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    April 2016
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Hilo Center Suspends Mammograms Pending FDA Recertification

Hawaii Radiologic Associates, Ltd. (HRA) has suspended mammography operations at its Hilo Women’s Imaging Center as it goes through a U.S. Food and Drug Administration process for recertification of its mammography services. The FDA notified HRA that patients who had mammograms between June 30, 2014 and August 24, 2015 should be notified of the possibility of inaccurate tests.
mammogramEach patient is being notified by certified letter of the potential concern and urged to review mammograms with their health care provider to determine if a retest is required.

HRA will review mammograms taken during that timeframe, if requested, and when necessary perform another mammogram at its Kona facility at no charge to the patient. Patients can also go to other certified mammogram centers of their choosing; HRA will provide previous mammographic examinations to that facility for review.

HRA’s Hilo Women’s Imaging Center continues to provide breast ultrasounds, magnetic resonance Imaging (MRI), bone density tests and breast biopsies.

James Lambeth, M.D., president of HRA, said the FDA ordered the suspension of the Hilo center mammograms after random samples showed that mammograms performed on one of the units failed to meet standards and further investigation resulted in the Hilo program being decertified.

“Patients who had mammography at our Hilo center during that time should not take this lightly,” said Dr. Lambeth. “Those who receive our letter should contact their doctors immediately to review their exam and determine if a repeat exam is warranted.”

Patients can go to the HRA website at www.hirad.com for more information and FAQs.

HRA performed 12,000 mammograms during the period.

“We apologize for this apparent lapse in quality assurance at our Hilo Center,” said Dr. Lambeth. “We want to make very clear that our Kona facility is unaffected by the decertification.”

Dr. Lambeth added that HRA is aggressively pursuing recertification for its Hilo facility and hopes to complete all requirements and be fully functional within three months. Technicians and other staff are undergoing additional training.

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