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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.

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Presentation Transcript
introduction
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
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
slide4
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
slide5
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
slide6
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.
slide7
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
slide8
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
slide9
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
slide10
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
slide11
QC
    • Volume : 10-20 ml
    • Factor VIII : > 70 IU/unit
    • Fibrinogen : > 140 mg per unit
    • Macroscopic : homogenous
    • Sterility: no growth
quality control for reagents
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
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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