تعريف هموويژلانس و اهميت آن

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- *TERMINOLOGY VIGILANCE .

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- * () ( ) .Debier J, Noel L, Aullen J, Frette C, Sari F, Mai MP, Cosson A. The French Haemovigilance system: VOX sang 1999; 77(2) : 77-81

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- *Recruitment Ensuring safety at each level*

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- *Blood collectionTestingProcessingReleaseStorageDistributionPrescriptionStorage of Blood stockTransfusion& follow upPretransfusiontestingRecruitment*

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1-ABC of Transfusion by Marcela Contreras 2009 page:832-Debier J, Noel L, Aullen J, Frette C, Sari F, Mai MP, Cosson A. The French Haemovigilance system:VOX sang 1999; 77(2):77-81

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- *Errors and Near-Misses ABC of Transfusion by Marcela Contreras 2009 page:84 table 15-1

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- *No Blame Culture L.L. Leape 2000

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- * (RBC) ( FFP ) . . .AABB TECHNICAL MANUAL 2008 chapter6 PAGE:189-225

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- *( Whole blood ) 450 ( ) 63 . 36 44 .

35 ) CPDA-1 )21 ( (CPD 6-1 .

AABB TECHNICAL MANUAL 2008 chapter6 PAGE:189-225

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g/dL 1 3 .

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Text book of Blood Banking and Transfusion Medicine 2007 by Sally V.Rudmann chapter14 page:370-396

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- * Massive Transfusion ( 4-5 24 ).

Exchange Transfusion

Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007 chapter 35 page:669-684

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Blood Transfusion Therapy;9Th Edition;2008;Chapter1;p:9

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- *(RBC ) 250 . 65 80 . ) CPDA-1 ) 35 6-1 . 300-150 5-2 . RBC ABO . g/dL 1 4-3 . ml/kg10-8 g/dL 2 6 . AABB TECHNICAL MANUAL 2008 chapter6 PAGE:189-225Text book of Blood Banking and Transfusion Medicine 2007 by Sally V.Rudmann chapter14 page:370-396

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* 15% Acute Blood loss>15%

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- * Fresh Frozen Plasma 250-200 . 30- 18- (EUROPE OF COUNCIL,IBTO SOP) . , , .

AABB TECHNICAL MANUAL 2008 PAGE:200-220

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- * Fresh Frozen Plasma* FFP 37 4 . 1 6 24 . * : 300-200 * : 120-60 * 260-170 ( ) . AABB TECHNICAL MANUAL 2008 chapter6 PAGE:200-210 & 620

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cc 10 cc 20 .

-Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007 chapter 35 page:669-684

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- - - (DIC) TTPPT,PTT 5/1 ( ) Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007 chapter 35 page:669-684

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Blood Banking & Transfusion Medicine;Hillyer;Second Edition;Table 19.1;page:260;2007

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- * Fresh Frozen Plasma ABO , AB A B . RhIG Rh plasma exchange 3 RhIG 50 .

-Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007 chapter 35 page:669-684-Transfusion Therapy :Clinical Principles and Practice;page429-430;2005

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- * (Cryoprecipitate) 15 . . 30- . 260-170 ( ) . 25- . 18- . (IBTO SOP)


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- * (Cryo precipitate) 37 . 6 . . ABO . Rh .

1-Blood Banking & Transfusion Medicine;Hillyer;Second Edition;page:271;20072-AABB TECHNICAL MANUAL 2008 chapter21 PAGE:613-622

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- * (Cryo precipitate)

* ( ) 5 10 .

1-AABB TECHNICAL MANUAL 2008 chapter6 PAGE:2022-Blood Banking & Transfusion Medicine;Hillyer;Second Edition;page:271;2007

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- * 8 ( ) ( ) 13 (DDAVP )

Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. chapter 35 page:669-684, 2007

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- *CryoPoorPlasma (CPP) 200 Cryo Precipitate-Reduced .

VIIIC .

TTP .

AABB TECHNICAL MANUAL, chapter26 PAGE:702 ,2008

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- * ( Platelet concentration ) 2 22 ( ) 3 . .

:70 - 50

AABB TECHNICAL MANUAL, chapter6 PAGE:189-225, 2008

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- ** Random donor PlateletsWhole blood 1 unitPlatelet Concentrate 1 unit> 5.5 x 1010 platelets in 50 - 70 ml of plasma 3 daysSingle donor platelets1 DonorPlatelet concentrate

> 3 x 1011 platelets in ~ 300 ml of plasma3 daysHenrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. chapter 35 page:669-684, 2007

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- * ( Platelet concentration )* ABO . Rh Rh . Rh .* CCI . 5 .* 10000-5000 60000-30000 .

1-Text book of Blood Banking and Transfusion Medicine, by Sally V.Rudmann chapter14 page:370-396, 2007 2-Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. chapter 35 page:669-684 ;2007 3-Blood Banking andTransfusion Medicine;Hillyer;p:326:2007

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- * * : - Plt

- ** ITP .*HIT(Heparin InducedThrombocytopenia) TTP .

Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007 chapter 35 page:669-684

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- *Random Donor PlateletVolume 50 70 ml

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- *Single Donor PlateletVolume ~ 300 ml

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- *Contains : at least 85% of original red cellsWBC < 5 x 106 Prevention of HLA alloimmunization, CMV, Repeated FNHTR ( Leukocyte depleted red blood cells )AABB TECHNICAL MANUAL 2008 chapter6 PAGE:189-225

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- *Indications for Leukoreduced Blood Components1-Reduce rate of recurrent febrile nonhemolytic transfusion reactions (FNHTRs)2-Reduce rate of HLA alloimmunization among hematologyoncology patients 3-Reduce rate of Cytomegalovirus transmission to susceptible recipients

Blood Banking and Transfusion Medicine;D.Hillyer;Second Edition;2007:Table 26-1;Page:361,

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- *: ABO ABO .Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007 chapter 35 page:669-684

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- *Henrys Clinical Diagnosis & Laboratory Management By Laboratory Methods. 2007chapter 35 page:669-684

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- * ABO& RhHandbook of Transfusion Medicine. D.Hillyer. 2001

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AABB TECHNICAL MANUAL 2008 chapter 15 PAGE:438-441

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1-AABB TECHNICAL MANUAL 2008 chapter 15 PAGE:438-4412- ABC of Transfusion by Marcela Contreras 2009 page:11

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1-AABB TECHNICAL MANUAL 2008 chapter 15 PAGE:4412- ABC of Transfusion by Marcela Contreras 2009 page:12

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1-AABB TECHNICAL MANUAL 2008 chapter 21 PAGE:613-6172- ABC of Transfusion by Marcela Contreras 2009 page:12

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. -AABB TECHNICAL MANUAL 2008 chapter 21 PAGE:617

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1-AABB TECHNICAL MANUAL 2008 chapter 21 PAGE:6172-ABC of Transfusion by Marcela Contreras 2009 page:113

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ABC of Transfusion by Marcela Contreras 2009 page :87

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- * Blood Warmer *Massive transfusion*Adminstration Rate:>50ml/min for 30 min in Adult >15 ml/kg/hr in Pedi.

*Exchange transfusion of a newborn

Transfusion Therapy;2nd Edition;page:603 ;2005

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- * : Bacterial contamination AHTRFNHTR TRALI Other Causes : Clinical Guide To Transfusion ; Canadian Blood Service ;Chapter10;p:82-111;July2006

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Bradykinin mediatedHypotension - -Sepsis -AHTR-TRALI-Other CausesClinical Guide To Transfusion ; Canadian Blood Service ;Chapter10;p:82-111;July2006

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1- 2- : - - DAT( DAT )- - ABO-Rh 3- Technical Manual ABB16TH,Chapter27;p:716-724;2008

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- **Bacterial Contamination*The source of the bacteria can be donor blood, donor skin flora, or contaminants introduced during collection, processing, and storage.*Numerous gram-positive and gram-negative organisms can occur: Staphyloccus aureus, Klebsiella pneumoniae, Serratia marcescens,Pseudomonas and Staphyloccus epidermidis.Technical Manual ABB16TH,Chapter8;p:256;2008

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- **Bacterial ContaminationBacterial sepsis;Incidence :Pooled RDP :1/700 1 Unit of RBC:1/31,000 Rate of bacterial infection/contaminationis higher with platelets is because they are stored at room temperature and the units are generally pooled between 6 and 10 donor units.

Technical Manual ABB16TH,Chapter8;p:256;2008Blood Banking & Transfusion Medicine;Sally v.rudman;Second Edition;page:407;2005

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- **Bacterial ContaminationPresentations: Fever Chills Tachycardia Hypotension Shock * The patient may also develop DIC and acute renal failure.Technical Manual ABB16TH,Chapter8 & 27;p:256-729-730;2008

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- **Laboratory evaluationin Bacterial Contamination *1-Visual examination returned component: -COLOR CHANGE -BUBBLES *2-Grams stain on returned component *3-Cultures on returned component & post transfusion specimen

Technical Manual ABB16TH,Chapter 27;p:719;2008

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- **Bacterial Contamination MANAGEMENT*Stop transfusion & maintain IV access*Take patient vital signs*Recheck identification of & blood products*Notify physician*Notify transfusion service: Other products from the same donor can be quarantined*Return clamped blood unit& tubing attached for cultureCollect blood samples for blood culture Broad spectrum antibiotic therapy

Clinical Guide To Transfusion ; Canadian Blood Service ;July2006

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- **Bacterial ContaminationPREVENTION : *Inspect all blood products for visual evidence of contamination

*The first 40 ml of blood collected is diverted in a pouch to reduce risk of transmitting organisms from skinTechnical Manual ABB16TH,Chapter 6;p:192;2008

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- **Acute Hemolytic Transfusion Reactions (AHTR)Pathophysiology: -Transfusion of ABO incompatible RBC -Other antibodies:Kell,Rh,Kidd,Duffy -Transfusion of ABO incompatible Plasma Incidence:Acute Hemolytic: 1/6000-1/20,000Fatal: 1/100,000-1/600,000

Technical Manual ABB16TH,Chapter 27;p:717-728;2008

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- **Acute Hemolytic Transfusion Reactions (AHTR)Pathophsiology:When incompatible blood is given, antibodies and complement in the recipient plasma attack the antigens on the donor RBC.Hemolysis ensuesThe antigen-antibody complex activate the Hageman factor (factor XII), which acts on the kinin system to produce bradykininBradykinin increases capillary permeability and dilates arterioles, both which cause hypotensionTechnical Manual ABB16TH,Chapter 27;p:725-728;2008

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- **Acute Hemolytic Transfusion Reactions (AHTR)Activation of the complement system results in the release of histamine and serotonin from mast cells resulting in bronchospasm.DICRenal damage occurs for several reasons, blood flow is reduced because of hypotension and renal vasoconstriction, free hemoglobin can cause a mechanical obstruction, and if DIC occurs fibrin thrombi can be deposited in the renal vascularTechnical Manual ABB16TH,Chapter 27;p:725-728;2008

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- **Signs and Symptoms of AHTRFeverChillsNausea and VomitingDiarrheaHypotensionFlushed appearance and DyspneaChest pain and back painPt is restless, and has a headacheHemoglubinuria, and possible diffuse bleedingTechnical Manual ABB16TH,Chapter 27;p:725-728;2008

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- **Symptoms under GAMany signs and symptoms will be masked by general anesthesia.

Hypotension, hemoglobinuria, and diffuse bleeding may be the only clues that a transfusion reaction has occurred.Clinical Guide To Transfusion ; Canadian Blood Service ;July2006

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- **Extended Testing*ABO/Rh on pre and post transfusion specimens*ABO/Rh on donor unit

*DAT on pre and post transfusion specimensTechnical Manual ABB16TH,Chapter27;2008

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- **Direct Antiglobulin Test (DAT)

*To determine if there is in vivo RBC sensitization*May be negative if all transfused red cells were destroyed*If positive, perform monospecific DAT to determine if it is IgG, C3 or bothTechnical Manual ABB16TH,Chapter27;p:723; 2008

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- **Additional laboratory evaluationin AHTR*Antibody screen on pre and post transfusion specimens

*CROSS MATCH should be repeated with pre and post transfusion specimens using IAT

*Serial Hb-LDH-Unconjugated bilirubin measurment

Technical Manual ABB16TH,Chapter27;p:723; 2008

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- **Management of AHTRManagement has 3 main objectives:1-Maintenance of systemic blood pressure

2-Preservation of renal function

3-Prevention of DIC Technical Manual ABB16TH,Chapter27;p:727; 2008

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- **Therapeutic Approach*Keep urine output >1/ml/kg/hr with fluid & IV diuretic (furosemide)*Analgesic( may need morphine)*Low dose dopamine *Haemostatic components (PlT,Cryo,FFP) for bleeding

Technical Manual ABB16TH,Chapter27;p:727-728; 2008

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- **Non immune Hemolysis

*Improper shipping or storage temp.

* Using small needle size

* Improper use of blood warmer

* Bacterial contamination

Technical Manual ABB16TH,Chapter27;p:728; 2008

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- **Minor Allergic Reactions*Soluble antigens in the donor plasma react with IgE bound to mast cells causing histamine release.*Allergic reactions can cause urticarial reactions in 1-3% of all transfusions*The pt. may have itching, swelling, and a rash as a result of histamine releaseTechnical Manual ABB16TH,Chapter27;p:730-733; 2008

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- **Therapeutic/Prophylactic Approach*Antihistamine,treatment or premedication(PO or IV)

*Transfusion restart slowly after Antihistamine if symptom resolveTechnical Manual ABB16TH,Chapter27;p:730-733; 2008

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- **Anaphylactic ReactionsThis occurs in :*Pts with hereditary IgA deficiency *Ab against C4-Haptoglobin-Ethylene OxideIncidence: 1/20,000-1/50,000 of transfusions Reactions include:Dyspnea, Bronchospasm, Hypotension, laryngeal edema, Wheezing,stridor, and shockTechnical Manual ABB16TH,Chapter27;p:730-733; 2008

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- **Laboratory evaluationin Anaphylaxis

*-Perform quantitative IgA test

*-Perform Anti IgATechnical Manual ABB16TH,Chapter27;p:718; 2008

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- **Therapeutic/Prophylactic Approach*Trendelenberg position*Epinephrine(Adult dose :0.2-0.5 ml of 1/1000 solution SC IM , in sever cases 1/10000 IV*Antihistamines,corticosteroids,beta-2 agonists Prevention:*transfusion of IgA deficient components or Washed cellular components


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- * - *Febrile Reactions (FNHTR)Definition:*Temperature increase of greater than 1 degree centigrade within 1-2 hours for which no other cause is identifiable.*The response occurs in 0.5-6% of RBCs transfused*Up to30% of PLT transfused

Technical Manual ABB16TH,Chapter27;p:729-730; 2008Blood Banking & Transfusion Medicine;Sally v.rudman;Second Edition;page:401;2005

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- **Febrile Reactions (FNHTR)Pathophysiology:1-Patients who receive multiple transfusions often develop antibodies to the HLA antigens on the passenger leukocytesDuring subsequent RBC transfusions, febrile reactions may occur as a result of antibody attack on donor leukocytes2-Generation of leukocyte-derived cytokines during storageTechnical Manual ABB16TH,Chapter27;p:729-730; 2008

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- **Febrile Reactions (FNHTR)TREATMENT:

*Antipyretic

(Acetaminophen, no aspirin)


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- **Transfusion-related acute lung injury (TRALI)Definition :* Acute Onset* Hypoxemia O2 saturation

- **Transfusion-related acute lung injury (TRALI)Incidence :1/5000-1/190,000 blood and blood components transfused*Packed red cells and -Cryo-FFP can cause TRALI* 15ml of blood component are sufficient to cause TRALI


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- **Transfusion-related acute lung injury(TRALI)Etiology:1-The antibody-mediated model (Ab to HLA Class-HNA)

2-The two-event (biologically response modifiers) model


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- **Transfusion-related acute lung injury (TRALI)Common symptoms and signs: FeverProgressive dyspneaCyanosisHypoxemiaHypotension or Hypertension (rarely)


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- **Additional laboratory evaluationin TRALI1-WBC Ab screening in donor & recipientIf positve antigen typing may be indicated

2- WBC cross match Technical Manual ABB16TH,Chapter27;p:719; 2008

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- **Transfusion-related acute lung injury (TRALI)Management :*Supportive *Transfusion of the suspected blood product should cease immediately* Oxygen therapy*Mechanical ventilation in severe TRALI* No diuretics* Corticosteroids in TRALI: unproven


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- **Transfusion-related acute lung injury (TRALI)Prognosis :*Most patients recover within 4896hr h*Hypoxemia and radiological evidence of pulmonary infiltration can persist for 7 days in 20% of patients*70% patients require mechanical ventilation*In-hospital mortality: 510%


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- **Transfusion-related acute lung injury (TRALI)Prevention :No universally agreed approach to donor management1-It is suggested that donors implicated in TRALI and who have demonstrable antibodies should be permanently disqualified from the donor pool 2-Deferring multiparous female3-Using male donor plasma4-Washed blood productsTechnical Manual ABB16TH,Chapter27;p:733-735; 2008

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- **Circulatory OverloadHigh risk patients are:Adults >60y & infantsIncidence :

- **Circulatory OverloadTreatment:Stop transfusionUpright postureOxygen therapyIV diuretic (furosmide)PhlebotomyPrevention: * Administer transfusion slowly(1ml/kg/hr)* Use of diureticsTechnical Manual ABB16TH,Chapter27;p:733-735; 2008 -Blood Banking & Transfusion Medicine;Hillyer;Second Edition;page:684;2007

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- *-Blood Banking & Transfusion Medicine;Hillyer;Second Edition;page:677;Table 50-1;2007

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- ** 1-Technical Manual ABB;16TH;2008

2- Blood Banking and Transfusion Medicine. D.Hillyer. 2007

3- Henrys Clinical Diagnosis & Laboratory Management by Laboratory Method;21 Edition,2007

4-Clinical Guide To Transfusion ; Canadian Blood Service ;July 2006

5-Textbook of Blood Banking & Transfusion Medicine; Second Edition; Sally v.Rudmann;2005

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- *MANAGEMENT ALGORITHM OF TRANSFUSION ADVERSE REACTION IN HOSPITALS8 Hours LEVEL ITRAINED NURSESLEVEL IIISTOP TRANSFUSION CONTACT WITH PHYSICIAN AND REPORT THE SIGNS & SYMPTOMSCOMPLETE ADVERSE REACTION FORM of TRANSFUSIONCONSULTANTPHYSICIAN

HAEMOVIGILANCE CENTRAL OFFICE 1- EVALUATE ADVERSE REACTION & GUIDE THE NURSES2- COMPLETE THE REST OF ADVERSE REACTION FORM3- DETERMINE THE ETIOLOGY 4- CONSULT WITH CONSULTANT PHYSICIAN IF NECESSARY5-FAX THE FORM TO HAEMOVIGIANCE OFFICE1- DETERMINE OR CONFIRM THE ETIOLOGY OF ADVERSE REACTION

1- ANALYSE THE REPORTED ADVERSE REACTION AND ISSUE THE RESULT TO HEALTH MINISTERY2- DETRMINE CORRECTIVE ACTION FOR PRVENTION OF ADVERSE REACTION 3- SUPERVISION FOR CORRECTIVE ACTIONS

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***Incorrect blood product transfused. This includes all mistakenly transfused products, such as blood component intended for another patient or blood component not suitable for patient, regardless whether or not harm arises. Also homologous blood transfused when autologous blood was available, or non -irradiated blood component transfused to a patient which was supposed to receive irradiated blood, is reportable. - This year we had already a few reports of mis-identifications. Fortunately, all patient were of the A blood group. -no harm was done, but a clear signal that the process is not safe and needs improvement. How do I react, when such errors are reported. - I try to get a clear picture of the process and which factors contributed to the error.Why did it happen. One report mentioned that an inexperienced nurse who was new in the department did not follow established procedures. I suppose this points to deficiencies in the job introductory program. One has to evaluate why errors and near misses happened, including all aspects, such as not enough staff, insufficient training, no written instruction to follow, in order to minimise reoccurrence and in an effort to implement solid and robust procedures.

Learn from errorsEliminate root cause of error**The effectiveness of the hemovigilance system depends on the participation of all institutions. An important factor is training of personnel to recognize an adverse event or the absence of the desired therapeutic effect. In order to have representative data which reflects an accurate picture, all institutions must participate in the hemovigilance scheme. Another major factor to the validity of the data are proper clinical information forwarded with the reports and results of laboratory investigations. Only, if we receive reports of high quality are the analysis and assessments of the reports of any value and form a basis for deductions and conclusions. ** Before I continue, I must mention one point which is extremely important to me. Despite having a mandatory Hemovigilance system, one of the main pillars of it is a no blame culture. Staff and patients involved in adverse events remain anonymous. *****************************************************************************

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تعريف هموويژلانس و اهميت آن