Amendment status not verified — confirm the current text below against the official source.
Laboratory equipment: (i) Refrigerators, for storing diagnostic kits and reagents, maintaining a temperature between 4 to 6 degree centigrade (plus/minus 2 degrees centigrade) with digital dial thermometer having provision for continuous power supply. (ii) Compound Microscope with low and high power objectives. (iii) Centrifuge Table Model. (iv) Water bath: having range between 37 degree centigrade to 56 degree centigrade. (v) Rh viewing box in case of slide technique. (vi) Incubator with thermostatic control. (vii) Mechanical shakers for serological tests for Syphilis. (viii) Hand-lens for observing tests conducted in tubes. (ix) Serological graduated pipettes of various sizes. (x) Pipettes (Pasteur). (xi) Glass slides. Drugs and Cosmetics Rules, 1945 278 (xii) Test tubes of various sizes / micrometer plates (U or V type). (xiii) Precipitating tubes 6mm x 50mm of different sizes and glass beakers of different sizes. (xiv) Test tube racks of different specifications. (xv) Interval timer electric or spring wound. (xvi) Equipment and materials for cleaning glass wares adequately. (xvii) Insulated containers for transporting blood, between 2 degree centigrade to 10 degree centigrade temperatures, to wards and hospitals. (xviii) Wash bottles. (xix) Filter papers. (xx) Dielectric tube sealer. (xxi) Plain and EDTA vials. (xxii) Chemical balance (wherever necessary). (xxiii) ELISA reader with printer, washer and micropipettes. J. SPECIAL REAGENTS : (1) Standard blood grouping sera Anti A, Anti B and Anti C 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. (2) Reagents for serological tests for syphilis and positive sera for controls. (3) Anti Human Globulin Serum (Coomb’s serum). (4) Bovine Albumin 22 percent Enzyme reagents for incomplete antibodies. (5) ELISA or RPHA test kits for Hepatitis and HIV I & II. (6) Detergent and other agents for cleaning laboratory glass wares. K. TESTING OF WHOLE BLOOD : (1) It shall be 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. (2) Freedom from HIV antibodies (AIDS) Tests. – 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. (3) Each blood unit shall also be tested for freedom from 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] VDRL and malarial parasite and results of such testing shall be recorded on the label of the container. NOTES (a) Blood samples of donors in pilot tube and the blood samples of the Recipient shall be preserved for 7 days after issue. (b) The blood intended for transfusion shall not be frozen at any stage. (c) Blood containers shall not come directly in contact with ice at any stage. L RECORDS : Drugs and Cosmetics Rules, 1945 279 The records which the licensee is required to maintain shall include inter alia the following particulars, namely: (2) 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 I and HIV II antibodies, Malaria, V.D.R.L. 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] 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. (3) 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 cros-matching report, indication for transfusion. (4 ) Records of components supplied: Quantity supplied; compatibility report, details of recipient and signature of issuing person. (5) Records of ACD/CPD/CPD-A/SAGM bags giving details of manufacturer, batch number, date of supply, and results of testing. (6) Register for diagnostic kits and reagents used: name of the kits/reagents, details of batch number, date of expiry and date of use. (7) Blood bank must issue the cross matching report of the blood to the patient together with the blood unit. (8) Transfusion adverse reaction records. (9) Records of purchase, use and stock in hand of disposable needles, syringes, blood bags, shall be maintained. NOTE : The above records shall be kept by the licensee for a period of five years. M. LABELS : The labels on every bag containing blood and/or component shall contain the following particulars, namely; (1) The proper name of the product in a prominent place and in bold letters on the bag. (2) Name and address of the blood bank (3) Licence number 1 Subs. by G.S.R. 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001). (1) Blood donor record: It shall indicate serial number, date of bleeding, name, address and signature of donor with other particulars of age, weight, haemoglobin, 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. Drugs and Cosmetics Rules, 1945 280 (4) Serial number (5) The date on which the blood is drawn and the date of expiry as prescribed under Schedule P to these rules. (6) A colored label shall be put on every bag containing blood. The following color 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 (7) The results of the tests for 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] syphilis, freedom from HIV I and HIV II antibodies and malarial parasite. (8) The Rh. Group. (9) Total volume of blood, the preparation of blood, nature and percentage of anti- coagulant. (10) Keep continuously temperature at 2 degree centigrade to 6 degree centigrade for whole human blood and/or components as contained under III of Part XII B. (11) Disposable transfusion sets with filter shall be used in administration equipment. (12) Appropriate compatible cross-matched blood without atypical antibody in recipient shall be used. (13) The contents of the bag shall not be used if there is any visible evidence of deterioration like haemolysis, clotting or discoloration. (14) The label shall indicate the appropriate donor classification like “Voluntary Donor” or “Replacement Donor” in no less prominence than the proper name. NOTES :