islamabad 2015 - safe blood transfusion...

ISLAMABAD 2015

Implemented by

TRAINING CURRICULUM FOR

TRANSFUSION MEDICINE

TABLE OF CONTENTS

PREFACE ............................................................................................................................ IX

TRAINING CURRICULUM .................................................................................................... X

CURRICULUM DESIGN AND MODULES ............................................................................ 1

MODULE 1: BLOOD SAFETY ............................................................................................. 2

LEARNING OBJECTIVES ................................................................................................. 2

CORE CONCEPTS ........................................................................................................... 2

MODULE OUTLINE ........................................................................................................... 2

1.1 National Blood Policy ............................................................................................. 2

1.2 Blood Donor Policy ................................................................................................ 2

1.3 Standards and Guidelines ...................................................................................... 3

1.4 Legal and Regulatory Issues ................................................................................. 3

1.5 Institutions in the Blood Transfusion System .......................................................... 3

TEACHING & LEARNING STRATEGIES ........................................................................... 3

SBTP DOCUMENTS CROSSLINKED ............................................................................... 4

MINIMUM COMPETENCIES TO BE ACHIEVED ............................................................... 4

2. INTRODUCTION TO BLOOD TRANSFUSION SERVICES .............................................. 5


CORE CONCEPTS ........................................................................................................... 5

MODULE OUTLINE ........................................................................................................... 5

2.1 Introduction to Organization and Management of BTS ........................................... 5

2.2 Introduction to Blood Donor Management .............................................................. 5

2.3 Introduction to Immunohaematology ...................................................................... 6

2.4 Introduction to blood screening for TTIs ................................................................. 6

2.5 Introduction to the Preparation of Blood Components ............................................ 6

2.6 Introduction to Benefits and Risks of Blood Transfusion ........................................ 6

2.7 Introduction to Quality Management Systems in BTS ............................................ 6

2.8 Introduction BTS/RBC/HBB .................................................................................. 6

2.9 Introduction to MIS in BTS .................................................................................... 6

2.10 Bio-Safety and waste management in BTS ............................................................ 7

TEACHING & LEARNING STRATEGIES ........................................................................... 7

SBTP DOCUMENTS CROSSLINKED ............................................................................... 7

MINIMUM COMPETENCIES TO BE ACHIEVED ............................................................... 8

3. BLOOD DONOR MANAGEMENT .................................................................................... 9


CORE CONCEPTS ........................................................................................................... 9

MODULE OUTLINE ........................................................................................................... 9

3.1 Safe Blood Transfusion ......................................................................................... 9

3.2 Motivation and Retention of VNRBD ...................................................................... 9

3.3 Donor Counselling and Assessment .................................................................... 10

3.4 Hands-on skills .................................................................................................... 10

3.5 Haemoglobin estimation ...................................................................................... 10

3.6 Hands-on skills .................................................................................................... 10

3.7 Collection of donation .......................................................................................... 10

3.8 Hands-on skills .................................................................................................... 10

3.9 Post donation care ............................................................................................... 11

3.10 First aid training for BTS ...................................................................................... 11

TEACHING & LEARNING STRATEGIES ......................................................................... 11

SBTP DOCUMENTS CROSSLINKED ............................................................................. 11

MINIMUM COMPETENCIES TO BE ACHIEVED ............................................................. 12

4. IMMUNOHAEMATOLOGY ............................................................................................. 13

LEARNING OBJECTIVES ............................................................................................... 13

CORE CONCEPTS ......................................................................................................... 13

MODULE OUTLINE ......................................................................................................... 13

4.1 Laboratory techniques for Immunohaematology .................................................. 13

4.2 Blood Group Systems .......................................................................................... 14

4.3 Compatibility testing ............................................................................................. 15




5. TRANSFUSION TRANSMISSIBLE INFECTIONS .......................................................... 19


CORE CONCEPTS ......................................................................................................... 19

MODULE OUTLINE ......................................................................................................... 19

5.1 Biology and Transmission of TTIs ........................................................................ 19

5.2 Basic Concepts in Serological Testing ................................................................. 20

5.3 Diagnostics Assays for TTI ................................................................................... 21

TEACHING AND LEARNING STRATEGIES ................................................................... 22



6. BLOOD PROCESSING AND STORAGE ....................................................................... 24


CORE CONCEPTS ......................................................................................................... 24

MODULE OUTLINE ......................................................................................................... 24

6.1 Introduction to blood components ........................................................................ 24

6.2 Red Blood Cell components ................................................................................ 24

6.3. Hands-on skills .................................................................................................... 25

6.4. Plasma components ............................................................................................ 25

6.5 Hands-on skills .................................................................................................... 25

6.6 Platelet components ............................................................................................ 25

6.7 Hands-on skills .................................................................................................... 25

6.8 Small volume blood components for neonates and infants .................................. 25

6.9 Distribution and returned blood components ........................................................ 26




7. BENEFITS AND RISKS OF BLOOD TRANSFUSION .................................................... 28


MODULE OUTLINE ......................................................................................................... 28

7.1 Component Therapy ............................................................................................ 28

7.2 Adverse effects of blood transfusions .................................................................. 29

7.3 Haemolytic Disease of the Foetus and New-born ................................................ 30




8. BEDSIDE TRANSFUSION ............................................................................................. 32


CORE CONCEPTS ......................................................................................................... 32

MODULE OUTLINE ......................................................................................................... 32

8.1 Pre-Transfusion Procedures ................................................................................ 32

8.2 Bed-side Transfusion Procedures ........................................................................ 32

8.3 Post-Transfusion Procedures .............................................................................. 33




9. QUALITY MANAGEMENT IN BTS ................................................................................. 34


CORE CONCEPTS ......................................................................................................... 34

MODULE OUTLINE ......................................................................................................... 34

9.1 Principles of QMS ................................................................................................ 34

9.2 Documentation and record keeping ...................................................................... 35

9.3 Material and equipment management .................................................................. 35

9.5 Internal and external quality control programmes ................................................ 35

9.7 Facilities, work safety ........................................................................................... 35

9.8 Management of non-conforming events ............................................................... 36




10. ORGANIZATION AND MANAGEMENT OF BTS ......................................................... 38


CORE CONCEPTS ......................................................................................................... 38

MODULE OUTLINE ......................................................................................................... 38

10.1 Organization of Blood Transfusion Services ........................................................ 38

10.2 Human Resource Management ........................................................................... 38

10.3 Management Framework ..................................................................................... 39

10.4 Production Management (Operational Plan) ........................................................ 39

10.5 Hands-on skills .................................................................................................... 39

10.6 Work Area Management ...................................................................................... 39

10.7 Hands-on skills .................................................................................................... 39

10.8 Inventory Management ........................................................................................ 40

10.9 Hands-on skills .................................................................................................... 40

10.10Procurement Management .................................................................................. 40

10.11Hands-on skills .................................................................................................... 40

10.12Preventive & Corrective Maintenance (PCM) of Equipment ................................ 40

10.13Hands-on skills .................................................................................................... 40

10.14Quality Assurance ............................................................................................... 40

10.15Hands-on skills .................................................................................................... 41

10.16Documents and Records Management ............................................................... 41

10.17Financial Management ........................................................................................ 41




ABBREVIATIONS

BDM Blood Donor Management

BTA Blood Transfusion Authorities

BTS Blood Transfusion Services

CCC Coombs Control Cells

CUB Clinical Use of Blood

DAT Direct Anti-Globulin Test

ELISA Enzyme-Linked Immunosorbent Assay (test)

FFP Fresh Frozen Plasma

GVHD Graft Versus Host Disease

HBB Hospital Blood Bank

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HDFN Haemolytic Disease of the Foetus and Newborn

HIV Human Immunodeficiency Virus

ICT Immune-Chromatographic Test

LISS Low Ionic Strength Saline

MCQ Multiple Choice Question

MIS Management Information System

NAT Nucleic Amplification Testing

PEG Poly Ethylene Glycol

PBL Problem Based Learning

PPM Planned Preventive Maintenance

PRP Platelet Rich Plasma

RBC Regional Blood Centre

RPR Rapid Plasma Reagin

SBTP Safe Blood Transfusion Project

SOP Standard Operating Procedure

TAT Turn Around Time

TPHA Treponema Pallidum Haemagglutination Assay

VNRBD Voluntary Non-Remunerated Blood Donation

WHO World Health Organisation

PREFACE

The development of the new Training Curriculum for Blood Transfusion Services, which has been

supported by so many excellent professionals from all provinces and regions, has been mandated by the

National Blood Policy and Strategic Framework 2014-2020, which formulates the objective „to strengthen

the human resource of the Blood Transfusion Services‟, among others through „develop[ing] standardised

and uniform curricula/training materials for teaching and training of the human resource at all levels […].‟

The Strategy also instructs to carry out a situation analysis of existing capacity development and academic

programmes.

The need for a general and standardized written curriculum was acknowledged across the sector, as

current training courses rather cater for specific audiences and provide ad hoc materials according to the

specific academic environment and often only to the best knowledge of the respective instructor. Training

contents are not uniform, which may contribute to sector „fragmentation‟ at the academic level and produce

a cadre with an undue diversity of knowledge and skills. A universal gap in all existing training curricula are

lectures on governance and institutional architecture of the transfusion system and the key policy,

regulatory and operational tools and guidelines which give substance to directives and instructions to be

followed at operational level.

When addressing the community of scholars, teachers and practitioners, we met with an overwhelming

response. A nationwide Working Group was established, with more than 160 members who supported the

design work with feedback on ground realities and needs and recommendations as to the structure,

contents, target groups and academic pathways to be followed. The SBT Programme contributed through

a small team of international (Dr. Julie Solum, Norway) and national (Brig. (R) Prof. Javaid Usman, Dr.

Bushra Moiz) experts, who were developing the structure and writing up the curriculum. Support was also

provided by the long-term TC Team.

Concomitantly with the development of the curriculum, we collected data and curricula for an “Inventory of

Institutes, Programmes and Curricula in Pakistan”, which is published in a separate document and

available on the Programme Website. Our Analysis and Consensus Workshops conducted in Peshawar,

Islamabad, Quetta, Karachi and Lahore permitted a direct interaction with representatives of some of the

important institutions which provided their current curricula. The modular structure would allow the

curriculum to be used in different learning environments and to be taught either as a complete training

programme of its own or as part of or in complementation for other existing curricula.

Unlike other existing curricula, the new National Curriculum proposed herewith comprises Regulatory

Modules (2), Technical Modules (6) and Managerial Modules (2). The regulatory section provides an

introduction to the concept of blood safety, policy and regulatory issues and an overview of blood

transfusion services and their organization. The technical section follows the vein to vein transfusion chain,

from Donor Management to Patient Management. The managerial section finally will provide facility

managers with an introduction to Quality Management and Service Organization.

The reading materials referenced are available on CD as soft copy and will also be uploaded to the SBT

Programme Website. It has been a wonderful experience to be able to interact both electronically and

through workshops with the most intellectual and experienced community of stakeholders, an exercise

which has helped to build a national consensus and commitment for the further development of the

transfusion sector.

Thanks a lot to all of you.

Prof. Hasan Abbas Zaheer

National Coordinator Safe Blood Transfusion Programme

Ministry of NHSR&C Government of Pakistan

TRAINING CURRICULUM

1

Curriculum Design and Modules

The modular curriculum herewith proposed is separated into three main sections. The first

section would provide an introduction to the overarching concept of blood safety, policy and

regulatory issues (Module 1) and give an overview of blood transfusion services and their

organization (Module 2). The second section (Modules 3-8) follows the vein to vein

transfusion chain, from Donor Management through Patient Management. The third section

finally is mainly directed at managerial staff, with a focus on Quality Management (Module 9)

and BTS Management (Module 10).

The modular structure would allow the curriculum to be used in different learning

environments and to be taught either as a complete training programme of its own or as part

of or in complementation of other curricula already existing. It should be clear, though, that

this is a curriculum, not the training document as such.

The modules follow a uniform design. They summarize the Learning Objectives, Core

Concepts addressed, provide an Outline of the module, detail the Teaching and Learning

Strategies recommended and provide references to important documents, most of which

are available on the website of the Safe Blood Transfusion Programme (www.sbtp.gov.pk).

The modules guide the instructor which topics to address in order to align the content of

modules with the transfusion policies and guidelines. Well-developed policies, guidelines,

regulatory and technical documents are easily available both in printed and online versions.

INTRODUCTORY

MODULES

MANAGERIAL

MODULES

1. The concept of Blood Safety

2. Introduction to Blood Transfusion Services

3. Blood Donor Management

4. Immunohematology

5. Transfusion Transmissible Infections

6. Blood Processing and Storage

7. Benefits and Risks of Blood Transfusion

8. Bed-side Transfusion

9. Quality Management Systems in BTS

10. Organization and Management of BTS

TECHNICAL

MODULES

http://www.sbtp.gov.pk/

2

LEARNING OBJECTIVES

After completing this module the learner would be able to:

1. outline the key policy documents regulating Blood Safety in Pakistan;

2. outline the main goals and objectives of the Safe Blood Transfusion

Programme;

3. describe the main Institutions of the Blood Transfusion System;

4. explain the role of the Blood Transfusion Authorities;

5. explain the Legal and Regulatory Frameworks regulating the Blood

Transfusion System;

6. discuss and link Policy documents to key operational tasks in Blood

Transfusion Institutions.

CORE CONCEPTS

National Blood Policy

Blood Donor Policy

Standards and Guidelines

Legal and Regulatory Issues

Institutions of the Blood Transfusion System

MODULE OUTLINE

1.1 National Blood Policy

Introduction to National Blood Policy and Strategic Framework

Organization and Management

Resources

Core Business

Planning and process improvement

1.2 Blood Donor Policy

Blood Donation trends in Blood Transfusion Services

Purpose of a Blood Donor Policy

Introduction to National Blood Donor Policy in Pakistan

Goals of the National Blood Donor Policy

MODULE 1: BLOOD SAFETY

Module code 1.0 Assessment methods

Credit hours Practical test

Module duration Assignment

Pre-requisite MCQ

Version Nov 05/2015 Final examination

3

1.3 Standards and Guidelines

Introduction to the purpose of standards and guidelines in Transfusion

Medicine

Standard Operating Procedures for Blood Bank Processes in Pakistan

Standards and Guidelines for Blood Banks and Transfusion Services

Guidelines for Quality Control in Blood Banking

1.4 Legal and Regulatory Issues

Introduction to the purpose and principles of Legal and Regulatory issues in

Transfusion Medicine

Role of Blood Transfusion Authorities in Pakistan

Provincial BTA

Blood Safety Legislation in Pakistan

1.5 Institutions in the Blood Transfusion System

Safe Blood Transfusion Programme

Teaching and Training Institutions

Services providers (public, private, non-governmental)

(Hospital) Blood Banks

(Regional) Blood Centers

Blood Donor Organizations in Pakistan

TEACHING & LEARNING STRATEGIES

Teaching methods

Lectures

Problem Based Learning (PBL)

Small group discussion

Student presentations on key features of policies

Self-study

Practical Sessions

Visit of institutions related to blood transfusion

Learning Materials

Handouts of lectures

Recommended Reading

See crosslinked reference documents

4

SBTP DOCUMENTS CROSSLINKED

Policies, Standards, Guidelines, Instructions

National Blood Policy and Strategic Framework 2014-2020.

National Blood Donor Policy, National Blood Transfusion Service, Ministry of

Health, Government of Pakistan.

Standards and Guidelines for Blood Banks and Transfusion Services, Safe

Blood Transfusion Programme, Government of Pakistan.

Guidelines for Quality Control in Blood Banking, National AIDS Control

Programme, Ministry of Health, Government of Pakistan, 2007.

Functional Brief Regional Blood Centres.

Business Plan for Blood Transfusion Services.

Functional Brief Management Information Systems.

Functional Brief Hospital Blood Banks.

Standard Operating Procedures for Blood Bank Processes in Pakistan, Safe

Blood Transfusion Programme, Government of Pakistan, 2013.

MINIMUM COMPETENCIES TO BE ACHIEVED

Knowledge of principal policy documents governing transfusion and their role

as regulatory tools.

5

2. INTRODUCTION TO BLOOD TRANSFUSION

SERVICES




Pre-requisite MCQ


LEARNING OBJECTIVES


1. outline basic concepts of the organization and management of BTS;

2. outline the various departments within a Regional Blood Centre and a Hospital

Blood Bank;

3. explain the various processes and activities within the departments;

4. explain the roles and responsibilities of the cadres of staff within the RBC and

HBB;

5. understand the purpose of Quality Management System;

6. understand basic concepts of Bio-Safety within BTS.

CORE CONCEPTS

Introduction to Organization and Management of BTS

Introduction to Blood Donor Management

Introduction to Immuno-haematology

Introduction to Blood Screening for Transfusion Transmissible Infections

Introduction to the Preparation of Blood Components

Introduction to Benefits and Risks of Transfusion

Introduction to Quality Management System

Introduction to Management Information System in BTS

Introduction to Bio-Safety in BTS

MODULE OUTLINE

2.1 Introduction to Organization and Management of BTS

Organization and structure of RBC and HBB

Organogram of RBC and HBB

Cadres of staff in BTS

Roles, responsibilities and Job descriptions

2.2 Introduction to Blood Donor Management

Processes in Blood Donor Management

Selection criteria for a blood donor

6

Pre-donation haemoglobin screening, counselling and examination

Voluntary blood donation

Blood collection (at the centre, through aphaeresis, through mobile camps)

2.3 Introduction to Immunohaematology

Introduction to blood groups (ABO and RhD)

Overview of purpose of antibody identification and screening

Introduction to pre-transfusion compatibility testing

Quality Management in BTS laboratory

2.4 Introduction to blood screening for TTIs

Overview of Transfusion Transmissible Infections

Testing for TTIs

Handling of non-conforming components

2.5 Introduction to the Preparation of Blood Components

Overview of Blood Components Preparation and their storage

Introduction to Whole Blood Components

Introduction to Red Cell Concentrates

Introduction to Fresh Frozen Plasma & Cryoprecipitate

Introduction to Platelet Concentrates

Introduction to components for neonatal and infant use

2.6 Introduction to Benefits and Risks of Blood Transfusion

Introduction to clinical use of blood components

Introduction to indication and use of different components

Introduction to risks, management and reporting of blood transfusion reactions

Corrective actions to be taken for the prevention of (future) adverse reactions

2.7 Introduction to Quality Management Systems in BTS

Introduction to principles of Quality Management System

Quality Management of V2V process chain from donor to recipient

Equipment and Material Management

Management of non-conformances

2.8 Introduction BTS/RBC/HBB

Visit to a Regional Blood Centre & Hospital Blood Bank with introduction to all

departments

2.9 Introduction to MIS in BTS

Introduction to concept and principle of MIS

MIS in vein to vein process

User groups and definitions

7

2.10 Bio-Safety and waste management in BTS

Introduction to Bio-safety and waste management

Introduction to disinfection of materials and equipment

Universal precautions (before, during and after procedures)

Individual responsibility

Handling of work areas

Handling and proper disposal of sharps

Handling and disposal of biological spills

Handling and disposal of chemicals

Incineration

Documentation

Policies and procedures

2.10.1 Waste Management

Type and categories of laboratory wastes

Means of disposal


Teaching methods

Lectures



Self-study

Practical Sessions

Demonstration of waste management

Visit to a Regional Blood Centre and a Hospital Blood Bank

Learning Materials


Recommended Reading

Section 15, Introduction to Blood Transfusion Technology, ISBT Science

Series, 2008.

Chapter 5, Introductory Module, Guidelines and Principles for Safe Blood

Transfusion Practice, Safe Blood and Blood Products, World Health

Organization, 2009.


Standard Operating Procedures

SOPs for Blood Bank Processes in Pakistan, Islamabad 2013.

8

Policy

Functional Brief Hospital Blood Banks

Functional Brief Regional Blood Centres


Knowledge about the scope of work in different departments of a blood centre

and a blood bank

Knowledge about the testing methods and equipment used in different blood

bank processes

Know about biosafety and how it applies in the various departments

9

LEARNING OBJECTIVES


1. outline the process of recruiting and collecting blood units from voluntary non-

remunerated donors;

2. perform key procedures of Blood Donor Management (BDM) including donor

interview, selection, pre-donation counselling, post-donation care and

management of donor adverse effects;

3. discuss the guidelines and policies related to voluntary blood donation;

4. explain quality management aspects in BDM including quality control,

documentation, and equipment /material management.

CORE CONCEPTS

Safe blood transfusion

Donor motivation and retention

Donor interview and physical assessment

Haemoglobin screening

Blood collection and handling of donated blood

Donor care and counselling for retention

Documentation and quality control

Material and equipment management

MODULE OUTLINE

3.1 Safe Blood Transfusion

Overview of transfusion transmissible infections

Safe blood donor

Self-deferral

3.2 Motivation and Retention of VNRBD

Donor types and significance of VNRBD

Strategies for motivation and retention of VNRBD

Sustainable safe blood transfusion service

IEC tools

Donor clubs/blood donor societies

Mobile donation camp (outreach activities)

3. BLOOD DONOR MANAGEMENT



Module duration 1 semester Assignment

Pre-requisite MCQ


10

3.3 Donor Counselling and Assessment

Reception of blood donors

Donor interview

Donor medical examination

Donor selection and deferral criteria (temporary and permanent)

Pre-donation information and counselling

3.4 Hands-on skills

Interview at least ten blood donors under supervision according to set

guidelines

Perform medical examination of at least ten blood donors under supervision

according to set guidelines

3.5 Haemoglobin estimation

Pre-donation Haemoglobin screening of blood donors

Quality control of Haemoglobin estimation

Various methods of Haemoglobin estimation (Copper Sulphate, Photometric,

Haematocrit and Automated CP analyser)

3.6 Hands-on skills

Practice at least twenty haemoglobin estimation in line with biosafety using

Copper Sulphate and haemoglobinometer

Perform quality control and documentation for Haemoglobin estimation

Handle non-qualified samples

Perform preventive maintenance of instrument

3.7 Collection of donation

Essential steps during collection of whole blood

Steps in collection through aphaeresis

Documentation and quality control in blood collection

Quality control and PPM of blood shaker

Significance of correct labelling of the blood bags

3.8 Hands-on skills

Prepare venipuncture site

Observe and practice phlebotomy

Collect whole blood

Perform QC

Observe Aphaeresis

Inspect physical condition of the blood bag

Document relevant information

Hand over collected units to appropriate staff for processing

11

3.9 Post donation care

Post-donation care

Management of adverse reactions to blood donations

Documentation

Donor refreshments

3.10 First aid training for BTS

Essential steps in first aid training for blood donation setting

3.10.1 Hands-on skills

First aid training relevant for blood donation setting


Teaching methods

Lectures



Self-study

Practical Sessions

Interview of blood donors

Medical examination of blood donors

Hb estimation

Phlebotomy

Blood collection

First aid training

Learning Materials


SOPs and worksheets for laboratory testing

Recommended Reading

Section 8,9, Introduction to Blood Transfusion Technology, ISBT Science

Series, 2008

Chapter 2,3, Guide to the preparation, use and Quality assurance of blood

components, European Committee of Blood Transfusion, 18th edition

Chapter 4-9, Module 1, Safe Blood Donation, Safe Blood and Blood Products,

World Health Organization

Chapter 5,6,7, AABB technical manual, 18th edition


Standard Operating Procedures SOPs for Blood Bank Processes in Pakistan, Islamabad 2013.

SOP/TP/02a+b

SOP/WP03

12

SOP/WP04

SOP/WP/05

SOP/WP/07

Policies

National Blood Donor Policy, Islamabad 2013.


Blood Transfusion Programme, Government of Pakistan, Islamabad 2013.


Selection and deferral criteria

How to conduct a donor interview

Physicals of donor

Perform Hb estimation

Arm preparation and phlebotomy

Documentation

QC of Hb estimation, blood shaker and collected unit

13

4. IMMUNOHAEMATOLOGY




Pre-requisite MCQ


LEARNING OBJECTIVES


1. outline the characteristics of antigen-antibody reactions in

immunohaematology;

2. outline and explain the most common techniques and methods applicable in

immunohaematology;

3. outline the characteristics of the most important blood group systems with

emphasis on ABO and Rh and correctly perform blood grouping;

4. explain the concepts of and perform compatibility testing;

5. explain quality management aspects in immunohaematology including

quality control of reagents, documentation, and equipment /material

management.

CORE CONCEPTS

Introduction to Laboratory techniques for immunohaematology

Background and clinical significance of ABO and Rh blood group system

Introduction to other blood group systems

Antibody screening and identification

Pre-transfusion compatibility testing

Investigation of transfusion reactions

Quality control and documentation


MODULE OUTLINE

4.1 Laboratory techniques for Immunohaematology

Specific Objective: The student will be able to discuss basic principles of

techniques commonly applied in immunohaematology and how these relate to

the various testing strategies.

4.1.1 Characteristics of antibodies in Immunohaematology tests

Characteristics of IgM and IgG antibodies

Structure of antibodies

Antigen binding sites

Affinity and avidity

Monoclonal versus polyclonal antibodies

Activation of complement system

14

4.1.2 Factors affecting antigen-antibody interactions

Red cell ionic charge

pH

Temperature

Ionic strength

Freshness of sample

Antigen-antibody ratio

4.1.3 Factors affecting antigen-antibody interactions

Albumin

Low Ionic Strength Saline (LISS)

Poly Ethylene Glycol (PEG)

Proteolytic Enzymes

4.1.4 Common Laboratory Techniques

Principles of Direct Haemagglutination

o 2 step process

o Grading of agglutination reactions

o Haemolysis as result

Principles of Indirect Anti-globulin Technique (IAT)

o Steps (Washing, IS, Incubation, AHG, CCC)

o Interpretation of results

Principles of Direct Anti-globulin Technique (DAT)

o Steps (Washing, AHG and CCC)

o Interpretation of results

4.1.5 Laboratory solutions

o Introduction to common solutions used in transfusion medicine

laboratories

o Calculation of concentrations

o Disinfection solutions

o Hypochlorite

o Saline

o Copper sulphate

o Stains for malaria smears

o Cell suspensions and sensitized cells

4.2 Blood Group Systems

Specific Objective: The student will be able to describe the characteristics of the

most important blood group systems and to perform blood grouping using a

variety of techniques

4.2.1 ABO Blood Group System

Introduction to the ABO blood group system

Genetics of the ABO blood group system

ABO Antigens and naturally occurring antibodies

ABO subgroup and Bombay phenotype

15

Clinical significance of ABO blood group antibodies

ABO Forward and reverse grouping

ABO grouping discrepancies

ABO grouping in neonates and infants

4.2.2 Hands-on skills in ABO blood group system

Preparation of standard 3-5% cell suspension (standardized and eyeballing)

Preparation of ABO standard cells

Forward and reverse grouping by tube method

ABO discrepancies

ABO grouping in infants and newborn

ABO quality controls

PPM on relevant equipment

Interpretation of results

Documentation requirements

4.2.3 Rh Blood Group

Introduction to Rh blood groups (D, C, c, E, e)

Weak D, partial D or D variants

Genetics of the Rh blood groups

Genotypes, phenotypes and nomenclature

Antigens, immunogenicity and clinical significance of antibodies

RhD and its role in HDFN

Investigation of HDFN

DAT in HDFN

4.2.4 Hands-on skills in Rh blood group

Perform RhD typing on at least ten positive and five negative samples

Confirmation of RhD negative results

Quality control of antisera


DAT on at least three positive and negative samples

4.2.5 Introduction to other blood groups

Basic overview of Kell blood group

Basic overview of other blood groups

4.3 Compatibility testing

Specific Objective: The student will be able to describe the pre-transfusion tests

applicable in compatibility testing, and outline the use and application of the

various tests

4.3.1 Antibody screening

Rational for performing antibody screening

Antibody screening cells

Sample, reagents and application of IAT

16

Interpretation of results and handling of reactive samples

Quality control and documentation throughout the process

Different methods in Antibody screening (tube, gel cards)

4.3.2 Hands-on skills in Antibody screening

Perform antibody screening on 5 negative and 3 positive samples

Quality control of reagents

Interpretation and documentation of results

Handling of positive samples

Trouble shooting when positive auto control

4.3.3 Antibody Identification

Rational for performing antibody screening

Rational for performing antibody identification

Commercially available ID-panels

Sample, reagents and application of IAT

Interpretation of results and handling of reactive samples

Quality control and documentation throughout the process

Different methods in Antibody identification (tube, gel cards)

4.3.4 Hands-on skills in Antibody Identification

Antibody identification using ID-Panel on 2 samples

Antibody Identification on prefilled ID panel results of 5 samples

Quality control of reagents


Handling of samples that require further investigation

Trouble shooting when positive auto-control

4.3.5 Crossmatch

Principles of crossmatch

Sample and documentation requirements

Blood request form and selection of appropriate unit

Considerations neonates and infants

Quick spin and IAT crossmatch

Quality control in crossmatching


Emergency crossmatch

Validity of crossmatch and return to stock

Issuing of blood

4.3.6 Hands-on skills in Crossmatch

Review blood request forms

Select appropriate units for crossmatch

Crossmatch on 10 negative and 3 positive samples


Handling of reactive samples for further investigation

17

Quality control in crossmatch


Teaching methods

Lectures


Short group discussion

Self-study

Practical Sessions

Preparation of standard cell suspensions

ABO grouping

ABO grouping discrepancies

RhD typing

DAT

Antibody screening

Antibody identification

Crossmatch

Learning Materials



Recommended Reading

Sections 3-7, Introduction to Blood Transfusion Technology, ISBT Science

Series, 2008.

Chapter 8, Guide to the preparation, use and Quality assurance of blood

components, European Committee of Blood Transfusion, 18th edition.

Chapters 3-7, Module 3, Blood Group Serology, Safe Blood and Blood

Products, World Health Organization.

Chapters 15-17, AABB technical manual, 18th edition.




SOP/TP/21a-23a

SOP/TP/21b-23b

SOP/TP/22

SOP/TP/24

SOP/TP/25-26a

SOP/WP/26b

SOP/WP/44

SOP/TP/45a+b

18

SOP/TP/46a+b

SOP/TP/47a

SOP/WP/47b

SOP/WP/48

Policies


Blood Transfusion Programme, Government of Pakistan, Islamabad 2013.


ABO grouping

Rh typing

Perform and interpret antibody screening

Perform and interpret antibody identification

Perform and interpret DAT

Perform QC of above mentioned tests

19

5. TRANSFUSION TRANSMISSIBLE INFECTIONS




Pre-requisite MCQ


LEARNING OBJECTIVES

After completing this module the learner should be able to:

1. list infections significant for transfusion medicine both nationally and globally;

2. explain biology and epidemiology of common TTIs in Pakistan;

3. discuss the principle of various types of serological tests;

4. explain the principle and methodology of common diagnostic assays for TTI;

5. critically appraise the choice of appropriate assays in our setting;

6. discuss quality management system for TTI screening.

CORE CONCEPTS

Background, biology and transmission of TTIs

Basic concepts in serological tests

Technical aspects of TTI testing

Quality and Documentation

Equipment and Material Management

MODULE OUTLINE

5.1 Biology and Transmission of TTIs

Specific Objective: The student will be able to discuss basic structure, serological

course, transmission and characteristic clinical features of HIV, HBV, HCV, Syphilis

and malaria

5.1.1 Viruses

Biology and epidemiology of HIV, HBV and HCV infections

Influence of viruses on blood transfusion services globally.

The routes of transmission

Characteristic clinical features

Course of viral infection including window period

Viral serology and diagnostic assays

5.1.2 Bacteria

Biology and epidemiology of Treponema pallidum- the organism causing

Syphilis.

Routes of transmission for Treponema pallidum

Characteristic clinical features for infection

Course of infection and diagnostic assays

20

Bacteria causing platelet contamination and prevention strategies

5.1.3 Parasites

List common Plasmodium species causing malaria in Pakistan

Biology and epidemiology of Plasmodium species

Routes of transmission for Plasmodium species,

Characteristic clinical features for infection

Important aspects of the life cycle of the parasite

Various diagnostic assays for malaria detection in donors

5.1.4 Other infections and emerging pathogens (overview)

Human T-Cell Lymphotropic Virus I&II (HTLV I&II),

Cytomegalo Virus (CMV)

Trypanosoma cruzi

Variant Creutzfeldt-Jakob Disease (vCJD),

West Nile Virus (WNV)

Dengue virus

Ebola virus.

5.2 Basic Concepts in Serological Testing

Specific objectives: The student will be able to list various serological techniques,

explain antigen-antibody interaction in each test type and discuss the benefits and

disadvantages of each assay

5.2.1 Immuno-chromatographic Tests (ICT)

Principle & Technique of ICT

Advantages and disadvantages of ICT

5.2.2 Agglutination tests

Principles and technique in particle agglutination test

Advantages and disadvantages of agglutination tests

5.2.3 Enzyme Linked Immuno Sorbent Assay

Principles of the four types of ELISA

Anti-globulin ELISA

Competitive ELISA

Sandwich ELISA

Antibody capture ELISA

Manual and automated techniques

Benefits and disadvantages of ELISA technique

New generation ELISA with Ag/Ab detection

5.2.4 Advanced testing

Principle of NAT

Advantages of NAT in TTI screening

Principle of Western Blot for HIV

21

5.3 Diagnostics Assays for TTI

Specific Objectives:

The students should be able to choose an appropriate assay (for availability and

feasibility) in a given setting for reliable and sustainable services. Follow SOP

relevant for the respective test. Inspect samples for suitability of for testing. Utilize

worksheet for documentation of samples and results (also if testing results are

invalid). Interpret test results and manage sero-reactive sample. Differentiate false

positive/false negative results from true results. Discuss the quality assurance of

diagnostic tests including quality control of samples, reagents, documentation, PPM

of equipment and material management

5.3.1 Laboratory testing of HIV

Antigens and antibodies of importance for HIV testing

Principles and application of ICT; ELISA and NAT (Western Blot)

Sensitivity and specificity

Interpretation of results, management of sero-reactive samples

Screening and confirmatory assays in the testing algorithms.

Quality and documentation requirements


Perform and interpret positive and negative samples by HIV rapid testing

Perform and interpret positive, negative and HIV borderline serum samples

through ELISA

Observe HIV NAT (where available)

5.3.3 Laboratory testing of HBV

Antigens and antibodies of importance for HBV testing

Principles and application of ICT; ELISA and NAT

Sensitivity and specificity of various tests

Interpretation of results, management of sero-reactive samples




Perform and interpret positive and negative samples by HBV rapid testing

Perform and interpret positive, negative and borderline samples through ELISA

Observe HBV NAT (where available)

5.3.5 Laboratory testing of HCV

Antigens and antibodies of importance for HCV testing

Principles and application of ICT; ELISA and NAT

Sensitivity and specificity

Interpretation of results, management of positive samples



22


Perform and interpret samples by HCV rapid testing

Perform and interpret positive, negative and borderline samples through ELISA

Observe HCV NAT (where available)

5.3.7 Laboratory testing of Syphilis

Antigens of importance for Syphilis testing

Principles and application of RPR and TPHA.

Sensitivity and specificity for the respective tests

Interpretation of results, management of reactive samples


Quality and documentation requirements in Syphilis testing

5.3.8 Hands-on skills for Syphilis

Perform and interpret positive and negative samples by RPR

Perform and interpret positive and negative samples by TPHA

5.3.9 Laboratory testing of Malaria

Antigens of importance for ICT

Microscopy of malaria parasites in thick and thin blood films

Sensitivity and specificity for the respective methods


Quality and documentation requirements in Malaria testing


Perform and interpret at least 10 positive and 10 negative samples by ICT

malaria

Perform and interpret at least 10 positive and 10 negative samples by

microscopy

Prepare and stain thick and thin smears ( at least 10 each) with Leishman and

Geimsa

TEACHING AND LEARNING STRATEGIES

Teaching methods

Lectures


Tutorials

Self-study

Practical Sessions

HIV testing

HBV testing

HCV testing

Syphilis testing

Malaria testing

23

Learning Materials


SOPs for laboratory testing

Recommended Reading


Series, 2008.



Chapters 2-8, Module 2, Screening for HIV and Other Infectious Agents, Safe

Blood and Blood Products, World Health Organization.

Chapter 8, AABB technical manual, 18th edition.




SOP/WP/14

SOP/TP/15a

SOP/TP/15b

SOP/TP/16a

SOP/TP/16b

SOP/TP/17a

SOP/TP/17b

SOP/TP/18a

SOP/WP/18b

SOP/WP/18c

SOP/TP/19a

SOP/TP/19b

SOP/WP/20

Policies

Blood Donation Screening of Transfusion Transmissible Infections, Country

Strategy, Safe Blood Transfusion Programme, Government of Pakistan, July

2013.


Common TTIs in Pakistan

Principle and methodology of TTI testing

Interpretation and troubleshooting of TTI testing

Quality assurance of test systems

24

6. BLOOD PROCESSING AND STORAGE




Pre-requisite MCQ


LEARNING OBJECTIVES


1. outline the processes of quality controlled component production from blood

units collected from VNRBD;

2. perform key aspects of blood processing including preparation of RBC,

Plasma and platelet components;

3. discuss the guidelines and policies related to blood processing in Pakistan;

4. explain quality management aspects in blood processing and storage

including quality control, documentation, temperature monitoring and

equipment /material management.

CORE CONCEPTS

Introduction to Blood Components

Red Blood Cells

Plasma components

Platelet components

Storage and transportation of blood components

Blood components for neonatal and infant use

Quality control of blood components



MODULE OUTLINE

6.1 Introduction to blood components

Overview of blood components

Introduction to different blood bag sets

Additive and storage solutions

Documentation requirements on blood bags

Equipment monitoring and maintenance in blood processing laboratory

6.2 Red Blood Cell components

Characteristics of RBC

Preparation of RBC (manual and automated plasma extractor)

Documentation and labelling of bags

Storage and shelf life of RBC

25

Quarantine release and handling of TTI positive units

Quality control of RBC

6.3. Hands-on skills

Preparation of RBC concentrates under supervision

Quality control RBC concentrates under supervision

6.4. Plasma components

Characteristics of Plasma components (Fresh Frozen Plasma [FFP],

Plasmaphaeresis and Cryoprecipitate)

Preparation of FFP (Manual, automated plasma extractor, aphaeresis)

Preparation of Cryoprecipitate


Storage and shelf life of FFP and Cryoprecipitate


Quality control of Plasma products

6.5 Hands-on skills

Preparation of FFP under supervision

Preparation of Cryoprecipitate under supervision

Quality control of FFP under supervision

6.6 Platelet components

Characteristics of Platelet components (Platelet Rich Plasma [PRP], Single

donor Platelet concentrates [PLT], Plateletphaeresis)

Preparation of PRP

Preparation of PLT


Storage and shelf life of PRP and PLT


Quality control of Platelet components

6.7 Hands-on skills

Preparation PRP under supervision

Preparation of PLT concentrates under supervision

Quality control of under supervision

6.8 Small volume blood components for neonates and infants

Introduction to blood transfusion in neonates and infants

RBC for neonatal and infant use

Plasma for neonatal and infant use

Platelets for neonatal and infant use

Exchange transfusion

26

6.9 Distribution and returned blood components

Distribution from RBC to HBB

Cold chain management in transportation


Handling of returned blood components


Teaching methods

Lectures

Problem Based Learning [PBL]


Self-study

Practical Sessions

Preparation of RBC

Preparation of FFP and Cryoprecipitate

Preparation of PRP and PLT

Learning Materials



Recommended Reading

Sections 11-12, Introduction to Blood Transfusion Technology, ISBT Science

Series, 2008.

Chapters 4-6, Guide to the preparation, use and quality assurance of blood


Chapter 5, Introductory Module, Guidelines and principles for safe Blood

Transfusion Practice, Safe Blood and Blood Products, World Health

Organization.

Chapters 6,7,9, AABB technical manual, 18th edition.





SOP/WP/27

SOP/WP/28

SOP/WP/29

SOP/WP/30

SOP/WP/40

SOP/WP/41

27

SOP/WP/42

SOP/WP/43




Inspection of blood bags and components

Preparation of components (RBC, PRP, PLT, FFP, Cryoprecipitate)

Storage of blood components

Temperature monitoring of storage equipment

Cold chain management during shipment of blood components

Issue and received blood components

Documentation

QC of blood components (RBC, PRP, PLT, FFP, Cryoprecipitate)

28

7. BENEFITS AND RISKS OF BLOOD

TRANSFUSION




Pre-requisite MCQ


LEARNING OBJECTIVES


1. outline the benefits and use of the blood components available in Pakistan;

2. outline the symptoms, management and prevention of adverse reactions to

blood transfusion;

3. outline the investigation of transfusion reactions;

4. explain the pathophysiology, treatment and prevention of Haemolytic

Disease of the Foetus and the Newborn (HDFN).

MODULE OUTLINE

7.1 Component Therapy

Specific Objective: The student will be able to describe the major indications and

objectives of blood transfusion therapy of the components commonly available in

Pakistan, and be able to relate the component requirements to transfusion in

patients with special needs.

7.1.1 Introduction to components and pre-transfusion requirements

Whole blood

Red Blood Cells

Plasma

Platelets

Cryoprecipitate

Introduction to other components not regularly produced in Pakistan

7.1.2 Indications and contradictions for use of components

Whole blood

Red Blood Cells (normal, Irradiated, Leukocyte depleted, washed)

Plasma (Fresh Frozen, Aphaeresis)

Platelets (single donor, pooled, aphaeresis)

Cryoprecipitate

Introduction to other components not regularly produced

29

7.1.3 Blood Transfusion in patients with special needs

Foetus, Neonates and infants

Patients on chemotherapy/Immuno-compromised

Surgical blood orders

Patients with Haematological disorders

o Thalassemia

Patients with Coagulation disorders

o Liver disease

o Disseminated Intravascular Coagulation (DIC)

Patients with haemostatic disorders

o Von Willebrand disease

o Haemophilia A

o Haemophilia B

7.1.4 Alternatives to blood transfusion

EPO

DDAVP

Anti-fibrinolytic

7.2 Adverse effects of blood transfusions

Specific Objective: The student will be able to describe the symptoms,

management and prevention of adverse reactions to blood transfusion

7.2.1 Overview to adverse reaction of blood transfusion

Introduction to transfusion reactions

Most common causes of transfusion reactions

Immune-mediated transfusion reactions

Non-immune mediated transfusion reactions

7.2.2 Investigation of transfusion reactions

Bedside procedures

Sample requirements

Laboratory investigations

Interpretation of investigation and final report

7.2.3 Immune-mediated transfusion reactions

Immediate immunological transfusion reactions

o Acute haemolytic reactions

o Febrile non-haemolytic reactions

o Allergic reactions

o Transfusion Associated Acute Lung Injury (TRALI)

Delayed immunological transfusion reactions

o Delayed haemolytic transfusion reaction

o Graft Versus Host Disease (GVHD)

o Post transfusion purpura

30

7.2.4 Non Immune-mediated transfusion reactions

Immediate non-Immunological transfusion reactions

o Bacterial contamination

o Circulatory overload

Delayed non-Immunological transfusion reactions

o Transmission of transfusion transmissible infections

o Iron overload

7.3 Haemolytic Disease of the Foetus and New-born

Pathophysiology of HDFN

Antibodies associated with HDFN

Antenatal screening and prevention of HDFN

Laboratory investigations of HDFN

Exchange transfusion


Teaching methods

Lectures



Self-study

Practical Sessions

Critically assess indications in a sample of blood request forms and compare with

anonymised patient files.

Learning Materials


Recommended Reading


Series, 2008.



Chapter 27, AABB technical manual, 18th edition.



Guideline for the appropriate clinical use of blood, Safe Blood Transfusion

Programme, Government of Pakistan, 2013.

31






Indications and use of blood components

Adverse reactions to transfusion

Investigation of transfusion reactions

Haemolytic Disease of the Foetus and New-born

32

8. BEDSIDE TRANSFUSION




Pre-requisite MCQ


LEARNING OBJECTIVES


1. outline the standard pre-transfusion considerations that has to be made prior

to blood transfusions;

2. discuss the rationale for a blood request and correctly place a request

following the SBTP guidelines;

3. outline the blood transfusion process;

4. outline the monitoring steps during and after blood transfusion;

5. recognize symptoms and correctly initiate investigations of adverse reactions

of transfusion.

CORE CONCEPTS

Pre-transfusion procedures and guidelines

Bedside transfusion procedures

Post transfusion routines and guidelines

MODULE OUTLINE

8.1 Pre-Transfusion Procedures

Patient consent

Pre-transfusion counselling

Clinical considerations – CUB guidelines

Requesting blood units- request form

Venous access

Pre-medications

Special requirements

8.2 Bed-side Transfusion Procedures

Assessment of recipient

Transportation of blood component

Identification of blood component and recipient

Infusion sets

Initiation and monitoring

33

Special transfusion requirements in ER and OR

8.3 Post-Transfusion Procedures

Monitoring

Documentation

Identifying adverse reactions

Investigation of adverse reactions to blood transfusion

Treatment and monitoring in patients with adverse reactions


Teaching methods

Lectures



Self-study

Practical Sessions

Not applicable

Learning Materials


Recommended Reading

The clinical use of blood handbook, World Health Organization.






Guidelines for the appropriate clinical use of blood, Safe Blood Transfusion

Programme, Government of Pakistan, 2013.






Discuss pre-transfusion events

Initiate and monitor transfusion of a blood unit

Monitor recipient after blood transfusion

Document inspection of unit and identifying correct recipient and component

Identify special needs in ER and OR

Discuss adverse reactions to blood transfusion and its investigation

34

9. QUALITY MANAGEMENT IN BTS




Pre-requisite MCQ


LEARNING OBJECTIVES


1. discuss quality concepts;

2. Explain key processes in quality management approach;

3. Discuss the significance of documenting policies, procedures, working

sheets and labels and record keeping;

4. Discuss the significance of quality management of all personnel;

5. Discuss the quality management of critical material, services and equipment;

6. Discuss monitoring of internal quality indicators and proficiency testing;

7. Explain processes related to general, biological, chemical, radiation and fire

safety and disaster preparedness;

8. List the deviations from pre-determined standards and discuss the

significance of documenting occurrences.

CORE CONCEPTS

Principles of Quality Management System (QMS)

Documentation and record keeping

Developing Human resources


Internal and external quality control programmes

Facilities, work safety

Management of non-conforming events

MODULE OUTLINE

9.1 Principles of QMS

Discuss principles of QMS with respect to quality control (QC), quality

assurance and quality management

Quality control of reagents, personnel, product

Quality assurance- SOPs, look-back, monitoring of quality indicators

Quality management (planning, control and improvement) in relation to

organization

35

9.2 Documentation and record keeping

Standardized formats for policies and procedures

Document creation with unique identifier

Review and approval process

Controlled documents

Archiving and storage

Use, retention and destruction of records

9.3 Material and equipment management

Supplier qualification

Qualifying incoming materials

Inventory management

Adequate storage conditions

Receipt, inspection and testing of incoming materials

Acceptance/rejection of materials

Tracing critical supplies

Selection and acquisition of equipment

Verification of performance of equipment

Installation, operation and calibration of instruments

Preventive maintenance and repairs of instruments

Retirement of instruments

9.4 Hands-on skills

Observe calibration and PPM of instrument

Verify performance of a given instrument

9.5 Internal and external quality control programmes

Quality control program

Validation of test systems

Monitoring and assessment of specified requirements

Monitoring of Quality indicators

Internal and external assessments

Proficiency testing

Data Analyses

9.6 Hands-on skills

Perform QC of reagents and record keeping

Perform QC of test system and record keeping

Analyses of quality indictors

Analyses of data for Proficiency testing

9.7 Facilities, work safety

Health and safety risks/programs

36

Communication and information management system

Hazard discards

Storage facilities

Design and space allocation

Disaster preparedness

9.8 Management of non-conforming events

Detection of deviations and non-conformities

Complaint handling

Untoward or sentinel event reporting

Root cause analysis

Immediate actions

Preventive strategies

9.9 Hands-on skills

Handling of complaints

Handling of deviations


Teaching methods

Lectures



Self-study

Practical Sessions

Observe calibration and PPM of instrument

Verify performance of a given instrument

Perform QC of reagents and record keeping

Perform QC of test system and record keeping

Analyses of quality indictors

Analyses of data for Proficiency testing

Handling of complaints

Handling of deviations

Learning Materials



Recommended Reading


Series, 2008.

AABB technical manual, 18th edition.

37



Guidelines for Quality Control in Blood Banking, National Aids Control

Programme, Ministry of Health, Government of Pakistan, 2007.

Quality Component in all technical procedures in Standard Operating

Procedures for Blood Bank Processes in Pakistan, Islamabad, 2013.


Biological, chemical and fire safety

Staff competence

QC of test systems (internal and external)

Instrument verification

Management of non-conformities

38

10. ORGANIZATION AND MANAGEMENT OF BTS




Pre-requisite MCQ


LEARNING OBJECTIVES


1. outline the organizational setup of BTS;

2. outline the available job cadres with roles and responsibilities within the BTS;

3. outline general management responsibilities and duties;

4. explain simple management tools and basics to develop an operational plan

CORE CONCEPTS

Organization of a BTS

Human Resource Management

Laboratory Manager Framework

Productivity Management (Operational Plan)

Work Area Management

Inventory Management

Procurement Management

Planned Preventive Maintenance

Quality Assurance

Document and Record Management

MODULE OUTLINE

10.1 Organization of Blood Transfusion Services

Organization of BTS (RBC and HBB)

Cadres of staff within the RBC and HBB

10.2 Human Resource Management

Staff competency assessment

Personnel records

Roles and responsibilities of the cadres, job descriptions and organogram

Duty roster – work delegation in accordance with job descriptions, personnel

skills and workloads

Employee empowerment

HR policies and their implementation

Staff and technical meetings

Maintenance of professional and technical knowledge through educational

workshops and seminars; CME, CTE

Grievance redressal and disciplinary procedures

39

Staff performance evaluation and staff development

Staff training needs assessment

Team building and team work of staff at different levels

Staff motivation and recognition of performance excellence

10.3 Management Framework

Job task lists (What)

Management routines (When)

Job aids and Management tools (How)

Assessment (Results)

Management meetings

10.4 Production Management (Operational Plan)

Basics to develop a plan of operation

Department and workspace - optimal workflow

Optimal use of resources

Interdepartmental coordination

Production Analysis

Inventory Analysis

Factors affecting production and operations management

Work plans and budget-based on needs

Departmental reporting

Feedback –staff, customers satisfaction, etc.

Assessment of demand

Monitoring and evaluation of the plan implemented

10.5 Hands-on skills

Demand/supply analysis

Future forecast

Comparative studies

10.6 Work Area Management

Occurrences and corrective actions

Equipment repairs

Staff adherence to rules and practices

Work environment for testing

Safety equipment and manuals

Reagent and component storage

Waste-management guidelines


Occurrence Management and corrective action tools

40

10.8 Inventory Management

Inventory log of equipment and parts

Inventory log of supplies and reagents

Blood inventory log: component/group wise, per issuance and expiry date

Monitor consumption of consumables for re-order

Stock management practices

Quality of existing inventory


Inventory and stock management tools

Daily balance sheet

10.10 Procurement Management

Needs for equipment, supplies and reagents

Procurement in accordance with institutional guidelines

Monitoring of procurement orders

Records of purchase orders and requisitions

Procurement forecasting


Procurement tools

10.12 Preventive & Corrective Maintenance (PCM) of Equipment

Equipment records

PCM - Delegated

Trouble shooting

Review of maintenance logs

Follow up on all corrective actions

Communication with BTS management


PPM tools

Equipment record tools

10.14 Quality Assurance

Quality Manuals and QC tests

Quality performance trends

Non-conforming QC results and corrective actions

Review of occurrence log and corrective actions

Reagent performance

SOP competency among all staff

EQA control programmes

Review specimen logs for completeness

41

Turn Around Time (TAT)


Quality Monitoring tools for testing, reagents, equipment, temperature

10.16 Documents and Records Management

Library of documents

Integrity, organization and confidentiality of records

Record retention, storage and disposal

10.17 Financial Management

Introduction to budgeting principles

Monthly and annual budgets

Budget estimation

Department ceiling budget

Activity budgets (technical areas, maintenance issues, mobile activities, etc.)

Budget monitoring

Stock management and budgets


Teaching methods

Lectures



Self-study

Practical Sessions

Occurrence Management and corrective action tools



Procurement tools

PPM tools

Equipment record tools

Quality Monitoring tools for testing, reagents, equipment, temperature

Learning Materials


Recommended Reading

Sections 15, 16, 17, Introduction to Blood Transfusion Technology, ISBT

Science Series, 2008.




42





Functional Brief Regional Blood Centres.

Business Plan for Blood Transfusion Services.

Manual of Operations for RBC and HBB.

Functional Brief Management Information Systems.

Functional Brief Hospital Blood Banks.




Organize department for optimal workflow

Prepare duty roaster according to available staff

Monitor testing environment

Monitor work environment for bio-safety

Plan, monitor and evaluate plans of operation

Monitor inventory and procure when needed

Monitor PPE and issues with equipment

Monitor QC performance

Safe Blood Transfusion Programme Pakistan

Ministry of National Health Services, Regulation & Coordination, Government of Pakistan

H. No. 4-B, Street No. 17, Sector F-8/3, Islamabad, Pakistan

Tel: +92 (51) 9263236-7, Fax: +92 (51) 9263238

E-Mail: [email protected], Website: www.sbtp.gov.pk