Date Issued: April 13, 2015
Audience:
- Patients who had a mammogram at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology, located in Huntington Park, California any time on or after September 8, 2014.
- Health care providers who have referred patients to J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology for a mammogram performed any time on or after September 8, 2014.
Medical Specialty: Primary Care, Oncology, Radiology, Internal Medicine, Obstetrics and Gynecology, Breast Surgery, General 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 J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology, located in Huntington Park, California, any time on or after September 8, 2014, 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 J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology.
Summary of Problem or Scope:
This facility was the subject of a prior FDA Safety Notification issued on March 10, 2011.
The FDA again became aware of problems related to the quality of mammograms performed at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology facility, located at the following address:
2679 Zoe Avenue
Huntington Park, California 90255
The American College of Radiology (ACR), conducted a review of mammograms performed at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology between September 8, 2014 and November 4, 2014. The clinical image review was conducted for the purposes of accreditation reinstatement following the August 31, 2010 ACR revocation of the facility’s accreditation. On September 8, 2014, the facility was provisionally certified to provide mammography services; however, a subsequent ACR clinical image review indicated problems with the quality of the mammography at the facility. The ACR revoked the facility’s application for accreditation effective February 20, 2015. The FDA suspended the facility’s certificate on March 6, 2015.
On April 8, 2015, the FDA required the facility to notify all patients who received mammograms at its facility any time on or after September 8, 2014, and their referring health care providers, about the problems with the mammography quality at the facility.
In accordance with its rules and requirements the State of California, Health and Human Services Agency, California Department of Public Health issued a Cease and Desist Order against the facility on February 9, 2015, based on a State investigation and the findings noted by the ACR during the Additional Mammography Review (AMR).
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 not legally perform mammography at this time due to the suspension of its certificate.
Recommendations/Actions:
The FDA recommends the following for patients who had a mammogram at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology facility any time on or after September 8, 2014:
- 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.