2. Testing routinely performed tests/activities on
materials and equipments to check their proper
The monitoring system that checks the
effectiveness of existing process/steps by
testing the quality of final products.
5. 1. Only individuals in good health should be
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
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
6. A check should be made before use to ensure
that the collection system is not damaged or
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
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
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
•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
3. Annual maintenance contract with
manufacturers and suppliers should be
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
freezers, water bath,
blood bag refrigerator
Thermometer Daily Technician
Cryofuge Tempt: thermometer
Platelet agitator Frequency of
Laminar flow hood and
sterile area filter
3 times a month
20. Equipments Method of control Frequency of
Blood mixer thermometer Daily Technician
Blood bag tube
21. Use according to manufacturer’s instruction
The new reagent has to be assessed &
The appearance of each reagent has to be
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