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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Before a facility permanently stops performing mammography, what actions should it take to avoid future MQSA problems and how should it deal with retention of mammographic medical records?

Policy Guidance Help System logoBefore a facility permanently stops performing mammography, it should do the following: 

  1. Inform its accreditation body that it will no longer be performing mammography;
  2. Notify its State radiation control program;
  3. Arrange transfer of each patient’s medical record (original mammography films and reports) to the mammography facility where the patient will be receiving future care, the patient’s referring physician or health care provider, or the patient. This transfer will address the requirement that the facility maintain the patient’s permanent medical record for a period of not less than 5 years, or not less than 10 years if no additional mammograms are performed at the facility, or longer if mandated by State or local law. The facility should make reasonable attempts to inform its former patients of how they can obtain their mammography records. Facilities should check with State or local agencies to determine if their requirements are more stringent. Note: Radiology practices and other medical facilities that still see patients but have permanently stopped performing mammography, may choose to keep the patients’ medical records rather than transfer them to another facility (unless the patient requests such a transfer).

If the option in number 3 is not viable, facilities could store the medical records in a hospital, if appropriate, or make arrangements to warehouse the records. The facility should assure that there is a mechanism to release the films to the appropriate entity when requested and that former patients are made aware of that mechanism. It should be noted that if no one else is willing to accept the records, the facility remains responsible for them. Under MQSA, facilities will not be held responsible for maintenance of examinations performed before October 1, 1994; however, State and local regulations may require otherwise.

Once the facility ceases operation, the MQSA certificate should no longer be displayed. The facility may file or destroy its MQSA certificate.

Due to the fact that some facilities have not followed the above recommendations, FDA has been receiving complaints from patients that their mammography facility has closed, that they were not informed, and that they cannot find out where or how to gain access to their mammography records. For this reason, FDA requests that the facility notify us of how it intends to fulfill its obligations with respect to medical records. Such information may be sent to:

FDA/CDRH/DMQS
Attention: Closed Facility Notification of Records Retention
10903 New Hampshire Avenue Building 66
Silver Spring, MD 20993-0002

Facilities certified by States (currently Iowa, Illinois, or South Carolina) may send the above information to:

Iowa: 

Bureau of Radiological Health
Iowa Department of Public Health 
401 SW 7th Street, Suite D 
Des Moines, IA 50309 
Or call 515-281-3478 

Illinois: 

Office of Radiation Safety 
Department of Nuclear Safety 
1035 Outer Park Drive 
Springfield, IL 62704 
Or call 217-785-9974 

South Carolina: 

Department of Health and Environmental Control 
Division of Electronic Products 
2600 Bull Street 
Columbia, SC 29201 
Or call 803-545-4400

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