quality assurance in blood banking

1. Quality Assurance in Blood
Banking
Dr.Shahida Baloch

2. Fitness for purpose
Quality is an ongoing activity,
not a goal to be reached.
Quality

3. Quality is a process
• A continues cycle of
• Plan
• Do
• Check
• Act (Deming cycle)

4. Quality Control
1.Checks puts in places to ensure that
process, procedures and products meets the
quality requirements.
2. (consistency)

5. Blood Banking
An Area which, designed, constructed
and adapted to suit the operation to
be carried out. Separate area for
1.Donor selection
2.Blood collection
3.Blood processing
4.Storage
5. Laboratory facilities
6. Auxiliary facilities (Supportive
facilities)

6. The quality requirements involve:-
1. Quality control and proficiency testing
2. Internal and external audits
3. Personnel and organization
4. Premises, equipment and materials
5. Documentation
6. Blood processing
7. Complaints and component recall
8. Investigation of errors and accidents

7. 1.Quality control and proficiency
testing
• Quality Control related test
• Commercially available control
• Known Lab made Control
• Standards
• Known Patient and Normal Control

8. 2.Internal and external audits
• HOW TO PERFORM BLOOD BANK
AUDIT
• Component Traceability
• Unique Number for identification
• Who Donate, who perform test, which
patient transfused by p/c, or FFP, Platelets

9. 3.Personnel and organization
• Personnel with job description + extra
responsibilities
• Training and evaluation
• Job satisfaction
• Organization commitments

10. 4.Premises, equipment and
materials
• Suitable area for each job

11. Equipments
• Mandatory equipments
• Equipment place with work area
• Calibrated
• Well trained staff
• Maintained
• Daily, monthly and annually maintenance
• Use according to manufacturer
recommendation

12. 5. Documentation
• SOPs: e.g.
– Sample processing
– Inspection of incoming goods
– Validation
– Regular kit or reagent control
– Equipment maintenance and calibration
– Safety
– Result interpretation

13. Documentation
Records: e.g.Records: e.g.
•Equipment calibrationEquipment calibration
•Equipment maintenanceEquipment maintenance
•TrainingTraining
•ValidationValidation
•Control chartsControl charts
•Test resultsTest results

14. 6.Blood processing

15. 7.Complaints and component
recall
Are taken seriously
May be about any area of
contact with the BTS
May range from serious to trivial
Are recorded and acknowledged

16. 7.Complaints and component
recall
• Standard procedures for handling
complaints
– Trained staff for dealing with complaints
– Always quickly and effectively dealt with
– Outcomes of investigations are always fed
back to donors, whatever the findings

17. 8.Investigation of errors and
accidents
• Error policy
• Error reporting
• Error analysis
• Correction, corrective action and
preventive action

18. References
• 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