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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Recordkeeping

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Citation:

900.12(c)(4)(i),(ii): Recordkeeping. Each facility that performs mammograms:

(i) Shall (except as provided in paragraph (c)(4)(ii) of this section) maintain mammography films and reports in a permanent medical record of the patient for a period of not less than 5 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; and

(ii) Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, or to a physician or healthcare provider of the patient or to the patient directly.

Questions:  
  1. Under MQSA, what medical records are facilities required to maintain and for how long should these records be kept?
  2. 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?
  3. What documentation should I get when a patient, or an individual acting on behalf of the patient, or the patient's physician requests the release of the patient's records? How long should I keep the documentation?
  4. With the introduction of Full Field Digital Mammography, what constitutes a mammogram for retention and transfer purposes, the digital data or the hardcopy film?
  5. Can a facility copy or digitize a film screen mammogram and use that copied or digitized image for retention purposes or final interpretation?
  6. Can a facility use lossless compression to store FFDM images for retention purposes?
  7. Can a facility use lossless compression to recreate FFDM images for final interpretation?
  8. Can a facility use lossy compression to store FFDM images for retention purposes?
  9. Can a facility use lossy compression to recreate FFDM images for final interpretation?

 

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