2. • It is integrated systems of quality assurance covering all matters that
influence the guarantee of quality.
• It includes:
• Quality control and proficiency testing
• Internal and external audits
• Personnel
• Premises, equipement and materials
• Documentation
• Blood processing
3. • Complaints and component recall
• Investigation of errors and accidents
4. • Premises:
• It should include separate areas for :
1. Donor selection
2. Blood collection
3. Blood processing
4. Storage
5. Laboratory facilities
• Personnel:
1. Appropriate personnel – appropriate educational qualification,
training & experience to ensure competent performance.
5. • Donor selection:
• Voluntary, non-renumerated donations
• Consent form
• Donor checked for permanent record
• Donor must be checked for self harm
• List of questionnaires
• Interval between blood donations less than 3 months
• Age group 18-60 years
• Not less than 45 kilograms
• Temperature and pulse normal
• SBP and DBP should be within normal limits
• HB not less than 12.5g/dl
• Free from skin disease at site of phlebotomy
• Free from transmissible disease
6. • Avoid if suffering from :
• Cancer
• Heart disease
• Chronic infection
• Liver disease
• Tuberculosis
• Polycythemia vera
• Asthma / Epilepsy
• Leprosy
7. Blood collection & processing
1. Aseptic techniques
2. Seal closed method
3. Immediate storage at 1 – 6 degree
4. Components preparation within 6hrs of collection
5. Labels/ record: ABO/Rh grouping
6. Screening, expiry date and volume of blood
8. • Quality control of reagents:
• ABO reagents
• RH anti-sera
• ABO reagents:
• Appearance: no turbidity or gel formation by visual inspection – Daily
• Specificity: positive with corresponding Red cell Ag, no reaction with
control – Daily & each new lot
• Reactivity: no immune hemolysis, rouleaux formation - each new lot
• Potency – undiluted serum – 3+ using 3% red cell suspension – each
new lot
9. • Rh anti-sera:
• Appearance: no turbidity, precipitate or gel formation by visual
inspection – each day
• Specificity – positive reaction with Rh positive cells – each day &
each new lot
• Reactivity – no immune hemolysis, roulex formation – each new lot
• Potency – undiluted serum – 3+ reaction in each serum
10. • Anti-globulin reagent:
• Appearance – no turbidity, precipitate by visual inspection
• Reactivity & specificity – no hemolysis or agglutination of
unsensitised red cells
• Agglutination of red cells sensitised with anti-D serum
• Agglutination of red cells sensitised with a C3b & C3d
11. • Whole blood:
• Volume : 350/450
• Anticoagulants : 49/63 ml – all units
• PCV : 30 to 40%
• HBsAg – negative by ELISA – all units
• Anti- HCV – negative by ELISA – all units
• Syphilis – negative by screening test – all units
12. • Red cell concentrate:
• Volume 350+/- 20 ml
• PCV – 55 – 65%
• Leucocytes poor red cells modified by centrifugation:
• White cells removed - < 70% leucocytes of original quantity
• Residual Red cells remaining - > 70% of original quanity
13. • Quality control of equipment:
• Refrigerator for storage of blood:
• Read according temperature chart & digital temp at least once a day
• 2 – 6 degree
• Alarm system should be battery operated & independent electric
supply
• Once a week by immersing sensor in ice water & in water at 15-20 c
• Blood refrigerator should be clean and lit
14. • Laboratory centrifuge:
• Should be checked every 3-4 months for speed & times with stop
watch
• Cleaned regularly
• Water bath and incubator:
• They should be kept clean and water changed frequently
• Temperature should be checked frequently
15. Biosafety in transfusion in laboratory
• Microbiological tests must be performed in a separate room
• 1% sodium hypochlorite solution is the disinfectant – viral and
bacteriological – 30 min
• For spillage & heavily soiled equipments – hypochlorite 10 times
strength
16. Record keeping
• Record of blood donors
• Record of blood donations
• Record of blood component preparation
• Recipients requisition form
• Compatibility test record on requisition form
• Blood & blood components issue record
• Record of blood transfusion reaction & their investigations
17. QC IN TRANSFUSION PRACTICE
This involves safety practices in:
• Transfusion transmitted diseases
• Donor compatibility
1. Comparing the indentity information received from pt
with data on the lab certificate of comptibility testing
18. 2.Checking the certificate of pt’s blood group against
the blood group denoted on the blood unit label
3. Checking the expiry date
4. Recording the identity of the patient
20. SAFE TRANSFUSION PRACTICES
• Blood group & compatibility testing
– major cross match : donor cells matched with patients serum
– In red cell transfusion, there must be ABO and RHD
compatibility between the donor's cells and recipients plasma
• Clinical transfusion procedures
21. • Storage and transportation
– Whole blood and red cells: Between 2 and 6 0C
– Platelet : 20 to 24 0C for 5 days
– Fresh frozen plasma stored at -250C for 1 year
– Checking the blood bag : Any sign of hemolysis in the
plasma indicatig that the blood has been contaminated,
allowed to freeze or become too warm
