Federal regulators are advising anyone who received a mammogram at Coastal Diagnostic Center in Pismo Beach any time since Feb. 24, 2013, to consider repeating the test elsewhere because of problems with the quality of testing at the center.
The U.S. Food and Drug Administration advisory issued Thursday said Coastal Diagnostic Center, which is owned by Dignity Health, cannot legally perform mammograms because its accreditation was revoked by the American College of Radiology on April 10.
Dignity Health spokeswoman Megan Maloney said the center submitted a correction plan and was notified by letter Thursday that the ACR had accepted the plan and would work with the FDA to reinstate the center’s accreditation.
Officials with the FDA and the American College of Radiology could not be reached Thursday afternoon for a copy of the letter or for details on the quality issues. Maloney declined to release the letter without ACR approval.
Coastal Diagnostic Center has offered services in mammography, ultrasound and a type of mammography-assisted breast biopsy procedure. It remains open and is continuing to provide ultrasound services while the issue is resolved, Maloney said.
The problem came to light when the clinic applied to renew its accreditation and the ACR noted deficiencies in mammography cases submitted with the application.
The ACR reviewed mammograms done between Feb. 24, 2013, and Feb. 24, 2015, and found the testing failed federal quality standards set out in the Mammography Quality Standards Act of 1992. The ACR revoked the center’s accreditation and its MQSA certification, which is needed to legally operate.
The FDA advisory did note that mammograms done at the center were not necessarily inaccurate, “but it does mean that the patients should consider having their mammograms re-evaluated at a (MQSA-certified) facility to determine if the patients need a repeat mammogram or additional medical follow-up.”
“Patients have the right to request their mammogram and copies of their medical reports from Coastal Diagnostic Center,” the advisory said.
The ACR notified Coastal Diagnostic Center on March 31 of the deficiencies, according to the center, and developed and implemented a correction plan.
“We have been working with the ACR and the FDA to ensure we meet their requirements regarding patient notification,” center officials said in a written statement. “As soon as we receive FDA approval of our letters, we will send letters to all Coastal Diagnostic Center patients who had mammograms performed at that site between Feb. 24, 2013, and Feb. 24, 2015.”
The statement said that any patients who want a board-certified radiologist to review their mammograms can call the center to schedule a free appointment.
Mammograms can also be repeated for free at Dignity Health’s other facilities: French Hospital Medical Center, Marian Regional Medical Center’s Mission Hope Cancer Center or San Luis Diagnostic Center.
The FDA advisory was issued as Dignity Health was announcing the acquisition of San Luis Diagnostic Center in San Luis Obispo, which is also an outpatient imaging center. The purchase, effective Friday, was unrelated to the problems at Coastal Diagnostic Center, Maloney said.