Standard Operating Procedures & Regulatory Guidelines: Blood Banking GP Saluja, GL Singal
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
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), 4
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, 5
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, 8
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, 215217
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
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
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, 9
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
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
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
M
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
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
O
Observation during transfusion, 192
Oxygen cylinder, 32
with accessories, 26
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
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), 5
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
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, 6
use of, 7
Spirit of ammonia, 32
Spirit wipes, 46
Splash to mucous membrane, 296
Standard operating procedure, 8
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
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
×
Chapter Notes

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1Standard Operating Procedures and Regulatory Guidelines BLOOD BANKING2
3Standard 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
4
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© 2014, Jaypee Brothers Medical Publishers
The views and opinions expressed in this book are solely those of the original contributor(s)/author(s) and do not necessarily represent those of editor(s) of the book.
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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.
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Inquiries for bulk sales may be solicited at: jaypee@jaypeebrothers.com
Standard Operating Procedures and Regulatory Guidelines–Blood Banking
First Edition: 2014
9789351522157
Printed at
5Dedicated 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
6
7Foreword
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)
8
9Foreword
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 do 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 do 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)
10
11Foreword
Commissioner, Food & Drugs Administration
Government of Haryana
Tel: 0172-2560124; Fax: 0172-2584066
It gives me immense pleasure to know that Dr GP Saluja and Dr GL Singal have teamed up to write the 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 is given to the right patient at the right time. This can only be achieved when procedures for prescribing, ordering, collecting, storing and administering blood components and clinical policies are based on the Drugs and Cosmetics Act, 1940 and Rules, 1945 as well as National Blood Policy.
The Act sets legally-binding standards for quality and safety in collection, testing, processing, storage and distribution of blood/blood components for which Standard Operating Procedures (SOPs) are required to be followed for ensuring safe blood transfusion. Besides, some of the legal judgments included in the book will help those associated with blood banking in understanding legal situation of the transfusions.
I am sure that this book will be of immense benefit to one and all working in this field and help them in achieving their objective of providing adequate, safe, and quality blood/blood components.
(Dr Rakesh Gupta)
12
13Preface
This book “Standard Operating Procedures and Regulatory Guidelines–Blood Banking” has been designed to provide blood bank technicians, students undergoing various courses in medical technology, blood bank specialists and residents with a concise and thorough practical and simple procedural guide to all the procedures to check the quality and safety of the blood donated for transfusion.
The first section of the book focuses on routine blood bank practices including donor selection, phlebotomy procedure, sample collection, component preparation, blood grouping—both routine and gel technology, screening for the transfusion transmitted infections (TTIs), compatibility testing, storage of blood/blood components, apheresis, labeling, issue and transport of blood units, transfusion of the right blood to the right patient, quality control/assurance, equipment maintenance and bio-waste disposal.
The second section deals with the regulatory guidelines including the Drugs and Cosmetics Act, 1940 and Rules, 1945, NACO guidelines for the safety of blood/blood components and procedural details as well as various documents required for processing of application for grant of license under the said Act to operate the blood banks.
Some of the judicial pronouncements related to the blood safety have also been included so as to create awareness amongst the blood bank fraternity regarding the various legal issues involved in blood transfusion.
The book is a culmination of the tremendous efforts of the dedicated professionals because they care about the blood bank profession, and it also aims at fostering improved patient care by providing the readers with a basic understanding of the various blood bank procedures and legal issues. We express our gratitude to all those associated including Dr Gautam Wankhede, Director, Medical Affairs, Alliance Transfusion (Pvt) Ltd, for contributing valuable inputs in compiling this publication.
GP Saluja
GL Singal
14
15Acknowledgments
We owe a great many thanks to a great many people who helped and supported us during the writing of this book.
We express our thanks to Dr Baljeet Singh Dahiya, the then Director General, Health Services, Government of Haryana, India, for the support and encouragement in the publication of “Standard Operating Procedures and Regulatory Guidelines” for the Health Department of Haryana in 2004. We are also thankful to the blood bank professionals, who had highly appreciated our efforts and encouraged us to write and bring out this book.
Our thanks are extended to M/s Jaypee Brothers Medical Publishers (P) Ltd, New Delhi, India, and their dedicated staff for professionally designing and printing this book.
Our deepest thanks to Sh M Mitra, Former Deputy Drugs Controller, CDSCO, Government of India, for guiding and providing his valuable inputs in bringing out this book.
We express our gratitude to Dr Gautam Wankhede, Director, Medical Affairs, Alliance Transfusion (Pvt) Ltd. for contributing his valuable inputs in compiling this publication.
We would also thank our institutions for extending their support in this endeavor.