The Blood Bank or Disposable Blood Transfusion Sets should have its ownconstitution, which defines the responsibility and authority of the management. The blood bank should function under the direction of a licensedphysician qualified by training and by experience as Transfusion MedicineSpecialist (Medical Officer, Blood Bank) who should be responsible for
all medical, technical and administrative services.
All Disposable Blood Transfusion Sets should be licensed by State Drug Controller and approved by Drugs Controller General-(India) and should be regulated
by Drugs and Cosmetics Act and rules there under.Blood bank should comply with laid-down standards in Drugs and Cosmetic Rules in recruitment and selection of blood donors, collection,processing, storage and distribution.All blood banks should have their own quality policy and prepare aquality manual that addresses the systems in use. Every section responsible for various services will define its own QC
program including outsource services. It is also recommended thatcenters participate in various EQAS programs.
Each blood bank should maintain a detailed standard operatingprocedure manual, as well as records (forms, registers, labels) in a
prescribed format prescribed by Drug & Cosmetics Rules. There should be adequate and competent staff as prescribed in Schedule
F Part XII B & C of Drug and Cosmetic rules. The records of theirqualifications, training and competency should be maintained. Suitable space, environment and equipment should be available tomaintain safe and acceptable standards of house keeping.
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