What constitutes an acceptable system for notifying patients of examination results?
Facilities must provide a summary of the results of the mammographic examination written in lay terms to all patients within 30 days (patients who do not have a health care provider must also receive the mammographic report within 30 days). Furthermore, when the mammography report assessment is “Suspicious” or, “Highly suggestive of malignancy,” the lay summary results and recommended course of action must be communicated as soon as possible. FDA believes that communication of suspicious or highly suggestive results can ordinarily be accomplished within five working days. One way to achieve this is through direct verbal communication with the patient; however, this does not obviate the need to also send written communication within 30 days. In the case of exams where the assessment is “Incomplete, Need additional imaging evaluation” FDA recommends that facilities communicate this (verbally or in writing) to the patient as soon as possible so as to avoid delays in patient work-up. FDA’s concern is that an effective communication system exists. The details of such a system are left to the facility and should be individualized to address the facility’s specific situation. A system that works well for one facility and its patients may not work well for another. One example of an acceptable system for patient communication would be through the use of the U.S. mail. Confirmation of the receipt of these results would not be required.