Legal

1. The blood bank should possess a license under Drugs and Cosmetics Act. The
license should be renewed periodically. For establishing a new Blood Bank, the ‘No
Objection Certificate’ should be obtained from ‘State Blood Transfusion Council (STBC)’
. (Check - Licenses and permits for hospital)

Building facility

1. The blood bank area should be hygienic and well ventilated. Screens or mesh should
be provided in windows to avoid entry of insects and rodents

2. The blood bank should have dedicated room for carrying out its functions. This
includes

a. Registration and examination room with adequate furniture for desk work, donor
screening. Adequate seating arrangements for
blood donors should be provided

b. Donor counselling section – this should be separate from registration and

examination room and should provide privacy

c. Blood collection area – The size should be as per the number of couches. This
area should be air-conditioned

d. Refreshment and rest room for donors – should be air-conditioned

e. Laboratory for testing blood for hepatitis, syphilis, malaria, TB and HIV antigen –
should be air-conditioned

f. Laboratory (separate section) for doing blood group serology. This should be air-
conditioned

g. Blood component preparation area with air-conditioning that maintains

temperature between 20 and 25 degree Celsius

h. Blood component preparation area (if component preparation is undertaken)

i. If apheresis is conducted then a separate air-conditioned area for this should be

provided

3. All the above areas should be clearly distinct with effective separation between them
4. The areas should be adequately equipped with furniture, storage space and work
desks

5. The areas should be well maintained and clean

6. Electricity back-up facility should be available for blood bank

Human Resources

1. The HR should meet the minimum regulatory criteria for blood bank. The HR of blood
bank should include following

a. Blood bank should have an identified in-charge who should fulfil any one of the
given criteria

i. MD - Transfusion medicine

ii. MD – Immunohematology and Transfusion Medicine

iii. MD – Pathology

iv. MBBS with diploma in clinical pathology or transfusion

medicine

v. MBBS with at-least one year experience in blood bank

b. Technical supervisor with and full-time technicians with one of the following
qualifications

i. D.M.L.T with six months experience in testing of blood or its

components

ii. Diploma should be from an institution recognized by central or

state government (UGC or AICTE approved)

c. Nurses with appropriate qualification from Nursing Council of India and registered
with state/central nursing council

d. Counselor – suitably qualified or experienced and trained for counselling

2. Written job description and responsibilities for each staff category should be available

Equipment

1. All equipment that is required for blood collection, testing, component preparation and
storage should be available
2. Each equipment should have an equipment log, that records its identification,
manufacturer’s details, calibration and maintenance history

3. Each equipment should have a label that identifies the equipment, calibration status
and due date of next calibration

4. Blood storage equipment (refrigerators) with necessary temperature control and

monitoring devices should be available. Storage refrigerators should have continuous
temperature monitoring system installed. The temperature should be checked and
recorded every 8 hours.

5. Back-up arrangement should be there in case of equipment breakdown or power

shutdown situation

Policies and Procedures

1. SOPs for following function

a. Donor screening (including criteria for donor selection)

b. Blood collection

c. Blood testing – SOP for each test

d. Labelling of blood and blood component bags

e. Blood storage (including Quarantine requirements)

f. Component preparation

g. Compatibility testing

h. Issuance of blood/blood component

i. Disposal of waste blood

2. Policy on rational use of blood and blood products. The policy should describe clinical
criteria to determine whether or not blood or blood component should be used on a
particular patient

3. Procedure of transfusion of blood and blood component. The procedure should

include instructions on following

a. Written order for transfusion, with details of pre-medications if any and rate of
transfusion in case of paediatric patients
b. Temporary storage in patient area before transfusion

c. Verification of blood/component before transfusion

d. Identification of patient

4. Policy on informed consent and its validity. Procedure to obtain informed consent
from patient before transfusion

5. Procedure for traceability of blood/component from blood collection to its issuance

6. Procedure to identify the recipient of blood from a donor who subsequently was found
to be suffering with transfusion transmitted infection

7. In above situation policy of immediately reporting this to the patient and his/her
physician and discarding of unused blood from that recipient

8. Procedure for obtaining blood/component in emergency situation. The procedure

should describe ‘what constitute an emergency transfusion’

9. Monitoring of patient during and after transfusion

10. post-transfusion recording of details, including reactions if any

11. Procedure for conducting transfusion reaction analysis and taking

corrective/preventive actions

12. Quality Control Process for testing of blood

Quality Indicators for blood bank and transfusion services

1. Percentage of blood wastage (whole blood and component-wise)

2. Adverse transfusion reaction rate

3. Turn-around time for blood issuance

4. Percentage of component quality control failure (for each component)

5. Adverse reaction rate with donors

6. Percentage of components in blood bank