QUALITY ASSURANCE & QUALITY CONTROL OF BLOOD COMPONENTS Syed Adnan Ali Cp = 10 .
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
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
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
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