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:
This includes, but is not limited to:
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
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 § 130.331 (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)
Transfusion services within a hospital must report adverse reactions as defined by the NHSN, as well as any incidents associated with them:
Types of adverse reactions include, but may not be limited to:
For further detail on what qualifies as a reportable incident or reaction, see the National Healthcare Safety Network's Biovigilance Manual.
In this context, "transfusion services" are those which dispense or administer whole blood, its components and/or derivatives by transfusion.
Please note that this question refers to the Department of Public Health's regulatory requirement to report transfusion-related adverse events, even though reports are made through the Centers for Disease Control and Prevention's National Healthcare Safety Network.
Reference: 105 CMR § 135.120; DPH: Revised Procedure for Reporting Blood Bank Activity
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)
The FDA requires you to report fatal complications of blood collection or transfusion.
(This requirement applies to facilities that collect, process, compatibility test, store, or distribute blood or blood components).
Facilities that perform blood compatibility testing should report fatal transfusion reactions, and facilities that collect blood should report fatal donor reactions. In this context, "compatibility testing" is the procedures performed to establish the matching of a donor's blood or blood components with that of a potential recipient.
If you determine that a blood product was at fault in a transfusion reaction, even if the reaction was not fatal, you must submit a copy of your findings to the manufacturer or collecting facility.
Reference: 21 CFR § 606.170. For definitions, see 21 CFR § 606.3.
