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Description : Checks and puts things in places to ensure that process, procedures and products meets the quality requirements.

Tags : Muna Hussien,blood,blood bank,about blood,quality in blood bank

Published on : Jan 30, 2023 | Views : 3795 | Downloads : 3

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Post-graduate presentation MSC ProgrammeHaematology Department
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QUALITY ASSURANCE IN THE BLOOD BANK Presented by: Muna Hussien
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Quality control Checks and puts things in places to ensure that process, procedures and products meets the quality requirements.
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The quality requirements involve Quality control and proficiency testing Internal and external audits Personnel and organization Premises, equipment and materials Documentation Blood processing Complaints and component recall Investigation of errors and accidents
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Quality System
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Quality assurance In Blood Banking is intended to ensure reliable test result with the necessary degree of precision and accuracy, It is included external and internal QC .
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QA IN COLLECTION OF BLOOD The quality, safety and efficacy of the product transfused is the result of many steps:- Donor selection Blood collection Component preparation Storage , issue and transportation
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Donor Selection Principle of self-sufficiency from voluntary and non- remunerated donations have been recommended and promote by the Council of the Europe Recommendations NO.R(95)14 Main 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. Information collection & evaluation Consent form Donor is registered for permanent record Donor must be checked for possible self harm or potential harm to recipient( list of questionnaires).
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Blood Collection Preparation for collection Equipment must be cleaned, calibrated & checked for performance e.g.: Blood container should be inspected for any defect in anticoagulant solution, moisture or discoloration of the surface of the bag or leakage. Blood bag refrigerator , centrifuge- need to be checked. Instruments must be washed with disinfectant- to minimize the contamination. Blood processing After blood Collection immediate storage at 1-6ºC Component's preparation must be done within 6 hours after collection Labels/Records : ABO and Rh grouping Screening, expiry date and volume of the blood
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Component Preparation Whole blood Red cell concentrates Platelet concentrates Fresh frozen Plasma Cryoprecipitate Granulocytes
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Whole bloodFrequency of control: 1% of all units with minimum of 4 units per month.Storage :- 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. QA Volume : 450ml ± 10 % of body volume excluding anticoagulant HCT : 40±5% pH > 6.5 K < 27mmol/L Hb minimum 45g/unit Sterility : no growth
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Red cell concentratesPerform the same assay as for Whole blood on the expiry date.Storage : 2-6º C, for 35 days if prepared from WB collected in CPDA-1 QA Volume : 280ml± 50ml, frequency of control 1% of all units. HCT : 0.65-0.75 pH > 6.5 K < 78 mmol/L Hb : minimum 45g/unit Sterility : no growth
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Platelet concentratesPrepared within 6H of blood collection.Must evaluate at least 4 platelet preparations monthly for platelet count, pH and plasma volume.Platelets should be selected from each centrifuge in use.The Tº at which pH is measured should be the same as stored.Label the volume, the actual volume by measurement must be 10% of the stated volume.Storage : 20-24ºC.Tº should be recorded at least every 4H during storage. QA Volume > 40ml pH : 6.8-7.4 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 tested WBC contamination: < 2 x 103/bag RBC contamination: < 2 x 109/bag Macroscopic appearance : no visible platelets aggregates Sterility : no growth
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Fresh frozen PlasmaEvery 10 unit/week estimate the volume.Storage: 24 months at below –30ºC. 12 months at –25 to –30ºC. 3 months at –18 to –25ºC.Thawed at Tº between 30-37ºC and transfused within 24H after thawing. QC: Volume: 220-250ml Factor VIIIc : > 0.7 IU/ml- every 2 months No leakage after pressure in plasma extractor, before freezing and after thawing Macroscopic : no abnormal color or visible clots Residual cell: Red cell: < 6.0 x 109/l Leukocyte: < 0.1 x 109/l Platelets : < 50 x 109/l
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CryoprecipitateAssayed on at least 4 bags/ month –for factor VIII.Storage: 24 months at below –30ºC. 12 months at –25 to –30ºC. 3 months at –18 to –25ºC.Must be thawed at 37ºC and used within 6H. QC Volume : 10-20 ml Factor VIII : > 70 IU/unit Fibrinogen : > 140 mg per unit Macroscopic : homogenous Sterility: no growth
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GranulocytesPrepared by apheresis.Storage: 20-24ºC for 24H. QC Volume : < 500ml Granulocytes : > 10 x 109 per unit- present in at least 75% of all units tested
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Transportation
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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 categories Errors of organization due to incorrect identification of samples or mistaken in transcription or in filing of results Technical errors due to poor quality of equipment, reagent or performance of the test. 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.
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Internal quality control are subdivided into: Control for equipment Control for reagents Control for techniques
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Control for equipment
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Blood Banking Refrigerator
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Blood Banking Refrigerator Monitoring System
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Blood Banking Equipment
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Blood Apheresis
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Full Automated Blood Banking Analyzer
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Control for reagents Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) by FDA Color codes by the FDA: Blue for anti-A Yellow for anti-B Green for AHG Use according to manufacturer's instruction The new reagent must be assessed & confirmed satisfactory The appearance each reagent must be checked each day The reactivity and specificity must check each new lot
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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)
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Grifols DG Gel 8 ABO/Rh cards for the determination of ABO forward and reverse group and D antigen. Qc Include positive and negative controls with testing on each day of use. If an unexpected control result is obtained, a complete assessment of the instrument, reagents and material used should be made. There are four levels of control (1, 2, 3, and 4) and for more accurate results in QC use confirmation card gel.
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Four Levels of Control
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Confirmation Card Gel.
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Blood Processing and Quality Control No leakage or puncture. Whole blood Pack Red cell Platelets FFP Cryoprecipitate
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External Quality control The internal QC should be complemented by regular external quality assurance e.g. : participation in a proficiency testing program. Proficiency program 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
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QC OF INFECTIOUS DISEASE TEST To reduce the blood borne infectious disease The 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 measure External quality checks, in confirmation of positive findings should be carried out Occasional internal exercise, using a panel of sera which have been built up by comparison with standards available External proficiency exercise, involving the testing of panel of sera circulated to lab by an approved reference institution Implementation of new technique should involve assessment on specificity and sensitivity Collection of representative data may be useful to monitor performance test
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QC IN TRANSFUSION PRACTICE Safety measure :- Transfusion transmitted diseases Donor compatibility Comparing the identity information received from pt with data on the lab certificate of compatibility testing Checking the certificate of the pt’s blood group against the blood group denoted on the blood unit label Checking the expiry date Recording the identity of the pt Sterility Clinical surveillance Careful observation of the pt during early stage of transfusion is mandatory to observe any transfusion reaction Transfused blood components on recommended time to avoid compromising clinical effectiveness and safety. Warming of blood Warming device used must be controlled and monitored to ensure the correct Tº achieved
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Cont.. Addition of medical products or infusion solutions to components No medical products added to prevent the risk of damage to blood components Handling of frozen units Handle with great care, no leak and transfused as soon as possible after thawing. The risk of air embolism It is possible under circumstances if the operator isn’t careful and skillful.
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Cont.. Transfusion complication Include adverse reactions and failure of expected therapeutic response Investigate.
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What are the steps when a blood transfusion reaction is suspected or occurs?
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Transfusion Reaction Laboratory Investigation Implicated Unit with attached giving set Repeat Group & X-match sample Blood Cultures on the patient if Temperature rise ≥ 1.5ºC above the baseline temperature together with chills or rigors Blood Culture from implicated treatment pack as per instructions below if high likelihood of bacterial contamination Full Blood Count Renal Profile MSU (mid-stream urine sample)
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Reference:
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THANK YOU