Contents
SECTION 1
Standard Operating Procedures
1. Standard Operating Procedure for Preparing, Revising
and Using Standar...
xviii Standard Operating Procedures and Regulatory Guidelines-Blood Banking
12. Traceability of the Blood Units 34
Scope a...
Contents xix
25. Saline Addition and Replacement Technique 102
Scope and Application 102; Responsibility 102; Materials
Re...
xx Standard Operating Procedures and Regulatory Guidelines-Blood Banking
38. Screening for Syphilis (RPR Test) 146
Scope a...
Contents xxi
51. Issue and Transport of Blood Units 178
Scope and Application 178; Responsibility 178; Materials
Required ...
xxii Standard Operating Procedures and Regulatory Guidelines-Blood Banking
63. Bio-medical Waste Management 290
Scope and ...
Contents xxiii
First Referral Unit, Community Health Center, Primary Health
Center or Any Hospital 355
71. Recent Amendmen...
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9789351522157

  1. 1. Contents SECTION 1 Standard Operating Procedures 1. Standard Operating Procedure for Preparing, Revising and Using Standard Operating Procedures (SOPs) 3 Scope and Application 3; Responsibility 3; Staff 3; Contents of SOPs 6; Use of SOPs 7 2. Criteria for the Donor Selection 8 Scope and Application 8; Responsibility 8; Material Required 8; Procedure 8; Annexure 2.1 11 3. Donor Screening 14 Scope and Application 14; Responsibility 14; Materials Required 14; Medical Examination 14 4. Donor Screening for Hemoglobin (Copper Sulfate Solution Method) 15 Scope and Application 15; Responsibility 15; Materials Required 15; Procedure 16; Interpretation 16 5. Estimation of Hemoglobin of the Donor (Sahli’s Method) 17 Scope and Application 17; Responsibility 17; Materials Required 17; Procedure 17; Interpretation 18 6. Estimation of Hemoglobin by Hemo-Control 19 Scope and Application 19; Responsibility 19; Materials Required 19; Procedure 19; Interpretation 21 7. Preparation of Phlebotomy Site 22 Scope and Application 22; Responsibility 22; Materials Required 22; Procedure 22 8. Selection of the Blood Bags 24 Scope and Application 24; Responsibility; 24 Materials Required 24; Procedure 24 9. Venipuncture and Blood Collection 26 Scope and Application 26; Responsibility 26; Materials Required 26; Procedure 26 10. Post-donation Care 29 Scope and Application 29; Responsibility 29; Materials Required 29; Procedure 29 11. Management of Adverse Reactions in the Donors 31 Scope and Application 31; Responsibility 31; Materials Required 31; Management of Adverse Reactions 32
  2. 2. xviii Standard Operating Procedures and Regulatory Guidelines-Blood Banking 12. Traceability of the Blood Units 34 Scope and Application 34; Responsibility 34; Materials Required 34; Procedure 34 13. Blood Components Separation 36 Scope and Application 36; Responsibility 37; Equipment and Materials Required 37; Procedure 38 14. Collection of Blood Sample for Grouping/Cross-matching 46 Scope and Application 46; Responsibility 46; Materials Required 46; Pre-requisites for Blood Sample Collection 46; Procedure 48; Troubleshooting Guidelines 51; Labeling and Documentation 53 15. Preparation of Red Cell Suspension 55 Scope and Application 55; Responsibility 55; Materials Required 55; Procedure 56 16. ABO Blood Grouping 57 Scope and Application 57; Responsibility 57; Equipment 57; Procedure 58; Interpretation 61 17. Resolution of ABO Group Discrepancy 63 Scope and Application 63; Responsibility 63; Materials Required 63; Procedure 64; Resolving ABO Discrepancies 65; Annexure 17.1 73; Annexure 17.2 74 18. Absorption and Elution (For Weak Subgroups of A or B) 75 Scope and Application 75; Responsibility 75; Materials Required 75; Procedure 76; Interpretation 77 19. Rh Blood Grouping 78 Scope and Application 78; Responsibility 78; Materials Required 78; Procedure 80; Interpretation of Results 82 20. Rh Du Blood Grouping 83 Scope and Application 83; Responsibility 83; Materials Required 83; Procedure 84; Interpretation 85 21. Antibody Screening 87 Scope and Application 87; Responsibility 87; Materials Required 87; Procedure 88; Interpretation 90 22. Pre-transfusion Testing (Compatibility Testing) 91 Scope and Application 91; Responsibility 91; Materials Required 91; Procedure 92; Interpretation 94 23. Direct Coomb’s Test/Direct Anti-globulin Test (DCT/DAT) 96 Scope and Application 96; Responsibility 96; Materials Required 96; Procedure 97; Interpretation 98 24. Indirect Coomb’s Test (ICT) 100 Scope and Application 100; Responsibility 100; Materials Required 100; Procedure 101; Interpretation 101
  3. 3. Contents xix 25. Saline Addition and Replacement Technique 102 Scope and Application 102; Responsibility 102; Materials Required 102; Procedure 102; Interpretation 103 26. Alternative Technologies in Blood Banking 104 Equipment 105; Principle 106; Interpretation of Results 107; Precautions to be Taken while Using ID Microtyping System 108; Disposal of Used ID Cards 109 27. Confirmation of ABO and Rh Blood Grouping of the Donor 111 Scope and Application 111; Responsibility 111; Sample and Materials Required 111; Procedure 111 28. Reverse Grouping of the Donor 113 Scope and Application 113; Responsibility 113; Sample and Materials Required 113; Procedure 113 29. Forward and Reverse Grouping of the Patient 115 Scope and Application 115; Responsibility 115; Sample and Materials Required 115; Procedure 115; Annexure 29.1 117 30. Testing for Du Weak Antigen 119 Scope and Application 119; Responsibility 119; Sample and Materials Required 119; Procedure 119 31. Antibody Screening in Coomb’s Phase 121 Scope and Application 121; Responsibility 121; Sample and Materials Required 121; Procedure 121; Annexure 31.1 123 32. Antibody Screening in Enzyme Phase 125 Scope and Application 125; Responsibility 125; Sample and Materials Required 125; Procedure 125 33. Coomb’s Cross-match 127 Scope and Application 127; Responsibility 127; Materials Required 127; Procedure 127; Minor Cross-match 128; Interpretation 128; Annexure 33.1 130; Instructions for Blood Transfusion 131 34. Coomb’s Test (Direct and Indirect) 132 Scope and Application 132; Responsibility 132; Materials Required 132; Procedure 132; Annexure 34.1 134; Annexure 34.2 136 35. ABO, Rh Grouping and DAT of Newborn 138 Scope and Application 138; Responsibility 138; Sample and Materials Required 138; Procedure 138; Method 139; Annexure 35.1 140 36. Detection of Cold Agglutinins 142 Scope and Application 142; Responsibility 142; Sample and Materials Required 142; Procedure 142 37. Screening for Transfusion Transmitted Infections (TTIs) 143
  4. 4. xx Standard Operating Procedures and Regulatory Guidelines-Blood Banking 38. Screening for Syphilis (RPR Test) 146 Scope and Application 146; Responsibility 146; Materials Required 146; Procedure 146; Interpretation 147 39. TPHA (Treponema pallidum Hemagglutination) Test for Syphilis (Rapid TP Test) 148 Scope and Application 148; Responsibility 148; Materials Required 148; Procedure 148; Interpretation 149 40. ELISA Test for Syphilis (Syphilis EIA II Total Antibody) 150 Scope and Application 150; Responsibility 150; Materials Required 150; Procedure 150; Interpretation 152 41. Testing for Hepatitis B Surface Antigen (Rapid Test) 153 Scope and Application 153; Responsibility 153; Materials Required 153; Procedure 153; Interpretation 154 42. Testing for Hepatitis B Surface Antigen (ELISA Method) 155 Scope and Application 155; Responsibility 155; Materials Required 155; Procedure 155; Validation and Interpretation 156 43. Anti-HIV Testing (Rapid TRI-DOT Method) 158 Scope and Application 158; Responsibility 158; Materials Required 158; Procedure 158; Interpretation 159 44. Anti-HIV Testing (ELISA Method) 160 Scope and Application 160; Responsibility 160; Materials Required 160; Procedure 160; Calculation of Results 161; Interpretation of Results 162 45. Testing for HCV Antibodies (Rapid TRI-DOT Method) 163 Scope and Application 163; Responsibility 163; Materials Required 163; Procedure 163 46. Testing for HCV Antibodies (ELISA Method) 166 Scope and Application 166; Responsibility 166; Materials Required 166; Procedure 166; Calculation of Results 168; Interpretation 168 47. Rapid Antigen Test for Malaria (Pan Malaria) 169 Scope and Application 169; Responsibility 169; Materials Required 169; Procedure 169; Interpretation 170 48. Labeling of the Blood Bags 172 Scope and Application 172; Responsibility 172; Materials Required 172; Procedure 173 49. Preservation of the Blood and Components 174 Scope and Application 174; Responsibility 174; Materials Required 174; Procedure 174 50. Inventory of the Blood Units and Components 176 Scope and Application 176; Responsibility 176; Materials Required 176; Procedure 176
  5. 5. Contents xxi 51. Issue and Transport of Blood Units 178 Scope and Application 178; Responsibility 178; Materials Required 178; Procedure 178 52. Return of Whole Blood/Packed Red Cells 181 Scope and Application 181; Responsibility 181; Materials Required 181; Procedure 181 53. Transfusion of Right Blood to the Right Patient 183 Scope and Application 183; Responsibility 183; Materials Required 183; Procedural Issues 183; Don’ts for Blood Transfusion 188; Annexure 53.1 190; Annexure 53.2 192; Annexure 53.3 194; Annexure 53.4 196 54. Investigation of Transfusion Reactions 198 Scope and Application 198; Responsibility 198; Materials Required 199; Procedure 200; Hemovigilance Program 209; Annexure 54.1 211 55. Quality Control/Assurance of the Blood/Blood Components 213 Scope and Application 213; Responsibility 213; Scheme for Quality Control/Assurance of Various Blood Components 214 56. Storage of the Consumables, Reagents and Kits 218 Scope and Application 218; Responsibility 218; Materials Required 218; Procedure 218 57. Equipment Maintenance 220 Scope and Application 220; Responsibility 220; Procedures 220 58. Quality Control of the Reagents 228 Scope and Application 228; Responsibility 228; Quality Control of the Reagents 228 59. Assessing Suitability of the Donor for Platelet Apheresis 235 Scope and Application 235; Responsibility 235; Materials Required 235; Procedure 235; Documentation 236; Annexure 59.1 237 60. Plateletpheresis Using Blood Cell Separator (Dual Needle) 243 Scope and Application 243; Responsibility 243; Materials Required 243; Procedure 244 61. Plateletpheresis Using Blood Cell Separator (Single Needle) 261 Scope and Application 261; Responsibility 261; Materials Required 261; Procedure 262; End of Reinfusion 278 62. Donor Care during and after Apheresis 281 Scope and Application 281; Responsibility 281; Materials Required 281; General Care during Procedure 282; Complications 283; Post-donation Care 289
  6. 6. xxii Standard Operating Procedures and Regulatory Guidelines-Blood Banking 63. Bio-medical Waste Management 290 Scope and Application 290; Responsibility 290; Materials Required 290; Types of Waste Generated, Segregation and on-site Storage 290 64. The Management of Sharps/Needle Stick Incidents and Other Exposure Incidents 294 Scope and Application 294; Responsibility 295; Procedure and Guidelines 295; Consent and Cost (Source Person) 302; Needle Stick Injury/Sharp Object/Body Fluid Exposure 303; Training and Prevention 304; Record and Documentation 305; Safe Work Practices 305 SECTION 2 Regulatory Guidelines 65. Regulatory Requirements of Blood and/or Its Components including Blood Products 311 National Blood Policy 312; Scenario of Legal Framework 312 66. Drugs and Cosmetics Rules, 1945 (Part X-B) 314 67. Schedule F (Part XII B)Under the Drugs and Cosmetics Rules, 1945 323 1. Blood Banks/Blood Components 323; A. General 323; B. Accommodation for a Blood Bank 324; C. Personnel 324; D. Maintenance 325; E. Equipment 326; F. Supplies and Reagents 327; G. Good Manufacturing Practices/ Standard Operating Procedures (SOPs) 328; H. Criteria for Blood Donation 330; I. General Equipment and Instruments 332; J. Special Reagents 334; K. Testing of Whole Blood 334; L. Records 335; M. Labels 336; 2. Blood Donation Camps 337; 3. Processing of Blood Components from Whole Blood by a Blood Bank 339 68. Storage Conditions, Expiry of Blood, Blood Components and Blood Products as Per Schedule P of the Drugs and Cosmetics Act, 1940, and Rules, 1945 345 69. Extract of Schedule K Under the Drugs and Cosmetics Rules, 1945 347 70. Blood Storage Centers 350 Requirements 350; Staff 351; Storage 351; Issue of Blood/Components 352; Blood Grouping 352; Cell Grouping 353; Serum Grouping 353; Cross-matching 353; Guidelines before Grant of Approval for Operation of Whole Human Blood and/or Its Components Storage Centers Run by
  7. 7. Contents xxiii First Referral Unit, Community Health Center, Primary Health Center or Any Hospital 355 71. Recent Amendments in the Drugs and Cosmetics Rules, 1945, and Guidelines 358 I. Amendments 358; Part XII-D of Schedule-F of the Drugs and Cosmetics Rules, 1945 365; II. Guidelines 375 72. Guidelines for the Preparation of Application for Grant/Renewal of License to Operate Blood Bank 378 Annexure 72.1 382 Annexure 72.2 383 Annexure 72.3 384 Annexure 72.4 385 Annexure 72.5 386 Annexure 72.6 387 Annexure 72.7 388 Annexure 72.8 389 Annexure 72.9 390 Annexure 72.10 391 Annexure 72.11 392 Annexure 72.12 393 Annexure 72.13 394 Annexure 72.14 395 Annexure 72.15 396 73. Judicial Pronouncements–Blood Safety 410 Glossary 429 Bibliography 433 Index 435

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