Letter To Physicians and Health Care Providers

November 2003

Dear Health Care Provider:

The State Department of Health today recommended that women whose most recent mammogram was performed at Park Avenue Medical Imaging and Mammography, P.C. immediately obtain another mammogram. Park Avenue Medical Imaging and Mammography, P.C. is a radiology facility that is located at 200 Park Avenue South in Union Square on the lower East side of Manhattan. The Medical Director, Yefim Vaynshelbaum, M.D., performs clinical breast exams (CBE), mammograms, and breast ultrasounds at this facility. Park Avenue Medical Imaging and Mammography, P.C. has reported providing approximately 4,000 mammograms per year since at least 1995.

The problems at this facility were originally uncovered through a quality assurance review undertaken by the Department’s Cancer Services Program of mammograms interpreted by Yefim Vaynshelbaum, M.D. The Department’s review found that there was a risk for missed cancer either because the appropriate diagnostic tests for abnormal mammograms were not ordered, or because the technical quality of the films was poor.

The Department’s review prompted additional mammography reviews by the U.S. Food and Drug Administration (FDA), the agency that oversees mammography quality in the nation, and the Centers for Medicare and Medicaid Services (CMS), which conducted a review of mammograms provided to Medicare beneficiaries at this practice.

Based on the results of these reviews, the FDA has determined that the mammograms performed at Park Avenue Medical Imaging and Mammography, P.C. during the review period were so inconsistent with established quality standards as to pose a significant risk to individual or public health. As a result, 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. Park Avenue Medical Imaging and Mammography, P. C. has requested an internal FDA review of the decision to require patient and physician notification.

Given the potential risk for missed cancer, I am urging women whose most recent mammogram was performed at this facility to be rescreened. I am requesting your assistance to ensure that your patients receive a prompt referral to a different facility for a repeat mammogram and that you provide them with a clinical breast exam, if indicated. Most health plans have committed to cover any additional exams for their affected beneficiaries. Medicare will also pay for repeat exams.

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, has translation services available, and will remain active for as long as it is needed. The telephone number is 1-800-808-1987.

Thank you for your assistance in providing quality health care to the women of New York State.

Sincerely,

Antonia C. Novello, M.D., M.P.H., Dr. P.H.
Commissioner of Health