DR.P.K.RATH MD(PATH)

GURU BRAHMA GURU VISHNU GURU DEVO MAHESWARAHA GURU SHATHSHATH PRA BRAMMAM DHASMAI SREE GURUVE NAMAHA

QUALITY ASSURANCE IN BLOOD BANKING

Aravindakshan. MURALIDHARAN Doctors Blood Bank & Research Centre Trichy

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.

The All Important - Blood Donor OUR DEMIGOD

 Donor Motivation  Donor Awareness  Donor Incentive

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

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

Blood Component Preparation

:  SOPs as per NABH, DGHS Guidelines for the preparation of Red Cells, FFP, Platelets & Cryo.

 Instrument calibration and validation

Storage

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

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.

QC of Blood Component Preparation  Whole blood :   Volume : 350mls excluding anticoagulant HCT : 40 ± 5%  pH > 6.5

 K < 27mmol/L  Sterility : no growth

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

Platelet Concentrates

:       Volume > 30ml pH : 6.8-7.4

Plt count : at least 5.5 x 10 10 /bag in at least 75% of the units tested at the end of the storage.

By apheresis : minimum 3 x 10 11 /bag platelets in at least 75% units tested WBC contamination: < 2 x 10 3 /bag.

RBC contamination: minimal   Macroscopic appearance : no visible platelets aggregates Sterility : no growth

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

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

Issue of Blood Products:

 SOPs for issue of individual products  Thawing procedures and calibration for thawing bath  Packing and transportation of the products

QC FOR EQUIPMENT

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

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

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

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

Thank you