Blood banks. What comes to your mind when you hear that word? An angel like institution which helps you in getting the required blood you need for you or for your near ones. You put complete trust in these blood banks and get services for them. But do you know they are required to get license from the government stating that they are government approved. No one can start a blood bank just like that without the approval of the government. Why a license? Because, they may cheat you or give you very bad quality of service by giving bad blood to you. Let’s look and see in brief.
WHAT BLOOD BANKS DO.?
Blood banks are responsible for things like taking of blood, storage of blood, grouping and cross matching, testing of diseases, blood transfusion and distribution and other things.
LICENSE AND LEGAL POLICY NEEDED FOR BLOOD BANKS TO OPERATE.
A right legal framework has been provided in Schedule X B of drugs and cosmetics Act and rules published by the Gazette of India which stipulates for mandatory testing of blood for blood transmissible diseases. The rules vouch for adequate testing procedures, quality control, standard qualifications, and maintenance of accurate records. The blood banks under the act require a manufacturing license.
APPLICATION FOR GRANTS/LICENSE AND RENEWAL FOR BLOOD BANKS
Application for grant or renewal of licence for blood bank shall be made in to the Licensing Authority in Form 27-C with the licence fee of Rs.600/-) and inspection fee of RS. 200 in the case of renewal of licence. If there is any need for duplicate copy in place of original which has been lost or damaged, Rs 100 shall have to be paid in full.
PRE-CONDITIONS FOR GRANTS AND RENEWAL FOR BLOOD BANKS
There are some preconditions for blood banks to fulfil, if they want to operate. These Preconditions have been fixed by the government authorities. Let’s have a look at some of them
The operation of the blood bank or operation of blood products shall have to be carried out under supervision and direction of expert technical staff or at least 1 person who should be a full time employee, a graduate medical officer having experience of at least 6 months in a blood bank. He should have all the required knowledge of the blood bank and its operations.
There should be adequate medical staff in the blood bank. There should also be adequate space, plant and equipment for any of the operations of the blood bank.
There should be adequate arrangements for storage of whole human blood , components and blood products.
DURATION OF LICENSE FOR BLOOD BANKS
The original license under form 28-C unless it is suspended or cancelled shall be valid up to 31st December of the following year. The centre shall apply for renewal of the approval to the licensing authority three months prior to the date of expiry of the approval.
CONDITIONS FOR LICENSE TO BLOOD BANK
The blood banks shall maintain proper number of staff, equipments and plan for the operation of the blood bank. They shall also maintain necessary records and papers as specified in the law in
Schedule F, Part XII-B and XII-C.
The records and the papers will have to be maintained at least for period of 5 years from the date of starting.
The license will allow the inspector to check with or without notice any premises of the blood bank to his satisfaction where the activities are being carried out for the blood bank.
The license will also allow the inspection to check any records and papers as maintained by the blood bank and question if necessary.
There should be an authorized doctor, an authorized nurse, blood bank technician and laboratory assistants needed for blood banks.
The applicant shall be First Referral Unit, Community Health Centre, Primary Health Centre or any Hospital.
The applicant shall furnish an undertaking to the licensing authority that the consumption of Whole Human Blood or Components shall not be more than 2000 units annually.
The applicant should furnish the following:
Name of the medical officer responsible for conducting operation of blood centre.
Attested certified copies of MBBS or MD qualification
The Name and certified copies of qualification and experience of the blood bank technician.
The applicant shall furnish the source of procurement of Whole Human Blood / Blood Components namely the name and address of the Blood Banks.
* The source of procurement of blood / components shall be from licensed Blood Banks run by Govt. Hospitals / Indian Red Cross Society / Regional Blood Transfusion Centres only.
* A letter of consent from the above Blood Banks who intend to supply Whole Human Blood / Blood Components to the Blood Storage Centres shall be furnished along with the application.
The Blood Banks who intend to supply the blood units / components shall test the following mandatory tests before supplying to Blood Storage Centres.
1. Blood Grouping
2. Anti Body Testing
4. HIV I & II Anti Bodies
5. Hepatitis B Surface antigen
6. Hepatitis C Anti Body