QUALITY ASSURANCE IN THE BLOOD BANK DR. WAN ASWANI WAN YUSOF M. 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 :- Donor selection Blood collection Blood processing Storage Laboratory facilities Auxiliary facilities .

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

Cont… Blood processing:- Donor selection Blood collection Component preparation Storage , issue and transportation 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.

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). Preparation for collection Equipment 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 checked c) instruments must be washed with disinfectant- to minimize the contamination

Blood collection & processing Aseptic technique Seal closed method Immediate storage at 1-6ºC Components preparation has to be done within 6 hours after collection Labels/records : ABO and Rh grouping Screening, expiratory date and volume of the blood

QC of blood component preparation Whole blood: Frequency 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

Red cell concentrates Perform 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

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 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.

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

Fresh Frozen Plasma Every 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 : > 0.7IU/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 –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

Granulocytes Prepared 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

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 1-10ºC during transport All component routinely stored at 20-24ºC should be maintain T during shipment All frozen components should be transport in frozen state at –18ºC or colder Periodic T check and documented to ensure the transportation adequate to meet the criteria

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.

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

Quality 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 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

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)

External Quality Assurance The internal QC should be complemented by 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 testing- ABO-grouping, Rh-typing and phenotyping and alloantibody detection

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 +ve findings should be carried out Occasional internal exercise, using a panel of sera which have been built up by comparison with standards available

Cont… 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 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

Cont… Clinical surveillance Warming of blood 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

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.

Cont… 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 patient’s 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.

Cont… 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