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 Requirements to move to the next page.

Department of Public Health

Serious Reportable Event

The following must be reported as an SRE:

  • Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider, or
  • Abduction of a patient/resident of any age, or
  • Sexual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting, or
  • Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting.

DPH offers the following additional guidance:

  • Impersonation. Includes instances in which 1) unlicensed individuals provide care or 2) licensed individuals represent themselves and practice beyond the scope of their licenses.
  • Abduction. This event is intended to capture removal of a patient, who does not have decision making capacity, without specific notification and approval by staff, even when the person is otherwise authorized to be away from the setting. Examples of individuals who do not have decision making capacity include infants, minors and patients with Alzheimer’s.

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 incident that seriously affected the health and safety of a patient or that caused serious physical injury to the patient, and/or
  • Any serious criminal act, whether or not it results 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.
  • Full or partial evacuation of the facility for any reason
  • Fire
  • Suicide
  • Pending or actual strike action by its employees, and contingency plans for operation of the facility
  • For any patient treated at your facility, any suspected instance(s) of abuse, neglect, mistreatment or misappropriation of a patient at a nursing home, rest home, home health, home maker or hospice 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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