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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 Reportable Event

Any of the following must be reported as an SRE:

  • Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a health care setting, or
  • Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances, or
  • Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting, or
  • Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a health care setting, or
  • Patient death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area

DPH offers the following additional guidance:

  • Electric shock. Does not include patient death or injury associated with emergency defibrillation in ventricular fibrillation or with electroconvulsive therapies.
  • Oxygen/gas. Includes events where the line is attached to a reservoir distant from the patient care unit or in a tank near a patient such as E-cylinders, anesthesia machines.
  • Burns. Examples include burns (other than first-degree burns) from:
    • operating room flash fire
    • hot water sunburn in a patient with decreased ability to sense pain
    • smoking in any patient care environment
  • Restraints. Includes instances where restraints are implicated in the death or serious injury; e.g., lead to strangulation/entrapment, etc. Death/injury resulting from falls caused by lack of restraints would be captured under “falls."
  • Metallic object in an MRI area. Includes events related to material inside the patient’s body or projectiles outside the patient’s body.

You are required to report an SRE that occurred at another hospital or ambulatory surgery center if you provided services that resulted from the event. You do not have to report the SRE if you have reason to believe the other facility has already reported it to DPH.

Reference: 105 CMR §§ 130.332, 140.308; SRE Reporting Guidance (2012)

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The Serious Incident section will become available only if “No” or “Unsure” is selected. Otherwise, by selecting ‘yes’ you will be given directions for reporting an SRE that may also be a serious incident.

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Serious Incident

DPH requires you to report any of the following:

  • Any incident that seriously affected the health and safety of a patient or that caused serious physical injury to the patient, or
  • Fire, whether or not it resulted in patient injury, or
  • Full/partial evacuation of your facility, whether or not it resulted in patient injury.

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.
  • Any serious criminal act
  • Suicide
  • Pending or actual strike action by its employees, and contingency plans for operation of the facility

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

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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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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