BLOOD BANK
Role of Blood
Objectives and Scope
Approach during Inspection
Equipment and Machinery
Procedure and Steps for Licence
Storage Centers
Inspection Report To Be Furnished by FDA Officers
Certificate Of Approval To Blood Storage Centre
Statistical Data


STORAGE CENTRES :-

The Government has announced a new scheme of promoting blood storage in urban and rural areas. These storage centers are to be affiliated to the larger Blood Banks. Previously, it was felt that some remote centers and non-accessible areas were facing shortage of blood supply under emergency situation. To overcome this problem, an amendment has been made to change Schedule K of the DCA, 1940. As per the amendment, the existing small blood banks collecting less than 2,000 units of the blood are to be converted into the storage area especially those will receive tested and processed blood and component from the Regional Centers for the use of patients in the hospitals. The Hospitals whether it can be Private or Government can also avail the benefit of storage centers. The area required for storage centers is only 10 sq.mtrs. with storage facility and testing equipments which includes the following accessories.

¨ Blood Bank Refrigerator.

¨ Microscope.

¨ Centrifuge.

¨ Incubator.

¨ Pipit.

¨ Glass.

Storage centres will have to maintain records of the procurement, cross-matching, issue of the blood and its component and such reports will be preserved at least for 5 years.

Storage centres will have to arrange technically qualified staff.
Laboratory Technician, who shall have the qualifications as per the blood bank. The Staff i.e. Medical Officer and technicians are not required to be full time employee but they will be considered totally responsible for over the activities of the storage centres.

 

BLOOD STORAGE CENTRE
CHECK LIST

(1)
  All Application form "ANNEXURE-A"
(2)
 Possession deed
(3)
 Plan of premises with Site Plan.
(4)
 Constitution copy. (If applicable).
(5)
 An undertaking of capital consumption which shall not be more 2000 units. Per annum Annexure-B.
(6)
 Attested of NBBS/MD/DCP of medical responsible for Blood Storage Center and experience Certificate, if applicable, Appointment letter, Consent letter,
(7)
 Attested copies qualification and experience of blood bank technician Appointment letter, consent letter.
(8)
  Source of procurement and alongwith consent letter from the respective licensed blood bank
(9)
 List of equipment/instruments for storage and testing ANNEXURE-'C'.
(10)
 SOP for storage, transport issue equipment maintenance, grouping and crossmatching.
(11)
 List of emergency items.
(12)
  Office furniture like Table, Chair, Cupboards, Racks.

 


ANNEXTURE-A

An application form for grant/renewal of a certificate of approval to blood storage center.

1)
Complete name and address of the applicant unit,  
2)
Status of the unit PHC/CHC/Private Hospital/Chemical Trust/Voluntary Organization.

3)
Full name and residential of the Director/Trustee/Medical officer Properties over all responsible for storage center.

 
4)
Mode of Communication Telephone office :
Residential :
E-mail :
Log on :
Webaite :
5)
Name of approval Medical officer, his education and experience.  
6)
Names of Laboratory Technician, his educational qualification and experience.  
7)
Names and address of the licensed blood bank as a procurement source.  
8)
Name of the Items to be Stored  
9)
Name of the indoor wards/OT/Sections attached with the hospitals/Polyclinic wailding.  
10)
Is there any voluntary services for Thalusaemia Hemophilia etc ? :  
11)
Is the storage center working for donors motivation, awakeness camp and IEC work; if yes, please give details.  
12)
Has the storage center got any noble work/services for cancer, AIDS mass endemic if so please give brief details.  
13)
Does the storage center have any of the listed extra facility? Answer Yes or No. a) sonography
b) Biopsy
c) C.T.Scanning
d) Organ Transplant.
e) Lithotripay
f) Dialysis
g) Research Center
h) Radiation/Chemotherapy.

I/We hereby willfully State the information given above by us are true and correct to the best of my/ our knowledge.

 

Date :

Place :

Signature of the authorized
Person & Rubber Stamp.

1).................................

2).................................

3).................................

 

 

ANNEXURE - B
UNDERTAKING

If granted and approval for blood storage Center, We, undersigned, hereby abide and assure to the Licensing Authority & Commissioner, food & Drugs Control Administration, Gujarat State, Gandhinagar, that under no circumstances we shall exceed our annual captive consumption of whole Human Blood and or its components 2000 units.

 

Date :

Place :

AuthorizedPerson's Signature

Rubber Stamp

Letter Head.

 

 

 

ANNEXURE- 'C'
LIST OF INSTRUMENT/EQUIPMENT FOR STORAGE AND TESTING
(1)
  Air conditioned Unit (Preferable but not essential)
(2)
  Blood Storage Refrigerator with temperature display, alarm, thermograph.
(3)
  Generator.
(4)
  Insulated Boxes for transport.
(5)
  Domestic Refrigerator for the storage of reagents, Kets, Pilot Samples etc.
(6)
  Deepp Refrigerator upto (For Component) -30 V temperature.
(7)
  Platelets Storage Devices with agitator.
(8)
  Microscope.
(9)
  Centrifuge.
(10)
  Incubator.
(11)
  Pipettes.
(12)
  Glassware.
(13)
  Grouping Reagents, Antisera, Anti-D, Bovine serrum, Albumen, AHG etc.
(14)
  Immwegwncy items like Oxygen Cylinder, Dextrose, Mannital, Normal Saline, Disposable sets & Needles.


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