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Blood

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 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 resident 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
  • Fire
  • Suicide
  • 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.

References: 105 CMR § 150.002(G); 105 CMR § 155.010(A)(3)

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Food & Drug Administration

Fatal Reaction - Blood Collection or Transfusion

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.

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