Is your mammogram wrong? Miami hospital ordered by FDA to halt service over concerns

Patients who received mammograms at a South Florida hospital in the past two years may have been given inaccurate results and should get tested again after a review found the images failed to meet standards, federal regulators say.

The U.S. Food and Drug Administration has ordered North Shore Medical Center, 1100 NW 95th St. in North Miami-Dade, to stop performing mammograms and notify patients about the problem, according to a letter obtained by the Miami Herald. It’s one of the most recent service stoppages at the struggling hospital, which has seen cutbacks and layoffs as owner Steward Health Care System seeks bankruptcy protection to thin out debt.

The possibly inaccurate mammograms were done at North Shore from March 14, 2022, to March 14, 2024, according to the hospital.

“Over this time, it was determined that the administration/evaluation of these mammographies were not in line with the industry standard and could be subject to an inaccurate interpretation,” hospital spokeswoman Cathy Pague told the Miami Herald in an email.

The news shocked patients, including Liz Guseila-Rizo, 67, who has a family history of breast cancer and has had her mammograms done at the hospital for years. Her most recent exam was in December.

“Could I possibly have cancer — breast cancer — and not know it?” said Guseila-Rizo, who has a genetic mutation that increases her breast cancer risk. She received a certified letter from the hospital notifying her about the problem in April, more than a month after the FDA ordered the hospital to shutter its mammography services.

‘Serious concern’ about mammography at North Shore

“There is a serious concern about the quality of the mammography that our facility performed,” Dr. Terri Noe, lead interpreting physician at North Shore, wrote in a letter to patients. Noe said the FDA determined North Shore “failed to meet the clinical image quality standards” established by the American College of Radiology, the facility’s mammogram accreditation body. “As a result, the FDA required us to stop performing mammography as of March, 14, 2024,” Noe wrote.

“This does not necessarily mean that the results you and your health care provider(s) were given are wrong,” Noe states in the letter. “However, most patients will need to have their mammogram(s) performed at our facility reviewed to determine whether a repeat mammogram at another facility is needed.”

It was a one-two punch for Guseila-Rizo, a longtime patient, therapist and 1199SEIU union delegate at North Shore, who was in the midst of unemployment paperwork when she received the letter. The music therapist, who worked at North Shore for more than 34 years, was part of a group of employees laid off in February after the hospital unexpectedly closed its critical but costly labor and delivery, neonatal, and behavioral health units to try to slow its financial bleeding.

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Steward Health Care System, which owns North Shore, filed for Chapter 11 bankruptcy in May and is looking to sell all 31 of its hospitals, including eight in Florida. They include North Shore, Palmetto General, Hialeah and Coral Gables hospitals in Miami-Dade, and Florida Medical Center in Broward.

“I don’t know if I’m OK. I don’t know how long it’s going to take me to get into a new doctor since I don’t live in Miami anymore,” said Guseila-Rizo, who now lives in Broward County and is in the process of setting up her new medical insurance to schedule an appointment.

“This is even more shocking that this went on for two years. ... How could this go on for two years?” she said, recalling how North Shore, like other hospitals, is periodically visited by various regulatory agencies. The former employee said she had to go in person to the hospital to get her results after the phone number the letter directed patients to call kept going straight to voicemail.

Pague, North Shore’s spokesperson, said the hospital has contacted patients and their physicians, as required by the FDA, and is also “voluntarily covering the costs for reevaluation of individual mammograms and offering new screenings for all those who have not had subsequent screenings.”

The letter sent to patients states that for North Shore to cover the reevaluation and screenings, it needs to be done at another certified facility within the hospital’s health network, or at a partner facility.

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Pague did not answer questions on how many patients are affected or why the mammograms did not meet image quality standards. The hospital spokesperson also did not answer questions on whether the hospital is planning to resume mammograms in the future or if the image quality issues extend to mammograms performed at Steward’s other hospitals in South Florida.

The FDA declined to answer the Miami Herald’s questions, saying it is “not able to discuss details of possible or ongoing regulatory actions.” Instead, the federal agency sent a detailed email explaining its role under the Mammography Quality Standards Act, or MQSA, which regulates mammogram centers and requires them to meet certain standards to legally perform screenings.

This includes meeting the standards for clinical image quality established by its FDA-approved accreditation body, which in the case of North Shore, is the American College of Radiology. Speaking generally, the FDA said that if an accreditation body revokes the facility’s accreditation, federal regulators can put the facility’s mammography certificate into a “No longer in effect status,” suspend the certificate, or revoke the certificate.

The facility is then no longer allowed to perform mammography or display a MQSA certificate. In order to get its certificate reinstated, the federal agency says that the facility will need to comply with all requirements and work with the accreditation body to “address any corrective actions that should be completed.”

North Shore says patients should speak to their doctor as soon as possible to discuss reevaluating their mammogram images and possibly undergo a new exam. Patients who have a new doctor or who are advised by their doctor to have their mammogram reviewed or repeated should contact North Shore.

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