Lab mistakes, poor oversight flagged in N.L. breast cancer inquiry
Newfoundland and Labrador's largest health authority failed hundreds of breast cancer patients with shoddy laboratory work and "practically non-existent" quality controls, a hard-hitting judicial inquiry has found.
Justice Margaret Cameron determined that Eastern Health not only made hundreds of mistakes with hormone receptor tests over an eight-year period, but also wasn't aware of it because it had almost no quality control measures in place to govern the pathology lab's work.
"There was a failure of both accountability and oversight at all levels," Cameron determined in a report released Tuesday in St. John's.
"The whole of the health-care system, to varying degrees, can be said to have failed the ER/PR patients," wrote Cameron, referring to the estrogen-receptor and progesterone-receptor tests that are used to help determine whether a breast cancer patient can benefit from Tamoxifen, a powerful antihormonal drug.
In a much-awaited report, Cameron also found that Eastern Health dropped the ball in communicating with patients, the public and government, and had no crisis management plan to deal with an issue that has overwhelmed the authority for several years.
Cameron also found that provincial government officials ought to have done more, including current Health Minister Ross Wiseman, who, Cameron said, did not exercise "due diligence" when he relayed wrong information from Eastern Health to the public in 2007 without questioning what he had been told.
"I accept responsibility for that," Wiseman told reporters Tuesday, while pledging to "strengthen" the health-care system in the wake of a report that found serious errors at almost every level.
Cameron, who sits on the Newfoundland Supreme Court's appeals division, submitted her final report just before midnight on Sunday, almost a year after she started hearing testimony.
Cameron herself will not be commenting on her report, in keeping with the policy of not granting interviews that she maintained throughout the inquiry.
Cameron heard evidence over a seven-month period on how almost 400 breast cancer patients received the wrong test results. A year ago, the government disclosed that 108 of those patients had died, although it will never be known if different treatments could have extended or saved any lives.
Mistakes in lab from early period
Cameron found that the pathology labs in St. John's were making mistakes with the complicated ER/PR tests for several years without anyone being aware that a silent monster was growing larger in their midst.
Cameron focused on problems with fixation, those process by which tissues were prepared for analysis, but found that even those errors in the lab and in operating rooms ought to have been caught much earlier than they were.
"The procedures and protocols within Eastern Health for ER/PR testing during the period from 1997 to 2005 were so deficient as to be practically non-existent," wrote Cameron.
Cameron found that Eastern Health's managers put a far greater emphasis on financial management than on protecting the public interest.
"Quality has to be given importance equal to that of the budget," wrote Cameron, whose 60 recommendations include urging the government to fund work intended to improve dramatically the work in Newfoundland and Labrador's hospitals and labs.
"The failures did not stop at the laboratory door," she wrote. "The fact that this problem existed for such a long time without discovery demonstrates not only deficiencies within the laboratory but also the failure of [the] management system."
Cameron found that quality control in health care must be highly valued, because people entrust their lives to physicians and lab work.
Review should have been triggered in 2003
"A regional health authority does not produce widgets," she wrote. "Its clients have no choice but to use its services; they cannot stop going to the hospital because the services received on the last visit were unsatisfactory."
"Had proper quality assurance and quality control policies been in place and had they been followed, the problem with ER/PR testing would certainly have been discovered much earlier," Cameron wrote.
Cameron noted that Eastern Health missed an opportunity to act when Dr. Gershon Ejeckam, a now-retired pathologist, flagged serious problems with hormone receptor testing in 2003. Cameron was told that Ejeckam's warnings did not make it to the desks of senior managers and that the laboratory manager did not take his complaints seriously.
She noted that the lack of proper record-keeping compounded problems.
"Had occurrence reports been filed, this, coupled with Dr. Ejeckam's observations about the tests, as stated in his 2003 memos, should have triggered a review at that time," wrote Cameron, adding that one expert witness — B.C. pathologist Dr. Diponkar Banerjee — had advised that Ejeckam's warnings were strong enough on their own to merit an independent investigation.
As well, Cameron pointed to evidence dating back as far as 1999 that could have alerted managers that there were faults in the lab.
Cameron found that Eastern Health made the correct and "timely" move to retest all of its ER/PR samples at Toronto's Mount Sinai Hospital in August 2005.
However, Cameron was highly critical of how Eastern Health communicated with patients, as well as with the public and the government itself.
Cameron recommended that the health minister report back to the legislature by March 2010 on the progress of implementing her advice.
Inquiry ordered in 2007
Premier Danny Williams and his government appointed the inquiry in July 2007, soon after Eastern Health, the largest health authority in the province, was shown to have withheld important information about errors in the hormone receptor tests.
Williams said the inquiry was needed to restore public confidence in the health-care system, although evidence produced at the inquiry often brought public outrage over how the health-care system was managed.
Williams himself expressed pique with the inquiry, and last May criticized the "inquisitorial tone" of inquiry lawyers. Cabinet minister Jerome Kennedy, who is now the finance minister, even suggested that the aggressive work of the inquiry could lead to the collapse of the health-care system, because physicians were being alienated by its work.
Many physicians, however, welcomed the scrutiny that the inquiry provided — as well as an increased public awareness of issues such as pay, workloads and turnover. Last spring, reacting to physician complaints, the Newfoundland and Labrador government awarded hefty pay increases to pathologists and some oncologists, and later extended the package to other medical specialists.
Far more pressing for the public, though, was a cascade of revelations, which included missed warnings of problems in the pathology lab to inadequate training and supervision of lab work.
The inquiry also cast a harsh light on Eastern Health, which was formed from several smaller boards in early 2005, just months before it learned that its estrogen receptor and progesterone receptor (ER/PR) tests were askew.
Eastern Health has been repeatedly criticized for what — and often how little — information it has released to the public. In July 2005, the authority persuaded the minister of health of the day, John Ottenheimer, to say nothing in public about its decision to retest samples from breast cancer patients.
Cameron was told that some physicians were concerned that their patients would be alarmed by public disclosure that there were possible mistakes, while some top Eastern Health executives were worried about lawsuits, even though a lawyer was not formally engaged for several months.
The process of retesting samples took many months longer than expected, and the public eventually learned of the issue through the news media. The true extent of the ER/PR crisis, though, did not emerge until 2007, when documents filed in connection with a class action suit in Newfoundland Supreme Court showed that Eastern Health executives knew about 42 per cent of a large sample of tests produced wrong results. That figure is several times higher than error rates described during media briefings in December 2006.
Eastern Health will formally respond to the Cameron report in the coming days.
It has, though, already made key changes. On Monday, it announced the appointment of Sudbury, Ont., hospital manager Vickie Kaminski, who will take the reins of the St. John's-based authority in mid-June.
Eastern Health has not had a permanent chief executive office since July 2007, when George Tilley quit the post under pressure from the Newfoundland and Labrador government.