May 1, 2008 11:00 pm US/Eastern
I-Team: Mammogram Mistakes
Reporting
Jim Osman
PHILADELPHIA (CBS 3) ―
The CBS 3 I-Team reviewed FDA inspection reports of mammogram facilities and found violations at imaging centers in our area.
A routine annual mammogram detected Lorelei McGlade's breast cancer at an early stage.
"I never said, why me, but it was just a shock that it could happen to me," said the Haddon Heights women.
Like many women, Lorelei knows getting yearly mammograms is crucial. And expectations of accuracy are very high.
Women shoppers in Cherry Hill were clear about what they expected from their mammogram facility.
"I expect it to be accurate," said Cora Pollard who is recovering from breast cancer that was detected by a mammogram.
"It's a life and death issue and it should be taken seriously. I expect them to have up-to-date equipment and a skilled technician", said Joyce Rader about her annual mammogram visits.
But the I-Team dug through four years of mammogram facility inspection records and uncovered some local facilities violating federal standards that 'may compromise the quality of mammograms'.
At Paoli Hospital in Chester County, the mammogram facility there was cited with four serious violations in 2007. Inspectors say during a seven month period, the hospital didn't do the required testing on mammogram machines.
At the Breast Imaging Center of the University of Pennsylvania Hospital, inspectors cited four serious violations late last year. The records show poor test images that check for accuracy of the machine which should have led the facility to make corrections before additional mammograms were done.
At DSI of Bucks County in Bensalem, there were 22 serious violations in the imaging center's last two inspections, including two repeat violations. The report contained more violations than any other facility we identified in this investigation.
"We're accountable and we're changing. We've changed how the process is being done," said Dr. Beth DuPree, the center's medical director.
In addition, inspectors found that the facility had missing test images that could indicate the accuracy of its machines. The center was also cited for lacking a concrete plan for infection control.
"Obviously I would wish we didn't have any deficiencies, but we are taking the suggestions they had. We have a strong action plan to fix them," said Dr. DuPree.
Diane Ranella, with the Federal Mammography Standards Committee, says women should take these inspection reports seriously because they could lead to grave mistakes.
"It would be a concern for me if I was a consumer going in for a mammogram," said Ranella.
But the head of Pennsylvania's Mammogram Inspection Program defends the facilities saying they wouldn't stay open if they posed a danger to women.
"There's not a facility in this state that I would be concerned about any member of my family or friends going to," says Allard.
Lorelei McGlade says women should be aware of what the I-Team is exposing. She believes everyone should ask their own questions about facilities. And more importantly, women should find a place they trust so that there is no hesitation about making that next appointment.
"Thank goodness for my mammogram because otherwise I wouldn't be here," said Lorelei.
There are no known cases of a misdiagnosed mammogram because of the violations we reported in this investigation.
In response to our report, Paoli Hospital says it has since corrected the problems. Its most recent inspection had no violations.
The University of Pennsylvania says it has initiated a plan to make sure violations don't occur again.
And DSI Bucks County Imaging Center says it is a relatively new facility. And that it is transitioning into new technology and doesn't expect similar violations in the future.
Additional information on requesting mammogram facility inspection reports:
To find out about inspection results at mammogram facilities in Pennsylvania, you can call the state's Department of Environmental Protection at
484-250-5900 and schedule a file review for a specific facility.
In New Jersey, make your request in writing to the New Jersey Department of Environmental Radiation's Bureau of Radiological Health:
25 Arctic Parkway
P.O. Box 415
Trenton, N.J. 08625
In Delaware, call the state's Division of Public Health at
302-744-4704.
For information about the FDA's Mammography Quality Standards Act (MQSA),
MQSA - FAQsThe American Cancer Society says women can also ask the facility for its MQSA Certificate and check the expiration date. The certificate means that the facility undergoes regular inspections to meet quality standards.
(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)
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