EXPANDED PROGRAMME ON

IMMUNIZATION (EPI) MANUAL

FOR HEALTH STAFF
6th Edition, 2022

Vaccine Preventable Disease Program

Department of Public Health
Ministry of Health
Royal Government of Bhutan

EPI Manual for Health Staff 1

2 EPI Manual for Health Staff
PREFACE

With the overarching aim to sustain high immunization coverage in Bhutan, the 2022 edition
of the EPI manual addresses the change in need surrounding immunization services that have
emerged in the past two years. Over the past three years, COVID-19 vaccines have been
developed and introduced to prevent or reduce disease severity in response to the pandemic
that has affected and taken millions of lives globally. Vaccines such as the Pfizer, Moderna,
AstraZeneca, CoviShield and Sinopharm are well covered in this manual to assist service
providers in contributing towards the battle against COVID-19.

In this edition, the chapter dedicated to managing vaccines and cold chain has been revised and
elaborated into two distinct chapters namely Vaccine Management and Maintenance of Cold
Chain Equipment. A distinct feature of this edition is the emphasis that has been placed not
only on vaccine management but also on the maintenance and repair of cold chain equipment
which is of equal significance for ensuring vaccine potency and sustaining optimum quality
service delivery in the field of immunization. In the 2022 edition, the chapter on Ensuring Safe
Injection also prioritizes waste management resulting from vaccines to ensure proper disposal
of immunization wastes.

This manual aims to provide the service providers with adequate and accurate knowledge on the
use of cold chain equipment and temperature monitoring devices. Hence, the chapter on Cold
Chain Equipment consists of the detailed types of cold chain equipment and description of its
components. To ease the monitoring and maintenance process, a chapter on Documentation
and Reporting has been included. The standard format for documentation, budgeting and
reporting included in this chapter would not only ensure uniformity in the data given by service
providers residing in different parts of the country but would also ease the process of indent
and management of the vaccines and equipment thereby easing the process of service delivery
of immunization as a whole.

To make the content of this manual less complex for the service providers who will be using
it, the manual has been made more pictorial and illustrative. With the inclusion of the newer
vaccines and technological changes in the immunization program, the manual is revised to
update the knowledge of the health workers on these new vaccines and enhance their skills
so as to deliver quality immunization services in the country.

First Edition : 2002

Second Edition : 2007
Third Edition : 2010
Fourth Edition : 2014
Fifth Edition : 2020
Sixth Edition : 2022

EPI Manual for Health Staff i

ACKNOWLEDGEMENTS

Authored by:

1. Dr. Dhrupthob Sonam Specialist in General Practice, JDWNRH

2. Mr. Tashi Dawa, Dy. Chief Programme Officer, VPDP, DoPH, Ministry of Health
3. Ms. Cheten Zangmo, Assistant Programme Officer, VPDP, DoPH, Ministry of Health
4. Dr. Indrani Chakma, Health and Nutrition Specialist, UNICEF Bhutan
5. Dr. Anshu Kumar, Cold Chain Specialist, UNICEF Bhutan
6. Dr. Chandralal Mongar, Health and Nutrition Officer, UNICEF Bhutan
7. Mr. Tshewang Dorji Tamang, National Consultant, UNICEF Bhutan
8. Mr. Sonam Wangdi, WHO Bhutan

Advisor:

1. Rixin Jamtsho, Chief Programme Officer, CDD, DoPH, Ministry of Health

2. Dr. Sonam Wangchuk, Head/Specialist, RCDC
3. Dr. Mimi Lhamu Mynak, Paediatrician, JDWNRH

Contributors

1. Teaching Faculty, FNPH

2. Health Staff, Bhutan

ii EPI Manual for Health Staff

ACKNOWLEDGEMENT

The Department of Public Health, Ministry of Health would like to acknowledge the support
of the Government of Japan, UNICEF for the financial and technical support and WHO for
technical support in the revision of this EPI Manual. The manual has been revised with an aim
to make it simpler, clearer, easier and pictorial for health workers to use so as to enhance
their knowledge, improve their technical capacity and quality of immunization service delivery.
We anticipate that this manual shall be extensively used by our health workers and contribute
towards further improvement in providing better immunization services in Bhutan.

Pemba Wangchuk,
Acting Secretary
Ministry of Health

EPI Manual for Health Staff iii

ABBREVIATIONS

AD Auto Disable (syringe)

ADB Asian Development Bank
AEFI Adverse Events Following Immunization
AFP Acute Flaccid Paralysis
AMC Average Monthly Consumption
AMF Auto Mains Failure
ANC Antenatal Care
BCG Bacillus Calmette-Guerin (tuberculosis vaccine)
bOPV Bivalent Oral Poliomyelitis Vaccine
COVID-19 Coronavirus Disease - 19
CCE Cold Chain Equipment
CCH Cold Chain handler
CCP Cold Chain Point
CCT Cold Chain Technician
CMO Chief Medical Officer
Combo Combination of ice-lined refrigerator and freezer
30 DTR 30 Days Temperature Recorder
DHO District Health Officer
DF Deep Freezer
DG Diesel Generator
DTP Diphtheria-Tetanus-Pertussis
EEFO Early Expiry First Out
EPI Expanded Program on Immunization
EVM Effective Vaccine Management
FEFO First Expiry First Out
HF Health Facility
Hep B Hepatitis B vaccine
Hib Haemophilus influenzae type b
HIMS Health Information Management System
HPV Human Papillomavirus vaccine
HW Health Worker
ILR Ice Lined Refrigerator
IPV Inactivated Polio Vaccine
LF Limes flocculation
MCH Maternal Child Health
MIS Management Information System
MMR Measles Mumps and Rubella

iv EPI Manual for Health Staff

MOI Medical Officer In charge
MO Medical Officer
MoH Ministry of Health
NEPIS National EPI Store
OPV Oral Polio Vaccine
ORC Outreach Clinic
PCV Pneumococcal Conjugate Vaccine
Penta Diphtheria-Pertussis-Tetanus-Hepatitis B and Hib
PHC Primary Health Center
PUF Polyurethane Foam
RI Routine Immunization
RCDC Royal Center for Disease Control
REPIS Regional EPI Store
SC Satellite Clinic
SDD Solar Direct Drive Refrigerator
TB Tuberculosis
Td Tetanus diphtheria
Td Tetanus diptheria
UIP Universal Immunization Programme
UNICEF United Nations Children’s Fund
VCCH Vaccine and Cold Chain handler
VHW Village Health Worker
VPDP Vaccine Preventable Disease Program
VVM Vaccine Vial Monitor
WHO World Health Organization
WIC Walk in Cooler
WIF Walk in Freezer

EPI Manual for Health Staff v

Contents
Preface i
Acknowledgement ii
Abbreviations iv

CHAPTER 1: INTRODUCTION 1
1.1 Background 3
1.2 Immunization supply chain levels in Bhutan 5
1.3 Supply chain system 6
1.4 Importance of Immunization Supply Chain System (ISCS) 8

CHAPTER 2: COMMON DISEASES PREVENTED BY VACCINATION 9

2.1 Tuberculosis (Baykey Ney) 10
2.2 Polio (Tsa Kam Ney) 10
2.3 Diphtheria (Kyem Ney) 11
2.4 Pertussis (Whooping Cough) (Lou Khok Ney) 11
2.5 Tetanus (TsaKum Ney) 12
2.6 Hepatitis B (Chhim Ney B) 12
2.7 Haemophilus influenza type B (HIB) Infection 13
2.8 Pneumococcal disease 13
2.9 Measles, Mumps and Rubella (Machhem Ney/Zatap boney) 14
2.10 Human Papilloma Virus (HPV) infection 15
2.11 Influenza 15

CHAPTER 3: ABOUT THE VACCINES 17

3.1 What is a vaccine? 18
3.2 Minimizing pain during multiple injections 21

CHAPTER 4: ROUTINE IMMUNIZATION SCHEDULE FOR CHILDREN AND ADOLESCENTS 23

4.1 Vaccine safety 26
4.2 Contraindications to immunization 26

CHAPTER 5: COLD CHAIN EQUIPMENT 29

5.1 Electric cold chain equipment 30
5.2 Solar cold chain equipment 34
5.3 Temperature Monitoring Devices and Stabilizer with cold chain equipment 35
5.4 Non-electrical cold chain equipment 39
5.5 Vehicle used for transportation 42

CHAPTER 6: MAINTENANCE OF COLD CHAIN EQUIPMENT 43

6.1 Maintenance schedule refrigerator/ILR/Combo 45
6.2 Solar refrigerator 47
6.3 Walk-inlcooler/Walk-in-freezer 48

vi EPI Manual for Health Staff

CHAPTER 7: VACCINE MANAGEMENT 49
7.1 How to maintain the correct temperature of vacciines? 50
7.2 vaccine sensitivities 51
7.3 Procedures 52
7.4 How long can vaccines be kept in the vaccine carrier? 52
7.5 Placing vaccines in the refrigerator 53
7.6 How to keep vaccines cold during the immunization session? 53
7.7 How to ensure that the vaccine was kept in the correct temperature 54
7.8 How to check for heat damaged vaccines? 54
7.9 Vaccine vial monitor and reaction rates 54
7.10 How to check the vaccines for damage by freezing 55
7.11 How to perform a shake test? 55
7.12 Results of the shake test 55
7.13 Routine Monitoring 56
7.14 Logistics management of EPI vaccines and consumables 57

CHAPTER 8: MANAGING DRY STORE FOR EPI 61

8.1 Dry Store Do’s and Don’t 63

CHAPTER 9: ENSURE SAFE INJECTIONS AND WASTE MANAGEMENT 65

9.1 What is a Safe Injection? 66
9.2 What are the risks associated with unsafe injections? 66
9.3 Simple ways to improve injection safety 66
9.4 Advantages of using AD syringes 67
9.5 Injection technique 67
9.6 Guideline for waste disposal 68

CHAPTER 10: PLANNING AND CONDUCTING IMMUNIZATION 73

10.1 What is the micro plan for immunization? 74
10.2 Listing equipment and supplies required for fixed immunization sessions 76
10.3 Listing equipment and supplies required for outreach clinic sessions 77
10.4 Arranging the immunization session 77
10.5 Conducting immunization session 78
10.6 Immunization services at outreach clinic 83

CHAPTER 11: ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) 85

11.1 What is an Adverse Event Following Immunization? 86
11.2 Categories of AEFIs 86
11.3 List of minor AEFIs 86
11.4 List of serious AEFIs 86
11.5 AEFI record and reporting system 86
11.6 Management of AEFIs 87
11.7 Distinguishing acute stress response and anaphylaxis 87

EPI Manual for Health Staff vii

 11.8 AEFI Kit 88
11.9 Step wise management of anaphylactic shock 88

CHAPTER 12: RECORDING, REPORTING AND USE OF VACCINATION DATA FOR ACTION 91
12.1 Importance of record-keeping 92
12.2 MCH handbook 92
12.3 Mother and child register 93
12.4 Tally sheets (Reporting form of immunization session site) 93
12.5 Bhutan vaccine system 93
12.6 Monthly report form 93
12.7 Vaccination monitoring chart 93
12.8 Vaccine wastage 95
12.9 Wastage factors 96

CHAPTER 13: INCREASING IMMUNIZATION COVERAGE 97

13.1 Introduction 98
13.2 Dropouts 98
13.3 Missed opportunities 99
13.4 Every opportunity should be used for vaccination 100
13.5 Use interpersonal communication to increase demand 100
13.6 Different methods for giving information to parents 101

CHAPTER 14: SURVEILLANCE OF VACCINE PREVENTABLE DISEASES 103

14.1 Definition of Surveillance 104
14.2 Goal of Vaccine Preventable Disease Surveillance 104
14.3 How to report suspected cases of Vaccine Preventable Diseases 104

CHAPTER 15: VACCINE AND COLD CHAIN EQUIPMENT INVENTORY,

DISTRIBUTION DOCUMENTATION, AND REPORTING 107
15.1 Documentation 108
15.2 Reporting 110
15.3 Support supervision and monitoring 110
15.4 Bhutan vaccine system (BVS) 111
15.5 Work plan/budget 111
15.6 Indent 111
15.7 Maintaining stock register and stock-taking 113
15.8 Verification of immunization status 113

viii EPI Manual for Health Staff

 CHAPTER 1:
INTRODUCTION

EPI Manual for Health Staff 1

 EPI STORES IN BHUTAN

THIMPHU

MONGAR

SARPANG
Gelephu

National EPI Store

Western EPI Store
Central EPI Store
Eastern EPI Store

2 EPI Manual for Health Staff

1.1 BACKGROUND

Immunization is one of the most effective interventions against preventing infectious diseases.
With the implementation of Universal Immunization Program (UIP), Bhutan has made significant
achievements in preventing and controlling Vaccine Preventable Diseases (VPDs). Immunization
needs to be sustained as a high priority in order to reduce the incidence of all VPDs, sustain the
eradication status of Polio, the elimination status of Measles and neonatal tetanus, while also
gearing towards eliminating rubella.

Under UIP, all the children in Bhutan are protected against the following Vaccine Preventable
Diseases (VPD) namely Tuberculosis, Polio, Hepatitis B, Diphtheria, Pertussis, Tetanus,
Haemophilus influenzae (type b) Meningitis, Pneumonia and Human papillomavirus. The
Expanded Program on Immunization (EPI) was launched in Bhutan on 15th November 1979
with the objectives to reduce morbidity, disability and mortality from the vaccine preventable
diseases to a level where these diseases cease to be a public health problem. The national
Immunization policy is to provide immunization to all children and to complete the primary
series of vaccination before the age of one year.

Immunization program was initially started with only 6 antigens (BCG, DTP, bOPV and Measles).
Subsequently, more antigens (Hepatitis B in 1996, Rubella in 2006, Haemophilus influenza B
in 2009 and Human Papilloma Virus (HPV) in 2010 for girls and in 2020 for boys, IPV in 2015,
Mumps in 2016, PCV and seasonal influenza vaccine in 2019) were added in the immunization
schedule keeping in view of the disease burden, financial implications and health infrastructure
in the country. During the COVID-19 pandemic, COVID-19 vaccines were administered to the
various category of eligible population in 2021 and 2022 based on available vaccine efficacy
evidence. In the event of disease outbreak, relevant vaccines will be introduced based on
disease burden and cost effectiveness.

In February 1988, the 66th National Assembly passed a resolution calling for all children and
pregnant mothers to have access to immunization and to be fully vaccinated. In the next
few years, immunization services were given high priority and in addition, the requirement
of producing the vaccination card for school admission, encouraged the people to bring
their children for immunization. In 1991, Bhutan achieved the certificate of Universal Child
Immunization (UCI).

The last case of clinical compatible polio was reported in 1986 and since then Bhutan has
maintained zero polio status. Bhutan received polio free certification from WHO as part of
SEARO countries polio free certification in 2014, measles elimination certificate in 2017 and
hepatitis B control certificate in 2018 for under five. Bhutan has also maintained the neonatal
tetanus elimination criteria ever since 1994. Bhutan has also been able to sustain high (>95%)
immunization coverage for the past several years (2002 and 2008 EPI coverage survey and 2012,
NHS). However, the challenge to the immunization program is to sustain high immunization
coverage especially with the hard-to-reach population and migrating population in the country.
Maintaining injection safety and to manage Adverse Events Following Immunization (AEFI) is
also a concern for the program. Further, strengthening of the cold chain system and replacement,
vaccine management, monitoring and supervision, advocacy and social mobilization for
immunization are some of the challenges faced by the program.

EPI Manual for Health Staff 3

 1979
01
1. DTP
2. BCG
3. Measles
4. OPV 1983
02 1. TT

1996
1. Hep - B (Monovalent)
03

2003
04
1. DTP and Hep -B
(Combination)
6 ANTIGENS
IN 1979 TO 13 2006
ANTIGENS IN 2022 1. Rubella
05

2009
06 1. Penta

2010
1. HPV for girls
07

2015
08 1. IPV

2016
1. Mumps
09

2019
10 1. PCV
2. Influenza

2020
1. HPV for Boys
11

2021
12 1. IPV2

Figure 1:The journey from 1979 to 2022

4 EPI Manual for Health Staff

The EPI programme was renamed as Vaccine Preventable Disease Program (VPDP) in 2005,
not to look only for immunization but to cover broader aspects for vaccine preventable disease.
The goal of the VPD program is to reduce morbidity, disability and mortality due to vaccine
preventable diseases.

The first National EPI Services Manual was developed as a field guide, training, and reference
material in 2002. The 2nd edition was published in 2007, 3rd in 2011, 4th in 2014, 5th edition
of the EPI manual in 2020 and now 6th edition in 2022. The revision of the manual is based on
the need like introduction of new vaccines and cold chain equipment.
In right quantity
In right quality
VACCINATED In right time
IMMUNIZED
In right temperature
PROTECTED
In right place
To right beneficiary

Figure 2: Immunization for the safe lives of children and women

1.2 IMMUNIZATION SUPPLY CHAIN LEVELS IN BHUTAN

Cold chain network in the country is the backbone to ensure the delivery of quality and potent
vaccines. Since the inception of UIP, the Immunization services are provided through a vast
health care infrastructure in two major ways –

a. Through fixed sites/facility level: consisting of District Hospitals, Primary Health Centres
(PHC), Sub-Post.

b. Outreach sessions: in Bhutan, planned routine immunization (RI) outreach sessions are
held at least once a month.

EPI Manual for Health Staff 5

1.3 SUPPLY CHAIN SYSTEM

The National EPI Store receives vaccines from manufacturers across the globe. These vaccines
are then distributed to the three regional stores known as Western EPI Store in Thimphu,
Eastern EPI Store in Mongar and Central EPI Store in Gelephu to meet the country’s demand.
The delivery of vaccines from National Store to Local Distribution (LD) till District level is
represented in the figure below:

Vaccine Air Transport Primary Store

Manufacturer (+2° to 8°C and -15° to WIC (+2° to 8°C) and WIF
-25°C, and -70° to -86°C) (-15° to -25°C), and Ultra Low
Temperature -70° to -86°C)
PARO
THIMPHU

Regional Store Refrigerated Van

WIC (+2° to 8°C) and WIF (-15° to -25°C), Ultra (+2° to 8°C)
Low Temperature -70° to -86°C), and Deep
Freezers (-15° to -25°C) GELEPHU | MONGAR | THIMPHU

Refrigerated District Vaccine Store Cold Box

Van / Cold Box ILR (+2° to 8°C) and (+2° to 8°C)
(+2° to 8°C) DF (-15° to -25°C)

Outreach Vaccine Carrier Primary Health Centre

Clinic (+2° to +8°C) ILR +2° to 8°C
HEALTH FACILITIES

PW and Child

Figure 3: The immunization supply chain system of Bhutan

6 EPI Manual for Health Staff

From District hospitals the vaccines are distributed to PHCs and Sub-posts, where routine
immunizations are provided via fixed session or as outreach clinic (ORC).

NATIONAL EPI STORE

THIMPHU

REGIONAL EPI STORE REGIONAL EPI STORE REGIONAL EPI STORE

WESTERN EPI CENTRAL EPI EASTERN EPI

STORE, THIMPHU STORE, GELEPHU STORE, MONGAR

Wangdicholing
Tsimalakha Hospital Lhuentse Hospital
Hospital

Pemagatshel
Gedu Hospital Dagapela Hospital
Hospital

Phuentsholing
Sarpang Hospital Nganglam Hospital
Hospital

Samdrupjongkhar
Gasa Hospital Trongsa Hospital
Hospital

Samdrupcholing
Haa Hospital Damphu Hospital
Hospital

Jomotsangkha
Paro Hospital Yebilaptsa Hospital
Hospital

Punakha Hospital Buli Hospital Trashigang Hospital

Samtse Hospital Panbang Hospital Riserboo Hospital

Wangdue Hospital Trashiyangtse

Hospital

Figure 4: Vaccines flow from National EPI Store, Thimphu

EPI Manual for Health Staff 7

1.4 IMPORTANCE OF IMMUNIZATION SUPPLY CHAIN SYSTEM (ISCS)

One of the important elements for improving the immunization coverage with quality is holistic
management of Immunization Supply Chain System (ISCS), which deals with cold chain and
vaccine logistics along with human resource, infrastructure, Management Information System
(MIS) and supportive supervision. ISCS is the backbone of the immunization programme and
plays a vital role in improving the immunization coverage with quality by timely supply of safe
and potent vaccines along with necessary logistics.

This EPI manual has been written for the Vaccine and Cold Chain Handlers serving at all
levels of Cold Chain Points i.e., National, Regional, District, PHC and Sub-posts. The Vaccine
and Cold Chain Handler is a key person for the management of cold chain, vaccine logistics
and responsible for safe storage of vaccines under UIP. The ISCS has evolved significantly
over the decades with evolving technology. This includes advances in cold chain equipment
and refrigerant technology, establishing equipment inventories, and continuous real-time
temperature monitoring. The increasing focus on quality of immunization along with coverage,
efficient management of cold chain space and the increasing cost of immunization requires a
coordinated and comprehensive approach to the capacity building of vaccine and cold chain
handlers.

8 EPI Manual for Health Staff

 CHAPTER 2:
COMMON DISEASES
PREVENTED BY
VACCINATION

EPI Manual for Health Staff 9

On-time vaccination throughout childhood is essential because it helps provide immunity before
children are exposed to potentially life-threatening diseases. Vaccines are tested to ensure that
they are safe and effective for children to receive at the recommended ages. The common
diseases prevented by vaccination are narrated in this chapter.

2.1 TUBERCULOSIS (BAYKEY NEY)

Tuberculosis (TB) is caused by bacteria (Mycobacterium tuberculosis). It is a highly contagious

disease that affects the lungs but can also affect the intestines, bones and joints, lymph glands,
meninges (membranes of the brain), and other organs of the body. TB can cause serious illness
and even death .

How to suspect the disease? Any child suspected

to be suffering from
• An ill child with a history of contact with a suspected or TB, please refer
confirmed case of pulmonary tuberculosis to the National
TB guideline for
• An ill child with one of the following: weight loss, cough and
management and
wheeze, which does not respond to antibiotic therapy for
treatment.
acute respiratory infection

How is it spread?

TB is spread through droplets of sneezing or coughing by active pulmonary TB patients. A variety

of tuberculosis called bovine tuberculosis occurs when milk of infected cattle is consumed
without boiling.

How is the disease prevented?

Vaccination with Bacillus Calmette-Guerin (BCG) at birth or as soon as possible after birth will
prevent severe forms of childhood tuberculosis.

2.2 POLIO (TSA KAM NEY)

Polio is a viral infection that affects the nervous system and can cause severe illness, paralysis,
and even death.

How to recognize the disease?

History of sudden onset of weakness and paralysis of the leg(s), and /or arm(s) and/or trunk.
The paralysis was not present at birth or associated with serious injury or mental retardation.

How is it spread?

Polio is transmitted by contact with fecal matter, usually as a result of poor hygiene, or indirectly
through contaminated water, milk, or food. More than 50 percent of all cases involve children
less than three years of age.

10 EPI Manual for Health Staff

How is the disease prevented?

Immunization with the Oral Polio Vaccine (OPV) and with the Inactivated Polio Vaccine (IPV) is
the way to effectively prevent infection apart from hygiene. Oral polio vaccine (OPV) should
be routinely administered as per the immunization schedule and during Supplementary
Immunization Activities (SIAs) until 5 years of age, if needed, good hygiene and sanitation
practices can prevent transmission of polio. Travelers to polio endemic countries need to take
one dose of OPV one month prior to travel.

2.3 DIPHTHERIA (KYEM NEY)

Diphtheria is caused by bacteria (Corynebacterium diphtheriae). Diphtheria is an infectious

disease that commonly infects the tonsils and pharynx, commonly presenting as a bluish-white
membrane in the back of the throat often causing difficulty in breathing and even death.

How to recognize the disease?

Any case with sore throat with gray patch or patches in the throat should be suspected to have
diphtheria.

How is it spread?

The bacteria causing diphtheria inhabit the mouth, nose and throat of an infected person. It
spreads from person to person through droplets by coughing and sneezing.

How is the disease prevented?

The most effective method of prevention is immunization with diphtheria vaccine in DTP- Hep
B- Hib vaccine (pentavalent) in early childhood and followed by booster dose.

2.4 PERTUSSIS (WHOOPING COUGH) (LOU KHOK NEY)

Pertussis commonly known as whooping cough is caused by bacteria (Bordetella pertussis).

Pertussis is a highly contagious bacterial disease, involving the respiratory tract. It is characterized
by repeated coughing that may lead to aspiration and possible death in some cases.

How to recognize the disease?

A history of repeated and violent coughing, with any one of the following: cough persisting for
two or more weeks, fits of coughing, cough followed by vomiting and typical whoop in older
infants.

How is it spread?

Pertussis bacteria live in the mouth and nose of the patients and spread easily through the air
usually by coughing or sneezing.

EPI Manual for Health Staff 11

How is the disease prevented?

Pentavalent vaccine contains pertussis component which is given according to the immunization
schedule will prevent pertussis.

2.5 TETANUS (TSAKUM NEY)

Tetanus is caused by bacteria (Clostridium tetani). People of all ages can become infected with
tetanus.

How to recognize the disease?

Neonatal tetanus presents after 2 days of life with inability to suck followed by stiffness of neck
and body and/or jerking of muscles. The child will have normal suck and cry during the first two
days of life.

Tetanus in age groups other than in the neonatal period presents with local spasms around a
wound, generalized convulsion and stiffness of the whole body, abnormal postures, lockjaw
and often death.

How is it spread?

Tetanus bacteria are present in dirt, intestines and feces of animals. It enters the body through
cuts, punctures or other wounds/infections (like ear infection) and occurs when bacteria come
in contact with broken skin or injuries, and also unclean cutting and dressing of the umbilical
cord. Neonatal Tetanus (NNT) affects newborn babies and can lead to death, if not treated.
It generally occurs during the first few days of life, often as a consequence of delivery in
unhygienic conditions.

How is the disease prevented?

Immunizing pregnant women with Td and children with DTP-HepB- Hib (pentavalent) vaccine
is an effective method of preventing both neonatal as well as tetanus in other age groups.
Ensuring clean birth surface, clean delivery and cutting umbilical cord with clean instruments
or blades are considered as essential factors in preventing neonatal tetanus.

2.6 HEPATITIS B (CHHIM NEY B)

Hepatitis B is a highly infectious viral disease (40-100 times more infectious than HIV) and is
the leading cause of jaundice, fulminant liver disease, cirrhosis and liver cancer. It is established
that the younger the age at infection, the more the chance of getting the complications from
hepatitis B infection like chronic active hepatitis, cirrhosis and carcinoma at later stages of life.
That is why it is important to provide three doses of hepatitis B vaccine to all children before
they reach the age of one.

12 EPI Manual for Health Staff

How to recognize the disease?

Clinical signs and symptoms include fever, headache, nausea, vomiting and jaundice (yellowish
eyes). Final confirmation is done by laboratory tests.

How is it spread?

The disease spreads through transfusion of infected blood, contact with infected blood or body
fluids. It can be acquired during childbirth, through unprotected sex, use of unsterilized needles
and sharing of needles and razors by intravenous drug users.

How is the disease prevented?

By immunizing children, we can prevent the infection and its complications. Hepatitis B vaccine
is given within 24 hours of birth and DTP-HepB- Hib (pentavalent) vaccine at 6, 10 and 14
weeks of age.

2.7 HAEMOPHILUS INFLUENZAE TYPE B (HIB) INFECTION

Haemophilus influenzae type b (Hib) is a bacterium associated with a number of severe

childhood diseases namely infection of the meninges (pyogenic meningitis), pneumonia,
sepsis and infection of other internal organs and bones. Hib accounts for roughly half of the
pyogenic meningitis cases in the age group of 6 months to 2 years and is also estimated to be
responsible for 20% of pneumonia cases in this age group.

How is it spread?

Hib is spread from person to person through droplets released during coughing or sneezing by
an infected person.

How is the disease prevented?

Hib disease has been eliminated in developed countries through immunization with Hib vaccine
(DTP-HepB-Hib) for children at the age of 6, 10 and 14 weeks. When infected by Hib, the child
can be treated with antibiotics, the resistance to antibiotics is common. Often the child may
die even after appropriate treatment or survive with neurological deficits.

2.8 PNEUMOCOCCAL DISEASE

Pneumococcal disease is a group of diseases caused by a bacterium called Streptococcus

pneumoniae, (also known as pneumococcus). Diseases caused by pneumococcus include

• severe diseases such as pneumonia, meningitis and bacteremia (presence of bacteria in

the blood), and
• milder diseases such as middle ear infection (otitis media), sinusitis and bronchitis.

EPI Manual for Health Staff 13

How to recognize the disease?

Although it is difficult to establish diagnosis, pneumococcal infections are normally diagnosed

through laboratory testing of the blood (for bacteraemia and bacteraemic pneumonias) or
suspected meningitis by performing a lumbar puncture.

How is it spread?

Pneumococcus is transmitted by respiratory secretions of people carrying pneumococcus in

their nose or throat.

How is the disease prevented?

Pneumococcal vaccination can prevent substantial mortality and morbidity.

2.9 MEASLES, MUMPS AND RUBELLA (MACHHEM NEY/ZATAP BONEY)

Measles is a highly infectious illness caused by a virus that can be found in the nose, mouth or
throat of an infected person. Infection is characterized by fever, cough and spreading rash that
may lead to death due to secondary infections like diarrhea and pneumonia.

Rubella is also called German measles, a viral disease with similar features as measles and
may not be possible to distinguish between the two diseases unless appropriate samples are
tested at specialized measles and rubella laboratories.

Mumps is an infection caused by a virus, sometimes called infectious parotitis, and it primarily
affects the salivary glands. Mumps is mostly a mild childhood disease, and most often affects
children between five and nine years of age. But the mumps virus can infect adults as well.
When it does, complications are more likely to be serious.

How to recognize measles?

A history of fever with rash with any of the following

• Cough or
• Running nose (coryza) or
• Red eyes (conjunctivitis)

How to suspect rubella?

Maculopapular rash with low grade fever that lasts for or up to 24 hours, associated with
appearance of rash on face and neck that may spread to the body. There is presence of post
auricular or suboccipital lymph nodes.

14 EPI Manual for Health Staff

How to recognize mumps?

Mumps is an infection caused by a virus and sometimes called infectious parotitis, and it
primarily affects the salivary glands. Initial symptoms are typically non-specific, such as
headache, malaise and fever, followed within a day by the swelling of the parotid (salivary)
glands.

How are diseases spread?

The viruses are transmitted through the air via direct contact or by airborne droplets expelled by
infected individuals during coughing and sneezing. Rubella can also be transmitted to newborn
through the infected mother causing Congenital Rubella Syndrome (CRS).

How are diseases prevented? Rubella vaccine

should not be given
The measles, mumps and rubella vaccines are effective in preventing to pregnant women,
measles, mumps and rubella; and should be given according to the which could lead to
immunization schedule. However, the Rubella vaccine should not be Congenital Rubella
given to pregnant women, which could lead to Congenital Rubella Syndrome.
Syndrome.

2.10 HUMAN PAPILLOMA VIRUS (HPV) INFECTION

In Bhutan, cervical cancer is one of the most prevalent cancers and a leading cause of death
in women. About 100 types of HPV are known to infect human beings and among which 40
are known to cause anogenital warts. HPV types that cause anogenital warts are low risk
types that are 6 and 11 and high-risk types 16 and 18 which are associated with more than
99% of all cervical cancers. HPV also causes cancer of vagina, vulva, anus and penis. It also
causes diseases at other sites often associated with esophageal and oropharyngeal cancer and
respiratory papillomas.

How does HPV spread?

HPV is mainly transmitted by sexual route, but there is also a vertical transmission from mother
to child during birth. It can also be transmitted by fomites.

How to prevent cervical and other cancers due to HPV?

The HPV vaccination will reduce the risk of developing cervical cancer. Abstaining or safe
sexual practices e.g. use of condoms and being faithful to partners prevent all STIs including
HPV. Routine screening like PAP smear and VIA combined with HPV vaccination programs
reduce incidences of cervical and anogenital cancers significantly.

2.11 INFLUENZA.

Influenza viruses (family Orthomyxoviridae) is the causative organism. The influenza viruses
are classified into types A, B and C on the basis of their nucleoprotein, whereas the subtypes of
influenza A viruses are determined by envelope glycoproteins possessing either haemagglutinin
(HA) or neuraminidase (NA) activity.
EPI Manual for Health Staff 15
How to recognize the disease?

The disease can present with fever, cough, sore throat, runny nose, headache, muscle and
joint pain and severe malaise. The fever and body ache may last 3–5 days and the cough for
2 or more weeks. In children, signs of severe disease include apnoea, tachypnea, dyspnea,
cyanosis, poor feeding, dehydration, altered mental status, and extreme irritability.

How is it spread?

Influenza A and B viruses transmitted mainly by droplets and aerosols originating from the
respiratory secretions of infected people, but occasionally also through contact with virus
contaminated fomites.

How is the disease prevented?

Vaccination with Influenza vaccine can prevent the disease which has varying efficacies
depending on the types.

16 EPI Manual for Health Staff

 CHAPTER 3:
ABOUT THE VACCINES

EPI Manual for Health Staff 17

3.1 WHAT IS A VACCINE?

Vaccines are biological preparation that is used to stimulate the body immune response against
infectious diseases.

The types of vaccines that act in different way are.

• live-attenuated: BCG, bOPV, MMR vaccines

• Inactivated Vaccines: IPV, Influenza
• Messenger RNA (mRNA) vaccines: Pfizer
• Viral vector vaccines: AstraZeneca
• Sub-unit, Recombinant, Polysaccharide and Conjugate vaccines: HepB, PCV
• Toxoid: Td, DTP

Vaccines are being provided to infants, children and pregnant women to prevent certain
diseases. The vaccine preventable diseases against which vaccines are currently available
under UIP are:
Sl. No. Name of the vaccine Disease Prevented

Pfizer, Moderna,
CoviShield,
1 COVID-19
AstraZeneca,
Sinopharm

2 IPV Polio

3 bOPV Polio

4 BCG Tuberculosis

5 Hep-B Hepatitis – B

6 Influenza Seasonal Flu

7 HPV (Boys and Girls) Cervical Cancer

8 PCV Pneumococcal Infection

9 MMR Measles, Mumps, and Rubella

10 Td (Tetanus diptheria) Maternal and Neonatal Tetanus

11 DTP Diphtheria, Tetanus and Pertussis (Whooping Cough)

Diphtheria, Pertussis, Tetanus, Hepatitis B,

12 Pentavalent
Haemophilus influenzae B, Meningitis and Pneumonia

Figure 5: Vaccine preventable diseases against each vaccines under UIP

18 EPI Manual for Health Staff
 Table 1: Vaccine, Storage, Side effects and Efficacy
Vaccine Storage Side effects Efficacy
Local reaction:
BCG (Bacillus of Calmette and Guerin) vaccine
- Minor:- Redness, soreness, pain at the site of 0-90% in preventing child
First vaccine to be used in the country to prevent - Freezing does not damage BCG
injection hood tuberculosis. Best pre-
an endemic infectious disease, it contains live
- Major:- Hypertrophy/ swelling of the lymph vents tuberculosis meningitis
attenuated bovine strain of tubercle bacilli, (bacillus - Should be stored at +2 to +8 ° C
glands in axilla and miliary tuberculosis
Calmette and Guerin). It is provided with diluents.
- Abscess in the injection area
- Normally no side effects For more than 95% of
Oral Polio Vaccine (bOPV) - Rarely Vaccine Associated Paralytic Poliomyeli- recipients, three doses of
- +2 to +8° C
Oral Polio vaccine contains live attenuated Polio- tis (VAPP) may be noted OPV produce immunity for all

EPI Manual for Health Staff

- Can be stored at −15 to −20° C
myelitis virus strains; type 1 and 3. three of the poliovirus types
in the vaccine
Adverse events following administration of IPV are
Inactivated Polio Vaccine (IPV) very mild and transient. More than 95% of recipients,
Inactivated Polio Vaccine (IPV) is produced from - +2 to +8° C - Redness and tenderness are common side three doses of IPV produce
wild-type poliovirus strains of serotypes 1, 2 and 3, - Not to be frozen effects immunity for all three of
that have been inactivated (killed) with formalin. It - Minor side effects include induration, erythe- the poliovirus types in the
is an injectable vaccine. ma, fever, hypersensitivity reactions to trace vaccine.
antibiotics
lPneumococcal Conjugate Vaccine (PCV)
Mild side effects such as soreness at the injection
PCV consists of sugars (polysaccharides) from the - +2 to +8° C
site, and transient fever has been reported in less
capsule of the bacterium Streptococcus pneumoni- - Heat and freezing damages
than 5% of vaccinees. Severe adverse reactions
ae that are conjugated to a carrier protein, and it is PCV
attributable to the vaccine are extremely rare.
a killed vaccine.
- Mild: - pain, redness, swelling at the site of
Diphtheria-Pertussis-Tetanus Vaccine (DTP injection Fever- disappear in 1-2 days
- +2 to +8° C
Vaccine) Severe /Rare:-
- Freezing damages Diphtheria
It is manufactured from: - Abscess – because of unsterile syringe/needle
and Tetanus toxoid part of the
Purified Diphtheria toxoid, or wrong technique
vaccine
Inactivated pertussis organism and - Persistent inconsolable crying
- Heat damages pertussis vaccine
Purified tetanus toxoid - Fever, Temperature in excess of 40.5° C
- Unusual screams
- Convulsion
- Hypotonic/Hypo responsive episode.
- Anaphylactic Reactions
Measles Mumps and Rubella Vaccine (MMR
- Local reaction: - redness, urticaria.
Vaccine)
- Store at +2 to +8° C - Generalised Rash
- Measles, Mumps and Rubella Vaccines are live,
- Freezing does not damage - Fever> 38° C Lifelong immunity for 90-
attenuated strains of measles (Edmonston-Za-
undiluted MMR vaccine. Keep - Febrile seizure 95% of immunized persons
greb) and Rubella (Wistar RA 27/3) virus, Mumps
diluents cool - Thrombocytopenia (bleeding disorder)
L-Zagreb
-Protect from light - Anaphylactoid reaction
- It is lyophilized and is provided with diluent

19
- Anaphylaxis
 20
Vaccine Storage Side effects Efficacy

Tetanus diphtheria (Td) - Store at +2 to +8° C - Do not - Local reactions:- mild pain, - 1 dose: minimal protection
-Td is prepared by combining purified diph- freeze redness, warmth and - 2 valid doses: 3 years
theria toxoid and tetanus toxoid. swelling protection
-Smaller “d” indicates reduced diphtheria - The severity and frequency - 3 valid doses: 5 years protection
antigen units (Lf) and capital “T” indicates of local reaction are more - 4 valid doses: 10 years protection
regular Tetanus components common in hyper immu- - 5 valid doses: all adult age protection
- Protects against tetanus including neona- nized persons, (child bearing age)
tal tetanus, if mother is immunized. - Systemic reaction: - fever,
malaise, shivering, general
aches/headache.
- Adverse events like urti-
caria, anaphylaxis, brachial
neuritis and GBS are rare
Haemophilus Influenza Type -B (Hib) Vac- Store at +2 to +8° C Local: 3 doses provide 95% immunity against
cine Liquid vaccine, if frozen should - redness Haemophilus influenza Type-B
Prevents meningitis, pneumonia and other be discarded. - swelling
serious infection, caused by Haemophilus - pain
influenza type-B bacteria). General:
Available in monovalent or in combination - fever, irritability
with other vaccines:-
- Pentavalent - DTP-HepB-Hib
Hepatitis B Vaccine - Store at +2 to +8° C - pain/swelling in the injec- 95% of children immunized with 3 dos-
Hepatitis B vaccine may be in mono-valent -Both heat and freezing dam- tion site es of Hepatitis vaccine develop lifelong
form or in combination with DTP-HepB ages HepB vaccine - mild fever immunity
(Tetravalent) or with DTP-HepB and Hib (DTP- - muscle pain
HepB-Hib) vaccine as pentavalent - Very rarely anaphylactic
reaction

Human Papilloma Virus Vaccine (HPV - Store at +2 to +8° C Local reaction:- soreness, 3 doses of HPV vaccine produces high
Vaccine) - Not to be frozen swelling and redness level of serum antibodies (98-100%
Inactivated viral particles of HPV types 6, 11, Systemic reaction:- Fever, protection against CIN II and CIN III and
16 and 18 headache, muscle or joint genital warts for up to 5 years after vacci-
aches nation)
Fainting attack, life threaten- - Does not eliminate all risks of cervical
ing allergic reactions are rare. cancer
Local and systemic reactions
are mild and last about one to
two days.

EPI Manual for Health Staff

3.2 MINIMIZING PAIN DURING MULTIPLE INJECTIONS

There are ways that healthcare providers can do when providing multiple injections to minimize
pain. Studies have found that pain during immunization can be decreased by:

1 Encouraging breastfeeding mothers to breastfeed their infants after the

vaccination

2 Securing the child before the vaccination by caregiver

3 Stroking the skin or applying pressure close to the injection site before and
during injection and not after the vaccination

4 Injecting the least painful vaccine (IPV) first when two or more vaccines are
being administered sequentially during a single visit

5 For intramuscular injections (IM), gently stretch and support the skin between
thumb and forefinger. Push the entire needle in at a 90 degree angle with
a quick, smooth action. For all injections, depress the plunger slowly and
smoothly, taking care not to move the syringe around. Pull the needle out
quickly and smoothly at the same angle that it went in.

6 The caregiver may hold a clean swab gently over the site if it is bleeding after
injection

MEASLES
1. The baby’s right arm
HOLD THE BABY embraces the parent’s
CORRECTLY FOR back and is held under the
parent’s left arm
VACCINATION 2. The parents’ hands firmly
hold and control the baby’s
FIRMLY IN THE LAP head and the baby’s left arm

BCG PENTA/IPV
1. The baby’s left arm 1. One of the baby’s arms
embraces the parent’s embraces the parent’s
back and is held under the back and is held under
parent’s right arm the parent’s arm.
2. The baby’s right arm and 2. The other arm and legs
legs are controlled by the are firmly controlled by
parent’s left arm and hand. the parent’s hand.

Figure 6: Steps to hold the baby correctly for vaccination

EPI Manual for Health Staff 21

22 EPI Manual for Health Staff
 CHAPTER 4:
ROUTINE IMMUNIZATION
SCHEDULE FOR CHILDREN
AND ADOLESCENTS

EPI Manual for Health Staff 23

The recommended National routine immunization schedule is provided below:

Table 2: Routine vaccination schedule

Minimum
Number Schedule and age interval
Vaccines Dosage Route/site
of doses for vaccination between
doses
BCG (Bacille At birth or at first Intradermal, right upper
1 NA 0.05ML
Calmette Guerin) contact arm
Hep. B at birth (Within
Intramuscular (IM) antero-
Hepatitis B (Pediatric) 1 24 hours as “Zero” NA 0.5 ML
lateral aspect of mid-thigh
dose)
Pentavalent (DTP- At 6, 10, and 14 Intramuscular (IM) antero-
3 4 Weeks 0.5 ML
Hep,B-Hib) weeks lateral aspect of mid thigh

Inactivated Polio At 14 weeks antero-lateral aspect of

2 4 months 0.5 ML
Vaccine (IPV) At 8 Months mid thigh

At 0 (within 14 days),
6, 10, and 14 weeks
Oral Polio Vaccine
4 *if the 0 dose is 4 weeks 2 drops Oral
(bOPV)
missed it should be
given at 9 months

4 weeks
between the
Pneumococcal
at 6, 10 weeks and 9 1st and 2nd dose antero-lateral aspect of
conjugate Vaccine 3 0.5 ML
months and 6 months mid-thigh
(PCV)
from 2nd to 3rd
dose

Measles, Mumps MMR 1 at 9 Months Subcutaneous-left upper

2 15 months 0.5 ML
and Rubella (MMR) MMR 2 at 24 Months arm

Diphtheria, Tetanus DTP booster at 24 Intramuscular (IM) antero-

1 NA 0.5 ML
and Pertussis (DTP) Months lateral aspect of mid-thigh

Td 1 at PP Class
student
Tetanus diphtheria Td 2 at Class seven Intramuscular (IM) upper
2 6 years 0.5 ML
(Td) students arm
Out of school 6 years
and 13 years old
<15 yrs
1st dose- 0
• Class six girls and 2nd dose –
boys 6 months
2 doses girls
Human • Out of schoolgirls
and boys >=15 yrs Intramuscular (IM) upper
Papillomavirus (HPV) and boys at 12 6 Months
below 15 1st dose- 0 arm
vaccine years of age
years of age 2nd dose-
• For 15 years and
above 3 doses 2months
3rd dose- 6
months

Hepatitis B (Adult) 3 at 0, 1 and 6 months NA 1.0 ML Upper arm

Note: Children brought late (less than 5 years) for subsequent doses should continue
from the missed dose for all routine antigens.

24 EPI Manual for Health Staff

Table 3: Influenza vaccination doses for high risk group

Number of
Vaccine High Risk Groups
doses
• Pregnant women
• Health Workers
• People with Existing Medical Conditions (heart disease,
Seasonal Influenza 1
cancer, lung disease, active pulmonary TB, liver disease,
Vaccine
kidney disease, diabetics patients on medication, HIV)
• Elderly Population 65 Years and above
• Others as defined by MoH
• Children 6 to <24 Months – 0.25ml
• Children 2- <3 years if they have existing medical
2 doses with an
Seasonal Influenza condition)- 0.3ml
interval of four
Vaccine • 3-8 years (if they have existing medical condition) -0.5ml
weeks
Note: all the above age groups will receive two doses or
only one dose if received earlier.

Table 4: Pregnant women with no previous record of Tetanus diptheria Vaccination

Vaccine Frequency/time Dosage Route/site

Td1 As soon as possible
Td2 4 weeks after 1st dose
Td3 6 months after 2nd dose 0.5 ml Intramuscular (IM) left upper arm
Td4 1 year after 3rd dose
Td5 1 year after 4th dose

Table 5: Pregnant women having record of Tetanus diptheria Vaccination

Number of prior Td received Td dose Frequency /Time Dose Rout/Site

- 2nd dose - As soon as possible
- 3rd dose - 4 weeks after 2nd dose
Pregnant women who have received - 4th dose - 6 months after 3rd
1st dose of Td vaccine dose
- 5th dose - 1 year after 4th dose
- 6th dose - 1 year after 5th dose
- 3rd dose - As soon as possible
- 4th dose - 4 weeks after 3rd dose
Pregnant women who have received
- 5th dose - 6 Months after 4th Intramuscular
2nd dose of Td vaccine
dose 0.5ML (IM) left upper
- 6th dose - 1 year after 5th dose arm
- 4th dose - As soon as possible
Pregnant women who have received - 5th dose - 4 weeks after 4th
3rd dose of Td vaccine dose
- 6th dose - 1year after 5th dose
Pregnant women who have received - 5th dose - As soon as possible
4th dose of Td vaccine - 6th dose - 1 year after 5th dose
Pregnant women who have received - 6th dose As soon as possible
5th dose of Td vaccine

EPI Manual for Health Staff 25

4.1 VACCINE SAFETY

Vaccines are sensitive to heat, cold and light. Therefore, vaccines should be kept at the
recommended temperature range from the time of manufacture to the time of use. Similarly
light-sensitive vaccines should be stored in cool and dark conditions. Vaccine Management has
an objective to maintain the safety and potency of vaccine during storage and transportation.
The vaccines lose their potency if they are not stored or transported at the recommended
temperature and condition. If vaccines are not stored safely (within recommended temp.), it
may lead to Adverse Event Following Immunization (AEFI). Hence all attempts should be made
to retain the safety of the vaccine and maintaining the recommended temperature.

HEAT
MOST SENSITIVE
BCG (after reconstitution)
←
bOPV
IPV
Measles (both before and after reconstituion)
DTP
BCG (before reconstitution)
Td/PCV
Pentavalent, Hep. B
LEAST SENSITIVE
Figure 7: Vaccine sensitivity to heat

4.5 CONTRA-INDICATIONS TO IMMUNIZATION

Table 6: Frequently asked questions and responses

BCG vaccine bOPV
Why is the BCG vaccine given on the right upper Till what age can a child be given OPV.
arm? If a child misses the dose in RI?
BCG is given on the right upper arm to maintain uniformity OPV can be given to children up to 5 years
and for helping surveyors in verifying the receipt of the of age.
vaccine.
IPV
If not given at birth, when should BCG be given?
What is the upper limit age for IPV
If not given at birth or along with DTP HepB1, it can vaccination if the child does not receive
be given at any time up to 2 years; the dose should be IPV at 14 weeks?
increased to 0.1ml, if given after the age of one year.
Ans: If the child misses IPV first dose at
If no scar appears after administering BCG, should 14 weeks, the child can be vaccinated at
health staff re-vaccinate the child? the next visit and the 2nd dose should be
given after 5 months interval.
There is no need to revaccinate the child if there is no
scar but vaccinated evidence. However, if you are not
sure about the vaccination history or documentation,
repeat the vaccination.

26 EPI Manual for Health Staff

Pentavalent (DTP-HepB –Hib vaccine) If a child who has never been vaccinated
but brought at 9 months of age, can all
If a child could not receive Pentavalent 1, 2, 3 till
the vaccines be given to a child on the
what age can the vaccine be given?
same day?
If a child misses one or more doses of Pentavalent
Yes, all the vaccines can be given at the
vaccination, subsequent doses can be given up to 4
same session but at different injection
years of age with a minimum gap of 4 weeks between
sites using separate sterile syringes
the doses to complete the immunization schedule.
and needles. It is safe and effective to
Why Pentavalent is given on the outer mid-thigh and give BCG, Pentavalent, bOPV and MMR
not in the gluteal region (buttocks)? vaccines and Vitamin A at the same time
Pentavalent is given in the outer mid-thigh to prevent to a 9 month old child who has never been
damage to the sciatic nerve. Moreover, the vaccine vaccinated.
deposited in the fat of the gluteal region may not develop If a child who has never been vaccinated
immunity. is brought between 1 and 4 years of
If a child comes after completing 5 years of age age, which vaccines can be given to
without any vaccination, which vaccines should be the child?
given? All childhood vaccines can be given except
Ans: bOPV (2 doses), IPV (2 doses), MMR (2 doses) with BCG if the child is 2years or older.
an interval of at least 1 month between the doses. Give Should one re-start with the first dose
2 doses of Td after completing 2nd doses of MMR and of a vaccine if a child is brought late for
IPV. subsequent doses?
Do not start the schedule all over again
even if the child is brought late for a dose.
Continue from the missed schedule and
ensure to complete it.

EPI Manual for Health Staff 27

28 EPI Manual for Health Staff
 CHAPTER 5:
COLD CHAIN EQUIPMENT

EPI Manual for Health Staff 29

Cold Chain Equipment is a set of equipment, which helps in providing recommended
temperature for the vaccines to preserve their quality during transportation and storage from
the manufacturing plant till their administration to the target beneficiary. The equipment used
in the UIP are classified as follows:

COLD CHAIN EQUIPMENT

STORAGE TRANSPORTATION
• Walk-in-Cooler (WIC)
• Walk-in-Freezer (WIF)
• Ice-lined Refrigerator (ILR)
Electrical • Refrigerated
• Deep freezer (DF)
vaccine van
• Domestic Refrigerator
• Insulated vaccine
van
• Cold Box
• Solar Refrigerator Battery • Vaccine carrier
Drive
Solar
• Solar Refrigerator Direct
Drive

Non-Electrical • Cold Box

• Vaccine Carrier

Figure 8: Classification of cold chain equipment

5.1 ELECTRICAL COLD CHAIN EQUIPMENT

There are different equipment for storage of vaccines at different levels, which are dependent
on electric supply to maintain the recommended temperature. The cold chain equipment which
runs on electricity is described below:

5.1.1 Walk-in-Cooler (WIC)

Walk-in-Cooler is a prefabricated modular

CFC free Polyurethane (PUF) insulated
panels assembled as a cold room with two
identical refrigeration units. They maintain
a temperature of +2°C to +8°C. In Bhutan,
under UIP WICs with capacity of 40m3 and
30m3 are in use. These are used for storage
of large quantities of all UIP vaccines like, Figure 9: Walk-in-Cooler to store large volume
BCG, Hepatitis B, DTP, Pentavalent, IPV, of vaccines at positive temperature
Measles and Td. These Walk-in-Coolers are installed at National EPI Store and three
Regional EPI Vaccine Stores. WICs and WIFs installed in Bhutan are fitted with real time
temperature monitoring devices (RTMD) and alarm systems. Once the temperature of
WIC/WIF exceeds or go below set limits the alarm system gives an alarm loudly and sends
sms to the cold chain handler. Similarly, in case of power failure, it gives immediate alarm.
A standby generator with automatic start and stop function is provided at National and
Regional Stores.

30 EPI Manual for Health Staff

 5.1.2 Walk-in-Freezer (WIF)

Walk-in-Freezer is a prefabricated modular WIF are used for bulk storage of

and also for the preparation of f
CFC free Polyurethane (PUF) insulated panels transportation.

assembled as a cold room with two identical They maintain a temperature bet
immunization program in India a
20, 32 and 40 Cubic meter. W
refrigeration units. They maintain a temperature installed at national, state & regio

of -15°C to -25°C. In Bhutan, all the WIFs are 3.2.2 Walk-in-Coolers (WIC)
The Walk-in-Cooler is a pre-fabr
(PUF) insulated panel assembled
20m3. These WIFs are installed at National EPI refrigeration units. They maintai
+8°C. In India, under UIP usually

Store and two Regional EPI Stores at Mongar and 40 Cubic meter are in use.

These are used for storage of

and Gelephu. An alarm or hooter system is also vaccines like, BCG, Hepatitis
Measles and TT. They have two

provided to alert in case of any temperature

Walk in Cooler
standby generator with automat

excursion and sms goes to the cold chain handler. Figure 10: Walk in Freezer to store large regional
These Walk-in-Coolers are in
vaccine store. The WIC
some district vaccine stores bas
A standby generator with automatic start and volume of vaccines at minus temperature and requirement.

stop function is provided at National and Regional Stores.

WIC & WIF come with continuou
alarm system. Once the tempera
recommended storage temperat
alarm loudly.

WICs/WIFs are equipped with following Temperature Monitoring Devices/components: WICs/WIFs are equipped with fo

Graphic chart temperature reco

measures cold/freezer room tempe
chart. Normally the chart complete

5.1.2.1 Graphic chart temperature recorder: A Temperature recorder

the charts need to be changed ev
chart needs to be reviewed and
temperature record should be kep
measures cold/freezer room temperature continuously on a circular In some of the recently supplied

chart. Normally the chart completes one cycle in seven days. So, the recorders, data loggers are install
The print out from the data logge
basis. Since the printer uses ther
charts need to be changed every week. After one cycle the chart needs hence photocopies of the printou
for minimum three years.

to be reviewed and signed by the supervisor. All temperature records Alarm systems: An alarm or hoo
alert regarding temperature excurs
should be kept for three years. Graphic chart temperature recorder temperature crosses the safe rang

24 • Handbook for Vaccine & Cold Chain Handlers, India 2016

5.1.2.2 Real-time Temperature Monitoring Device: WICs/WIFs are

installed with RTMDs. These RTMDs are installed with a Lithium-ion
battery and sim card, four temperature sensors, one door opening sensor
and one power failure sensor. RTMD of WIC and WIF are using internet/
GSM services. More details are provided in cold chain Temperature
Monitoring Devices.

5.1.2.3 Alarm systems: An alarm or hooter system is provided to give

alert in case of any temperature excursion. As soon as the temperature
crosses the safe range a hooter gives a loud alarm.

5.1.2.4 Servo Controlled Voltage Stabilizer: The main power to WIC/WIF

is connected through a Servo Controlled Voltage Stabilizer to safeguard
the WIC/WIF from voltage fluctuations by providing a constant voltage.
All the stabilizers are equipped with a human-machine-interface (HMI)
touch screen.

5.1.2.5 Diesel generator (DG): WICs/WIFs are meant for continuous

operation. Hence in the event of mains’ power failure, DG set is used
to provide the standby power supply. The DG set is equipped with
Auto Mains Failure (AMF) panel for providing automatic start and stop
facilities. AMF panel enables DG set to automatically start as soon as
the power goes off and stops when main power returns.

EPI Manual for Health Staff 31

 5.1.3 Ice Lined Refrigerator (ILR)

An ILR is known as an ice-lined vaccine refrigerator. It is a

device that maintains the temperature between +2°C to
+8°C. It is used to store all Universal Immunization Program
vaccines at the Health Facilities. The ILR is used because the
power supply at health facilities may be unreliable. An ILR can
maintain a temperature from +2°C to +8°C with as little as
8 hours of power supply in 24 hours. If the electricity supply
fails, then the ice lining maintains the inside temperature of
the refrigerator at a safe level for vaccines. Also, an ILR has
a top-opening lid which prevents loss of cold air during door
opening. Therefore, the temperature is maintained in ILR for
a much longer duration. ILRs are available in two sizes – large Figure 11: ILR to maintain
(for districts) and small (for PHCs). The bottom of the ILR is its the set temperature
coldest part and the vaccines are arranged according to their freeze sensitivity; the least
freeze-sensitive vaccines are placed at the bottom of the basket and the most freeze-
sensitive vaccines are placed at the top. In ILR leave a space of 2 cm between the vaccine
boxes and ILR wall for better circulation of cold air. Place a 30 DTR among the vaccines in
the basket.

5.1.3.1 Hold Over Time: In the event of power failure, “holdover time” for any cold-chain
equipment is defined as “the time taken by the equipment to raise the inside cabinet temperature
from its cut-off temperature to the maximum temperature limit of its recommended range”,
e.g. in the case of ILR, if the temperature is 4°C, then the time taken to reach 8°C from 4°C will
be the holdover time for that ILR. Hold over time depends on the following factors:

• Ambient temperature—A higher ambient temperature will result in short hold over time
• Number of frozen ice packs inside
• Frequency of opening of lid
• Quantity of vaccines kept inside with adequate space between the containers
• Condition of ice packs inside nonelectric equipment (frozen/partially frozen/melted)
e.g. the holdover time for an ILR is minimum of 20 hours at 43oC.

Note: Unlike ILR, a ‘Deep Freezer’ does not have holdover time, as it does not have an ice
lining inside its wall. It is dependent only on the number of frozen ice packs kept inside it, if any.

5.1.4 Deep Freezer (DF)

The Deep Freezer is an equipment, which operates

on a vapour compression system similar to any
conventional type of refrigerator operating on
220 volts A.C. mains supply. However, DF has a
top opening lid to prevent loss of cold air during
door opening. DFs have been supplied under the Figure 12: Deep Freezer to make frozen
immunization program for storage of vaccines at ice packs and to store OPV vaccine

32 EPI Manual for Health Staff

appropriate level and preparation of Ice Packs. The cabinet temperature is maintained
between -15°C to -25°C. This is used for storing of OPV vaccine (district level and above
only) and also for freezing of ice packs. At PHC level it is used for freezing ice packs. Unlike
the ILR, the DF has got little or limited holdover time which is dependent on the number of
frozen ice packs in it and the frequency of opening. These are available in different sizes-
large and small.

5.1.5 Combo

A combo is known as a combination of refrigerator (+2°C to

+8°C) and deep freezer (-15°C to -25°C). This combo is very
useful where the target population is small. Its storage capacity
varies from model to model and brand to brand. Bhutan has
a maximum quantity of VLS 064A RF. It is the most energy
efficient ice lined refrigerator available in the global market. Its Figure 13: To store vaccines
ambient working range is +5C to +43C. In the new models of at positive temperature and
Combo, the stabilizer is built in. There is no need to provide make ice packs
extra stabilizer.

5.1.6 Ultralow Temperature Freezer (ULTF)

ULTF works at a temperature of -60°C to -86°C. It is meant for

COVID-19 Pfizer vaccines storage, in general. It has a cascade
refrigeration system to maintain the minus temperature. The
handlers of this ULTF need to understand that while loading or
unloading the vaccines to this ULTF have to wear the cryogenic
gloves, otherwise frostbite can happen. ULTF has electronic Figure 14: To store vaccines
temperature monitoring devices, which can store the data for at -860C temperature
five years. In case of temperature excursion, it has audio and visual alarms.

5.1.7 Kerosene and Electric Refrigerator (SIBIR)

The popular name of this refrigerator is SIBIR. It runs with

Kerosene-Electric, Gas-Electric. This refrigerator do no
have any compressor like mechanical refrigeration system,
however generator and heater are there. In case of no power,
it runs on kerosene or gas, based on the design. In Bhutan it
is available in two models V110KE and V170KE. VK110KE is
single door refrigerator with a vaccine storage capacity of 17 Figure 15: To store vaccines
liters whereas VK170KE/GE is double door with 55 liters of at positive temperature and
vaccines storage capacity and 36 liters of freezing capacity. make ice packs

5.1.8 Cold Chain Equipment-make, model number, gross storage-vaccine storage-

freezer storage capacity

Bhutan has a variety of cold chain equipment like ILR, Deep Freezer, Combo and ULTF. A
few of them are mentioned below to support the health staff in understanding the model
no., gross storage capacity, and vaccines storage capacity apart from freezer capacity.

EPI Manual for Health Staff 33

 STORAGE VACCINE
STORAGE CAP
MAKE MODEL CAPACITY STORAGE
FREEZER
(GROSS) LITERS CAPACITY

Vestfrost MF 214 171 138

Vestfrost MF 114 105 98
Vestfrost MK 144 64 48
Vestfrost MK 204 218 105
Vestfrost MK 304 296 200
Vestfrost MK 404 240 135
Vestfrost MKF 074 54 16 9
Vestfrost VLS 064A RF 75 52.5 5.1
Vestfrost VLS 200A 113 60
Vestfrost VLS 504A 314 242
Vestfrost VLS 404A 235 145
Vestfrost VLS 204A 113 60
Vestfrost VLS 026 RF SDD 69.3 20 1.8
Vestfrost VLS 056 RF SDD 60 36
Vestfrost SB 202 198 189
SIBIR V110KE 110 17
SIBIR V170GE 170 55 36
SIBIR V170KE 170 55 36
Electrolux TCW1151 290
BM System TFW800 290

5.2 SOLAR COLD CHAIN EQUIPMENT

Accurate and uniform temperature in a refrigerator plays a key role in ensuring the life of vaccines,
reagents and other biologicals. Keeping heat-sensitive vaccines at the right temperature is
crucial yet often in difficult areas with limited or no electrical power or frequent or long-duration
power outages that makes the use of grid-powered cooling impractical for vaccine storage.

In recent years a new approach to solar refrigerator design has

emerged that eliminates the expensive (and problematic) energy
storage batteries. “Direct-drive” technology uses the sun’s
energy to freeze water or other phase change material and then
uses the cooling from that “ice bank” to keep the refrigerator cold
during the night and cloudy days. These refrigerators are called
“Solar direct-drive refrigerators” because they are wired directly
to the photovoltaic generators. In Bhutan, during the summer, the
electricity grid often does not reach rural areas, and is not always
reliable. As keeping vaccines at the appropriate temperature is
vital, solar powered refrigerators are a cost-effective alternative
that can be highly reliable. A typical system will use a solar Figure 16: Solar ILR and DF
photovoltaic panel to generate electricity from sunlight. The
compressor runs at very low volage as compared to the conventional refrigerator. It is a

34 EPI Manual for Health Staff

refrigerator cum freezer having basket for storing of vaccine and freezing of icepacks. It has
two separate compartments.

1. Vaccine storage compartment maintains temperature range of +2°C to +8°C (Refrigerator).

2. Freezer compartment is for storing frozen icepack maintaining temperature up to -15°C
(Freezer).

5.2.1 Solar Panel and Array

Solar panels, commonly called solar modules, are

the key components used to convert sunlight into
electricity. The solar array (two or more solar panels
connected together) must be permanently positioned
where the modules will receive the maximum amount
of sunshine. However, they are very fragile and should Figure 17: Solar Panel and array
not be located where they may be damaged. A suitable position must be found away from
trees and tall objects, to avoid shading the array, as this will impair the performance of the
modules. Array structures are designed to withstand wind loads of +200 kg per square
meter and are supplied with fixings for either ground or roof mounting.

5.3 TEMPERATURE MONITORING DEVICES AND STABILIZER WITH COLD CHAIN

EQUIPMENT

Temperature of ILRs/Deep Freezers used for storage of vaccines must be recorded twice daily.
These records should be checked during supervisory visits. A break-down in the cold chain is
indicated if temperature rises above +8°C or falls below +2°C in the ILR; and above -15°C in the
Deep Freezer. ILR and Deep freezers should have separate thermometers and comprehensive
logbooks. The serial numbers of ILR and Deep Freezers should be indicated in the designated
space provided in the temperature record book and should be available near the equipment.
Every supervisory and preventive maintenance visit should be documented in the logbook. The
repair maintenance work done for the equipment should also be recorded in the respective
logbook. The storage temperature and excursion devices are as follow:

5.3.1: 30 DTR

Electronic data loggers are also being introduced to monitor the

temperature of ILR. It is an electronic device placed with the vaccine
which records the vaccine temperature for 60 days, even though the
device is called 30DTR. It has an alarm system and as soon as the
temperature of the equipment storing the vaccine crosses the safe Figure 18: 30 DTR
range visual alarm alerts the handlers. to monitor the
temperature

EPI Manual for Health Staff 35

This device assists in temperature monitoring through following features.

• It shows the temperature of ILR in digital LCD screen all the time.
• It indicates if there was any alarm situation during the past 60 days.
• It shows the duration of temperature excursion for every alarm situation happened in past
60 days. To see the duration of temperature excursion, device is equipped with a “Read”
button which guides the user through the history of past 60 days starting from “today” till
“last 60 days”.
• It shows an “OK” sign if there has been no excursion of temperature in past 60 days.
• It has a shelf life of two to six years from the date of activation of device.
• The device once activated, cannot be stopped throughout its operational life. Hence, it
provides round the clock monitoring of ILRs without any need of
intervention of users for two to six years of time. At all Health facilities
• It has been specifically designed to be used with ILRs, Combo two 30DTRs are
(Refrigerator compartment), and Walk-in-Coolers that are required required. One should
to maintain the temperature between +2°C to +8°C. be marked as ONLY
FOR ILR and other
• If the cross sign appears on the device does not mean that the
for ORC/VACCINE
devices has gone faulty. After 30 days the cross will automatically COLLECTION.
go off, if the temperature for the next 30 days is within set limits.

5.3.2: Eye Sensor with GPS (Temperature excursion device)

This eye sensor comes with GPS system in compact size to record
and transmit temperature and humidity. The eye sensor senses the
temperature and humidity and pass it through Bluetooth to GPS
device. GPS device passes the data to central server. It can operate
from -25°C to +55°C. In case of any temperature excursion (pre-set
temperature) it provides alert to the health staff through sms. If the
health staff does not attend to the call, the message will pass to
ADHO/DHO, the Regional EPI Stores and National Store to take the Eye Sensor
corrective action followed by the program.

These devices are Low Energy ID beacon and sensor models with
robust casing and long life-time battery. They are designed for a low-
cost fast and easy configuration and integration to save precious time,
GPS System
resources, and improve vaccine efficacy. Battery lifetime is up to 10
years reducing the financial and environmental cost. It comes in robust and waterproof
IP67 casing enhancing longevity. All the android and iOS compatible apps are available for
fast and easy configuration. These devices are fitted with local sim card and installed in all
the health facilities of Bhutan for keeping the vaccine safe.

Health
ADHO/DHO Regional EPI Store National EPI Store VPDP
Staff

Figure 19: Temperature excursion flow message hierarchy

36 EPI Manual for Health Staff

The functioning of this device is as:

Notification Alerts
(Email/SMS/Whatsapp)

ADMINISTRATOR

12 V POWER SUPPLY SERVER

GS Server
GPS HEX Digits

FMT100 Converted Data

(TRACKING DEVICE) Application
API Server
Temperature Data View

Save
BLUE PUCK T-PROBE MONITORING
(TEMPERATURE SENSOR) SYSTEM Database

FREEZER/COLD STORAGE

Figure 20: Temperature excursion flow system

5.3.3: Realtime Temperature Monitoring Devices (RTMD)

The Realtime Temperature Monitoring Devices are the

preferred temperature monitoring devices across globe. It
can operate from -25°C to +55°C. These kinds of devices run
on single or dual-SIM design with a global or local SIM card.
It gives complete network redundancy anywhere in the world
without the need for physical network infrastructure. The
off-grid and on-grid design makes it completely immune to
damage from spikes, surges, brownouts and blackouts. This
device has a major advantage in parts of the world where
power supply is unreliable. The device is easy to install,
requiring no tools and no special training. A typical installation
takes less than 10 minutes. It has a run time of up to 10 years
without the need to recharge or replace the batteries offering
the lowest possible maintenance cost. It can simultaneously
monitor up to 2 to 4 temperature sensors as well as the Figure 21: RTMD to
mains power status, and door position. It also monitors both remotely monitor the
the ambient temperature and humidity. It also offers real-time temperature of vaccine in
GPS tracking when monitoring the cold chain in mobile assets the refrigerator
like trucks, containers and cooler boxes when installed in the specific equipment.

EPI Manual for Health Staff 37

 5.3.4: Freeze Alert

It is also an electronic device to monitor vaccines exposed

to less than 0°C. It contains an electronic temperature
measuring circuit with associated LCD display. If the
indicator is exposed to a temperature below 0°C for more
than 60 minutes the display will change from “good” (√)
status in to the “alarm” status (X). The freeze indicator is
placed in between freeze sensitive vaccine (Hepatitis B,
DTP, TT, IPV, Pentavalent etc.) Once it changes to cross
(X), it cannot be re-used or reset and will be discarded. Figure 22: Temperature indicator
shows if a vaccine has been
The vaccines should never be used without shake test
exposed to freezing
when freeze tag shows the cross mark (X). Its shelf life
is five years.

5.3.5: Temperature Monitoring Thermometer

Measuring temperature of cold chain equipment is helpful

in:

a. Ensuring vaccine safety

b. Monitoring the functionality of the cold chain equipment

Hence temperature should be monitored for all the cold

chain equipment available in the health facility (Cold Chain
Point) twice every day on all days of the week irrespective
of Sundays and holidays. Temperature should also be
monitored and recorded for the Deep Freezers meant for
freezing icepacks. Only situations, where the temperature
is not recorded are

1. Equipment is non-functional and

2. Equipment is not put to use due to various reasons.

To measure the temperature during storage/transport, Figure 23: To measure the

different type of thermometers and temperature temperature of vaccine
measuring instruments are used.

Alcohol Stem Thermometers are much more sensitive and accurate than dial thermometers.
They can record temperatures from -40°C to +50°C and can be used for ILRs and Deep
Freezers.

38 EPI Manual for Health Staff

 5.3.6: Voltage Stabilizer

The function of the voltage stabilizer is to monitor the

range of fluctuations in the main incoming voltage and to
safeguard equipment from excessive voltage variation.
Voltage stabilizers provide constant stabilized voltage to
CCEs (ILRs, Combos, and DFs) for its desired optimum
operation and in turn protect vaccines.

Types of voltage stabilizers

Voltage stabilizers can be classified as follows: Figure 24: Single phase voltage
stabilizer
i. Normal Voltage stabilizers: The voltage range: 150 – 280 V.
ii. Low range voltage stabilizers: voltage range: 110 – 280 V.
iii. Low range stabilizers for specific areas: 90 – 280 V.

Stabilizers should be selected and installed as per the input voltage available.

Low input voltage range (90V – 280V) voltage stabilizers are recommended in the areas
with low voltage supply.

Instructions to User:

• Every refrigeration unit must be connected to an individual stabilizer.

• Bypassing of Stabilizer is not recommended, as such practice may lead
to damage of the CCE and in turn safety of vaccines and hence must be
avoided.
• Proper earthing should be available and connected.
• Emphasize on repairing stabilizers immediately. Local help can be sought.
Identify authorized and qualified service provider.
• Include status of stabilizer in monthly report, it is an integral and important
part of cold chain equipment.

5.4 NON-ELECTRICAL COLD CHAIN EQUIPMENT

5.4.1 Vaccine carriers

Vaccine carriers are used for carrying vaccines (16-

20 vials) to out-reach sites. They maintain the cold
chain during transport from the Health Centers to
immunization sites. Vaccine carriers have thick
walls and lids are made of a special material that
Figure 25: Vaccine Carrier to store and
prevents heat from passing through and maintain
transport vaccines

EPI Manual for Health Staff 39

 the required temperature for the vaccines. The vaccine carrier is filled with polyurethane
foam. The inside temperature of a vaccine carrier is maintained between +2 to +8°C with 4
conditioned ice packs for 4 -10 hrs (cool life at +43oC, it depends on frequency of opening
and other factors). The vaccine carrier comes in the following:

a. Short range vaccine carrier

b. Long range vaccine carrier
c. Freeze free vaccine carrier

Bhutan has only two types of vaccine carriers:

a. Short range vaccine carrier: It requires the ice pack conditioning prior to loading of
vaccines
b. Freeze free vaccine carrier: This vaccine carrier can be directly loaded with ice packs
without conditioning

How to pack the vaccine carrier:

5.4.1.1 Ice packs for vaccine carrier

• Ice packs are plastic

containers filled with
water. These are
frozen in the deep
freezer.
• Ice packs can be filled
with tap water up to
the mark as shown in
the picture and the cap Unconditioned ice-packs may damage freeze sensitive vaccines
tightly closed, so that
there is enough ice and Figure 26: Ice pack and its proper ice-pack conditioning
the water does not leak when the ice melts.
• Excess water filled in ice pack will swallow the ice pack and less water in ice pack will
squeeze the ice pack, so fill proper water upto the marked level
• Only conditioned ice packs to be used in vaccine carriers
• Conditioned Ice packs are kept along the walls of the vaccine carrier.
• The outer surfaces of the ice packs should be cleaned with dry cloth before putting
these in the deep freezer for freezing cold boxes
• In the cold box icepacks are to be kept along the walls, on the floor and on top of the
vaccines.

40 EPI Manual for Health Staff

 5.4.2 Cold Boxes

Cold boxes are used to collect and transport

vaccines from EPI stores to the hospitals, and
hospital to PHC/sub-posts. They are also used to
store vaccines when the ILR and refrigerators are
out of order and when defrosting the freezer to
keep vaccines at correct temperatures. Before the
vaccines are placed in the cold box, conditioned
ice packs should be placed at the bottom and
sides of the cold box. Thereafter, vaccines should
be placed in cartons or polythene bags and placed
Figure 27: Cold Box for storage of
in the cold box. The vaccines should be covered
vaccines / ice packs
with a layer of conditioned ice packs before the
cold box is closed. The vials of DTP-HepB-Hib, HPV, DTP, Td and Hepatitis B should be
wrapped in thick paper to prevent the vaccine from freezing. Vaccines should be transported
or stored in cold boxes only with sufficient number of conditioned ice packs. In such a
situation, vaccines can be stored for 12 - 52 hrs cool life at 43oC in cold box, depending
upon the openings and atmospheric temperature. The temperature of the cold box should
be monitored by keeping a freeze tag or 30 DTR inside the cold box.

5.4.2.1 Ice packs for Cold box

• Please read the instructions mentioned inside the lid for

loading the cold box
• Ice packs are plastic containers filled with water. These are
frozen in the deep freezer.
• Ice packs can be filled with tap water up to the mark as
shown in the picture and the cap tightly closed, so that
there is enough ice, and the water does not leak when the
ice melts.
• Excess water filled in ice pack will swallow the ice pack
and less water in ice pack will squeeze the ice pack, so fill When Cold Box is not
proper water up to the marked level in use, place properly,
do not close lid with
• Only conditioned ice packs to be used in vaccine carriers
lock.
• In the cold box icepacks are to be kept along the walls, on
the floor and on top of the vaccines.
• The outer surfaces of the ice packs should be cleaned with dry cloth before putting these
in the deep freezer for freezing

EPI Manual for Health Staff 41

5.5 VEHICLE USED FOR TRANSPORTATION

Refrigerated Vaccine Van

Transportation equipment forms an important link in the

entire cold chain system. It can be used for transportation
of vaccines in bulk quantity. This can be used to provide
transportation solution from National Store to Regional
Stores and from Regional Stores to District Hospitals.
Apart from it, it is used to collect the vaccines when
vaccines land at airport. The refrigerated vaccine van can
provide temperature range as per the specific requirement
of vaccine like +2°C to +8°C. At present Bhutan is using
only +2°C to +8°C. The use of Refrigerated vaccine van
does not require the cold boxes or ice packs for vaccine
transportation. The refrigeration system in the vaccine
refrigerated van should be started to get the required
temperature before loading the vaccine.
Figure 28: Safe transportation of
vaccines through refrigerated van

42 EPI Manual for Health Staff

 CHAPTER 6:
MAINTENANCE OF
COLD CHAIN EQUIPMENT

EPI Manual for Health Staff 43

The fact of life is that every piece of equipment needs maintenance. It may be routine
maintenance, such as changing the oil in your car to prevent problems from occurring later on,
or it may be the larger actions to repair or replace damaged parts. Sometimes you may even
have to replace your car’s entire engine. Both types of maintenance, preventive and curative,
are important to keep your car running as best as it can. Similarly, cold chain equipment (CCE)
used to keep vaccines at an optimum temperature range of +2°C to +8°C, -5°C to -25°C and
-60°C to -86°C needs regular preventive maintenance. This is necessary to keep the equipment
functioning optimally, to maintain the vaccine’s quality and effectiveness against disease,
and to save lives. Maintenance plans need to be realistic and backed-up with a HR, technical
capacity and available funds.

For immunization programs in Bhutan, ensuring CCE is continuously working properly has
been an ongoing challenge, because often equipment was installed decades ago (Domestic
and SIBIR refrigerators) and it’s easy to understand the challenge. The scope is huge – each
program like EPI and Health has thousands of pieces of equipment installed across the country,
many in very hard-to-reach areas. The electrical grid that runs much of this equipment can be
unreliable, which can put a strain on the CCE. Spare parts for the equipment are often not
available locally, which complicates a quick response to a maintenance issue. And there are
never enough technicians when and where they are needed, or inadequate financial resources
to deploy them.

Bhutan is in process of development of maintenance plan into the country plan that details
the on-going preventive maintenance for CCE, such as keeping it clean, not overloading
the equipment, and defrosting when needed. The plans should also provide the details of
what to do when a piece of equipment breaks down – who is responsible to fix it; expected
quantity of spare parts needed and where they should be stored; estimated costs of corrective
maintenance; and who authorizes decommissioning of equipment that can’t be repaired,
among many other details. Also, annual maintenance contract (AMC) can also be designed to
improve the regular maintenance of cold chain equipment. Models that are ten or more years
old are still being used, some with no problems and some that should be retired/replaced and
will still require maintenance. The maintenance system must be available for all equipment,
not just those recently procured. Older equipment will naturally need more care and attention
to maintain the optimum temperature range.

That maintenance plans need to be realistic and backed-up with a budget and available funds.
Even if a cold chain technician can create the most accurate budget for maintenance of all
equipment, if the funds are not available when the technician needs to buy fuel for the vehicle
to go out to a health facility to fix a piece of equipment, the problem will persist. On the other
hand, if the needed spare part is stored at the national level, regional level, and the district level,
it can avoid delay in maintenance. These are the “nuts and bolts” of a maintenance system
that still need to be addressed. At the country level as well, immunization program managers,
logisticians, and cold chain technicians should continue to advocate for the funds and attention
necessary to establish strong and reliable maintenance systems to protect the investment in
equipment and in children’s lives.

44 EPI Manual for Health Staff

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Daily Tasks: Weekly Tasks: Monthly Tasks:

1. Check and record 1. Remove any water 1. Defrost the equipment
temperature daily at the bottom of the 2. Clean refrigerator with
morning and evening. refrigerator with a cloth lukewarm water and
2. If the temperature is or through the drainage mild detergent from
>8oC or <2oC, take hole inside and outside
corrective action. 2. Wipe of water droplets 3. Clean the grill on
on the inside wall the right side of the
3. Check if lid gasket is refrigerator
sealing properly when
the lid is closed

HOW TO DEFROST A VACCINE REFRIGERATOR

1. Transfer vaccines to a working refrigerator or cold box with

conditioned icepacks
2. Turn off the power supply to the refrigerator
3. Leave the lid or door open and wait for the ice to melt. Do
not try to remove the ice with a knife or other sharp object.
Doing this can permanently damage the lining. Clean and
dry the inside of the appliance
4. Turn the power supply ON
When the temperature falls below to +8oC or lower (but not less than +2oC), return the
vaccines, diluents, and/or cool water packs back to the refrigerator.

47 47 47

EPI Manual for Health Staff 45

 SERVICE TECHNICIAN TO CHECK
☐ Is the green diode in the control panel ON (power check)
☐ Is the internal temperature inside the acceptable range of +2o to +8o
☐ Is the vaccine compartment clean and without condensation (water)
☐ Is the Compressor running
☐ Are baskets used and in place
☐ Is the appliance placed according to the instruction in the manual
☐ Does the lid close tight to cabinet and is the lid gasket in good condition
☐ Is the grill for compressor compartment clean
☐ Is the condenser coils on the backside clean
☐ Are all electrical components working properly
☐ Is there condensation on electric parts (water condensation)?
☐ Over all condition of the cabinet - internal and external: any corrosion, rusting, cracks?
☐ Inspection of the refrigeration line (the condenser, evaporator, the whole refrigeration circuit/line)

HOW TO MAINTAIN YOUR VACCINE REFRIGERATOR

hat repairs can be carried out immediately or as
1 Check Installation
Refrigerator is:
3 Store vaccines
properly
mbo seals to ensure that cold air does not leak out.
• Outside of direct The vaccine
eplacement
sunlight compartment
event ice building
• In upawhich
well reduces efficiency. includes;
ventilated area
nd and under) the ILR/Deep Freezer/Combo is clean • An alcohol stem
• Clear of any heat thermometer
source
ctions by EPI/BMED technicians. Inspections may or an electronic freeze indicator in the
• On a level floor coldest area.
erator ages
• Has enough space • No food or drink inside the equipment
for air circulation • Vaccines with earliest expiration date are
• More than 50 mm between the easiest to access
back and the wall • Notice of emergency plan for vaccine
e freezer compartments
• Moreof refrigerators
than 100 mm from or the storage if equipment failure or power cut
m), it is time to defrost
righttoside
remove
of the the ice.
refrigerator
frigerator, move the vaccines
(grille) to any
and the wall
igerator must also • be monitored
More than 200to mmensure
between 4 Arrange packaged vaccines
Vaccine cartons and
8°C is maintained.vaccineIf there refrigerators.
is no other vials are:
d box with icepacks. Continue to monitor • Stored in baskets
2 Protect the power supply
vaccine refrigerator is ready for use again.
Refrigerator power
or in uncovered
containers with
back the vaccines in the ILR once the ILR
supply is protected slotted sides
with: placed inside these
• “Do Not Unplug” baskets
sign by the outlet • Stored with vertical
• “Do Not Interrupt space between
Power” warning stacks of cartons
label by the circuit breaker to allow air to circulation
• Signs including current emergency • Not in contact with the walls of the 48
contact information and notification refrigerator or freezer
● Reportplan
of emergency breakdowns immediately so that • repairs candirectly
Not stored be carried
in of out immediately
fan or outlet or as
soon
• A voltage regulator as possible from freezer compartment
● Regularly check ILR/Deep Freezer/Combo seals to ensure that cold air does not leak out.
If they are brittle or torn arrange for replacement
● 49 Freezer/Combo to prevent ice building up which reduces efficiency.
Defrost ILR/Deep
46 EPI Manual for Health Staff
● Ensure the area around (including behind and under) the ILR/Deep Freezer/Combo is clean
and dust free
● Arrange for regular maintenance inspections by EPI/BMED technicians. Inspections may
 • Report breakdowns immediately so that repairs can be carried out immediately or
as soon as possible
• Regularly check ILR/Deep Freezer/Combo seals to ensure that cold air does not
leak out. If they are brittle or torn arrange for replacement
• Defrost ILR/Deep Freezer/Combo to prevent ice building up which reduces
efficiency.
• Ensure the area around (including behind and under) the ILR/Deep Freezer/Combo
is clean and dust free
• Arrange for regular maintenance inspections by EPI/BMED technicians.
Inspections may need to be more frequent as the refrigerator ages

Defrosting or Cleaning

When there is solid ice in and around the freezer compartments of refrigerators or the sides of
ILRs or deep freezer (5 mm), it is time to defrost to remove the ice. When defrosting or cleaning
the refrigerator, move the vaccines to any refrigerator. This temporary storage refrigerator
must also be monitored to ensure the correct temperature +2°C to +8°C is maintained. If there
is no other refrigerator, store the vaccines in a cold box with conditioned icepacks. Continue
to monitor the temperature inside the cold box till vaccine refrigerator is ready for use again.
Refrigerator should be kept clean. Put back the vaccines in the ILR once the ILR temperature
reaches +2°C to +8°C.

DAILY CHECK MONTHLY 6 MONTH

• Monitor Temperature • Clean grill for • Clean condenser coils

• Internal lid is placed compressor
properly compartment
• Lid fits and lock tight
to cabinet
• Lid gasket not faulty

YEARLY REGULARLY

• Check electrical • Clean Solar Panels

connections and • Check Solar Panels are
components not shaded at any time
• Check electrical of the day
connections, cables,
wiring from PV panel
system

Figure 29: Maintenance of Solar refrigerator

EPI Manual for Health Staff 47

6.2 SOLAR REFRIGERATOR

6.3 WALK-IN-COOLER/WALK-IN-FREEZER

ROUTINE MAINTENANCE INSTRUCTIONS

1 Regularly check the surface of the condenser and clean foreign objects to keep the
condenser clean
Regularly check the operation condition of the condenser, and ensure that each fan
2
operates normally
Regularly check the time required for each unit to run the refrigerating cycle, and
3
analyze and eliminate the potential problems
Regularly check the inner door lock to protect the personnel from being trapped due
4
to broken lock
Regularly check whether the door frame heater is normal to avoid condensation due
5
to damages of the heater

48 EPI Manual for Health Staff

 CHAPTER 7:
VACCINE MANAGEMENT

EPI Manual for Health Staff 49

7.1 HOW TO MAINTAIN THE CORRECT TEMPERATURE OF VACCINES?

As some vaccines are sensitive to heat and light and some vaccines are sensitive to cold, a
proper care must be taken when packing vaccines and transporting them from the EPI Vaccine
store and Health Centers to the immunization sessions and using them during the sessions.
This involves people, equipment, and procedures.

Vaccines require to be stored at the recommended temperature during their entire shelf life to
retain its potency. Various cold chain equipment are used to ensure that the vaccines are stored
at the recommended temperature right from the manufacturer to the time of administration.
Below table explains the right temperature at all levels. It is essential to store adequate stock of
vaccines at every level of the immunization supply chain. If it is less than the required quantity
the immunization programme may suffer and in the case of excess quantity, there are chances
of losing vaccine potency. While storing the vaccine in ILRs, the following care should be taken:

•← Keep the vaccine boxes containing the vaccines in neat rows.

•← Different vaccines should be kept separately to facilitate easy identification.
•← Keep about, 2 cm. space between boxes of vaccines for circulation of air. Keep a
30DTR/thermometer among the vaccines to ascertain the actual vaccine temperature.
•← Store Freeze sensitive vaccines (DTP, Td, IPV, PCV, Penta and Hep. B) away from the
bottom of the ILR to avoid any temperature excursion.
•← Always keep the vaccines in the basket provided in the ILR. bOPV, BCG, and MMR
vaccine to be stored at bottom of basket of the ILR.
•← Diluents of freeze-dried vaccines must be kept in the ILR at least for 24 hours before
issuing vaccine for administration.
•← This is to ensure that at the time of reconstitution, the vaccine and diluent are in the
same temperature to avoid thermal shock to vaccines.
•← Vaccine should be stored as per their heat and cold sensitivity.

Table 7: Vaccine storage specifications at different levels

At National At Regional At District At PHC, sub- During
Level Level Level post Level Transportation
Name of vaccines All vaccines under UIP except OPV All vaccines
Storage Equipment WIC WIC ILR (L) ILR (S) In Cold Box with
Storage Temperature +2 to +8 C
o o
+2 to +8 C
o o
+2 to +8 C
o o
+2 to +8o C
o Conditioned ice
Maximum Stock packs
6 6 3 2
(months)
Minimum Stock
3 1 1 1
(months)
OPV
Storage Equipment WIF WIF DF (L) ILR (S)
In Cold Box with
Storage Temperature -15o to -25o C -15o to -25o C -15o to -25o C +2o to +8o C
hard frozen ice
Maximum Stock packs
6 6 3 2
(months)
Minimum Stock
3 1 1 1
(months)

50 EPI Manual for Health Staff

7.2 VACCINE SENSITIVITIES

As indicated in the chart below, DTP-HepB-Hib, DTP, Td, IPV, PCV and HPV vaccines will lose
their potency if frozen. Reconstituted BCG and MMR vaccines are the most heat and light
sensitive vaccines and should not be used after 6 hours of reconstitution.

Table 8: Summary of Vaccine Sensitivities

Vaccine Exposure to heat/light Exposure to cold Temperature of refrigerators

Heat and light sensitive vaccines
Relatively heat stable,
BCG Not damaged by freezing +2° to +8°C
but sensitive to light
+2° to +8°C
Sensitive to heat and (PHC and sub-posts)
bOPV Not damaged by freezing
light 15-25 °C
(EPI stores and hospitals)
IPV Relatively heat stable Damage by freezing +2° to +8°C
Sensitive to heat and
MMR Not damaged by freezing +2° to +8°C
light
If lyophilized, it is not damaged
by freezing, but liquid
formulations can be damaged
Sensitive to heat and
Hib by freezing. +2° to +8°C
light
Once reconstituted, freeze-
dried or lyophilized vaccine also
should not be frozen
-86° to -60°C at National and
COVID-19
Regional EPI Stores till date of
(Pfizer)
expiry

COVID-19 -20°C at the national and

(Moderna) regional levels

COVID-19
+2° to +8°C at all levels
(Others)
Freeze sensitive vaccines
Freezes at –0.5°C.
Hepatitis B Relatively heat stable +2° to +8°C
Should not be frozen
Pentavalent
Relatively heat stable Should not be frozen +2° to +8°C
(DTP-HepB-Hib)
PCV Relatively heat stable Should not be frozen +2° to +8°C
Should not be frozen as it is
DTP Relatively heat stable +2° to +8°C
freeze sensitive
Td Relatively heat stable Should not be frozen +2° to +8°C
HPV Relatively heat stable Should not be frozen +2 to +8°C
Influenza vaccine Relatively heat stable Should not be frozen +2 to +8°C
At PHC level all vaccines are kept at +2° to +8°C

EPI Manual for Health Staff 51

7.3 PROCEDURES

7.3.1 How to load vaccines in Vaccine Carrier

The vaccines should be collected on the day of immunization as per schedule.

1 Check the vaccine carrier and make sure the lid fits tightly. Check the insulation for
cracks.
2 Conditioning of ice packs-Remove the ice packs from the freezer and keep them
outside till you see water droplets on the surface of the ice packs. You will hear the
crackling sound from inside the icepack when the ice pack is shaken. This means that
there is water in the ice pack and not just ice. The time taken for conditioning ice packs
depends on the outside temperature. Use of conditioned ice packs prevents freezing
of vaccines that may come in contact with the ice packs.
3 Pack four conditioned ice packs into the vaccine carrier along the four sides.
4 Take the required quantities of MMR, bOPV, BCG, Td, DTP-HepB-Hib, DTP, HPV, IPV,
PCV and Hepatitis B vaccine, plus one vial of diluents for every BCG and MMR vials
and place inside a plastic bag. Place this bag in the centre of the vaccine carrier, away
from the ice packs. This will prevent labels from peeling off from the vaccine vials. The
vials of DTP-HepB-Hib, HPV, DTP, Td, IPV and Hepatitis B vaccine should not be placed
in direct contact with ice packs. The dropper for bOPV should also be placed inside the
vaccine carrier in the plastic bag.
5 Put 30 DTR/freeze tag/freeze alert/dial thermometer with the vaccine.
6 Close the lid securely after putting the foam
7 Use freeze tag/alert and/or 30 DTR and thermometer during transportation of vaccines
in all levels.
8 Print 30 DTR records after reaching the destination and after return from outreach
clinics.
9 The 30 DTR should be marked as ORC/Vaccine Collection

7.4 HOW LONG CAN VACCINES BE KEPT IN THE VACCINE CARRIER?

Usually, vaccines can be stored in a vaccine carrier for one to two working days only. However,
this depends on the condition of the ice packs and the ambient temperature. Vaccines can be
kept safely in a vaccine carrier only till the ice packs remain at least partially frozen.

52 EPI Manual for Health Staff

 • Only the diluents provided by the manufacturer should be used and SHOULD NOT
BE INTERCHANGED.
• Diluents should be stored with the vaccine in the vaccine carrier during transportation
(temperature of diluents and vaccine should be same at the time of reconstitution).
Diluents need to be cooled before use but should not be frozen. So, it should not
come in direct contact with the ice pack.
• Do not drop or sit on the vaccine carrier: this can damage the carrier.
• Do not carry vaccines in handbag as this can spoil vaccines that are sensitive to heat
• Do not empty the ice packs even when ice has melted when vaccines are still in the
carrier

7.5 PLACING VACCINES IN THE REFRIGERATOR

• Store bOPV, MMR, BCG on the bottom shelf of ILR/Combo

• Diluents of MMR and BCG vaccines must be stored at room temperature. However, the
diluents must be stored at 2°-8°C for 24 hours at the upper self of ILR/Combo before the
immunization session.
• During the immunization sessions at the ORCs, the diluents should be packed and
transported along with the vaccines.
• All freeze sensitive vaccines (DTP-HepB-Hib, DTP, HPV, IPV, PCV and Td) should be
stored on the upper shelf
• The freeze alert/freeze tag or 30 DTR should be kept along with the freeze sensitive
vaccines

7.6 HOW TO KEEP VACCINES COLD DURING THE IMMUNIZATION SESSION?

Vaccine carrier comes with a foam pad

that has slits/holes in it for keeping vaccine
vials. During the immunization session,
the vaccine in use should be kept in the
slits in the foam pad which is kept on top
of the ice packs in the carrier as shown in
the figure.

If the vaccine carriers do not have foam

pads, in such cases during immunization
session take out only one ice pack for
keeping bOPV and reconstituted BCG and
MMR vaccines. The ice pack, once taken
out, should not be put inside the carrier
Figure 30: To keep open vaccine vial cold
till the end of the session. DTP-HepB-Hib,
PCV, Td, DTP, HPV, IPV and Hepatitis B vaccines should never be kept directly on the ice pack.

EPI Manual for Health Staff 53

In most areas, the temperature in a vaccine carrier will stay below +8°C for one day. In order
to achieve this:

• Keep the carrier in the shade and in a cool place

• Reconstituted BCG and MMR vaccine should be used within 6 hours of reconstitution.
• Write the time of reconstitution on the label of the vaccine vial and discard after six hours
or at the end of the session, whichever comes first.

7.7 HOW TO ENSURE THAT THE VACCINE WAS KEPT IN THE CORRECT
TEMPERATURE

• Vaccine can lose its potency due to excessive heat and freezing.
• You can check whether vaccine is exposed to excessive heat or freezing by checking
VVM and Shake Test respectively.

7.8 HOW TO CHECK FOR HEAT DAMAGED VACCINES?

7.8.1 Vaccine Vial Monitor (VVM)

Reading VVM: VVMs are labels

VACCINE VIAL MONITOR (VVM)
on vaccine vials that have a
small white square inside a blue Inner square is lighter than outer ring = USE = Good
circle. As the vial is exposed to Inner square is still lighter than outer ring = USE = Good
cumulative high temperature, Discard point - Inner square matches colour of
the color of the white square outer ring = DO NOT USE = Bad
will change. Read the VVM
Beyond discard point - Inner square is darker = Bad
(see below) and determine
than outer ring = DO NOT USE
whether the vaccines have been
damaged by heat. If the vaccine vials show change in colour to the discard point, then discard
the vaccines. Remove vaccines that have reached discard point from the vaccine carrier.

7.9 VACCINE VIAL MONITOR AND REACTION RATES

There are four types of VVM, which are assigned based on the different stability characteristic
of the product. The table below summarizes different levels of VVM reaction rates by category
of heat stability

Figure 9: VVM stages of vaccines

No. of days to end No. of days to end Time to end point

Category (vaccines)
point at +37°C point at + 25°C at +5°C
VVM 30: High stability 30 193 >4 years
VVM 14: Medium stability 14 90 >3 years
VVM7: Moderate rate stability 7 45 >2 years
VVM 2: Least stable 2 NA 225 days

54 EPI Manual for Health Staff

7.10 HOW TO CHECK THE VACCINES FOR DAMAGE BY FREEZING

Hepatitis B, DTP-HepB-Hib, PCV, DTP, HPV, IPV, PCV and Td vaccines should not be frozen.
If suspected to be frozen, perform Shake test. Discard the vial if it has a slower or same
sedimentation rate as the control vial and/or contains flakes.

DO NOT USE T-SERIES VACCINES, HPV, IPV, PCV AND HEPATITIS B IF:
- Frozen: There is no need to carry out the shake test if the vaccine is obviously
frozen or
- If not frozen then only perform the shake test

7.11 HOW TO PERFORM A SHAKE TEST?

The SHAKE TEST is designed to determine whether freeze sensitive vaccines were frozen.
Sedimentation occurs faster in a vaccine vial which has been frozen than in a vaccine vial from
the same manufacturer which has never been frozen.

Note that individual batches of vaccine may behave differently from one another. Therefore,
the test procedure described below should be repeated with all suspect batches.

Test procedure:

1 Prepare a frozen control sample: Take a vial of vaccine of the same type and batch
number, from the same manufacturer as the vaccine you want to test. Freeze the vial
until the contents are solid, and then let it thaw. This vial is the control vial. Clearly mark
the vial “FROZEN” so that it cannot later be used by mistake.

2 Choose a test sample: Take a vial of vaccine from the batch that is suspected to been
frozen. This is the test vial.

3 Shake the control and test vials simultaneously:

Hold the control vial and the test vial together in one hand and shake vigorously for
10–15 seconds.
4 Allow the vials to rest: Leave both vials to rest for 15 minutes
5 Compare the vials: View both vials against the light to compare the sedimentation rate

7.12 RESULTS OF THE SHAKE TEST

1. If the test vial shows a much slower sedimentation rate than the control vial, the vaccine is
not frozen and can be used.
2. If the sedimentation rate is similar or faster and the test vial contains flakes, the vial under
test has probably been frozen and considered as positive. The vaccine should not be used.

Note that some vials have large labels which conceal the vial contents. This makes it difficult to
see the sedimentation process. In such cases, turn the test and control vials upside down and
observe sedimentation taking place in the neck of the vial.

DO NOT USE THE VACCINE WITH POSITIVE SHAKE TEST.

RECORD AND DISCARD THE VACCINE.

EPI Manual for Health Staff 55

Power Failures

During power failure of 4 hours or less, the refrigerator door should be kept closed. If the
power failure continues for more than 4 hours, store vaccines in a cold box with conditioned
ice packs. If power failures are a common occurrence, consider purchasing a power generator
or solar freezers.

Unpacking Vaccines after Transport

On receiving the vaccines, store them in their packaging regardless of their bulkiness. Removing
the vaccines from the original packaging exposes vaccines to room temperature and light.
Check the temperature, freeze tag/alert and VVM status to ascertain the vaccines have not
been exposed to temperatures above +8°C or below +2°C.

Placing vaccines in Ice-Lined Refrigerators:

ILR has got two sections- the top and the bottom. The bottom of the refrigerator is the coldest
place. ILR maintains the temperature of +2° to +8°C. DTP-HepB-Hib, PCV, influenza vaccine,
DTP, IPV and Td vaccines are kept in this section in the baskets provided with the refrigerator.
At the PHC level, bOPV, MMR and BCG vaccines are stored at the bottom section.

7.13: ROUTINE MONITORING

7.13.1 Temperature monitoring

Temperature monitoring is a simple but very useful tool for checking the freeze or heat damage
to the vaccines. The following tools are usually used for temperature monitoring.

• Thermometers
- Mercury thermometers
- 30 DTR (daily temperature recording)
• Temperature record sheet is the uniform temperature monitoring chart used at various
levels. The temperature shown by the thermometer/30 DTR is recorded twice a day by the
health workers even on weekends and holidays.
Temperature records of 30 DTR should be printed monthly and kept for minimum of 3
years. 30 DTR should be used during transportation of the vaccines from national EPI store
to the regional EPI stores and from regional EPI store to the district hospital. The vaccine
receiver should print the record after reaching the destination. When 30 DTR is used for
transporting to ORCs, the staff responsible for immunization session should print the record
after returning from ORCs. In case of temperature excursion, necessary action should be
taken and documented. (Include flow chart of vaccine flow).

• Freeze tag
Freeze tag/alert is used for monitoring of vaccines that are at risk of being damaged by
freezing temperatures during shipment and storage. Freeze tag/alert should be put beside
freeze sensitive vaccines. It should be checked every morning whether the freeze tag/
alert shows (tick:☑) or (Cross: X). If the tag shows cross X, the vaccines were exposed to
freezing temperature at certain point of time. Perform Shake test.

56 EPI Manual for Health Staff

• Temperature excursion monitoring and alarm device
The temperature excursion devices are meant to manage the data remotely and centrally.
In case of the temperature goes beyond set temperatures, a sms will go to health staff
that temperature has gone plus/minus, kindly check cold chain. If health staff is unable to
take the call due to any unforeseen reason, then a sms will flash to senior authorities of the
district and further regional stores. This will keep the vaccine safe with full efficacy.

• Realtime Temperature Monitoring Devices

These devices are expensive devices to monitor the real time temperature and provide
alarm through different ways i.e. audio, visual and through sms.

7.13.2 Action points guided by Temperature monitoring

• Temperature between +2°C and +8°C. Situation normal, no action necessary.

• Temperature at or below 0°C. VACCINE AT RISK. Take immediate action to correct the low
temperature and ensure that the problem does not arise again. Inspect the freeze-sensitive
vaccines and carry out a shake test if the vaccine is suspected to be frozen.
• Temperature between +8°C and +10°C. If there has been a temporary power failure, no
further action is necessary. Check that the refrigeration unit is working, monitor the situation
closely and take appropriate action if temperature is not within the normal range at the time
of the next inspection.
• Temperature above +10°C. VACCINE AT RISK. Take immediate action to implement the
agreed contingency plan, and make a report.
• In the event of alarm, attend the cold chain equipment immediately.
Identify a range of contingency options
• Move the vaccine to another cold store in cold boxes maintaining appropriate cold chain
• Move the vaccines to cold boxes, report to your supervisor and regional cold chain in-
charges to fix the problems

7.14 LOGISTICS MANAGEMENT OF EPI VACCINES AND CONSUMABLES

Ensure adequate quantity of vaccines and injection devices are in place for providing timely
immunization services.

7.14.1 Setting of maximum and minimum stock levels

1. Annual consumption is calculated based on:

- Previous year consumption (from Stock Ledger) for each vaccine or

- Target population for each Vaccine and wastage factor of particular Vaccine

2. Average Monthly consumption (AMC) for each vaccine is calculated by dividing annual
consumption by 12.

EPI Manual for Health Staff 57

3. Months of Stock (see table below) is converted to vials by following formula:

Maximum Stock (vials) = [AMC for each vaccine] X [Month of Stock for Maximum]
Minimum Stock (vials) = [AMC for each vaccine] X [Month of Stock for Minimum]

Recommended Month of Stock Maximum Minimum

Regional Stores 6 months 3 months
District Hospitals 4 months 1 month
Hospitals and PHCs 2 months 1 month
PHC (remote and difficult to access) 3 months 1 month

Example-1 (calculation with annual consumption based on District Hospital)

A hospital issue/use 960 vials of BCG vaccine in previous year

AMC=960 / 12 = 80 (vials).
Maximum Stock for BCG is 80 X 4 = 320 (vials) and
Minimum Stock for BCG is 80 X 1 = 80 (vials).

Example-2 (calculation with target population based on Hospital and PHCs)

bOPV
Target Population :100
No. of doses required= 4 doses
Wastage factor: 1.67
Total Annual OPV doses required= 100 x 4 x 1.67 = 668 doses or 67 vials (10 dose vials)
Monthly Requirement = 67/12 = 6 vials (Approx.)
Maximum stock = 12 vials (2 months)
Minimum stock = 6 vials (1 month)

4. A table indicating maximum and minimum stock level needs to be pasted on the refrigerator
or on the wall nearby.

5. The Maximum and Minimum stocks are revised annually based on consumption of previous
year.

7.14.2: Vaccine Storage procedure

1. All vaccines should be kept in the WHO prequalified refrigerator/deep freezer.

2. Do not keep vaccines in door pockets. If refrigerator has door pockets, keep water bottles
to prevent rapid temperature rise in case of electricity failure.
3. In order to avoid frequent door opening/closing and thus temperature rise, do not keep
other items in the refrigerator.

58 EPI Manual for Health Staff

7.14.3: Arrangement and labeling inside refrigerator

1. Label the trays in the refrigerator clearly, with type of vaccine and expiry date
2. Vaccine should be arranged according to FEFO, which means that the shortest expiry vials
are put in front or in the most accessible place.
3. Open vial vaccines should be labelled and kept in a separate tray with date of opening
written on the vaccine vial.

7.14.4: Contingency plan for emergency vaccine management

All CHUs, PHCs, and sub-posts should have a written contingency plan for vaccine management
(storage and handling) during planned power cut or electricity power failure or other disasters.
Too much exposure to heat, cold, or light at any time will lead to cold chain failure and damage
vaccines, resulting in loss of vaccine potency. Once lost, vaccine potency cannot be restored.
Eventually, if the cold chain is not properly maintained, potency will be lost completely, and
vaccines will be useless.

Preparations for vaccine management during power failure:

1. All Health workers handling vaccines are responsible for vaccine management during power
failure and other disasters.
2. Cold boxes and vaccine carriers should be available and accessible at all times to vaccine
handlers.
3. Prepare and keep sufficient ice packs at any time.
4. Vaccine refrigerator should be connected to generator, if available, which may have auto
switch system.
5. Avoid frequent opening of refrigerator/deep freezer doors.
6. Plug in only one cold chain equipment per power socket/electrical outlet.
7. Any switch used to connect cold chain equipment to the power supply should be clearly
identified ‘Refrigerator– Do Not Switch Off’ or ‘Deep freezer – Do Not Switch Off’

In the event of power failure, do the following as soon as possible:

a. Temperature of the refrigerator should be monitored until either the supply is reinstated or
alternative arrangements for storage can be made.
b. Enquired BPCL (Bhutan Power Corporation Limited) regarding electricity failure.
c. Arrange transfer of vaccines from the refrigerator to cold box before temperature reaches
+80C or when power failure is known to exceed 24 hours.
d. Transfer vaccines to the nearest health facility if needed.
e. Use temperature monitoring devices when vaccines are stored in cold boxes or transferred
to the health facility.

EPI Manual for Health Staff 59

60 EPI Manual for Health Staff
 CHAPTER 8:
MANAGING DRY
STORE FOR EPI

EPI Manual for Health Staff 61

1 AD syringes and vaccine carriers should always be stored in a clean, dry place free of
insects with proper ventilation preferably in standard metal/wooden racks.
2 Syringes should not be exposed to excessive heat or direct sunlight. Such exposure
will result in discoloration of the polythene and paper cover and destruction of
portions sensitive to heat. There should be good air circulation around the outside of
the storage unit. Store must have well ventilated facilities such as open windows with
curtains, fan and AC.
3 Dry stores must have a thermometer to monitor and maintain records of room
temperature.
4 Boxes containing syringes should not be placed directly on the floor, but on wooden or
metal racks to avoid collection of moisture, to prevent infestation with fungi. Further,
the insects may enter the boxes and damage the covers, which will affect the sterility.
5 Syringes should not be stored close to acids or corrosive chemicals, which may result
in corrosion and decaying of the metal parts of the syringes.
6 When stacking boxes of syringes on racks, a space of at least six inches should be
provided in between the wall and the cases to prevent insects coming into contact
and to provide air circulation.
7 In order to facilitate easy handling and regular inspection, the cases should be stored
on top of one another at a convenient height (maximum 4 feet) and a narrow space
should be provided in between stacks of syringe cases.
8 No hooks or other equipment with sharp points should be used when lifting or handling
boxes which will tend to affect sterility of the covers.
9 When storing boxes of syringes different brands of boxes should not be stacked
together. Stocks of syringes should be used in order of receipt. To facilitate this,
cases should be stacked in separate rows, according to the date of manufacture,
expiry and lot number.
10 Frequent checks should be done to ascertain whether any available stocks of syringes
are close to expiry and such stocks should be used before expiry. Follow the first
expired first out (FEFO) strategy.
11 Opened or half-used boxes should be stored separately, and the syringes therein
should be completely used before opening new cases.
12 The rooms, stores and racks where these syringes are stored should be cleaned every
week and careful inspection should be done as regards to collection of moisture,
fungi, discoloration, damages to cover, and insect attacks. Necessary steps should
always be taken accordingly.
13 For proper recording and reporting, stock ledgers and issue registers should be
properly maintained indicating dates of receipts, dates of issues, lot numbers, dates
of manufacture and dates of expiry.
14 Vaccine carriers and cold boxes must be cleaned and dried well after use. Keep their
lids open until fully dried. If they are left wet with their lids closed, there will be
growth of fungus which will spoil the equipment, If possible, store cold boxes and
vaccine carriers with the lids open.

62 EPI Manual for Health Staff

15 Knocks and sunlight can cause cracks in the walls and lids of cold boxes and vaccine
carriers. This exposes the insulation and increases the risk of heat exposure to the
vaccines inside. If a cold box or vaccine carrier wall has a small crack, use adhesive
tape to cover it until an undamaged container becomes available.
16 Condemnation: The process of disposing all non-repairable cold chain equipment.
A large number of condemned equipment often clutters valuable space in dry
storerooms. Concerned health workers should understand the current procedures for
condemnation of equipment and help in clearing off condemned materials. Contact
respective procurement sections for guidance.
17 Always maintain 5s (sort, set, shine, standardize and sustain) in the dry store.

8.1 DRY STORE DO’S AND DON’TS.

Table 10: Do’s and Don’ts for dry stock

SL. NO. CRITERIA DO’S DON’TS

Within the health facility campus, in

Separate from the health facility
a room with no direct exposure to
campus. In a room exposed to
1 Location sunlight, covered from all sides with
direct sunlight. Open and exposed
a secure door which can be closed if
on one or multiple sides.
required.

Small areas between rooms or

Large enough to accommodate all dry verandahs, or scattered areas
2 Size storage space and also adequate space where different equipment, dry
for loading and distribution commodities and staff areas are
placed.

All wirings carried out by a qualified • Poor quality wiring using plugs
electrician and sockets of improper quality
• Circuits having inadequate or
All circuits having sufficient earth
Electrical lack of earth protection coiled or
protection
3 loose cables/wires
Fittings Refrigerators and freezers should be • No connection of stabilizers
wired directly to stabilizers which in with equipment
turn should have direct wiring into wall • Loose wires put into electrical
units sockets.
ILRs and deep freezers should be
spaced 10 cms. from walls and 10 cms.
Space away from other equipment. Equipment too close to or touching
between ILRs and freezers should be mounted walls /each other.
4
equipment about 10 cm clear of the floor on their Direct placement of electrical cold
and walls own wooden pallets, stands or blocks. chain equipment on the floors
This prevents corrosion when water is
swept under units during floor cleaning
Level floors preferably with a concrete
5 Flooring Broken or unlabeled floors.
slab beneath

EPI Manual for Health Staff 63

64 EPI Manual for Health Staff
 CHAPTER 9:
ENSURING SAFE
INJECTIONS AND
WASTE MANAGEMENT

EPI Manual for Health Staff 65

9.1 WHAT IS A SAFE INJECTION?

A safe injection does not harm the recipient, does not expose the provider to any avoidable
risks and does not result in waste that is dangerous for the community. Health workers should
assume that all used injection equipment are contaminated and should not be reused. They
should take precautions to ensure that no person is potentially exposed to infection or accidental
needle-stick injuries.

9.2 WHAT ARE THE RISKS ASSOCIATED WITH UNSAFE INJECTIONS?

Health workers reusing syringes and needles can cause cross-infection and put people at risk.
The most common, serious infections transmitted by unsafe injections are hepatitis B, hepatitis
C, and HIV/AIDS among others. Poorly administered injections can also cause injuries or drug
toxicity with the wrong injection site, wrong vaccines, wrong diluents, or wrong dose is used.
It is important to understand the risks of accidental needle-stick injury, and the importance of
safely disposing injection equipment to prevent risks to the community at large.

9.3 SIMPLE WAYS TO IMPROVE INJECTION SAFETY

• Keep hands clean before giving injections

• Wash or disinfect hands prior to preparing injection material.
• Avoid giving injections if the skin of the recipient is infected or
• Avoid local infections (such as a skin lesion, cut, or weeping dermatitis), select
alternative site for the injection.
• Cover any small cuts on the service provider’s skin
• Use sterile injection equipment, every time
• Prevent the contamination of vaccine and injection equipment
• Prepare each injection in a designated clean area
• Avoid contamination from blood or body fluid.
• If the injection site is dirty, wash with clean water.
• Always pierce the rubber cap of the vial with a sterile needle.
• Do not leave the needle in the stopper of the vial.
• Follow product-specific recommendations for use, storage, and handling of a vaccine.
• Discard any needle that has touched any non-
sterile surface.
• Assume all used equipment are contaminated
• Practice safe disposal of all medical sharps
waste
• Fill the safety box up to about 75% full (Do not
over fill the box) and then carry to the PHCs
for safe disposal.
Discard the used syringe and its
• Prevent needle-stick injuries, put syringe and
parts into the safety box;
needle into safety box immediately after use
DO NOT recap the needle.
without recapping.
• Anticipate sudden movement of the child.

66 EPI Manual for Health Staff

 UNSAFE IMMUNIZATION PRACTICES

DO NOT RECAP THE NEEDLE

DO NOT LEAVE THE NEEDLE INSIDE THE VIAL

DO NOT TOUCH THE NEEDLE

Use disposable syringes and needles for reconstitution of BCG and MMR vaccines. One
syringe and needle should be used for each vial. All syringes used for vaccination should be
auto-disable.

9.4 ADVANTAGES OF USING AD SYRINGES

• AD syringes are designed to prevent the re-use of non-sterile

syringes.
If you touch any
• The fixed-needle design reduces the dead space in the syringe
part of the needle,
that wastes vaccine. It eliminates chances of entry of air
discard the syringe
bubbles into the syringe caused by loose fitting of the needle. and vaccine in the
• AD syringes are dose-specific (0.05ml, 0.1ml, 0.25ml and syringe. Use a new
0.5ml) and hence, drawing the plunger to the full length to AD syringe.
the specified marking ensures the correct dose. No further
adjustment is required.
• In AD syringes the plunger can go back and forward only once. The plunger gets locked
after the complete dose of vaccine is pushed in.

9.5 INJECTION TECHNIQUE

• Select the correct syringe for the vaccine to be administered. BCG 0.05 ml and all others
0.5ml can be put on the table.
• Check the packaging. Don’t use if the package is damaged, opened, or expired.
• Peel open or tear the packet from the plunger side and remove the syringe by holding the
barrel. Discard the packaging into a waste bin.
• Remove the needle cover/cap and discard it into the waste bin. Do not move the plunger
until you are ready to fill the syringe with the vaccine and do not inject air into the vial as
this will lock the syringe

EPI Manual for Health Staff 67

• Take the appropriate vaccine vial and insert the needle such that the tip is within the level of
the vaccine. If inserted beyond you may draw air bubble which is difficult to expel. Do not
touch the needle or rubber cap (septum) of the vial.
• Pull the plunger back slowly to fill the syringe. The plunger will automatically stop when
the necessary dose of vaccine has been drawn (0.05 or 0.5ml). Do not draw air into the
syringe. In case air accidentally enters the syringe, follow these steps to remove the air
bubble: Remove the needle from the vial. Hold the syringe upright, tap the barrel to bring
the bubbles towards the tip of the syringe. Then carefully push the plunger to the dose
mark (0.1 or 0.5 ml) thus expelling the air bubble.
• If the injection site is dirty, then clean it with clean water swab and allow it to dry, and
administer the vaccine. (BCG: right upper arm, DTP-HepB-Hib and Td: anterolateral aspect
(outer side) of mid thigh, MR: left upper arm, TT and HPV: Upper arm. Push the plunger
completely to deliver the dose. Do not rub the injection site after the vaccine is given
• Discard the syringe with needle into the safety box; DO NOT RECAP. Fill the Safety Box
up to about 75% of its capacity and carry to designated place for waste disposal according
to procedure.

9.6 GUIDELINES FOR WASTE DISPOSAL

Safety Boxes

All used syringes and needles must be disposed of immediately after use
by dropping them into the safety boxes. Tape the nearly (approximately
3/4) full box securely shut and store the box in a safe place until it can be
properly disposed-off. Safety boxes should not be over-filled (not more
than ¾) or reused.

One box can hold 100 syringes and needles. If for any reason the safety
boxes run out at health centers, used injection equipment can be disposed
of in a puncture-resistant container with a lid, such as bucket/ plastic Figure 31: Safety Box
container.

NOTE:
• The safety boxes should be properly assembled according to instruction printed on the
boxes.
• Do no open the safety boxes after use, this may be DANGEROUS
• A cardboard box is NOT puncture-resistant, BE CAREFUL

9.6.1 Collection of syringes with needle attached

The used syringes and needles should be put directly into the safety boxes.

9.6.2 Transportation and Disposal of Contaminated Sharps

Filled safety boxes should be collected on a regular basis and sent to the health facility/
designated area for treatment (autoclaving) or for onsite burial. Detailed logistical plan must
be put in place for movement of safety boxes from the facility/ outreach to the disposal point.

68 EPI Manual for Health Staff

Please refer to the infection control guidelines go online to download https://www.moh.gov.bt/
wp-content/uploads/afd-files/2014/11/ICMWM-guideline.pdf

9.6.3 Handling of safety boxes

Contaminated sharps should not be transferred from container to container and must not be left
in a public area or health facility. Care should be taken to avoid spillage from filled containers.
The vehicles used to transport the filled containers must be disinfected if spillage occurs.

9.6.4 Methods for disposal of all leftover/expired/unusable vaccines

All used/expired vials, caps are to be deactivated before disposal. The safest method of disposal
would be incineration which is not available in our health centers. So the only options are heat
sterilization and chemical disinfection as the primary treatment followed by disposal into deep
burial pits or municipal waste disposal. The following options are to be followed:

1. For health center with separate autoclave for wastes

• Collect the vials in the red/infectious bags from MCH and ORCs
• Autoclave every week with other wastes

2. For health centers without autoclave

• Use chemical disinfection method

• Collect the vials in the red/infectious bag or any leak proof containers
• Freshly prepare 0.5% bleaching solution (mix 16.7 grams of 30% chlorine powder with
one liter of water) or as per the infection control procedures.
• Open the used/expired OPV vials and immerse all the vials caps and droppers (collected
for the week), into this solution and keep for 30 minutes (all vials should be immersed in
the solution)
• After 30 minutes – drain the solution as per the infection control protocol like other
wastes.

• If the chlorine tablet (1000mg = 0.1%) is supplied to prepare a chlorine solution:

Strength: 0.1% (cleaning purposes)

Dissolve 1 tablet in 1 liter water
Strength: 0.5% (decontamination purposes)
Dissolve 5 tablets in 1 liter water
After treating the used vials with one of the above methods, dispose-of by ONE of the following
methods convenient to the individual centers:

EPI Manual for Health Staff 69

1. Disposal with other wastes into municipal wastes

Any infectious wastes treated properly with one of the above methods are safe for disposal
with other non-infectious wastes. This can be disposed of with other wastes into municipal
wastes. This can even be sent for recycling if facilities are available, but the treatment should
have been properly done.

2. Disposal into the deep burial pit

If the health center has no municipal wastes collection facility, the treated vials can be disposed
into the deep burial pits in the health facility. Ensure that the burial pit has cover and a sign
board.

9.6.5 Autoclave procedure

• Collect all expired and unused vaccines in a biohazard bag and seal it.
• Put on autoclave machine and place the biohazard bag in autoclave
• Allow it to heat till the temperature reaches 121°C.
• Keep heating for 15 minutes at 121°C
• After 15 minutes of heating at 121°C, switch off the autoclave and allow it to cool.
• Take out the autoclaved biohazard bag and dispose with other hospital waste for land fill or
sewerage

9.6.6. Handling of leftover/expired/unusable vaccines

• Wear gloves
• Open all the vials to be disposed
• Empty all the contents into a small bucket
• Prepare 0.5% bleaching solution as above (fresh preparation, not more than 24 hrs)
• To the known volume of vaccine put at least equal or more of 0.5% Chlorine solution and
keep for at least 30 minutes.
• After 30 min, dilute with lots of water and dispose the mixture into drainage system.
Refer infection control guideline
• Treat empty vials as in used vials and dispose by one of the above methods

70 EPI Manual for Health Staff

 SAFE DISPOSAL OF SHARPS, NOT TO HARM COMMUNITY

Dos Don’ts
• DO immediately place used needles and other • DON’T throw loose needles
sharps in a sharps disposal container to reduce and other sharps into the
the risk of needle sticks, cuts or punctures from trash.
loose sharps.
• DON’T flush needles and
• DO use an FDA-cleared sharps disposal other sharps down the
container or safety boxes provided by the toilet.
department.
• DON’T put needles and
• DO carry a portable sharps disposal container for other sharps in your
outreach clinics. recycling bin -- they are not
• DO follow your community guidelines for getting recyclable
rid of your sharps’ disposal container. • DON’T try to remove, bend,
• DO call your local trash or public health break, or recap needles
department to find out about sharps disposal used by another person.
programs in your area. This can lead to accidental
• DO keep all sharps and sharps disposal needle sticks, which may
containers out of reach of children and pets. cause serious infections.
• DO seal sharps disposal containers when • DON’T attempt to remove
disposing of them, label them properly and refer the needle without a needle
infection control guideline on how to properly clipper because the needle
dispose of them. could fall, fly off, or get lost
• DO report a problem associated with sharps and and injure someone.
disposal containers.

Figure 32: Do’s and Don’ts for safe disposal

EPI Manual for Health Staff 71

72 EPI Manual for Health Staff
 CHAPTER 10:
PLANNING AND
CONDUCTING
IMMUNIZATION

EPI Manual for Health Staff 73

10.1 WHAT IS THE MICRO PLAN FOR IMMUNIZATION?

In terms of immunization, the micro plan for a PHC/Hospital includes:

• Total population
• Target population (infants, under 5, 6 years old, 12 years old, 13 years old, pregnant women,
elderly population, population with existing medical conditions)
• Number of sessions in a month
• Human resource availabilities and responsibilities
• Session sites with dates
• Availability of vaccines, logistics, finance and other resources
• Approximate travel distance and time for each ORC in the catchment area- by vehicle or on
foot

10.1.1 Beneficiaries and yearly target

• Infants (0-11months): Number of children born in the past year can be obtained from
different sources depending upon the type and size of the catchment area like birth registers,
household survey of the previous year, or estimation based on National Crude Birth Rate of
17.9 (NHS 2012) of total population.
• Children 12-23 months for all practical purposes can be safely estimated to be equal to the
number of infants
• Children under-5 years of age can be best estimated from the household survey, alternate
source could be calculation of 15% of total population in the catchment area
• Pregnant women: approximately 110% of the number of infants
• School going children: the information can be obtained from household survey or school
admission register
• BVS can be also used to gather information for some cohorts

If annual household survey is not accurate or not conducted, Dzongkhag population projection
is used for the estimation of target population (Ref. PHCB 2017, NSB).

Example

Population of PHC = 5500

Infant population for the year = (Total population) X (National Crude Birth Rate)
= 5500 X 1.2/100 = 66 Children
12-23 months of age = same as infants = 66
Children under 5 years = (Total Population) X 15%
= 5500 X 15/100 = 825
Pregnant women = 110% of infant
= 66 X 110/100 = 73

74 EPI Manual for Health Staff

10.1.2 Estimation of monthly targets and contacts

• Once we have estimated the yearly target in the catchment area for each group of
beneficiaries we can safely reduce the average monthly target by dividing the annual target
by 12.
• Number of doses required is obtained by multiplying number of target as shown below.

Infants BCG: 1 dose

OPV: 4 doses
DTP-HepB-Hib: 3 doses
IPV: 2 doses
MMR:1 dose
PCV: 3 doses
Under 5 years: MMR: 1 dose
DTP: 1 dose
Class VI/12 year boys and girls
HPV: 2 or 3 doses
Class PP and 7:
Td: 2 doses
Pregnant women Td: as per the new schedule
5 high risk groups: Influenza: 1 dose each except for children
less than 24 months (follow the schedule)

10.1.3. Guidelines for estimation of the number of sessions for each CHU/PHC

• The number of sessions at PHC will depend upon monthly targets for different groups of
beneficiaries, especially considering the population of the adjoining community.
• Organization and frequency of ORC will depend upon accessibility, number of beneficiaries
in the targeted ORC, number of available health personnel, availability of transport and other
logistic support
• Health facilities can conduct vaccination sessions more than once a month depending upon
their target population. In the ORCs, sessions should be organized at least once a month.
In remote and difficult to access areas, sessions can be planned and conducted as per the
need.
• In any case, plan of immunization session whether at Fixed Site or at any ORC should be
shared with all stake holders and all measures should be taken to adhere to the plan.
• Health staff should inform the Village Health Worker, Community Leaders, Caregivers and
Parents on:
• Where and when the next session is
• Children due for vaccination, to ensure that they bring all children to the session

EPI Manual for Health Staff 75

10.1.4 Steps in preparation of a CHU/PHC/ORC micro plan

STEP 1: List all villages and settlements in the area

STEP 2: Write the population of each village/ settlement
STEP 3: Write estimated number of beneficiaries (children and pregnant mothers).
STEP 4: Prepare a map of PHC showing;

• All villages and settlements with their population and expected beneficiaries.
• The location of the PHC, ORCs
• All-important landmarks
• Distance of villages from the PHC and the mode of transport
• Important road networks etc. Disease Program
Vaccine Preventable
Department of Public Health
sl. no. 000001
Ministry of Health
STEP 5: Prepare the PHC Session Plan and Work Plan
Vaccinator’s Logistics Diary
10.2 LISTING EQUIPMENT AND SUPPLIESNameREQUIRED
Name of Vaccinator................................................................................................................................ FOR FIXED IMMUNIZATION
of Health Facility .............................................................................................................................................
SESSIONS
Session Site: .......................................................................................................................................... Date of session ............................................................................................................................................................

Opened, Un-Opened Vaccines & Syringes

Item Issued (In Doses) Returned (In Doses)
No. of doses
Sl. VVM administered Opened Un-opened Doses Vaccine wastage VVM
Name of the Item Quantity Manufacturer Batch No. Exp. Date Quantity
No. Stage No. of doses No. of doses discarded in % Stage
1 BCG
2 Diluent BCG
3 OPV
4 Dropper
5 DTP
6 HepB (Birth Dose)
7 HPV (GIRLS)
8 HPV (BOYS)
9 Influenza
10 IPV
11 MMR
12 Diluent MMR
13 PCV
14 Penta
15 Td

1 Syringe 0.05 ml
2 Syringe 0.25 ml
3 Syringe 0.5 ml
4 Syringe 2 ml
5 Syringe 5 ml

1 Safety Box

Issuer Receiver Returning Details

Sl. No.
Name and designation of Person Item Name and designation of PersonSl. No. Item
Name and designation of Person
Transport modality (by car/foot) Transport modality (by car/foot) Transport modality (by car/foot)
1
Date & Time Clean water Date & Time 11 MCH handbook Date & Time

2 Vaccines and diluents 12 Tally sheets

3 AD Syringes 13 MCH Register
4 Reconstitution syringes 14 Table, stools and chair
5 Safety Box 15 Cotton swabs
6 Paracetamol 16 Vitamin A capsules
7 AEFI emergency kit 17 Albendazole tablet
8 Soap/Hand Sanitizer 18 Scissors
9 Metal file to open ampoules 19 Height and Weight measuring instruments
10 BP Instrument 20 Vaccinator’s Logistic Diary

76 EPI Manual for Health Staff

In addition to immunization PHC workers are reminded to include the following equipment and
supplies required for outreach (ORC)immunization sessions:

10.3 LISTING EQUIPMENT AND SUPPLIES REQUIRED FOR OUTREACH CLINIC SESSIONS

Sl. No. Item Sl. No. Item

1 Clean water 13 MCH handbook
2 Vaccines and diluents 14 Tally sheets
3 AD Syringes 15 MCH Register
Height and Weight measuring
4 Reconstitution syringes 16
instruments
5 Safety Box 17 Cotton swabs
6 Paracetamol 18 MCH Bag
7 AEFI emergency kit 19 Albendazole tablet
8 Soap/Hand Sanitizer 20 Scissors
9 Metal file to open ampoules 21 Conditioned Ice packs
10 Vaccine carrier with foam pad 22 Vitamin A capsules
11 Disposable syringes 23 BP instrument
12 30 DTR or freeze alert 24 Vaccinator’s Logistic Diary

10.4 ARRANGING THE IMMUNIZATION SESSION

Ideally, the immunization session sites should have;

• A clean area not directly exposed to sunlight, rain or dust

• Adequate space to accommodate beneficiaries before and after being immunized, space
for registration, immunization and recording
• A table for vaccines and injection equipment
• A seat on which a parent can sit while holding a child for immunization
• A seat for the health worker

Place everything you need within reach

A table is required to hold the equipment and stationery used while giving immunization. On
the table you should put:

• Vaccine carrier
• Safety box
• MCH handbook and records
• MCH register
• Cotton swabs
• Clean water for cleaning the injection site
• AEFI Kit

Also keep a bowl, water and soap for scrubbing your hands clean before beginning the
immunization session and every time your hands come in contact with any un-sterile surface.

If needed, use only wet cotton swab for cleaning the injection site.

EPI Manual for Health Staff 77

10.5 CONDUCTING IMMUNIZATION SESSION

10.5.1 Steps in conducting the immunization session

Vaccine
Carrier Safety
Box
Box of
Cotton Syringes
Water Wool
Container Tally Sheet
Seat for
Table mother/child

Soap

Basin
Seat for
health worker

Figure 33: Layout of an Immunization Site

You should follow the steps given below while conducting an immunization session:

1 Welcome the beneficiaries

2 Verify beneficiaries’ record and age and check if the beneficiary is due for vaccination
3 Explain what vaccine(s) will be given and route of administration
4 Screen for eligibility of vaccine(s) and for the contraindications
5 Check vial expiry date and double check vial label. Do not use if there is no label on
vaccine vial
6 Check VVM for all vaccines; If VVM is in Stage 3 or 4 do not use; If any vaccine vials are
suspected to be frozen, do SHAKE TEST if possible and if not DO NOT USE.
7 Wash hands before reconstituting vaccine and conducting the session. Write the time
of reconstitution on the vial (BCG, MMR). Reconstitute vaccine making sure that at least
one recipient is present; do not reconstitute before the session.
8 Maintain aseptic technique throughout.
9 For T-Series vaccines lightly shake the vials before withdrawing the dose.
10 Use only diluents supplied with the vaccine from the same manufacturer; do NOT use
diluents of one vaccine for the other.
11 Inject the right vaccine at the correct site to the correct recipient, Do not
with correct technique and correct route. e.g. intra dermal; massage
subcutaneous; intramuscular the injection
12 Inject the vaccine using steady pressure site after the
injection.
13 Withdraw the needle at the angle of insertion

78 EPI Manual for Health Staff

 14 Discard the syringe and needle without recapping into the safety box.
Explain potential minor side-effects/ problems that may occur due to the vaccine and
15
how to deal with them.
16 Ask beneficiaries to wait for at least 30 minutes after immunization
17 Fully document each immunization in MCH handbook, tally sheets and MCH register
18 Remind beneficiaries /parents about the next visit and ask them to bring the hand book
on next visit.
19 Disposal of syringes and needles in the safety boxes should be done as per guidelines.
20 At the end of the session return all unopened vials in the vaccine carrier to the PHC
and return them into refrigerator after checking VVM. If the immunization session is
taking place at a fixed site, partially used vials can be used on the next session if all the
criteria of WHO Recommended Open Vial Policy are met. However, all vaccines that are
reconstituted should be discarded at the end of the session.

10.5.2 WHO Recommendations concerning Open Vials (Multi-dose, opened vial policy)

The term “Open Vial” means a vial from which one or more doses of vaccine have been taken,
following the universal rules of asepsis.

The WHO Multi dose open vial policy states that liquid vaccines (OPV, DTP-HepB-Hib, DTP,
Td, and HepB) may be used up to 28 days after opening of the vial provided the following
conditions are met:

• Their expiry date is not passed

• Their VVM is not in the discard stage
• They are properly stored, between +2ºC and +8º C
• It be practiced only in fixed clinics (Hospitals and PHCs)
• The vial septum was not submerged into water or into any other liquid

They must be discarded in the following cases:

• The procedures of asepsis were not followed

• The open vial is suspected to be contaminated
• There are evident signs of contamination (change of appearance, particles in suspension)

Reconstituted Freeze-dried vaccines (BCG and MMR) must be discarded at the

end of the immunization session or after 6 hours of reconstitution or whichever
is earlier. These vaccines do not qualify to be considered in open vial policy.

EPI Manual for Health Staff 79

10.5.3 Selecting safe and potent vaccines

Before beginning your immunization session, and before giving each vaccine, follow these
steps to ensure that every dose that you are going to give is safe and effective

• All vaccines including BCG and MMR vials should be opened even for one beneficiary
on clinic day. Spend sufficient time for each child for immunizing, recording and
communicating.
• Check label: Make sure the label on the vaccine vial is attached and clear enough to read. If
you find that the label is not clear enough to read or has come off, discard the vial.
• Check vaccine: Check that the vaccine being given is the correct one.
• Check expiry: Look for the expiry date on the vial. If the expiry date has passed, do not use
the vial; Discard it.
• Check the vaccine vial monitor (VVM) to make sure that the vaccine is in the usable stage.

10.5.4 Reconstituting vaccines

BCG and MMR vaccines are freeze-dried and must be reconstituted with diluents before use.
Do not freeze the diluents because the ampoules can break when frozen. Keep diluent in the
refrigerator for 24 hours to ensure that the temperature of the diluent is same as of the vaccine
during immunization.

When reconstituting vaccines, follow these steps carefully:

• Double check that you have chosen the correct diluents, which has been supplied by the
manufacturer for the specific freeze-dried vaccine you are going to reconstitute.
• Reconstitute the vaccine even when only one eligible child is present. Vaccination is
more important than wastage.
• Use a separate syringe for reconstitution for each vaccine vial. Do not use the reconstitution
syringe for injection.
• Open the vaccine vial and open an ampule of diluent.
• Draw the required quantity of the diluents into the reconstitution syringe. Tap the vaccine
vial or ampoule before opening and then shake till all the vaccine powder has settled to
the bottom.
• Insert the reconstitution needle into the vaccine vial, inject the diluents into the vial and
remove the needle.
• Do not leave the needle in the septum of the vial.
• To reconstitute the vaccine and diluents, shake the vial gently between your thumb and
forefinger.
• Write the time of reconstitution on the vials.
• Use the reconstituted vaccine, within 6 hours after reconstitution. After 6 hours discard
the vaccine and reconstitute a new one.

80 EPI Manual for Health Staff

10.5.5 Positioning the child for immunization

The correct positioning of a child for immunization is to ask the mother (or caregiver) to sit with
the baby on her lap with one arm around the back of the baby, holding the baby’s hand and leg
steadily. The baby’s other arm should be wrapped around the mother’s side.

10.5.6 Giving the injection

Vaccine administration is the key to the successful

outcome of any immunization program. The ease and
efficiency with which vaccine administration is done
goes a long way towards establishing confidence in the
minds of beneficiaries and helping to achieve the goal
of full coverage. The following are critical to delivery of
safe and effective immunization services. Figure 34: Various needle positions

10.5.6.1: Intra-dermal injection (BCG)

An Intra-dermal injection is one given into the dermis (skin) layer. Carry out the following steps
when giving an intra-dermal injection:

1. Position the baby and load the reconstituted BCG

vaccine 0.05ml for infants under one year and
0.1ml for children older than one year.
2. Position your left hand under the child’s right arm
and gently pull the skin under the arm to stretch
the skin at the injection site.
3. Hold the syringe in your right hand with the beveled
edge of the needle pointing up towards you.
4. Insert the tip of the needle into skin a little bit at an
angle of 15°. Figure 35: How to give Intra-dermal
injection (BCG)
5. Do not push too far, and do not point downward
(This way, the needle will go under the skin and will make the injection subcutaneous,
instead of intra dermal)
6. Put your left thumb over the needle-end of the syringe (not on the needle itself) to hold it
in position.
7. Hold the plunger end of the syringe between the index and middle fingers of your right
hand and press the plunger in with your right thumb.
8. Inject vaccine (0.05/0.1 ml as required) and withdraw the needle.
9. Discard the syringe and needle into the safety box.
10. If the technique is correctly followed, there will be a clear, flat-topped swelling in the skin.
The swelling may look pale, with very small pits (like an orange peel).

EPI Manual for Health Staff 81

After 2-3 weeks of a correct injection, a papule develops which
increases slowly in size up to 5 weeks (4-8mm). It then subsides
and breaks into a shallow ulcer. Healing occurs spontaneously
within 6-12 weeks, leaving a permanent tiny round scar, 4-8 mm
diameter. This is a normal reaction. When the technique is incorrect
(the vaccine will go in easily and no swelling will be visible).

1. If the whole dose has been delivered under the skin, consider
the child vaccinated. Do not repeat the injection.
2. If the whole dose has not been administered, reposition the Figure 36: Intra-dermal
needle and give the remaining dose. Needle Position
3. Follow-up for side effects such as abscess and enlargement of the glands.

10.5.6.2: Intra-muscular injection (DTP-HepB-Hib, HepB, Td, IPV, DTP, HPV)

Intra-muscular injections are injections given into the muscle

tissue. All intramuscular injections should be given in the antero-
lateral aspect of mid-thigh. In pregnant women injection should
be on the outer aspect of the upper arm. Carry out the following
steps when giving an intra-muscular injection:

1. Check the vaccine vial.

2. Position the child on the mother’s lap.
3. Shake the liquid vaccine well before use to maintain uniform
suspension of vaccine. Figure 37: Inter-muscular
Needle Position
4. Load the vaccine into a 0.5 ml AD syringe (throw the AD syringe wrapper or plastic caps in
the plastic bag).
5. If necessary, expel excess air from the syringe by tapping the syringe.
6. Make sure you have exactly 0.5 ml of vaccine in the syringe (no more, no less).
7. Put your finger and thumb of your hand on either side of the injection site.
8. Stretch the skin flat between finger and thumb.
9. Hold the syringe like a pen in the hand and push
the needle straight down at 90º (as it will traumatize
fewer muscle fibers) through the skin between finger
and thumb. Penetrate deep into the muscle, but not
CAUTION
all the way to the bone.
10. Press the top of the plunger with the thumb to inject
Infants should never be given
the vaccine. injections in the buttock as
11. Withdraw the needle and press the site of injection evidence indicates that there is
with a dry cotton swab. risk of damaging the nerves in
the area. The vaccine will also be
12. Discard the syringe and needle into the safety box, less effective if injected deep into
13. Do not massage the injection site after vaccination fatty tissues.

82 EPI Manual for Health Staff

10.5.6.3: Subcutaneous injection (MMR)

A subcutaneous injection is one that is given into the thin

layer of tissue between the dermis (skin) and the muscle.
The injection should be given in the left arm in the deltoid
site of the skin. Carry out the following steps when giving
a subcutaneous injection:

1. Make sure the reconstituted vaccine has not expired.

2. Position the child on the mother’s lap.
3. Load the vaccine into a 0.5ml AD syringe (put the AD
Figure 38: Subcutaneous Needle
syringe wrapper or plastic caps in the bucket) position
4. If necessary, expel excess air from the syringe by tapping the syringe.
5. Make sure you have exactly 0.5ml vaccine in the syringe (no more, no less).
6. Pinch the skin of the left upper arm between index finger and thumb.
7. Push the needle in a slanting position at 45º angle into the pinched-up skin. Do not push the
needle too far in.
8. Press the plunger with your thumb to inject the vaccine.
9. Withdraw the needle and press the site of injection with a dry cotton swab.
10. Discard the syringe and needle into the safety box.

10.5.6.4: Oral administration (bOPV)

The Oral Polio Vaccine (bOPV) comes in a glass/plastic vial with a sterile dropper. The vaccine
is given orally; two drops in the child’s mouth

1. Check VVM on the vial before use

2. Remove the metal or rubber cap on the vaccine vial
3. Fit the dropper on the vial
4. Put two drops directly in the mouth of the child. Take care that the dropper does not touch
the mouth
5. Make sure the child swallows the vaccine. If it is spitted out, repeat the dose

10.6 IMMUNIZATION SERVICES AT OUTREACH CLINIC:

Outreach Clinic facility is one of the nearest and easily accessible health care services in the
community and it is provided monthly by the health workers from the primary Health Centres,
Hospitals and sub-posts. Therefore, it is crucial to have guidelines for the programme to
reach immunization and other health services in the communities for prevention of vaccine
preventable diseases.

EPI Manual for Health Staff 83

10.6.1 Services provided at ORC.

1. Immunization services
2. Growth monitoring for under 5 years children
3. Care for Child Development (C4CD plus) services and referral
4. Reproductive, maternal and neonatal health care services- ANC, PNC, family planning
5. health education
6. first aid treatment, and management and referral.
7. Recording and reporting of the health, nutrition, water and sanitation activities
Target Population at the ORC includes pregnant and lactating mothers, children, adolescents
and sick people.

10.6.2 Micro plan of the ORC Should include

1. Target population of children, adolescents, pregnant and lactating women

2. Frequency of ORC sessions with dates
3. Line listing of elderly persons (65 years and above)
4. Display in a board at the PHC/CHU/Subpost.

10.6.3 Infrastructure -a standard place to conduct immunization

ORC sessions should not be conducted in an open space and under direct sunlight. Proper
shade and privacy is required for immunization to maintain the quality of vaccine and for ANC.

10.6.4 Transportation of Vaccines to ORC:

Vaccines should be packed and loaded by health workers and may be transported by caretaker/
VHW or health workers.

Care must be taken to avoid exposure of vaccines to direct sunlight or rain during transportation.

10.6.5 What to do with the leftover vaccines at ORCs

• Opened vials should be brought back to PHC for disposal (refer guideline for waste disposal)
• The unopened vials which are cold chain maintained should be marked, brought back to the
health facility and used in the subsequent immunization session.
• Used AD syringes and other syringes which are put in the safety boxes should be returned
to the health center
• Unused AD syringes and other syringes should be used in the next session.

84 EPI Manual for Health Staff

 CHAPTER 11:
ADVERSE EVENTS
FOLLOWING
IMMUNIZATION (AEFI)
MONITORING DEFINITION

EPI Manual for Health Staff 85

11.1 WHAT IS AEFI?

An adverse Events Following Immunization (AEFI) is any untoward medical occurrence which:

• Occurs after immunization;

• Does not necessarily have a causal relationship with vaccine usage;
• May be an unfavorable symptom about which a vaccine recipient complains; and may be
abnormal laboratory findings, signs or disease found by medical staffs

11.2 CATEGORIES OF AEFI

1. Vaccine product-related reaction: caused or precipitated by a vaccine due to one or more of

the inherent properties of the vaccine product
2. Vaccine quality defect-related reaction: cause or precipitated by a vaccine that is due to
one or more quality defects of the vaccine product, including its administration device as
provided by the manufacturer.
3. Immunization error-related reaction: caused by inappropriate handling, prescribing or
administration of vaccines
4. Immunization anxiety-related reaction: arising from anxiety about the immunization and
fear of injection.
5. Coincidental event: event that happens after vaccination but is not caused by vaccine or
vaccination process

11.3 LIST OF MINOR AEFIS

The list of common minor AEFIs:

Injection site
Fever Headache Fatigue
tenderness/pain

Myalgia Nausea Chills Cough/cold

11.4 LIST OF SERIOUS AEFIS

1. Death
2. Life threatening; Anaphylaxis, severe allergic reactions,
3. Requiring hospitalization,
4. Causing disability and congenital anomaly

11.5 AEFI RECORD AND REPORTING SYSTEM

All the health centers will monitor AEFI of vaccines, record and report to DHO during the
campaign and routine immunization services

• All minor AEFIs will be recorded and reported along with monthly AFP Zero report to DHO
• All serious AEFIs should be reported to the CMO/MOI immediately for clinical management
and treatment (Annexure III). Then, CMO/MOI will submit the report to DHO

86 EPI Manual for Health Staff

• The District AEFI committee coordinated by the DPHO will initiate the investigation
immediately upon receipt of AEFI report from CMO/MOI and submit the report within 72
hours to the VPDP
• All serious AEFI cases should be investigated by the AEFI committee, as per the AEFI
investigation Form (Annexure IV)
• Designated National AEFI committee members will review the case details immediately
• National AEFI committee will do the causality assessment immediately
• Final AEFI causality assessment report should be submitted to the MoH, NITAG and BFDA.

11.6 MANAGEMENT OF AEFIs

Signs and symptoms of Anaphylaxis.

1 or more signs and symptoms of any of the two systems (respiratory, cardiovascular and
dermatological):

1. Respiratory: Noisy breathing, wheeze or stridor; persistent cough; swelling of tongue

and lip; cyanosis
2. Cardiovascular: Fast pulse, hypotension; decreased level/loss of consciousness
3. Dermatological: Red, raised itchy rash; swollen eyes and face; generalized rash
4. Others: Anxiety; diarrhea, nausea and vomiting; sneezing and rhinorhhea

11.7 DISTINGUISHING ACUTE STRESS RESPONSE AND ANAPHYLAXIS

Figure 11: Acute stress responses and anaphylaxis

Acute stress response

General acute stress Vasovagal syncope - Anaphylaxis
response VVS
At onset Suddenly, before, at time of Suddenly, before, at time Usually 5 min after
or soon after injection (<5 of or soon after injection exposures, almost all cases
min) (<5 min) within 1 hour
May present after 5 mins
if the individual suddenly
stands up
Skin Pale, cold, sweaty/clammy Pale, cold, sweaty/ Red, raised itchy rash,
clammy swollen eyes and face,
generalized rash
Respiratory Rapid deep breathing Normal to deep breaths Nosiy breathing, wheeze or
stridor, persistent cough
Heart Normal or fast pulse or Slow pulse, transient Fast pulse, hypotension
hypertension hypotension
Gastro- Nausea Nausea, vomiting Abdominal cramps,
intestinal vomiting, nausea
Neurologic Fearfulness, dizziness, Transient loss of May develope loss of
numbness, weakness, consciousness reversed consciousness not relieved
tingling around lips, spasms by supine position by supine position
in hands and feet

EPI Manual for Health Staff 87

 11.8 AEFI KIT

AEFI kit should have the following essential items:

Mandatory list Optional

1 Injection Adrenaline (1:1000) 1 Tab. Cetirizine

2 Injection Promethazine 2 SPO2 Monitor

3 Injection Hydrocortisone acetate

4 Promethazine tablet
5 Intravenous Fluid – Ringer lactate/normal saline
6 IV cannula
7 IV drip set
8 1ml syringe with needle
9 Disposable Syringes with needle- 2ml, 5ml, 10ml
10 Adhesive tape
11 Stethoscope
12 Alcohol/spirit swab
13 BP instrument

11.9 STEP WISE MANAGEMENT OF ANAPHYLACTIC SHOCK:

In the event of any anaphylaxis, follow the following procedure immediately:

1. Put patient in recovery position, if required

2. Check for airway, breathing and circulation
3. Check for pulse and BP
4. Administer adrenaline injection 1:1000 as follows:
• 0 months to < 12 months – 0.05mg (0.05ml)
• 12months to <6 years – 0.1mg (0.1ml)
• 6 years to < 12 years - 0.2mg (0.2ml)
• 12 years and above - 0.3mg -0.5mg (0.3ml-0.5ml)
• The route is IM at the anterolateral aspect of the thigh and can be given through the
clothing.
Note: Dose of the adrenaline should not be changed even in the child with obesity
or wasting.
• Give oxygen by face mask, if available

88 EPI Manual for Health Staff

 • Call for professional assistance but never leave the patient alone.
• Call ambulance (or arrange other means of transportation) and a medical officer, if
necessary, after the first injection of adrenaline, or sooner if there are sufficient people
available to help you.
5. If no improvement after 5 minutes, repeat the dose for two times, if required
6. Start an IV line.
7. Stabilize the patient and admit to the health center for further management
*In the event of any Anaphylaxis, the Inj. Adrenaline is the most important drug to be given. For
other AEFIs, manage as per their symptoms

8. Inj. Promethazine 25mg(stat dose) if required

9. Inj. Ranitidine 150mg (state dose) If required
10. Give inj. Hydrocortisone 5mg/kg body weight (stat dose) If required

*Follow anaphylactic shock management protocol

EPI Manual for Health Staff 89

Table 12: Frequency and nature of serious vaccine reactions
Interval between Number of events per
Vaccine Reaction
vaccination and onset million doses
Suppurative adenitis 2-6 months 100-1000
BCG Osteitis Up to several years -
BCG
Disseminated BCG
1-12 months -
infection
Hep B Anaphylaxis 0-1 hour 1-2
Febrile seizures 5-12 days 330
Thrombocytopenia (low
MMRa 60 days 30
platelets)
Anaphylaxis 0-1 hour 1
Vaccine-Associated
bOPV 4-30 days Up to 0.4b
Paralytic Poliomyelitis
Brachial Neuritis 2-28 days 5-10
Tetanus
Anaphylaxis 0-1 hour 1-6
diphtheria (Td)
Sterile abscess 1-6 weeks 6-10
Persistent (>3hours)
0-48 hours 1,000-60,000
inconsolable screaming
Seizures 0-3 days 600c
DTP Hypotonic Hypo
Responsive Episode 0-24 hours 30 - 990
(HHE)
Anaphylaxis/Shock 0-1 hour 1 -6
fever, general 12 per 100 children aged
Influenza 1 – 5 years, 5
discomfort and muscle 6–12 hours
vaccine
pain per 100 aged 6 - 15 years
a. Reactions (except anaphylaxis) do not occur if already immune (~ 90% of those receiving a
second dose): children over six years are unlikely to have febrile seizures
b. Seizures are mostly febrile in origin, and the rate depends on past history, family history and
age, with a much lower risk in infants under the age of 4 months

90 EPI Manual for Health Staff

 CHAPTER 12:
RECORDING, REPORTING
AND USE OF VACCINATION
DATA FOR ACTION

EPI Manual for Health Staff 91

12.1 IMPORTANCE OF RECORD-KEEPING

Accurate, reliable and timely information is critical to the success of any activity. The following
records are the foundation of all the health information generated at the health centers:

• MCH handbook
• Tally sheet
• Mother and child health register
• Monitoring chart (for coverage, dropout and left out)
• Monthly activity report
• Bhutan Vaccine System

The records should not be seen only as a source of information for your supervisors, but these
should be viewed as important tools for self-monitoring and guidance. Store all immunization
records in a safe place

12.2 MCH HANDBOOK

MCH Handbook is used to record child immunization, maternal immunization and care. This
MCH handbook is important for the following reasons:

• It serves as a reminder for parents to return to the clinic on the scheduled date until the
child has achieved full immunization.
• It helps the health worker to determine a child’s immunization status
• It helps the health system to track coverage, dropouts and performance

To properly use the handbook:

For Beneficiaries coming for the first time:

• If the mother is not issued an MCH handbook before delivery, she should then be issued
a handbook to record the child immunization at first contact (just after birth or as soon as
possible). In case of twins, issue another MCH handbook to the second baby.
• Inform the mother that the handbook is an important document; as it records all the necessary
information about the child; is necessary for future follow up; for growth monitoring and
immunization and to record medical problems of the child.
• Record the date, month and year of all entries clearly
• Write the date of birth of the infant and not the age in months.
• If the beneficiary cannot give the exact date, try to get the exact dates using local calendar/
fairs and festivals.

If the MCH handbook is lost, issue a duplicate booklet and record previous dates

92 EPI Manual for Health Staff

For the beneficiaries coming subsequently:
Check the child’s immunization record before giving immunization and identify missed doses
(if any) and complete according to the schedule.

• After every dose, ensure that the parent is informed of the next immunization date.
• Give back the booklet to mother/parent of the child following immunization
• Tell the mother that the handbook must be kept in a good condition. She must bring
the handbook whenever the child is brought to the health center or out-reach clinic for
immunization.

12.3 MOTHER AND CHILD REGISTER

The mother and child register should be used by the Health Worker in planning immunization
sessions, recording the work during the session and for following up and tracking of the
defaulters after the session. It is used before, during and after the immunization session.
Follow the MCH guidebook.
12.4 TALLY SHEETS (REPORTING FORM OF IMMUNIZATION SESSION SITE)
Tally sheets are forms on which health workers make a mark every time they administer a dose
of vaccine. These are used as a basis for monitoring and reporting. Use a new tally sheet for
each session. The same tally sheet can be used to mark both vaccines given to children and
mothers. Use separate tally sheet for separate immunization sessions
12.5 BHUTAN VACCINE SYSTEM (BVS)
During the Covid-19 pandemic, the Ministry of Health has developed the Bhutan Vaccine System
(BVS) for the nationwide Covid-19 vaccination. This is a web-based portal aimed for ensuring
quality data collection, proper planning and management of Covid-19 vaccination program. The
BVS is used for real time monitoring of vaccines distribution, coverage, vaccines inventory and
monitoring of AEFI. The BVS has also opportunities to incorporate other EPI vaccines in the
system. Currently the reporting of HPV and influenza vaccination have been incorporated into
the BVS.

12.6 MONTHLY REPORT FORM

Every health facility including PHC should submit a consolidated monthly immunization report
to the district using the monthly activity report form. The consolidated monthly report from
districts should reach the HMIS. Data should be analyzed and reviewed at every level to
improve the quality of EPI services.
12.7 VACCINATION MONITORING CHART
The monitoring chart is a tool showing the annual total target children in the catchment
area to monitor vaccination coverage. At-a-glance, it provides information on target figures
and trends in immunization coverage, particularly in terms of dropouts. It should include the
children vaccinated from the catchment area of the home health center only. Do not include
the vaccinated children who belong to other catchment areas but give feedback or report to
the concerned catchment areas. It should be updated every month by the health workers after
completing the immunization session. Here is an example for calculating coverage dropouts for
DTP-HepB-Hib1 and DTP-HepB-Hib3. A similar chart can be prepared for other vaccines.

EPI Manual for Health Staff 93

 workers after completing the immunization session. Here is an example for
calculating coverage dropouts for DTP-HepB-Hib1 and DTP-HepB-Hib3. A similar
chart can be prepared for other vaccines.

Vaccination monitoring chart

180
160 156
143
No. of children vaccinated
140
130
120 117
100 104
91 91
80 84
78 77
65 70 70
60 58
52 55
41 46
40 39 35
26 29
25
20 22
17
13
10
8
0 0
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Expected cummulative 0 13 26 39 52 65 78 91 104 117 130 143 156
Monthly DTP-Hep B Hip 1 0 10 12 7 12 14 15 14 7
Cummulative DTP-Hep B Hip 1 0 10 22 29 41 55 70 84 91
Monthly DTP-Hep B Hip 3 0 8 9 8 10 11 12 12 7
Cummulative monthly DTP-Hep B
0 8 17 25 35 46 58 70 77
Hip 3

Fig. Example of vaccination monitoring chart

Figure 39: Example of vaccination monitoring chart
For example: If the yearly target for DTP-HepB-Hib1 is 156 children in a PHC with
a population of 12,000, then the monthly target is 156/12 = 13 children. On the
For example: If the yearly target for DTP-HepB-Hib1 is 156 children in a PHC with a population
chart, the months of the year are given on the horizontal axis starting from
of 12,000, January
then thetomonthly target is 156/12 = 13 children. On the chart, the months of the
December. On the vertical axis, the line is divided into 12 equal parts
year are given on the horizontal axis starting
each representing the monthly from
target (in January
this case, to December.
13 children). On on
Plot above thethe
vertical axis,
the line is divided
graph, the into 12 equal
cumulative parts
total each representing
of DTP-HepB-Hib1 theSimilarly,
monthly. monthlyplottarget (in this case, 13
DTP-HepB-
children). Plot
Hib3above on the color
in a different graphinisthe
thesame
cumulative
column. total of monthly DTP-HepB-Hib1. Similarly,
plot DTP-HepB-Hib3 in calculate
You can also a different colorrate
dropout in the
by same column.
using the formula:
(DTP-HepB-Hib1- DTP-HepB-Hib3) x100
You can also calculate dropout rate by using the formula:
DTP-HepB-Hib1
This will give you the dropout rate in percentage.
(DTP-HepB-Hib1- DTP-HepB-Hib3) x100
Similar monitoring charts with dropout rates can be calculated for other antigens
like OPV1, OPV3, BCG, MMR, etc. When Hib-vaccine is introduced as DTP-
DTP-HepB-Hib1
HepB-Hib vaccine, DTP-HepB-Hib1-DTP-HepB-Hib3 monitoring chart should be
ideally used.
This will give you the dropout rate in percentage.
You can calculate the coverage percentage by using the formula:
Similar monitoring charts with dropout rates can be calculated for other antigens like bOPV1,
bOPV3, BCG, MMR, etc. When Hib-vaccine is introduced as DTP-HepB-Hib vaccine, DTP-
HepB-Hib1-DTP-HepB-Hib3 monitoring chart should be ideally used. 92

You can calculate the coverage percentage by using the formula:

Percentage Coverage = No. of doses administered X 100

Target population

94 EPI Manual for Health Staff

12.8 VACCINE WASTAGE

The wastage rate is the percentage of vaccine doses that are wasted.

12.8.1 What are some of the reasons for vaccine wastage?

Some unused doses may have to be thrown away, for example they have passed their expiry
date or lost their labels

Some doses may be spoilt for one reason or another - vaccines damaged by storage at the
wrong temperature or some vials or ampoules may be broken during transport and handling

12.8.2 Acceptable vaccine wastage rates:

For liquid vaccines supplied in single or two-dose vials (e.g. PCV and pentavalent vaccines) a
wastage rate of 5% is acceptable

For bOPV, a wastage rate of 10% is considered acceptable

For liquid vaccines supplied in multi-dose vials of 10 or more doses, a wastage rate of 15% is
acceptable

For reconstituted vaccines, wastage rates of 50% for BCG and 25% for measles vaccines are
considered acceptable

12.8.3 How to calculate the wastage rate

To calculate Wastage Rate (WR) = (No. of doses used - No. of Children vaccinated) X 100/No.
of doses used.

Eg. No. of doses used = 20

No. of children vaccinated = 2

WR = (20-2)/20 X 100

WR = 18/20 X 100

WR: 90%

EPI Manual for Health Staff 95

12.8.4 Calculating the wastage factor

The wastage factor (wf) is the number by which estimated vaccine needs is multiplied to allow
for some doses being wasted.

Wastage factor (wf) = 100 ÷ (100 minus % wastage rate), where wastage rate is the number
of doses wasted, expressed as a percentage.

Example

If the wastage rate is 30%, what is the wastage factor?

= 100 ÷ (100 – 30)

= 100 ÷ 70
= 1.43

Therefore, if 30% of the doses are wasted, the wastage factor will be 1.43.

12.9 WASTAGE FACTORS

NO. OF DOSES WASTAGE WASTAGE
PER VIAL RATE (%) FACTORS
VACCINES

BCG 20 90 10

MMR 5 50 2

bOPV 10 40 1.67

DTP-HepB-Hib 1 5 1.05

Td 10 15 1.18

PCV 4 5

IPV - - -

DTP 10 - -

Figure 40: How to calculate wastage factor

96 EPI Manual for Health Staff

 CHAPTER 13:
INCREASING
IMMUNIZATION COVERAGE

EPI Manual for Health Staff 97

13.1 INTRODUCTION

As a health worker you are responsible for immunization services at your PHC/hospitals. Your
goal is to ensure that all children in your area are fully immunized before their first birthday. This
also means that children should be protected against neonatal tetanus through the immunization
of their mothers. In terms of immunization, the community where you work can typically be
divided into four groups.

The four groups can be represented as:

COMMUNITY
GROUPS

FULLY IMMUNIZED
MISS OPPORTUNITIES
DROPOUTS
LEFT OUT/UN-REACHED

Your aim is to expand the inner circle to cover the entire universe of eligible children. Since
there are varied reasons for each of the above behavior groups, they also require different
interventions.

13.2 DROPOUTS

Dropouts are children who receive one or more vaccination, but do not return for subsequent
immunization. Common reasons for Dropout are:

• Parents are not told or forget when to return

• Parents are not aware of the reason of following an immunization schedule
• Parents do not know that immunization is important
• Parents develop misconceptions about immunization
• Families move to a new village or place.
• Attitude of health workers
• No proper plan of follow up
• Long distance/hard to reach areas
• Fear of AEFI

98 EPI Manual for Health Staff

13.2.1: Why bother about dropouts?

Parents of children who “drop-out” of the immunization system are the easiest to reach and
convince to return for full immunization. If you focus your efforts on reducing dropouts, you can
increase coverage significantly in your area.

13.2.2: Actions to be taken to minimize dropouts:

• Immunization Schedule should be carried out in fixed date irrespective of Government

holidays
• Maintain a list of children who have not completed full immunization
• Fill in correctly and completely in the MCH handbook and record in mother and child register
• Inform the parents about next date for immunization and advise them to come again on
that date
• Visit dropouts before the next session to find out the reasons why they missed the session.
Often, people have misconceptions about immunization. Talk to them, answer their
questions and doubts and provide advice accordingly.
• Sometimes parents refrain from subsequent visits to immunization sessions due to minor
AEFIs like fever, pain after the previous session, or even sometimes due to major AEFIs,
which were not reported (like abscess, high fever or lymphadenitis) or due to fear of AEFI.
During your visits to the dropouts, if such situations are revealed, talk to them and try to
provide answers to their questions as much as possible. If some questions are beyond your
knowledge, report to your supervisor.
• Take the help of your community teams (VHW, Community leaders, NGOs etc.) and share
with them the list of dropouts so that they can remind parents about the importance of full
immunization and inform them about the date and time of the next session.
• Provide immunization services to children from outside the area, if they are brought to the
session and provide their parents with a follow-up schedule
• Develop your own solutions based on the responses of parents who have dropped out of
the immunization program. For example, if most parents complete the full immunization
schedule except MMR vaccine, give a talk in the village about the MMR vaccine to answer
questions and clear doubts.
• IEC and IPC on immunization

13.3 MISSED OPPORTUNITIES

A missed opportunity occurs when an eligible child or a woman come to outreach site, PHC
or any other health facility (along with a sibling or parent or child, who is getting a service or
receiving a service) and the immunization status of the child or woman is not enquired about
and immunization service is not provided in spite of eligibility.

13.3.1: How to minimize missed opportunities?

• Whenever mothers or children visit PHC/CHU or at outreach clinics for any service including
growth monitoring, ask whether the child has been fully immunized. Ask to see the MCH
Handbook or check the register.

EPI Manual for Health Staff 99

• If the child is eligible for any of the vaccines, provide it, although the mother or the caregiver
is not asking for it after explaining the need.
• Ask any woman 15-49 years of age coming to the PHC or ORC for any service about her
Td immunization status. Check Td card, if available, and/or MCH register. If the woman is
eligible for the next dose of Td, administer it to her after explaining the need.
• Put a reminder about immunization in the waiting area of the PHC, ORC or hospital
• In the hospitals reorient the doctors, nurses and other service providers about immunization
schedule and remind them to refer any eligible woman or child to CHU unit of the hospital
• Keep sufficient stock of vaccines available in order to provide services to beneficiaries

13.4 EVERY OPPORTUNITY SHOULD BE USED FOR VACCINATION

13.4.1: Left-outs/Un-reached population

Left outs/un-reached population is children and women who do not utilize the immunization
services or zero dose vaccination for reasons due to difficult geographical access and migration/
mobile population or other social factors.

13.4.2: Actions to be taken to reach the unreached:

• Develop a list of children who have never accessed immunization services in the area
• Look for migrant populations traveling through your service delivery area and reach out to
them. Tell them about immunization and give them the date, time and place of the nearest
session or get it from any health facilities nearby.
• Visit several of these households to find out the reasons why they have never accessed
immunization services. Use the opportunity to clear up any doubts expressed by the
families. Help them find ways to overcome any barriers that prevent them from bringing
their child to the next session.
• During planning of immunization session think of setting up of Seasonal/Mobile clinic in
these areas
• Take the help of the community (Community leaders, teachers, religious leaders, Village
Health Workers and NGOs) to talk to parents about the importance of full immunization and
give them the date and time of the next session.

13.4.3: How can you deal with difficult geographical access?

You can bring the issue to the attention of your supervisors and request them to reorganize
your catchment area in order to provide immunization services to unreached populations.
Sometimes, the best solution will be to visit the remote site once every two or three months
and conduct at least 4 immunization sessions in a year.

13.5 USE INTERPERSONAL COMMUNICATION TO INCREASE DEMAND

As a health worker you are in direct contact with parents and caregivers. Perhaps the most
important contribution you can make towards increasing demand is by being a friendly,
efficient, interested person, who sincerely cares. Smile, be friendly, and reassure both parents

100 EPI Manual for Health Staff

and children. This ensures that parents will listen to your advice, change their behavior and
return for a full course of immunization for their children.

13.5.1: Tips for effective communication with parents at the facility or outreach session

• Act respectfully towards the mother/parent

• Praise parents/caregivers for bringing their children for immunization.
• Give clear information on side effects and the date for next immunization.
• Encourage them to continue bringing their child to the immunization session and bring the
handbook until fully vaccinated and keep the handbook for future reference.
• Keep information simple and clear and be sure to remind the parent on the date of next
vaccination.
• Encourage parents to ask questions

13.5.2: Give basic information to all parents on immunization

Besides understanding the value of immunization, parents need to know:

• When and where they should bring their child for the next immunization.
• The number of additional contacts needed for the child to complete its vaccination schedule.
• Explain common side effects that may occur after immunization.
• Discuss what they should do if side effects do occur.
• The importance of bringing the MCH Handbook each time the child comes for healthcare.

13.5.3: Use the MCH Handbook to remind parents when to return with their child

MCH Handbooks for each child are important communication tools. Educated parents can
determine from the handbooks, the type of vaccine and dosage given and the due dates. For
those less educated, recognizing a vaccine by how it is delivered is one way of keeping abreast
of their child’s schedule.

• Information on immunization is easier to understand when one vaccine at a time is discussed.

• In addition to being a healthcare provider, you are also a health educator.
• In most situations, one-to-one, interpersonal communication is the best when providing
specific information.

13.6 DIFFERENT METHODS FOR GIVING INFORMATION TO PARENTS

13.6.1: Call upon other trusted sources of information

Involve formal and informal leaders and other community resource persons like the village
heads, political leaders, teachers, religious leaders and village health workers in the program
and then conduct immunization orientation training.

EPI Manual for Health Staff 101

13.6.2: Identify locations to communicate with parents

Identify places where people frequently gather, such as markets, bus stops, temples and
monasteries, and display information related to the session site, date, and program details.

13.6.3: Make use of community-based organizations

Build a rapport with community-based organizations and NGOs in your area. Conduct health
talks on the vaccine preventable diseases, the immunization and common side effects.

13.6.4: Use schools

Teachers and students may be important players in creating awareness in the community about
immunization. Visit the schools and give talks to the teachers and students about immunization
programs explaining the need and schedule of immunization. Explain how they can help by
bringing their own relatives, siblings or children to the immunization session.

102 EPI Manual for Health Staff

 CHAPTER 14:
SURVEILLANCE OF
VACCINE PREVENTABLE
DISEASES

EPI Manual for Health Staff 103

14.1 DEFINITION OF SURVEILLANCE

An ongoing, systematic collection, analysis, and interpretation of health-related data essential

to the planning, implementation, and evaluation of public health practice, closely integrated
with the timely dissemination of these data to those responsible for prevention and control.

VPD surveillance is disease specific surveillance system and all health centers are reporting
centers. AFP, measles and rubella are case based surveillance while Diphtheria, Pertussis, and
Tetanus are reported as aggregate on monthly basis including zero-reporting by health centers
to district health office and to VPDP. CRS and AES/JE are sentinel-based surveillance.

All suspected cases of Vaccine Preventable Diseases (Poliomyelitis, Diphtheria, Pertussis,

Neonatal Tetanus, Measles/Rubella) are immediately notifiable diseases and should be
reported to RCDC in NEWARS. A single lab confirmed case of Measles, Rubella and AFP
should be considered as an outbreak and active case investigation should be carried within 72
hours using standard investigation norms (refer Integrated Surveillance Guideline for selected
Vaccine Preventable Diseases, 2018)

14.2 GOALS OF VACCINE PREVENTABLE DISEASE SURVEILLANCE

1. Early detection and notification of suspected cases

2. Monitoring trends of VPD’s over the period of time
3. Ensuring adequate and timely response to cases/outbreak notified
4. Identifying risk population for institution of appropriate prevention measures
5. Monitoring and evaluation of vaccine preventable Disease Program performance
6. Resource prioritization and mobilization for implementing preventive and control measures
based on the information obtained through the surveillance
7. To determine the effectiveness and impact of Vaccination Program.

14.3 HOW TO REPORT SUSPECTED CASES OF VACCINE PREVENTABLE DISEASES

1. If any clinicians including specialists, nurses and health workers suspect any Vaccine
Preventable Diseases, they should immediately report it in the NEWARS online system.
2. If the suspected case is in the PHCs/Sub-post, complete the Case Investigation Form (refer
Integrated Surveillance Guideline for selected Vaccine Preventable Diseases, 2018) and
send the patient to the nearest hospital for sample collection (inform the laboratory in-
charge through a call and confirm).
3. If the suspected case is in the hospitals, the clinicians/health workers/nurses should
complete the Case Investigation Form and direct the patient to the laboratory unit for
sample collection.
4. While waiting for the report, search for similar cases in the locality and provide necessary
health advice. If necessary, activate the Dzongkhag Health Rapid Response Team (DHRRT)
before the arrival of the report from RCDC.

104 EPI Manual for Health Staff

 Cause: Bordetella Pertussis
C/F:
Catarrharal symptoms initially
Cough with characteristic “whoop” in 1-2 weeks – paroxysms of who
Affects
5. If the report is positive, then all ages
the DHO but typical
will activate pertussis
the DHRRT occurs infor
immediately children aged 1- 5 year
active case
investigation. early infancy in countries with well established vaccination programm
6. The investigation team should Convalescent
submit the stage may last
preliminary several months.
investigation report to RCDC and
VPDP. Transmission: Droplet infection
Treatment:by the DHRRT, the final report should be submitted
7. Upon completion of the investigation
to RCDC and VPDP. Macrolide antibiotics – erythromicin
Prevention:
wP and aP
1 2 3

Neonatal Tetanus
C/F:
Unable to suck milk after 2 days – lock jaw

4 5
Image 1: Measles Rash
Image 2: Pertussis (Whopping Cough)
Image 3: Diptheria
Image 4: Neonatal Tetanus
Image 5: CRS

EPI Manual for Health Staff 105

106 EPI Manual for Health Staff
 CHAPTER 15:
VACCINE AND COLD
CHAIN EQUIPMENT
INVENTORY, DISTRIBUTION
DOCUMENTATION, AND
REPORTING

EPI Manual for Health Staff 107

15.1 DOCUMENTATION

The Department of Public Health, Ministry of Health has developed certain formats for recording and
reporting of information related to UIP at all the cold chain points. These are as follows:

• Vaccine Stock Ledger

• Syringes/ Safety box stock register
• Vaccine and Logistics indent and issue book
• Vaccinator logistics diary
• Cold chain equipment – repair and maintenance logbook
• Cold chain equipment – indent and issue form
• Cold chain equipment inventory ledger
• Temperature monitoring logbook

The sample of each format is provided here:

Description Title Page Inner Page

Vaccine and diluent Stock RegiSteR - iSSue and Receipt 001

name of the Health Facility:

name of the Vaccine/diluent:

issued to (Regional
opening VVM Status closing
Received issued Store/ Hospital/ no. of no. of doses
Sl. Balance Received indent (1, 2 usable/ name of the expiry Balance
date (dose/ (dose/ pHc/ Sub-post/ Batch no. doses unutilized Remarks
no. (dose/ From no. 3, 4 non- Manufacturer date (dose/
numbers) numbers) oRc/ discarded- utilized (Wastage)
numbers) usable) numbers)
Reason)

VACCINE PREVENTABLE DISEASE PROGRAMME

DEPARTMENT OF PUBLIC HEALTH

Vaccine Stock Ledger MINISTRY OF HEALTH

VACCINE AND DILUENT STOCk REGISTER - ISSUE AND RECEIPT

Name of the EPI Store/Hospital/PHC/Sub-Post:

Name of the District:

Year:

Syringe and Safety Box Stock regiSter - iSSue and receipt 001
name of the Health facility:
name of the Syringes/Safety Box:

issued to (regional no. of no. of

received
opening Store/ Hospital/ Syringes Syringes/ closing
Sl. Syringes/ received issued indent name of the expiry
date Balance pHc/ Sub-post/ Batch no. / Safety Safety Boxes Balance remarks
no. Safety Boxes from (numbers) no. Manufacturer date
(numbers) orc/ discarded- Boxes unutilized (numbers)
(numbers)
reason) utilized (Wastage)

Syringes/ Safety box stock VACCINE PREVENTABLE DISEASE PROGRAMME

DEPARTMENT OF PUBLIC HEALTH
MINISTRY OF HEALTH

register SYRINGE AND SAFETY BOX STOCK REGISTER - ISSUE AND RECEIPT

Name of the EPI Store/Hospital/PHC/Sub-Post:

Name of the District:

Year:

Vaccine Preventable Disease Program

Department of Public Health
Ministry of Health

Vaccine, Syringe and Safety Box Indent and Issue Book

Indent No.: 000001 Date:
From (Regional Store/ Hospital/ PHC/ Sub-Post):
............................................................................................................................................................................................................
To (Regional Store/ Hospital/ PHC/ Sub-Post):
............................................................................................................................................................................................................
To be filled by the requester To be filled by the issuer
Total doses Balance
received doses on Doses Doses Expiry No. of doses
Item till date in Batch No. VVM
Date Status
current year date indent
of requested Issued received
(1st Jan - 31st Dec)

BCG
Diluent BCG
OPV
Dropper

Vaccine and Logistics indent

DPT
HepB (Birth Dose)
HPV (GIRLS)
HPV (BOYS)

VACCINE PREVENTABLE DISEASE PROGRAMME

Influenza
IPV
MMR

and issue book

DEPARTMENT OF PUBLIC HEALTH Diluent MMR
PCV

MINISTRY OF HEALTH
Penta
Td

Syringe 0.05 ml
Syringe 0.25 ml
Syringe 0.5 ml

VACCINE, SYRINGE
Syringe 2 ml
Syringe 5 ml

Safety Box

AND SAFETY BOx •

•
•
Please fill out this form in triplicate and send 1st page (white) and 2nd page (pink) to the store.
(Amount to Indent) = [Maximum Stock] - {Stock on Hand}
All the requirements are to be indented monthly/quarterly.

INDENT AND ISSUE BOOk Remarks (if any):

Signature of Requester: Signature of Issuer: Signature of Receiver:

Name: Name: Name:
Designation: Designation: Designation:
Date: Date: Date:

Name of the EPI Store/Hospital/PHC/Sub-Post:

Name of the District:

Year:

108 EPI Manual for Health Staff

 Vaccine Preventable Disease Program
Department of Public Health
sl. no. 000001
Ministry of Health

Vaccinator’s Logistics Diary

Name of Vaccinator................................................................................................................................ Name of Health Facility .............................................................................................................................................

Session Site: .......................................................................................................................................... Date of session ............................................................................................................................................................

Opened, Un-Opened Vaccines & Syringes

Item Issued (In Doses) Returned (In Doses)
No. of doses
Sl. VVM administered Opened Un-opened Doses Vaccine wastage VVM
Name of the Item Quantity Manufacturer Batch No. Exp. Date Quantity
No. Stage No. of doses No. of doses discarded in % Stage
1 BCG
2 Diluent BCG
3 OPV

VaccinE PrEVEntaBLE DisEasE PrograMME

4 Dropper
5 DTP

Vaccinator logistics diary

6 HepB (Birth Dose)
DEPartMEnt oF PUBLic HEaLtH 7
8
HPV (GIRLS)
HPV (BOYS)

Ministry oF HEaLtH 9
10
Influenza
IPV
11 MMR
12 Diluent MMR
13 PCV

Vaccinator’s Logistics Diary 14

15
Penta
Td

1 Syringe 0.05 ml
2 Syringe 0.25 ml
3 Syringe 0.5 ml
4 Syringe 2 ml
Name of the EPI Store/Hospital/PHC/Sub-Post: 5 Syringe 5 ml

Name of the District: 1 Safety Box

Issuer Receiver Returning Details

Year: Name and designation of Person Name and designation of Person Name and designation of Person
Transport modality (by car/foot) Transport modality (by car/foot) Transport modality (by car/foot)
Date & Time Date & Time Date & Time

COLD CHAIN EQUIPMENT (ACTIVE AND PASSIVE) REPAIR AND MAINTENANCE LOG-BOOK
Signature of
Type of
S. No. of Date of Date of Breakdown Action taken Date of Detail of work CCT/BMED
S.N. Cold Chain Remarks
Equipment Installation breakdown details (Email/Letter) repair carried out technician/
Equipment
Engineer

Cold chain equipment – VACCINE PREVENTABLE DISEASE PROGRAMME

DEPARTMENT OF PUBLIC HEALTH

repair and maintenance MINISTRY OF HEALTH

COLD CHAIN EQUIPMENT (ACTIVE AND PASSIVE) REPAIR AND MAINTENANCE LOG-BOOK

logbook
Name of the EPI Store/Hospital/PHC/Sub-Post:

Name of the District:

Year:

Vaccine Preventable Disease Program

Department of Public Health
Ministry of Health
Cold Chain EquipmEnt indEnt and issuE Form

Indent No.: Date:

From (Regional Store/ Hospital/ PHC/ Sub-Post):

To (Regional Store/ Hospital/ PHC/ Sub-Post):
to BE FillEd BY rEquEstEr to BE FillEd BY issuEr
Working quantity Gross
model Current condition of requested quantity model serial storage price per
item stock the CCE as issued no. number Capacity unit
no.
of date in liters
ILR

ILR

ILR

VACCINE PREVENTABLE DISEASE PROGRAMME Deep Freezer

DEPARTMENT OF PUBLIC HEALTH

Cold chain equipment –

Deep Freezer

Deep Freezer
MINISTRY OF HEALTH Combo
Solar Direct
Drive
WIC

indent and issue form

WIF
Ultralow

COLD CHAIN EQUIPMENT

Temp
Freezer
RTMD

INDENT AND ISSUE FORM

Vaccine
Carrier
Cold Box

30-DTR
Freeze Alert/
Tag
Foam Pads

Stabilizers

Ice packs

Others
Name of the EPI Store/Hospital/PHC/Sub-Post:

Name of the District:

Signature of Requester: Signature of Issuing Staff: Signature of Receiver:

Year: Name: Name: Name:

Designation: Designation: Designation:
Date: Date: Date:

COLD CHAIN EQUIPMENT - STOCK INVENTORY LEDGER

Name of Equipment: .......................................................................................................................................................................................................................................................................

Net
PO/ Indent Gross Net Capacity Expiry
Vaccine
Received Issued & Issue Name of PQS Model Serial Year of Storage Freezer of Date Qty. Price Qty.
Sl. No. Date Storage Balance Sig.
from to Form Manufacturer Number Number Number Mfg. Capacity Capacity Stabilizer (30- Received per unit Issued
Capacity
Number in liters in liters (kVA) DTR)
in liters

VACCINE PREVENTABLE DISEASE PROGRAMME

Cold chain equipment DEPARTMENT OF PUBLIC HEALTH

MINISTRY OF HEALTH

inventory ledger COLD CHAIN EQUIPMENT - STOCK INVENTORY LEDGER

Name of the EPI Store/Hospital/PHC/Sub-Post:

Name of the District:

Year:

Figure 41: Sample of recording formats

EPI Manual for Health Staff 109

15.2
15.2 Reporting:
REPORTING
Allthe
All thehealth
health facilities
facilities should
should reportreport the vaccine
the vaccine and dry
and dry stock stock on
on monthly monthly
basis as per the
basis as per
below format: the below format:

Figureare
Only numerical values 42:accepted
Vaccine andindry stock
this recording format
format.
For any
Only support
numerical onare
values stock ledgers,
accepted in thisindent
format.book etc., kindly contact National
EPI Store, Thimphu or Regional Stores at Thimphu, Gelephu and Mongar.
For any support on stock ledgers, indent book etc., kindly contact National EPI Store, Thimphu
Every
or health
Regional facility
Stores must Gelephu
at Thimphu, maintain the
and records of 30 DTR every month on
Mongar.
the first day of the month. Always take only one month to print from 1st to
Every health
30th or 31stfacility
in one must maintain the records of 30 DTR every month on the first day of the
page.
month. Always take only one month to print from 1st to 30th or 31st in one page.

15.3 SUPPORTIVE SUPERVISION AND MONITORING:

15.3
The Supportsupervision
supportive Supervisionand&monitoring
Monitoring:are important; this will include observation, use
of data and problem solving. The supervision and monitoring has to be performed by the
The supportive
Program, DHOs andsupervision andinmonitoring
EPI regional staff are important;
their own respective this using
health centers will standard
include
observation,
checklist use ofhas
and feedback data andprovided
to be problem solving.
in writing for The supervision
further improvement and
andmonitoring
it should be
properly
has to documented
be performed at least 2-3 years.
by the The supervisor
Program, DHOs and should
EPI visit at least
regional oncein
staff in their
year and
ownto
follow up on the implementation status of previous visit recommendation.
respective health centers using standard checklist and feedback has to be The supervision also
enhances the knowledge of the health staff in their respective fields.
110 EPI Manual for Health Staff
104
15.4 BHUTAN VACCINE SYSTEM (BVS)

During the Covid-19 pandemic, the Ministry of Health has developed the Bhutan Vaccine System
(BVS) for the nationwide Covid-19 vaccination. This is a web-based portal aimed for ensuring
quality data collection, proper planning and management of Covid-19 vaccination program. The
BVS is used for real time monitoring of vaccines distribution, coverage, vaccines inventory and
monitoring of AEFI. The BVS has also opportunities to incorporate other EPI vaccines in the
system. Currently the reporting of HPV and influenza vaccination have been incorporated into
the BVS.

15.5 WORK PLAN/BUDGET

The annual work plan should be developed as per the goal and program strategies. This will
guide the program for allocation of resources to achieve the plan. The work plan should have a
budget allocation for each activity. The implementation status of budget/expenditure should be
monitored. In the hospital/PHC if the budget is managed by the District level atleast essential
activities budget should be included in the hospital/PHC example annual budget for conducting
out-reach-clinic (ORC) etc.

15.6 INDENT

Vaccines should be indented timely by the staff responsible to ensure that vaccines are
available for all immunization sessions. Before the indent, stock taking should be conducted
for all vaccines and consumables.

15.6.1 Schedule for vaccine indent

Table 13: Time schedule for vaccnie indenting

Name of vaccine store level Frequency/Dates Mode of Transport

For collection of vaccines by Bi-annually
Regional EPI Stores from National January, and July (preferred first Refrigerated Van
EPI Store week of the month)
January, April, July and October
Vaccine distribution by regional EPI
(preferred second week of the Refrigerated Van
stores to District Hospitals
month)
Vaccine distribution by District Cold Box and/or
preferred first week of every month
Hospitals to PHCs vaccine Carrier
Cold Box and/or
For remote and difficult to access vaccine Carrier or in
Once in two months
PHCs regular indent placed emergency Chopper
Services

15.5.2 Amount to Indent is [Maximum stock] – [Current Stock]

• Fill up the Indent/Issue Form in triplicate and send 1st and 2nd page to the vaccine provider.
• Fill the total doses received in current year (1st January – 31st December)
• Fill balance doses in your stock on the day of indent

EPI Manual for Health Staff 111

• As per the target population, request the balance number of doses as required
• When indenting a vaccine, all other vaccines are to be indented up to maximum.
• Whenever stock of any vaccine goes below minimum, urgent indent is placed immediately.
• Consumables are indented in the same procedure.

15.6.3: Receipt

1. When you receive the vaccine, confirm the type, amount and expiry date of the vaccine,
referring Indent/Issue Form, as well as check VVM, freeze tag/alert status and temperature
and record it.
2. After checking the vaccines, put the vaccine inside the refrigerator according to “First
Expiry, First Out (FEFO).”
3. Update Stock Ledger.

15.6.4: Issue

• Vaccines should be indented within the prescribed period as recommended in table #---)
• Issuing staff checks the indent;
• All necessary columns are filled out
• Amount indented is reasonable
• All vaccines are indented
• Considering the current stock, the staff decides the amount of vaccine to be issued.
• Following FEFO, the shortest expiry vaccine is issued.
• To far remote PHCs, longer expiry vaccines should be issued.
• Short expiry vaccines can be issued only to nearby immunization sites (PHCs or hospitals)
with prior information.
• Issuing staff fills up “quantity issued, Expiry date, batch #, VVM status in Indent/Issue Form
in duplicate,
• The 3rd page of the form is returned to the requester with the indented vaccines
• Issuing staff ensures the vaccines are properly packed.
• Issuing staff updates stock register

15.6.5: Transportation

During the transportation, the vaccine carrier or cold box should not be kept under direct
sunlight. Vaccines are transported from National EPI Store to Regional EPI store bi-annual, and
from regional EPI store to district hospitals quarterly by refrigerated vans. From the district
hospitals to other hospitals and PHCs and sub-posts monthly or hard-to-reach PHCs and sub-
posts once in two months.

112 EPI Manual for Health Staff

15.7 MAINTAINING STOCK REGISTER AND STOCK-TAKING

• Stock register is a record of stock in which all transactions of vaccine and consumables are
recorded.
• Whenever vaccines are taken out or put into the stock, update the records promptly.
• Stock-taking should be conducted at least once a month for vaccines and consumables.
• For vaccines, take out the stock of vaccine from the refrigerator and count physically by
type and by expiry date, with checking VVM. Then compare the figure to its record.
• If there is discrepancy between physical quantity and its record at stock–taking, staff
updates the figure of the physical quantity.

15.8 VERIFICATION OF IMMUNIZATION STATUS

The respective DHOs, Thromdey Health Officers, Hospitals and PHC in charge should
coordinate with the respective DEOs, and School principal in every academic year to verify
the immunization status during the admission of children at primary level both in government
and private schools, as per the format. The children who are not fully immunized should be
vaccinated accordingly. The report should be submitted to DHOs/Thromdey Health Officers
and further DHOs and Thromde Health Officers will submit the school wise report to VPD
Program, DoPH by 20th March annually.

Format for verification of Immunization status during school Admission at Primary Level is as
below:

Name of Dzongkhag
Name of School/
Government/Private
Date of Verification
Fully Immunized If no, which MCH
vaccine Handbook No.

Sl. No. Name Yes No

Definition of Fully Immunized

1. One dose of BCG

2. Three doses of OPV
3. Three doses of Pentavalent
4. One doses of Measles Rubella (MR or Measles Rubella Mumps (MMR)
5. Three doses of PCV from 2025 onwards

EPI Manual for Health Staff 113

114 EPI Manual for Health Staff
 ANNEXURES

EPI Manual for Health Staff 115

ANNEXURE I: FORMAT FOR INVESTIGATION OF DEATHS FOLLOWING
IMMUNIZATION

Name of child: ....................................................................... Date of death: .............................

Name of investigator: ............................................................ Contact no: .................................
Hospital Registration No: ............................................................................................................
1). Investigation of sequelae leading to death and past history
Identification and related basic information
Name, address and contact number of the parent
Date of birth
Age on the date of immunization
Sex
Birth weight
Weight on the date of immunization
Responsible vaccine (if known)
Date and time of vaccination
Time interval between immunization and death

2). Clinical description of the event as described by the mother

2.1 Assessment of the child before the immunization
• Feeding .............................................................................................................................
• Activity ..............................................................................................................................
• Features of any acute illness prior to immunization (specify) ..........................................
..........................................................................................................................................
• Any medication in last 24 hours prior to immunization. Yes or No. If yes , please specify

Drug Dose Time of last dose

3). Assessment of the child during immunization

• Incriminated Vaccine .............................. Date and time of vaccination ..........................
• Medications given with vaccination ..................................................................................
• Description of significant adverse event noted by mother ..............................................
..........................................................................................................................................

3.1. Measures taken by mother / guardian to overcome the adverse event

1. Treatment at another health centre ...............................................................................
2. When was the child taken to the hospital? ....................................................................
3. Diagnosis made at this health centre ............................................................................
4. Medicines prescribed, dose frequency and time of last dose .......................................

116 EPI Manual for Health Staff

 .............................................................................................................................................
5. Traditional medicine, specify (if applicable) ....................................................................
6. Any other measures/treatments ....................................................................................
7. Outcome of the above measures on the observed adverse event ...............................
.........................................................................................................................................

3.2. Was the child hospitalized? YES/NO

If yes, give details as per mother/attendant ...............................................................................
....................................................................................................................................................
3.3 Description of final event as per mother .............................................................................
....................................................................................................................................................
3.4 Was the child sleeping at the time of death? If yes, give details. Sleeping place, sleeping
position, other people sleeping in the same place ......................................................................
....................................................................................................................................................
4). Antenatal and birth history
• Antenatal complications:
• Place of birth:
• Mode of deliver:
• APGAR score:
• Significant finding in neonatal examination:
5) Developmental history .........................................................................................................
....................................................................................................................................................
6) Past medical history .............................................................................................................
....................................................................................................................................................
7). Congenital or acquired disease for which the child is on treatment .............................
....................................................................................................................................................
8). Previous immunization
Vaccine Date Batch Adverse event

9). Family and social history

• Smoking and alcohol use:
• Neonatal or infant death in family:
• Details of siblings:
• Medical history of siblings:
10). Details of management of the case at the hospital
• Name of the hospital:
• Date and time of admission:
• Name of doctor taking care of the patient:

EPI Manual for Health Staff 117

Clinical description and clinical findings as per admitting doctor
....................................................................................................................................................
....................................................................................................................................................
Details of subsequent management as per records
....................................................................................................................................................
....................................................................................................................................................
Investigations
Investigation Interpretation
Hematological
Biochemistry
Radiological
Others

Management
• Pharmacological:
• Non-pharmacological:
• Probable diagnosis:

118 EPI Manual for Health Staff

ANNEX II

Vaccine Preventable Disease Program

Department of Public Health
Ministry of Health

ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI) Reporting Forms

Patient Information: Name: Date of birth: Sex:

Name and Address of the Parent/Guardian : Mobile No:
Information on the vaccine
Name of Vaccine Date of Time of Dose (0,1st, Batch/Lot Expiry VVM Status (I,
Received vaccination vaccination 2nd, 3rd, 4th ) Number date II, III, IV)

Diluent Used: 🖵 No 🖵 if ‘yes’, Diluent batch lot number Expiry date of Diluent :
Place of vaccination: ______________________________________________________________________

Adverse Events: Date of AEFI reported: _______________ Time of AEFI started: ______________

Adverse event(s):
🖵 Severe local reaction 🖵 Seizures 🖵 Abscess 🖵 Sepsis
🖵 Encephalopathy 🖵 Toxic Shock Syndrome 🖵 Thrombocytopenia 🖵 Anaphylaxis
🖵 Fever ≥38°C 🖵 Others (specify)………….

Describe AEFI (Signs and Symptoms)

Date and Time referring to higher center

Medical History/other Outcome:
Hospitalized: Yes /No if ‘Yes’, Hospital Registration No: _________
Still in the hospital 🖵 Discharged 🖵
Outcome Recovered completely 🖵 Partially recovered 🖵
Death 🖵
Name of Health Centres:
Date of the notification: Name of Health Centers:
Name and Signature of the notifying officer:
Mobile No:

EPI Manual for Health Staff 119

ANNEX III: AEFI CASE INVESTIGATION FORM

A. PATIENT INFROMATION

A.1. Name of the patient: Hospital registration No.:

A.2. Address:
A.3 Date of birth: Gender: Male/Female

B1. PRESENT ILLNESS:

B1. What is the AEFI reported? B4. Was patient admitted to B7. Outcome of the case
hospital?
......................................................... Recovered 🖵 Died 🖵
Yes 🖵 . No. 🖵 Unknown 🖵
B2. Date of onset Unknown 🖵
B5. If yes, date of admission:
........................................................ B8. Date of discharge, Refer
..............................................
or death: ..............................
B3. Where was the patient treated?
B6. Name of the health facility
B9. If referred name of
........................................................ hospital .................................
..............................................

C. CLINICAL DATA
C1. Symptoms and signs C2. Date of onset C3. Laboratory investigation C4. Treatment

🖵 Fever ..................................
🖵 Inconsolable cry
🖵 Painful swelling at
..................................
the injection site ..................................
🖵 Enlarged tender axillary ..................................
lymph nodes ..................................
🖵 Convulsions
.................................
🖵 Altered sensorium
Any other symptoms and
signs:

D. PAST MEDICAL AND FAMILY HISTORY

Yes No Unknown if yes (specify) No
and Place
D1. Existing congenital disease 🖵 🖵 🖵 …………...…
D2. Persisting underlying disease 🖵 🖵 🖵 ………......…
D3. Previous history of significant illness 🖵 🖵 🖵 …...…………
D4. Family history of similar event 🖵 🖵 🖵 ………………
D5. Previous history of similar event 🖵 🖵 🖵 …….………

120 EPI Manual for Health Staff

E. OTHER RELEVANT HISTORY
Yes No Specify
E1 Delays in taking patient to the hospital 🖵 🖵 ……………………
E2 Delays in transferring patient to the hospital 🖵 🖵 ……………………
for specialized hospital
E3 Delays in receiving treatment 🖵 🖵 ……………………

F. IMMUNIZATION HISTORY

F1. Date of immunization: Time of immunization:

F2. Place of immunization: Hospital/PHC/ORC

F3. Type of vaccine F4. Dose F5. Expiry F6. F7. F8. Diluents
(please √ appropriate box) Date Batch No. Manufacture Batch No.
and Expiry
date
🖵BCG 🖵bOPV 🖵Penta 🖵 1st
......................
🖵MMR 🖵DTP 🖵PCV 🖵 2nd

🖵IPV 🖵Td 🖵Hep.B 🖵 3rd

🖵 Others 🖵 4th

G. INFORMATION ON COLD CHAIN /STORAGE / VACCINATION TECHNIQUE

G1. Vaccines and G2. Vaccine transported G3. Status of the data logger for 1
diluents stored in the: in a: month period prior to the date of the
immunization:
🖵 Refrigerator 🖵 Vaccine carrier
Maximum temperature
🖵Others (Specify) 🖵 Cold box ………....................……
.......................................
🖵 Others (specify) Minimum temperature
....................................... .…….......................……

Duration of temperature excursion

..............................................................

EPI Manual for Health Staff 121

 At the time of the observation of the immunization Satisfactory Unsatisfactory Not observed
G5. Maintenance of cold chain
1. Packing of vaccine
2. Maintenance of cold chain in unopened/opened 🖵 🖵 🖵
vials during immunization 🖵 🖵 🖵
G6. Vaccination procedure
🖵 🖵 🖵
1. Reconstitution
🖵 🖵 🖵
2. Drawing of vaccine
🖵 🖵 🖵
3. Injection technique
G7. Types of Syringes used: .................................................................................................................

H. AEFI IN THE CLINIC CENTRE / FIELD

Any history of similar events reported among those vaccinated No Yes Unknown

H1. At the same clinic session 🖵 🖵 🖵

H2. Using same vaccine at previous clinic session at the same
clinic center 🖵 🖵 🖵
H3. Using same vaccine at the other clinic centre 🖵 🖵 🖵
H4. History of similar events reported among those
unimmunized 🖵 🖵 🖵

I. CONCLUSION AS TO THE CAUSE OF AEFI

Immunization Vaccine Vaccine Immunization Coincidental Unknown

errors related product quality anxiety events Event that
reaction Event related defect of related happens after
caused by an reaction the related reaction immunization but
error in vaccine Event reaction Event from not caused by the
preparation caused by Event caused anxiety about vaccine- a chance
handling or the inherent due to quality or pain from association
administration properties of defects of the injection
the vaccine the vaccine itself rather
product than the
vaccine
If possible, describe the cause in below given area

Others information: Type of delivery: Birth weight during delivery:

Place of delivery:
Nos. of children immunized same day with same vaccine:

Corrective action taken ...............................................................................................................

Remarks ......................................................................................................................................

122 EPI Manual for Health Staff

Signature of the investigation team (member 1) ...................................................
Name ....................................................................................................................
Designation ..........................................................................................................
Date .......................................................................................................................

Signature of the investigation team (member 2)...................................................

Name ....................................................................................................................
Designation ..........................................................................................................
Date .......................................................................................................................

Signature of the investigation team (member 3)...................................................

Name ....................................................................................................................
Designation ..........................................................................................................
Date .......................................................................................................................

Signature of the investigation team (Team leader)................................................

Name ....................................................................................................................
Designation ..........................................................................................................
Date .......................................................................................................................

EPI Manual for Health Staff 123

REFERENCES:

1. 5th Edition EPI manual 2020

2. WHO Immunization in Practice A practical guide for health staff 2015 update
3. WHO Introduction of pneumococcal vaccine PCV13, A handbook for district and health
facility staff
4. Vaccines against influenza WHO position paper –November 2012. No. 47, 2012,87, 461–
476 http://www.who.int/wer
5. Operational guidelines initial management of anaphylaxis using injection adrenaline by
ANMS 2018. Developed with support from WHO Country Office for India.
6. Handbook of Vaccines and Cold Chain Handlers. 2nd Edition India 2016.

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EPI Manual for Health Staff 125