Presentation on theme: "QUALITY ASSURANCE IN THE BLOOD BANK"— Presentation transcript:
1 QUALITY ASSURANCE IN THE BLOOD BANK DR. WAN ASWANI WAN YUSOFM. PATH YEAR 1
2 INTRODUCTIONQuality management is an integrated systems of quality assurance covering all matters which individually or collectively influence the components in order to guarantee their quality.Good Manufacturing Practice (GMP), quality control and audit programmed, all are closely linked together with the management of errors and accidents.Internal quality control and proficiency testing are aspects of quality system concerns with examination of material component and the proficiency of the staff
3 The quality requirements involve:- Quality control and proficiency testingInternal and external auditsPersonnel and organizationPremises, equipment and materialsDocumentationBlood processingComplaints and component recallInvestigation of errors and accidents
4 Quality control- activities including steps of verification and testing which are used to assure the materials and processes meet their intended specifications.Proficiency testing – an aspect of Quality Assurance which monitors the ability to perform laboratory procedures within established limits of accuracy through the analysis of unknown specimens distributed by an external sourceThe line between QC and PT in some cases is ill defined. The performance of QC procedures on component and reagent will be in itself a measure of the proficiency of the staff preparing these components.
5 Internal audits- to ensure that all procedure and associated quality control are performed according to the principles of GMP, and should be carried out according to an established programme by responsible person.External audits should also be performed by a designated approved authority.Personnel and organization- adequate number of qualified and trained personnel.Presence of organization chart showing the hierarchical structure of the blood transfusion service.
6 Cont….Premises- must be located , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :-Donor selectionBlood collectionBlood processingStorageLaboratory facilitiesAuxiliary facilities.
7 Cont…Equipment- manufactured equipment should be designed and maintained to suit its intended purpose and should not present any hazard to donors, components or operators. Periodic maintenance and calibration should be carried and documented according to established procedures.Documentation- adequate documentation prevent errors which may result from communication.It include:-all manufactures steps, data affecting the quality of the component to be checked, from the donor to the recipient of the blood component and vice-versa
9 Complaints and component recall- investigate as soon as possible the complaint and information that may suggest the defective blood componentsInvestigation of errors and accidents- organization involve with the blood bank should document and investigate the errors and accidents in order to identify system problems correction.”Near- miss” events as well as actual events with benign outcomes should be addressed as part of the quality system review related to errors and accidents.Document the corrective actions.
10 QA IN COLLECTION OF BLOOD The quality, safety and efficacy of the product transfused is the result of many steps:-Donor selectionBlood collectionComponent preparationStorage , issue and transportationContract testing
11 Donor selectionPrinciple of self-sufficiency from voluntary and non- remunerated donations have been recommended and promote by the Council of the Europe Recommendations No.R(95)14Main purpose is to determine whether the person in good health, in order to protect the donor against damage to his/her own health, and to protect the recipient against transmission of disease or drugs which could be detrimental to the patient.
12 Information collection & evaluation Consent formDonor is registered for permanent recordDonor must be checked for possible self harm or potential harm to recipient( list of questionnaires).Preparation for collectionEquipment must be cleaned, calibrated & checked for performance eg:a)blood container should be inspected for any defect in anticoagulant solution, moisture or discoloration of the surface of the bag or leakage,b) blood bag refrigerator , centrifuge- need to be checkedc) instruments must be washed with disinfectant- to minimize the contamination
13 Blood collection & processing Aseptic techniqueSeal closed methodImmediate storage at 1-6ºCComponents preparation has to be done within 6 hours after collectionLabels/records : ABO and Rh groupingScreening, expiratory date and volume of the blood
14 QC of blood component preparation Whole blood:Frequency of control: 1% of all units with minimum of 4 units per monthStorage :- 2ºC to 6 ºC, for CPDA-1 the storage time is 35 days, CPD & CD2D – 22days.On expire date :- measure HCT, pH, total Hb , K+ and perform sterility assays
15 QA:-Volume : 450ml ± 10 % of body volume excluding anticoagulantHCT : 40±5%pH > 6.5K < 27mmol/LHb minimum 45g/unitSterility : no growth
16 Red cell concentratesPerform the same assay as for Whole blood on the expiry dateStorage : 2-6º C, for 35 days if prepared from WB collected in CPDA-1QA:Volume : 280ml± 50ml, frequency of control 1% of all unitsHCT :pH > 6.5K < 78 mmol/LHb : minimum 45g/unitSterility : no growth
17 Platelet concentrates: Prepared within 6H of blood collectionMust evaluate at least 4 platelet preparations monthly for platelet count,pH and plasma volumePlatelets should be selected from each centrifuge in useThe Tº at which pH is measured should be the same as storedLabel the volume, the actual volume by measurement must be 10% of the stated volumeStorage : 20-24ºCTº should be recorded at least every 4H during storage.
18 QCVolume > 40mlpH :Plt count : at least 5.5 x 1010 /bag in at least 75% of the units tested at the end of the storage.By apheresis : minimum 3 x 1011/bag platelets in at least 75% units testedWBC contamination: < 2 x 103/bagRBC contamination: < 2 x 109/bagMacroscopic appearance : no visible platelets aggregatesSterility : no growth
19 Fresh Frozen Plasma Every 10 unit/week estimate the volume Storage: 24 months at below –30ºC12 months at –25 to –30ºC3 months at –18 to –25ºCThawed at Tº between 30-37ºC and transfused within 24H after thawingQCVolume: mlFactor VIIIc : > 0.7IU/ml- every 2 monthsNo leakage after pressure in plasma extractor, before freezing and after thawing
20 QC Macroscopic : no abnormal color or visible clots Residual cell: Red cell: < 6.0 x 109/lLeukocyte: < 0.1 x 109/lPlatelets : < 50 x 109/l
21 Cryoprecipitate Assayed on at least 4 bags/ month –for factor VIII Storage:24 months at below –30ºC12 months at –25 to –30ºC3 months at –18 to –25ºCMust be thawed at 37ºC and used within 6H
22 QC Volume : 10-20 ml Factor VIII : > 70 IU/unit Fibrinogen : > 140 mg per unitMacroscopic : homogenousSterility: no growth
23 Granulocytes Prepared by apheresis Storage: 20-24ºC for 24H QC Volume : < 500mlGranulocytes : > 10 x 109 per unit- present in at least 75% of all units tested
24 TransportationA system must be use to ensure that all blood and blood components shipped by or received into a blood bank or blood transfusion service have been maintained within T required.All liquid RBC components kept at T of 1-10ºC during transportAll component routinely stored at 20-24ºC should be maintain T during shipmentAll frozen components should be transport in frozen state at –18ºC or colderPeriodic T check and documented to ensure the transportation adequate to meet the criteria
25 QC IN BLOOD GROUP SEROLOGY To ensure safety by providing a good and uniform quality and minimizing errors.Staff training, assessment of staff capability, equipment maintenance and calibration is important.Errors : 2 major categoriesErrors of organization due to incorrect identification of samples or mistaken in transcription or in filing of resultsTechnical errors due to poor quality of equipment, reagent or performance of the test.
26 Cont..General approach in QC- to compare ABO- and Rh-typing results with previous data.This will disclose errors of both categories.Based upon internal QC and external QC.Internal quality control are subdivided into:Control for equipmentControl for reagentsControl for techniques
29 Quality control for reagents Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) by FDAColor codes by the FDA:Blue for anti-AYellow for anti-BGreen for AHGUse according to manufacturer's instructionThe new reagent has to be assessed & confirmed satisfactoryThe appearance each reagent has to be checked each dayThe reactivity and specificity has to checked each new lot
30 Quality control of technique Provided the quality of equipment and reagents fulfill the requirement, false result are due to technique itself, either inadequate method or operational errors(inaccurate performance or incorrect interpretation)
33 External Quality Assurance The internal QC should be complemented by regular external quality assurance eg : participation in a proficiency testing programmeProficiency programme test, coded “normal” and “problem” blood samples are distributed from national or regional reference laboratory to the participants usually 2x to 4x a year.The exercise limited to compatibility testing- ABO-grouping, Rh-typing and phenotyping and alloantibody detection
34 QC OF INFECTIOUS DISEASE TEST To reduce the blood borne infectious diseaseThe specific approach to quality of the screening must rely on the following categories:-Internal QC covering the reagents and techniques. Batch pre acceptance testing(BPAT) of new batches of kits could be performed as an additional QA measureExternal quality checks, in confirmation of +ve findings should be carried outOccasional internal exercise, using a panel of sera which have been built up by comparison with standards available
35 Cont…External proficiency exercise, involving the testing of panel of sera circulated to lab by an approved reference institutionImplementation of new technique should involve assessment on specificity and sensitivityCollection of representative data may be useful to monitor performance test.
36 QC IN TRANSFUSION PRACTICE Safety measure :-Transfusion transmitted diseasesDonor compatibilityComparing the identity information received from pt with data on the lab certificate of compatibility testingChecking the certificate of the pt’s blood group against the blood group denoted on the blood unit labelChecking the expiry dateRecording the identity of the ptSterility
37 Cont… Clinical surveillance Warming of blood Careful observation of the pt during early stage of transfusion is mandatory to observe any transfusion reactionTransfused blood components on recommended time to avoid compromising clinical effectiveness and safety.Warming of bloodWarming device used must be controlled and monitored to ensure the correct Tº achieved
38 Cont..Addition of medical products or infusion solutions to componentsNo medical products added to prevent the risk of damage to blood componentsHandling of frozen unitsHandle with great care, no leak and transfused as soon as possible after thawing.The risk of air embolismIt is possible under circumstances if the operator isn’t careful and skillful.
39 Cont… Transfusion complication Include adverse reactions and failure of expected therapeutic responseInvestigate:Check all identification of recipient and blood productCheck that the ABO and Rh blood group of the blood unit label is compatible with the patient’s blood group certificateA blood sample taken before the transfusion and after the transfusion, the blood unit with the transfusion set maintained in site sent for investigation. Recommended to do a direct smear, bacterial culture of the blood unit, serological Ix for blood group incompatibility and inspection for any damage.
40 Cont… Hospital transfusion committees Should include representatives of the blood transfusion center and the main clinical units with a significant transfusion activityInclude:physicians,nurses and administrative personnelMain goals are :-To define blood transfusion policies adapted to the local clinical activitiesTo conduct regular evaluation of blood transfusion practicesTo analyze any undesirable events due to blood transfusionTo take any corrective measures if necessary
41 Reference:Guide to the preparation, use and quality assurance of blood components, 7th edition, Council of Europe PublishingTechnical Manual American Association of Blood Banks, 11th edition