1. QUALITY ASSURANCE IN THE BLOOD BANK
DR. WAN ASWANI WAN YUSOF
M. PATH YEAR 1

2. INTRODUCTION
Quality management is an integrated systems of quality assurance covering all matters which individually or collectively influence the components in order to guarantee their quality.
Good Manufacturing Practice (GMP), quality control and audit programmed, all are closely linked together with the management of errors and accidents.
Internal quality control and proficiency testing are aspects of quality system concerns with examination of material component and the proficiency of the staff

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

4. Quality control- activities including steps of verification and testing which are used to assure the materials and processes meet their intended specifications.
Proficiency testing – an aspect of Quality Assurance which monitors the ability to perform laboratory procedures within established limits of accuracy through the analysis of unknown specimens distributed by an external source
The line between QC and PT in some cases is ill defined. The performance of QC procedures on component and reagent will be in itself a measure of the proficiency of the staff preparing these components.

5. Internal audits- to ensure that all procedure and associated quality control are performed according to the principles of GMP, and should be carried out according to an established programme by responsible person.
External audits should also be performed by a designated approved authority.
Personnel and organization- adequate number of qualified and trained personnel.Presence of organization chart showing the hierarchical structure of the blood transfusion service.

6. Cont….
Premises- must be located , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :-
Donor selection
Blood collection
Blood processing
Storage
Laboratory facilities
Auxiliary facilities .

7. Cont…
Equipment- manufactured equipment should be designed and maintained to suit its intended purpose and should not present any hazard to donors, components or operators. Periodic maintenance and calibration should be carried and documented according to established procedures.
Documentation- adequate documentation prevent errors which may result from communication.It include:-all manufactures steps, data affecting the quality of the component to be checked, from the donor to the recipient of the blood component and vice-versa

8. Cont… Blood processing:- Donor selection Blood collection
Component preparation
Storage , issue and transportation
Contract testing

9. Complaints and component recall- investigate as soon as possible the complaint and information that may suggest the defective blood components
Investigation of errors and accidents- organization involve with the blood bank should document and investigate the errors and accidents in order to identify system problems correction.”Near- miss” events as well as actual events with benign outcomes should be addressed as part of the quality system review related to errors and accidents.Document the corrective actions.

10. QA IN COLLECTION OF BLOOD
The quality, safety and efficacy of the product transfused is the result of many steps:-
Donor selection
Blood collection
Component preparation
Storage , issue and transportation
Contract testing

11. Donor selection
Principle of self-sufficiency from voluntary and non- remunerated donations have been recommended and promote by the Council of the Europe Recommendations No.R(95)14
Main purpose is to determine whether the person in good health, in order to protect the donor against damage to his/her own health, and to protect the recipient against transmission of disease or drugs which could be detrimental to the patient.

12. Information collection & evaluation
Consent form
Donor is registered for permanent record
Donor must be checked for possible self harm or potential harm to recipient( list of questionnaires).
Preparation for collection
Equipment must be cleaned, calibrated & checked for performance eg:
a)blood container should be inspected for any defect in anticoagulant solution, moisture or discoloration of the surface of the bag or leakage,
b) blood bag refrigerator , centrifuge- need to be checked
c) instruments must be washed with disinfectant- to minimize the contamination

13. Blood collection & processing
Aseptic technique
Seal closed method
Immediate storage at 1-6ºC
Components preparation has to be done within 6 hours after collection
Labels/records : ABO and Rh grouping
Screening, expiratory date and volume of the blood

14. QC of blood component preparation
Whole blood:
Frequency of control: 1% of all units with minimum of 4 units per month
Storage :- 2ºC to 6 ºC, for CPDA-1 the storage time is 35 days, CPD & CD2D – 22days.
On expire date :- measure HCT, pH, total Hb , K+ and perform sterility assays

15. QA:-
Volume : 450ml ± 10 % of body volume excluding anticoagulant
HCT : 40±5%
pH > 6.5
K < 27mmol/L
Hb minimum 45g/unit
Sterility : no growth

16. Red cell concentrates
Perform the same assay as for Whole blood on the expiry date
Storage : 2-6º C, for 35 days if prepared from WB collected in CPDA-1
QA:
Volume : 280ml± 50ml, frequency of control 1% of all units
HCT :
pH > 6.5
K < 78 mmol/L
Hb : minimum 45g/unit
Sterility : no growth

17. Platelet concentrates:
Prepared within 6H of blood collection
Must evaluate at least 4 platelet preparations monthly for platelet count,pH and plasma volume
Platelets should be selected from each centrifuge in use
The Tº at which pH is measured should be the same as stored
Label the volume, the actual volume by measurement must be 10% of the stated volume
Storage : 20-24ºC
Tº should be recorded at least every 4H during storage.

18. QC
Volume > 40ml
pH :
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: < 2 x 109/bag
Macroscopic appearance : no visible platelets aggregates
Sterility : no growth

19. Fresh Frozen Plasma Every 10 unit/week estimate the volume Storage:
24 months at below –30ºC
12 months at –25 to –30ºC
3 months at –18 to –25ºC
Thawed at Tº between 30-37ºC and transfused within 24H after thawing QC
Volume: ml
Factor VIIIc : > 0.7IU/ml- every 2 months
No leakage after pressure in plasma extractor, before freezing and after thawing

20. QC Macroscopic : no abnormal color or visible clots Residual cell:
Red cell: < 6.0 x 109/l
Leukocyte: < 0.1 x 109/l
Platelets : < 50 x 109/l

21. Cryoprecipitate Assayed on at least 4 bags/ month –for factor VIII
Storage:
24 months at below –30ºC
12 months at –25 to –30ºC
3 months at –18 to –25ºC
Must be thawed at 37ºC and used within 6H

22. QC Volume : 10-20 ml Factor VIII : > 70 IU/unit
Fibrinogen : > 140 mg per unit
Macroscopic : homogenous
Sterility: no growth

23. Granulocytes Prepared by apheresis Storage: 20-24ºC for 24H QC
Volume : < 500ml
Granulocytes : > 10 x 109 per unit- present in at least 75% of all units tested

24. Transportation
A system must be use to ensure that all blood and blood components shipped by or received into a blood bank or blood transfusion service have been maintained within T required.
All liquid RBC components kept at T of 1-10ºC during transport
All component routinely stored at 20-24ºC should be maintain T during shipment
All frozen components should be transport in frozen state at –18ºC or colder
Periodic T check and documented to ensure the transportation adequate to meet the criteria

25. QC IN BLOOD GROUP SEROLOGY
To ensure safety by providing a good and uniform quality and minimizing errors.
Staff training, assessment of staff capability, equipment maintenance and calibration is important.
Errors : 2 major categories
Errors of organization due to incorrect identification of samples or mistaken in transcription or in filing of results
Technical errors due to poor quality of equipment, reagent or performance of the test.

26. Cont..
General approach in QC- to compare ABO- and Rh-typing results with previous data.This will disclose errors of both categories.
Based upon internal QC and external QC.
Internal quality control are subdivided into:
Control for equipment
Control for reagents
Control for techniques

27. QC FOR EQUIPMENT

29. Quality control for reagents
Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) by FDA
Color codes by the FDA:
Blue for anti-A
Yellow for anti-B
Green for AHG
Use according to manufacturer's instruction
The new reagent has to be assessed & confirmed satisfactory
The appearance each reagent has to be checked each day
The reactivity and specificity has to checked each new lot

30. Quality control of technique
Provided the quality of equipment and reagents fulfill the requirement, false result are due to technique itself, either inadequate method or operational errors(inaccurate performance or incorrect interpretation)

33. External Quality Assurance
The internal QC should be complemented by regular external quality assurance eg : participation in a proficiency testing programme
Proficiency programme test, coded “normal” and “problem” blood samples are distributed from national or regional reference laboratory to the participants usually 2x to 4x a year.
The exercise limited to compatibility testing- ABO-grouping, Rh-typing and phenotyping and alloantibody detection

34. QC OF INFECTIOUS DISEASE TEST
To reduce the blood borne infectious disease
The specific approach to quality of the screening must rely on the following categories:-
Internal QC covering the reagents and techniques. Batch pre acceptance testing(BPAT) of new batches of kits could be performed as an additional QA measure
External quality checks, in confirmation of +ve findings should be carried out
Occasional internal exercise, using a panel of sera which have been built up by comparison with standards available

35. Cont…
External proficiency exercise, involving the testing of panel of sera circulated to lab by an approved reference institution
Implementation of new technique should involve assessment on specificity and sensitivity
Collection of representative data may be useful to monitor performance test.

36. QC IN TRANSFUSION PRACTICE
Safety measure :-
Transfusion transmitted diseases
Donor compatibility
Comparing the identity information received from pt with data on the lab certificate of compatibility testing
Checking the certificate of the pt’s blood group against the blood group denoted on the blood unit label
Checking the expiry date
Recording the identity of the pt
Sterility

37. Cont… Clinical surveillance Warming of blood
Careful observation of the pt during early stage of transfusion is mandatory to observe any transfusion reaction
Transfused blood components on recommended time to avoid compromising clinical effectiveness and safety.
Warming of blood
Warming device used must be controlled and monitored to ensure the correct Tº achieved

38. Cont..
Addition of medical products or infusion solutions to components
No medical products added to prevent the risk of damage to blood components
Handling of frozen units
Handle with great care, no leak and transfused as soon as possible after thawing.
The risk of air embolism
It is possible under circumstances if the operator isn’t careful and skillful.

39. Cont… Transfusion complication
Include adverse reactions and failure of expected therapeutic response
Investigate:
Check all identification of recipient and blood product
Check that the ABO and Rh blood group of the blood unit label is compatible with the patient’s blood group certificate
A blood sample taken before the transfusion and after the transfusion, the blood unit with the transfusion set maintained in site sent for investigation. Recommended to do a direct smear, bacterial culture of the blood unit, serological Ix for blood group incompatibility and inspection for any damage.

40. Cont… Hospital transfusion committees
Should include representatives of the blood transfusion center and the main clinical units with a significant transfusion activity
Include:physicians,nurses and administrative personnel
Main goals are :-
To define blood transfusion policies adapted to the local clinical activities
To conduct regular evaluation of blood transfusion practices
To analyze any undesirable events due to blood transfusion
To take any corrective measures if necessary

41. Reference:
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