Below are detailed descriptions of reportable adverse events, grouped by state or federal agency. Answer the question that appears beneath EACH description. When you're finished, click View Reporting Instructions to move to the next page.

Department of Public Health

Serious Incident

DPH requires you to report any incident that seriously affected the health or safety of a patient if it resulted from your employee's or volunteer's act or omission.

Reference: 105 CMR § 141.201(E)

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Food & Drug Administration