Communication of all results to the referring health care provider must be done within 30 days by a written report.
In addition, when there are “Suspicious” or “Highly suggestive of malignancy” results, the facility must also make reasonable attempts to communicate the results to the referring health care provider or a responsible designee as soon as possible. “Suspicious” or “Highly suggestive of malignancy” results should be communicated to the health care provider within three working days, using either a written report or documented verbal communication. If this is achieved through direct verbal communication with the health care provider, 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 to the health care provider 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 health care providers may not work well for another. One acceptable system for health care provider communication would be through the use of the U.S. mail. Confirmation of the receipt of these results would not be required.