Date Issued

April 26, 2019

Audience

• Patients who had a mammogram(s) at East Palestine Family Medical Clinic, located in East Palestine, Ohio, any time on or after March 28, 2017.
• Health care providers who may discuss this Safety Notice with patients of East Palestine Family Medical Clinic, located in East Palestine, Ohio, about a mammogram(s) performed on or after March 28, 2017.

Medical Specialty

Primary Care, Family Medicine, Internal Medicine, Obstetrics and Gynecology, Radiation Oncology, Radiology, General Surgery, Breast Surgery.

Product

A mammogram is a safe, low-dose, X-ray picture of the breast. It is currently the most effective primary method of detecting breast cancer in its earliest, most treatable stages.

Purpose

The U.S. Food and Drug Administration (FDA) is alerting patients who had a mammogram(s) at East Palestine Family Medical Clinic, located in East Palestine, Ohio, on or after March 28, 2017, about possible problems with the quality of their mammograms. The purpose of the notification is to communicate to health care providers and patients that they should consider having these mammograms re-evaluated at a Mammography Quality Standards Act-certified facility to determine if a repeat mammogram or additional medical follow-up is needed. Patients or their representatives have the right to request their mammograms and copies of their medical reports from East Palestine Family Medical Clinic.

Summary of Problem or Scope

The FDA became aware of problems associated with the quality of mammograms performed at East Palestine Family Medical Clinic located at the following address:

50410 State Rt. 14
East Palestine, OH 44413

The results of an annual Mammography Quality Standards Act inspection of this facility in October 2018 indicated that the facility was unable to meet the parameters for a key quality control test on the day of the 2018 annual inspection. The facility also failed to meet quality control parameters dating back to October 2017, based on a review of the facility’s quality control records. As a result, the FDA notified the facility that it was required to undergo an Additional Mammography Review to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the Mammography Quality Standards Act.

The American College of Radiology conducted an Additional Mammography Review of mammograms performed by East Palestine Family Medical Clinic, and the results indicated the mammograms did not meet the American College of Radiology's clinical image evaluation criteria. On April 1, 2019, the American College of Radiology revoked the facility's accreditation, and on April 2, 2019, the FDA placed the facility's Mammography Quality Standards Act certificate in a "no longer in effect" status.

Under the Mammography Quality Standards Act of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility does not meet the standards for mammography quality under that Act. This facility must no longer perform mammograms, as it does not have an active Mammography Quality Standards Act certificate.

On March 28, 2019, the FDA directed the facility's CEO to notify all patients who received mammograms at East Palestine Family Medical Clinic on or after March 28, 2017, which represents a two-year screening window back from the date of the notification order, about the problems with the mammography quality at the facility. To date, the facility has not performed the ordered notifications.

Recommendations and Actions

The FDA recommends the following for patients who had a mammogram(s) at East Palestine Family Medical Clinic on or after March 28, 2017:

• If you have had a more recent mammogram at a different Mammography Quality Standards Act-certified facility since then, you should follow the recommendations from that facility.
• If you have not had a mammogram at a different Mammography Quality Standards Act-certified facility since then, follow these guidelines:
  • Consider requesting your mammogram(s) and copies of your medical reports from East Palestine Family Medical Clinic, and have your mammogram(s) reviewed at another Mammography Quality Standards Act-certified facility to determine whether a repeat mammogram or additional medical follow-up is needed.
  • A database of Mammography Quality Standards Act-certified facilities in your area is available online, or you can call the National Cancer Institute's information number at 1-800-422-6237 to find a Mammography Quality Standards Act-certified facility in your area.

FDA Activities

The FDA will continue to monitor this issue and keep the public informed as new information becomes available.

Contact Information

If you have questions about this communication, please contact the Mammography Quality Standards Act Hotline by phone: 1-800-838-7715, email: [email protected] or fax: 1-443-285-0689.