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Surgical or Invasive Procedure

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:

  • Surgery or other invasive procedure performed on the wrong site, or
  • Surgery or other invasive procedure performed on the wrong patient, or
  • Wrong surgical or other invasive procedure performed on a patient, or
  • Unintended retention of a foreign object in a patient after surgery or other invasive procedure, or
  • Intraoperative or immediately postoperative/post procedure death in an ASA Class 1 patient

Also, be sure to review the additional reporting requirements for defects in a device, drug or biologic if relevant to the event.

DPH offers the following additional guidance:

  • Wrong site, wrong patient, and wrong surgical or other invasive procedures are surgeries or invasive procedures that are not consistent with the correctly documented informed consent for the patients.
  • Wrong-site:
    • Examples include, but are not limited to:
      • Use of incorrectly placed tubes, vascular catheters, etc.
      • Delivery of fluoroscopy or radiotherapy to the wrong region of the body, or
      • Surgery or other invasive procedure on the right body part but on the wrong location/site on the body.
    • This includes wrong site surgery or invasive procedures that were corrected during the procedure.
  • Wrong patient: This is intended to capture surgical and/or invasive procedures (whether or not completed) initiated on one patient intended for a different patient.
  • Wrong surgical or other invasive procedure: An example is the insertion of the wrong medical implant into the correct surgical site.
  • Retention of a foreign object:
    • This event is intended to capture occurrences of unintended retention of objects at any point after the surgery/procedure ends, regardless of setting and regardless of whether the object is to be removed after discovery. (Does not include objects retained during the first part of a two-part procedure that are removed during the second part of the procedure.)
    • This is not intended to capture objects intentionally left in when the risk of removal exceeds the risk of retention.
    • A retained foreign body that results from a device failure should be reported as a device-related SRE, if it causes serious injury. Return to the previous page and click on "Drug, Device or Biologic."
  • ASA Class 1 patient death: Includes patient deaths in situations where anesthesia was administered, whether or not the planned surgical procedure was carried out. If the provider determines, post-procedure, that the patient was improperly classified as ASA Class I, and should have been classified as being at higher anesthesia risk, the event is still reportable as an SRE.

Surgery begins, regardless of setting, at point of surgical incision, tissue puncture, or insertion of instrument into tissues, cavities, or organs. It ends after all incisions or procedural access routes have been closed in their entirety, device(s) such as probes or instruments have been removed, and, if relevant, final surgical counts confirming accuracy of counts and resolving any discrepancies have concluded, regardless of setting.

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

Does your event fit this description?

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.

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

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.)

Does your event fit this description?

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Quality and Patient Safety Division, Board of Registration in Medicine

Major Incident

QPSD requires you to report any of the following as a major incident:

  • 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.
  • Type 4: 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.

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.

Major incidents types 1 – 3 are specific outcomes that should be reported to QPSD without regard to the underlying circumstances.

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

Reference: 243 CMR § 3.08(2)

Does your event fit this description?

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