Appendix-B-BV-Protocol

NHSN Biovigilance Component
Protocol v1.3.1
www.cdc.gov/nhsn

Appendix B. Adverse Reaction Clinical and Laboratory Definitions
Blood pressure decrease:
Adults (18 years of age or older):
Drop in systolic BP of 30 mmHg or more AND systolic BP of 80mmHg or less.
Infants, children and adolescents (1 year to less than 18 years of age):
Greater than 25% drop in systolic BP (e.g., drop in baseline systolic BP of 120mmHg to below 90mmHg).
Neonates and small infants (less than 1 year of age OR any age and less than 12 kg body weight):
Greater than 25% drop in baseline value in whatever measurement is being recorded (e.g,, mean BP).
Bronchospasm (wheezing): A contraction of smooth muscle in the walls of the bronchi and bronchioles,
causing acute narrowing and obstruction of the respiratory airway. This constriction can result in a rasp or
whistling sound while breathing.
Chills/rigors: A feeling of cold with shivering or shaking and pallor.
Disseminated intravascular coagulation (DIC): Bleeding disorder characterized by reduction in the factors
involved in blood clotting due to their use in widespread clotting within the vessels. The intravascular clotting
ultimately produces hemorrhage because of rapid consumption of clotting factors.
Edema: Swelling of soft tissues as a result of excessive fluid accumulation.
Epistaxis: Bleeding from the nose.
Fever: An increase of at least 1°C in temperature over the pre-transfusion.
Hematuria: Presence of blood or red blood cells in the urine.
Hemoglobinemia: The presence of free hemoglobin in the blood plasma.
Hemoglobinuria: Presence of free hemoglobin in the urine.
Hypoxemia: Abnormal deficiency in the concentration of oxygen in arterial blood. PaO2 / FiO2 less than or
equal to 300 mm Hg OR oxygen saturation is less than 90% on room air.
Jaundice: New onset or worsening of yellow discoloration (icterus) of the skin or sclera (scleral icterus)
secondary to an increased level of bilirubin.
Oliguria: New onset of decreased urinary output (less than 500cc output per 24 hours).
Other rash: Non-urticarial skin rash.
Pruritus: Itching.
Shock: A drop in blood pressure accompanied by a drop in cardiac output including rapid heart rate (increase
to 100 beats per minute or more), rapid breathing, cutaneous vasoconstriction, pallor, sweating, decreased or
scanty urine production, agitation and/or loss of consciousness that required fluid resuscitation, with or without
inotropic support.
Shortness of breath (dyspnea): New onset or significant worsening of shortness of breath; or a significant
increase in respiratory rate (with or without hypoxemia).
Urticaria (hives): Raised red spots (with or without itching).

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June 2011