3. Should be located away from sewage, drain, unhygienic
conditions.
Location surrounding
4. The building should be so designed and constructed that:
(a) the operation of blood centre under hygienic conditions shall be
possible,
(b) The entry of insects, rodents and flies shall be prevented
(c) The premises shall be well lighted, ventilated and screened
(d) The walls and roofs of rooms shall be smooth, clean and washable
(e) The well designed and adequate size drainage shall be available.
Building
5. Health, clothing & sanitation of staff
1. Free from contagious diseases.
2. Provided with clean overalls, head-gears, foot wears and gloves.
3. Adequate , clean and convenient hand washing and toilet facilities
shall be provided.
6. Blood centre shall have 100 square meter area for it's operation and
additional 50 square meter for preparation of components.
It shall consist of rooms with air conditioners (wherever necessary) for:
(a) Registration and medical examination,
(b) Blood collection,
(c) Blood component preparation,
(d) Laboratory for blood group serology,
(e) Laboratory for blood transmissible diseases,
(f) Sterilization-cum-washing room,
(g) Refreshment-cum-restroom,
Accommodation for blood centre
7. Personnel
Blood centre shall have following technical staff possessing
prescribed qualifications:
a) Medical officer
b) Blood centre technicians
c) Registered nurses
d) Technical supervisors(where blood components are prepared)
8. Maintence
Premises shall be clean and maintained
in proper manner.
Facilities shall be provided for:
1. Examination of donor.
2. Collection of blood from donar.
3. Storage for blood/ blood components
pending completion of tests.
4. Storage of finished products.
9. Equipment
1. Shall be maintained in clean and proper manner.
2. Shall be Placed in a manner easy to clean and maintain.
3. Shall be Observed, standardized and calibrated regularly.as
prescribed in SOP.
10. Supplies and Reagents
Shall be stored at proper
temperature in a safe and
hygienic place, in proper
manner as specified in the
rules.
11. 1. SOP shall be available to the personnel for use
in the concerned area.
2. Shall include the details specified in the rules.
3. Shall include steps to be followed in the
collection, processing, compatibility testing,
storage and sale or distribution of blood
/components.
G.M.P/S.O.P
12. 1. Equipment and instruments for:
(a) Blood collection room
(b) Hemoglobin determination,
(c) Temperature and pulse determination,
(d) Laboratory.
2. Blood containers,
3. Emergency equipments and items,
4. Accessories
General equipment and instruments
13. Records
License is important to maintained following records.
1. Blood donor record
2. Master record of blood and its components
3. Issue register
4. Records of components supplied
5. Records of bags manufactured
14. Labels
The labels on every blood bag containing blood/components shall
contain particulars specified in the rules.
15. Functions of blood centre
• Blood centre plays important role in health care
system.
1. Recruitment of donors and maintenance of their records.
2. Management of blood donation camps.
3. Determination of blood type.
4. Collection of blood from donors or another licensed
blood centre.
5. Processing of collected blood and preparation of
components.
6. Storage and preservation of collected blood and
processed components.
16. 7. Safety of recipient and donor.
8. Rapid response to urgent requests for blood
components.
9. Selection of suitable blood component for each
clinical condition.
10. Safe delivery and handling of blood components.
11. Continuous training of staff members.
12. To comply with regulatory requirements.
13. To undertake research activities.
Functions of blood centre