"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."
PRINCE EDWARD ISLAND HEALTH MINISTER DOUG CURRIE:
-------------------------------------------------------------------------------
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.
Next?
Harold Levy...hlevy15@gmail.com;
Showing posts with label breat cancer tests. Show all posts
Showing posts with label breat cancer tests. Show all posts
Saturday, May 3, 2008
Thursday, March 20, 2008
Newfoundland Judicial Inquiry into inaccurate breast cancer test results; The Third Pathology-Related Inquiry Now Under Way In Canada;
SHORTLY BEFORE THE INQUIRY BEGAN TO HEAR EVIDENCE ON WEDNESDAY (MARCH 19), THE NEWFOUNDLAND GOVERNMENT REVEALED THAT 108 0F THE 383 PATIENTS WHOSE TESTS HAD BEEN MISREAD HAD SINCE DIED - ALTHOUGH IT MAY EVER BE KNOWN HOW MANY OF THEM DIED AS A RESULT OF MISSING OUT ON APPROPRIATE TREATMENT;
The judicial Inquiry into inaccurate breast cancer test results given to 383 patients in Newfoundland - one of three public inquiries involving pathology now under way in Canada - was ordered by Ross Wiseman, the province's Minister of Health on May 22, 2007.
Shortly before the Inquiry began to hear evidence on Wednesday (March 19), the Newfoundland government revealed that 108 0f the 383 patients whose tests had been misread had since died - although it may ever be known how many of them died as a result of missing out on appropriate treatment;
Canadian Press reporter Tara Brautigam reported on the experience of two of the women affected by the misread test results in a story which appeared today in the Toronto Star under the heading: "Cancer patients tear into "sneaky board"..."Newfoundland inquest opens with angry stories of botched tests and the grief that has resulted."
"ST. JOHN'S, Nfld.–The Newfoundland health board responsible for botched breast cancer tests failed to fully inform patients of the flawed results and the consequences of the mistakes, a public inquiry heard," Brautigam's story began.
"The inquiry opened yesterday on a startling note when Beverly Green outlined events leading from her diagnosis of breast cancer in 2001 to the moment when she first discovered her test result was inaccurate six years later," it continued.
"The whole way it was handled was very unprofessional, very sneaky, deceiving," Green said.
The inquiry, headed by provincial Supreme Court Justice Margaret Cameron, was set up by the province to examine how almost 400 patients were given inaccurate results on their breast cancer tests.
At the time of her breast cancer diagnosis in January 2001, doctors told Green her test result meant she was ineligible for hormone therapy treatment, so she underwent chemotherapy, radiation and had part of her breast removed.
After her breast cancer test was sent to Mount Sinai Hospital in Toronto for retesting in the fall of 2005, it was discovered that her test result was misread. But Green said she didn't find that out until almost two years later.
In April 2007, Green asked her oncologist for a copy of her medical chart after learning another breast cancer patient had been notified her test was inaccurate.
"I was very disappointed. How come certain people had the privilege of getting a phone call and some of us did not?" said Green, wearing a knitted wool cap.
The inquiry is focusing on hormone receptor tests, which are critical because they can help determine the course of treatment for a breast cancer patient.
If patients are found to be estrogen- and/or progesterone-positive, they may respond to hormone therapy such as Tamoxifen. If not, they may be given other treatment, such as chemotherapy or radiation.
Green, whose cancer has since spread to her liver, said she would have chosen hormone therapy treatment had she known she was eligible for it.
"I know I have a disease that's probably going to destroy my life at some time," Green, 45, told commission counsel Sandra Chaytor.
"But the way this was handled, it was just unforgivable."
Later, Elizabeth White told the inquiry she wasn't made aware of her inaccurate test result until December 2007 – eight years after she was diagnosed with the disease.
White, who had her right breast removed and underwent chemotherapy, learned of the misread results through a phone message from an oncologist.
White, 65, said her husband knew of the mistake after Eastern Health contacted his sister, who was listed as White's alternate contact, but he decided to spare her the news.
"He didn't want to spoil my Christmas," she said. Like Green, White said she would have taken advantage of hormonal therapy if her breast cancer test was accurate.
"I fell through the cracks," she said.
"I certainly would have done what was necessary at the time."
Norman White, who was diagnosed with breast cancer in 1999, later testified that he received a call from an Eastern Health official in 2005 asking for his permission to have his test redone.
"I had no idea what was going on, so I just said yes," he said.
White, 70, said he was in Alberta for more than six months and asked his sister to forward important mail, but he didn't receive any correspondence from Eastern Health.
He said he didn't hear that his test results had changed until a doctor tracked him down in October 2006.
"I lost all faith, confidence in people we put a lot of trust in," he said.""
Brautigam notes that the Newfoundland Inquiry will also examine why the errors went undetected for eight years - and whether the Eastern Health authority responded to patients and the public in an appropriate and timely manner.
For the record: Here is Newfoundland Health and Community Service's Minister Wiseman's official announcement of the Inquiry -dated May 22, 2007, under the heading: "Government to Undertake Judicial Commission of Inquiry on Estrogen and Progesterone Receptor Testing for Breast Cancer Patients."
"In order to maintain confidence in the provincial estrogen and progesterone receptor (ER/PR) breast cancer testing system at Eastern Health, the Honourable Ross Wiseman, Minister of Health and Community Services, today announced that the Provincial Government will undertake a Judicial Commission of Inquiry on estrogen and progesterone receptor testing for breast cancer patients.
On Friday, Eastern Health CEO George Tilley apologized for the confusion that has ensued over this issue and stated that ‘at no time did Eastern Health withhold any personal information from any of the patients impacted by our decision to retest for ER/PR’ and that ‘Eastern Health has acted and will continue to act in the best interest of our patients.’
“Government recognizes it is of the utmost importance for those directly involved and the general public to understand what happened to ensure that this situation does not reoccur,” said Minister Wiseman. “Through an independent review, we will endeavor to get those answers. It is critical that patients and their families are assured that government takes this matter very seriously and that any questions they have are addressed in an open and transparent manner."
A Judicial Commission of Inquiry will be established by the Provincial Cabinet under Section 3 of the Public Inquiries Act, 2006. Cabinet will appoint a commissioner, set the terms of reference for the inquiry and authorize an appropriate budget. Once the commissioner’s report is completed, it will be submitted to the Minister of Health and Community Services and will be released publicly.
The review will address six key questions:
1. What went wrong with the ER/PR tests that resulted in a high rate of conversions when re-tested?
2. Why was the problem with the tests not detected until 2005? Could it have been detected at an earlier date? Were the testing protocols during that period reasonable and appropriate?
3. Once detected, did the responsible authorities respond in an appropriate and timely manner to those categories of people who needed re-tests and those who were being tested for the first time?
4. Once detected, did the responsible authorities communicate in an appropriate and timely manner with the general public about the issues and circumstances surrounding the change in test results and the new testing procedures?
5. Are the testing systems and processes currently in place reflective of "best practice"?
6. Does Eastern Health currently employ an effective quality assurance system to provide maximum probability that the testing problems will not reoccur?
The Commissioner will provide recommendations as necessary and appropriate to address the questions for the inquiry as identified above. The minister will announce further details regarding the Commission of Inquiry, including the appointment of a commissioner.
Minister Wiseman added, "I look forward to receiving the commissioner’s report which will answer the many questions that have arisen with respect to this issue."
A "backgrounder" to the calling of the Inquiry that was released by the government under the heading, "ER/PR Testing for Breast Cancer Patients" reads as follows:
"This issue is not about breast cancer screening. At no time has there been a question of accuracy of mammograms or biopsy results to diagnose breast cancer.
Estrogen and progesterone testing (ER/PR) takes place after a breast cancer diagnosis to determine whether cancer cells have estrogen or progesterone receptors. Breast cancers that are either ER-positive or PR-positive (or both) may respond to hormone therapy, such as the drug Tamoxifen. Hormonal therapy, chemotherapy and radiation are considered to be adjuvant therapies. The aim of adjuvant therapy is to decrease breast recurrence rates and improve overall survival rates. Adjuvant therapies are generally additional treatments given after potentially curative surgery.
Eastern Health first became aware of a problem with ER/PR test results in May 2005 and immediately conducted an internal review. In July 2005 it made a decision to retest all negative ER/PR tests done between May 1997 and August 2005 to ensure that if there was one patient who could benefit as a result of a change in their test result and subsequent treatment change that it was important that this be done. Eastern Health also suspended their own testing at that time.
The process to retest and conduct external and internal reviews in the lab took about one year to complete. Once test results came back, the results were assessed to determine if a recommended treatment change was necessary. The assessments were conducted by a panel of experts in cancer care, including oncologists, pathologists and surgeons. The first test results were received by Eastern Health in October 2005. All test results were received by February 2006.
There were a total of 939 patients with ER negative reports. Of the 763 patients reviewed, 317 patients had a change in result. Of that number, 117 of the patients had a resulting change in treatment. A further 176 patients, of the total 939, originally reported as negative are deceased.
Eastern Health contacted each patient who was affected by the ER/PR test review or their family physician to make sure they received all the information and support they required. They were told either one of three things:
That their tissue had been retested and there was no change in the original results;
That their tissue had been retested and that Eastern Health was recommending a change in their treatment; or
That although there was a change from their original test result, no change in treatment was recommended.
There was full disclosure to patients and their families once test results became available. Unfortunately, test results came back at different times and there was a delay in the retesting process which led to some patients feeling they were not informed in a timely fashion. Ultimately, Eastern Health’s primary concern was notifying all affected individuals.
Eastern Health held a media briefing in December 2006. At the time the focus was on the 117 patients who had a change in test result and a change in treatment plan and this was communicated to the media. Unfortunately, the media were not provided with the number of test results that had changed (317).
Eastern Health has committed to retest results for the 176 patients who are deceased and to ensure that all patients’ families are contacted for follow up.
Eastern Health apologized on Friday for the confusion created by not disclosing all of the information to the media in December. Although the media were not informed, the 317 patients who were directly impacted were informed of their individual circumstances.
Eastern Health has implemented a number of measures to provide a high standard of ER/PR testing for new breast cancer patients. These measures include a quality management program, seeking national accreditation for the laboratory and ensuring all technologists and pathologists receive special training. In addition, as a measure of quality control, a random sample of tests are sent to Mount Sinai to ensure the accuracy of Eastern Health test results. Eastern Health resumed ER/PR testing in St. John’s on February 1, 2007. "Harold Levy...hlevy15@gmail.com
The judicial Inquiry into inaccurate breast cancer test results given to 383 patients in Newfoundland - one of three public inquiries involving pathology now under way in Canada - was ordered by Ross Wiseman, the province's Minister of Health on May 22, 2007.
Shortly before the Inquiry began to hear evidence on Wednesday (March 19), the Newfoundland government revealed that 108 0f the 383 patients whose tests had been misread had since died - although it may ever be known how many of them died as a result of missing out on appropriate treatment;
Canadian Press reporter Tara Brautigam reported on the experience of two of the women affected by the misread test results in a story which appeared today in the Toronto Star under the heading: "Cancer patients tear into "sneaky board"..."Newfoundland inquest opens with angry stories of botched tests and the grief that has resulted."
"ST. JOHN'S, Nfld.–The Newfoundland health board responsible for botched breast cancer tests failed to fully inform patients of the flawed results and the consequences of the mistakes, a public inquiry heard," Brautigam's story began.
"The inquiry opened yesterday on a startling note when Beverly Green outlined events leading from her diagnosis of breast cancer in 2001 to the moment when she first discovered her test result was inaccurate six years later," it continued.
"The whole way it was handled was very unprofessional, very sneaky, deceiving," Green said.
The inquiry, headed by provincial Supreme Court Justice Margaret Cameron, was set up by the province to examine how almost 400 patients were given inaccurate results on their breast cancer tests.
At the time of her breast cancer diagnosis in January 2001, doctors told Green her test result meant she was ineligible for hormone therapy treatment, so she underwent chemotherapy, radiation and had part of her breast removed.
After her breast cancer test was sent to Mount Sinai Hospital in Toronto for retesting in the fall of 2005, it was discovered that her test result was misread. But Green said she didn't find that out until almost two years later.
In April 2007, Green asked her oncologist for a copy of her medical chart after learning another breast cancer patient had been notified her test was inaccurate.
"I was very disappointed. How come certain people had the privilege of getting a phone call and some of us did not?" said Green, wearing a knitted wool cap.
The inquiry is focusing on hormone receptor tests, which are critical because they can help determine the course of treatment for a breast cancer patient.
If patients are found to be estrogen- and/or progesterone-positive, they may respond to hormone therapy such as Tamoxifen. If not, they may be given other treatment, such as chemotherapy or radiation.
Green, whose cancer has since spread to her liver, said she would have chosen hormone therapy treatment had she known she was eligible for it.
"I know I have a disease that's probably going to destroy my life at some time," Green, 45, told commission counsel Sandra Chaytor.
"But the way this was handled, it was just unforgivable."
Later, Elizabeth White told the inquiry she wasn't made aware of her inaccurate test result until December 2007 – eight years after she was diagnosed with the disease.
White, who had her right breast removed and underwent chemotherapy, learned of the misread results through a phone message from an oncologist.
White, 65, said her husband knew of the mistake after Eastern Health contacted his sister, who was listed as White's alternate contact, but he decided to spare her the news.
"He didn't want to spoil my Christmas," she said. Like Green, White said she would have taken advantage of hormonal therapy if her breast cancer test was accurate.
"I fell through the cracks," she said.
"I certainly would have done what was necessary at the time."
Norman White, who was diagnosed with breast cancer in 1999, later testified that he received a call from an Eastern Health official in 2005 asking for his permission to have his test redone.
"I had no idea what was going on, so I just said yes," he said.
White, 70, said he was in Alberta for more than six months and asked his sister to forward important mail, but he didn't receive any correspondence from Eastern Health.
He said he didn't hear that his test results had changed until a doctor tracked him down in October 2006.
"I lost all faith, confidence in people we put a lot of trust in," he said.""
Brautigam notes that the Newfoundland Inquiry will also examine why the errors went undetected for eight years - and whether the Eastern Health authority responded to patients and the public in an appropriate and timely manner.
For the record: Here is Newfoundland Health and Community Service's Minister Wiseman's official announcement of the Inquiry -dated May 22, 2007, under the heading: "Government to Undertake Judicial Commission of Inquiry on Estrogen and Progesterone Receptor Testing for Breast Cancer Patients."
"In order to maintain confidence in the provincial estrogen and progesterone receptor (ER/PR) breast cancer testing system at Eastern Health, the Honourable Ross Wiseman, Minister of Health and Community Services, today announced that the Provincial Government will undertake a Judicial Commission of Inquiry on estrogen and progesterone receptor testing for breast cancer patients.
On Friday, Eastern Health CEO George Tilley apologized for the confusion that has ensued over this issue and stated that ‘at no time did Eastern Health withhold any personal information from any of the patients impacted by our decision to retest for ER/PR’ and that ‘Eastern Health has acted and will continue to act in the best interest of our patients.’
“Government recognizes it is of the utmost importance for those directly involved and the general public to understand what happened to ensure that this situation does not reoccur,” said Minister Wiseman. “Through an independent review, we will endeavor to get those answers. It is critical that patients and their families are assured that government takes this matter very seriously and that any questions they have are addressed in an open and transparent manner."
A Judicial Commission of Inquiry will be established by the Provincial Cabinet under Section 3 of the Public Inquiries Act, 2006. Cabinet will appoint a commissioner, set the terms of reference for the inquiry and authorize an appropriate budget. Once the commissioner’s report is completed, it will be submitted to the Minister of Health and Community Services and will be released publicly.
The review will address six key questions:
1. What went wrong with the ER/PR tests that resulted in a high rate of conversions when re-tested?
2. Why was the problem with the tests not detected until 2005? Could it have been detected at an earlier date? Were the testing protocols during that period reasonable and appropriate?
3. Once detected, did the responsible authorities respond in an appropriate and timely manner to those categories of people who needed re-tests and those who were being tested for the first time?
4. Once detected, did the responsible authorities communicate in an appropriate and timely manner with the general public about the issues and circumstances surrounding the change in test results and the new testing procedures?
5. Are the testing systems and processes currently in place reflective of "best practice"?
6. Does Eastern Health currently employ an effective quality assurance system to provide maximum probability that the testing problems will not reoccur?
The Commissioner will provide recommendations as necessary and appropriate to address the questions for the inquiry as identified above. The minister will announce further details regarding the Commission of Inquiry, including the appointment of a commissioner.
Minister Wiseman added, "I look forward to receiving the commissioner’s report which will answer the many questions that have arisen with respect to this issue."
A "backgrounder" to the calling of the Inquiry that was released by the government under the heading, "ER/PR Testing for Breast Cancer Patients" reads as follows:
"This issue is not about breast cancer screening. At no time has there been a question of accuracy of mammograms or biopsy results to diagnose breast cancer.
Estrogen and progesterone testing (ER/PR) takes place after a breast cancer diagnosis to determine whether cancer cells have estrogen or progesterone receptors. Breast cancers that are either ER-positive or PR-positive (or both) may respond to hormone therapy, such as the drug Tamoxifen. Hormonal therapy, chemotherapy and radiation are considered to be adjuvant therapies. The aim of adjuvant therapy is to decrease breast recurrence rates and improve overall survival rates. Adjuvant therapies are generally additional treatments given after potentially curative surgery.
Eastern Health first became aware of a problem with ER/PR test results in May 2005 and immediately conducted an internal review. In July 2005 it made a decision to retest all negative ER/PR tests done between May 1997 and August 2005 to ensure that if there was one patient who could benefit as a result of a change in their test result and subsequent treatment change that it was important that this be done. Eastern Health also suspended their own testing at that time.
The process to retest and conduct external and internal reviews in the lab took about one year to complete. Once test results came back, the results were assessed to determine if a recommended treatment change was necessary. The assessments were conducted by a panel of experts in cancer care, including oncologists, pathologists and surgeons. The first test results were received by Eastern Health in October 2005. All test results were received by February 2006.
There were a total of 939 patients with ER negative reports. Of the 763 patients reviewed, 317 patients had a change in result. Of that number, 117 of the patients had a resulting change in treatment. A further 176 patients, of the total 939, originally reported as negative are deceased.
Eastern Health contacted each patient who was affected by the ER/PR test review or their family physician to make sure they received all the information and support they required. They were told either one of three things:
That their tissue had been retested and there was no change in the original results;
That their tissue had been retested and that Eastern Health was recommending a change in their treatment; or
That although there was a change from their original test result, no change in treatment was recommended.
There was full disclosure to patients and their families once test results became available. Unfortunately, test results came back at different times and there was a delay in the retesting process which led to some patients feeling they were not informed in a timely fashion. Ultimately, Eastern Health’s primary concern was notifying all affected individuals.
Eastern Health held a media briefing in December 2006. At the time the focus was on the 117 patients who had a change in test result and a change in treatment plan and this was communicated to the media. Unfortunately, the media were not provided with the number of test results that had changed (317).
Eastern Health has committed to retest results for the 176 patients who are deceased and to ensure that all patients’ families are contacted for follow up.
Eastern Health apologized on Friday for the confusion created by not disclosing all of the information to the media in December. Although the media were not informed, the 317 patients who were directly impacted were informed of their individual circumstances.
Eastern Health has implemented a number of measures to provide a high standard of ER/PR testing for new breast cancer patients. These measures include a quality management program, seeking national accreditation for the laboratory and ensuring all technologists and pathologists receive special training. In addition, as a measure of quality control, a random sample of tests are sent to Mount Sinai to ensure the accuracy of Eastern Health test results. Eastern Health resumed ER/PR testing in St. John’s on February 1, 2007. "Harold Levy...hlevy15@gmail.com
Subscribe to:
Posts (Atom)
