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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 Incident

DPH requires you to report any incident that seriously affected the health and safety of a resident or that caused serious physical injury to the resident.

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 resident death that is
    • The result of an error
    • Unrelated to the natural course of the patient’s illness or underlying condition, or
    • Unanticipated
  • 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 reportable condition or illness that is 1) believed to be part of a cluster or outbreak, 2) believed to be unusual, 3) related to food consumption or 4) believed to be transmissible through food.
    • Illness: An abnormal condition or functional impairment resulting from infection, metabolic abnormalities, physical or physiological injury or other cause, marked by subjective complaints and clinical signs
    • Unusual Illness: An illness, by any indication, occurring for the first time or under rare circumstances, or an illness associated with signs and symptoms not otherwise expected to occur based on the known or presumed etiology of the illness.

These events are reportable if they occurred on premises covered by your facility's license.


Reference: 105 CMR § 150.002(G)(1)(3) (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)

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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 a "device user facility" becomes 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.

This requirement applies to "device user facilities" (as defined in 21 CFR § 803.30) which include, among other facility types, entities that operate to primarily provide skilled nursing or rehabilitation services. It is possible that some long-term care facilities may not fall under the definition of "device user facilities"; however, these facilities may voluntarily report the event.

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 medical 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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Glossary
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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