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

 

Equipments And Machinery
Blood Bank Equipments
Laboratory Equipemnts
Reagents
Records

 

RECORDS :-

Records : the permanent records which the license is required to maintain shall include the following particulars :

 

1. Blood Donor Register : Indicating

i)
 Serial number
ii)
 Date of Bleeding
iii)
 Name of Donor with particulars
iv)
  Age
v)
  Weight
vi)
  Hemoglobin
vii)
  Blood Pressure
viii)
 Medical Examination
ix)
  Signature of Medical Officer Bleeding the Donor
x)
  Bottle bag number
xi)
 Patient's detail for donated in case of recipient donation
xii)
  Remarks on donation (Volunta

2. Blood Stock Register : Indicating

i)
 Bottle bag number
ii)
 Date of collection
iii)
 Date of Expiry
iv)
 Quantity in ml.
v)
 ABO.Rh Group
vi)
 Result for Testing of HIV
vii)
 Malaria
viii)
 V.D.R.L.
ix)
 Hepatatis
x)
 B Surface Antigen
xi)
 Irregular Antibodies (if any)
xii)
 Name of Door with Particulars
xiii)
  Utilization Issue Number
xiv)
 Components Prepared or Discarded
xv)
  Certified by Medical Officer Incharge

Group stock register shall be maintained

Note : similar records shall be made for Blood components.

3. Issue Register : Indicating

Serial NumberDate and Time of IssueBottle Number
ABO/Rh Group Total Quantity in ml.Name of the Recipient
Group of RecipientDetails of Cross MatchingIndication for Transfusion
Unit/institutionReport 

Particulars of product supplied (Whole Human Blood, Red Cell/Platelet concentrates, cryprecipiates etc.). quantity supplied, compatibility report, signature of issuing persons.

4. Register for A.C.D./C.P.D./CPD-A, bottles/bags giving

Details of firm                           Batch Number
Date of Supply                         Result of Testing.

5. Register of Diagnostic Reagents used :

Name of the reagents details of batch number and date old supply nd date of use.


6. Blood Bank must issue the cross-matching report of the blood of the     patient     alongwith the blood bottle.


7. Transfusion advance Reaction Records.


8. Records of purchase, use and stock in hand of disposable needles,     syringes, Plastic     bags, sets shall be maintained.

 

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