The document provides guidelines for approval of blood storage centres at First Referral Units (FRUs) in India. Key points: - FRUs can store up to 2000 units of whole blood or components annually without a license under certain conditions. - Conditions include having a medical officer, trained technician, adequate space and equipment for proper storage and transportation of blood. - Blood must be procured from a licensed mother blood bank and tested, and detailed records must be maintained. - Training of staff is required to ensure proper handling, storage, cross-matching and issue of blood to reduce maternal mortality from lack of blood availability at FRUs.

1. GUIDELINES FOR APPROVAL OF BLOOD AND/OR
ITS COMPONENTS STORAGE CENTRES

2. Blood availability FRU
 Maternal mortality -related to pregnancy and
childbirth is high in India
 First Referral Units at the Community Health Centre
(CHC/sub district hospital) set up for provision of
emergency obstetric care
 Non-availability of blood storage/transfusion facilities
at FRU -major constraint in provision of emergency
obstetric care services.

3. The Drug and Cosmetics Act amendment
 Amended to setting up blood storage facilities at the FRUs / CHCs /
PHCs-for abundant availability of whole human blood or its
components without taking license
 Under Schedule K of Drugs & Cosmetics Rules, 1945 under serial no.
5B. Ministry of Health & Family Welfare (Department of Health) vide
Notification No. GSR 909(E) dated 20th December, 2001

4. Conditions
Type of org -First Referral Unit, Community Health Centre, Primary Health
Centre and / or any Hospital
Approval authority the State / Union Territory Licensing after inspection
Captive consumption or Whole Human Blood I.P. or its components not more
than 2000 units annually
Mother blood bank -Government Blood Bank and/or Indian Red Cross Society
Blood Bank and/or Regional Blood Transfusion Centre duly licensed.-

5. Conditions
Manpower - Medical officer and blood bank tech
or lab tech (trained in bb)
Area -10 sq m –well lighted,clean and pref air
conditioned
24 hrs power supply
Equipment acc to list

6. CERTIFICATE OF APPROVAL TO BLOOD STORAGE CENTRE FOR STORAGE OF WHOLE HUMAN
BLOOD AND*/ OR ITS COMPONENTS
No. _____________________________ Date of Issue ____________________________
M/s ____________________ is hereby approved to store the following
items on the
premises situated at __________________________________under the
supervision of the following technical staff:
1. Names of the approved medical officer
:2. Names of the items
:3. Name of the qualified Blood BankTechnician
4. Name & address of the licensed BloodBank from whom the blood units
would be procured
The approval shall be in force from ......................... to ............................
Dated
Signature
Designation
Licensing Authority

7. CONDITIONS
The Blood Storage Centre shall comply with the conditions as stipulated under item 5B of Schedule K of the Drugs and
Cosmetics Rules which also includes as under :-
The captive conception of Whole Human Blood or its components in the above said centre shall not be more than 2000
units annually.
In the event of any change in the technical staff shall be forthwith reported to the licensing authority.
In the event of any change in the name of the licensed blood bank from whom the blood units are procured, the same shall
be intimated to the licensing authority for approval.
The centre shall apply for renewal of the approval to the licensing authority three months prior to the date of expiry of the
approval.
The centre shall maintain records and registers including the details of procurement of blood* / its components.
The centre shall store samples of donors’ blood as well as patients’ sera for a period of 7 days after transfusion.
Delete whichever is not applicable.

8. Application-annexure
 UNDERTAKING- to the licensing authority that the
captive consumption of Whole Human Blood or
Components shall not be more than 2000 units annually.
 LETTER OF CONSENT from mother blood bank
 PLAN of premises
 LIST OF EQUIPMENT.
 STAFFING DETAILS -Name of the medical officer and
blood bank technician –in BSC with documents of
qualification and training in blood bank

9. Medical officer -BSU
should be trained in bb and has following duties
 proper procurement,
 storage
 cross matching of blood and/or its components.
 responsible for identifying haemolysed blood
 ensure non-supply of date expired blood or its
components.

10. Equipment
 Blood Bank Refrigerators - storage capacity of 50 units.
 Deep Freezers - freezing ice packs required for
transportation (The deep freezers available in the FRUs
under the Immunisation Programme can be utilised for this
purpose._)
 Insulated Carrier boxes with ice packs
 Microscope and centrifuge: These should be supplied
only if they are not already available in lab

11. Consumables
 -Pasteur Pipette-12 dozens/year
 Glass tubes-7.5 to 10 mm -100 dozens/year
 Glass Slides-1"x2" boxes of 20 or 25 each/year
 Test Tube Racks-6 racks, each for 24 tubes
 Rubber Teats-6 dozens / year
 Gloves-Disposable rubber gloves 500
 Blotting/tissue paper
 Marker Pen (Alcohol Based)
 Reagents from mother bank (-anti A,anti B,anti AB,Anti D(Blend Ig G and Ig M),-2 vials each per month
 AHG-1 vial (polyclonal ) per month
 Bleach & Hypochlorite Solution


12. UNITS
 5 units each of A, B, O (Positive)

 2 units of AB (Positive)

 1 units each of A, B & O (Negative)

 This can be modified according to the actual
requirement.

13. STORAGE & TRANSPORTATION
 Cold Chain -insulated carrier boxes packed properly
and ice packs not in direct blood contact
 Storage -of whole blood in blood bank refrigerator -
4-6°C ± 2°C.and temp monitored continuously .
 Storage -blood components - -the storage procedures
of the mother blood bank should be followed.
 unused blood bags -returned to the Mother Centre at
least 10 days before the expiry ( 35/42days) of the
blood

14. ISSUE OF BLOOD
 Before issue -Patients' blood grouping and cross
matching done for compatibility with proper record
 First In and First Out (FIFO) policy, whereby blood
closer to expiry date is used first,

15. DISPOSAL
 Since all the blood bags will already be tested by the
Mother Centre, disposal of empty blood bags as per
latest guidelines


16. TRAINING

Training of doctors and technicians, who will be responsible for the Blood Storage Centre,
should be carried out for 3 days in an identified centre as per the guidelines. Training will
include:
 Pre transfusion checking, i.e. patient identity and grouping
 Cross-matching
 Compatibility
 Problems in grouping and cross-matching
 Troubleshooting
 Issue of blood
 Transfusion Reactions and its management
 Disposal of Blood Bags

17. Records
 Master Records / Receiving Records for blood and its
components: It shall indicate Blood / Component, bag serial number,
date of collection, date of expiry, quantity in ml. ABO/Rh group, results
of testing of HIV1 and HIV2 antibodies, malaria, test for Syphilis,
hepatitis B surface antigen and hepatitis C virus antibody, and irregular
antibodies (if any), utilisation issue number, temperature at the time of
receiving, discarded and signature of the medical officer/in-charge.
 Issue Register: It shall indicate serial number, date and time of issue,
bag serial number; ABO/Rh group, total quantity in ml., name and
address of the recipient, group of recipient, name of hospital and
unit/ward, details of cross-matching report, indication for transfusion,
and identification of staff issuing the unit.

18. Records –cont
 Record of components supplied: Quantity
supplied; compatibility report, details of recipient
and signature of issuing person.
 Register for reagents and kits used: Name of
the kits/reagents, details of batch number, date of
expiry, date of use and records of purchase of
reagents and kits.
 Blood Inventory register

19. Records -cont
1. Patient/ recipient records
2. Transfusion Adverse Reaction Records.
3. Record showing the daily temperature recordings.
4. Record of quality assurance (internal and external).
5. Record of equipment maintenance.
6. Record of document control
7. Daily group-wise blood stock register (inventory) showing its receipt, issue and
balance, units discarded with reason of discarding.
8. Stock register (consumable and non-consumables used in blood bank)
9. Documentation of staff qualifications, training and competency.
10. Staff attendance register or any other recording system.
11. Grievance reporting register
Note: The above said records shall be kept at least for a period of 5 years


20. Mother blood bank records
 Details of issued blood /component
 Transfusion Adverse Reaction Records.
 Mother blood bank to test all units and label should include test reports
and date of testing