A dozen mammography centers in the metropolitan area received warning letters from the Food and Drug Administration earlier this year for various violations.
Four of the New York facilities – New York Community Hospital and Diagnostic Imaging Associates in Brooklyn, Long Island Radiology Associates and Gramercy Radiology Group in Manhattan – failed to label patients’ mammograms in assessment categories ranging from one (normal) to five (suspicious-malignancy).
“This labeling is crucial for physicians to determine if an immediate course of action – such as a biopsy – is necessary,” explained Dr. Stephen Feig, director of breast imaging at Mount Sinai Hospital.
Another four – St. Charles Hospital and Rehabilitation Center, Elmont Open MRI and Long Island Jewish Radiology Center, all on Long Island, and Medical Imaging Services for Women in Poughkeepsie – were reprimanded for having inexperienced staff on site.
Northeast Radiology in Jefferson Valley, the medical practice of Beranbaum, Khilnani, Neistadt, Jacobs, Hertz & Sherman in Manhattan and Our Lady of Mercy Medical Center in The Bronx were all missing records needed to indicate machinery was up-to-date.
Albany Memorial Hospital Medical Imaging Services for Women in the state capital was cited for failing to immediately telephone or fax information on serious cases, instead waiting to send results by mail.
Officials at almost half of the cited centers – Gramercy Radiology Group; the Manhattan practice of Beranbaum et al, Long Island Jewish Radiology Center, St. Charles Hospital and Rehabilitation Center and Albany Memorial – told The Post they immediately corrected all violations.
Several of the centers contacted by The Post downplayed the seriousness of the violations.
“It was ridiculous,” said Albert Trachtenberg of St. Charles Hospital and Rehabilitation Center.
Trachtenberg says he wasn’t made aware of an FDA requirement stipulating the level of expertise required of a radiologist.
“If we had known, we would have gotten several of our radiologists up to speed,” he said.
Steward Berliner, of Our Lady of Mercy Medical Center, said, “Our mammography center is fine. When inspectors come, they always find a couple little things. It’s not like we failed.”
But doctors say the violations are not to be taken lightly.
“If a center isn’t releasing results in a timely fashion or has someone inexperienced reading slides, women’s lives are at stake,” Feig said. “These regulations are there for a reason.”
The FDA said it was not particularly alarmed about the findings from its New York office, which covers the state. The agency noted that the Minneapolis area also received 12 warnings.
New York state has 716 mammography centers, “so 12 violations don’t seem as extreme as in a city with a much smaller population, such as Minneapolis,” an FDA spokeswoman told The Post.
The following mammography centers received FDA warning letters earlier this year.
Cited for failing to label patients’ mammograms into assessment categories ranging from normal to suspicious-malignancy:
New York Community Hospital, Brooklyn
Diagnostic Imaging Associates, Brooklyn
Long Island Radiology Associates, Hewlett, L.I.
Gramercy Radiology Group, Manhattan
Cited for not having experienced enough staff on site:
St. Charles Hospital and Rehabilitation Center, Port Jefferson, L.I.
Elmont Open MRI, Elmont, L.I.
Long Island Jewish Radiology Private Practice, New Hyde Park, L.I.
Medical Imaging Services for Women, Poughkeepsie
Cited for missing records needed to indicate machinery was up-to-date:
Northeast Radiology, Jefferson Valley
Practice of Beranbaum, Khilnani, Neistadt, Jacobs, Hertz & Sherman, Manhattan
Our Lady of Mercy Medical Center, Bronx
Cited for failing to immediately telephone or fax information on serious cases, instead waiting to send results by mail:
Albany Memorial Hospital Medical Imaging Services for Women, Albany