2. Testing routinely performed tests/activities on
materials and equipments to check their proper
function.
The monitoring system that checks the
effectiveness of existing process/steps by
testing the quality of final products.

3. 01
DONOR SELECTION
02
BLOOD COLLECTION
03
COMPONENT PREPARATION,
STORAGE AND
TRANSPORTATION
04
EQUIPMENT AND
REAGENTS

5. 1. Only individuals in good health should be
accepted
2. The health and safety of the donor as well
as the recipient must be safeguarded.
3. Regularly review the selection criteria,
without discrimination of any kind
including gender, race, nationality or
religion.
4. Donor’s health status and medical history
should be evaluated.

6. 5. The BloodTransfusion Service should
provide appropriate donor information and
a simple donor questionnaire and risk
assessment and obtain the donor’s
informed consent to blood donation.
6. Staff should be suitably qualified and
trained in the donor selection process.
7. Donor confidentiality should be assured.

8. 1. Area for collection must be adequate, with
suitable equipment and services.
2. Donor identification and assessment of
eligibility to donate should take place
before each donation.
3. Must ensure that the sample tubes and
blood bags are from the same donor,
uniquely labelled and linked to the donor’s
record to allow full product traceability.

9. 4. The donor must be re-identified immediately
prior to venipuncture
5. Appropriate preparation of the venipuncture
site is important to reduce the risk of
bacterial contamination.
6. A check should be made before use to ensure
that the collection system is not damaged or
contaminated.
7. A system for donor vigilance and the
management of adverse reactions related to
blood donation must be in place.

11. •Frequency of control: 1% of all units
with minimum of 4 units per month
•Storage : 1˚C to 6˚C
•CPDA-1 the storage time is 35 days
CPDA-1 : anticoagulant citrate-phosphate-dextrose-adenine solution.

12. Prepared by separating the RBC from the plasma proteins
Storage temperature: 1-6˚C
Transported in properly insulated container between 1-10˚C
Expiration date according to the manufacturer’s
recommendations:
21 days for RBC in CPD
35 days for RBC in CPDA-1
42 days for RBC in additive solutions
24 hours post-opening the RBC unit
ADDITIVE SOLUTIONS:
Are anticoagulant‐preservative
solutions that contain varying
concentrations of adenine,
which allow increased storage of
RBCs to a maximum of 42 days.

13. •Prepared within 6 hours of blood collection
•Storage : 20o-24ºC
•Transported in properly insulated container
as close as possible to 20-24˚C

14. •Frozen within 6 hours of blood
collection using –80oC deep freezers or
blast freezers
•Stored at –30oC
•Shelf life: 1 year

15. Stored at -18˚C
During transportation are maintained at
frozen state in properly insulated container.
Expiration date: 1 year

17. 1. Preventive maintenance should be planned for
trouble free operation
2. Uninterrupted power supply should be
planned for all equipment with efficient back
up system
3. Annual maintenance contract with
manufacturers and suppliers should be
obtained
4. A written record of periodic function checks
and maintenance on each piece of equipment
should be mandatory.

18. Equipments Method of control Frequency of
control
Control
executed by
Laboratory refrigerator,
freezers, water bath,
blood bag refrigerator
Thermometer Daily Technician
Cryofuge Tempt: thermometer
Precision RPM:
tachometer
Daily Technician
Platelet agitator Frequency of
agitation
Monthly Technician
Laminar flow hood and
sterile area filter
Air pressure
Particle counter
Daily
3 times a month
Microbiologist

19. CRYOFUGE
PLATELET AGGITATOR
BLOOD BANK FREEZER

20. Equipments Method of control Frequency of
control
Control executed
by
Blood mixer thermometer Daily Technician
Blood bag tube
sealer
Calibration with
standard
Daily Technician
Blood transport
container
Calibration;
reference sample
Daily Technician

21. Use according to manufacturer’s instruction
The new reagent has to be assessed &
confirmed satisfactory
The appearance of each reagent has to be
checked daily
The reactivity and specificity has to checked
each new lot
FIFO shall be maintained

22. Reagents Frequency of testing
along with Controls
Anti human globulin serum Each day of use
Blood grouping serum Each day of use
Antibody screening and
reverse grouping cells
Each day of use
Enzymes Each run
Normal saline (LISS and BPS) Each day of use
Bovine albumin Each day of use
Frequency of Quality Control of Reagent

23. •HBsAg
•HIV 1 & 2
•HCV
•Syphilis
•Malaria Parasite

24. Reagents Frequency of testing along
with controls
Hepatitis B Antigen Each run
HIV 1 & 2 Antibody Each run
Hepatitis C Virus Each run
Syphilis serology
reagents
Each run
Malaria Test Each run