Standard operating procedures regulatory guidelines blood banking 1e 2014 UnitedVRG pdf

Standard Operating Procedures and Regulatory Guidelines BLOOD BANKING Standard Operating Procedures and Regulatory Guidelines BLOOD BANKING GP Saluja MBBS MD Senior Consultant, Blood Bank Alchemist Hospitals Ltd Panchkula, Haryana, India GL Singal M Pharm PhD LLB State Drugs Controller Department of Food and Drugs Administration Panchkula, Haryana, India JAYPEE BROTHERS MEDICAL PUBLISHERS (P) LTD New Delhi • London • Philadelphia • Panama Jaypee Brothers Medical Publishers (P) Ltd Headquarters Jaypee Brothers Medical Publishers (P) Ltd 4838/24, Ansari Road, Daryaganj New Delhi 110 002, India Phone: +91-11-43574357 Fax: +91-11-43574314 Email: jaypee@jaypeebrothers.com Overseas Offices J.P Medical Ltd 83, Victoria Street, London SW1H 0HW (UK) Phone: +44-2031708910 Fax: +02-03-0086180 Email: info@jpmedpub.com Jaypee-Highlights Medical Publishers Inc City of Knowledge, Bld 237, Clayton Panama City, Panama Phone: +1 507-301-0496 Fax: +1 507-301-0499 Email: cservice@jphmedical.com Jaypee Medical Inc The Bourse 111, South Independence Mall East Suite 835, Philadelphia, PA 19106, USA Phone: +1 267-519-9789 Email: jpmed.us@gmail.com Jaypee Brothers Medical Publishers (P) Ltd 17/1-B, Babar Road, Block-B, Shaymali Mohammadpur, Dhaka-1207 Bangladesh Mobile: +08801912003485 Email: jaypeedhaka@gmail.com Jaypee Brothers Medical Publishers (P) Ltd Bhotahity, Kathmandu, Nepal Phone: +977-9741283608 Email: kathmandu@jaypeebrothers.com Website: www.jaypeebrothers.com Website: www.jaypeedigital.com © 2014, Jaypee Brothers Medical Publishers The views and opinions expressed in this book are solely those of the original contributor(s)/author(s) and not necessarily represent those of editor(s) of the book All rights reserved No part of this publication may be reproduced, stored or transmitted in any form or by any means, electronic, mechanical, photo­copying, recording or otherwise, without the prior permission in writing of the publishers/editors All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners The publisher is not associated with any product or vendor mentioned in this book Medical knowledge and practice change constantly This book is designed to provide accurate, authoritative information about the subject matter in question However, readers are advised to check the most current information available on procedures included and check information from the manufacturer of each product to be administered, to verify the recommended dose, formula, method and duration of administration, adverse effects and contra­indications It is the responsibility of the practitioner to take all appropriate safety precautions Neither the publisher nor the author(s)/editor(s) assume any liability for any injury and/or damage to persons or property arising from or related to use of material in this book This book is sold on the understanding that the publisher is not engaged in providing professional medical services If such advice or services are required, the services of a competent medical professional should be sought Every effort has been made where necessary to contact holders of copyright to obtain permission to reproduce copyright material If any have been inadvertently overlooked, the publisher will be pleased to make the necessary arrangements at the first opportunity Inquiries for bulk sales may be solicited at: jaypee@jaypeebrothers.com Standard Operating Procedures and Regulatory Guidelines–Blood Banking First Edition: 2014 ISBN 978-93-5152-215-7 Printed at Dedicated to Our families and our dear parents whose inspiration, motivation, blessings and moral support continue to contribute a great deal to our academic endeavors & Everybody striving to contribute to the blood safety Foreword Minister of Health & Medical Education Government of Haryana Tel: 0172-2740278; Fax: 0172-2748043 I am extremely happy to know that Dr GP Saluja and Dr GL Singal have come up with their book “Standard Operating Procedures and Regulatory Guidelines–Blood Banking” that incorporates the latest updated procedural guidelines regarding the operation of blood banks This book covers all the aspects of blood transfusion including regulatory guidelines framed under the Drugs and Cosmetics Act, 1940 and Rules, 1945 This book will serve both the student fraternity and the blood bank professionals and will go a long way in achieving the accuracy and proficiency in the various blood bank procedures I am also confident that this book will broaden the horizon of all those working in blood banks and medical fraternity in understanding the legal issues pertaining to safe blood transfusion (Rao Narinder Singh) Foreword Additional Chief Secretary Health Department Government of Haryana Tel: 0172-2711706; Fax: 0172-2771310 Blood transfusion plays an important role in the modern health system of both developing and developed nations across the globe These services are well-organized in the developed countries; while in vastly populated developing countries, these are yet to be brought at par with those available in the developed countries Blood transfusion is an essential component of health care that underpins the management and care of millions of patients each year in both emergency and routine situations Yet an unknown number of patients lose their lives unnecessarily every day because they not have access to safe blood transfusion Therefore, it is necessary to ensure the right quality of blood and its components for safe transfusions Blood transfusion is a multi-step and multi-actor’s process and desired quality results can only be achieved by following standard operating procedures (SOPs) At every step, any lowering of quality would reflect adversely on the final product, particularly when the institutions/individuals not have the proper knowledge about the requirements for grant/renewal of license to operate the blood banks, SOPs, quality and legal understanding of blood transfusions I am confident that this book will broaden the horizon of all those working in blood banking, understanding the legal issues and providing safe blood transfusion to the needy patients (Navraj Sandhu) 428  Standard Operating Procedures and Regulatory Guidelines-Blood Banking maltreated by the husband, does not absolve the Hospital from its professional obligation ” 24 Affirming the aforesaid view of the State Commission, the National Commission held thus: “ It is seen that the patient’s kidney was damaged and the blood level reached to 100 gms Percentage, hemoglobin came down to mg after the mismatched blood transfusion was given by the Doctor in the said Hospital It was only after the complainant gave the written complaint to the hospital regarding the wrong transfusion of blood given to the patient, an inquiry was made and it was found correct The damage control treatment started only after the written complaint was given by the complainant Though it is argued by the Counsel for the Appellant that the percentage levels were brought down to normal, it is very clear to us that the internal imbalances of liver and kidney functioning and deteriorating hemoglobin levels started only after the mismatched blood transfusion was given Though septicemia has been written as the ultimate cause of death, the patient’s health took a nose dive only after wrong blood was given to her and this is clearly negligence on the part of the Doctors of the Hospital which the appellants cannot disown or absolve themselves ” 25 We concur with the view of the National Commission as it does not suffer from any error of law 26 In the result, the appeal fails and is dismissed with costs which we quantify at Rs 20,000/- Bibliography A comparative study between antiglobulin cross-match, type and screen procedures for compatibility testing by Vanessa Zammit, Supervisor: Dr M Caruana MDA project submitted in partial fulfilment of requirements for the BSc (Hons) in Health Sciences (MLS): May 2004 Anthony R Green, 6th edn 2011 A Victor Hoffbrand, Daniel Catovsky, Anthony R Green, Edward GD Tuddenham Postgraduate Haematology Wiley Blacwell 6th edn, 2010 Chitnis V, Vaidya K, Chitnis DS Biomedical waste in laboratory medicine: Audit and management Indian Journal of Medical Microbiology Vol 23, No 1, January-March, 2005; pp 6–13 Blood collection: Routine venepuncture and specimen handling: http://library.med.utah.edu/WebPath/TUTORIAL/PHLEB/PHLEB05 html Drugs and Cosmetic Act 1940 and Rules 1945 Guidelines for setting up blood storage centers NACO Ministry of Health and Family Welfare, Govt of India, New Delhi 2007 Guidelines for the clinical use of blood cell separators by Joint working party of the transfusion and clinical hematology task forces of the British Committee for standards in Haematology Clin Lab Haem 1998;20: 265–78 Hemovigilance Program-India, Asian Journal of Transfusion Science Vol 7, Issue January-June 2013 10 Manual on the management, maintenance and use of blood cold chain equipment, WHO Geneva, 2005 11 Model Standard Operating Procedures for Blood Transfusion ServiceWHO New Delhi 12 Modern Blood Banking and Transfusion Practices by Denise M Harmening, 5th edn 2005 13 National Guidebook on Blood Donor Motivation (MoH & FW, NACO, GOI)-2nd edn 2003 14 Practice of safe Blood Transfusion-Compendium of Transfusion Medicine by Dr RN Makroo, 2nd edn 2009 15 Quality Control: http://whatis.techtarget.com/definition/0,sid9_ gci112738200.html 16 Screening donated blood for transfusion-transmissible infectionsRecommendations WHO, 2010 17 Standards for blood banks and blood transfusion services, NACO Ministry of Health and Family Welfare, Govt of India, New Delhi, 2007 434  Standard Operating Procedures and Regulatory Guidelines-Blood Banking 18 Technical Manual of American Association of Blood Banks-16th edn 2008 19 Technical Resource Manual for Hospital Transfusion Services, BC Provincial Blood Co-ordinating Office, 2nd edition, 2005 20 Textbook of Medical Laboratory Technology by Praful B Godkar, 2nd edn 2003 21 The Blood Cold Chain-Guide to selection and procurement of equipment and accessories WHO Geneva 2002 22 The Clinical Use of Blood (Handbook) WHO Geneva 23 The User Manuals of Blood Bag Monitor and Tube Sealer 24 Transfusion Medicine Technical Manual (DGHS) 1991 25 Treatment of discarded blood units: Disinfection with hypochlorite/ formalin versus steam sterilization by V Chitinis, S Chitnis, S Patil, D Chitnis-Department of Microbiology, Choithram Hospital and Research Centre, Indore, India, Indian Journal of Medical Microbiology Year: 2003, Volume: 21,  Issue: 4, Page: 265–67 26 Zarin Bharucha, Chauhan DM Introduction to Transfusion Medicine 1st edn 1990 Glossary • • • • • • • • • • • • • • Absorption: The removal of antibodies from serum/plasma through the addition of red blood cells having corresponding antigen Adsorption: The uptake of antibody onto the specific receptors on the red blood cell (RBC) surface under optimal conditions, therefore, removing the antibody from the serum Ambient Temperature: Means atmospheric temperature of the immediate surroundings Amplitude of the Agitation: Means side-to-side movement of the trays in a platelet agitator The amplitude is expected to be within the range of 3.6 to 4.0 cm Apheresis: Means the process by which blood drawn from a donor, after separating plasma or platelets or leukocytes, is retransfused simultaneously into the said donor Atypical Antibody: An antibody which occurs as irregular a feature in the serum of some individual, whose red cells lack the corresponding antigen Autoantibody: An atypical antibody that sensitizes or agglutinates own red cells Biomedical Waste: Waste generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining thereto or in the production and testing biological products Blood Cold Chain: Means continuous maintenance of mandatory storage conditions (e.g to 6°C for whole human blood) from the point of collection/preparation to the point of use of blood and its components Blood: Means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant Blood Bank: Means a place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, to be returned for apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components Blood Component: Means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor, e.g red cells, platelet concentrates or fresh frozen plasma, etc Blood Product: Means a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from the donors Cross-matched Blood: Donor’s whole blood or its components matched with the blood of the recipient 430  Standard Operating Procedures and Regulatory Guidelines-Blood Banking • • • • • • • • • • • • • • Donor: Means a person who voluntarily donates blood after he has been declared medically fit after medical examination, for donating blood, on fulfilling the criteria given hereafter, without accepting in return, any consideration in cash or kind from any source, but does not include a professional or paid donor Defrost Cycle: Process of removing of excess ice from plasma freezer cabinets without change in the temperature of the freezer Whenever, such frost or ice builds up in the plasma freezer cabinets it requires to be removed to avoid excessive running of the compressor Modern freezers have an automatic defrost cycle The temperature of the cabinet should not rise during the defrost cycle Elution: The removal of antibody from the RBC surface Total elution removes the antibody coating the RBCs and destroys the antigens to which they were attached Partial elution removes the antibody, but allows the antigen to remain intact Eluate: A fluid medium containing the antibodies that have been deliberately removed from RBCs, allowing for antibody identification FIFO Policy: First-in-first-out policy Incomplete Antibody: Any antibody which sensitizes red cells suspended in saline but fails to agglutinate them These antibodies react in albumin/enzyme medium or with AHG serum Major Cross-match: Test to determine compatibility between donor serum and patient’s red cells Minor Cross-match: Test to determine compatibility between patient’s serum and donor red cells Mixed Field Agglutination Reaction: A reaction wherein a few cells are agglutinated while many cells are unagglutinated Prozone Phenomenon: Negative reaction of antibody in low dilution and positive reaction in higher dilution of the same antibody Processed Blood: Blood which has been processed into components Generally refers to the red cell component The essential tests may or may not have been done Professional Donor: Means a person who donates blood for a valuable consideration, in cash or kind, from any source, on behalf of the recipient-patient and includes a paid donor or a commercial donor Quality Assurance: As part of the overall quality management program, the range of activities and systems that provide confidence within the organization and for the authorities that all quality requirements are met Quality Control: A component of quality management, these are tests put in place to ensure that processes, procedures and products meet the quality requirements Glossary  431 431 • • • • • • • • • • • • Quarantine: Temporary storage in isolation For example, unprocessed/ untested blood is kept in isolation (not accessible for use) until all essential processes/tests are completed Rouleaux Formation: A form of pseudo-agglutination in which the red cells look like pile of coins Replacement Donor: Means a donor who is a family friend or a relative of the patient/recipient Standard Operating Procedure (SOP): Written instructions for the performance of a specific procedure Stroke: Number of times the tray of the platelet agitator moves from side to side per minute; 65 to 75 strokes per minute are considered adequate Screening: Preliminary testing Sensitivity: Probability that the test result will be reactive in an infected individual Serum: Fluid portion of clotted blood Specificity: Special affinity between an antigen and its corresponding antibody Validation: Confirmation and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled It is a part of quality assurance system that evaluates in advance the steps involved in operational procedures or product preparation to ensure quality, effectiveness and reliability Wharton’s Jelly: Mucoid connective tissues that make the matrix of the umbilical cord “30 Minute Rule”: General rule in the blood bank stating that a maximum time of 30 minutes is allowed for a blood or its component issued from the blood bank to a ward to be returned 435 Index Page numbers followed by ‘f ’ refer to figure and ‘t’ refer to table A ABO blood grouping, 57 confirmation of, 111 discrepancies and possible resolution, 74 chart, resolving, 73 resolving, 65 group discrepancy, resolution of, 63 Acute reactions, 206 Adhesive tapes, 26, 29 Adrenaline, 31 Agglutination, grading of, 61 AHG reagent, 97, 100 Air embolus, 288 handling systems, 370 Air-borne particulate for manufacture of sterile products, 370t Alarm test, screen display during, 251f Albumin, 354 technique for Rh typing, 81 Allergic balm, 32 reactions, 286 tablets, 31 transfusion reaction, 206 Anaphylactic transfusion reaction, 206 Antibody screening, 87 antenatal mother, 123 Anti-coagulant blood samples of donors, 84 delivery of, 283 Anti-globulin reagent, quality of, 233 technique, indirect, 94 test direct, 96 indirect, 89, 133 Anti-HIV testing, 158, 160 Antihuman globulin reagent, quality control of, 233 globulin serum, 96 Apheresis set, installation of, 246 Apply cold compresses to forehead and back, 32 Applying cuff, 272 Arterial puncture, 53f Artery forceps, 22, 26 Atropine sulfate, 31 Autoclave, 327 Automatic operation, 256, 275 B Bacterial infection, 288 Bag after centrifuge, 42f Bandages, 32 Band-aids, 32 Bench centrifuge, 224 Betnovate ointment, 32 Bevel of needle against vein wall, 52f Binometer, 327 Biomedical waste management, 290 Blood and components, preservation of, 174 assurance of, 213 bag contains RBC, 39f for blood components, selection of, 25 436  Standard Operating Procedures and Regulatory Guidelines-Blood Banking labeling of, 172 selection of, 24 total weight of, 217 types of, 24 banks, 323 accommodation for, 324 alternative technologies in, 104 and release, 360 of umbilical cord blood derived stem cells, 365 deep freezers, 225 operate, 378 refrigerator, 37, 225 technician(s), borne viruses, infection control of, 305 borne viruses, occupational health measures to prevent transmission of, 305 cells, packed, 36 cold chain from collection to transfusion, 175 collecting CPD-A bags, 26 collection, 26, 360 cycle, 275 monitor, 26, 224 requirements for, 365 room, for, 332 compatibility test of, 343 components, 323, 335 and manufactured, assurance of various, 214 categories of, 340 from whole blood by blood bank, processing of, 339 issue of, 352 requisition form for, 190 separation, 36 concentrate samples, 260 containers for, 332 cross-matching, 353 cycle control, 275 return, 276 donation camps, 337 consent for, 12 criteria for, 330 deferment of, 331 donor deferment of, 10t questionnaire and informed consent form, 11 record, 335 selection, criteria for, flow, return, 276 group, interpretation of, 61 grouping, 352 license, conditions of, 364 pressure, checking of, 32 processing, 360 requirements for, 365 products, 186, 211 components including, 311 manufacture of, 360 transfusion of, 194 quality assurance, 214, 215-217 control of, 213 records for, 335 requisition form for, 190 return of whole, 181 safety and infection control, 50 sample collection, pre-requisites for, 46 for cross-matching, 46 for grouping, collection of, 46 safegaurds/preventions during, 49 stops flowing into tube– 52 storage, 360 cabinets, 225 centers, 350, 381 requirements for, 365 testing, 360 of whole, 334 requirements for, 365 transfusion of, 194 don’ts for, 188 reaction reporting form for, 211 record/reaction form, 192 typing, 326 unit before transfusion, 185 Index  437 437 checking, 184 inventory of, 176 issue of, 178 physical checking of, 184f traceability of, 34 transport of, 178 Bovine albumin technique, 93 BP apparatus, 22 C Calcium tablets, 31 Cell and serum results, discrepancies between, 62, 116 control, 97, 100 grouping, 353 preparation of packed, 40 Centrifugation, 41f Centrifuge, 326 Chemiluminescent immunoassays, 143 Citrate toxicity, 283 symptoms of, 284 treatment of, 284 Clean wooden sticks, 79 Clinical thermometer, 32 Clotted blood sample of donors/patients, 92 patients, 84 Code of injury, algorithm to determine exposure, 297 Cold agglutinins, detection of, 142 Collapsed vein, 52f Color coding for components, 38f for segregation of bio-medical waste, 291 in blood bank, 292 Community health center, 355 Compatibility testing, 91 Complete collection or no blood obtained, 51 Component blood, 213 laboratory, 292 preparation, 36f supplied, records of, 335 Conjunctiva, 296 Control cuvette, 19 Controls for Rh grouping, 79 Convulsions, 32 Coomb’s cross-match, 127 phase, antibody screening in, 121 serum, 97, 100 test direct, 96, 132, 134, 141 indirect, 100, 132, 136 tubes for patient pre-transfusion, 88 prenatal testing, 88 Coplin jar, 15 Copper sulphate record book, 15 solution, 15 method, 15 Cord blood bank technician, 370 processing, 369 area, 367 reception, 367 release, 375 stem cells banking and release of umbilical, 363 process umbilical, 363 store umbilical, 363 test umbilical, 363 umbilical, 360, 362 Cryobath, 226 Cryogenic storage unit, 368 Cryo-poor-plasma, 44 Cryoprecipitate, 343 preparation of, 43 thawing bath, 37 Crystalline CuSO4, 15 Cysteine in frozen state, 92 D DCT/DAT, interpretation of, 98 Deaeration of concentrate bags and collection of samples, 260, 279 Deep freezer –40°C and –80°C, 37 438  Standard Operating Procedures and Regulatory Guidelines-Blood Banking Demethylated spirit, 22 Dextrose, 31 Diazepam, 31 Direct antiglobulin test, 110, 132, 201 Disposal box, 58, 76, 84, 88 of used ID cards, 109 of waste and infectious material, 366 Distilled water, 15, 17 Donor additional qualifications of, and collecting pre-donation sample, connecting, 254, 272 care during and after apheresis, 281 couch, 26 for platelet apheresis, assessing suitability of, 235 room, 218, 292 screening, 14 for hemoglobin, 15 station, 225 values, screen display for adding, 254f, 273 Double bag for preparation of PRC and FFP, 38f Dressings, 32 Drugs and Cosmetics Rules 1945 (Part X-b), 314 1945, and guidelines, recent amendments in, 358 1945, extract of schedule K under, 347 2011, 2nd amendment, 358 2011, 3rd amendment, 359 Dry bath, 75, 84 rubber balancing material, 37 Du weak antigen, testing for, 119 E E cryoprecipitate, 216 EDTA blood sample, 169 of hemoglobin concentration, 15 Electrolyte replacement fluid, 31 Electronic weighing scale, 37 ELISA method, 155, 160, 166 test for syphilis, 150 washer, 224 Emergency equipments/items, 333 Emergent/life-threatening circumstances, 195 Enzyme immunoassays, 143 method, 354 papaine, deep freezer to store, 92 phase, antibody screening in, 125 technique, 93 Epinephrine, 31 Equipment contamination, 288 maintenance, 220 F Febrile non-hemolytic reaction, 206 Fever with septic shock, 207 First aid administration of, 296 tray, 26 Fresh frozen plasma, 25, 36, 40, 343 Furesemide, 31 G Gauze sponges, 46 Gel cards centrifuge for, 220 quality control of, 233 Gel test, advantages of, 109 Getting blood from blood bank, 183 Glass slide, 58, 76, 79, 84, 88, 92 method, 58, 59 test tube, 58 method, 60 technique, 80 Glassware, 15 Glucocorticoid, 31 Glucose, 31 saline, 31 Index  439 439 Graft-versus-host disease, 208 Granulocyte concentrates, 343 H H reference samples, 373 HBV, 302 HCV, 302, 303 antibodies, testing for, 163, 166 Healthcare worker or injured person, 302 Heart failure, congestive, 207 Hemagglutination, 143 Hematocrit, 326 Hematology laboratory, 367 Hematoma, 33 formation problem in older patients, 53 prevention of, 49 under skin, 53f Hemo-control photometer, 19 Hemoglobin by hemo-control, estimation of, 19 determination, for, 332 of donor, estimation of, 17 Hemolysis, 287 Hemolytic transfusion reaction, 206 Hemovigilance program, 209 Heparin and benzyl nicotinate ointment, 32 Hepatitis B prophylaxis for reported sharps injuries, 301t surface antigen, testing for, 153, 155 HIV, 303 status code, determining, 298 HLA typing laboratory, 367 Hospital Infection Control Committee, 295 Human blood, operation of whole, 355 Human red blood corpuscles, concentrated, 340 Hyperkalemia, 208 Hypocalcemia, 207, 283 Hypothermia, 208 I IAT method, 354 ID microtyping system, 108 ID-centrifuge, 106 6S, 106f ID-incubator, 105 37 SI, 105f IGG coated cells, 97, 100 Inadequate citration, 284 Incompatibility, resolution of, 95 Incubator, 57, 63, 75, 84, 223 for gel cards, 221 Infection control nurse, 295 officer, 295 Inflate cuff display, 272f Informed consent, 10, 194 Infusion set, 32 Install set, display for, 264 Installation of set, screen display after continuing on, 249f Iron overload, 209 J Judicial pronouncements–blood safety, 410 L Laminar flow bench, 37 Lamivudine, 299 Lancet, 17 Landsteiner’s law, 57 Leaflet for post-donation instructions, 29 Leukapheresis, 343, 344 Licence for blood banking and release, 362 collection, 362 processing, 362 storage, 362 testing, 362 License to collect umbilical cord blood stem cells, 363 Low-ionic strength saline solution, 55, 64, 89, 97, 100 440  Standard Operating Procedures and Regulatory Guidelines-Blood Banking M O Machine malfunction, complications due to, 287 Management of sharps, 294 Menu screen for calculated values, 255f, 274f Menus, 254 Metoclopramide, 31 Microcuvettes, 19 Microplate, 58 elisa reader, 223 Microtubes, 58, 76, 84, 88 Microwell plate, 58 Minor cross-match, 128 Monitoring transfused patient, 186 Monoclonal anti-D reagents, 79 saline agglutination test, using, 80 Mucocutaneous exposure to blood or other body fluids, 301t Observation during transfusion, 192 Oxygen cylinder, 32 with accessories, 26 N NACO for post-exposure prophylaxis, recommendations of, 300 National Blood Policy, 312 Needle angle with surface of arm, 49f destroyer, 26 not in lumen of vein, 51f penetrated too far, 51f stick incidents and exposure incidents, 294 injury, 303 sharps injury or cut, 296 Negative antibody screen, causes of incompatible cross-match in presence of, 94 test, 81 Newborn, ABO/Rh/DAT of, 140 Non-governmental organizations, 311 Non-intact skin, 296 Nucleic acid amplification technology assays, 143 P Pan malaria, 169 Paracetamol, tablet 31 Particle agglutination assays, 143 Pasteur pipettes, 17, 58, 76, 79, 84, 88, 92 Pheniramine maleate, 31 Phlebotomy site, preparation of, 22 Pilot samples, 340 tubes, plain and edta, 26 Plasma bath, 226 collection of, 344 additional, 257 expresser, 37 fresh frozen, 216 or saline, 84 pheresis, 343, 344 room, 292 Plastic beakers, 80 Platelet, 25 agitator and incubator, 226 with incubator, 37 apheresis donor selection 237 concentrate, 40, 215, 341 and set, removing 260, 279 donation, selection of program for, 245, 263 pheresis 344 using blood cell separator dual needle 243 single needle, 261 poor plasma, 42f program, selection of, 244, 262 rich plasma, 39, 42 using double bags, 38 separation, screen display after completion of, 258f, 277 during, 256f, 275 Index  441 441 Platepheresis 343 Polyclonal human anti-D serum, 79 Positive test, 81 Post-transfusion purpura, 208 Post-donation care, 29, 289 Post-exposure prophylaxis, 299 Post-transfusion urine sample, tests on, 204 Povidone iodine solution, 22 Prepare separation, screen display for, 253f Pressure test 250, 268 Pre-transfusion, 196 testing, 91 Prevent hemolysis, 50 Primary health center, 355 Priming of set, screen display after, 252f preparing for, 266 screen display during, 252f Print out, display end of procedure for, 280 Prochlorperazine maleate, 31 Program, screen display for selection of, 263 Protect yourself, 50 PRP to bag 2, 41f Pulse checking of 32 determination, for temperature and, 332 Q Quality control tests, frequency of, 229 R Rapid antigen test for malaria 169 tests, 143, 153 TP test, 148 tri-dot method, 158, 163 RBCs in bag, packed, 39f Reactions in blood donors, management of adverse, 31 Reagents, quality control of, 228, 233 Records and store room, 368 Red blood cells, 25 frozen, packed, 215, 341 Red cell preparation of packed, 38 reagents, quality control of, 232 serology laboratory, 218 suspended in native serum, 84 suspension, preparation of, 55 unit, packed, 181 Red top vacutainer, 47f Redressal Commission, 412, 414, 416, 419, 420 Refrigerated centrifuge, 37 Refrigerator, 63 Register for diagnostic kits and reagents used, 335 Registered medical practitioner, 178 nurse(s), Regulatory guidelines, 309 requirements of blood, 311 Reinfusion, 257, 278 end of, 278 screen display during, 259f guiding for start of, 279 Reverse grouping of donor, 113 with weak or missing reactions, 69 Rh blood grouping, 78 of donor, 111 Rh Du blood grouping, 83 grouping, interpretation of, 85 Rh view box, 80 Rubber teats, 58, 76, 80, 84, 88, 92 S SAGM solution, double bags or triple bags with, 37 to bag 1, 42f Sahli’s hemoglobinometer, 17 method, 17 442  Standard Operating Procedures and Regulatory Guidelines-Blood Banking Saline addition and replacement technique, 102 method, 353 technique, 93 Sample and materials required, 111 Savlon solution, 32 Scenario of legal framework, 312 Scheme for quality control, 214 Scissors, 26 Screening tests, 372 Separation preparing for, 253, 271 screen display for starting, 255f Serology laboratory, 367 Serum and Coomb’s tubes, racks to hold, 88, 92 grouping, 353 tubes, 58, 76, 84, 88, 92 racks to hold, 84 Sexually transmitted diseases, 148 Sharp instruments, management of, 306 Skin around venipuncture site, eczematous reactions of 33 Skip priming, 268 Slide method for blood grouping, 59f Rh blood grouping, 81f SN-bag empty, 278 screen display for stopping, 278 Sodium bicarbonate, 31 chloride, 31 Software version display, 244f, 262f Sops contents of, use of, Spirit of ammonia, 32 Spirit wipes, 46 Splash to mucous membrane, 296 Standard operating procedure, Start of reinfusion, screen display guiding for, 258f Starting separation, screen display for, 274 Sterile connecting device, 37 cotton gauze/swabs, 22, 26 swabs, 17 disposable hypodermic needles, 26 syringes, 26 gauze/cotton, spirit, 19 swabs, 29 testing laboratory, 367 Sterilization-cum washing, 368 Sterilizing tray, 22 Suitability of donor, 340 Syphilis screening for, 146 test for, 148 T Table top centrifuge, 57, 63, 75, 84, 92 machine, 55 Temperature, 326 Terminating reinfusion, 259 Test kit, 169 tube, 15, 63, 79 rack for, 58, 63, 80 stand, 15 Testing elute, 77 Tetany/muscular spasm/twitching, 33 Thermometers, laboratory, 327 Thrombophob ointment, 29 Tissue paper, 15 Tongue depressor, 32 Tourniquet, 46 Transfer bags, 37 Transfusion of reactions, investigation of, 198 related lung injury, 206 right blood to right patient, 183 transmissible disease screening laboratory, 367 infections testing, 218 transmitted diseases, 209 Index  443 443 infections, 143 quality control of kits for testing, 234 screening for, 143 Treponema pallidum, 148, 150 hemagglutination, 148 Triple bag system for preparation of packed cells, 40f with or without additive solution, 40 Troubleshooting guidelines, 51 Tube sealer, 26, 37, 225 U Umbilical cord blood component collection of processed, 368 storage of processed, 368 stem cells, 362 Urinometer, 15 V Vacutainers, 46 purple top, 47f Vascular access, complications of, 287 Vasovagal, 285 syndrome, 32 Vein selection, 48 Venipuncture performance of, 48 Venipuncture, 26 site selection, 47 Visual inspection, 201 Vitamin C tablets, 31 Vomiting, 32 W Warming blood, 186 Washed packed red cell, 44 Waste generated, types of, 290 segregation, 292 Water bath, 75, 327 distillation still, 37 Weighing scale, 15 White tile method, 58 Whole blood, 214 Wooden blocks to hold microtubes, 80, 84, 88 Z Zidovudine, 299 ... book Standard Operating Procedures and Regulatory Guidelines Blood Banking for the blood bank professionals in providing and using blood components to make sure that the right blood/ blood components... safe, and quality blood/ blood components (Dr Rakesh Gupta) Preface This book Standard Operating Procedures and Regulatory Guidelines Blood Banking has been designed to provide blood bank technicians,... with their book Standard Operating Procedures and Regulatory Guidelines Blood Banking that incorporates the latest updated procedural guidelines regarding the operation of blood banks This