900.12(c)(2)(i),(ii): Communication of mammography results to the patients. Each facility shall send each patient a summary of the mammography report written in lay terms within 30 days of the mammographic examination. If assessments are "Suspicious" or "Highly suggestive of malignancy," the facility shall make reasonable attempts to ensure that the results are communicated to the patient as soon as possible.
(i) Patients who do not name a health care provider to receive the mammography report shall be sent the report described in paragraph (c)(1) of this section within 30 days, in addition to the written notification of results in lay terms.
(ii) Each facility that accepts patients who do not have a health care provider shall maintain a system for referring such patients to a health care provider when clinically indicated.
- What constitutes an acceptable system for notifying patients of examination results?
- 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?
- What are the requirements for notification of examination results to patients who have a primary health care provider?
- What are the requirements for notification of examination results to patients who do not have a primary health care provider?
- Our facility currently gives the patient the examination results verbally. Will this meet the patient communication requirements under the final regulations?
- Will giving the referred patient a written lay summary of results at the time of the examination satisfy the patient communication requirements under the final regulations?
- What is the difference between self-referred and self-requesting patients and how does this affect what types of reports these patients receive?
- Does a facility have to accept self-referred patients?
- Must lay summaries of the "addendum" or "comparison" medical report be provided to all patients, even if there is no change in the findings or recommended course of action?
- A facility performs non-mammographic breast imaging studies on the same day as the mammographic examination. Must the facility provide the patient a separate mammography lay summary, or can the facility provide a combined lay summary that represents the overall results and recommendations for all the breast imaging studies performed that day?
- Our facility currently uses a computerized telephone system for communicating mammography results to our patients. Will this system meet the patient communication requirements under the final regulations?
- 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 care provider and the patient even if there is no change in the final assessment category or recommended course of action?
- Does the lay summary have to be signed by the interpreting physician?
- Does the lay summary have to have a final assessment category?
- Do we have to provide lay summaries translated into different languages for our patients who cannot read English?
- How should a facility handle a lay summary that is returned "undeliverable?"
- How is a facility required to deal with providing lay summaries to patients who, for whatever reason, cannot communicate?
- Must the radiologic technologist performing the mammogram be identified in the mammography report and lay summary?
- Must a lay summary be provided to the 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)?
- Must a facility provide the patient with a written lay summary even if the results are incomplete and additional imaging is needed?
- Our facility's lay summaries are accessible to our patients on computer. Because of this, we do not print out summaries to send to the patients. Will providing the lay summary through the use of computers (e.g., E-mail) be acceptable under the final regulations?
- What type of lay summary should be sent to a patient who has a normal mammogram, but the facility is aware that the patient has an abnormal physical exam?
- If a patient specifically asks the facility not to provide her with a lay summary, can the facility comply with her request?
- Are there any additional issues we should be aware of when providing mammography results to referring healthcare providers and patients?
If a mammogram is interpreted as “Suspicious” or “Highly Suggestive of Malignancy” (a positive mammogram) the mammography report and lay summary are to be provided as soon as possible. Previously issued guidance mentions 3-5 days. Is that measured from the date of the mammogram or the date the mammogram was interpreted as positive?