Form No number No number Adverse reaction report

OMB No. 0920-0666

Exp. Date: XX-XX-XXXX

Hemovigilance Adverse Reaction

* Required Field

Facility ID #: _________

Adverse Reaction #: ________

Patient Information

*Patient ID: ______________ *Gender: M F *Date of birth: ____/___/_______

*Patient’s blood group: A+ A- B+ B- O+ O- AB+ AB-

Reaction Details

*Date reaction occurred: ___/___/______

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

*Facility location where reaction occurred:

_____________________

*Is this reaction associated with an incident? YES If YES, Incident #: _________ NO

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

Chills/rigors Fever Urticaria Other skin rash Shortness of breath Hypoxemia

Decrease in blood pressure Increase in blood pressure Diffuse hemorrhage Shock Jaundice

Nausea/vomiting Dark urine Oliguria Hematuria Hemoglobinemia

Abdominal pain Back pain Chest pain Flank pain Headache Pain at infusion site

Other pain (specify) __________________ Other (specify) _____________________________

Component Details (Use worksheet on page 3 for additional units)

*Date / Time MM/DD/YYYY HH:MM	*Component code (Check system used) ISBT-128 Codabar	*# of Units	Unit number *Required for TRALI, GVHD, Infection	*Unit expiration date MM/DD/YYYY	*Blood group of unit	Implicated in the adverse reaction?
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A

Investigation Results (See Case Definition Criteria)

*Was a particular unit implicated in the adverse reaction? YES NO

Assurance of Confidentiality: The 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).

CDC 57.304

*Adverse reaction (Select one):

Allergic reaction, including anaphylaxis

Hemolytic transfusion reaction:

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

Hypotensive transfusion reaction

Infection A. Bacterial (incl. sepsis) Viral Other B. Organism (specify)__________________

Blood culture performed on unit: YES NO

If YES, were any culture results positive YES Organism__________________ NO

Blood culture performed on recipient post-transfusion: YES NO

If YES, were any culture results positive YES Organism__________________ NO

Post transfusion purpura (PTP)

Transfusion associated circulatory overload (TACO)

Transfusion associated dyspnea (TAD)

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

Has the patient received any non-irradiated blood product(s) in the past two months? Yes No

Transfusion related acute lung injury (TRALI)

(Optional) Antibody studies performed:

	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) _________________________________________

i. Meets Case Definition Criteria: Def = Definitive, Pro = Probable, Pos= Possible, NA

i i. Grade: NS= Non-severe, S = Severe, LT = Life-threatening, D = Death, ND= Not Determined

iii. Relationship to Transfusion: Def =Definite, Pro =Probable, Pos =Possible, Dou=Doubtful, RO= Ruled out, ND

*For adverse reaction selected indicate: i. Case Definition Criteria _____ ii. Grade ____ iii. Relationship _____

Outcome

* Death+ Major or long-term sequelae Minor or no sequelae Not determined

Date of death ____/____/________

+Note: 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

______________________ ___/___/___

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___/___/____

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___________

______________________ ___________

Comments:

Worksheet for Additional Units

Component Details

*Date / Time MM/DD/YYYY HH:MM	*Component code (Check system used) ISBT-128 Codabar	*# of Units	Unit number * Required for TRALI, GVHD, Infection	*Unit expiration date MM/DD/YYYY	*Blood group of unit	Implicated in the Adverse Reaction?
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A
__/__/____ __ __:__ __	__ __ __ __ __		__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __	__/__/____	A+ B+ O+ AB+ A- B- O- AB- N/A

4