57.313 Hemovigilance Adverse Reaction - Infection (with revised GISAB questions in tracked changes)

Form Approved

OMB No. 0920-0666

Exp. Date: 12/31/22

www.cdc.gov/nhsn

Hemovigilance Module

Adverse Reaction

Infection

*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):________

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

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: __________________________________________________

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).

Infection

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

* Infection

*Case Definition

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

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 ____________________

Check all that apply:

Temporally associated unexplained clinical illness consistent with infection

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?

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?

No other potential exposures to the pathogen could be identified in the recipient.

Evidence is clearly in favor of a cause other than 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.

Check all that apply:

Evidence of the pathogen in the transfused component.

Evidence of the pathogen in the donor at the time of donation.

Evidence of the pathogen in an additional component from the same donation.

Evidence of the pathogen in an additional recipient of a component from the same donation.

Evidence that the identified pathogen strains are related by molecular or extended phenotypic comparison testing with statistical confidence (p<0.05).

Evidence that the transfused component was negative for this pathogen at the time of transfusion

Evidence that the donor was negative for this pathogen at the time of donation.

Evidence that additional components from the same donation were negative for this pathogen.

Evidence that the recipient was not infected with the pathogen prior to transfusion.

Laboratory evidence that the recipient was infected with this pathogen prior to transfusion.

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

_______________

______/______/________

________________

______/______/________

_______________

___________________

________________

__________________

Comments

CDC 57.313 Rev.2, v9.2 Page 3 of 10