St. John's lab problems flagged in 2003, memo shows

Warnings were issued about the largest pathology laboratory in Newfoundland and Labrador in 2003, two years before problems with hormone receptor tests were disclosed, internal memos show.

A judicial inquiry is pending on flawed hormone receptor tests which determined what course of treatment breast cancer patients should received carried out at the Eastern Health lab between 1997 and 2005.

A class action lawsuit involving about 100 breast cancer patients wascertified Monday at Newfoundland Supreme Court.

Eastern Health has maintained it was not aware of problems at the lab until 2005, when samples were sent to Mount Sinai Hospital in Torontofor retesting.

However, a June 2003 memo written by former pathologist Gershon Ejeckam lays out a litany of problems with the lab, from "grossly inadequate" staffing to "persistent [and] erratic results of immunostains."

Ejeckam, who retired last year, wrote that the lab was doing tests in a location without proper humidity controls, which might affect results.

He also warned about an ever-increasing workload, inadequate relief staffing and concerns about obtaining "reliable, reproducible and consistent results"with samples.

Ejeckam, whose memo identified lab problems that extended beyond hormone receptor tests, clearly flagged the risks of not dealing seriously with quality issues.

"Diagnosis based on inappropriate immunostain will surely jeopardize patient care and may even expose the [authority] to litigation," he wrote.

The memo was sent to an administrator with the former St. John's Health Care Corp., one of the authorities merged into Eastern Health.

The memo was obtained this weekby CBC News.

In response, Eastern Health released other memos on Thursdaythat suggest Ejeckam's concerns were dealt with, and that he was satisfied.

Chief executive officer George Tilley maintains the concerns were a part of a routine quality control program within the system.

"So what we shared with you today is a snapshot of a piece of quality control work that's been going on in the laboratory and in fact really shows some of the complexity of the organization," he said.

The memos that Eastern Health released included an April 15, 2003, minute that shows that hormone receptor testing was suspended for six weeks because of a technical problem.

Tilley said that the problems identified in 2003 did not affect the diagnosis or treatment of patients.

"Within months of that letter coming out, the person who oversaw that particular area signed off on the resolution to it," Tilley said.

In 2005, Eastern Health became aware of inaccurate results of hormone receptor tests.

In late2006, the authority said that retests showed an error rate ranging between 10 and 15 per cent.

However, documents filed with the Newfoundland Supreme Court show that the error rate involving hundreds of retested samples is 42 per cent.

Of 763 breast cancer patients who had tested negative, 317 had been given wrong results, according to an affidavit signed by Heather Predham, assistant director of quality and risk management with Eastern Health.

Of those, 104 patients required a change in treatment, with 96 eventually being prescribed Tamoxifen, an anti-hormonal drug that has been clinically shown to improve a patient's chances of survival.

A subsequent document filed with the court showed that 36 women who have since died had received inaccurate hormone receptor tests.

The hormone receptor issue has been at the forefront of political debate for weeks, since CBC News reported the error rate outlined in the court affidavit.

On Thursday, the Liberal Opposition called on Premier Danny Williams to replace Tilley as Eastern Health's CEO. Williams earlier in the week appointed Robert Thompson, the province's chief civil servant, to prepare a pending judicial inquiry and to serve as deputy minister of health.