Quality Control in Blood Bank

Blood Components Preparation & QC

1. By
Dr. Nashwa Elsayed
Clinical Pathologist, CPHQ
Hospital Accreditations Manager
Laboratory & Blood Bank Quality Manager
KFH – Medina

Quality Control
in Blood Banking

2. QC is a Technique Used To Detect And Correct
Errors Before They Result In Defective Product or
Service.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

3. •Internal Quality Control 1
•External Quality Control 2

Quality Control in Blood Banking
Dr. Nashwa Elsayed

4. Quality Control in Blood Banking
Dr. Nashwa Elsayed

5. •Immunohematology Laboratory 1
•Transfusion Transmitted Disease Testing 2
•Component Preparation Lab 3

Quality Control in Blood Banking
Dr. Nashwa Elsayed

6. Quality Control in Blood Banking
Dr. Nashwa Elsayed

7. 1
•Ensure the Performance Of Reagents Quality Control On Each Day Of Use.
2
•Ensure Anti-sera Are Checked Against Known Positive And Negative Cells.
3
•Ensure Reagent Red Blood Cells Are Checked Against Known Positive & Negative
Anti-sera.
4
•Ensure Results Are Checked Against Predefined Acceptable Results.
5
•Ensure Results Are Reviewed And Reagents are Approved Before Use For Patient
Testing.
6
•Corrective Actions Are Taken For Unacceptable Results.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

8. The Primary Objective Of A Reagent Quality
Control Is

To Ensure That Reagent Is Functioning As
Expected.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

9. - All Reagents should be Clearly Labelled with:
1. * Batch Number.
2. * Expiry Date.
3. * Storage Temperature.
- Instructions For Use should be In-form of SOPs.
- All Reagents should be used according to the
 Manufacturer’s Instructions.
- FIFO shall be maintained

Quality Control in Blood Banking
Dr. Nashwa Elsayed

10. Supply, Storage And Transportation of Kits And
Reagents should be Strictly Standardized
According to Manufacturer’s Instructions

•With Ensured Continuous Power Supply And
Periodic Temperature Monitoring.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

11. Reagents Frequency of Testing
Blood Grouping Serum Each day of use
Reverse Grouping Cells (A cells & B Cells) Each day of use
Antibody Screening Cells Each day of use
Antibody Identification Cells

Each day of use

Quality Control in Blood Banking
Dr. Nashwa Elsayed

12. Parameters Quality Requirement Frequency of
Control
Appearance No turbidity, precipitate, particles or gel formation by visual
inspection
Each day
Specificity Positive reaction with red cells having corresponding antigen(s);
and no reaction with negative control
Daily and of each new
lot/batch
Avidity Macroscopic agglutination with 50% red cells suspension in
homologous serum/normal saline using the slide test at R.T;
10 seconds for anti-A, anti-B and anti-AB with A1 and/or B cells
20 seconds with A2 and A2B cells.
Daily and of each new
lot/batch
Reactivity No Immune Haemolysis, Rouleaux Formation or Prozone Each new lot/batch.
Potency Undiluted serum should give +++reactions in saline tube test
using a 3% red cells suspensions at R.T.,
Each new lot/batch.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

13. Quality Control in Blood Banking
Dr. Nashwa Elsayed

14. Quality Control in Blood Banking
Dr. Nashwa Elsayed

15. HBsAg.
Anti-HBc.
Anti-HCV.
Anti-HIV-1/2.
Anti-HTLV-I/II.
HIV-1 RNA.
HCV RNA.
HBV DNA.
Serological Test for Syphilis.
Malaria Parasite

Quality Control in Blood Banking
Dr. Nashwa Elsayed

16. Reagents Frequency of Testing
Hepatitis B Antigen Each Run
Anti-HBc Antibody Each Run
Anti-HIV 1 & 2 Antibody Each Run
Anti-HTLV-I/II Antibody Each Run
NAT (HIV-1 RNA, HCV RNA & HBV DNA) Each Run
Anti-HCV Antibody Each Run
Syphilis Serology Reagents Each Run
Malaria Test Each Run

Quality Control in Blood Banking
Dr. Nashwa Elsayed

17. •Collect optical density (OD) values for Controls for each
assay run.

•Collect cut-off (CO) value for each run.

•Calculate ratio of OD to CO (OD/CO) for each

•Use these ratio values to calculate the Mean, SD and
•CV%

Quality Control in Blood Banking
Dr. Nashwa Elsayed

18. •

Quality Control in Blood Banking
Dr. Nashwa Elsayed

19. •When 2 level QC Material are used Reject the Run:
•• Any QC value is outside 3 SD (1 3S)
•• Both QC value are outside 2 SD on the same side but
within 3 SD (2 2S)
•• Difference between both QC values is >4 SD (R 4S)
•• Ten consecutive values of same level are on one side of
mean (10X)
•• Five consecutive values of one level and five consecutive
value of other level QC are on same side of mean but within
2 SD (10X)

Quality Control in Blood Banking
Dr. Nashwa Elsayed

20. Quality Control in Blood Banking
Dr. Nashwa Elsayed

21. Parameters Quality Requirement Frequency of Control
Volume 350/450 ml + 10% 1% of all units
Anticoagulants 49/63 ml All units
PCV (Hct) 30 to 40% 4 units per month
TTD Negative by ELISA All units
Sterility By culture Periodically (1% of all units).

Quality Control in Blood Banking
Dr. Nashwa Elsayed

22. 1
•Prepared by separating the RBC from the plasma proteins.
2
•Stored under properly controlled conditions between 1 and 6°C.
3
•Transported in properly insulated container between 1 and 10°C.
4
•Expiration date according to the manufacturer’s recommendations or:
•21 Days for RBC in CPD.
•35 Days for RBC in CPDA-1.
•42 Days for RBC in additive solution.
•24 hours post opening the RBC unit.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

23. Ensure That 1% Of The Monthly Production but Not
Less Than 4 Units Every Month are Subjected To
Quality Control Testing.

All Tested RBC Units have a Hematocrit of < 80 %
•
RBC in Additive Solution Are Exempted From Quality
Control Requirement

Quality Control in Blood Banking
Dr. Nashwa Elsayed

24. The Quality Control of Red Cell Concentrate (Prepared from 450 ml Blood)
Parameters Quality Requirement Frequency of Control
Volume 280 + 40 ml 1% of all units
PCV (Hct) < 80 % Periodically (1% of all units)

Quality Control in Blood Banking
Dr. Nashwa Elsayed
The Quality Control of Red Cell in Preservative Sol. (ADSOL/SAGM)
Parameters Quality Requirement Frequency of Control
Volume 350 + 20 ml 1% of all units
PCV (Hct) 55 – 65 % Periodically (1% of all units)

25. 1
•Ensure that LR-RBC units are prepared by retaining 85% of the RBC in
the original product.
2
•Residual WBC count of less than 5 X10⁶ WBC/ unit
3
•Requirements for RBC Preparation, Storage, Transport and Expiration
apply

Quality Control in Blood Banking
Dr. Nashwa Elsayed

26. Ensure that 1% of the Quarterly Production but Not
Less Than 12 Units Every Three Months Are Subjected
To Quality Control Testing.

All Tested LR-RBC units have a RBC Recovery Rate of
More Than 85%

All Subjected Units have Residual WBC Count of Less
Than 5 X10⁶ WBC/unit.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

27. Quality Control in Blood Banking
Dr. Nashwa Elsayed

28. 1
•Prepared by separating the platelets from whole blood within 8 hours of
collection
2
•Stored under properly controlled conditions between 20 and 24°C with
continuous agitation.
3
•Transported in properly insulated container as close as possible to 20 and
24°C.
4
•Expiration date of:
•Twenty four hours to five days from the day of whole blood collection.
•According to the manufacturer’s recommendations.
•four hours of opening PC unit

Quality Control in Blood Banking
Dr. Nashwa Elsayed

29. Ensure That 1% Of The Monthly Production but Not
Less Than Four Units Every Month are Subjected to
Quality Control Testing.

On the Expiration Date or at Issue, 90% of the
Subjected Units have a Platelet Count of 5.5 X10¹º
platelets/unit or more

Minimum pH of 6.2

Quality Control in Blood Banking
Dr. Nashwa Elsayed

30. 1
•Prepared by retaining 85% of the platelets in the original product.
2
•Residual WBC count of:
•Less than 8.3 X10⁵ WBC/ unit
•or 5 X10⁶ WBC/pool of six units.
3
•Requirements for PC Preparation, Storage, Transport and Expiration
apply

Quality Control in Blood Banking
Dr. Nashwa Elsayed

31. Ensure that 1% of the Quarterly Production but Not Less
Than 12 every Three Months are subjected to quality
control testing.

Volume of All units 35 - 50 ml.

All Tested LR-PC units have a Platelets Recovery Rate of
More Than 85%

Residual WBC count of less than 8.3 X10⁵ WBC/Unit
or 5 X10⁶ WBC/Pool of Six Units.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

32. Quality Control in Blood Banking
Dr. Nashwa Elsayed

33. 1
•Prepared by separating the platelets from whole blood using
apheresis machine
2
•Requirements for PC Preparation, Storage, Transport and
Expiration apply

Quality Control in Blood Banking
Dr. Nashwa Elsayed

34. Ensure that 1% of the Quarterly Production but Not less than 4
units every Month are subjected to quality control testing.

Volume of All units >200 ml

On the Expiration Date or at Issue, 90% of the Subjected Units
have a Platelet Count of 3 X10¹¹ platelets/unit or more

Minimum pH of 6.2

Residual WBC count of 5 X10⁶ WBC/Unit.




Quality Control in Blood Banking
Dr. Nashwa Elsayed

35. Quality Control in Blood Banking
Dr. Nashwa Elsayed

36. 1
•Prepared by separating and freezing the plasma from;
•The whole blood within 8 hours of collection.
•Or within 6 hours for plasma collected by apheresis.
2
•Stored under properly controlled conditions below -18°C.
3
•During transportation are maintained at frozen state in properly insulated
container.
4
•Expiration date of one year from the day of whole blood collection

Quality Control in Blood Banking
Dr. Nashwa Elsayed

37. 1
•Prepared by thawing the FFP between 30 and 37°C without direct contact
with the water.
2
•Stored under properly controlled conditions between 1 and 6°C.
3
•Transported in properly insulated container between 1 and 10°C.
4
•Expiration time of twenty four hours from the thawing time

Quality Control in Blood Banking
Dr. Nashwa Elsayed

38. Ensure that 1% of the Quarterly Production but Not
less Than 12 every Three Months are subjected to
quality control testing.

Volume of units 200–220 ml.

75% of the Tested Units must have Minimum Factor
VIII level of 700 IU/L.




Quality Control in Blood Banking
Dr. Nashwa Elsayed

39. Quality Control in Blood Banking
Dr. Nashwa Elsayed

40. 1
•Prepared by separating cold insoluble proteins from Fresh Frozen Plasma
and re-freezing of the product within one hour of preparation.
2
•Stored under properly controlled conditions below -18°C.
3
•During transportation are maintained at frozen state in properly insulated
container.
4
•Expiration date of one year from the day of whole blood collection

Quality Control in Blood Banking
Dr. Nashwa Elsayed

41. 1
•Prepared by thawing CRYO units between 30 and 37°C without direct
•contact with the water.
2
•Stored and Transported at Room Temperature (between 20 and 24°C).
3
•Expiration Time:
•Six hours from the thawing time for individual units
•Four hours from the thawing time of pooled units.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

42. Ensure that 1% of the Quarterly Production but Not
less Than 12 every Three Months are subjected to
Quality Control Testing.

Volume of units 10–20 ml

75% of the Tested Units must have minimum:
Factor VIII level of 80 IU/Unit
and 150mg of Fibrinogen/Bag.




Quality Control in Blood Banking
Dr. Nashwa Elsayed

43. Quality Control in Blood Banking
Dr. Nashwa Elsayed

44. 1.High Htc in RBCs ?
2.High WBC in LR-RBC ?
3.Low Factor VIII in FFP or Cryo ?
4.Low Fibrinogen in Cryo ?
5.Bacterial Contamination ?
6.Low Plt Count in PC ?
7.RBC Contamination of PC or FFP?


Quality Control in Blood Banking
Dr. Nashwa Elsayed

45. Quality Control in Blood Banking
Dr. Nashwa Elsayed

46. The Performance of the Testing Procedures in Blood
Bank Laboratory are regularly assessed by participation
in a formal Proficiency Testing system;
CAP
EQAS
RICAS


Quality Control in Blood Banking
Dr. Nashwa Elsayed

47. •1. HBsAg
•2. Anti- HIV 1&2
•3. Anti- HCV
•4. Syphilis (VDRL)
•5. Malarial Parasite
•6. NAT ( HBV/ HCV/ HIV-1, HIV-2, HIV-O & HIV-M)
•7. Haemoglobin
•8. Blood Group
•9. Cross-match
•10. Antibody Screening & Identification
•11. Factor VIII
•12. Fibrinogen
•13. Sterility Testing
•14. APTT

Quality Control in Blood Banking
Dr. Nashwa Elsayed

48. •JAT Transfusion Medicine (Automated)
• Blood Group
• Cross-match
• Antibody Screening & Identification
•BDP5 Bacterial Detect Plts, 5 challenge
•NAT Nucleic Acid Testing
•VM Viral Markers
•GA Syphilis Serology

Quality Control in Blood Banking
Dr. Nashwa Elsayed

49. 1.Monitor Blood Bank performance and evaluate QC
measures.
2.Establish inter-Blood Bank comparability.
3.Ensure credibility of Blood Bank.
4.Stimulate performance improvement and promote
high standards of practice.
5.Encourage use of standard reagents/methodology
6.Identify common errors.

Quality Control in Blood Banking
Dr. Nashwa Elsayed

50. 1.Standards for Blood Banks and Transfusion Services, 30th edition, Bethesda,
MD, AABB 2016.

2.The Unified Practical Procedure Manual for Blood Banks in The Arab
Countries, 2013.

3.CBAHI CLBB/ NHS Standards 2016


Quality Control in Blood Banking
Dr. Nashwa Elsayed