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

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 Procedur

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Standard Operating Procedures and Regulatory Guidelines

BLOOD BANKING

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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

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Jaypee Brothers Medical Publishers (P) Ltd.

4838/24, Ansari Road, Daryaganj

New Delhi 110 002, India

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

Website: www.jaypeebrothers.com

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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.

All rights reserved No part of this publication may be reproduced, stored or transmitted in any form or by any means, electronic, mechanical, photo copying, 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 contra indications 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

Mobile: +08801912003485 Email: jaypeedhaka@gmail.com Jaypee Brothers Medical Publishers (P) Ltd.

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Jaypee Brothers Medical Publishers (P) Ltd.

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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

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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)

Minister of Health & Medical Education

Government of Haryana

Tel: 0172-2740278; Fax: 0172-2748043

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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

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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

Commissioner, Food & Drugs Administration

Government of Haryana

Tel: 0172-2560124; Fax: 0172-2584066

(Dr Rakesh Gupta)

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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

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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

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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

Required 15; Procedure 16; Interpretation 16

5 Estimation of Hemoglobin of the Donor (Sahli’s Method) 17

6 Estimation of Hemoglobin by Hemo-Control 19

7 Preparation of Phlebotomy Site 22

Required 22; Procedure 22

8 Selection of the Blood Bags 24

Scope and Application 24; Responsibility; 24 Materials

9 Venipuncture and Blood Collection 26

10 Post-donation Care 29

11 Management of Adverse Reactions in the Donors 31

Required 31; Management of Adverse Reactions 32

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xviii Standard Operating Procedures and Regulatory Guidelines-Blood Banking

12 Traceability of the Blood Units 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

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

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

19 Rh Blood Grouping 78

Required 78; Procedure 80; Interpretation of Results 82

20 Rh D u Blood Grouping 83

21 Antibody Screening 87

22 Pre-transfusion Testing (Compatibility Testing) 91

23 Direct Coomb’s Test/Direct Anti-globulin Test (DCT/DAT) 96

24 Indirect Coomb’s Test (ICT) 100

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Contents xix

25 Saline Addition and Replacement Technique 102

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

28 Reverse Grouping of the Donor 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 D u Weak Antigen 119

31 Antibody Screening in Coomb’s Phase 121

Sample and Materials Required 121; Procedure 121;

Annexure 31.1 123

32 Antibody Screening in Enzyme Phase 125

33 Coomb’s Cross-match 127

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

Required 132; Procedure 132; Annexure 34.1 134;

Annexure 34.2 136

35 ABO, Rh Grouping and DAT of Newborn 138

and Materials Required 138; Procedure 138; Method 139; Annexure 35.1 140

36 Detection of Cold Agglutinins 142

37 Screening for Transfusion Transmitted Infections (TTIs) 143

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xx Standard Operating Procedures and Regulatory Guidelines-Blood Banking

38 Screening for Syphilis (RPR Test) 146

39 TPHA (Treponema pallidum Hemagglutination)

Test for Syphilis (Rapid TP Test) 148

40 ELISA Test for Syphilis (Syphilis EIA II Total Antibody) 150

41 Testing for Hepatitis B Surface Antigen (Rapid Test) 153

42 Testing for Hepatitis B Surface Antigen (ELISA Method) 155

Required 155; Procedure 155; Validation and

Interpretation 156

43 Anti-HIV Testing (Rapid TRI-DOT Method) 158

44 Anti-HIV Testing (ELISA Method) 160

Required 160; Procedure 160; Calculation of Results 161;

Interpretation of Results 162

45 Testing for HCV Antibodies (Rapid TRI-DOT Method) 163

46 Testing for HCV Antibodies (ELISA Method) 166

Required 166; Procedure 166; Calculation of Results 168;

Interpretation 168

47 Rapid Antigen Test for Malaria (Pan Malaria) 169

48 Labeling of the Blood Bags 172

49 Preservation of the Blood and Components 174

50 Inventory of the Blood Units and Components 176

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Contents xxi

51 Issue and Transport of Blood Units 178

52 Return of Whole Blood/Packed Red Cells 181

53 Transfusion of Right Blood to the Right Patient 183

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

57 Equipment Maintenance 220

Scope and Application 220; Responsibility 220; Procedures

220

58 Quality Control of the Reagents 228

Quality Control of the Reagents 228

59 Assessing Suitability of the Donor for Platelet Apheresis 235

Required 235; Procedure 235; Documentation 236;

Annexure 59.1 237

60 Plateletpheresis Using Blood Cell Separator (Dual Needle) 243

61 Plateletpheresis Using Blood Cell Separator (Single Needle) 261

Required 261; Procedure 262; End of Reinfusion 278

62 Donor Care during and after Apheresis 281

Required 281; General Care during Procedure 282;

Complications 283; Post-donation Care 289

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xxii Standard Operating Procedures and Regulatory Guidelines-Blood Banking

63 Bio-medical Waste Management 290

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

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

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

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Contents xxiii

First Referral Unit, Comm unity 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

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Standard Operating

Procedures

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SCOPE AND APPLICATION

Standard operating procedures are essential documents for ensuring smooth, efficient and lawful functioning/operation of any blood bank These SOPs may be numerous in a particular blood bank defining their functions but there are some SOPs which remain common for all the blood banks, e.g SOP for collection of blood, grouping and cross-matching of blood and issuing procedures, etc, These may also include SOP for policies guiding the rational use of blood and blood components, time-frame for availability of whole blood and its components and instructions in case of established transfusion reaction SOPs are critical sub-elements of the quality system and are essential to ensure that every procedure is undertaken in a standardized way for generation

of consistent results Therefore individual blood bank must develop its own blood bank specific SOPs based on infrastructure available, test procedures to be followed and availability of reagents

RESPONSIBILITY

It is the responsibility of the Management/Medical Officer/Technical staff working in the blood bank to frame and follow the SOPs to yield the desired quality results

(SOPs)

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4 Standard Operating Procedures and Regulatory Guidelines-Blood Banking

• Supervision of all the functions like donor selection, phlebotomy, grouping and cross-matching, TTI testing, storage, component preparation, labeling, etc

• Ensure timely indent of reagents, blood bags, gel cards, equipment and other items required in the blood bank

• Testing of blood units for HIV, HBsAg, HCV, VDRL and malarial parasites

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Standard Operating Procedure for Preparing, Revising and Using 5

• Recording and maintaining of temperature of different blood bank refrigerators

• Informing technical supervisor immediately in the event of breakdown of equipment or any discrepancy in results of tests

• Contact to other blood banks for supply of blood at the time of emergency

• Any other work assigned from time to time by the management or the medical officer in charge of blood bank

• Testing of blood bags for HIV, HBsAg, HCV, VDRL and malarial parasites

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The specimen of the header is given below:

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Standard Operating Procedure for Preparing, Revising and Using 7

Name & Address of Blood

The specimen of the footer is given below:

Prepared & Issued By Approved By

Each of the SOPs needs to be validated It includes setting up criteria for acceptance of results generated by SOPs, report of a workshop formulating a protocol, undertaking testing using SOPs, comparing the observed results with the predefined criteria and, if matched, declaring that the SOPs have been validated

USE OF SOPs

• Once prepared and approved for implementation, SOPs become the roadmaps for operationalizing the Blood Bank

• Every staff member must have access to all SOPs that affect actions and areas of responsibility

• SOP’s should be followed as approved and maintained by a particular blood bank and if any amendment is required, it has to

be documented and must be made by authorized persons only after following proper procedure

• Any deviation from the SOP must be documented and got approved from authorized person

• All SOPs including the outdated ones are to be retained in the blood bank for the period as per blood bank policy

• Their use is mandatory by all the staff members of the Blood Bank every time they perform any activity in the blood bank

• The licensing and accreditation procedures also demand compulsory use of SOPs

• The SOPs are also used for capacity building in the quality management of blood transfusion services in which emphasis is laid on ensuring consistency in performing various activities so that the safety and quality of blood is guaranteed

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This Standard Operating Procedure (SOP) describes the criteria for a donor to be accepted or rejected for blood donation, for ensuring safety

of donor as well as recipient The purpose of donor selection is to identify the factors that might make an individual unsuitable as a donor, either temporarily or permanently

RESPONSIBILITY

The Medical Officer is responsible for determining the suitability of donor for blood donation He/she should confirm that the criteria are fulfilled after evaluation of Blood Donor Questionnaire and Informed Consent Form duly filled by the donor and medical examination including the results of pre donation screening tests

MATERIAL REQUIRED

• Donor Questionnaire and Informed Consent Form (Annexure 2.1)

PROCEDURE

Criteria for Selection of Blood Donor

Accept only voluntary/replacement non-remunerated blood donors if following criteria are fulfilled—

1 General: No person shall donate blood and no blood bank shall

draw blood from a person, more than once in three months The donor shall be in good health, mentally alert and physically fit and shall not be inmate of jail, person having multiple sex partner and drug-addict The donors shall fulfill the following requirements, namely:

Criteria for Donor Selection

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Criteria for Donor Selection 9

a The donor shall be in the age group of 18 to 65 years

b The donor shall not be less than 45 kilograms

c Temperature and pulse of the donor shall be (As per Transfusion Medi cine Technical Manual; Govt of India, the oral temperature should not exceed 37.5°C and pulse should be 80–100/min and

re gular);

d The systolic and diastolic blood pressures are within normal limits without medication (As per Transfusion Medicine Technical Manual; Govt of India, the systolic and diastolic pressures should be bet ween 100–180 and 50–100 mm of Hg respectively)

e Hemoglobin should not be less than 12.5 grams

f The donor shall be free from acute respiratory diseases

g The donor shall be free from any skin diseases at the site of phle botomy

h The donor shall be free from any disease transmissible by blood transfusion, in so far as can be determined by history and exam ination indicated above

i The arms and forearms of the donor shall be free from skin punctures or scars indicative of professional blood donors or addiction of self-injected narcotics

2 Additional qualifications of a donor: No person shall donate

blood, and no blood bank shall draw blood from a donor, in the conditions mentioned in column (1) of the Table 2.1 given below before the expiry of the period of deferment mentioned in the column (2) of the said Table

3 No person shall donate blood and no blood bank shall draw blood from a person, suffering from any of the diseases mentioned below, namely:

a Cancer

b Heart disease

c Abnormal bleeding tendencies

d Unexplained weight loss

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n Leprosy

o Schizophrenia

p Endocrine disorders

Table 2.1: Deferment of blood donors

2 History of blood transfusion 6 months

5 History of malaria and duly treated 3 months (Endemic)

3 years (Non-endemic area)

7 Breast-feeding 12 months after delivery

8 Immunization (Cholera, Typhoid,

Diphtheria, Tetanus, Plague,

Gamma globulin)

15 Days

9 Rabies vaccination 1 year after vaccination

10 Hepatitis in family or close contact 12 months

11 Hepatitis immunoglobulin 12 months

Private interview

A detailed sexual history should be taken to exclude any risky behavior

Informed consent

Provide information regarding:

1 Need for blood

2 Need for voluntary donation

3 Regarding transfusion transmissible infections

4 Need for questionnaire and honest answers

5 Safety of blood donation

6 How the donated blood is processed and used

7 Tests carried out on donated blood

Note

Request the donors to sign the Donor Questionnaire and Informed Consent Form indicating that he/she is donating voluntarily This will give the donor an opportunity to give his/her consent if they feel them selves as safe donors.

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Criteria for Donor Selection 11Annexure 2.1: Blood Donor Questionnaire and Informed

Consent FormHospital/Blood

Blood Unit & Segment No

Starting Time of Phlebotomy:

Duration of Phlebotomy: _

Ending Time of Phlebotomy: _Min

Phlebotomy Site: Right/Left Antecubital

Fossa

Weight of Blood Unit: _ gms

Donor’s Name: _ Father’s Name: Age/DOB: Sex: _

BLOOD DONOR QUESTIONNAIRE CONFIDENTIAL

[√] Tick wherever applicable

Please answer the following questions correctly This will help to protect you and the patient who receives

your blood.

Occupation: Address: _ Tel No: _ Mobile No: _E-mail: _

Type of Donor: Voluntary Replacement, if Replacement Patient Name MR No:

Would you like us to call you on your mobile: Yes No

Have you donated previously: Yes No

If yes, how many occasions: When Last: _

Did you have any discomfort during/ after donation? Yes No

Your Blood Group: _ Time of last meal:

[√] the appropriate answer:

AIDS, and/or venereal disease?

Continuous low-grade fever

Sexually Transmitted diseases

Dental Extraction

Dog Bite/Anti-rabies vaccine (1 yr.)

Contd

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10 For women donors

a Are you menstruating?

Contd

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Criteria for Donor Selection 13

(c) My blood will be tested for Hepatitis B, Hepatitis C, Malarial parasite, HIV/AIDS and venereal diseases

in addition to any other screening tests required to ensure blood safety The medical and personal information and results of testing will be held by the Blood Bank in strict confidence and will not

be disclosed to anyone unless specifically authorized by me in writing or as required by the Govt authority or legal process.

I acknowledge that I have read and understood the information provided on this form about Blood Donation

I have truthfully, completely and accurately answered all the questions on this form.

I hereby voluntarily consent to donate my blood/blood components to be used as directed by the Blood Bank as per policy of the Govt for the blood safety.

General Physical Examination

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This SOP describes performance of physical examination of the donor for confirming fulfillment of the criteria which ensure safety of the donor

as well as of the recipient

• Check and record height and weight of the donor

• Record BP, pulse and temperature of the donor

• Estimate and record the hemoglobin of the donor

Donors are accepted/rejected/deferred on the basis of findings

in Donor Questionnaire and Informed Consent Form by the Medical Officer Record for the deferral donors is to be maintained separately

Donor Screening

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This SOP describes the method for estimation of hemoglobin of blood donors by copper sulfate solution before blood donation for assessing their suitability in order to ensure their safety as well as product quality.Copper sulfate solution is used for testing the hemoglobin con centration of blood donors before blood donation

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16 Standard Operating Procedures and Regulatory Guidelines-Blood BankingPROCEDURE

i Dissolve 170 gms crystalline CuSO4.5H2O in 1000 ml distilled water

ii Dilute 51 ml of stock solution with distilled water to make it

100 ml Label it as working solution

iii Check and adjust specific gravity of the working solution using urinometer to 1.053 by adding stock solution or distilled water Copper sulfate solution is checked to ensure that a drop of blood sample of predetermined hemoglobin value reacts as expected (sinks/floats)

iv Transfer 30 ml copper sulfate working solution in a Coplin jar

v Clean the fingertip with a spirit swab thoroughly Allow it to dry

vi Puncture the fingertip with a sterile disposable lancet to ensure good free flow of blood Do not squeeze the finger repeatedly to avoid dilution of blood with excess tissue fluid

vii Wipe out the first drop of blood Allow second drop of blood to fall gently from the finger from a height of about 1 cm above the surface

of the copper sulfate solution, into the Coplin jar

viii Observe the drop of blood for 15 seconds

Note

• The working solution is prepared fresh every morning and changed after every 25 tests

• The Coplin jar is kept covered when not in use.

• The lancet and capillaries are disposed off in a container with 1% sodium hypochlorite solution.

INTERPRETATION

• If the drop of blood sinks within 15 seconds, it shows that the donor’s hemoglobin is more than 12.5 gm/dl

• However, if the blood drop floats for more than 15 seconds or sinks mid way, it shows that the donor’s hemoglobin is less than 12.5 gms/dl

• Test the hemoglobin of the donor using Sahli’s method in case the drop sinks slowly, hesitates and then goes to the bottom of the jar.The donors having hemoglobin 12.5 gm/dl and more are accepted for blood donation

The results are entered in the Donor Questionnaire and Informed Consent Form/Donor Register

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This SOP describes the method for hemoglobin estimation of blood donors before blood donation by Sahli’s hemoglobinometer This method is used to re-determine the hemoglobin status of those donors who fail in the copper sulfate solution method

ii Clean the fingertip with a spirit swab thoroughly Allow it to dry iii Puncture the fingertip with a sterile disposable lancet to ensure good free flow of blood Do not squeeze the finger repeatedly to avoid dilution of blood with excess tissue fluid

iv Draw blood up to 20 ul mark in the Hb-pipette Adjust the column carefully without bubbles Wipe excess of the blood on the sides of the pipette by using a dry piece of cotton

Estimation of Hemoglobin of the

Donor (Sahli’s Method)

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