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PATH YEAR 1
INTRODUCTION
Quality 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
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
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 source The 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.
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.
Cont.
Premises- must be located , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :a) Donor selection b) Blood collection c) Blood processing d) Storage e) Laboratory facilities f) Auxiliary facilities .
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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
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Blood processing:a) Donor selection b) Blood collection c) Component preparation d) Storage , issue and transportation e) Contract testing
Complaints and component recall- investigate as soon as possible the complaint and information that may suggest the defective blood components Investigation 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.
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 Contract testing
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.
within 6 hours after collection Labels/records : ABO and Rh grouping Screening, expiratory date and volume of the blood
QA:-
Volume : 450ml 10 % of body volume excluding anticoagulant HCT : 405% pH > 6.5 K < 27mmol/L Hb minimum 45g/unit Sterility : no growth
the expiry date Storage : 2-6 C, for 35 days if prepared from WB collected in CPDA-1 QA:
units HCT : 0.65-0.75 pH > 6.5 K < 78 mmol/L Hb : minimum 45g/unit Sterility : no growth
Platelet concentrates:
Prepared 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 T 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 : 20-24C T should be recorded at least every 4H during storage.
QC
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
Volume: 220-250ml Factor VIIIc : > 0.7IU/ml- every 2 months No leakage after pressure in plasma extractor, before freezing and after thawing
QC
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
Cryoprecipitate
Assayed on at least 4 bags/ month for factor
VIII Storage: 24 months at below 30C 12 months at 25 to 30C 3 months at 18 to 25C Must be thawed at 37C and used within 6H
QC
Volume : 10-20 ml Factor VIII : > 70 IU/unit Fibrinogen : > 140 mg per unit Macroscopic : homogenous Sterility: no growth
Granulocytes
Prepared by apheresis Storage: 20-24C for 24H QC
Volume : < 500ml Granulocytes : > 10 x 109 per unit- present in at least 75% of all units tested
Transportation
A 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 1-10C during transport All component routinely stored at 20-24C should be maintain T during shipment All frozen components should be transport in frozen state at 18C or colder Periodic T check and documented to ensure the transportation adequate to meet the criteria
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.
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 equipment Control for reagents Control for techniques
QC FOR EQUIPMENT
preparation has been established for ABO, Rh and antihuman 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 has to be assessed & confirmed satisfactory The appearance each reagent has to be checked each day The reactivity and specificity has to checked each new lot
reagents fulfill the requirement, false result are due to technique itself, either inadequate method or operational errors(inaccurate performance or incorrect interpretation)
regular external quality assurance eg : participation in a proficiency testing programme Proficiency 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 testingABO-grouping, Rh-typing and phenotyping and alloantibody detection
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 +ve findings should be carried out Occasional internal exercise, using a panel of sera which have been built up by comparison with standards available
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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.
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 pts blood group against the blood group denoted on the blood unit label Checking the expiry date Recording the identity of the pt
Sterility
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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 T achieved
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Addition of medical products or infusion
solutions to components
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Transfusion complication
Include adverse reactions and failure of expected therapeutic response Investigate:
Check all identification of recipient and blood product Check that the ABO and Rh blood group of the blood unit label is compatible with the patients blood group certificate A 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.
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Hospital transfusion committees
Should include representatives of the blood transfusion center and the main clinical units with a significant transfusion activity Include:physicians,nurses and administrative personnel Main goals are : To define blood transfusion policies adapted to the local clinical activities To conduct regular evaluation of blood transfusion practices To analyze any undesirable events due to blood transfusion To take any corrective measures if necessary
Reference:
Guide to the preparation, use and quality
assurance of blood components, 7th edition, Council of Europe Publishing Technical Manual American Association of Blood Banks, 11th edition