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ICR 202410-0920-013 · OMB 0920-0666 · Object 147633901.

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application/vnd.openxmlformats-officedocument.wordprocessingml.document
57.311
NHSN OMB Forms 2020
HV, AR-FNHTR
CDC/NCEZID/DHQP
Writer
2024-09-13
2026-08-31
complete

Extracted Text

Hemovigilance Module
Adverse Reaction
Febrile Non-hemolytic Transfusion Reaction
*Required for saving
*Facility ID#: _________
NHSN Adverse Reaction #: __________

Patient Information
*Patient ID: ___________________
*Gender: M   F   Other        
*Date of Birth: ____/____/_____
Sex at Birth: M   F   Unknown





        




Gender Identity (Specify): 
Male
Female
Male-to-female transgender
Female-to-male transgender
Identifies as non-conforming
Other
Asked but unknown________
Social Security #: ______________
Secondary ID: _________________
Medicare #: _________________
Last Name: ___________________
First Name: ____________________
Middle Name: _______________
Ethnicity (Specify): 
Hispanic or Latino
Not Hispanic or Latino
Unknown
Declined to respond
_________________________
Race (Specify): (Select all that apply):
American Indian or Alaska Native
Asian
Black or African American
Middle Eastern or North African
Native Hawaiian or Pacific Islander
White
Unknown
Declined to respond _________________________
Preferred Language (Specify):__________________
Interpreter Needed: Yes   No Declined to Respond     Unknown  
*Blood Group:
 A-
 A+
 B-
B+
 AB-
 AB+
 O-
 O+
 Blood type not done

 Transitional ABO / Rh +
 Transitional ABO / Rh -

 Transitional ABO / Transitional Rh
 Group A/Transitional Rh
 Group B/Transitional Rh
 Group O/Transitional Rh
 Group AB/Transitional Rh
Patient 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)  
 UNKNOWN


 NONE

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Febrile Non-hemolytic Transfusion Reaction


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)  
 UNKNOWN


 NONE

Code: _______________
Description: ________________________________________________

Code: _______________
Description: ________________________________________________

Code: _______________
Description: ________________________________________________

Additional Information __________________________________________________________________________________
Transfusion History 

Has the patient received a previous transfusion?
 YES
 NO
 UNKNOWN

Blood Product:
 WB
 RBC
 Platelet
 Plasma
 Cryoprecipitate
 Granulocyte

Date of Transfusion:
____/____/_____
 UNKNOWN

Was the patient’s adverse reaction transfusion-related? 
 YES
 NO

If yes, provide information about the transfusion adverse reaction.

Type of transfusion adverse reaction:
 Allergic
 AHTR
 DHTR
 DSTR
 FNHTR

 HTR
 TTI
 PTP
 TACO
 TAD
 TA-GVHD
 TRALI
 UNKNOWN

 OTHER
Specify  __________________________________________________________________________
Reaction Details
*Date reaction occurred:___/____/____
*Time reaction occurred: __ __:__ __
 Time unknown
*Facility location where patient was transfused:
______________________________________________
Is this reaction associated with an incident?
 Yes
 No
If Yes, Incident #: ________________
Investigation Results
* Febrile non-hemolytic transfusion reaction (FNHTR)


*Case Definition

Check all that occurred during or within 4 hours of cessation of transfusion:

  Fever (greater than or equal to 38°C/100.4°F oral and a change of at least 1°C/1.8°F) from pre-transfusion value

  Chills/rigors are present

Check all that apply:

 FNHTR is suspected, but reported symptoms and/or available information are not sufficient.
Other signs and symptoms: (check all that apply)
Generalized:
 Nausea/vomiting
Cardiovascular:
 Blood pressure decrease
 Shock
Cutaneous:
 Edema
 Flushing
 Jaundice

 Other rash
 Pruritus (itching)
 Urticaria (hives)
Hemolysis/Hemorrhage:
 Disseminated intravascular coagulation
 Hemoglobinemia

 Positive antibody screen

Pain:
 Abdominal pain
 Back pain
 Flank pain
 Infusion site pain
Renal:
 Hematuria
 Hemoglobinuria
 Oliguria
Respiratory:
 Bilateral infiltrates on chest x-ray
 Bronchospasm
 Cough

 Hypoxemia
 Shortness of breath

 Other: (specify) __________________________________________________________________________

*Severity

Did the patient receive or experience any of the following? 

 No treatment required
 Symptomatic treatment only

 Hospitalization, inlcuding prolonged hospitalization
 Life-threatening reaction

 Disability and/or incapacitation
 Congenital anomaly or birth defect(s) of the fetus

 Other medically important conditions
 Death
 Unknown or not stated


*Imputability

Which best describes the relationship between the transfusion and the reaction?

  Patient has no other conditions that could explain signs/symptoms.

  There are other potential causes present that could explain signs/symptoms, but transfusion is the most likely cause.

  Other present causes are most likely, but transfusion cannot be ruled out.

 Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

 There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

 The relationship between the adverse reaction and the transfusion is unknown or not stated.


Did the transfusion occur at your facility?
 YES
 NO




Module-generated Designations
NOTE: 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?
 YES
 NO

^Please indicate your designation  _________________________________________________________


*Do you agree with the severity designation?
 YES
 NO

^Please indicate your designation  _________________________________________________________


*Do you agree with the imputability designation?
 YES
 NO

^Please indicate your designation  _________________________________________________________

Patient Treatment

Did the patient receive treatment for the transfusion reaction?
 YES
 NO
 UNKNOWN

If yes, select treatment(s): 

 Medication (Select the type of medication)

 Antipyretics
 Antihistamines
 Inotropes/Vasopressors
 Bronchodilator
 Diuretics

 Intravenous Immunoglobulin
 Intravenous steroids
 Corticosteroids
 Antibiotics

 Antithymocyte globulin
 Cyclosporin
 Other



 Volume resuscitation (Intravenous colloids or crystalloids)


 Respiratory support (Select the type of support)

 Mechanical ventilation
 Noninvasive ventilation
 Oxygen


 Renal replacement therapy (Select the type of therapy)

 Hemodialysis
 Peritoneal
 Continuous Veno-Venous Hemofiltration


 Phlebotomy

 Other
Specify: ____________________________________________________________
Outcome

*Outcome:
 Death
 Major or long-term sequelae
 Minor or no sequelae
 Not determined

Date of Death:
____/____/_____


^If recipient died, relationship of transfusion to death:

 Definite
 Probable
 Possible
 Doubtful
 Ruled Out
 Not determined

Cause of death:
______________________________________________________

Was an autopsy performed?
 Yes
 No

Component Details
*Was a particular unit implicated in (i.e., responsible for) the adverse reaction?
 Yes
 No
 N/A
Transfusion 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 unit
Implicated 
Unit?
^IMPLICATED UNIT
____/____/___
 ISBT-128
 Entire unit
 Partial unit
______mL
__ __ __ __ __
___/___/_____
 A-
 A+
 B-
Y
___ ___:_____
 Codabar

__ __





____/____/___
___ ___ ___ ___ ___

__ __ __ __ __ __
_____ : _____
B+
 AB-
 AB+

___ ___:_____
_________________

__ __   __

 O-
 O+
 N/A

____/____/___
 ISBT-128
 Entire unit
 Partial unit
______mL 
__ __ __ __ __
___/___/_____
 A-
 A+
 B-
N
___ ___:___ _
 Codabar

__ __





____/____/___
___ ___ ___ ___ ___

__ __ __ __ __ __
_____ : _____
B+
 AB-
 AB+

___ ___:_____
_________________

__ __   __

 O-
 O+
 N/A

Custom Fields
Label

Label

_______________
______/______/________
________________
______/______/________
_______________
___________________
________________
__________________




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