Date Issued: April 30, 2015
Audience:
- Patients who had mammograms at Coastal Diagnostic Center located in Pismo Beach, California any time on or after February 24, 2013.
- Health care providers who have referred patients to Coastal Diagnostic Center for a mammogram performed any time on or after February 24, 2013.
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 method of detecting breast cancer in its earliest, most treatable stages.
Purpose:
The FDA is alerting patients who had mammograms at Coastal Diagnostic Center located in Pismo Beach, California anytime on or after February 24, 2013, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (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.
Summary of Problem or Scope:
The FDA became aware of problems associated with the quality of mammograms performed at Coastal Diagnostic Center located at the following address:
921 Oak Park Blvd.
Suite 100B
Pismo Beach, CA 93449
The American College of Radiology (ACR), conducted a clinical image review of mammograms performed by Coastal Diagnostic Center between February 24, 2013 and February 24, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility’s accreditation renewal application. The ACR revoked the facility’s accreditation effective April 10, 2015.
On April 24, 2015, the FDA required the facility to notify all patients who received mammograms at Coastal Diagnostic Center any time on or after February 24, 2013, and their referring health care providers, about the problems with the mammography quality at the facility.
Under the MQSA 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 did not meet standards for mammography quality under the Act. The facility may no longer legally perform mammography at this time due to the revocation of its accreditation by the ACR and its MQSA certification being no longer in effect.
Recommendations/Actions:
The FDA recommends the following for patients who had a mammogram at Coastal Diagnostic Center any time on or after February 24, 2013:
- If you have had a more recent mammogram at a MQSA-certified facility since then, you should follow the recommendations from that facility.
- If you have not had a mammogram at an MQSA-certified facility since then, follow these guidelines:
- Talk with your health care provider as soon as possible about the need for a follow-up exam
- If your health care provider recommends a repeat mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy. A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute’s (NCI) information number at 1-800-422-6237.
- If you need a repeat mammogram and your health insurance will not pay for it, you can call the National Cancer Institute’s (NCI) information number at 1-800-422-6237 for a listing of MQSA-certified facilities near you that will provide free or low- cost mammograms.
FDA Activities:
The FDA will continue to monitor this issue and keep the public informed as new information becomes available.This safety communication is provided by the FDA’s commitment to inform the public about safety issues.
Contact Information:
If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to [email protected] or fax to 1-410-290-6351.