Requirement for operation/functioning of the Blood Banks for processing of Whole Human Blood and/or components
FORM OF APPLICATION:-
The application on Form 27C to the Drugs & Cosmetics Rules, 1945 be addressed to the Licensing Authority and copies of the same be forwarded to Drugs Controller General India , FDA Bhawan, Kotla Road, New Delhi & Deputy Drug Controller, North Zone , Kamla Nehru Nagar Ghaziabad along with necessary documents.
A fee of Rs. 7500/- to be deposited in the Government Treasury under account head 0210- Medical .
LOCATION & SURROUNDINGS:-
The blood bank shall be located at a place which shall be away from open sewage, drain, public lavatory or similar unhygienic surroundings.
ACCOMMODATION FOR A BLOOD BANK:-
A blood bank shall have an area of 100 square meters for its operations and an additional area of 50 square meters for preparation of blood components. It shall be consisting of room each for:-
- Registration cum medical examination room with adequate furniture and facilities for registration and selection of donors.
- Blood collection (air conditioned).
- Refreshment –cum-rest room (Donor rest room )(air-conditioned).
- Blood component preparation.(This shall be air-conditioned to maintain temperature between 200C -250C )
- Laboratory for blood group serology (air-conditioned).
- Laboratory for transfusion transmitted infections like HIV-I & II, Hepatitis, Syphilis, Malaria, HIV-antibodies (air-conditioned).
PERSONNEL (TECHNICAL STAFF):-
Medical Officer:- The operation in the Blood Banks shall be carried out under the active direction and personal supervision of competent Technical staff consisting of at least one person who is whole time employee and who is Medical Officer possessing qualification as under:-
- Post Graduate Degree in Medicine-MD (Pathology/Transfusion medicines); or
- Degree in Medicine (MBBS) with Diploma in Pathology or Transfusion Medicine having adequate knowledge in Blood group serology, blood group methodology and medical principles involved in the procurement of the blood and/or preparation of components; or
- Degree in Medicine (MBBS) having experience in blood bank for one year of regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of it’s components . The Degree or Diploma being from a University recognized by the Central Government.
Blood Bank Technicians possessing :-
- Degree in medical laboratory technology (MLT) with 6 months experience in the testing of blood and/or it’s components.
- Diploma in medical laboratory technology (MLT) with one year’s experience in the testing of blood and /Or it’s components, the Degree or Diploma being from a University /institution recognized by the Central Government or State Government.
Note:- It shall be the responsibility of the licensee to ensure through maintenance of records and other latest techniques used in blood banking system that the personnel involved in blood banking activities for collection, storage, testing and distribution are adequately trained in the current Good Manufacturing Practices/Standard Operating Procedures for the tasks undertaken by each personnel. The personnel shall be made aware of the principles of Good Manufacturing Practices/Standard Operating Procedures that affect them and receive initial and continuing training relevant to their needs.
- Medical Officer:- The operation in the Blood Banks shall be carried out under the active direction and personal supervision of competent Technical staff consisting of at least one person who is whole time employee and who is Medical Officer possessing qualification as under:-
The premises shall be maintained in a clean and proper manner to ensure adequate cleaning and maintenance of proper operation with provision for safe and sanitary disposal of :-
- Blood and/or blood components not suitable for use, distribution or sale.
- Trash and items used during the collection, processing and compatibility testing of blood and/or; blood components.
General Equipments & Instruments:-
Equipment used in the collection, processing, testing, storage and sale/distribution of blood and its components shall be maintained in a clean and proper manner and so placed as to facilitate cleaning and maintenance:-
For blood collection room:
- Donor couches, chairs and tables: These shall be suitably and comfortably cushioned and shall be of appropriate size.
- Bed-side table.
- Sphygmomanometer and Stethoscope.
- Recovery beds for donors.
- Refrigerators, for storing separately tested and untested blood, maintaining temperature between 2 to 6 degree centigrade with digital dial thermometer, recording thermograph and alarm device, with provision for continuous power supply.
- Weighing devices for donor and blood containers (Blood Mixers).
For Haemoglobin determination:
- Copper sulphate solution (specific gravity 1.053)
- Sterile lancet and impregnated alcohol swabs.
- Capillary tube (1.3x1.4x96 mm for Pasteur pipettes)
- Rubber bulbs for capillary tubings.
- Sahli’s haemoglobinometer / Colorimeteric method.
For Temperature and Pulse Determination:
- Clinical thermometers.
- Watch (fitted with seconds-hand) and a stop-watch.
For Blood Containers:
- Only disposable PVC blood bags shall be used (closed system) as per the specifications of IP/USP/BP.
Anti-coagulants:- The anti-coagulant solution shall be sterile , Pyrogen-free and of the following composition that will ensure satisfactory safety and efficacy of the Whole blood and/or for all the separated blood components.
- Citrate Phosphate Dextrose Solution(CPD) or Citrate Phosphate Dextrose Adenine-1 (CPDA-1), 14 ml. solution required for be required for 100 ml of blood.
- Oxygen cylinder with mask, gauge and pressure regulator.
- 5 percent Glucose or Normal Saline.
- Disposable sterile syringes and needles of various sizes.
- Disposable sterile I.V. infusion sets.
- Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or Dexamethasone, Metoclorpropamide injections.
- Such as blankets, emesis basins, haemostats, set clamps, sponge forceps, gauze, dressing jars, solution jars, waste cans.
- Medium cotton balls, 1.25 cm. adhesive tapes.
- Denatured spirit, Tincture Iodine, green soap or liquid soap.
- Paper napkins or towels.
- Autoclave with temperature and pressure indicator.
- Stand by generator.
- Refrigerators, for storing diagnostic kits and reagents, maintaining a temperature between 4-60 C ± 20 C with digital dial thermometer having provision for continuous power supply.
- Compound Microscope with low and high power objectives.
- Centrifuge (Table Model).
- Water bath: having range between 370 - 560 C .
- Rh viewing box in case of slide technique.
- Incubator with thermostatic control.
- Mechanical shakers for serological tests for Syphilis.
- Hand-lens for observing tests conducted in tubes.
- Serological graduated pipettes of various sizes.
- Pipettes (Pasteur).
- Glass slides.
- Test tubes of various sizes/ microwell plates (U or V type).
- Interval timer electric or spring wound.
- Equipment and materials for cleaning glass wares adequately.
- Insulated container for transporting blood, between 2 degree centigrade to 10 degree centigrade temperatures, to wards and hospitals.
- Wash Bottle.
- Filter Papers.
- Dielectric tube sealer.
- Plain and EDTA vials.
- Chemical balance (wherever necessary).
- ELISA reader with printer, washer and micropipettes.
- For blood collection room:
GOOD MANUFACTURING PRACTICES (GMPs)/STANDARD OPERATING PROCEDURES (SOPs):-
Written Standard Operating Procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility, testing, storage and sale or distribution of blood and/or preparation of blood components for homologous transfusion, antilogous transfusion and further manufacturing purposes. Such procedures shall be available to the personnel for use in the concerned areas. The Standard Operating Procedures shall interalia include :
- Criteria used to determine donor suitability.
- Methods of performing donor qualifying tests and measurements including minimum and maximum values for a test or procedure, when a factor in determining acceptability.
- Solutions and methods used to prepare the site of phlebotomy so as to give maximum assurance of a sterile container of blood
- Method of accurately relating the product(s) to the donor.
- Blood collection procedure, including in-process precautions taken to measure accurately the quantity of blood drawn from the donor.
- Methods of component preparation including, any time restrictions for specific steps in processing.
- All tests and repeat tests performed on blood and blood components during processing.
- Pre-transfusion testing, wherever applicable, including precautions to be taken to identify accurately the recipient blood components during processing.
- Procedures of managing adverse reactions in donor and receipient reactions.
- Storage temperatures and methods of controlling storage temperatures for bold and its components and reagents.
- Length of expiry dates, if any, assigned for all final products.
- Criteria for determining whether returned blood is suitable for reissue.
- Procedures used for relating a unit of blood or blood component from the donor to its final disposal.
- Quality control procedures for supplies and reagents employed in blood collection, processing and re-transfusion resting.
- Schedules and procedures for equipment maintenance and calibration.
- Labeling procedures to safe guard its mix-ups, receipt, issue, rejected and in-hand.
- Procedure of plasmapheresis, plateletphersis and leucapheresis if performed, including precautions to be taken to ensure re-infusion of donor’s own cells.
- Procedures for preparing recovered (salvaged) plasma if performed, including details of separation, pooling, labeling, storage and distribution.
- All records pertinent to the lot or unit maintained pursuant to these regulations shall be reviewed before the release or distribution of a lot or unit of final product. The review or portions of the review may be performed at appropriate periods during or after blood collection, processing, testing and storage. A thorough investigation, including the conclusions and follow-up, of any unexplained discrepancy or the failure of a lot or unit to meet any of its specification shall be made and recorded.
- Standard blood grouping sera Anti-A, Anti-B and Anti-D with known controls. Rh typing sera shall be in double quantity and each of different brand or if from the same, supplier each supply shall be of different lot numbers.
- Reagents for serological tests for syphilis and positive sera for controls.
- Anti-Human Globulin Serum (Coombs’ serum).
- Bovine Albumin 22 percent & Enzyme reagents for incomplete antibodies.
- ELISA or RPHA test kits for Hepatitis B & C and HIV I & II.
- Detergent and other agents for cleaning laboratory glass wares.
TESTING OF WHOLE BLOOD :-
- It shall be the responsibility of the licensee to ensure that the whole blood collected, processed and supplied conforms to the standards laid down in the Indian Pharmacopoeia and other tests published, if any, by the Government.
- Freedom from HIV antibodies (AIDS) Test – Every licensee shall get samples of every blood unit tested, before use, for freedom from HIV 1 and HIV II antibodies either from laboratories specified for the purpose by the Central Government or in his own laboratory. The results of such testing shall be recorded on the label of the container.
- Each blood unit shall also be tested for freedom from Hepatitis B surface antigen, and Hepatitis C Virus antibody. VDRL and malaria parasite and results of such testing shall be recorded on the label of the container.
STICKERS AND LABELS :-
The labels on every bag containing blood and/or component shall contain the following particulars, namely:
- The proper name of the product in a prominent place and in bold letters on the bag.
- Name and address of the blood bank.
- Licence Number.
- Serial number.
- The date on which the blood is drawn and the date of expiry as prescribed under Schedule P to these rules.
A coloured label shall be put on every bag containing blood. The following colour scheme for the said labels shall be used for different groups of blood:
Blood Group Colour of the Label O Blue A Yellow B Pink AB White
- The results of the tests for Hepatitis B surface antigen, and Hepatitis C virus antibody, syphilis, freedom from HIV I and HIV II antibodies and malarial parasite.
- The Rh group.
- Total volume of blood, the preparation of blood, nature and percentage of anti-coagulant.
- Keep continuously temperature 20 C- 60 C for whole human blood and/or components as contained under III of Part XII B.
- Disposable transfusion sets with filter shall be used in administration equipment.
- Appropriate compatible cross matched blood without a typical antibody in recipient shall be used.
- The contents of the bag shall not be used if there is any visible evidence of deterioration like haemolysis, clotting or discoloration.
- The label shall indicate the appropriate donor classification like "Voluntary Donor" or "Replacement Donor" in no less prominence than the proper name.
The records which the licensee is required to maintain shall include inter alia the following particulars, namely:-
- Blood donor record: It shall indicate serial number, date of bleeding, name, age, address and signature of donor with other particulars of age, weight, hemoglobin, blood grouping, blood pressure, medical examination, bag number and patient’s detail for whom donated in case of replacement donation, category of donation ( voluntary/replacement) and deferral records and signature of Medical Officer In-charge.
- Master records for blood and its components : It shall indicate bag serial number, date of collection, date of expiry, quantity in ml. ABO/Rh Group, results for testing of HIV 1 and HIV II antibodies, Malaria, V.D.R.L., Hepatitis B surface antigen and irregular antibodies (if any), name and address of the donor with particulars, utilization issue number, components prepared or 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, unit/institution, details of cross matching report, indication for transfusion.
- Records of components supplied : quantity supplied; compatibility report, details of recipient and signature of issuing person.
- Records of A.C.D. / C.P.D. / CPD-A/SAGM bags giving details of manufacturer, batch number, date of supply and results of testing.
- Register for diagnostic kits and reagents used: name of the kits/reagents, details of batch number, date of expiry and date of use.
- Blood bank must issue the cross matching report of the blood to the patients together with the blood unit.
- Transfusion adverse reaction records.
- Records of purchase, use and stock in hand of disposable needles, syringes, blood bags shall be maintained.