BSU guidelines ppt (1).pptx

blood storage unit set up guidelines

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 withou t 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 20 th 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 UNDERTAKIN G- 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 DETAIL S -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. SUGGESTED QUANTITIES OF WHOLE BLOOD UNITS TO BE AVAILABLE AT A BLOOD STORAGE 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 Patient/ recipient records Transfusion Adverse Reaction Records.  Record showing the daily temperature recordings.  Record of quality assurance (internal and external). Record of equipment maintenance. Record of document control Daily group-wise blood stock register (inventory) showing its receipt, issue and balance, units discarded with reason of discarding. Stock register (consumable and non-consumables used in blood bank) Documentation of staff qualifications, training and competency.  Staff attendance register or any other recording system.  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