How should a facility handle a lay summary that is returned "undeliverable?"

The requirement to communicate results to the patient can be fulfilled by mailing the lay summary to the patient (at the patient’s last known address), even when the lay summary is returned to the facility and marked as “undeliverable.” While this will satisfy the MQSA requirement, the facility may still be responsible for further attempts at patient communication under their State requirements or Standards of Care. This is especially true where the results are “suspicious” or “highly suggestive of malignancy.