Form 57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Trans

Form Approved

OMB No. 0920-0666

Exp. Date: xx/xx/20xx

www.cdc.gov/nhsn

Hemovigilance Module

Adverse Reaction

Delayed Hemolytic 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: __________________________________________________
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 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 D-74, Atlanta, GA 30333 ATTN: PRA (0920-0666). CDC 57.309 Rev.1 v8.8

Delayed Hemolytic Transfusion Reaction

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

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: ____________________________________________

(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 (Only answer questions listed under the selected reaction type.)

* Delayed hemolytic transfusion reaction (DHTR)

Immune

Antibody: ______________

Non-immune (specify) ________________________

*Case Definition

Check all that occurred between 24 hours and 28 days after cessation of transfusion:

Positive direct antiglobulin test (DAT)

Newly-identified red blood cell alloantibody in recipient serum

Positive elution test with alloantibody present on the transfused red blood cells

Inadequate rise of post-transfusion hemoglobin level or rapid fall in hemoglobin back to pre-transfusion levels

Otherwise unexplained appearance of spherocytes

None of the above

Continued >>

Delayed Hemolytic Transfusion Reaction

Investigation Results (continued)

Check all that apply:

Incomplete laboratory evidence

DHTR is suspected, but reported symptoms, test results, and/or available information are not sufficient

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

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?

No other explanation for symptoms or newly-identified antibody is present.

An alternate explanation for symptoms or newly-identified antibody is present, but transfusion is the most likely cause.

Other explanations for symptoms or newly-identified antibody are more 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

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 _________________________________________________________

Continued >>

Delayed Hemolytic Transfusion Reaction

Do you agree with the imputability designation?

YES

NO

Additional Information _____________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

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

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 >>

Delayed Hemolytic 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) & 253 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 # of Units	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

CDC 57.309 R1, v8.8

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