QUALITY MANAGEMENT SYSTEMS IN BLOOD BANKS.pdf

Quality management system in Blood Banks

1. QUALITY MANAGEMENT
SYSTEMS IN BLOOD
BANKS

2. INDEX
Quality managements and its objectives
Elements in QMS
Organization of blood bank
Documentation and control
General requirements of blood bank
( Area , Accommodation, Staff )
Equipmentent management
Quality Control of reagents and blood components
Quality in transfusion services
Quality assurance
Audits in blood bank

3. Blood Transfusion Safety and Regulatory Requirements
•Blood bank is a vital part of National Health
Services.
•Human blood is covered under the definition of
“Drugs” under sec 2A(b)of Drugs and Cosmetics
Act (D & C Act).
•Blood Banks are regulated under the Drugs and
Cosmetics Act and license granted for operating it
by the State Licensing and Central License
Approving Authorities after inspection.

4. OBJECTIVES OF QMS TRAINING OF BLOOD BANKING
1 QUALITY CONTROL
(QC) includes evaluating a test or
procedure within a process, and it
also determines whether it works
as expected or not at a particular
time.
In this-organization should perform
QC of reagents, blood
components, equipment, etc.
2QUALITYASURANCE
Quality assurance is defined as a
system designed to produce a good
quality product from input source
materials by implementing a
consistently performed
manufacturing process.
Quality assurance aims to implement a
safe and effective process that
ensures continuous safety and
quality of the product.
Quality assurance includes detection,
investigation, prioritization, and
correction of errors with the
ultimate aim of error prevention.

5. ESSENTIAL ELEMENTS OF THE QUALITY MANAGEMENT
SYSTEMS IN BLOOD BANK
1. Organization and
leadership
2. Human resources
3. Equipment
management
4. Suppliers and materials
management
5. Process control and
management
6. Documents and records
7. Information
management
8. Management of non-
conforming events
9. Monitoring and
assessment
10. Process improvement
11. Facilities, work
environment, and safety

6. ORGANISATION MANAGEMENT
•Organogram
It is a written, dated and signed organizational
structure of the Blood Banks, which clearly
defines the reporting structures and hierarchies
of the management and staff.
The organogram should be displayed at a place
where it can be viewed by the staff. All staff
within the blood bank should have clearly defined
lines of authority and responsibility.
Responsibility should not be given without
authority.

8. PERSONNAL

9. DOCCUMENTATION AND CONTROL
Documentation hierarchy
It has 4 levels

10. General Requirements of Blood bank (as per
D&C Act, 1945)
1. Premises shall be well lighted, ventilated and
screened (mesh), wherever necessary.
2. Walls and Floors of the rooms shall be
smooth & washable.
3. Drains shall be of adequate size and equipped
with traps to prevent back siphonage.
4. Permit operation under hygienic conditions.

11. Accommodation
A blood bank shall have an area of 100 sq.mt for its
operation and an additional area of 50 sq.mt. for
preparation of blood components as detailed below:
Registration & Medical Examination Room
Blood Collection Room (A/C).
Blood Component Preparation Room (A/C)
Laboratory for Blood Group Serology (A/C)
Laboratory for Blood Transmissible Diseases (A/C)
Sterilization-cum-Washing Room
Refreshment-cum-rest Room (A/C)
Store-cum-records Room

12. EQUIPMENT MANAGEMENT
Following equipment are used in Blood Bank
Blood Collection
-Donor weighing balance
-Haemoglobinometer
-Sphygmomanometer
-Stethoscope
-Blood mixer and shaker
-Tube stripper and
electrictube sealer
-Needle destroyer
Blood Processing
-Refrigerated Centrifuges
-Double pan balance
-Plasma Expresser -
Manual/Automated

13. Blood Storage
-Blood Bank Refrigerator
-35°C Deep Freezers
-80°C Deep Freezers
-Platelet Agitator and
-Incubator
-Cell Separators (Apheresis
machine)
Blood Testing
-pH Meter
-Cell Counter (optional)
-Coagulometer(optional)
-Automated Cell Grouping
system (optional)
-Equipment for Gel technology
(optional)
-Table top centrifuge
-Serological water bath
-ELISAreader(Plate reader/ strip
reader)
-VDRLshaker

14. Equipment management program

15. Equipment Calibration

17. QC OF REAGENTS

18. Acceptance titreand avidity of ABO
reagents

19. QC OF ANTI D antisera

21. . Quality control of saline reagents:

22. QC OF WHOLE BLOOD

23. QC OF RED BLOOD CELLS

24. QC OF Random Donor Platelet

25. QC OF Single Donor ApheresisPlatelet

26. QC OF PLASMA

27. QC OF CRYOPRECIPITATE

28. QUALITY OF TRANSFUSION SERVICES
TRANSPORTATION
Collection of the component to and from the blood bank, maintaining
the cold chain and delivering to the ward/theatre involves following
steps:-
-the patient’s relative accompanied by ward attendant
collect the blood Following care is to be taken before
issuing
-Check the patients name, age and registration number
with the details on the cross-match tag.
-Check that blood group and unit number on the cross
match tag tallies with those on the blood unit.
-Check the expiry date.
-Check for any leakage, discoloration or haemolysis.
-Deliver the blood unit only in insulated containers.
-Deliver it to ward nurse/ doctor who shall be responsible
for proper storage till transfusion

29. Pre Transfusion Checks
•Before administering blood component, FINAL IDENTITY check of the patient,
blood unit compatibility tag and the complete documentation should be done.
•1. This is the last chance to detect an identification error and to
prevent a potentially incompatible transfusion.
•2. Ask the patient, if conscious, to identity himself/ herself by name,
parentage, age or any other identification.
•3. If unconscious ,ask relatives or any other staff to verify the patient’s
identity.
cont…..

30. •4. Check that details on the compatibility tag
exactly match with the documentation.
•5. Check that there is no discrepancy between
the unique donation number, blood group
between the blood unit and the compatibility tag.
•6. Check that expiry date on the unit has not
already passed.
•7. Check the blood unit for any leakage and for
any visible discoloration.

31. Storage in Ward/Operation Theatre
•Proper storage of blood and blood components
both in the blood bank and in the clinical area is
important to preserve the function and prevent
bacterial contamination.
•Red cells are to be stored in refrigerator at 2-6
oC,Platelets are to be kept at room temperature
of 20-24oC till transfused.
•In case a domestic refrigerator is being used, do
not keep the component on the shelves of the
door or chill tray.

32. Time Limits of Transfusion
Monitoring the transfused patients.
•1. Encourage the patient to notify any discomfort during
transfusion.
•2. Acute reaction generally occurs within 15 minutes.

33. Recording the Transfusion
•The following information should be recorded . Pre-
transfusion checks carried out and found satisfactory.
•Condition of blood unit and the identity of the
recipient are found satisfactory.
•1. Time the transfusion is started
•2. Time the transfusion is completed.
•3. Volume and type of all the components transfused.
•4. Unique donation number of all components
transfused.
•5. Any adverse effects.
•6. Signature of the person giving transfusion.

34. EXTERNAL QUALITY ASSURANCE
•The internal QCshould 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 twice to four times
in a year.

36. EQAS-Benefits to participating Labs
•Comparison with performance of other
participating labs.
•Identification of problems relating to laboratory
processes, techniques and reagents .
•Provision of information & education to improve
performance
•Encouragement of best practice
•Enhanced credibility of the laboratory
•Access to a network of labs for exchange of
information.

37. EQAS in Transfusion Medicine
•Method by which entire testing process including
quality of results generated by a lab is assessed
•Assess laboratory’s performance using samples
of known but undisclosed content
•Monitors
-Whether samples are handled correctly
-Assays are performed accurately & efficiently
-Results are recorded appropriately

38. AUDITS
•Internal audits
to ensure that all procedures and associated quality control are
performed according to the principles of Good Manufacturing
Practices.( GMP)
•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.