Revision History
Current mammograms and records must be kept by the facility:
For at least 5 years, or
For at least 10 years if no additional mammograms of the patient are performed at the facility, or
Longer if mandated by state or local law, or
Until a request is made by or on behalf of the patient, to permanently or temporarily transfer her records to a medical institution, her physician or health care provider, or to the patient herself
For FFDM, either the original or lossless compressed digital data or hard-copy films of final interpretation quality must be maintained.
In digital mammography, data “compression” is a mathematical method used to reduce the size (i.e., number of “bits”) of a digital image file so that less computer storage is necessary and images can be more efficiently transmitted. There are various techniques of accomplishing this, with varying results. Lossless compression refers to methods of data compression in which all the original data is preserved and can be completely restored. Lossy compression refers to methods in which the original data cannot be completely reconstituted. The FDA requires a facility to use lossless compressed images for final interpretation and storage. You may burn a case to CD for interpretation; however, it must be saved as an original or lossless compressed file. Check with the FFDM manufacturer to verify the files are being saved accordingly. See the FDA's Policy Guidance Help System.
The FDA requires that each mammography facility permanently or temporarily transfer the original mammograms and copies of the patient’s reports to the patient or to her medical institution, physician, or health care provider upon request or on behalf of the patient. For FFDM, the facility must be able to provide hard-copy films of final interpretation quality or, when it is acceptable to the recipient (e.g., a transfer between two FFDM facilities), with original or lossless compressed digital images. Any exchange of images between requesting and image-providing facilities is to be accomplished in a mutually agreed-upon format since there is no regulation dictating format. However, if the facility does provide hard copy images to the medical institution, physician, health provider, patient or patient’s representative, the hardcopy films should be of final interpretation quality. The FDA does not specify who is responsible for printing or releasing records. The facility should have a system in place to ensure that the printed and transferred hardcopy images are of final interpretation quality. The quality control technologist and lead interpreting physician should ensure the task is performed in accordance with these regulations.
When patients request the release of their mammogram and you print a hardcopy, you may not charge them for the first hardcopy version; however, if the patient requests additional hardcopies, the facility may pass the costs of the additional hardcopies on to the patient. Appropriate charges for transfer of mammographic records could include items such as: administrative time costs incurred in logging in the request, retrieving the mammography films and reports, having the patient sign a release, packaging and mailing charges for the materials, and photocopying costs incurred in making copies of reports. See the FDA's Policy Guidance Help System.
The ACR will assist patients calling to report that their mammography facility will not transfer original images by calling the mammography facility to inform them about the FDA requirement for original image transfer. If the facility continues to refuse to transfer the images, ACR staff will refer the patient to appropriate staff at the FDA.
The refusal to transfer images is considered a “Serious Complaint” according to the FDA’s criterion, i.e. a serious adverse event “for which a facility fails to take appropriate corrective action in a timely manner.” The ACR can initiate an investigation of the facility.
Digitizing Film Mammograms:Archived film images may not legally be digitized in order to discard old film images (for example, to reduce storage needs). FDA regulations do not allow this because a digitized film image is not produced through radiography of the breast; under MQSA it is not considered a mammogram and cannot be used for retention or final interpretation. The FDA does allow digitized or copied images of previously obtained film mammograms to be used for comparison purposes, if the interpreting physician deems that acceptable. However, because such images are not considered mammograms under MQSA, they cannot be counted towards initial or continuing experience requirements for the interpreting physician. For more information, see the FDA's Policy Guidance Help System.
Revision History for this Article | ||
Date | Section | Description of Revision(s) |
12-12-19 | All | Article created; FAQs incorporated; No criteria changes |
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