Mammogram Record Retention: FDA Offers Advice

Posted 05 January 2017 By Zachary Brennan

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Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law).

Under the Mammography Quality Standards Act (MQSA), original mammograms and their reports are considered medical records.

“This requirement to retain prior exams facilitates the comparison of a patient’s more recent exams to her earlier exams, since assessing for stability or change over time can be a very important aspect of mammographic interpretation,” FDA says.

States may impose more stringent requirements for medical record retention, and FDA notes that MQSA’s record retention requirement is a baseline standard. For continuity of care, if a patient is returning regularly for subsequent exams, many facilities opt to retain all of that patient’s mammograms, FDA says, not only those exams which are less than five years old.

FDA also makes clear: “there is no difference in the required length of time for retention of digital mammograms compared to screen-film mammograms. Screen-film mammograms should be retained in their original form, neither as copy films nor digitized.”

And in this current era of digital mammography, the actual transfer of the original digital mammogram is rare, FDA says, noting that since digital copies of mammograms are usually released while the facility retains the originals, the transfer provision of MQSA does not apply.

“Finally, there are MQSA recommendations for the disposition of medical records (mammograms and reports) if a facility closes or ceases performing mammography. The facility should (a) inform its accreditation body that it will no longer be performing mammography; (b) notify its State radiation control program; (c) arrange transfer of each patient’s medical records to the facility where the patient will receive future care, to the patient’s referring provider or other provider designated by the patient, or to the patient or her representative; and (d) inform the patient of the arrangements made.

Facilities should also check with State or local agencies to determine whether other requirements apply,” FDA adds.
The agency also notes that some facilities have not followed these recommendations and patients have contacted FDA with concerns about where and how to request their records.

“Therefore, we also request that a closing facility notify us (or its State certifying agency, if applicable) of how it intends to fulfill its obligations with respect to medical records. Access to mammography records is extremely important for patient care, and we hope that this article helps facilities recognize and carry out their responsibilities with respect to mammography medical records,” FDA adds.

Mammography Record Retention: What Should I Keep, and For How Long?

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Categories: Medical Devices, Crisis management, Quality, Regulatory intelligence, News, US, CDRH

Tags: mammogram, FDA and mammography, MQSA

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