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

2. 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

3. 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

4. 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

5. 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 :
pH > 6.5
K < 78 mmol/L
Hb : minimum 45g/unit
Sterility : no growth

6. 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.

7. QC
Volume > 40ml
pH :
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

8. 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: ml
Factor VIIIc : > 0.7IU/ml- every 2 months
No leakage after pressure in plasma extractor, before freezing and after thawing

9. 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

10. 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

11. QC Volume : 10-20 ml Factor VIII : > 70 IU/unit
Fibrinogen : > 140 mg per unit
Macroscopic : homogenous
Sterility: no growth

12. 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

13. 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

14. Thank You