Serious Problems Plague Newfoundland Laboratory

Inaccurate cyclosporine test results trigger lab director resignations and more media scrutiny

CEO SUMMARY: Newfoundland’s St. John laboratory was rocked by revelations in February that its cyclosporine testing was flawed, exposing patients to the harmful affects from inappropriately high doses of the immunosuppressant drug. Within weeks of this news, the Chief of Laboratory Medicine resigned. Now a team from Toronto’s University Health Network (UHN) is at the laboratory to conduct a review of operations and make recommendations to the health authority.

THERE IS MORE TROUBLE with laboratory testing services at Eastern Health, the largest health authority in the Newfoundland-Labrador health system. New disclosures of laboratory test errors and an unflattering outside review of the laboratory again generated national news headlines in Canada.

It was 2005 when it was discovered that this same laboratory had reported inaccurate breast cancer test results. Between 1997 and 2005, almost 500 women were given inaccurate breast cancer test results. Even today, the consequences from this failure in laboratory test accuracy continue to reverberate throughout Canada today. (See TDR, May 18, 2009.)

Over the past four to six weeks, the St. John laboratory has been rocked by a new series of events. First, in mid-February, it was disclosed that the laboratory had reported inaccurate cyclosporine testing since June 2009 and these problems went undetected until just days earlier.

Next, within weeks of this disclosure, the Chief of Laboratory Medicine, pathologist Dr. Nash Denic, was asked by Eastern Health President Vickie Kaminski to either resign or be terminated. Just days later, it was learned that Denic had tendered a resignation back in December and—at that time—Eastern Health officials had asked him to stay on.

More Resignations

Following Denic’s resignation, two more pathologists resigned from their laboratory directorships. They were Dr. Ford Elms at Health Sciences Center and Dr. Don Cook, at St. Clare’s Hospital. Both pathologists continue to handle clinical duties. Another chief of laboratory service resigned days later. These resignations were in support of Denic.

Days later, Dr. Jim Hutchinson resigned his management position, but did not mention support of Denic as a reason for his decision. He remained on staff in the microbiology department at Health Sciences Center.

The next grenade that exploded in this story was public release of an outside study of the St. John laboratory. On Monday, March 15, Kaminiski and Health Minister Jerome Kennedy told the press about the findings of the study.

It was conducted by the Institute of Quality Management in Healthcare (IQMH), based in Toronto, Ontario. The report was signed by pathologist Gregory J. Flynn, M.D., who is IQMH’s CEO.

Lab Work Environment

The study was based on interviews with staff at the St. John laboratory. The interviews were conducted in the months between Denic’s attempt to resign in December and the March 12 submission of the findings to Eastern Health officials. In its report, the IQMH described the work environment in the St. John laboratory as “dysfunctional”, “autocratic”, “toxic”, and “hostile.”

All of these events were extensively covered by the press. In defense of Denic, the President of the Newfoundland and Laboratory Association of Pathologists, Dr. Barry Gallagher, wrote a letter to the St. John Telegram, commending Denic for “remarkable improvements” made during his tenure at the laboratory. “How he managed such a heavy workload for so long is a mystery to us all,” said Gallagher.

On March 20, Kaminiski told reporters that seven of the authority’s 24 pathologists were on sick leave. She admitted that a work backlog was building within the Eastern Health laboratories.

In response to these developments, Health Minister Jerome Kennedy announced that a team from University Health Network (UHN) of Toronto, Ontario, would come in and review laboratory work flow within Eastern Health.

All of these events were widely-reported by the Canadian press. It was just last year when Judge Margaret Cameron released the findings of her commission, which investigated the reasons for the failure of the St. John laboratory’s breast cancer testing program during the years 1997-2005. Not surprisingly, disclosure of more lab testing failures at the St. John lab was a major story.

In fact, officials at Eastern Health were caught off guard by the discovery of problems with cyclosporine testing. A critically- ill 14-year-old boy was admitted to intensive care in early February. He had received an excessive amount of cyclosporine.

That’s when it was determined that the laboratory test results underreported his cyclosporine level. The faulty cyclosporine test results were caused by a new mass spectrometer which was brought into service last June and it was not properly calibrated.

In February, after this discovery, Kaminiski confirmed to reporters that problems with cyclosporine testing had been identified at Eastern Health’s St. John laboratory. Beginning in June 2009, 235 patients had received inaccurate test results, mostly underreporting the patient’s actual level of cyclosporine. At least 13 of these patients had died. If administered in high doses, this immunosuppressant drug can cause kidney damage.

THE DARK REPORT believes the ongoing story of Newfoundland’s St. John laboratory is an early and important example of what happens when a parent health system underfunds its laboratories over a sustained period of time.

If the parent health system fails to provide adequate capital for expansion and modernization of testing systems, then at some point the laboratory cannot accommodate the increase in specimens required to support clinical services. Similarly, failure to fund competitive salaries and benefits prevents the laboratory from recruiting and retaining the needed number of skilled laboratory scientists.

Inadequate Lab Funding

Thus, the problems now visible at the St. John lab are probably not of recent origin. Rather, they are mostly likely the consequence of inadequate budgets going back 10 years or longer. The truth of this will become more obvious with each passing year. However, it costs much more to “restore” an underperforming lab than to maintain it as a start-of-the-art testing service. In the meantime, patients will pay the ultimate cost of a poorly-funded lab testing service.

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