Ambulatory Surgery Center
Patient Protection

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:

  • Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person, or
  • Patient death or serious injury associated with patient elopement (disappearance), or
  • Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a health care setting

DPH offers the following additional guidance:

  • Discharge or release. Examples of individuals who do not have decision making capacity include infants, minors or adults with Alzheimer’s disease. Release to “other than authorized person” includes removing the patient/resident without specific notification and approval by staff, even when the person is otherwise authorized.
  • Patient elopement. Elopement refers to a situation where a patient or resident who is cognitively, physically, mentally, emotionally, and/or chemically impaired wanders/walks/runs away, escapes, or otherwise leaves a care-giving institution or setting unsupervised, unnoticed, and/or prior to their scheduled discharge. This event is not intended to capture death or serious injury that occurs due to circumstances unrelated to the elopement after the patient is located.
  • Suicide/Self-Harm: Events that result from patient actions after admission/presentation to a healthcare setting. Does not include deaths resulting from self-inflicted injuries that were the reason for admission to the healthcare facility.

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: M.G.L. c. 111, § 51H, 105 CMR §§ 130.332, 140.308; DPH, 2012 SRE Reporting Guidance; Circular Letter #12-9-570

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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:

  • Suicide, 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.
  • 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 facility
  • Surgery and anesthesia-related complication(s) 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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