57.308 - Centers for Disease Control and Prevention
Hemovigilance ModuleAdverse ReactionAllergic Transfusion Reaction*Required for saving*Facility ID#: _________NHSN Adverse Reaction #: __________Patient Information*Patient ID: ___________________*Date of Birth: ____/____/_____*Sex at Birth: ?M ?F ?Unknown *Gender Identity (Specify):________Social Security #: ______________Secondary ID: _________________Medicare #: _________________Last Name: ___________________First Name: ____________________Middle Name: _______________Ethnicity FORMCHECKBOX Hispanic or Latino FORMCHECKBOX Not Hispanic or Not LatinoRace FORMCHECKBOX American Indian/Alaska Native FORMCHECKBOX Asian FORMCHECKBOX Black or African American FORMCHECKBOX Native Hawaiian/Other Pacific Islander FORMCHECKBOX White*Blood Group: FORMCHECKBOX A- FORMCHECKBOX A+ FORMCHECKBOX B- FORMCHECKBOX B+ FORMCHECKBOX AB- FORMCHECKBOX AB+ FORMCHECKBOX O- FORMCHECKBOX O+ FORMCHECKBOX Blood type not done FORMCHECKBOX Transitional ABO / Rh + FORMCHECKBOX Transitional ABO / Rh - FORMCHECKBOX Transitional ABO / Transitional Rh FORMCHECKBOX Group A/Transitional Rh FORMCHECKBOX Group B/Transitional Rh FORMCHECKBOX Group O/Transitional Rh FORMCHECKBOX Group AB/Transitional RhPatient Medical History List the patient’s admitting diagnosis. (Use ICD-10 Diagnostic codes/descriptions)Code: ______________Description: __________________________________________________Code: ______________Description: __________________________________________________Code: ______________Description: __________________________________________________List the patient’s underlying indication for transfusion. (Use ICD-10 Diagnostic codes/descriptions)Code: ______________Description: __________________________________________________Code: ______________Description: __________________________________________________Code: ______________Description: _________________________________________________List the patient’s comorbid conditions at the time of the transfusion related to the adverse reaction. (Use ICD-10 Diagnostic codes/descriptions) FORMCHECKBOX UNKNOWN FORMCHECKBOX NONECode: ______________Description: __________________________________________________Code: ______________Description: __________________________________________________Code: ______________Description: __________________________________________________Assurance of Confidentiality: The voluntarily provided information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence, will be used only for the purposes stated, and will not otherwise be disclosed or released without the consent of the individual, or the institution in accordance with Sections 304, 306 and 308(d) of the Public Health Service Act (42 USC 242b, 242k, and 242m(d)).Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS H21-8, Atlanta, GA 30333, ATTN: PRA (0920-0666).List the patient’s relevant medical procedure including past procedures and procedures to be performed during the current hospital or outpatient stay. (Use ICD-10 Procedure codes/descriptions) FORMCHECKBOX UNKNOWN FORMCHECKBOX NONECode: _______________Description: ________________________________________________Code: _______________Description: ________________________________________________Code: _______________Description: ________________________________________________Additional Information __________________________________________________________________________________Transfusion History Has the patient received a previous transfusion? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX UNKNOWNBlood Product: FORMCHECKBOX WB FORMCHECKBOX RBC FORMCHECKBOX Platelet FORMCHECKBOX Plasma FORMCHECKBOX Cryoprecipitate FORMCHECKBOX GranulocyteDate of Transfusion:____/____/_____ FORMCHECKBOX UNKNOWNWas the patient’s adverse reaction transfusion-related? FORMCHECKBOX YES FORMCHECKBOX NOIf yes, provide information about the transfusion adverse reaction.Type of transfusion adverse reaction: FORMCHECKBOX Allergic FORMCHECKBOX AHTR FORMCHECKBOX DHTR FORMCHECKBOX DSTR FORMCHECKBOX FNHTR FORMCHECKBOX HTR FORMCHECKBOX TTI FORMCHECKBOX PTP FORMCHECKBOX TACO FORMCHECKBOX TAD FORMCHECKBOX TA-GVHD FORMCHECKBOX TRALI FORMCHECKBOX UNKNOWN FORMCHECKBOX OTHERSpecify __________________________________________________________________________Reaction Details*Date reaction occurred:___/____/____*Time reaction occurred: __ __:__ __ FORMCHECKBOX Time unknown*Facility location where patient was transfused:______________________________________________Is this reaction associated with an incident? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, Incident #: ________________Investigation Results* FORMCHECKBOX Allergic reaction, including anaphylaxis*Case DefinitionCheck the following that occurred during or within 4 hours of cessation of transfusion: FORMCHECKBOX Conjunctival edema FORMCHECKBOX Edema of lips, tongue and uvula FORMCHECKBOX Localized angioedema FORMCHECKBOX Hypotension FORMCHECKBOX Erythema and edema of the periorbital area FORMCHECKBOX Respiratory distress; bronchospasm FORMCHECKBOX Urticaria FORMCHECKBOX Generalized flushing FORMCHECKBOX Maculopapular rash FORMCHECKBOX PruritusOther signs and symptoms: (check all that apply)Generalized: FORMCHECKBOX Chills/rigors FORMCHECKBOX Fever FORMCHECKBOX Nausea/vomitingCardiovascular: FORMCHECKBOX ShockCutaneous: FORMCHECKBOX JaundiceHemolysis/Hemorrhage: FORMCHECKBOX Disseminated intravascular coagulation FORMCHECKBOX Hemoglobinemia FORMCHECKBOX Positive antibody screen Pain: FORMCHECKBOX Abdominal pain FORMCHECKBOX Back pain FORMCHECKBOX Flank pain FORMCHECKBOX Infusion site pain Renal: FORMCHECKBOX Hematuria FORMCHECKBOX Hemoglobinuria FORMCHECKBOX OliguriaRespiratory: FORMCHECKBOX Bilateral infiltrates on chest x-ray FORMCHECKBOX Cough FORMCHECKBOX Hypoxemia FORMCHECKBOX Shortness of breath FORMCHECKBOX Other: (specify) ________________________________________________________________*SeverityDid the patient receive or experience any of the following? FORMCHECKBOX No treatment required FORMCHECKBOX Symptomatic treatment only FORMCHECKBOX Hospitalization, inlcuding prolonged hospitalization FORMCHECKBOX Life-threatening reaction FORMCHECKBOX Disability and/or incapacitation FORMCHECKBOX Congenital anomaly or birth defect(s) of the fetus FORMCHECKBOX Other medically important conditions FORMCHECKBOX Death FORMCHECKBOX Unknown or not stated*ImputabilityWhich best describes the relationship between the transfusion and the reaction? FORMCHECKBOX No other evidence of environmental, drug or dietary risks. FORMCHECKBOX There are other potential causes present that could explain acute hemolysis, but transfusion is the most likely cause. FORMCHECKBOX Other present causes are most likely, but transfusion cannot be ruled out. FORMCHECKBOX Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded. FORMCHECKBOX There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion. FORMCHECKBOX The relationship between the adverse reaction and the transfusion is unknown or not stated.Did the transfusion occur at your facility? FORMCHECKBOX YES FORMCHECKBOX NOWhen did the reaction occur in relation to the transfusion? FORMCHECKBOX Occurred during or within 2 hours of cessation of transfusion. FORMCHECKBOX Occurred 2 - 4 hours after cessation of transfusion.Did the same reaction occur after the transfusion was restarted (rechallenge)? FORMCHECKBOX YES FORMCHECKBOX NOModule-generated DesignationsNOTE: Designations for case definition, severity, and imputability will be automatically assigned in the NHSN application based on responses in the corresponding investigation results section above.*Do you agree with the case definition designation? FORMCHECKBOX YES FORMCHECKBOX NO^Please indicate your designation _________________________________________________________*Do you agree with the severity designation? FORMCHECKBOX YES FORMCHECKBOX NO^Please indicate your designation _________________________________________________________*Do you agree with the imputability designation? FORMCHECKBOX YES FORMCHECKBOX NO^Please indicate your designation _________________________________________________________Patient TreatmentDid the patient receive treatment for the transfusion reaction? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX UNKNOWNIf yes, select treatment(s): FORMCHECKBOX Medication (Select the type of medication) FORMCHECKBOX Antipyretics FORMCHECKBOX Antihistamines FORMCHECKBOX Inotropes/Vasopressors FORMCHECKBOX Bronchodilator FORMCHECKBOX Diuretics FORMCHECKBOX Intravenous Immunoglobulin FORMCHECKBOX Intravenous steroids FORMCHECKBOX Corticosteroids FORMCHECKBOX Antibiotics FORMCHECKBOX Antithymocyte globulin FORMCHECKBOX Cyclosporin FORMCHECKBOX Other FORMCHECKBOX Volume resuscitation (Intravenous colloids or crystalloids) FORMCHECKBOX Respiratory support (Select the type of support) FORMCHECKBOX Mechanical ventilation FORMCHECKBOX Noninvasive ventilation FORMCHECKBOX Oxygen FORMCHECKBOX Renal replacement therapy (Select the type of therapy) FORMCHECKBOX Hemodialysis FORMCHECKBOX Peritoneal FORMCHECKBOX Continuous Veno-Venous Hemofiltration FORMCHECKBOX Phlebotomy FORMCHECKBOX OtherSpecify: ____________________________________________________________Outcome*Outcome: FORMCHECKBOX Death FORMCHECKBOX Major or long-term sequelae FORMCHECKBOX Minor or no sequelae FORMCHECKBOX Not determinedDate of Death:____/____/_____^If recipient died, relationship of transfusion to death: FORMCHECKBOX Definite FORMCHECKBOX Probable FORMCHECKBOX Possible FORMCHECKBOX Doubtful FORMCHECKBOX Ruled Out FORMCHECKBOX Not determinedCause of death:______________________________________________________Was an autopsy performed? FORMCHECKBOX Yes FORMCHECKBOX NoComponent Details*Was a particular unit implicated in (i.e., responsible for) the adverse reaction? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX N/ATransfusion Start and End Date/Time *Component code (check system used)Amount transfused at reaction onset^Unit number(Required for Infection and TRALI) *Unit expiration Date/Time *Blood group of unitImplicated Unit?^IMPLICATED UNIT____/____/___ FORMCHECKBOX ISBT-128 FORMCHECKBOX Entire unit FORMCHECKBOX Partial unit______mL__ __ __ __ _____/___/_____ FORMCHECKBOX A- FORMCHECKBOX A+ FORMCHECKBOX B-Y___ ___:_____ FORMCHECKBOX Codabar__ ______/____/______ ___ ___ ___ _____ __ __ __ __ _______ : _____ FORMCHECKBOX B+ FORMCHECKBOX AB- FORMCHECKBOX AB+___ ___:________________________ __ __ FORMCHECKBOX O- FORMCHECKBOX O+ FORMCHECKBOX N/A____/____/___ FORMCHECKBOX ISBT-128 FORMCHECKBOX Entire unit FORMCHECKBOX Partial unit______mL __ __ __ __ _____/___/_____ FORMCHECKBOX A- FORMCHECKBOX A+ FORMCHECKBOX B-N___ ___:___ _ FORMCHECKBOX Codabar__ ______/____/______ ___ ___ ___ _____ __ __ __ __ _______ : _____ FORMCHECKBOX B+ FORMCHECKBOX AB- FORMCHECKBOX AB+___ ___:________________________ __ __ FORMCHECKBOX O- FORMCHECKBOX O+ FORMCHECKBOX N/ACustom FieldsLabelLabel_____________________/______/______________________________/______/____________________________________________________________________________Comments ................
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