The Hilo Women’s Imaging Center has resumed regular mammogram procedures after receiving provisional certification from the U.S. Food and Drug Administration.
The FDA suspended the procedures in March, prompting a review of more than 3,000 mammogram images taken between June 30, 2014, and Aug. 24, 2015, on one of the center’s two machines. A random sampling of 30 images from that time period had not met quality standards mandated by the center’s accrediting body, the American College of Radiology.
The temporary loss of ACR accreditation and subsequent decertification came as a shock to the clinic, which opened in 1972 and was the first ACR-designated Center of Excellence in Hawaii.
“It was certainly unfortunate for us and for the community,” said Dr. James Lambeth, president of Hawaii Radiologic Associates Ltd., which operates the Hilo center. “We’re really sorry to let our patients down.”
He said the feeling in the center on May 27, when the FDA telephoned with the recertification news, was one of relief.
“And a feeling that we had to be sure we never got into that situation again,” Lambeth continued. “The patients have been remarkably patient. There were a few people who were justifiably upset.”
As part of the mandated process toward recertification, the FDA required that 12,000 certified letters be sent to all of the imaging center’s patients. Patients were asked to check with their doctors about whether they would need a re-review of their mammogram.
“The FDA later informed us that they … had never requested such a large patient notification,” Lambeth said. “They had some qualms about whether we could actually accomplish it, but we did, and we did it on schedule.”
Dr. David Camacho, a radiologist and Hawaii Radiologic partner, previously told the Tribune-Herald that “it’s not necessarily that there are (errors), but that there could be.” Many patients had already returned to the clinic for an annual checkup when the machine was fully accredited.
Mammogram machines are regularly tested by the state to help ensure quality, but this also depends on factors such as how technicians set up the image or whether a woman accidentally moves during the procedure.
Lambeth said that about 3,100 images were re-reviewed at the request of patients or their physicians. Of those, 36, or about 1 percent, were images that “we felt either needed to come back for additional views or for a repeat of the study,” he said.
Staffers began offering mammograms at the Hilo center on May 31 and have since performed more than 600, Lambeth said. The center is open six days a week, with radiologists working all day on Saturday to address to backlog of appointments.
“Some people (had appointments) that were deferred,” Lambeth said. “If available, those were the ones that were brought in first.”
Still, he said that the clinic was not doing more than 30 procedures per machine per day.
“We’re trying to take more time with the examinations to be sure we are doing it correctly,” Lambeth said. “We’ve gone from being sure we could accommodate all the patients and getting them through, (to having) our focus now on the quality of the examinations, which is where it used to be.”
The final step in recertification takes place this week, when the list of 600 procedures will be sent to the ACR for another random sampling of 30 images.
“They will have an expert radiologist review them, and from that they will make a decisions as to whether we are granted the usual three-year accreditation,” Lambeth said. That decision will come in four to six weeks.
The staff has been re-trained (twice, Lambeth said) in mammogram procedures, and the center is now seeking an expert mammographer of its own, whose sole job would be “supervise the quality of the work of the other mammographers.”
The center has several imaging machines and offers CT scans, MRIs, ultrasounds and X-rays in addition to its mammogram equipment. All other equipment remained certified during the FDA review process.
“We’re glad the community was so patient,” Lambeth said.
“We really want to get back to the place where we were.”
Email Ivy Ashe at iashe@hawaiitribune-herald.com.
