Mammograms in Canada on Faulty or Uncertified Equipment?
April 30 2005 Globe and Mail story below:
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There is a less invasive, less painful way. It is called thermography? A 'high tech' scientific medical diagnostic technique. Uses a digital infrared camera and high speed computer for imaging. Measures body tissue heat energy. Generally "problem areas" show high temperatures due to increased blood flow and increased metabolic activity.

No pain, no pain...
Medical Thermography, International Inc

--------- Here is the Globe and Mail Story -------------

By LISA PRIEST
Saturday, April 30, 2005
GLOBE AND MAIL

About 150 hospitals and clinics across Canada are operating breast-cancer screening machines that have failed a national quality test, have never been tested, or are no longer being tested, causing health-care experts to worry that cancers may be missed.

For thousands of Canadian women, that means they are being screened on equipment that is too old or of questionable quality. Or they are being sent to a facility that has let its accreditation with the Canadian Association of Radiologists lapse, or has never applied for it.

"If the accreditation was lost for quality reasons, there is a concern that cancers could be missed if the quality is really bad," said Normand Laberge, chief executive officer of the association. "Or women could be falsely told they may have cancer."

Unaccredited machines can be found in small clinics in rural areas and in big cities. Two of Ontario's 51 unaccredited machines are in Canada's biggest cancer hospital, Princess Margaret Hospital in Toronto. Further west, accreditation on a North Battleford machine run by the Saskatchewan Cancer Agency was suspended, a Globe and Mail investigation has found.Fewer than half of New Brunswick's machines are accredited, while Prince Edward Island has none. In Newfoundland and Saskatchewan, almost one-third of the machines are not accredited, Mr. Laberge said.

The accreditation process involves testing the machines and scrutinizing the qualifications of the people operating them and the doctors interpreting the mammography films. There are also surprise inspections.

In much of the country, accreditation is voluntary. Only Alberta, Nova Scotia and Quebec demand breast-screening mammograms be done on accredited machines; British Columbia plans to do the same by the end of this year.

For the rest of Canada, nothing stops the 50 machines that have failed accreditation from being used.

Another 48 machines were never evaluated and 50 others have allowed their accreditation to lapse. Currently, 540 mammography machines have accreditation or are in the process of renewing it, Mr. Laberge said.

Dr. Rene Shumak, chief radiologist of the Ontario Breast Screening Program, does not recommend any woman get a mammogram at an unaccredited centre.

"If somebody hasn't gotten accredited by now, they aren't keen enough and maybe they shouldn't be doing screening mammography," Dr. Shumak said.

"If you go to a site that is not accredited, we don't know that it's no good but they haven't made the effort to prove that it is good."

Clinics are under no obligation to post their accreditation, or lack thereof, and women must consult the association's website to find clinics and hospitals that have passed the test.

Due to confidentiality agreements, Mr. Laberge could not identify clinics and hospitals that have failed accreditation. However, he would confirm or contradict information that clinics and hospitals provided for this article.

Some clinics told The Globe and Mail that the process is too costly, with it averaging $400 annually for three years, at which time the accreditation has to be renewed. A few have moved to digital machines and have had difficulty fulfilling the printing requirements.

Such is the case at Princess Margaret Hospital, in downtown Toronto, where 11,500 diagnostic and screening mammograms are performed each year.

Dr. Marcus Dill-Macky, who heads the hospital's breast-imaging department, said the quality available there is as good or better than at any accredited centre. The hospital, he said, let its accreditation lapse on one analog machine as there were plans to replace it. However, its replacement didn't work out.

Due to printing and bureaucratic issues, the hospital has not been able to obtain accreditation for the second machine, a digital one.

Princess Margaret Hospital plans to join the Ontario Breast Screening Program, which demands accreditation, by the end of summer, said Jennifer Kohm, the hospital's spokeswoman.

The accreditation on the Saskatchewan Cancer Agency's mobile North Battleford machine has been suspended, said Lois Harrison, executive director of the prevention and early detection division. She said the association believed an uncertified radiologist was interpreting the films when, in fact, a certified radiologist from Saskatoon was the one reading them.

"Our accreditation was suspended and we're not 100-per-cent sure exactly why," Ms. Harrison said. "There is some confusion as to whether there was an uncertified radiologist reading for us. There is not an uncertified radiologist reading for us." The quality of mammograms has never been an issue, she said.

Mr. Laberge confirmed the accreditation in North Battleford was suspended four months ago. Meanwhile, the association and cancer agency's screening program are reviewing the process to ensure standards are maintained, he said.

In stark contrast, no mammography machine can operate in the United States without a licence from the U.S. Food and Drug Administration and an accreditation from the American College of Radiology.

Dr. Charles Finder, the FDA's associate director of mammography quality and radiation programs, said a voluntary accreditation program was established in 1987. But five years later, only 42 per cent of the machines had become accredited and only 10 states had adopted regulations requiring it.

After concerns were voiced about unaccredited facilities, the Mammography Quality Standards Act was passed in 1992, compelling all mammography facilities to be certified by October of 1994.

"Prior to implementation of the program in 1994, there was no enforceable standard for quality or radiation dose. Some women were getting mammograms at doses higher than they could have been," Dr. Finder said. "With the introduction of the MQSA program, all facilities must meet the established quality and radiation standards."

Dr. Nancy Wadden, a radiologist on the Public Health Agency's Canadian Breast Screening Initiative, made up of representatives of screening programs across Canada and others, said her group does "recommend the adoption of the accreditation program for all facilities."

And she recommends any woman needing a mammogram go only to an accredited facility.

"There are places doing wonderful mammography that are not accredited," Dr. Wadden said. "But you really have no external proof that that is so."

Indeed, Dr. Keith Sparrow, chairman of the radiology association's mammography accreditation committee, said he believes good work is being done at unaccredited centres.

However, "the danger [with an unaccredited machine] is always that an abnormality that might be seen is not seen because of poor positioning of the patient's breast," Dr. Sparrow said. ". . . Or the equipment is old and not working properly. Technical issues like that could be present and you would not know about them."

The Moncton Hospital failed its accreditation test in 2001 for a number of reasons, including film-processing problems, technical issues and the fact it had no chief technologist, according to Dr. Roy Tingley, the hospital's chief of radiology.

Knowing that its off-site Katherine Wright Family Wellness Centre would not be accredited for the same reasons, the hospital did not reapply; the accreditation lapsed in December of 2003. "If you see a boat going down over by the reef and then you send another boat by the reef, it's probably going to go down, too," Dr. Tingley said.

Since late 2003, the hospital and wellness centre have changed the film, bought new processors, hired a chief technologist and is looking toward gaining its accreditation again, a process it hopes to complete this year.

Dr. Tingley said the quality of the images is very good.

Michele Bernier, director of public relations for the Beauséjour Regional Health Authority, which oversees the Dr. Georges L. Dumont Regional Hospital in Moncton, said initially that one of its two machines was accredited until May of 2005. However, Mr. Laberge contradicted that information, saying that accreditation for one machine was revoked in January of 2004. Accreditation on the second machine lapsed.

Michele Leblanc, the hospital's mammography technician, said the facility has since replaced the problem piece of film-processing equipment and solved the dust problem created during hospital renovations.

And Dr. Louis Simard, the hospital's vice-president of medical services, said good-quality screening mammography is being done there, adding that "we feel we could pass the exam with flying colours right now."

In Prince Edward Island, a dust problem caused a machine at the Queen Elizabeth Hospital in Charlottetown to fail its accreditation. Knowing they would have the same problem on the second machine, officials did not apply for accreditation. Accreditation was not applied for at the Summerside site, where the machine is relatively new, said Calvin Joudrie, technical director of diagnostic imaging for the provincial service health authority.

Though construction is now over, dust remains an issue, despite the purchase of a new film processor and other equipment. However, Mr. Joudrie insisted that the quality of the breast images had no bearing on disease detection. He said there are plans to upgrade the machines to a special type of digital form that has not yet been licensed.

"There is nothing wrong with the machine," Mr. Joudrie wrote in an e-mail. ". . . The equipment and training were fine, the image quality had no issue with disease pickup, however there is a limit to dust allowed within the field of view."

In Corner Brook, Nfld., Western Memorial Regional Hospital does not have its machine accredited because it was never sought, Damon Clarke, its corporate director of communications said initially.

However, Mr. Laberge said the hospital began the process in 2002 and, after a full review, "it was found that the quality did not meet standards and therefore corrective measures were recommended and accreditation not granted." Western Memorial Regional Hospital was invited after the implementation of the recommendations to reapply. When it didn't, the file was closed, he said.

In a follow-up interview, Mr. Clarke said he was mistaken when he said they never sought accreditation. Western Memorial Regional Hospital has since purchased a new, second machine and is planning to become part of the provincial breast-screening program this fall and will be pursuing accreditation for both machines. The hospital, he said, is doing everything an accredited centre would.

In Ontario, about 82 per cent of clinics are accredited, just below the national average of 85 per cent. That leaves 51 machines that are not.

One of them is in Mississauga and another is in Etobicoke, says Dr. Murray Miller, a radiologist who works in those clinics and who is also on the association's accreditation committee. He refused to identify the two clinics that have unaccredited machines but said neither is accredited because both are brand new. He said he is pursuing accreditation for both.

"The bottom line is the quality is first rate," Dr. Miller said, adding that he believes the mammography quality at unaccredited Ontario centres to be very high.

Linwell X-Ray Centre-Midtown Plaza in St. Catharines allowed its accreditation to lapse because it didn't spell extra business.

"I think the quality of the films are there, it's just that we thought maybe it would increase our business but it didn't seem to matter," said its manager, Mrs. Briggs Jude. "But I still have everything done that we need for accreditation."

Though West Lincoln Memorial Hospital in Grimsby, Ont., failed its accreditation, it still says it provides high-quality mammograms and is actively pursuing that stamp of approval from the radiologists' group.

"You have a period of time where if you don't pass it the first time, you can resubmit, but it's all part of the same application," said David Bird, executive director of West Lincoln Memorial Hospital. "I guess you could say we failed."

Problems with dust and the film developer have been the main issues, he said. They have since cleaned up the area, replaced the ceiling tiles and purchased a new mammography machine and a new film developer. As well, they have a very experienced radiologist.

"I think the quality of our mammograms was still quite high, although it did not meet the standard at the time from the Canadian Association of Radiologists," Mr. Bird said.

In Winnipeg, the Breast Health Centre is not accredited because it does not perform a minimum volume of scans necessary to attain it, according to Heidi Graham, spokeswoman for the Winnipeg Regional Health Authority.

"Because of the volume we do, we wouldn't qualify," said Ms. Graham, adding that by the time most women get to the centre, they have already had a cancer diagnosis.

Also in Winnipeg, Tache X-Ray Services said it allowed its accreditation to lapse, largely due to the volume of paperwork.

"It's one of those things where you are running your clinic on a daily basis, you sometimes don't have time for the extra paperwork involved," said Dorothy Beckman, the head technologist who has been performing mammograms for 17 years. "But everything is always being kept up to the standards that they recommend so you can be confident that things are working properly."

Women Beware: Can you Trust Your Mammogram