue samples before they underwent testing. More importantly, though, he found a poor understanding of what could be expected from the new, sophisticated Ventana testing technology that the St. John's lab had recently acquired. "If you just took the manufacturer's protocols, they may not necessarily work in your lab because there are other variables to correct for it," Banerjee said. "We use the manufacturer's data sheet as just a starting point," said Banerjee, adding that the conditions in the critical process of fixation — in which proteins in samples are effectively halted so that they can be analyzed — will vary from one lab to the next. "Even the morphology would look variable for the same reasons, [so] it is not appropriate for any lab to just to take the manufacturer's protocols and say, 'This is what they say — you should use and expect it to work,' because it will not." Equipment nonetheless cited as probable causeDespite that finding, Eastern Health would tell government officials and the public that it believed faulty equipment — including the previously used system, known as DAKO — was the probable reason hundreds of patients got the wrong results in estrogen receptor and progesterone receptor cases. Eastern Health maintained until last year that if human error were a factor, it would be the job of the courts to sort that out. Newfoundland Supreme Court certified in 2007 a still-pending class-action lawsuit filed on behalf of breast cancer patients. Following a fall 2005 visit, Banerjee — also the executive medical director of B.C.'s Provincial Health Services Laboratory — wrote a report that found significant problems with how the lab was functioning. Eastern Health had fought unsuccessfully in Newfoundland Supreme Court to keep that report — as well as another highly critical review written by Trish Wegrynowski, a technologist at Toronto's Mount Sinai Hospital — out of the public eye. Lab a house divided, inquiry toldBanerjee told Justice Margaret Cameron that he observed a house divided in the Eastern Health pathology lab. Pathologists were at odds with non-medical managers, and technologists were caught in the middle. He said Dr. Donald Cook, the lead pathologist at Eastern Health, was frustrated in not being able to have a say in the lab's management. Banerjee, though, said he found that Terry Gulliver and Barry Dyer were both "very eager to do a good job and they're very much in touch with the industry side" of how the lab worked. "They felt that they were perhaps not as appreciated by the pathologists as they would like, in terms of bringing innovation to the lab and that [they] acquired some new equipment which was sitting idle because the pathologists weren't interested," Banerjee testified. "That suggested that there wasn't a team approach to building the department, and there was some separation of medical and technical staff in terms of planning quality assurance and so on." Banerjee, meanwhile, said he did not think that the "dual management" system in the lab — in which physicians shared decisions with non-medical staff — should be replaced, with a pathologist ultimately responsible. "This is a model that's evolved across the country [with] separation of management from the medical staff. I personally think it's the wrong one, but I'm a minority, as far as saying that publicly, I guess," Banerjee testified. "The structure should be independent of the personalities, so if you have a dual management model where the lab director and the program or lab manager get along very well, then it works," he said. "But if they don't get along very well, the structure doesn't help the situation because when things go wrong, nobody is actually accountable." Cameron, a Newfoundland Supreme Court's appeals division judge, has been hearing evidence since March on the bungled tests, and on how Eastern Health and government officials responded to the problems. Wegrynowski testified in June that she found the technologists had received such little training on immunohistochemical staining that she turned one review session into an impromptu training exercise. She testified that staff did not even have basic reference materials, nor even internet access for reference and research. 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