Document
Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction
ICR 201607-0920-013 · OMB 0920-0666 · Object 67060801.
This document may belong to an older filing. More recent activity for OMB 0920-0666:
Document Viewer [docx]
Document Metadata
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction |
| Author | Haass, Kathryn (CDC/OID/NCEZID) (CTR) |
| Last Modified By | Writer |
| File Modified | 2016-05-12 |
| File Created | 2026-10-30 |
| Conversion State | complete |
Extracted Text
Hemovigilance Module Adverse Reaction Acute 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: __________________________________________________ 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 25 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 57.307 Rev.0 v8.6 Acute Hemolytic Transfusion Reaction Patient Medical History (Use worksheet on page 4 for additional codes and descriptions.) (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 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 #: ________________ After recognition of the transfusion reaction, was the current transfusion: Continued Stopped and restarted Stopped indefinitely Investigation Results Acute hemolytic transfusion reaction (AHTR) Immune Antibody: ______________ Non-immune (specify) ________________________ Case Definition Check the following that occurred during, or within 24 hours of cessation of transfusion with new onset: Back/flank pain Chills/rigors Epistaxis Disseminated intravascular coagulation (DIC) Oliguria/anuria Hypotension Fever Hematuria (gross visual hemolysis) Pain and/or oozing at IV site Renal failure None of the above Continued >> Acute Hemolytic Transfusion Reaction Investigation Results (continued) Check all that apply: Decreased fibrinogen Decreased haptoglobin Elevated bilirubin Elevated LDH Hemoglobinemia Hemoglobinuria Plasma discoloration c/w hemolysis Spherocytes on blood film Positive direct antiglobulin test (DAT) for anti-IgG or anti-C3 Positive elution test with alloantibody present on the transfused red blood cells Serologic testing is negative, and physical cause (e.g., thermal, osmotic, mechanical, chemical) is confirmed. Physical cause is excluded but serologic evidence is not sufficient to meet definitive criteria. Physical cause is suspected and serologic testing is negative. AHTR is suspected, but symptoms, test results, and/or information are not sufficient to confirm reaction. None of the above Other signs and symptoms: (check all that apply) Generalized: Nausea/vomiting Cardiovascular: Shock Cutaneous: Edema Flushing Jaundice Other rash Pruritus (itching) Urticaria (hives) Hemolysis/Hemorrhage: Hemoglobinemia Positive antibody screen Pain: Abdominal pain Respiratory: Bilateral infiltrates on chest x-ray Bronchospasm Cough Shortness of breath Hypoxemia Other: (specify) _____________________________________________________________________ Severity Did the patient receive or experience any of the following? (Response definitions listed in the 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? ABO or other allotypic RBC antigen incompatibility is known. Only transfusion-related (i.e., immune or non-immune) cause of acute hemolysis is present. There are other potential causes present that could explain acute hemolysis, but transfusion is the most likely cause. 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 Continued >> Acute Hemolytic Transfusion Reaction Investigation Results (continued) Additional Information ______________________________________________________________________ _________________________________________________________________________________________ _________________________________________________________________________________________ Patient Treatment *Did the patient receive treatment for the transfusion reaction? YES NO 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 >> Acute 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) 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 *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