Transfusion Reactions – Hemovigilance Definitions 北京/Transf… · Transfusion Reactions – Hemovigilance Definitions Katie Wilkinson, MD Bloodworks Northwest, Seattle, WA Institute

Transfusion Reactions –Hemovigilance Definitions

Katie Wilkinson, MDBloodworks Northwest, Seattle, WA

Institute of Blood TransfusionChinese Academy of Medical Sciences

and Peking Union Medical CollegeJuly 24-25, 2018

1

National Healthcare Safety Network

• Group of transfusion medicine specialists, AABB, and CDC (Centers for Disease Control) staff

• Definitions based on International Society of Blood Transfusion (ISBT) draft definitions

• Intended to standardize definitions for transfusion reactions

• Allows for tracking and data collection

2

Key Terms

• Case definition criteria – Provide surveillance criteria for defining a case

– Definitive

– Probable

– Possible

• Grade – Severity of the reaction

• Imputability – Relationship of the transfusion to the reaction

3

Adverse Reactions

• Allergic reaction

• Hemolytic transfusion reaction

– Acute hemolytic transfusion reaction (AHTR)

– Delayed hemolytic transfusion reaction (DHTR)

– Delayed serologic transfusion reaction (DSTR)

• Hypotensive transfusion reaction

• Febrile non hemolytic transfusion reaction (FNHTR)

• Post transfusion purpura (PTP)

4

Adverse Reactions

• Transfusion associated circulatory overload (TACO)

• Transfusion associated dyspnea (TAD)

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

• Transfusion-related acute lung injury (TRALI)

• Infection

• Other – diagnosis known but not one of the above

• Unknown pathophysiology

5

Severity Grade

• Grade 1 (Non-Severe): Medical intervention or symptomatic treatment required, but lack of treatment would not result in permanent damage or impairment

• Grade 2 (Severe): Inpatient hospitalization or prolonged hospitalization directly attributable to the event and/or persistent or significant disability or incapacity or a medical or surgical intervention is necessary to prevent permanent damage or impairment

6

Severity Grade

• Grade 3 (Life-threatening): Major intervention required following transfusion (vasopressors, intubation, transfer to intensive care) to prevent death

• Grade 4 (Death): Only should be used if death is possibly, probably, or definitely related to transfusion

7

Imputability

• Definite (certain): Conclusive evidence beyond a reasonable doubt that the adverse reaction is caused by the transfusion

• Probable (likely): Evidence is clearly in favor of attributing the adverse reaction to the transfusion

• Possible: Evidence is indeterminate for attributing the adverse reaction to the transfusion

8

Imputability

• Doubtful: Evidence is clearly in favor of attributing the adverse reaction to causes other than transfusion (do not report to NHSN)

• Ruled Out: Conclusive evidence beyond reasonable doubt that they adverse reaction can be attributed to causes other than transfusion (do not report to NHSN)

• Not determined: The relationship between the adverse reaction and the transfusion is not known

9

Case 1

• 62 year old woman, no prior transfusions, on warfarin for atrial fibrillation, subdural hematoma from a ground level fall

• Pre-transfusion vital signs: BP 123/68, P 72, RR 13, T 36.7

• Patient received fresh frozen plasma to reverse the warfarin. Halfway through the third unit of plasma, the patient developed hives and itching on her arms and legs

• Transfusion stopped. Diphenhydramine given, symptoms resolved in 30 minutes.

• Laboratory analysis showed no hemolysis or clerical errors

10

Case 1 – Allergic Reaction

• Diagnosis: Allergic Reaction

• Case Definition Criteria: Definitive

• Severity: Grade 1, Non-Severe

• Imputability: Definite

11

Allergic Reaction Case Definition Criteria

• Definition: The result of an interaction of an allergen with preformed antibodies

• Definitive: Any combination (2 or more) of the following occurring during transfusion:

• Rash with or without itching• Hives• Generalized flushing• Localized angioedema• Edema of lips, tongue, and

uvula

• Periorbital itching, redness, edema

• Conjunctival edema• Respiratory distress,

bronchospasm• Hypotension

• Probable – N/A

• Possible – N/A12

Allergic Reaction Severity Grade

• Grade 1 (Non-severe): No immediate risk to the patient’s life AND quickly responds to symptomatic treatment

• Grade 2 – 4: See definitions on slides 6-7. Involve respiratory and/or cardiovascular symptoms. Presents like an anaphylactic reaction

13

Allergic Reaction Imputability

• Definite: No other environmental, drug, or dietary risks and occurs within 1-2 hours of transfusion

• Probable: Other potential causes in a patient with known susceptibility (atopic; previous allergic reactions) and occurs within 1-2 hours of transfusion

• Possible: Other likely causes such as medication or exposures but transfusion cannot be ruled out and occurs within 2-4 hours of transfusion

14

Case 2

• 37 year old man with a GI bleed, blood type B+• Patient received 1 unit of RBCs• 45 minutes into the unit he developed shaking chills, back

pain, dyspnea, nausea, and oxygen desaturation.• Laboratory test reveal gross hemolysis, post transfusion

blood type of A+, and a positive DAT with anti-A eluted from the red blood cells

• Over the next 24 hours patient developed acute renal failure with decreased urine output and a creatinine of 2.0. LDH, potassium, and bilirubin became elevated, and the hemoglobin fell from 7.2 to 6.5 (additional transfusion required)

• Dialysis not required, renal function improved over the next several days, patient discharged home

15

Case 2 – Acute Hemolytic Transfusion Reaction (AHTR)

• Diagnosis: AHTR


• Severity: Grade 2, Severe


16

AHTR Signs and Symptoms• Definition: Rapid destruction of red blood cells immediately

after or within 24 hours of a tranfusion

• Definitive: Occurs during, immediately after, or within 24 hours of a transfusion with any of the following:

• Chills/rigors• Fever• Back/flank pain• Hypotension• Hemoglobinuria during or

shortly after transfusion

• Epistaxis• Oliguria/anuria• Renal failure• Disseminated intravascular

coagulopathy (DIC)• Pain or oozing at IV site

• AND either known ABO or other RBC antigen incompatibility ORClerical check indicated wrong unit transfused

• Probable: Any combination of clinical features above, but incomplete laboratory confirmation

• Possible: N/A 17

AHTR Laboratory/Radiology

• Definitive: Serologic work up consistent with hemolytic transfusion reaction– Positive DAT for anti-IgG or anti-C3 AND

– Positive elution test with alloantibody present on the transfused red blood cells

• AND 2 or more of the following

• Elevated LDH• Elevated bilirubin• Low haptoglobin

• Hemoglobinuria• Low fibrinogen• Elevated plasma

hemoglobin

• Probable: Incomplete definitive criteria laboratory confirmation

• Possible: N/A18

AHTR Severity Grade

• Grade 1 – 4: See definitions on slide 6-7

• This patient had a severe (Grade 2) reaction due to the acute renal failure and because medical intervention was required to prevent further harm to the patient

19

AHTR Imputability

• Definite: Occurs during, immediately after, or within 24 hours of transfusion

• AND EITHER• Known ABO or other RBC antigen incompatibility OR• Serologic work up consistent with AHTR

• Probable: No serologic evidence AND blood bank testing shows abnormal results but AHTR may be due to auto-antibodies in recipient

• Possible: Evidence of non-immune contributing factors (such as mechanical hemolysis, use of hypotonic solutions, etc.)

20

Case 3

• 35 year old man with a fever and pneumonia, on IV antibiotics

• Patient received 1 unit of RBCs during admission without reaction, hemoglobin rose from 7.2 to 8.5 g/dL

• Patient was admitted two weeks later and another type and screen was performed

• Antibody screen was now positive, anti-Jkb antibody identified, DAT negative

• Hemoglobin had fallen to 7.4 without evidence of bleeding

• LDH and bilirubin were elevated

• The segment from the transfused unit was tested and found to be Jkb positive

21

Case 3 – Delayed Hemolytic Transfusion Reaction (DHTR)

• Diagnosis: DHTR

• Case Definition Criteria: Probable


• Imputability: Probable

22

DHTR Signs and Symptoms• Definition: Recipient develops antibody to RBC antigens

between 24 hours and 28 days after a transfusion and clinical or biological signs of hemolysis are present

• Definitive: Patient may be asymptomatic or have similar but milder symptoms to AHTR (not required to meet definition)

– Milder symptoms include:

• Chills/rigors• Fever• Back/flank pain• Hypotension

• Hemoglobinuria/hematuria• Jaundice• Oliguria/anuria

• Probable: Same as above but without serologic confirmation of HTR

• Possible: N/A23

DHTR Laboratory/Radiology

• Definitive: Any of the following– Positive DAT AND EITHER– Positive elution test with alloantibody present on the

transfused red blood cells OR Newly identified RBC alloantibody

• AND EITHER– Inadequate rise of post-transfusion hemoglobin or

rapid fall in hemoglobin to pre-transfusion levels OR– Otherwise unexplained appearance of spherocytes– If performed LDH and bilirubin will rise and fall back to

baseline in the following days• Probable: Newly identified RBC alloantibody


DHTR Severity Grade


• This patient had a non-severe (Grade 1) reaction – no medical intervention or risk of harm to the patient

25

DHTR Imputability

• Definite: – Newly identified RBC alloantibody AND

– Occurs between 24 hrs to 28 days after a transfusion AND

– Positive DAT with identification of a new antibody in the serum or eluate AND

– No other explanation for drop in hemoglobin

• Probable: – Occurs between 24 hrs to 28 days after a transfusion AND

– No other explanation for drop in hemoglobin AND

– No confirmation on serologic testing


Case 4

• 48 year old woman with leukemia• Patient received 4 units of RBCs during chemotherapy

admission without reaction• Patient was admitted two weeks after initial

discharge and another type and screen was performed

• Antibody screen was now positive, anti-Jka and E antibodies identified, DAT negative, hemoglobin stable, LDH and bilirubin were normal

• The segment from the transfused units were tested and 2 were found to be Jka positive, 1 was found to be E positive

27

Case 4 – Delayed Serologic Transfusion Reaction (DSTR)

• Diagnosis: DSTR




28

DSTR Signs and Symptoms

• Definition: Demonstration of new, clinically significant alloantibodies against RBCs between 24 hours and 28 days after a transfusion despite an adequate hemoglobin response to transfusion that is maintained

• Definitive: No clinical or laboratory signs of hemolysis

• Probable: N/A

• Possible: N/A29

DSTR Laboratory/Radiology

• Definitive: After a transfusion there is demonstration of new, clinically significant antibodies against RBCs that were not present in the pre-transfusion specimen EITHER THROUGH:– Positive DAT OR– Positive antibody screen with newly identified RBC

alloantibody

• Probable: Newly identified RBC alloantibody

• Possible: N/A

30

DSTR Severity Grade

• Grade 1 – These cases are always grade 1 (non-severe since there are no clinical findings

31

DSTR Imputability

• Definite:

– Recent RBC transfusion with subsequent formation of newly identified RBC alloantibody OR

– Positive DAT

• Probable: N/A

• Possible: N/A

32

Case 5

• 28 year old man with lymphoma and sepsis, on IV antibiotics and pressors

• Patient received 1 units of RBCs– Blood pressure fell from 110/69 to 70/30 during transfusion

– Transfusion stopped, and saline bolus given

– Blood pressure rose to baseline within 10 minutes

– Transfusion was re-started and blood pressure fell again

– Saline bolus was given again without improvement

– Despite aggressive treatment, the patient died of a cardiac arrest after prolonged severe hypotension

• Transfusion reaction investigation revealed no laboratory evidence of bacterial growth or immunohematologicincompatibility

33

Case 5 – HypotensiveTransfusion Reaction

• Diagnosis: Hypotensive transfusion reaction

• Case Definition Criteria: Possible

• Severity: Grade 4, Death


34

Hypotensive Transfusion ReactionSigns and Symptoms

• Definition: Drop in systolic and/or diastolic blood pressure of >30 mmHg occurring during or within one hour of transfusion

• Definitive: All of the following:

– Hypotension (>30 mmHg drop in systolic and/or diastolic BP)

– Occurs within 15 minutes after the start of the transfusion

– Responds rapidly (within 10 minutes) to cessation of transfusion and supportive treatment

– All other categories of adverse reactions presenting with hypotension must have been excluded

35

Hypotensive Transfusion Reaction Laboratory/Radiology

• Probable: Same as definitive except:

– Onset is >15 minutes after start of transfusion OR

– Patient does not respond within 10 minutes to cessation of transfusion and supportive treatment

• Possible: – Same as definitive EXCEPT other conditions are

present or were present before the transfusion that could explain the hypotension (sepsis in this patient)

• Probable: Newly identified RBC alloantibody

• Possible: N/A

36

Hypotensive Transfusion Reaction Severity Grade

• Grade 1 – Requires only discontinuation of transfusion and symptomatic

management AND– No long-term morbidity

• Grade 2– Recipient required inpatient hospitalization due to hypotension

or hypotension led to long-term morbidity AND– Vasopressors are not required

• Grade 3– Recipient required vasopressors

• Grade 4– Recipient died as a result of hypotension or as a result of

treatment due to hypotension37

Hypotensive Transfusion Reaction Imputability

• Definite:

– Meet definitive protocol criterion

– The patient had no other conditions that could explain hypotension

• Probable: Other conditions that could explain hypotension are unlikely but not fully excluded

• Possible: Other conditions that could readily explain hypotension are present (sepsis)

38

Case 6

• 51 year old female• Patient received 1 units of RBCs

– Fifteen minutes after the end of transfusion, the patient’s temperature had risen from 37.1°C to 38.8°C

– She also developed shaking chills – Acetaminophen was given, and the patient’s temperature

fell to 38.6°C within 2 hours– She had no other episodes of fever before or after this

incident

• Transfusion reaction investigation revealed no laboratory evidence of hemolysis, bacterial growth, clerical error, or immunohematologic incompatibility

• DAT was negative39

Case 6 – Febrile Non-Hemolytic Transfusion Reaction (FNHTR)

• Diagnosis: FNHTR




40

FNHTRSigns and Symptoms

• Definition: Fever and/or chills without hemolysis occuring in the patient during or within 4 hours of transfusion

• Definitive:

– Fever (≥ 38°C and a change of ≥ 1°C from pre-transfusion value ≥ 38°C)

– Occurs during or within 4 hours of transfusion

• Probable: N/A

• Possible: N/A

41

FNHTR Severity Grade


• This patient had a non-severe (Grade 1) reaction –minimal intervention (acetaminophen) with no risk of permanent harm to the patient

42

FNHTR Imputability

• Definite: Meets definitive protocol criterion and patient has no other conditions that could explain symptoms

• Probable: Other conditions that could explain fever/chills are unlikely but not fully excluded

• Possible: Other conditions are present or were present before the transfusion that could explain the symptoms

43

Case 7

• 17 year old female was shot in the abdomen with a liver injury causing intraabdominal hemorrhage

• Patient received 12 units of RBCs, 8 units of plasma, 2 units of platelets, and 1 unit of pooled cryoprecipitate over three days

• Hemoglobin stabilized at 9 g/dL, platelet count stabilized at 120,000

• 16 days after her first transfusions, her platelet count fell to 43,000

• 3 days later, the platelet count fell further to 11,000• The platelet count remained between 10,000 and 14,000 for 5

days, after which it began to rise slowly to the normal range, reaching 230,000 on day 21; no treatment was needed

• Patient was found to have anti-HPA-1A and was HPA-1A negative

44

Case 7 – Post Transfusion Purpura (PTP)

• Diagnosis: PTP




45

PTP Signs and Symptoms

• Definition: Thrombocytopenia usually arising 5-12 days after transfusion of blood products

• Definitive: Thrombocytopenia (decrease to <20% of pre-transfusion count) AND occurs 5-12 days after transfusion

• Probable: – Clinical presentation largely consistent with definition BUT– Timeframe not met OR– Thrombocytopenia (decrease to <20% of pre-transfusion count)

with competing explanations OR– Drop in platelets between 20% and 80% of pre-transfusion count

• Possible: – Clinical and laboratory presentation consistent with definition.

HPA antibodies presnet but alternate explanations more likely OR– Clinical presentation consistent with definition, however HPA

antibodies not tested or negative46

PTP Laboratory/Radiology

• Definitive/Probable: Alloantibodies in the patient directed against HPA-1a or other platelet specific antigen detected at or after development of reaction

• Possible: HPA antibodies not tested or negative

47

PTP Laboratory/RadiologySeverity Grade


• This patient had a non-severe (Grade 1) reaction – no medical intervention with no permanent harm to the patient

48

PTP Imputability

• Definite: Protocol criterion = Definitive/Probable

• Probable: N/A

• Possible: Protocol criterion = Possible

49

Case 8

• 68 year old female on chronic warfarin treatment admitted with spontaneous subarachnoid hemorrhage

• Patient received 6 units of plasma over 36 hours

• The patient developed shortness of breath, lung crackles, and decreased oxygen saturation

• Chest X-ray showed bilateral dependent pulmonary infiltrates

• Laboratory investigation showed no hemolysis

• Patient was treated with furosemide and her symptoms resolved within 24 hours

50

Case 8 – Transfusion Associated Circulatory Overload (TACO)

• Diagnosis: TACO




51

TACO Signs and Symptoms

• Definition: Volume infusion that cannot be effectively processed by the recipient either due to high rates and volumes of infusion or underlying cardiac or pulmonary pathology

• Definitive: Characterized by new onset or exacerbation of ≥ 3 of the following within 6 hours of transfusion:– Acute respiratory distress (dyspnea, orthopnea, cough)– Evidence of positive fluid balance– Elevated Brain Natriuretic Peptide (BNP)– Radiographic evidence of pulmonary edema– Evidence of right heart failure– Elevated Central Venous Pressure (CVP)

• Probable: N/A• Possible: N/A

52

TACO Laboratory/RadiologySeverity Grade


• This patient had a severe (Grade 2) reaction –medical intervention (furosemide) was necessary to prevent permanent damage or impairment of body function (lung function)

53

TACO Imputability

• Definite: Meets definitive protocol criterion and no other cause of volume overload

• Probable: Judgment call by attending physician. Patient received other fluids, and transfusion is likely contributory to volume overload

• Possible: For patients with pre-existing cardiac insufficiency, imputability should not be classified as higher than possible

54

Case 9

• 75 year old man with elevated INR of unknown etiology

• Patient received 2 units of plasma prior to liver biopsy• The patient became agitated during the second unit.

He developed shortness of breath and decreased oxygen saturation to 92%

• Patient was treated with furosemide with no effect • Patient recovered within 24 hours• Chest X-ray showed increased interstitial markings in

the left lower lobe and increased cardiac size• Laboratory investigation showed no hemolysis

55

Case 9 – Transfusion Associated Dyspnea (TAD)

• Diagnosis: TAD




56

TAD Signs and Symptoms

• Definition: Characterized by respiratory distress within 24 hours of transfusion that does not meet the criteria of TRALI, TACO, or allergic reaction

• Definitive:

– Acute respiratory distress (dyspnea, orthopnea, cough) AND

– Occurs within 24 hours of transfusion AND

– TRALI, TACO, allergic reaction and patient’s underlying condition ruled out

• Probable: N/A

• Possible: N/A57

TAD Severity Grade


• This patient had a non-severe (Grade 1) reaction –patient improved without medical intervention; furosemide had little effect

58

TAD Imputability

• Definite: Meets definitive protocol criterion and the patient has no other conditions that could explain symptoms

• Probable: Other conditions that could explain respiratory distress are unlikely but not fully excluded

• Possible: Other conditions are present or were present before the transfusion that could explain the symptoms

59

Case 10

• 3 year old boy with neuroblastoma receiving chemotherapy at a university hospital

• Patient received 2 units of non-irradiated blood at a community hospital for severe anemia

• Approximately four weeks after the second unit, the boy was admitted with an erythemetous rash, hepatic dysfunction, diarrhea, and pancytopenia

• Despite aggressive treatment the child died one week later

• The parents refused HLA typing of themselves or the child

60

Case 10 – Transfusion Associated Graft vs. Host Disease (TA-GVHD)

• Diagnosis: TA-GVHD

• Case Definition Criteria: Possible

• Severity: Grade 4, Death

• Imputability: Possible

61

TA-GVHD Signs and Symptoms

• Definition: The introduction of immunocompetentlymphocytes into susceptible hosts. The allogeneic lymphocytes engraft, proliferate, and destroy host cells

• Definitive: A clinical syndrome occurring from 2 days to 6 weeks following transfusion characterized by symptoms of:

• Probable: – Clinical presentation of TA-GVHD with biopsy confirmation– No confirmation by chimerism studies (not done or negative)

• Possible: Clinical presentation without confirmation by biopsy or chimerism (not done or negative) studies

• Fever• Characteristic rash• Hepatomegaly• Diarrhea• Liver dysfunction

• Pancytopenia• WBC chimerism• Characteristic histologic

appearance on skin or liver biopsy

62

TA-GVHD Severity Grade

• Grade 1: N/A

• Grade 2: Patient had marked symptoms, responded to treatment

• Grade 3: Patient alive due to treatment (such as immunosuppression or bone marrow transplant)

• Grade 4: Death

63

TA-GVHD Imputability

• Definite: – Meets definitive protocol criterion and related to

blood donor

– Matching chimeric alleles in donor and recipient

• Probable: Presentation consistent with TA-GVHD; however chimerism demonstrated in recipient but matching alleles could not be tested in donor

• Possible: Apparent TA-GVHD when alternative explanations of cause are likely but TA-GVHD cannot be confirmed

64

Case 11

• 24 year old man multiply transfused due to aplastic anemia

• Patient received 1 unit of RBC as an outpatient

• Approximately 30 minutes into the transfusion, patient “did not feel well”, 10 minutes later he began to cough and the oxygen saturation was 86%

• Patient was admitted to the hospital and required supportive care including intubation for 2 days

• Chest X-ray showed bilateral infiltrates

• He recovered and was sent home on day 3

• Laboratory investigation revealed no hemolysis; the patient was HLA-A3 positive, plasma from the segment was shown to have strong anti-HLA-A3

65

Case 11 – Transfusion Related Acute Lung Injury (TRALI)

• Diagnosis: TRALI


• Severity: Grade 3, Life Threatening


66

TRALI Signs and Symptoms• Definition: Acute hypoxemia (FiO2 ratio <300 mmHg) combined

with chest X-ray showing bilateral infiltrates in the absence of left atrial hypertension (circulatory overload ruled out)

• Definitive: – No evidence of prior acute lung injury (ALI) to transfusion AND– Acute onset of ALI during or within 6 hours of transfusion AND– Hypoxemia

• PaO2 / FiO2 ≤ 300 mmHg OR• Oxygen saturation <90% on room air OR• Other clinical evidence

– AND– No evidence of left atrial hypertension (circulatory overload) AND– No temporal relationship to an alternative risk factor for ALI

during or within 6 hours of completion of transfusion AND– Bilateral infiltrates on Chest X-ray

• Probable: Same as definitive 67

TRALI Signs and Symptoms

• Possible: Same as definitive EXCEPT there is a temporal relationship to one of the following alternate risk factors:

- Direct lung injury• Aspiration• Pneumonia• Toxic inhalation• Lung contusion• Near drowning

– Indirect lung injury• Severe sepsis

• Shock• Multiple trauma• Burn injury• Acute pancreatitis• Cardiopulmonary bypass• Drug overdose

68

TRALI Severity Grade

• Grade 1 - 4: See slides 6-7

• This patient has Grade 3 (life-threatening) TRALI –intubation required to prevent death

69

TRALI Imputability

• Definite: If protocol criterion = Definitive, then relationship is Definite

• Possible: If protocol criterion = Possible then relationship is Possible

70

Infection-related Adverse Events

71

Infection Investigation Triggers• Identification of an unexpected bacterial, mycobacterium,

fungus, virus, or parasite in a recipient within the appropriate time period from transfusion to onset of infection

• Any of the above identified in the blood unit upon testing• Unexplained clinical events occurring after transfusion that

are consistent with transfusion-transmitted disease, such as:– Encephalitis, meningitis, or other unexplained central nervous

system abnormalities– Sepsis with or without multi-symptom organ failure– Death

• Infection in the recipient occurring within 6 months of transfusion if:– Initial donation testing was negative and donor was

subsequently found to be infected, but– Recipient had no pre-transfusion history of the same infection

72

Infection and Imputability

• To make this decision, the following is considered:

– Evidence of contamination of recipient unit upon testing

– Pre- and post-transfusion infection status of recipient

– Evidence of other recipients with infection from the same organism who received blood from the same donor

– Evidence of donor infection with the same organism

73

Case 12• 44 year old man with sickle cell anemia and a history of

multiple transfusions• Patient received 7 unit of RBCs during an exchange

transfusion• Approximately 3 months later, the patient presented with

jaundice and elevated liver enzymes• Anti-HCV was positive with a viral load >100,000 GEU/mL;

previous HCV testing had been negative• The donor was brought back in for testing and showed new

evidence of HCV infection (initial testing at time of donation was negative)

• Liver biopsy revealed moderate periportal necrosis (grade 2) and no fibrosis (grade 0). Iron staining was strong

• Patient received treatment for HCV• 3 months later his viral load was negative74

Case 12 – Infection

• Diagnosis: Infection – Hepatitis C Virus




75

Infection Severity Grade


• This patient has Grade 2 (severe) infection –treatment required to prevent significant morbidity

76

Infection Imputability

• Definite:

– An investigation trigger with laboratory evidence of the suspected organism in the recipient AND

– Laboratory evidence that the same recipient was negative for this organism prior to transfusion AND

– Laboratory evidence of the same organism in the donor or unit AND EITHER

– Laboratory evidence of the same organism in other recipients from the same donor OR

– Laboratory evidence of the same organism in the recipient unit upon residual testing

77


• Probable: – An investigation trigger with laboratory evidence of

the suspected organism in the recipient Plus any TWO of the following

– Laboratory evidence that the same recipient was negative for this organism prior to transfusion OR

– Laboratory evidence of the same organism in the donor or unit OR



78


• Possible:

– An investigation trigger

– Information essential for confirming or ruling out a case is missing, not available, or cannot be obtained

– Case fails to meet definition for definite, probable, or ruled out

79

Case 13

• 64 year old woman with leukemia

• Patient received 1 unit of platelets as an outpatient

• During transfusion she developed hypotension of 83/55, O2 saturation of 93%, fever of 39.4°C, chills, nausea, and vomiting

• Patient was transferred to ICU and started on antibiotics for presumed sepsis

• Laboratory analysis of the platelet unit showed abundant gram negative rods, later revealed to be Salmonella choleraesuis. The patient’s blood cultures revealed the same bacteria.

• The patient recovered and was discharged 80

Case 13 – Infection

• Diagnosis: Infection – Bacterial


• Severity: Grade 3, Life Threatening


81

Infection Severity Grade


• This patient has Grade 3 (life threatening) infection –ICU admission and treatment required to prevent death

82


• Definite:

– An investigation trigger with laboratory evidence of the suspected organism in the recipient AND

– Laboratory evidence that the same recipient was negative for this organism prior to transfusion AND

– Laboratory evidence of the same organism in the donor or unit AND EITHER



83


• Probable: – An investigation trigger with laboratory evidence of the

suspected organism in the recipient Plus any TWO of the following

– Laboratory evidence that the same recipient was negative for this organism prior to transfusion

– Laboratory evidence of the same organism in the donor or unit

– Laboratory evidence of the same organism in other recipients from the same donor


– Laboratory evidence of the same organism in the recipient upon residual testing

84


• Possible:

– An investigation trigger

– Information essential for confirming or ruling out a case is missing, not available, or cannot be obtained

– Case fails to meet definition for definite, probable, or ruled out

85

Questions?

86

References

• NHSN Hemovigilance Module https://www.cdc.gov/nhsn/pdfs/biovigilance/bv-hv-protocol-current.pdf

• https://www.cdc.gov/nhsn/PDFs/slides/Biovigilance_Component_Adverse_Reactions_Exercises_with_notes.pdf

87

https://www.cdc.gov/nhsn/pdfs/biovigilance/bv-hv-protocol-current.pdf

https://www.cdc.gov/nhsn/PDFs/slides/Biovigilance_Component_Adverse_Reactions_Exercises_with_notes.pdf

Transfusion Reactions – Hemovigilance Definitions 北京/Transf… · Transfusion Reactions – Hemovigilance Definitions Katie Wilkinson, MD Bloodworks Northwest, Seattle, WA Institute

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