Hemovigilance Adverse Reaction - Unknown Transfusion Reaction

Status: Original and derived artifacts are available for this document.

Download: docx | pdf | html

Hemovigilance Module
Adverse Reaction
Unknown Transfusion Reaction
*Required for saving
*Facility ID#: _________
NHSN Adverse Reaction #: __________

Patient Information
*Patient ID: ___________________
*Gender:
 M
 F
 Other
*Date of Birth: ____/____/_____
Social Security #: ______________
Secondary ID: _________________
Medicare #: _________________
Last Name: ___________________
First Name: ____________________
Middle Name: _______________
Ethnicity
 Hispanic or Latino
 Not Hispanic or Not Latino

Race
 American Indian/Alaska Native
 Asian
 Black or African American

 Native Hawaiian/Other Pacific Islander
 White
*Blood Group:
 A-
 A+
 B-
B+
 AB-
 AB+
 O-
 O+
 Blood type not done
Patient Medical History (Use worksheet on page 4 for additional codes and descriptions.)

(part 1)  List the patient’s admitting diagnosis. (Use ICD-10 Diagnostic codes/descriptions)

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

(part 2) List the patient’s underlying indication for transfusion. (Use ICD-10 Diagnostic codes/descriptions)

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: _________________________________________________

(part 3)  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: __________________________________________________
                                                                                                                                                                 Continued >>








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 25 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 D-74, Atlanta, GA 30333 ATTN:  PRA (0920-0666).
CDC 57.319 (Front) Rev 0, v8.6
Unknown Transfusion Reaction

Patient Medical History (Use worksheet on page 4 for additional codes and descriptions.)

(part 4)  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: ____________________________________________

(part 5)  Additional Information ________________________________________________________________________

_____________________________________________________________________________________________________

_____________________________________________________________________________________________________
	
Transfusion History (Use worksheet on page 4 for additional transfusion history.)

Has the patient received a previous transfusion?
 YES
 NO
 UNKNOWN

**If yes, provide information about the transfusion event. If not, skip to Reaction Details section. 

Blood Product:
 WB
 RBC
 Platelet
 Plasma
 Cryoprecipitate
 Granulocyte

Date of Transfusion:
____/____/_____
 UNKNOWN

Did the patient experience a transfusion adverse reaction? 
 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 #: ________________
After recognition of the transfusion reaction, was the current transfusion:

 Continued
 Stopped and restarted
 Stopped indefinitely


Investigation Results

 Unknown


Diagnosis of case: ______________________________________________________________________




List tests relevant to reaction investigation:

Test name:
________________
Testing date:
_______________
Test result:
_________________


Test name:
________________
Testing date:
_______________
Test result:
_________________

                                                                                                                                                                 Continued >>

Unknown Transfusion Reaction

Investigation Results (continued)

Other signs and symptoms: (check all that apply)

Generalized:
 Chills/rigors
 Fever
 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? (Response definitions listed in protocol)

 Symptomatic treatment only
 Hospitalization, inlcuding prolonged hospitalization

 Life-threatening reaction
 Disability and/or incapacitation

 Congenital anomaly or birth defect(s) of the fetus
 Death

 Other medically important conditions
 Unknown or not stated


Imputability

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

 Conclusive evidence exists that the adverse reaction can be attributed to the transfusion.

 Evidence is clearly in favor of attributing the adverse reaction to the transfusion.

 Evidence is indeterminate for attributing the adverse reaction to the transfusion or an alternate cause.

 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

Additional Information  _____________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
                                                                                                                                                                 Continued >>
Unknown Transfusion Reaction

Patient Treatment

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

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
 H1 receptor blockers
 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

Continued >>
Unknown Transfusion Reaction

Component Details (Use worksheet on page 4 for additional units.)
*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 
*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

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

__ __





____/____/___
___ ___ ___ ___ ___

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

___ ___:___ __
_________________

__ __   __

 O-
 O+
 N/A


Custom Fields
Label

Label

_______________
______/______/________
________________
______/______/________
_______________
___________________
________________
__________________
_______________
___________________
________________
__________________
_______________
___________________
________________
__________________
Comments
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________


Hemovigilance Module
Additional Worksheet
		
Patient Medical History

(part 1)  List the patient’s admitting diagnosis. (Use ICD-10 Diagnostic codes/descriptions)

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________




(part 2) List the patient’s underlying indication for transfusion. (Use ICD-10 Diagnostic codes/descriptions)

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: _________________________________________________

(part 3)  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: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

(part 4)  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: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: ______________
Description: __________________________________________________

Code: _______________
Description: ____________________________________________

(part 5)  Additional Information ________________________________________________________________________

_____________________________________________________________________________________________________

_____________________________________________________________________________________________________

_____________________________________________________________________________________________________
Hemovigilance Module
Additional Worksheet

Transfusion History

Has the patient received a previous transfusion?
 YES
 NO

**If yes, provide information about the transfusion event. If not, skip to Reaction Details section. 

Blood Product:
 WB
 RBC
 Platelet
 Plasma
 Cryoprecipitate
 Granulocyte

Date of Transfusion:
____/____/_____
 UNKNOWN

Did the patient experience a transfusion adverse reaction? 
 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  __________________________________________________________________________




Has the patient received a previous transfusion?
 YES
 NO

**If yes, provide information about the transfusion event. If not, skip to Reaction Details section. 

Blood Product:
 WB
 RBC
 Platelet
 Plasma
 Cryoprecipitate
 Granulocyte

Date of Transfusion:
____/____/_____
 UNKNOWN

Did the patient experience a transfusion adverse reaction? 
 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  __________________________________________________________________________




Has the patient received a previous transfusion?
 YES
 NO

**If yes, provide information about the transfusion event. If not, skip to Reaction Details section. 

Blood Product:
 WB
 RBC
 Platelet
 Plasma
 Cryoprecipitate
 Granulocyte

Date of Transfusion:
____/____/_____
 UNKNOWN

Did the patient experience a transfusion adverse reaction? 
 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  __________________________________________________________________________





Hemovigilance Module
Additional Worksheet
	
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 
*Unit expiration Date/Time 
*Blood group of unit
Implicated 
Unit?
____/____/_____
 ISBT-128
 Entire unit
 Partial unit
______mL 
__ __ __ __ __
___/___/_____
 A-
 A+
 B-
N
___ ___:___ ___
 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

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

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

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

__ __





____/____/_____
___ ___ ___ ___ ___

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

___ ___:___ ___
_________________

__ __   __

 O-
 O+
 N/A