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.
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:
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.)
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.
Reference: 243 CMR § 3.08(2)
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:
Some clinics may not fall under the definition of "device user facility"; however, these clinics may voluntarily report the event. ("Device user facilities" include outpatient diagnostic facilities and outpatient treatment facilities (as defined in 21 CFR § 803.30), but do not include physician offices that operate for the primary purpose of examination, evaluation, and treatment or referral of patients.)
In this context, "serious injury" is an injury or illness that:
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.
