DR.P.K.RATH MD(PATH)

1. DR.P.K.RATH MD(PATH) GURU BRAHMA GURU VISHNU GURU DEVO MAHESWARAHA GURU SHATHSHATH PRA BRAMMAM DHASMAI SREE GURUVE NAMAHA

2. QUALITY ASSURANCE IN BLOOD BANKING Aravindakshan. MURALIDHARAN Doctors Blood Bank & Research Centre Trichy

3. INTRODUCTION • WHO defines the term QUALITY as, “ The consistent and reliable performance of Services or product in conformity with specified standards” • QUALITY ASSURANCE is vital for the successful operations of any blood transfusion services.

4. The All Important - Blood Donor - OUR DEMIGOD • Donor Motivation • Donor Awareness • Donor Incentive

5. Donor Selection • The Single most important factor towards Our Final Goal SAFE BLOOD Donor Experience Donor Retention Adherence to the SOPs

6. Blood Collection • Blood Bank policy regarding the blood usage • Choice of Bags : Quality of bag/ Type of Bag, Examination of Bags. • Good phlebotomy procedures • Blood Donor recovery and refreshment

7. Blood Component Preparation:- SOPs as per NABH, DGHS Guidelines for the preparation of Red Cells, FFP, Platelets & Cryo. Instrument calibration and validation

8. Storage • Calibration and validation of various equipments involved in storage such as BBRs, Deep Freezers, Platelet incubator and agitator etc.

9. Q A in Screening of Blood • Grouping : Manual / Automated • TTI Screening : Manual / Automated Quality control in this with positive control, negative controls, L J chart in this will help.

10. QC of Blood Component Preparation • Whole blood : • Volume : 350mls excluding anticoagulant • HCT : 40±5% • pH > 6.5 • K < 27mmol/L • Sterility : no growth

11. Red Cell Concentrates The expected values • Volume : 280ml ± 50ml, frequency of control 1% of all units • HCT : 65- 75 % • pH > 6.5 • K < 78 mmol/L • Sterility : no growth

12. Platelet Concentrates : • Volume > 30ml • 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: minimal • Macroscopic appearance : no visible platelets aggregates • Sterility : no growth

13. Fresh frozen plasma • Quality Control • Volume: 175 - 250ml • Should contain necessary units of factor VIII, factor IX, vWF and other plasma clotting factors • Macroscopic Examination: no abnormal color or visible clots

14. Cryo precipitate Quality Control : • Volume : 10- 15 ml • Factor VIII : 80 – 100 units/ Conc. • Fibrinogen : 150 – 250mg/ Conc. • von-Willebrand factor :40–70% of the original • Fibronectin : 55 mg • Factor XIII: 20-30% of the original • Sterility: no growth References : Compendium of Transfusion Medicine – Dr. Makroo

15. Issue of Blood Products: SOPs for issue of individual products Thawing procedures and calibration for thawing bath Packing and transportation of the products

16. QC FOR EQUIPMENT

20. Trouble shooting of untoward incidences • Reporting and recording of untoward incidences • Recall of components and rechecking (separate SOP for this should maintain) Changes in SOP for prevention of such incidences

21. TO CONCLUDE • Donor Selection and Retention • Instrument calibration • Test Validation • Maintanence of periodic QC of various blood products • Strict adherence to SOPs • Good Laboratory Practices - GLP

22. Quality Assurance is the right of every patient and it is the Duty of Every Blood Centre.

23. References: Compendium of Transfusion Medicine by Dr. R.N, Makroo MBBS, DIBT, MD Second Edition 2009. Transfusion Medicine Technical Manual by Director General of Health Services, INDIA - Second Edition 2003

24. Thank you