Information for Clinical Providers
Park Avenue Medical Imaging and Mammography, P.C.
Breast Cancer Screening Quality Concerns-October 2003
Information for Clinical Providers
The New York State Department of Health (NYSDOH) announced on November 5, 2003 that women who had their most recent mammogram at Park Avenue Medical Imaging and Mammography, PC at 200 Park Avenue South in Union Square in Manhattan should immediately be rescreened.
Why is there a need for rescreening?
Three independent reviews by the NYSDOH, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have recently been conducted at this facility. The first review, initiated by the NYSDOH Cancer Services Program, included the women in the NYS Healthy Women’s Partnerships who were screened at Park Avenue Medical Imaging, P.C. (PAMI).
- A review of a random sample of patients' films undertaken by a medical consultant to the NYSDOH found that in 74% of cases there was a risk for missed cancer either because the appropriate diagnostic tests for abnormal findings were not ordered, or because the technical quality of the films was poor.
- At the request of the FDA, the American College of Radiology (ACR) conducted an additional mammography review. The ACR review found areas of concern in both the technical quality of the films and with the interpretations by the doctor.
- CMS initiated its own review and found quality of care concerns in 53% of cases and the need for rescreening in 17.5% of the sample it reviewed.
On October 2nd, the FDA directed Park Avenue Medical Imaging and Mammography, P.C. to notify at risk patients seen between August 12, 2001 and July 25, 2003 and their physicians of the potential health risk because the mammograms performed at the facility during the review period were "so inconsistent with established quality standards as to pose a significant risk to individual or public health." Park Avenue Medical Imaging and Mammography, P. C. has requested an internal FDA review of the decision to require patient and physician notification.
What Actions Should Clinical Providers Take?
Women who had their most recent breast screening at Park Avenue Medical Imaging, P.C. should be provided a complete exam, which includes a mammogram, and a clinical breast exam. Women will need a referral to an accredited facility for mammography examination. Currently accredited facilities can be found at: www.fda.gov/cdrh/mammography/certified.html
Who will pay for this exam?
Most health plans have committed to cover any additional exams that are required for their beneficiaries. Medicare will also pay for repeat exams. If the woman is no longer insured, she may contact the helpline to locate the Healthy Woman Partnership in her area to apply for free mammography and diagnostic services.
How can women get additional information?
The Department of Health has established an information helpline for patients seen at Park Avenue Medial Imaging and Mammography, P.C. The helpline is in operation 24 hours a day and 7 days a week and will remain active for as long as it is needed. The telephone number is 1-800-808-1987.
Can women have their films from Park Avenue reviewed by another radiologist?
Yes, women may obtain the original mammograms from Park Avenue Medical Imaging, P.C. and have them reviewed by another accredited facility. However, the accredited facility may require a repeat exam.