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

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