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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:

  • Full or partial evacuation of the facility for any reason,
  • Fire,
  • Pending or actual strike action by its employees, and contingency plans for operation of the hospital, or
  • Any incident that seriously affected the health and safety of a patient or that caused serious physical injury to the patient.

DPH uses the term “serious incident” to cover several broad categories of reportable events. In addition to the above, it also includes any of the following:

  • A patient death that is
    • Unanticipated
    • Unrelated to the natural course of the patient’s illness or underlying condition, or
    • The result of an error
  • Suicide
  • A serious criminal act

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

For examples of emergency conditions reportable to DPH, see Circular Letter DHCQ 07-02-474]

Reference: 105 CMR § 130.331. (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)

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Code Black

You must follow special reporting requirements if your hospital is under "Code Black" status, when the hospital Emergency Department is closed to all patients due to an "internal emergency."

In this context, an "internal emergency" is facility damage or other events that compromise the health, safety and/or security of patients, visitors and/or staff that render the Emergency Department unavailable to the public, or requires relocation or evacuation of the Emergency Department.

Examples of internal emergencies include, but are not limited to, events such as fires, explosions, hazardous material spills or releases, or other environmental contamination, flooding, power or other utility failures, bomb threats, or violent or hostile actions impacting the Emergency Department.

A situation that requires "Code Black" status would also qualify as a "serious incident."

Reference: Circular Letter #15-04-635 – 4/16/2015

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Quality and Patient Safety Division, Board of Registration in Medicine

Major Incident

QPSD requires you to report any major or permanent impairment of bodily functions or death of a patient not ordinarily expected as a result of the patient's condition on presentation. This is a Type 4 major incident.

QPSD defines major impairment as a significant change in the patient’s functional status either physically or mentally.

For your information, there are 3 other types of major incidents, which are reportable to QPSD regardless of the patient’s underlying condition.

  • Type 1. Maternal death related to delivery,
  • Type 2. Death in the course of, or resulting from, elective ambulatory procedures,
  • Type 3. Any invasive diagnostic procedure or surgical intervention performed on the wrong organ, extremity or body part.

Reference: 243 CMR § 3.08(2)

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Glossary
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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