So, we just got hit on this by JC and they recommended us to use guidelines established by the CDC on the hemovigilance program. This is located on the following website: https://www.cdc.gov/nhsn/acute-care-hospital/bio-hemo/index.html
There are over 10 different categories for an adverse reaction and they have 4 sections to it: Case Definition, Severity, Imputability, and Other. From what I gather, if the investigation falls under Doubtful or Ruled out (both options under Other), then it is not considered and adverse reaction or safety concern.
The Case Definition gives physicians and pathologists a criteria they can use to rule out that specific Adverse Reaction. For example, TACO would need to meet the following to be considered Definitive:
New onset or exacerbation of 3 or more of the following within 6 hours of cessation of transfusion:
Acute respiratory distress (dyspnea, orthopnea, cough)
Elevated brain natriuretic peptide (BNP)
Elevated central venous pressure (CVP)
Evidence of left heart failure
Evidence of positive fluid balance
Radiographic evidence of pulmonary edema
It is a great guide for physicians and pathologist to use once and adverse event is reported to them. The problem I struggle with here is that all of these with the exception of Acute respiratory distress are procedures that are ordered after you suspect an event. We want to make sure the nurse is calling it a transfusion adverse event under the right circumstance. For example, if a patient was hypotensive 90/40 and received ended with a BP of 125/75 while receiving a second unit. Does this require the physician to order those diagnostics tests to rule out TACO? I think this is where each facility has to come together and develop a policy to rule out adverse events before having to order all those diagnostic tests. For example, if the patient does jump in BP, but has no respiratory distress, pulse oxygen has not decrease greater than "X", and lungs sounds have not worsen or present crackles and rales; then no workup should be initiated. All this should be documented and the physician and blood bank pathologist should still be notified, since techs and nurses are not allowed to make that call. Transfusions can be stopped momentarily while the initial investigation is taken place and resumed if no adverse effect is determined.