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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 of the following:

  • A participant death that is
    • Unanticipated
    • Unrelated to the natural course of the patient’s illness or underlying condition, or
    • The result of an error
  • Suicide
  • Full or partial evacuation of the facility for any reason
  • Fire
  • Suicide
  • A serious criminal act
  • Pending or actual strike action by the program's employees, and contingency plans for operation of the program
  • An illness that is 1) believed to be part of a cluster or outbreak, 2) believed to be unusual, 3) related to food consumption or 4) believed to be transmissible through food
  • Any other incident that seriously affected the health and safety of a patient or that caused serious physical injury to the participant.

These events are reportable if they occurred on premises covered by your program's license.

Reference: 105 CMR § 158.031(C). (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)

Does your event fit this description?

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The Patient Safety Navigator is provided by the Betsy Lehman Center for informational purposes. You cannot submit adverse event reports or other data through the Navigator. Your use of the Navigator will not be monitored, and no data will be collected beyond what is explicitly noted in the Website Privacy Statement. Although the Betsy Lehman Center intends to maintain the Navigator’s contents, we cannot guarantee that the information will be accurate, complete, or up-to-date at all times. You should be aware that regulations and reporting systems are subject to change without our knowledge or could be interpreted differently by the agencies that oversee them. By using the Navigator, you agree that you are solely responsible for determining any reporting obligations applicable to you or your organization. For further terms and conditions, see the Terms of Use.
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