Radiation-Emitting Products

What should a facility do if it closes or decides that it will no longer provide mammography services?

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Before 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; and
  3. Arrange transfer of each patient’s medical record (original mammography films and/or lossless compressed digital files 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 statuatory and regulatory 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. 42 U.S.C. 263b(f)(2)(G)(i)(I): 21 CFR 900.12(c)(4). 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 than those of MQSA. 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 transfer of each patient's medical record 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 records 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 received inquiries from patients complaining 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 a facility that plans to stop performing mammography notify its Certifying Agency of how it intends to fulfill its obligations with respect to medical records. Such information may be sent to:

FDA/CDRH/OIR/DMQS
Attention: Closed Facility Notification of Records Retention
10903 New Hampshire Avenue, WO66-4675
Silver Spring, MD 20993-0002

Facilities certified by States may send the above information to:

State of Illinois
Office of Radiation Safety
Division of Registration and Certification
1035 Outer Park Drive
Springfield, IL 62704
217-785-9974

State of Iowa
Mammography Certification Program
Bureau of Radiological Health
Iowa Department of Public Health
Lucas State Office Bldg., 5th Floor
321 East 12th Street
Des Moines, Iowa 50319
515-281-3478

State of South Carolina
Mammography Certification Program
Department of Health and Environmental Control
Bureau of Radiological Health
2600 Bull Street
Columbia, SC 29201
803-545-4400

State of Texas
Texas Department of State Health Services
Mammography Certification Program
Machine Source Group
P.O. Box 149347
Mail Code 2835
Austin, TX 78714-9347
512-834-6688, Extension 2245 

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Page Last Updated: 08/13/2014
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