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.
The following must be reported as an SRE:
DPH offers the following additional guidance:
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: 105 CMR §§ 130.332, 140.308; SRE Reporting Guidance (2012)
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.
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)