Saturday, May 3, 2008

Part Two: Crisis Deepens: (Even Further); Prince Edward Island And Manitoba Added To The List; Data Questioned At Princess Margaret;




In a recent posting "Part One: Canadian Pathology Crisis Deepens," I recorded Dr. Andrew Padmos' observation that systemic problems in hospital laboratories and are not likely isolated to the cases under investigation in Newfoundland, New Brunswick, and now Ontario.

Padmos should know: He is the Chief Executive Officer of the Royal College Of Physicians and Surgeons of Canada;

As if to prove the point, Prince Edward Island and Manitoba have now been added to the disturbing list which appears to be spreading across the country like an infection - and problems concerning clinical drug trial data have risen at a Toronto hospital;

These developments have been recorded in three recent newspaper stories;

First, Prince Edward Island;

A story in the Charlotte Guardian, April 28, 2008, by Colin Foley, headed: "High error rate sparks review of P.E.I. radiologist's work."

"CHARLOTTETOWN -- Prince Edward Island has ordered a review of a radiologist's work after a preliminary sample audit of the tests read by the doctor showed an unacceptable error rate of between 8% and 19%," the story begins.

"About 4,500 patients who had regular X-rays, MRIs, CT scans or ultra-sounds are affected and 5,700 images will be re-evaluated. That process is expected to be completed in the next couple of weeks," it continues;

"The radiologist began work on the island on Dec. 2, 2007, and on April 2, 2008, there was an agreement for a leave of absence while a review took place.

"Patient safety and quality care are our top priorities and that's why this review is happening," said Health Minister Doug Currie. "We know exactly which images were read by the radiologist over the past four months and all of them will be evaluated again to ensure amended reports are sent to attending or referring physicians if necessary."

The radiologist's name is being withheld because "identification of the radiologist would not have a bearing on the outcome of the evaluation or provide any benefit to patients," the health ministry said.

The results of the evaluation so far show that the majority of cases were not of a serious nature.

There are no plans for this radiologist to return to work in P.E.I. Health officials contend that the physician is well qualified and has as an excellent career track record and has been extremely co-operative in this process.

It is standard practice on Prince Edward Island for radiologists to monitor each other's diagnostic imaging tests.

Earlier this month, when three tests were reviewed by the radiologist's colleagues and amended reports had to be issued, a sample audit was carried out as a quality review check.

This preliminary sample audit, consisting of 10% of the diagnostic imaging tests read by the radiologist, showed an unacceptable error rate, averaging 12%, so a decision was made at that time to do a further evaluation of all images read by the radiologist.

Nuclear medicine, bone mineral densitometry and mammography exams were not affected.

"It is very important to remember that diagnostic imaging tests are only a part of a patient's care and treatment," said Dr. Colin Foley, provincial medical director, diagnostic imaging services. "Patients typically go through a variety of tests leading up to their diagnoses and have more than one health care professional collaborating in the overall care."

Letters will be sent to every patient whose tests will be evaluated.

The review is the second to be conducted in Atlantic Canada into the work of a radiologist.

Last November, a review in Newfoundland into suspect radiology reports found the radiologist who conducted them missed tumours and fractures in some of his patients.

In total, 6,412 diagnostic imaging orders were reviewed -- including X-rays and CT scans. The review found problems with 11% of those. While that number falls within the accepted variance rate for radiologists, the review discovered much higher discrepancies for certain tests.

For instance, one in four CT scans required further assessment. Some 3,781 patients had at least one report reviewed. Some had multiple tests reassessed.

The Prince Edward Island review also comes as Newfoundland conducts a public inquiry into breast cancer tests carried out at a St. John's pathology lab.

Another inquiry is set for New Brunswick into the work of a Miramichi pathologist, where alleged errors have led to some 24,000 cases being re-examined."

Second: Manitoba;

A Canadian Press story dated Friday May 2, 2008 and published under the heading, "Winnipeg Health Authority reviewing pathologist's findings after mistakes found."

"WINNIPEG — A Manitoba pathologist has been placed on leave while more than 700 diagnostic tests he performed over the past year are reviewed," the story begins;

"Out of the 142 cases that have been re-examined so far, nine errors have been uncovered, the Winnipeg Regional Health Authority announced Friday," it continues;

""Of the nine cases where errors were found, we do not know what the clinical impact on patients will be yet," said health authority spokeswoman Heidi Graham. "We are waiting to hear back from physicians."

Though the review is still in its early stages, the health agency decided to publicize some of its details because of pathologist evaluations in other provinces.

In Newfoundland, almost 400 patients received the wrong breast cancer test results between 1997 and 2005. An inquiry has been told a former deputy health minister knew about the situation but didn't tell the cabinet secretariat or the premier's office.

The issue became public when a newspaper in St. John's reported on the problem in October 2005.

"One of the things we've learned from other provinces ... there's been a lot of criticisms of the systems if they don't disclose early in the process," said Dr. Brock Wright, vice-president of the Winnipeg Regional Health Authority.

In Manitoba, the pathologist in question handled 735 cases. They are being reviewed by a pathologist hired specifically for the task from outside the Winnipeg health agency.

Most of the tests were for cancer, said Wright.

"Some of the diagnostic errors relate to whether it was one sub-type of cancer or another," Wright said, adding "it may or may not be clinically significant."

Physicians and their patients are being contacted directly to discuss the changes in their diagnoses. The health agency has also set up a special phone line for patients who have questions about the review.

However, the health authority declined to release the pathologist's name, and other than noting he is an "experienced" pathologist, they also would not say how long he has worked in the field.

"There's nothing to be gained by releasing his name right now. In fairness to him, we won't do that unless there is a substantive issue," Wright said.

Wright wouldn't speculate on what sort of sanctions the pathologist could face, although he noted further training and early retirement are two options.

For complex diagnostic tests, there is an expected error rate of 15 per cent, said Dr. Amin Kakabani, the chief medical officer for Diagnostic Services of Manitoba.

"Sometimes calling it an error rate implies a clear black and white, and there isn't. For some of the cases, people never agree. Some people call 'x,' the other calls 'y.' "

Manitoba's review came to light the day after Grey Bruce Health Services in southwestern Ontario announced it will expand a probe of a pathologist's work following an initial review of 600 tests found a high rate of error.

Dr. Barry Sawka, who voluntarily withdrew from practice in February after a routine test identified an error in one of his findings, is estimated to have overseen about 40,000 cases over 14 years at the hospital.

In New Brunswick, some 24,000 pathology tests are being reviewed and a judicial inquiry has been called after an audit said there were incomplete or misdiagnosed results in the work of pathologist Dr. Rajgopal Menon.

Menon, who called the review "unjustified and unfair," has filed a civil suit against the regional health authority.

Diagnostic imaging tests of about 4,500 patients are also being reviewed in Prince Edward Island after questions were raised about the work of a single pathologist."

Lastly, Toronto;

The Canadian Press reported on April 14, 2008 - surprisingly with no public reaction - that mistakes had occurred in clinical drug data involving three hundred patients at Toronto's Princess Margaret Hospital;

"An investigation of mistakes in clinical drug trial data involving 300 patients at one of Canada's premier cancer centres has turned up no evidence of deliberate tampering, the hospital says," the story, under the heading, "Hospital blames cancer study errors on carelessness" begins..

"There's no evidence of fraudulent activity here, it's more a matter of carelessness of data management," Dr. Robert Bell said Monday, referring to errors discovered in records for three trials of breast cancer treatments at Toronto's Princess Margaret Hospital," the story, by Sheryl Ubelacker, continues.

""There's no systematic changing of results that would make it look like it was a fraudulent attempt to alter an outcome of a study," said Bell, president and CEO of the University Health Network, which includes Princess Margaret.

The problem with incorrect data came to light in November when ``an external sponsor" noticed some problems with data for a few breast cancer trials, which led Princess Margaret to order an external audit of all its breast cancer studies.

Women who participated in the trials comparing different drugs were informed by letter of the problems, but Bell stressed "there was no harm done to any patients."

"First of all, the clinical records and the clinical treatment for these patients was absolutely according to protocol and the documentation and the clinical record was appropriate. But the transcription of some data values into what's called the research record in some cases was inaccurate."

In some cases, numbers were transposed in records, so that the wrong date of treatment was entered, Bell explained. In other cases, medical scans that should have been done on some women were not carried out.

"They've now either been done or are being ordered to be done," he said. "But there were a few missing data points based on scans being missing."

Those scans of such organs as the kidneys and heart were aimed at determining any long-term effects of drugs being tested and were not diagnostic in nature.

Bell said the hospital is still looking into which personnel were involved in the errors, which affected between 20 and 30 of the 300 participants whose charts were investigated.

"But we don't want to point the finger at anyone personally, we simply want to make sure it never happens again."

Still, those responsible for the mistakes could "potentially" face disciplinary action, he acknowledged.

"But I think the most important lesson for us is the requirement first of all to ensure that we have standard operating procedures in place of data validity," Bell said, noting that the hospital will implement ongoing random audits of all patient trials in the future.

He called the new policy an "unusual step to take, but one that we think is appropriate for this organization."

Princess Margaret Hospital, which along with Toronto General and Toronto Western hospitals makes up the University Health Network, bills itself as one of the leading cancer treatment and research centres in the world.

Dr. Ralph Meyer, director of the clinical trials group for the National Cancer Institute of Canada (NCIC), said problems with accuracy of data such as those detected with the Princess Margaret studies rarely occur.

"Conducting clinical trials is complex and because of their complexity, there are levels of scrutiny that are done within an institution and by the people who are sponsoring the trial in terms of how data is reviewed," said Meyer, confirming that NCIC was the external sponsor that alerted the hospital about accuracy problems while reviewing the data.

But the fact that the errors were caught shows review processes built into the system are working and shouldn't undermine patients' confidence in research or stop them from volunteering to take part in trials, he said.

"For those patients who are going into clinical trials, I think it's important that they know the system did work and that the data that should be used will be used.""

Ontario, New Brunswick, Newfoundland, Prince Edward Island, Manitoba. Pathology. Pathologists; Radiology. Radiologists.