Form 57.304 Hemovigilance Adverse Reaction

OMB No. 0920-0666

Exp. Date: XX-XX-XXXX

Hemovigilance Module

Adverse Reaction

*Required for saving

*Facility ID#: ____________________

NHSN Adverse Reaction #: _______________

Patient Information

*Patient ID: _______________

Social Security #: _____________________

Secondary ID: ______________

Last Name: ____________________

First Name: _____________________

Middle Name: _______________

*Gender:

M

F

Other

*Date of Birth: __ __/__ __/__ __ __ __

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+

Type and crossmatch not done

*Primary underlying reason for transfusion:

Coagulopathy

Genetic Disorder

Hematology Disorder

Hemolysis

Internal Bleeding

Malignancy

Medical

Surgery

Unknown

Other (specify) _________________________________________________________________________

Reaction Details

*Date reaction occurred: __ __/__ __/__ __ __ __

*Time reaction occurred: __ __:__ __ (HH:MM)

Time unknown

*Facility location where reaction occurred:

_____________________________________________________

*Is this reaction associated with an incident?

Yes

No

If Yes, Incident #: ___________________

*Signs and symptoms, laboratory: (check all that apply)

Cardiovascular:

Cutaneous:

Pain:

Blood pressure decrease

Edema

Abdominal pain

Shock

Flushing

Back pain

Hemolysis/Hemorrhage

Jaundice

Flank pain

Disseminated intravascular coagulation

Other rash

Infusion site pain

Hemoglobinemia

Pruritis

Respiratory:

Positive antibody screen

Urticaria

Bilateral infiltrates on chest x-ray

Generalized:

Renal:

Bronchospasm

Chills/rigors

Hematuria

Cough

Fever

Hemoglobinuria

Hypoxemia

Oliguria

Shortness of breath

Other: (specify) __________________________________________________________________________

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 10 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).

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

*Transfusion Date/Time MM/DD/YYYYHH:MM

*Component code (check system used)

*# of units

^Unit number Required for TRALI, GVHD, Infection

*Expiration Date/Time MM/DD/YYYY HH:MM

*Blood group of unit

Implicated in the adverse reaction?

___/___/______

ISBT-128

__ __ __ __ __

___/___/______

A-

A+

B-

Codabar

__ __

__ __:__ __

__ __ __ __ __

__ __ __ __ __ __

__ __:__ __

B+

AB-

AB+

__ __ __

O-

O+

N/A

___/___/______

__ __ __ __ __

__ __ __ __ __

___/___/______

A-

A+

B-

__ __

__ __:__ __

__ __ __ __ __ __

__ __:__ __

B+

AB-

AB+

__ __ __

O-

O+

N/A

___/___/______

__ __ __ __ __

__ __ __ __ __

___/___/______

A-

A+

B-

__ __

__ __:__ __

__ __ __ __ __ __

__ __:__ __

B+

AB-

AB+

__ __ __

O-

O+

N/A

Investigation Results (Use case definition criteria in protocol.)

*Was a particular unit implicated in the adverse reaction?

Yes

No

*Adverse reaction: (check one)

Allergic reaction, including anaphylaxis

Acute hemolytic transfusion reaction (AHTR)

Immune

Antibody: ______________

Non-immune (specify) ________________________

Delayed hemolytic transfusion reaction (DHTR)

Immune

Antibody: ______________

Non-immune (specify) ________________________

Delayed serologic transfusion reaction (DSTR)

Antibody: ______________

Febrile non-hemolytic transfusion reaction (FNHTR)

Hypotensive transfusion reaction

Infection

Was a test to detect a specific pathogen performed on the recipient post-donation?

Yes

No

If Yes, positive or reactive results?

Yes

No

Org1 _______________________

Org2 _______________________

Org3 _______________________

Was a test to detect a specific pathogen performed on the donor post-donation?

Yes

No

If Yes, positive or reactive results?

Yes

No

Org1 _______________________

Org2 _______________________

Org3 _______________________

Was a test to detect a specific pathogen performed on the unit post-transfusion? (i.e., culture, serology, NAT)

Yes

No

If Yes, positive or reactive results?

Yes

No

Org1 _______________________

Org2 _______________________

Org3 _______________________

Post transfusion purpura (PTP)

Transfusion associated circulatory overload (TACO)

Transfusion associated dyspnea (TAD)

Transfusion associated graft vs. host disease (TA-GVHD)

Did patient receive non-irradiated blood product(s) in the two months preceding the reaction?

Yes

No

Transfusion related acute lung injury (TRALI)

Antibody studies performed: (optional)

	Not Done	Negative	Test result positive
			Cognate or cross reacting antigen present	No cognate or cross reacting antigen present	Not tested for cognate antigen
Donor or unit HLA specificity
Donor or unit HNA specificity
Recipient HLA specificity
Recipient HNA specificity

Unknown pathophysiology

Other (specify) ____________________________________________________________________________

*Case definition criteria:

Definitive

Probable

Possible

N/A

*Severity:

Non-severe

Severe

Life-threatening

Death

Not determined

*Imputability:

Definite

Probable

Possible

Doubtful

Ruled Out

Not determined

Outcome

*Outcome:

Death⁺

Major or long-term sequelae

Minor or no sequelae

Not determined

Date of Death: __ __/__ __/__ __ __ __

⁺Deaths attributable to transfusion must be reported to FDA.

^If recipient died, relationship of transfusion to death:

Definite

Probable

Possible

Doubtful

Ruled Out

Not determined

Custom Fields

Label

Label

________________

__ __/__ __/__ __ __ __

________________

__ __/__ __/__ __ __ __

________________

___________________

________________

___________________

________________

___________________

________________

___________________

________________

___________________

________________

___________________

Comments

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

Component Details
*Transfusion Date/Time MM/DD/YYYYHH:MM	*Component code (check system used)	*# of units	^Unit number Required for TRALI, GVHD, Infection	*Expiration Date/Time MM/DD/YYYY HH:MM	*Blood group of unit			Implicated in the adverse reaction?
___/___/______	ISBT-128		__ __ __ __ __	___/___/______	A-	A+	B-
	Codabar		__ __
__ __:__ __	__ __ __ __ __		__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A
___/___/______	__ __ __ __ __		__ __ __ __ __	___/___/______	A-	A+	B-
			__ __
__ __:__ __			__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A
___/___/______	__ __ __ __ __		__ __ __ __ __	___/___/______	A-	A+	B-
			__ __
__ __:__ __			__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A
___/___/______	__ __ __ __ __		__ __ __ __ __	___/___/______	A-	A+	B-
			__ __
__ __:__ __			__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A
___/___/______	__ __ __ __ __		__ __ __ __ __	___/___/______	A-	A+	B-
			__ __
__ __:__ __			__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A
___/___/______	__ __ __ __ __		__ __ __ __ __	___/___/______	A-	A+	B-
			__ __
__ __:__ __			__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A
___/___/______	__ __ __ __ __		__ __ __ __ __	___/___/______	A-	A+	B-
			__ __
__ __:__ __			__ __ __ __ __ __	__ __:__ __	B+	AB-	AB+
			__ __ __		O-	O+	N/A

CDC 57.304 Rev. 1, v6.4

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