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Fillable Printable 57.304 Hv Adverse Reaction Blank 8 1

Fillable Printable 57.304 Hv Adverse Reaction Blank 8 1

57.304 Hv Adverse Reaction Blank 8 1

57.304 Hv Adverse Reaction Blank 8 1

OMB No. 0920-0666
Exp. Date: 10-31-2016
www.cdc.gov/nhsn
CDC 57.304 Rev. 4, v8.1
Page 1 of 4
Hemovigilance Module
Adverse Reaction
*Required for saving
*Facility ID#: ______________ ______ NHSN Adverse Reacti on #: _______________
Patient Information
*Patient I D: __________ ________ _
*Gender:
M F Other
*Date of Birth: __ __/__ __/ __ __ __ __
Social Se cur ity #: _____________ __ Secondar y ID: ________________ _
Medicare #: _________ _________ _
Last Name: _________ _________ __
First Na me: ________ __________ __
Middle Name: ____ ___ ______ ___ _
Ethnicity
Hispanic or Latino
Not Hispanic or Not Lat in o
Race
Asian
Black or A frican Americ an
Native Hawaiian/Other Pacific I s lander
White
*Blood Group:
A-
A+
B-
B+
AB-
AB+
O-
O+
Type and crossmatch not done
*Primary underlying re ason for trans fus ion:
Coagulopathy
Genetic Disorder
Hemato lo gy Disorder
Hemolysis
Internal B leeding
Malignancy
Medical
Surgery
Unknown
Other (specify) _________________________________________________________________________
Reaction Detail s
*Date reac t ion o c cur r ed: __ __/__ __/__ __ __ __
*Time reaction occurred: __ __:__ __ (HH:MM ) Time un known
*Facility location where patient was t r ansfused: __________________________________________________
*Is this react ion associat ed with an incid ent ? Yes No If Yes, Incident #: _____________ ______
*Signs and s ymptoms, laboratory : ( check a ll that apply )
Cardiovascular:
Cutaneous:
Pain:
Blood pres sur e decrease
Edema
Abdomin al pain
Shock
Flushing
Back pain
Hemolysis/Hemorrhage
Jaundice
Flank pain
Dissem inat ed intravascular coagu lation
Other r ash
Infusion s ite pain
Hemoglobinemia
Pruritus (itching)
Respiratory:
Positiv e ant ibody screen
Urticar ia (hives)
Bilateral infiltrates on chest x-ray
Generalized:
Renal:
Bronchospasm
Chills/rigors
Hematuria
Cough
Fever
Hemoglobinuria
Hypoxemia
Nausea/vomiting
Oliguria
Shortnes s of breath
Other: (s peci fy) _______ __________ _________ _________ _________ _________ _________ ________ ____
Assurance of Confidentiality: The voluntarily provided information obtained in this surveillanc e system that would permit ident ification of any
individual or inst itut i on is collect ed with a guarantee that it will be held in strict c onfidence, will be used only for the purposes stated, and will not
otherwise be disclosed or released without the consent of the indi vi dual, or the inst itution in accordance with S ect i ons 304, 306 and 308(d) of the
Public Health Servic e Act (42 USC 242b, 242k, and 242m(d)).
Public reporting burden of t his collecti on of informati on is estim ated to average 15 minutes per response, including the time for reviewing instruct i ons,
searching exist i ng data sources, gathering and mai ntaini ng the dat a needed, and completing and reviewing the col l ect i on 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 cont rol
number. Send comments regarding this burden estimate or any other aspect of this collection of information, incl udi ng suggest i ons f or reducing this
burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS D-74, Atlanta, GA 30333 ATTN: PRA (0920-0666).
OMB No. 0920-0666
Exp. Date: 10-31-2016
www.cdc.gov/nhsn
CDC 57.304 Rev. 4, v8.1
Page 2 of 4
Investigation Results (Use case d efinition criteria in protocol.)
*Adverse reaction: (check one)
Allergic reaction, including anaphylaxis
Acute hemolytic transfusion reaction (AHTR)
Immune
Antibody: ______________
Non-im mun e ( specify) ____________ _________ ___
Delayed hemolytic transfusion reaction (DHTR)
Immune
Antibody: ______________
Non-im mun e ( specify) ____________ _________ ___
Delayed serologic transfusion reaction (DSTR)
Antibody(ies):
____
____
____
____
____
____
Febrile non-hemolytic transfusion reaction (FNHTR)
Hypotensive transfusion reaction
Infection
Was a test to det ec t a specific pathogen perfor m ed on the recipient post-transfusion?
Yes
No
If Yes, positiv e or r eactive r esults ?
Yes
No
Org1 _____________ _______
Org3 _____________ _______
Was a test to det ec t a specific pathogen perfor m ed on the donor post-donation?
Yes
No
If Yes, positiv e or r eactive res ults?
Yes
No
Org1 _____________ _______
Org3 _____________ _______
Was a test to det ec t a specific pathogen perfor m ed on the unit post-transfus ion? (i.e., culture, serology, NAT)
Yes
No
If Yes, positiv e or r eactive res ults?
Yes
No
Org1 _____________ _______
Org3 _____________ _______
Post transfusion purpura (PTP)
Transfusion associated circulatory overload (TACO)
Transfusion associated dyspnea (TAD)
Transfusion associated graft vs. host disease (TA-GVHD)
Did patient r eceive non-irradiated bl ood product (s ) i n t he t wo months preceding the reaction?
Yes
No
Transfusion related acute lung injury (TRALI)
Antibody s t udi es performe d: ( opt ional)
Not
Done
Negative
Test result positive
Cognate o r
cross reacting
antigen present
No cognate or
cross reacting
antigen present
Not tested
for cognate
antigen
Donor or unit HLA specif icity
Donor or unit HNA specificity
Recipient HLA specificity
Recipient HNA s pe c ificity
Unknown
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
OMB No. 0920-0666
Exp. Date: 10-31-2016
www.cdc.gov/nhsn
CDC 57.304 Rev. 4, v8.1
Page 3 of 4
Outcome
*Outcome:
Death
+
Major or long-term seque lae
Minor or no sequelae
Not determined
Date of Death: __ __/__ __/__ __ __ __
+
Deaths attributable to transfusion must be reported to FDA.
^If recipient died, relationship of transf usion to death:
Definite
Probable
Possible
Doubtful
Ruled Out
Not determined
Component Details (Use worksheet on page 4 for additional units.)
* Was a particular unit i mp l icated in (i.e., r esponsible for) t he adverse reaction?
Yes
No
N/A
*Transfusion
End Date/Time
*Component code
(check system used)
*# of
units
^Unit num ber
Required for
TRALI, GVHD,
Infection
*Unit expiration
Date/Time
*Blood group of unit
Implicated
in the
adverse
reaction?
^IMPLICATED UNIT
___/___/______
ISBT-128
1
__ __ __ __ __
___/___/______
A- A+ B-
Y
Codabar
__ __
__ __:__ __
__ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __
__ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __
__ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
Custom Fields
Label
Label
________________
__ __/__ __/__ __ __ __
________________
__ __/__ __/__ __ __ __
________________
___________________
________________
___________________
________________
___________________
________________
___________________
________________
___________________
________________
___________________
Comments
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
OMB No. 0920-0666
Exp. Date: 10-31-2016
www.cdc.gov/nhsn
CDC 57.304 Rev. 4, v8.1
Page 4 of 4
Component Details (continued)
*Transfusion
End Date/Time
*Component code
(check system used)
*# of
units
^Unit num ber
Required for
TRALI, GVHD,
Infection
*Unit expiration
Date/Time
*Blood group of unit
Implicated
in the
adverse
reaction?
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
___/___/______
ISBT-128
__ __ __ __ __
___/___/______
A- A+ B-
N
Codabar
__ __
__ __:__ __ __ __ __ __ __
__ __ __ __ __ __
__ __:__ __
B+ AB- AB+
__ __ __
O- O+
N/A
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