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Device, Drug or Biologic

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.

Please note that this section does not yet include reporting requirements for serious adverse drug events (SADEs) under M.G.L. c. 111, § 51H. DPH is expected to promulgate regulations to further specify reporting requirements related to SADEs. Updates will be posted here after they are available.

Department of Public Health

Serious Reportable Event

A patient death or serious injury associated with one of the following must be reported as an SRE:

  • The use of contaminated drugs, devices, or biologics provided by the health care setting, or
  • The use or function of a device in patient care, in which the device is used or functions other than as intended, or
  • Intravascular air embolism that occurs while being cared for in a health care setting, or
  • A medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)

DPH offers the following additional guidance:

  • Contaminated drugs, devices or biologics. These events are reportable regardless of the source of contamination and/or product.[Includes the threat of disease that changes the patient’s risk status for life-requiring medical monitoring not needed before the event.]Examples include administration of contaminated vaccine or medication, serious infections from contaminated drugs or devices in an invasive procedure, and occurrences related to use of improperly cleaned or maintained devices.
  • Use or function of a device. Devices include, but are not limited to, catheters, drains and other specialized tubes, infusion pumps, ventilators, and procedural and monitoring equipment.
  • Intravascular air embolism. Examples include (but are not limited to) high-risk procedures involving the head and neck, vaginal delivery and caesarean section, spinal instrumentation procedures, and liver transplantation; and low-risk procedures related to lines placed for infusion of fluids in vascular space. Does not include neurosurgical procedures that are known to present a high risk of intravascular air embolism.
  • Medication error. This includes, but is not limited to, death or serious injury associated with:
    • over- or under-dosing,
    • administration of a medication to which a patient has a known allergy or serious contraindication,
    • drug-drug interactions for which there is known potential for death or serious injury, or
    • improper use of single-dose/single-use and multi-dose medication vials and containers leading to death or serious injury as a result of dose adjustment problems

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
  • A surgery or anesthesia-related complication that results 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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Food & Drug Administration

Death or Serious Injury Related to a Device

If a medical device caused or contributed to a patient death or serious injury, inform the FDA.

The incident is reportable if you become aware of information that reasonably suggests that a device has or may have caused or contributed to the death or serious injury of a patient. This includes instances when the medical device may have merely been a factor in the death or serious injury, including, but not limited to instances of:

  • Failure,
  • Malfunction,
  • Improper or inadequate design,
  • Manufacture,
  • Labeling, or
  • User error.

In this context, "serious injury" is an injury or illness that:

  1. Is life-threatening,
  2. Results in permanent impairment of a body function or permanent damage to a body structure, or
  3. Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Note that the FDA’s definition of device is fairly broad. For more information about FDA regulations on adverse events reporting please visit FDA Mandatory Reporting Requirements.

Reference: 21 CFR §§ 803.3, 803.30.

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