Radiation-Emitting Products

Communication of Results to Providers

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900.12(c)(3)(i),(ii): Communication of mammography results to health care providers. When the patient has a referring health care provider or the patient has named a health care provider, the facility shall:

(i) Provide a written report of the mammography examination, including the items listed in paragraph (c)(1) of this section, to that health care provider as soon as possible, but no later than 30 days from the date of the mammography examination; and

(ii) If the assessment is “Suspicious” or “Highly suggestive of malignancy,” make reasonable attempts to communicate with the health care provider as soon as possible, or if the health care provider is unavailable, to a responsible designee of the health care provider.

  1. What are the requirements for notification of examination results to the referring health care provider?
  2. What criteria will FDA use to determine that facilities meet the MQSA requirements for providing lay summaries and mammography reports to their patients and health care providers?
  3. If a facility issues an "addendum" or "comparison" report after the initial mammography report has already gone out, are these reports required to have an overall final assessment category? Must the "addendum" or "comparison" report also be provided to the referring health careprovider and the patient even if there is no change in the final assessment category or recommended course of action?
  4. Our facility's mammography reports are accessible to our health care providers on computer. Because of this, we do not print out reports to send to the providers. Will providing the mammography reports through the use of computers (e.g., E-mail) be acceptable under the final regulations?
  5. Must a mammography report be provided to the health care provider or self-referred patient if the images from an examination are re-read by a physician not associated with the facility where the examination was originally performed and interpreted (e.g., if the patient or health care provider requests a second opinion from another facility)?
  6. Under new Centers for Medicare and Medicaid Services (CMS) guidelines, we can now charge for screening and diagnostic exams done on the same patient on the same day. Can we combine the two exams into one report or must we issue two separate reports?


Page Last Updated: 09/09/2014
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