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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 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
  • Full or partial evacuation of the facility for any reason
  • Fire
  • Suicide
  • A serious criminal act
  • Pending or actual strike action by its employees, and contingency plans for operation of the facility
  • A surgery or anesthesia-related complication that result in serious morbidity or death of a patient

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

Reference: 105 CMR § 140.307. (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)

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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.

Note that it is expected that all events reported to the Department of Public Health as SREs will also be reported to QPSD as major incidents. In addition, QPSD encourages facilities to identify, analyze and report “near miss” incidents.

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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Food & Drug Administration

Fatal Reaction - Blood Collection or Transfusion

The FDA requires you to report fatal complications of blood collection or transfusion.

(This requirement applies to facilities that collect, process, compatibility test, store, or distribute blood or blood components).

Facilities that perform blood compatibility testing should report fatal transfusion reactions, and facilities that collect blood should report fatal donor reactions. In this context, "compatibility testing" is the procedures performed to establish the matching of a donor's blood or blood components with that of a potential recipient.

If you determine that a blood product was at fault in a transfusion reaction, even if the reaction was not fatal, you must submit a copy of your findings to the manufacturer or collecting facility.

Reference: 21 CFR § 606.170. For definitions, see 21 CFR § 606.3.

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