How is a facility required to deal with providing lay summaries to patients who, for whatever reason, cannot communicate?

The requirement to communicate results to the patient can be fulfilled by providing (e.g., mailing) the lay summary to the patient, even when the patient cannot communicate. In most of these cases, however, the facility will be aware of this condition at the time of the study and should identify a legally responsible party to whom to send the lay summary. While sending a lay summary to the patient (or a legally responsible party) constitutes official communication and will satisfy the MQSA requirement, the facility may still be responsible for further attempts at patient (or legally responsible party) communication under their State requirements or Standards of Care. This is especially true where the results are “suspicious” or “highly suggestive of malignancy.” Facilities should make reasonable accommodations to try to ensure that results are communicated to all patients or their legally responsible party.