Radiation-Emitting Products

What should a facility do if a patient (or someone acting on her behalf) requests permanent or temporary transfer of mammograms and/or reports? Who should pay for it? What recourse does the patient have if the facility overcharges for the transfer or refuses to cooperate?

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The facility must transfer the original mammograms and copies of the patient's reports to the patient’s designated recipient upon such written request by the patient (or someone acting on her behalf). Facilities should be aware that the Federal Law pertaining to transfer of original mammograms supersedes any conflicting State or Local requirements. The mammograms and reports may be sent to a medical institution, a health care provider, or to the patient. If the designated recipient is not available, the facility should work with the patient (or someone acting on her behalf) to designate an alternate destination. The facility may charge the patient a fee for this service but it must not derive a financial profit from it. If the facility overcharges for the transfer or refuses to transfer the records, the patient should complain to the facility. If that doesn’t resolve the issue, the patient should notify the facility’s AB. If that still doesn’t resolve the issue the patient may inform the FDA via the Facility Hotline at 1-800-838-7715 or by writing to the following address: MQSA Hotline, P.O. Box 6057, Columbia MD 21045-6057. Patients in Certifying States should contact their State Certifying Agency directly.

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Page Last Updated: 08/13/2014
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