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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

The following must be reported as an SRE:

  • Any patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen.

Additional guidance:

  • Includes events where specimens are misidentified, if another procedure cannot be done to produce another specimen. Can occur in an excisional biopsy, organ removal, etc..

You are also required to report this event to the Department of Public Health (DPH) as a serious reportable event even if it occurred at another hospital or ambulatory surgery center UNLESS 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.

Checkmark Selection recorded

Serious Incident

DPH requires you to report any of the following as a serious incident:

  • 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
  • Surgery and anesthesia-related complication(s) that result in serious morbidity or death of a patient
  • Any incident that seriously affected the health and safety of a patient or that caused serious physical injury to the 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.)

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?

Checkmark Selection recorded
The Patient Safety Navigator is provided by the Betsy Lehman Center for informational purposes. You cannot submit adverse event reports or other data through the Navigator. Your use of the Navigator will not be monitored, and no data will be collected beyond what is explicitly noted in the Website Privacy Statement. Although the Betsy Lehman Center intends to maintain the Navigator’s contents, we cannot guarantee that the information will be accurate, complete, or up-to-date at all times. You should be aware that regulations and reporting systems are subject to change without our knowledge or could be interpreted differently by the agencies that oversee them. By using the Navigator, you agree that you are solely responsible for determining any reporting obligations applicable to you or your organization. For further terms and conditions, see the Terms of Use.
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