2 LEARNING OBJECTIVESThis presentation aims to familiarize participants withessential quality elements that govern quality control of blood components including sampling and the criteria for quality control for different componentsmaintenance and calibration of equipment used in preparation of blood componentsParticipants will also understand the factors that affect quality of blood components
4 Quality Blood Components can be made available only if all aspects of blood collection, component preparation, testing, storage and transport are monitoredProceduresPersonnelEquipmentsReagentsIndicated in the contents of the final products
5 Quality Control of Blood Components (1) Definition:Testing of random components to ensure they achieve reliably certain specific standardsIt includes analysis of test results and detection of irregularities to identify deficiencies in production of Blood & Blood Components
6 Quality Control of Blood Components (2) Indian standardsDrugs and Cosmetics Act 1940, Rules 1945 (Sch F, Part XII-B), Govt of IndiaTransfusion Medicine Technical Manual DGHS, Ministry of Health And Family Welfare, Govt of India, 2nd edition 2003Blood Bank Standards of NACO, Ministry of Health and Family Welfare, Govt of IndiaNABH Accreditation Standards for Blood Banks
7 Quality Control of Blood Components (3) Should be performed on at least 1% of all componentsproduced per month for all parameters to be measuredIf fewer than 100 per month, then at least 475% or more of components monitored must meetspecifications
8 Quality Control of Blood Components VolumeVol (ml) = Weight of bag + blood components(g) – wt of empty bagSpecific gravity of componentSpecific gravityPacked RBC =Platelets = 1.035Plasma = 1.030Whole blood = 1.050Volume should be recorded on all unitsAppropriate labels should be put
9 SAMPLING (1)Non-destructive sampling methods usually involve use of pack tubingMixing of product and stripping of lines are vital and methods need to be standardisedFor platelet count samples should be taken into a dry EDTA tube, to induce disaggregationSampling methods must be validated to ensure that they produce consistent samples, regardless of the operator
10 SAMPLING (2) NOT to be taken from the last part of the tube This section is difficult to strip properly and the last 2 cm should be cut off after stripping the rest of the line
11 QC of Blood and Blood Components WHOLE BLOODParameterQuality requirementFrequency of controlVolume350/450 ml +10%1% of all unitsAnticoagulants49/63 mlAll unitsPCV (Hct)30-40%4 units / monthSerology (HIV1+2, HBsAg, HCV, MP, Syphilis)NegativeSterilityBy culturePeriodically (1% of all units)
12 QC of RED CELL CONCENTRATE (from 450 ml blood) ParameterQuality requirementFrequency of controlVolume280 ml + 40 ml1% of all unitsPCV (Hct)70% + 5%PeriodicallySterilityBy culture(1% of all units)
13 QC of RED CELL CONCENTRATE in preservative solution (Adsol/SAGM) ParameterQuality requirementFrequencyof controlVolume350 ml + 20 ml1% of all unitsPCV (Hct)60% + 5%PeriodicallySterilityBy culture(1% of all units)
14 QC of Fresh Frozen Plasma (FFP) ParameterQuality requirementFrequency of controlVolumeml4 units / monthStable coagulation factors200 unitsof each factorFactor VIII0.7 units/mlFibrinogenmg
15 QC of Cryoprecipitate Parameter Quality requirement Frequency of controlVolume10-20 mlOccasionallyFactor VIIIunits*von-Willebrand factor40-70% of the original*Factor XIII20-30% of the originalFibrinogenmg*Fibronectin55 mgParameters marked with an asterisk are not mandatory75% units sampled and tested should have the values indicated above
16 QC of Platelet concentrate (RDP from 450 ml whole blood) ParameterQuality requirementFrequency of controlVolume50-70 mlAll unitsPlatelet count> 4.5 x 10104 units / monthpH> 6.0RBC contamination< 0.5 ml(5.5 x 109 RBCs)WBC contamination< 5.5 x x 108Values of Platelet count, RBC count & WBC counts are per bagNo pink/red discoloration on visual inspection= insufficient red cells to cause immunization
17 QC of Platelet concentrate (RDP from 450 ml whole blood) Platelet count> 4.5 x 1010per bag4 units / monthPlatelet Count in bag = Concentration x VolumeConcentration = x 109 / L= x 109 / ml1000 ml = x 10950 ml = ?= 50 x x 1091000= 50 x x = x 1010= x per bagExample is given to explain the calculation of Platelet count
18 QC of Platelet concentrate (RDP from 450 ml whole blood) RBC contamination< 0.5 ml(5.5 x 109 RBCs)4 units / monthNo pink/red discoloration on visual inspection= insufficient red cells to cause immunizationMCV of RBC = 90 m3 ~ 100 m3 = 102 m31 ml = 1 cc = 1 cm3 = 1 x (10 mm)3= 1 x m30.5 ml = 0.5 x m3= 0.5 x x 102 m3= 0.5 x RBCs= 5 x 109 RBCsCalculation is given to explain how to convert the red counts in ml
19 QC of Platelet concentrate (prepared from buffy coat) ParameterQuality requirementFrequency of controlVolume70-90 ml4 units / monthPlatelet count> 6-9 x 1010pH> 6.0RBC contaminationTraces to 0.5 mlWBC contamination< 5.5 x 106
20 QC of platelet concentrate (by Apheresis) ParameterQuality requirementFrequency of controlVolumeml4 units / monthPlatelet count> x 1011pH> 6.0RBC contaminationTraces to 0.5 mlResidual leucocytes< 5.0 x 106
21 Quality Check for Platelet Concentrates All units should show ‘swirling’ effect‘Absence of swirling in platelet concentrates is highly predictive of poor post-transfusion platelet count increments and increasedrisk of bacterial contamination’
22 When to Perform Quality Control For platelet products it should be done on expiry date (end of storage period) of the component.On installation and after repair of equipments (refrigerator, centrifuges, deep freezers etc.)Modification in procedure for components preparation.Recruitment of new personnel.
23 Factors Affecting the Quality of Blood Components (1) Selection of donorAntiplatelet drug therapy, defer for 72 hoursQuality of blood bag and anticoagulant preservative solution usedTechniques of phlebotomyClean venipunctureMinimal tissue traumaFlow-continuous and uninterrupted and should be completed in 8-10 minFrequent gentle mixing.
24 Factors Affecting the Quality of Blood Components (2)Time period: separation should be done within 8 hrs of collectionTransit temperature: C for not more than 8 hoursRefrigerated centrifuge calibration for maximum yield in minimum timeCritical variables – speed, temp, duration, rotor sizeAccurate balancing – dry weight preferredBag positionSwinging cups better than fixed angle cups
25 Factors Affecting the Quality of Blood Components (3) Storage temperature4±20C = WB, PRBC200C-240C = PRP-PC, BC-PC, AP-PC≤ -300C = FFP, CryopptUninterrupted, gentle flat bedded platelet incubator/agitator60-70 cycles /min1½” inch movement on either side.
26 QC OF EQUIPMENTS REFRIGERATED CENTRIFUGE Buckets & centrifuge bowls – clean with- warm water and mild detergent- 1% Na hypochlorite after each spill/breakageCalibrated upon receipt, repairs or if low platelet yieldsPreventive Maintenance- calibration of speed with a tachometer (twice a year)- cleaning and lubrication of motor- regular change of worn out carbon brushesPM = Preventive Maintenance
27 QC OF EQUIPMENTS CRYOPRECIPITATE BATH/WATER BATH Temperature - checked and recorded dailyChange water once a week or if leakageRecalibration of temperature controller if- temp. probe/ circuit board replaced- diff. in digital display & certified thermometer
28 QC OF EQUIPMENTS Platelet Agitator No. of strokes – 60-70/min Periodic cleaning & lubrication
29 QC OF EQUIPMENT FOR COMPONENT STORAGE Daily temp check of REFRIGERATORS,FREEZERS & PLATELET INCUBATORVisual and audio alarms – check regularlyMonitoring device - THERMOGRAPH(continuous temperature recorder)Temperature check- different locations in large equipmentActual temperature checked withHg thermometer in glycerolAlarm test - sensor dipped in abeaker with tap water / ice slush
30 Documentation Registers Component preparation Quality control of packed red cellsQuality control of platelets (PRP-PC & BC-PC)Quality control of AP-PCQuality control of FFP and cryoprecipitate
31 LEARNING OUTCOMEAt the end of this presentation, for ensuring good quality of blood components, participants must be familiar with1. Criteria for quality control for different componentsMaintenance and calibration of equipment used in preparation of blood componentsFactors that affect quality of blood components
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