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DEBIRE BIRHAN UNIVERSITY

COLLEGE OF BUSINESS AND ECONOMICS DEPARTMENT OF

LOGISTICS AND SUPPLY CHAIN MANAGEMENT

ASSESSMENT ON VACCINE COLD CHAINS MANAGEMENT: IN THE CASE OF

PUBLIC HEALTH FACILITIES AT N/S/LAFTO SUB CITY, ADIS ABABA

A THESIS RESEARH SUBMITED TO THE DEPARTMENT OF LOGISTICS AND

SUPPLY CHAIN MANAGEMENT FOR PARTIAL FULFILMENTS OF THE

REQUIRMENTS OF THE POST GRADUATE (MASTERS DEGREE IN LSCM)

By:Yohannes Besufikad

ADVISOR:Yohannes Tefera (ASS. Professor)

June, 2020

DebreBirhan,Ethiopia

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DEBIRE BIRHAN UNIVERSITY

COLLEGE OF BUSINESS AND ECONOMICS DEPARTMENT OF LOGISTICS AND SUPPLY CHAIN

MANAGEMENT DEPARTMENT OF LOGISTICS AND SUPPLY CHAIN MANAGEMENT

ASSESSMENT ON VACCINE COLD CHAINS MANAGEMENT: IN THE CASE OF PUBLIC HEALTH

FACILITIES AT N/S/LAFTO SUB CITY, ADIS ABABA

By: Yohannes Besufikad Aytenfissu

Approved by Board of Examine

_________________ ________________ _______________

Advisor Signature Date

_____________________ ______________________ ______________________

Internal Examiner Signature Date

________________________ ______________________ _______________________

External Examiner Signature Date

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DECLARATION

This is to certify that the work is my own and not of any other person, the work has not previously

been submitted in any form to other institution for assessment or for any other purpose.

Declared by: Yohannes Besufikad

Name______________________________________

Signature_________

Date_____________

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Letter of Certification

This thesis has been submitted to Debire Birhan University Department of Logistics and Supply

Chain Management for examination with my approval as a University advisor.

Advisor: Yohannes Tefera (Ass. Professor)

Date: ________________________

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Acknowledgement

First of all, I would like to thank the almighty God who is the reason for my existence and gave me

His grace to accomplish this research paper successfully. Next to God my deepest appreciation

goes to my beloved family especially to my wife (Tirsit Getachew), children (Bilen Yohannes and

Betsolot Yohannes) without them it is impossible to do so. Then my deepest gratitude goes to my

advisor Yohannes Tefera (Ass. professor) for his valuable comments and unreserved guidance

during this research work. Additionally, my gratitude also goes to all my colleagues who have

been helping me morally and professionally.

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ABSTRACT

This research was a descriptive study into the cold chain management of childhood vaccines by

cold chain manager/EPI focal person at health centers and woredas in N/S/L sub city Addis Ababa,

Ethiopia. It is imperative for health professionals to follow the procedures and policies set out by

the health manuals and by of the World Health Organization. The success of any childhood

vaccination programme depends on how well cold manager and health professionals are able to

adhere to the laws, regulations and procedures. There is also a need for cold chain to be flexible

enough to deal with certain constraints so that the vaccination programmes are not interrupted for

extended periods of time but rather run efficiently and benefit the intended population. As a result

pandemics are easily avoided and a healthy generation of children will bring about a better society.

The study was carried out in two phases i.e. an observational study and a self-administered

questionnaire. In the first phase, the observational study was carried out at 4 different Cold chain

Facilities. In the second phase, the cold chain management of vaccines was explored by means of a

self-administered questionnaire.

The key findings of the observational study include that on most occasions policy was not being

implemented. Furthermore there were no contingency plans to deal with equipment and electricity

issues, no monitoring and evaluation systems, poor recording keeping, poor management of the

cold box, access to stock and the actual management of the cold chain for vaccines. The self-

administered questionnaire was completed by 18 respondents. The most noteworthy aspects of the

research in this phase of the study revealed that education and experience are crucial to the

sustainability. Not surprisingly, some of the findings were similar to that of the observational

study. Issues surrounding equipment and electricity, monitoring and evaluation systems, poor

recording keeping, poor access to stock and ordering of stock were prevalent in this phase of the

research as well.

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List of Acronyms /Abbreviations

EPI – Expanded Program on Immunization

EVM – Effective Vaccine Management

FMOH – Federal Ministry of Health

HF – Health Facility

ISCL – Immunization Supply Chain and Logistics

MDVP - Multi-Dose Vial Policy

MOH – Ministry of Health

NIP – National Immunization Program

EPSA – Ethiopia Pharmaceuticals Supply Agency

SCM – Supply Chain Management

UCI – Universal Childhood Immunization

UNICEF – United Nation Children‟s Fund

VRF – Vaccine Requisition Form

VVM - Vaccine Vial Monitors

WHO-World Health Organization

WoHO – Woreda Health Office

SCHD-Sub City Health Department

N/S/L-Nifas Silk Lafito

UIP-Universal Immunization Programme

VPDs-Vaccine Preventable Diseases

WDA-Women‟s Development Army

BOFED-Bureau of Finance and Economy Development

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Table of Contents

Acknowledgement .....................................................................................................................................................iv

ABSTRACT ................................................................................................................................................................ I

List of Acronyms /Abbreviations ............................................................................................................................... II

CHAPTER ONE: INTRODUCTION ........................................................................................................................ 1

1.1. Back ground of the Study ............................................................................................................................... 1

1.2. Statement of the problem ................................................................................................................................ 3

1.3. Research Questions ......................................................................................................................................... 4

1.4. Significance of the Study ................................................................................................................................ 4

1.5. Objective of the Study .................................................................................................................................... 4

1.5.1. General Objective .......................................................................................................................... 4

1.5.2. Specific Objectives ........................................................................................................................ 4

1.6. Scope of the study ........................................................................................................................................... 4

1.7. Limitation of the Study ................................................................................................................................... 5

1.8. Organization of the Study ............................................................................................................................... 6

DEFINITION OF TERMS ........................................................................................................................................ 6

Chapter Two: Literature Review................................................................................................................................ 8

2.1. Introduction ..................................................................................................................................................... 8

2.2. Supply chain.................................................................................................................................................... 8

2.3. Logistics .......................................................................................................................................................... 8

2.4. Cold chain ....................................................................................................................................................... 9

2.5. Vaccine cold chain .......................................................................................................................................... 9

2.5.1. Importance of Cold Chain and Vaccine Logistics Management .................................................. 10

2.5.2. Criteria effective vaccine management (EVM) ........................................................................... 11

2.5.3. Components of The cold Chain ................................................................................................... 11

2.6. Immunization ................................................................................................................................................ 12

2.7. Cold Chain Status Globally........................................................................................................................... 15

2.8. Cold Chain Status in Africa .......................................................................................................................... 15

2.9. Cold Chain Status in Ethiopia ....................................................................................................................... 16

CHAPTER THREE: RESEARCH METHODOLOGY........................................................................................... 17

3.1. Introduction ................................................................................................................................................... 17

3.2. Study Area and Population ........................................................................................................................... 17

3.3. Research Design ............................................................................................................................................ 17

3.4. Sampling Methods, design and Techniques .................................................................................................. 18

3.5. CONCEPTUAL FRAMEWORK ................................................................................................................. 18

IV

3.6. Data Sources and Types ................................................................................................................................ 20

3.7. Instruments and Data Collection Procedures ................................................................................................ 20

3.8. Criteria for Inclusion and Exclusion ............................................................................................................. 21

3.9 RELIABILITY AND VALIDITY OF THE INSTUMENT .......................................................................... 21

3.10. Data Analysis .............................................................................................................................................. 22

3.11. Ethical Considerations ................................................................................................................................ 22

CHAPTER FOUR: RESULTS AND DISCUSSIONS ............................................................................................ 23

4.1. Introduction ................................................................................................................................................... 23

4.2. OBSERVATION STUDY ............................................................................................................................ 23

4.2.1 STANDARDS OF COLD CHAIN MANAGEMENT ................................................................. 23

4.2.2. CURRENT PROCESSES OF COLD CHAIN MANAGEMENT ............................................... 23

4.3. SELF-ADMINISTERED QUESTIONNAIRE ............................................................................................. 31

4.3.1. INTRODUCTION ....................................................................................................................... 31

4.3.2. Response Rate .............................................................................................................................. 31

4.3. 3.THE RESEARCH INSTRUMENT ............................................................................................. 32

4.3.4. PRESENTATION OF THE RESULTS ....................................................................................... 32

4.3.5. SECTION A – BIOGRAPHICAL DATA ................................................................................... 32

4.3.6. SECTION B – VACCINE MANAGEMENT.............................................................................. 33

CHAPTER FIVE: CONCLUSION AND RECOMMENDATION ......................................................................... 43

5.1. CONCLUSION ............................................................................................................................................. 43

5.2. RECOMMENDATIONS .............................................................................................................................. 43

APPENDIX 1 – Questionnaire for the Cold Chain Management of Vaccines ........................................................ 45

APPENDIX 2 – Observation Study Guidelines ....................................................................................................... 48

Reference ................................................................................................................................................................. 52

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CHAPTER ONE: INTRODUCTION

1.1. Back ground of the Study

In the early days of EPI since its launch 40 years ago at the World Health Assembly (in May

1974), vaccines were the only essential commodity that required their own specific supply chain

system – with vaccines needing to be kept in a 2-8°C cold chain unlike any other essential

medicines at the time (WHO & UNICEF Joint Statement, 2014)

The „cold chain‟ is the system of transporting and storing vaccines within the safe temperature

range of +2°C to +8°C. The cold chain begins from the time the vaccine is manufactured,

continues through to state or territory vaccine distribution centers and immunization service

providers, and ends when the vaccine is administered. Correct vaccine storage and handling has

been an important factor in preventing and eradicating many common vaccine-preventable

diseases. Yet, each year, storage and handling errors result in revaccination of many clients and

significant financial loss because of wasted vaccines. Failure to store and handle vaccines properly

can reduce vaccine potency, resulting in inadequate immune responses in clients and poor

protection against disease. Clients can lose confidence in vaccines and immunisation service

providers if they have to be revaccinated after receiving vaccines that may have been

compromised. Vaccines are delicate biological substances that can become less effective or

destroyed if they are: frozen, allowed to get too warm and exposed to direct sunlight or ultraviolet

(UV) light, including fluorescent light(Health and Ageing 2013)

Childhood vaccinations have been shown to be effective in protecting children against vaccine

preventable diseases in low and middle income countries (Lee, Lewis et al. 2008, Danielsson,

Fakakovikaetau et al. 2009). Vaccines prevent more than 2.5 million child deaths per year. The

Expanded Programme on Immunization (EPI) was initiated by the World Health Organization

(WHO) in 1974 to control vaccine preventable diseases worldwide. In Ethiopia, EPI was first

launched in 1980 and its vaccination schedule is based on the WHO recommendations (Berhane,

Masresha et al. 1995, Organization 2007). The national guideline was later published in 1988 and

recently the Ethiopian immunization policy was updated in 2007(Ethiopia 2010). Tremendous

progress in improving vaccination coverage has been made over the past four decades in many

Africa countries. Ethiopia has made encouraging improvements in accessibility and provision of

primary healthcare services, especially since the establishment of the Health Extension Program in

2003. Recently, the country is also deploying and reinforcing the Women‟s Development Army

(WDA) initiative under the package of the health extension program. Immunization is a key

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component of the health extension program package. However, full vaccination coverage has not

been completed in Ethiopia as planned. The full immunization coverage remained only 24.3 % in

2011(Authority 2001, Lakew, Bekele et al. 2015) and as a result many children in Ethiopia have

not received the benefits of full immunization(Machingaidze, Wiysonge et al. 2013). The country

has slightly higher infant and under 5 mortality rates that account for 59 and 88 deaths per 1000

live births, respectively as compared to other developing countries(UNICEF 2011).

Cold chain management weaknesses are often observed during transportation and storage of the

vaccines. Some factors contributing to weaknesses of the cold chain are delays during

transportation, quality of refrigerators, a method of storage, too long storage at the health unit,

improper use of refrigerators, power interruption, equipment breakage, and lack of trained

personnel capable of managing the cold chain(Hanjeet, Lye et al. 1996, Nelson, Wibisono et al.

2004).In Ethiopia, there is a real problem of vaccines losing their potency during storage at these

centers even if they were potent on arrival.(Bogale, Amhare et al. 2019)

The Expanded Immunization Programme (EIP) is considered one of the great successes of public

health ever recorded. According to WHO estimates, Immunization prevents annually two to three

million deaths. Despite the successes, the EIP is facing difficulties; including threats to access to

EIP services, supply chain and logistics management. WHO estimates that one in five children still

do not receive the program's basic vaccines (Organization 2009). With the introduction of new

vaccines in developing countries, serious challenges emerged in the supply chain systems that

threaten access to vaccines, the availability and the quality of vaccines. Hence there is a need for

optimization and improvement of supply chain and logistics‟ systems in these countries

(Organization 2007).

The EPSA management of vaccine supply chain is also creating new opportunities to improve how

vaccines are distributed throughout the country, focused on improving the delivery of vaccines. In

the past, regional, sub city, woreda, and health facility staff collected vaccine supplies from the

level above. Now EPSA is delivering vaccines from the central cold room to their regional hubs,

and then to the sub city/zonal and/or woreda level using refrigerated trucks. Existing Country

Context for Vaccine Distribution Cold Chain system for vaccines and other cold storage requiring

health commodities consists of five levels, following the FMOH administrative structures.

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1.2. Statement of the problem

The role of vaccine supply chain is to ensure effective vaccine storage, handling, and stock

management; rigorous temperature control in the cold chain; and maintenance of adequate logistics

management information systems (Bishara 2006).For cold chain management to be efficient, three

major elements are required. These include well trained personnel, reliable transport/storage

equipment and efficient management procedures. An absence of any of these would lead to a

deficient cold chain system (Ogboghodo, Omuemu et al. 2017). When the cold chain fails:

Assuring vaccine quality and maintaining the cold chain are shared responsibilities among

manufacturers, distributors, public health staff, and health care providers. An effective cold chain

relies on three main elements: A well-trained staff, reliable storage and temperature monitoring

equipment, accurate vaccine inventory management (Vaccine Storage and Handling Toolkit).

The other factors that affect supply chain management of vaccine are maintaining the cold chain to

keep vaccines in a safe temperature range. The safe range is generally considered to be 2°C to 8°C

with the freezing of vaccines the biggest concern. Some exposure to temperature above 8°C is

acceptable, although this varies across vaccines. The WHO guidelines are that vaccines should not

be exposed to temperatures of less than -0.5°C for more than one hour, or temperatures of more

than 8°C for more than 10 hours. These conditions are referred to as alarm conditions

(Organization 1998). If the cold chain is not properly maintained, vaccine potency may be lost,

resulting in a useless vaccine supply. Vaccines must be stored properly from the time they are

manufactured until they are administered. Potency is reduced every time a vaccine is exposed to an

improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain.

Once lost, potency cannot be restored (Vaccine Storage and Handling Toolkit, 2019).Overall

because of the research gaps identified and limited research carried out in n/s/lafto sub city, Addis

Ababa Ethiopia with regard to cold chain management practice of vaccines, the study assessed the

cold chain management of vaccines in temperature monitoring, vaccine storage and handling

practices and cold chain equipment status in public health facilities at n/s/lafto sub city, Addis

Ababa Ethiopia.

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1.3. Research Questions

The following questions was considered relevant to the study design

How is current process of cold chain management of vaccines?

How is occasional policy to implement at public health facilities?

How are storage practices of vaccines at woreda and health center?

How is availability and condition of cold box at public health facilities?

1.4. Significance of the Study

This study will be intended primarily to assess the actual cold chain management and availability

of vaccines in public health facilities of N/S/L sub city, Addis Ababa Ethiopia. The result of the

study will help to create awareness among cold chain managers and other concerned bodies to

improve cold chain management practice. The result will hopefully give a baseline data for any

public health facilities to take an appropriate measure to improve the cold chain management

system of vaccines in the respective sub city, woredas and health centers. After conducting the

research the leaders, managers, logistics officers and cold chain managers at all levels will be

highly involved to improve the cold chain system of vaccines maximizing their effort how to

improve the cold chain system. The study will help to clearly picture the problems of cold chain

supply chain management practice. This study can also serve as a baseline for any further studies

in relation with cold chain practice to be done at different levels of health institution.

1.5. Objective of the Study

1.5.1. General Objective

To assess the cold chain management practice of vaccines in public health facilities at N/S/L/sub

city, Addis Ababa Ethiopia.

1.5.2. Specific Objectives

To assess current processes of the cold chain management of vaccines.

To assess the occasional policy to implement at public health facilities.

To assess the storage practice of vaccines at public health facilities.

To assesses availability and condition of cold box at public health facilities.

1.6. Scope of the study

WHO & UNICEF Joint Statement, 2014 described the vaccine cold chain management covers the

effective vaccine management(EVM) practice towards the nine criteria namely; Vaccine arrival: to

assess that pre-shipment and arrival procedures ensure that every shipment from the vaccine

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manufacturer reaches the receiving store in satisfactory condition and with correct paperwork,

Temperature control: to assess that vaccines and diluents are stored within the WHO recommended

temperature ranges in the cold chain system, Storage capacity: to assess that cold storage, dry

storage and transport capacity is sufficient to accommodate all vaccines and supplies needed for

the programme, Infrastructure: to assess whether the state of the storage buildings, the cold chain

equipment and the fleet of vehicles for distributing vaccines and supplies is acceptable,

Maintenance: to assess that the maintenance systems for the storage buildings, the cold chain

equipment and vehicles is satisfactory, Stock management: to assess that effective stock

management systems and procedures are in place, Distribution: to assess that vaccines are

distributed between each level in the supply chain in an effective manner, Vaccine management: to

assess that appropriate vaccine management policies are adopted and implemented at all levels of

the immunization supply chain, Information systems: to assess that relevant information systems

and supportive management functions are satisfactory and three important elements of trained

staff, equipment and procedures. But the current study will focus on few of the effective vaccine

management activities. These are temperature control, equipment status, stock management and

vaccine management together with the three important cold chain elements.

This study will not consider procurement, cost relate issues and the remaining five criteria of

effective vaccine management activities because the scope of the research were focus on vaccine

cold chains management on public health facilities at n/s/lafto sub city, adis ababa and the activity

of the facilities on vaccine cold chain were bounded on temperature control, equipment status,

stock management and vaccine management together with the three important cold chain elements

and the remaining criteria were performed by EPSA. The geographical scope of the study

includes woredas and health centers N/S/Lafito sub city Addis Ababa .This study will not consider

cold chain management activities at federal ministry of health, regional health bureau, central

EPSA and EPSA hubs, Private clinics, hospitals and health posts.

1.7. Limitation of the Study

Corona (covid-19) epidemic has great impact on movement of people from place to place in Addis

Ababa particularly in health facility and the activity of one wereda heath office and one health

center were transferred to corona treatment center. The data collections were performed with used

of personal protective equipment like face mask, sanitizer and glove to protect the transmission of

this virus.

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1.8. Organization of the Study

The Study was organized in to five chapters each dealing with different ideas for one common

purpose. In chapter one; background of the study, statement of the problem, objective of the study

both general and specific objectives, research questions, significance of the study, scope of the

study, limitation of the study, conceptual frame work and study variables were included. In chapter

two, reviews of theoretical and empirical literatures were included to support the study. In chapter

three; research design and methodology was briefly discussed including the research type,

population of the study, sampling method, sample size, data collection instrument, and method of

data analysis. Observation, Questionnaires and other documents used in the study annexed in the

appendices.

DEFINITION OF TERMS

Temperature control: - All vaccines and their diluents are stored and distributed within a cold-

chain system that maintains, at all times, the WHO-recommended temperatures ranges for all types

of vaccines.

Vaccine management:-All recommended policies for vaccine management are adopted and

implemented, including the use of vaccine vial monitors (VVMs), the shake-test, the multi-dose

vial policy (MDVP), the use of diluents and the monitoring of vaccine wastage rates.

Stock management Systems:- and procedures for managing the stocks of vaccines are effective,

in terms of vaccine handling, physical inventory, stock-control systems, adequate stock-level

policy, good warehousing practice, and disposal procedures for damaged and expired vaccines.

Maintenance: - Preventive and curative maintenance systems are standard and operational for

storage buildings, cold-chain equipment and vehicles used to distribute vaccines.

Cold Chain: - The system used for storing vaccines in good condition and it consists of a series of

links that are designed to keep vaccines within WHO recommended temperature ranges, from the

point of manufacture to the point of administration.

Cold Chain Management: - is an effective vaccine storage, handling, and stock management;

rigorous temperature control in the cold chain; and maintenance of adequate logistics management

information systems to ensure the uninterrupted availability of quality vaccines from manufacturer

to service-delivery levels.

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Wastage Rate: A measurement of the amount of vaccine that is not administered (due to both

open and unopened vial wastage), compared to the amount of vaccine issued.

Vaccine Vial Monitors (VVMs): are small stickers that adhere to vaccine vials and change color

as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely

used for immunization.

Cold Chain Capacity: The total volume of functional temperature controlled storage including

fridges, cold room, vaccine carriers, or other temperature controlled storage equipment.

Cold Chain Equipment: - All equipments used for storing, transporting and monitoring vaccines.

Cold Chain Managers: - are health professionals who are assigned at administrative level of zone

and woreda to manage vaccines and other pharmaceuticals that need cold chain

Potency: - A vaccine‟s strength or effectiveness; in the context of this toolkit, potency refers to a

vaccine‟s response to environmental conditions.

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Chapter Two: Literature Review

2.1. Introduction

The reviewing of literature is a key step in the research process. Literature reviews enable the

researcher to gather information about current theoretical and scientific knowledge regarding

particular phenomena under study and allows deductions to be made on what is known and what is

unknown. It is a critical summary of the research on a topic of interest, often prepared to put a

research problem in context. It reviews various research studies and literatures on effects and

consequences brought about by improper vaccine cold chain management, storage and handling.

This chapter also focuses on previous research studies conducted globally, in African countries and

in Ethiopia and evaluates the available literature to give a wider perspective on the cold chain

management in Ethiopia and how the cold chain for vaccines is maintained from the time of

receipt in the facility until the time of administration. In addition, this chapter also examines

various vaccine storage guidelines and policies regarding vaccine cold chain management.

2.2. Supply chain

A supply chain is a network between a company and its suppliers to produce and distribute a

specific product to the final buyer. This network includes different activities, people, entities,

information, and resources. The supply chain also represents the steps it takes to get the product or

service from its original state to the customer. A supply chain involves a series of steps involved to

get a product or service to the customer. The steps include moving and transforming raw materials

into finished products, transporting those products, and distributing them to the end-user. The

entities involved in the supply chain include producers, vendors, warehouses, transportation

companies, distribution centers, and retailers (F2Fsourcing show, 2020)

2.3. Logistics

Logistics refers specifically to the part of the supply chain that deals with the planning and control

of the movement and storage of goods and services from their point of origin to their final

destination. Logistics management begins with the raw materials and ends with the delivery of the

final product. Successful logistics management ensures that there is no delay in delivery at any

point in the chain and those products and services are delivered in good condition (Will Kenton

Updated Feb 10, 2020)

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2.4. Cold chain

The term cold chain or cool chain denotes the series of actions and equipment applied to maintain

a product within a specified low-temperature range from harvest/production to consumption. A

cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted

series of refrigerated production, storage and distribution activities, along with associated

equipment and logistics, which maintain a desired low-temperature range. It is used to preserve

and to extend and ensure the shelf life of products, such as fresh agricultural produce, seafood,

frozen food, photographic film, chemicals, and pharmaceutical products. Such products, during

transport and when in transient storage, are sometimes called cool cargo. Unlike other goods or

merchandise, cold chain goods are perishable and always en route towards end use or destination,

even when held temporarily in cold stores and hence commonly referred to as cargo during its

entire logistics cycle. Cold chain logistics includes all of the means used to ensure a constant

temperature for a product that is not heat stable, from the time it is manufactured until the time it is

used. Moreover, cold chain is considered as a science, a technology and a process. It is a science as

it requires the understanding of the chemical and biological processes associated with product

perishability. It is a technology as it relies on physical means to ensure desirable temperature

conditions along the supply chain. It is a process as a series of tasks must be performed to

manufacture, store, transport and monitor temperature sensitive products. Cold chains are common

in the food and pharmaceutical industries and also in some chemical shipments. One common

temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C (36 to 46 °F), but the

specific temperature (and time at temperature) tolerances depend on the actual product being

shipped. Unique to fresh produce cargoes, the cold chain requires to additionally maintain product

specific environment parameters which include air quality levels (carbon dioxide, oxygen,

humidity and others), which makes this the most complicated cold chain to operate. This is also

important in the supply Cold chain being maintained using ice box while transporting vaccine

(National vaccine storage guidelines Strive for 5, 2019)

2.5. Vaccine cold chain

The „cold chain‟ is the system of transporting and storing vaccines within the safe temperature

range of +2°C to +8°C. The cold chain begins from the time the vaccine is manufactured,

continues through to state or territory vaccine distribution centers and immunization service

providers, and ends when the vaccine is administered National vaccine storage guidelines (Strive

for 5). A cold chain is a temperature-controlled supply chain that includes all vaccine-related

equipment and procedures. The cold chain begins with the cold storage unit at the manufacturing

plant, extends to the transport and delivery of the vaccine and correct storage at the provider

10

facility, and ends with administration of the vaccine to the patient (Vaccine Storage and Handling

Toolkit, 2019). Proper vaccine storage and handling are important factors in preventing and

eradicating many common vaccine preventable diseases. Yet, each year, storage and handling

errors result in revaccination of many patients and significant financial loss due to wasted

vaccines. Failure to store and handle vaccines properly can reduce vaccine potency, resulting in

inadequate immune responses in patients and poor protection against disease. Patients can lose

confidence in vaccines and providers if they require revaccination because the vaccines they

received may have been compromised (Vaccine Storage and Handling Toolkit, 2019). The purpose

of the vaccine “cold chain” is to maintain product quality from the time of manufacture until the

point of administration by ensuring that vaccines are stored and transported within WHO-

recommended temperature ranges (module 2:The vaccine cold chain,2015)

If the cold chain is not properly maintained, vaccine potency may be lost, resulting in a useless

vaccine supply. Vaccines must be stored properly from the time they are manufactured until they

are administered. Potency is reduced every time a vaccine is exposed to an improper condition.

This includes overexposure to heat, cold, or light at any step in the cold chain. Once lost, potency

cannot be restored (Vaccine Storage and Handling Toolkit, 2019).

2.5.1. Importance of Cold Chain and Vaccine Logistics Management

One of the important elements for improving the immunization is cold chain and vaccine logistics

management which is backbone of immunization programme. Cold Chain and vaccine

management are the left and right hands of immunization programme. As a cold chain handler, you

play a very important role in improving the Immunization coverage of mothers & children by

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providing safe and potent vaccines and logistics in time (Handbook for Vaccine & Cold Chain

Handlers, 2010)

2.5.2. Criteria effective vaccine management (EVM)

WHO & UNICEF Joint Statement, 2014 described the vaccine cold chain management covers the

effective vaccine management(EVM) practice towards the nine criteria namely; Vaccine arrival: to

assess that pre-shipment and arrival procedures ensure that every shipment from the vaccine

manufacturer reaches the receiving store in satisfactory condition and with correct paperwork,

Temperature control: to assess that vaccines and diluents are stored within the WHO recommended

temperature ranges in the cold chain system, Storage capacity: to assess that cold storage, dry

storage and transport capacity is sufficient to accommodate all vaccines and supplies needed for

the programme, Infrastructure: to assess whether the state of the storage buildings, the cold chain

equipment and the fleet of vehicles for distributing vaccines and supplies is acceptable,

Maintenance: to assess that the maintenance systems for the storage buildings, the cold chain

equipment and vehicles is satisfactory, Stock management: to assess that effective stock

management systems and procedures are in place, Distribution: to assess that vaccines are

distributed between each level in the supply chain in an effective manner, Vaccine management: to

assess that appropriate vaccine management policies are adopted and implemented at all levels of

the immunization supply chain, Information systems: to assess that relevant information systems

and supportive management functions are satisfactory.

2.5.3. Components of The cold Chain

The cold Chain has three mam components:, personnel training: For all staff who administers or

handle vaccines, it is essential to provide comprehensive training about proper vaccine handling

and storage, the importance of maintaining the vaccine cold chain, and the procedures to follow if

there is a break in the cold chain (Centers for Disease Control and Prevention [CDC], 2008),

efficient management procedures: The WHO (2009) states that program planning and management

is a main component of a well-functioning immunization program system. In vaccine cold chain,

efficient management is essential to ensuring consistent oversight and control of vaccine stock and

storage. Efficient management includes the elements of inventory management, equipment

maintenance, access control considerations, power supply, and quality improvement activities,

transport and storage equipment: Equipment maintenance ensures consistent and reliable

functioning of refrigeration equipment to facilitate vaccine cold chain (CDC, 2008). Refrigerators,

freezers, portable coolers, ice packs, and thermometers should be routinely inspected and cleaned.

Policies and procedures for correcting and servicing defective equipment should also be

accomplished in advance. When the cold chain fails: Assuring vaccine quality and maintaining the

12

cold chain are shared responsibilities among manufacturers, distributors, public health staff, and

health care providers. An effective cold chain relies on three main elements: A well-trained staff,

reliable storage and temperature monitoring equipment, accurate vaccine inventory management

(Vaccine Storage and Handling Toolkit).

2.6. Immunization

Immunization is one of the most well-known and effective methods of preventing childhood

diseases. With the implementation of Universal Immunization Programme (UIP), significant

achievements have been made in preventing and controlling the Vaccine Preventable Diseases

(VPDs). Immunization has to be sustained as a high priority to further reduce the incidence of all

VPDs, control measles, eliminate tetanus and eradicate poliomyelitis(Delhi).Successful

immunization programmes are built on functional end-to-end supply chain and logistics systems.

The role of the supply chain is to ensure effective vaccine storage, handling, and stock

management, rigorous temperature control in the cold chain, maintenance of adequate logistics and

information system management(Agueh, Jerome et al. 2016)

To save lives of millions of infants and young children dying from vaccine preventable diseases,

namely tuberculosis, tetanus, whooping cough, diphtheria, poliomyelitis and measles, the

Expanded Programme on Immunisation(EPI) was launched by WHO in 1974. Ethiopia, as one of

the member states, adopted EPI in 1980. Achieving high coverage rates is considered as one of the

parameters to measure success of immunisation programme. However, disease reduction which is

the ultimate goal of EPI depends mainly on the provision of potent vaccines to the children.

Vaccine potency is ensured, among other things, by maintaining a functional cold chain system at

all levels. Vaccines could lose potency easily if the cold chain breaks at any point, from the

manufacturer to the vaccine. The cold chain system is highly sensitive to any kind of mishandling

and power interruption. It is assumed to be at greatest risk, particularly in tropical countries where

power supply is unreliable and facilities for its maintenance are not well developed.

Vaccination has greatly decreased the burden of infectious diseases globally and has dramatically

decreased the threat of diseases that were once wide spread and often times fatal (Drummond,

Chevat et al. 2007). Vaccination decreases health care cost to both patients and the health care

system by decreasing the incidence of vaccine preventable diseases (Drummond, Chevat et al.

2007). For vaccine delivery system to be successful, essential vaccine needs to be available and

of good quality. The quality of vaccines can only be ensured by a functional cold chain system.

Vaccines are highly thermo-sensitive substances which have a fixed shelf life that lose viability

over time. This loss is irreversible and accelerated if proper storage and temperature conditions are

13

not maintained(Reach 2014). Freezing or heat exposure can totally or irreversibly damage the

efficacy of vaccines and increase the risk of side effects(Ronveaux, Rickert et al. 2005).

Administration of vaccines that are not potent will lead to failed immunization of the individual

against vaccine preventable diseases. For cold chain management to be efficient, three major

elements are required. These include well trained personnel, reliable transport/storage equipment

and efficient management procedures(McKhann, Drachman et al. 1984). An absence of any of

these would lead to a deficient cold chain system. Health workers play an important role in

maintaining an undisrupted cold chain as they are the last point of contact between the vaccines

and the recipient. Hence, it is very pertinent that they be trained and supervised regularly in order

to ensure efficient practice of cold chain management. In addition to training and supportive

supervision of health workers, logistic materials and tools for monitoring storage temperature

(thermometers, VVMs, temperature logging charts among others) should be available at health

facilities(McKhann, Drachman et al. 1984). These contribute to encouraging health workers to put

into practice knowledge that has been acquired, hence, supporting effective and efficient

immunization (McKhann, Drachman et al. 1984).Cold chain is the system of transporting and

storing vaccines within the safe temperature range of 2°C to 8°C. The chain begins with the

refrigerator or freezer at the vaccine manufacturing plant, vaccine distributor and then to the

provider's office (immunization clinic) and ends with the administration of the vaccine to the

recipients. Cold chain components include equipment transport and storage, trained personnel, and

efficient management procedures. All three elements must be maintained at every link in the chain

to ensure that the administration of the vaccine is safe. Any alteration in temperature such as

exposure to excessive heat or cold damages the vaccines, resulting in loss of potency. Vaccines are

powerful public health tools that require a conscious effort to evaluate the cold chain at different

levels. Managers of immunization services have to organize staff training and plan for the physical

and budgetary implications of any problems of storage or handling.

To ensure the optimal potency of vaccines, careful attention is needed in handling practices at all

levels of the cold chain. These include storage and transport of vaccines from the manufacturer

through the primary vaccine store down to the end user at the health facility and further down at

the outreach sites. A cold chain is the integrated system of equipments (e.g., cold rooms, shipping

containers, refrigerators, vehicles), procedures, records, and activities used to handle, store,

transport, distribute and monitor temperature-sensitive products. Preventing loss of vaccine

potency during storage and handling is increasingly important as new, more expensive vaccines

are introduced, in at least one case requiring a different approach to storage.

14

The quality of vaccines can only be ensured by a functional cold chain system because vaccines

are temperature sensitive and need to be kept in a cold chain, between 2 °C and 8 °C, to remain

potent. Vaccines have a fixed shelf life that loses viability over time. This loss is irreversible and

accelerated if proper storage and temperature conditions are not maintained. Freezing or heat

exposure can totally or irreversibly damage the efficacy of vaccines and increase the risk of side

effects. Administration of vaccines that are not potent will lead to failed immunization of the

individual against vaccine preventable diseases.

Vaccine Storage temperature range Warning

Oral Polio Vaccine 2-8 ºC Check VVM status cannot be

frozen and thawed

Bacilles Calmette Guerin

(BCG)

2-8 ºC Check VVM status cannot be

frozen and thawed

Measles Vaccine 2-8 ºC Check VVM status cannot be

frozen and thawed

Tetanus Toxoid (TT) 2-8 ºC Check VVM status cannot be

frozen and thawed

Hepatitis B Vaccine (HBV 2-8 ºC Check VVM status cannot be

frozen and thawed

The maximum vaccine potency is preserved by, among other things, maintaining its functional

cold chain system at all levels. It implies for those involved, mastering vaccines sensitivity to

temperature and being adequately skilled and equipped regarding conditions of storage and

transportation for each vaccine as well as cold chain and power supply monitoring. The monitoring

of cold chain at each level is to be insured by trained personnel. Each health facility in charge of

storing vaccines or organizing vaccination sessions should have adequate functional cold chain

equipment. To monitor the temperature in the freezer or refrigerator used to store vaccines,

temperature should be read twice daily and recorded on the temperature sheet pasted on it.

Most live virus vaccines tolerate freezing temperatures, but deteriorate rapidly after they are

removed from storage. Inactivated vaccines can be damaged by exposure to temperature

fluctuations (e.g., extreme heat or freezing temperatures). Potency can be adversely affected if

vaccines are left out too long or exposed to multiple temperature excursions (out-of-range

temperatures) that can have a cumulative negative effect. Thus, World Health Organization

(WHO) recommends the following vaccines be stored and transported at 0–10 oC: Diptheria-

tetanus containing vaccines, tetanus toxoid (TT), hepatitis A and B, human papillomavirus (HPV),

15

meningitis C, pneumococcal (PCV), cholera, influenza, haemophilus influenza b (Hib), typhoid

and inactivated poliovirus (IPV) Storage Condition of Vaccines.

2.7. Cold Chain Status Globally

In the United States, a temperature study was conducted of refrigerators used to store vaccines in

medical clinics. Thermometers were used to measure the minimum and maximum temperatures for

a 24-hour period. The results indicated that only 2 of the 21 clinics studied had refrigerator

temperatures that fell within the acceptable range. About 63% of the samples had temperatures that

fell below the acceptable range, 59% reached temperatures higher than the acceptable range, and

93% were both higher and lower than the acceptable range. Since the study measured only the

minimum and maximum temperatures, it is impossible to know how long the temperatures

remained outside the acceptable range. During a three-day monitoring period, a study in New

South Wales used data loggers to measure the temperature of 53 vaccine refrigerators in

pharmacies and found that only 19% of the refrigerators studied had temperatures that fell within

the acceptable range, while 23% of the refrigerators had temperatures that fell to less than 0°C and

29% had temperatures higher than 8°C.

2.8. Cold Chain Status in Africa

Cold chain monitoring is still a major challenge in developing countries, including Cameroon.

Previous studies suggest that only about 56% of health facilities fill their temperature charts

systematically twice a day as recommended. 53 out of 65 health facilities (81.5%) had at least one

functional vaccine refrigerator. The national guideline of EPI was not present in 21(33.9%) health

facilities. Temperature chart was complete/correctly filled in 25(50%) of the 50(96.2%) facilities

having it. About 14 (26.9%) of the health facilities record at least one abnormal temperature during

the last 2 months following data collection. 17 (28.3%) personnel did not know the correct vaccine

storage temperature.

An external EPI review in 2012 done in provinces at Democratic republic of Congo, which found

that 40% of health zones and 32% of health facilities, had to interrupt immunization services

during the six month preceding the review due to limited stock availability of vaccines and issues

with the cold chain (Village Reach 2015). Evaluation of the Performance of Expanded

Immunization Programme Supply Chain and Logistics Management in Southern Benin Rural

Health District shows that in the 19 health centers, vaccines and liquid for dilution were stored at a

temperature between 2 °C and 8°C on the day of the survey in 17 centers (89.47%), a temperature

monitoring device was placed in the refrigerator in 18 (94.74%) centers, the recommended

16

standards of vaccines storage were met in 15 (78.95%) centers and effectiveness of twice-daily

temperature monitoring of refrigerators was noted in 17 centers (89.47%).

2.9. Cold Chain Status in Ethiopia

Cold chain status assessment conducted at facilities in Ethiopia showed that complete temperature record

was observed in 57.8% of the health centers. Thermometer was not available in 6.3% and temperature

reading was found to be outside the optimal range in another 10.9% of the health centers. Vaccine storage

in the refrigerator was not proper in 73.4% health centers. Majority of the health centers had neither trained

personnel nor budget for maintenance of the cold chain.

The research done for the status of surveillance and routine immunization performances in Amhara region,

there had been vaccine stock out in the 3 months before assessment in 28/82 (34%) of the sites (Lakew GA

et al. 2017). According to estimates made during the EVM assessment, stock outs at the health center level

could be responsible for missed opportunities to vaccinate 14% of the target population per facility. This

could potentially lead to a loss of immunization coverage.

17

CHAPTER THREE: RESEARCH METHODOLOGY

3.1. Introduction

This chapter presents the research methodology used to guide the study. It describes the research

design, the research instruments used to obtain data, the validity and reliability of the research

instruments, the data collection process, the method for analyzing the data collected. In addition to

this, this chapter presents the theoretical framework that was used to guide the study.

3.2. Study Area and Population

The study was conducted in public health facilities (health centers and woredas) at N/S/Lafito Sub

City Addis Ababa Ethiopia. According to the Addis Ababa Region Bureau of Finance and

Economy Development (BOFED), N/S/Lafito sub city is estimated to have 402,005 populations.

There are 10 health centers and 10 woreda in N/S/Lafito sub city. The study units were the health

centers and woreda vaccine stores. The study population was health professionals from health

centers and woreda health offices under the sub city. For the purpose of this study, the health

centers and woreda vaccine stores were included. The data was collected from February to April

2020 G.C in woredas and health centers. The population was respondents from cold chain

managers assigned at woreda and facility level as shown below the table. The total population of

the study was 20 respondents (10 health centers having one EPI focal person and 10 woredas

having one cold chain manager).

Table 3.1.Number of Health facilities and respondents

Level Respondent Number of

Study Unit

Number of Respondents (Study

Population

woreda vaccine stores Cold chain manager 10 10*1=10

Health Center EPI Focal Person 10 10*1=10

Total 20 20

Data Source: Researcher Data Survey 2020

3.3. Research Design

Research design is an advance planning of the methods to be adopted for collecting the relevant

data and the techniques to be used in their analysis, keeping in view the objective of the research

and the availability of staff, time and money. It has a great effect on the reliability of the results as

being the architectural backbone of the study in that it allows the researcher to identify measures to

reduce bias, stipulate the frequency of data collection, and provides the answer to questions and

18

guides the comparisons that will be made. Therefore, descriptive research approach was used to

assess the status of cold chain management practice at health centers and woredas under N/S/L

afito Sub City Addis Ababa, Ethiopia.

3.4. Sampling Methods, design and Techniques

The study was census and the population was all public health facilities found in N/S/L afito Sub

City Addis Ababa, Ethiopia. These were all health centers and woreda vaccine stores and the

sample size was 20 respondents.

In light of this, a quantitative descriptive survey design was selected for this study and conducted

in two ways. In the first, an observational study was carried out by the researcher using a

structured observation guideline. At the 4 of the 20 cold chain facilities selected, using interval

sampling technique, 2 from 10 health center and 2 from 10 woreda vaccine stores. The researcher

will observe if the cold chain for vaccines was maintained according to National/regional and

Operational guidelines. Observations were recorded on a pre-planned checklist that contains the

aforementioned guidelines. Second, the cold chain management of vaccines by EPI Focal Person/

Cold chain manager was explored by means of a self-administered questionnaire.

3.5. CONCEPTUAL FRAMEWORK

The purpose of the cold chain system is to ensure effective transport and storage of vaccines to

enable their administration in a potent state to the person being immunized. The WHO proposes a

framework (Figure 3.2) for effective cold chain management of vaccines in addition to National

and operational guidelines. This framework was adapted for this study, to aid in investigation of

the cold chain for vaccines. This framework is made up of nine constructs, split into five strategic

steps. As recommended by WHO, these five steps should be followed to ensure quality vaccine

Management.

19

Figure 3.2: Conceptual Framework Adapted from Vaccine Management (WHO, 2005)

immunization, vaccine guidelines.

The first step is setting the quality standard. This is the step in which quality models available for

vaccine management is identified. Staff allocated to Cold Room facilities must practices duties

regarding the management of vaccines based on national programme policy guidelines as

recommended by WHO and UNICEF. Following the policy guidelines in the selected quality

model ensures that the integrity of vaccines is maintained.

In step two, a general approach to vaccine management is established. Overall requirements for

vaccine management are identified. Thereafter, standard operating procedures are prepared and

adopted.

20

Step three entails establishing standard procedures. Specific tasks and procedures for vaccine

management are identified. These tasks and procedures are set out to ensure that standard of

performance prepared in step two are achieved. Instructing and training staff is a vital step in this

process. In order to carry out each task competently, staff are instructed and trained during

orientation programmes and in-service training. It is also important to ensure sufficient equipment

for cold chain management. Equipment servicing and testing should be done on a regular basis.

Lastly, it is suggested that good records are kept. This will ensure that the task has been carried out

effectively, in doing this, vaccine programme managers can verify that sound vaccine management

is in place and has been maintained over a period of time.

This framework provides the foundation for determining the level of quality of the management of

vaccines at the selected Facilities with in the cold chain system. In addition, assessing vaccine

management using this framework enables staff to highlight the strengths and weaknesses of

vaccine management and introduce the changes where necessary.

3.6. Data Sources and Types

The main data sources of this study were primary and secondary data. Primary data was obtained

from either through direct communication with respondents or through observation. Self-

administered questionnaire and observation for cold chain managers/EPI focal person was used for

this particular study. In addition to primary data, secondary data source was used. These data are

already available which have been collected and utilized by someone else. Secondary data source

used for the study include literature reviews from books, journals, various publications, reports and

other relevant documents related to vaccine cold chain management.

3.7. Instruments and Data Collection Procedures

According to Burns and Grove (2009), data collection is the process of acquiring participants and

collecting information from these participants that is relevant to the study. The authors further state

that ensuring consistency and controls during the data collection process ensures the integrity and

validity of the study. With that in mind the data collection process will occur in two phases. The

first phase was an observation study which uses a structured observation guide as a means of

recording the researcher‟s observation. For the purpose of this study the researcher requested to

view all policies, procedures and documentation pertaining to cold chain management of

vaccines.In observational study the researcher was stationed in to 2 health center and 2 wereda.The

cold chain facilities were semi randomly selected by using interval sampling.

21

The second phase warranted the use of a questionnaire which was developed through careful

review of the existing literature and in accordance with the framework suggested by WHO for

effective cold chain vaccine management. The questionnaire includes items regarding Policy,

procedures and guidelines as well as cold chain maintenance, Equipment and stock availability. A

self-administered questionnaire was distributed to 10 health centers and 10 woredas. From health

centers and woredas, 10 EPI focal persons and 10 cold chain managers respectively was

participated as a respondent in the study. Hence a total of 20 respondents were expected for the

study. Regarding data collection procedure the data was collected by the principal investigator

using self-administered semi-structured questionnaire

3.8. Criteria for Inclusion and Exclusion

Inclusion Criteria

Woreda and health center cold chain managers were considered in the study. All full-time health

professionals directly involved in cold chain management employed at woreda and health center

level was considered. In addition, all health professionals who have a full time delegation for the

position of cold chain management were included in the study, in case if the designated personnel

were absent

Exclusion Criteria

Regarding the staffs, staff members who were not directly involved in the daily activities, student

health professionals practicing at facilities, those healthcare personnel who were unwilling to

participate and those who were on leave during the study was excluded from the study. In addition

health professionals who didn‟t handle vaccines and absent during collection was excluded.

3.9 RELIABILITY AND VALIDITY OF THE INSTUMENT

According to Polit and Beck (2008) reliability is the degree of consistency or dependability with

which an instrument measures an attribute. In addition Polit and Beck (2008) state that the

reliability of a quantitative measure is an important criterion for assessing its quality. The

researcher ensured that the same questionnaire was administered to all participants for this study

and the same structured observational guide was used in all selected HCs and woreda

Observation and Questionnaire design were the only one step in the process that ultimately leads to

generating answers to research questions of interest. After the questionnaire and observation were

designed, a pilot test was run to make sure it was understandable and acceptable to the intended

audience; to increase the clarity of the questions for respondents‟ understanding and to ensure the

appropriateness of the questions, before launching the full scale study.

22

Hence, before starting upon data collection, pretest of the prepared questionnaires was performed

in two HCs and worked. The principal investigator was involved in the data collection process and

review completed questionnaires to clarify any data inconsistencies. In order to assure the quality

of data, the same questionnaire was administered to all participants for the study in all facilities.

During the study measures were taken in order to ensure consistence of data quality including

verification of filled questionnaires and Coding of the questionnaires.

3.10. Data Analysis

The quantitative data was entered and analyzed using Microsoft Excel 2010 and statistical method

used was descriptive. Study results have been presented by using tables.

3.11. Ethical Considerations

Before commencing data collection, ethical clearance was obtained from Debre birhan University

College of Business and Economics where by written letter was given to the host organization

(N/S/Lafito Sub city Health department) so as to accept the data collection activity at the area.

Then the Sub city Health department wrote ethical clearance to the respective woredas and health

centers for smooth communication and data collection activity. Participants of the study were

asked for consent before participating in the study. During the consent process, they were provided

with information regarding the purpose of the study, why and how they were selected to be

involved in the study, and what was expected from them and that they can withdraw from the

study at any time. Participants were also assured about confidentiality of the information obtained

in the course of the study by not using personal identifiers and analyzing the data in aggregates.

Consent claims that participants were not be at risk by refusing to participate in the assessment or

stopping their collaboration during the study. Confidentiality was maintained throughout the

process of data collection.

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CHAPTER FOUR: RESULTS AND DISCUSSIONS

4.1. Introduction

The previous chapter outlined the methodology adopted in conducting this study. This study gives

attention on cold chain management practice in health facilities based on standard storage and

proper handling of vaccine at N/S/Lafito Sub city and presents the data obtained from the study.

An observation guideline checklist and a self-administered questionnaire were used to collect the

data from the facilities who manage vaccines at woreda and facility level. This chapter presents the

answer in a logical way to assess the cold chain status of vaccines, to assess the effective vaccine

management activities, and to assess the cold chain equipment status at facilities. This chapter was

presents the findings of the observation guideline and self-administered questionnaire and provides

a detailed analysis of the data collected from the survey. It starts by analyzing data according to the

research questions which guided this study. The questionnaire and observation guideline were the

primary tool used to collect data for the study. The questionnaire was distributed to cold chain

mangers at woreda and EPI focal persons at health centers.

4.2. OBSERVATION STUDY

4.2.1 STANDARDS OF COLD CHAIN MANAGEMENT

The criterion used for standards of cold chain management during the observation study was based

on the National/Global standards of vaccine management according to the WHO.

The observation guideline checklist was used to observe whether the EPI Focal Person\Cold chain

manager maintained the standards of cold chain for vaccine management regarding vaccine arrival

procedures, refrigerator, cold box, and availability of Policies, procedures and guidelines.

The observation guideline was the primary tool used to collect data for this study. The observation

study was conducted in two Health Center and two woreda vaccine stores. A total of four facilities

were observed. Both Health Center and two woreda vaccine stores to which they belonged were

evaluated against the criteria discussed below.

4.2.2. CURRENT PROCESSES OF COLD CHAIN MANAGEMENT

Cold chain Facilities should evaluate their vaccine cold chain policies and procedures on a regular

basis to ensure that best practices are followed. All Cold Room facilities should develop a detailed

plan on all aspects of vaccine management. This plan should include vaccine ordering, storing of

vaccines and monitoring storage conditions (The Vaccine Storage and Handling Toolkit, 2012:

13).

24

4.2.2.1. POLICIES, PROCEDURES AND GUIDELINES OF COLD CHAIN

MANAGEMENT AS SUGGESTED BY NATIONAL/GLOBAL STANDARDS OF WHO

An observation guideline checklist with eight criteria was used to observe whether Employees in

the cold room followed policy, procedures and guidelines in the management of the cold chain for

vaccines.

Table 4.1. Assessment on Policies, procedures and guidelines

1.Policies, procedures and guidelines

Yes No

1.1 Policies, procedures and guidelines available for vaccine management. 0 100

1.2. Are contingency plans in place for problems with equipment/electricity

used in the cold chain management of vaccines?

0 100

1.3. Is there evidence of maintenance to cold chain equipment available? 0 100

1.4. Is there evidence of filling in of stock cards for vaccines? 75 25

1.5. Is there evidence of physical inventories of vaccine stock? 75 25

1.6. Is there evidence of dedicated room for vaccine Storage 75 25

1.7 Is there evidence of records of in case of recall /batch numbers for

vaccines

75 25

1.8 Is there evidence of good vaccine records i.e. temperature records, training

record, cold room service reports?

75 25

As can be seen in Table 4.1, there are eight criteria relating to policy, procedure and guidelines of

cold chain vaccine management. Four of the facility observed have a large negative alignment

100% (n=0) for policy, procedure and guidelines. In this facility there was no written evidence of

contingency plans for faulty equipment and electricity failure, maintenance of equipment,

management of vaccine waste, training records and managing of AEFI. There was evidence of

filling in of stock cards in 75% (n=3) Cold-rooms and in 25% (n=1) this was not evident.

In 75 (n=3) of Cold-rooms there was compliance with having a dedicated room for vaccine storage

and procedures. There was non-compliance in 25% (n=1) of the Cold-rooms observed.

Record keeping regarding in-service training for cold room EPI Focal Person\Cold chain manager,

cold room service reports, and records for recall of batch numbers were documented in 75% of the

cold rooms.

25

Discussion on Policies, procedures and guidelines

The observation study revealed that policy, procedures and guidelines were available. However, on

most occasions policy had not been implemented. Each Cold room facility must have written

policies, procedures and protocols in place (National Vaccine Storage Guidelines Strive for 5,

2013: 8). Health care facilities should develop and adhere to detailed written routine vaccine

storage and handling plan that is updated annually. A written plan helps vaccine providers to

remain organized and serves as a reference and training tool as well as providing assurance of

proper vaccine management and prevention of vaccine wastage (The Vaccine Storage and

Handling Toolkit, 2012: 13).

It was observed in this study that there were no written contingency plans in place for problems

associated with equipment and electricity used for cold chain management of vaccines. Some

verbally communicated what actions would be taken in an emergency situation to ensure vaccines

are not compromised and the cold chain system is still managed effectively, but there was no

evidence of written documentation in this regard.

According to the National Vaccine Storage Guideline Strive for 5 (2013: 8) the following records

must be maintained: Servicing of the refrigerator and data logger, checking the accuracy of

thermometers and batteries, Cleaning the refrigerator; and Policy in case of power failure.

One cannot overemphasize the importance of a backup plan to deal with problems of equipment

being affected by electricity. There has to be some kind of a contingency plan in place such as a

petrol or diesel generator to overcome the problem of a lack of electricity. It is thus imperative that

Pharmacists develop and communicate their backup plans to management so that appropriate

allocations can be made in the budget to purchase the required equipment so that it is in place

when the need arises for implementation of such plans. Regular workshops and training on vaccine

management is recommended. Such workshops should be compulsory for all so that there is

holistic improvement and negligence or carelessness will not be prevalent .This observation study

further revealed that 75 percent adhered to filling of stock cards, using these tool more seriously

should allow for called rooms to never run out of stock as an out of stock situation means missed

opportunities and a breakdown in the System. The EPI Focal Person\Cold chain manager should

fill and monitor their stock card and be able to act quickly before stock out.

26

4.2.2.2. VACCINE ARRIVAL PROCEDURE

Four criteria, as seen in Table 4.2, were used in the observation study to observe how the cold

room EPI Focal Person\Cold chain manager responded to and stored vaccines when they arrived.

Table 4.2: Assessment on Vaccine arrival procedure

2. Vaccine arrival procedure Yes No

2.1. Does the EPI Focal Person\Cold chain manager respond immediately

when vaccines arrive in Cold-room?

75 25

2.2. Does the EPI Focal Person\Cold chain manager check vaccines for

discrepancies, leakage and breakage before receipt?

75 25

2.3. Are vaccines stored immediately on receipt? 75 25

2.4. Are vaccines packed according to the first-in first-out principle?

75 25

Table 4.2 shows results for each of the criteria on vaccine arrival procedures

Table 4.2 indicates that each of the criteria on vaccine arrival procedures were observed that 75%

(n=3) of the facility scored “Yes” and 25% (n=1) scored “No”, indicating compliance. The results

show that 75% (n=3) the EPI Focal Person\Cold chain manager were responded immediately when

vaccines arrive in Cold-room while 25 %( n=1) the EPI Focal Person\Cold chain manager were not

responded immediately when vaccines arrive in Cold-room.75% (n=3) indicate that vaccines were

checked discrepancies, leakage and breakage before receipt while 25% (n=1) the vaccines were not

checked discrepancies, leakage and breakage before receipt.75% (n=3) indicated that vaccines

were stored immediately on receipt were as 25(n=10) the vaccines were not stored immediately on

receipt.75% (n=3) indicated that the first-in first-out principle were applied when packing and

using vaccines. 25% (n=1) stated that this principle is never applied.

Discussion on vaccine arrival procedures

The results of the study revealed that 75 % percent observed responded immediately to the arrival

of vaccines and 25 percent did not respond immediately. The maintenance of the cold chain during

distribution and arrival of vaccines to the facility is important to ensure the potency of vaccines

(The EPI Cold Chain Standard Operating Procedure Manual, 2009: 4). Therefore it is necessary to

carefully examine and check the quantity and quality of vaccines which are received.

27

This study further reveals that 75 percent of checked vaccines for discrepancies, leakage and

breakage and stored vaccines immediately on receipt and 25 percent were not compliant. The EPI

Cold Chain Standard Operating Procedure Manual (2009: 4) states that those involved in vaccine

management must attend to receive vaccines immediately and record any discrepancies, leakages

and breakages on the delivery note.

The results of this study revealed that 75 percent of facilities were compliant with packing the

vaccines according to the first-in-first-out principle and 25 percent were non-compliant with this

principle. According to the National Vaccine Storage Guidelines-Strive for 5 (2013: 3) the vaccine

stock must be rotated so that vaccines with the shortest expiry dates are used first. This practice

ensures that vaccines are not wasted as a result of being compromised upon reaching the expiration

date (National Vaccine Storage Guidelines-Strive for 5, 2013: 3)

4.2.2.3. REFRIGERATOR

During the observation study ten criteria as indicated in Table 4.3 was used to observe the

refrigerator in which vaccines were stored.

Table 4.3: Assessment on refrigerator

3. Refrigerator Yes No

3.1. Is the refrigerator appropriate to store vaccine? Size, freezer

compartment for icepacks.

75 25

3.2. Is the refrigerator is dedicated for vaccines only? No other drugs 50 50

3.3. Is the refrigerator temperature between (2 - 8ºC)? 75 25

3.4. Is the temperature of the refrigerator recorded on chart twice daily? 75 25

3.5. Is the refrigerator packed correctly with vaccines and diluents? 75 25

3.6. Is the refrigerator overstocked? 75 25

3.7. Are there vaccines in the door? 100

3.8. Are vaccines frozen? 100

3.9 Is the refrigerator in a locked room or does the fridge have a lock and

key?

50 50

3.10 .Is there a working thermometer hanging in correct place? 0 100

The results show that 75% (n=3) the refrigerators were always appropriate used to store vaccine

while 25 %( n=1) indicate that the refrigerator never appropriate to store vaccine.50 %( n=2) the

refrigerators were always dedicated for vaccines only whereas 50 %( n=2) the refrigerator never

28

dedicated for vaccine only. Regarding the refrigerator temperature, 75 %( n=3) the temperature

were always between (2 - 8ºC) while 25 %( n=1) indicate that the temperature were never between

(2 - 8ºC). 75% (n=3) the temperature of the fridge were always documented twice daily on the

temperature chart while 25% (n=1) indicate that the temperature of the fridge were never

documented twice daily on the temperature chart.75 %( n=3) the refrigerators were always packed

correctly with vaccines and diluents whereas 25 %( n=1) the refrigerator never packed correctly

with vaccines and diluents. 75 %( n=3) the refrigerator were always overstocked while 25 %( n=1)

the refrigerator were never overstocked.100 %( n=4) there were never vaccines stored on the door

of the refrigerator and vaccines frozen. 50 %( n=2) the refrigerators were always either locked or

stored in a lockable room and 50 %( n=2) the refrigerators were never either locked or stored in a

lockable room.100 %( n=4) there were never worked thermometer hanging in correct place.

Discussion on refrigerator

Analysis of the study results showed that 75 percent of the stored vaccines in a refrigerator that

was of the correct size, type and had a freezer compartment for icepacks. However, 25 percent of

refrigerators used in clinics were not complaint. Some use a bar Type fridge to store vaccines.

According to The National Vaccine Storage Guidelines Strive for 5 (2013: 7) domestic and bar

refrigerators are not recommended for vaccine storage as they increase the risk of adverse vaccine

storage events. This is supported by the findings in a study conducted by Carr, Byles and Durrheim

(2009: 35) in Australia which recommended that bar-type refrigerators should be outlawed for

storage of vaccines as they posed an unacceptable threat to vaccine cold chain integrity. In the bar

type fridge the temperatures fluctuated between too high or too low, leading to vaccines being

subjected to too much heat or cold thus placing vaccines at a risk (Carr, Byles and Durrheim, 2009:

38). The findings of the study further revealed that 75 percent of the facility observed maintained

the correct fridge temperature between two to eight degrees Celsius and 75 percent recorded the

temperature twice a day. However, 25 percent of the facility failed to maintain the correct

refrigerator and 25 percent failed to record the refrigerator temperature twice daily. According to

The Vaccine Storage and Handling Toolkit (2012: 53) vaccines must be stored at a temperature of

between two to eight degrees Celsius. Exposure outside this range may result in reduced vaccine

potency and increased risk of vaccine preventable diseases. The temperature recording chart

should be kept on the outside door of the fridge as it is visible to all staff.

The National Vaccine Storage Guidelines Strive for Five (2005: 14) recommends that refrigerator

temperatures be checked and recorded twice daily. Checking and recording the temperature before

administration of the vaccine enables the identification of problems before the vaccine is used.

29

During this study it was observed that temperature charts are available in most facility, however,

some EPI focal person/cold chain manager failed to record findings. Regarding correctly packing

the refrigerator with vaccines and their diluents together, the study revealed that 25 percent were

non-compliant and 75 percent were compliant. According to The Vaccine Storage and Handling

Toolkit (2012: 54) diluents must be stored in the refrigerator next to the corresponding vaccines.

Diluents packaged separately from their corresponding vaccines may be stored at room

temperature or in the refrigerator. Vaccines mixed with incorrect diluents can cause damage to

vaccines and can further cause AEFI (The Vaccine Storage and Handling Toolkit, 2012: 54).

The National Vaccine Storage Guideline-Strive for 5 (2013: 12) recommends that refrigerator

shelves must not be overcrowded and there must be space in-between vaccine containers to allow

for air to circulate. The guideline further states that overstocking of the refrigerator will prevent air

circulation and it will be difficult to maintain stable temperatures within the refrigerator. The

results of this study revealed that 75 percent of the refrigerators were not overstocked and only 25

percent of the clinics refrigerators were overstocked. According to the results of this study, 100

percent of facility did not store vaccines in the door of the refrigerator. It is important to store

vaccines appropriately in the refrigerator in order to maintain their integrity (National Vaccine

Storage Guidelines Strive for 5 2013: 12).

This study results further revealed that fridge thermometers were available in all 4 facility

observed however, none of the thermometers were working. Most facility used the thermostat dial

in the refrigerator to monitor the fridge temperature. This state of non-working thermometers is

contrary to the guidelines of the Vaccine Storage and Handling Toolkit (2012:38). These

guidelines state that thermometers are a critical part of good storage and handling practice.

Accurate temperature monitoring is imperative for effective vaccine management. This is also

supported by Safe Vaccine Handling, Cold Chain and Immunization Guidelines WHO (1998)

which state that if the refrigerator does not have a working thermometer there is no way of telling

if the vaccine is being stored at the right temperature and is maintaining its potency.

4.2.2.4. COLD BOX

During the observation study four criteria as indicated in Table 4.4 was used to observe the

standards of cold chain management related the cold box.

Table 4.4: Assessment on COLD BOX

4. Cold box Yes No

4.1.Is the cold boxes in a good condition and right size? 75 25

30

4.2. Is there a working thermometer in the cold box? 75 25

4.3. Is the temperature of the cold box between 2-8 degrees? 75 25

4.4. Is the cold box packed correctly i.e. 6 ice packs? 25 75

During the observation study it was observed that in regard to cold boxes, the results show that

75% (n=3) to indicate that cooler boxes were in a good conditioned while 25% (n=1) the cooler

boxes are never in a good conditioned.75% (n=3) stated that a dial thermometer is always available

for cooler boxes and is working where as 25% (n=1) indicated that thermometer is never

available.75% (n=3) indicated that the temperature in the cooler box were between two to eight

degrees Celsius while 25% (n=1) indicated that the temperature were never the case.75% (n=3)

stated that vaccines were correctly packed in the cooler box while 25% (n=1 indicated that

vaccines were not correctly packed in the cooler box.

Discussion on cold box

The results of this study revealed that in 75 percent cold boxes were in good condition and in 25

percent facility the cold boxes were not in good condition or were not the right size. It was

observed that in one of the facility the cold box was either too large or too small and also damaged;

therefore vaccines could not be maintained at the correct temperature. The cold boxes should be of

a good condition, meaning that it should not be broken or damaged and should have a properly

fitting lid (EPI Guidelines WHO-1998: 19). The pros and cons of the cold boxes are listed in

(Burstein et al., (2012). The pros and cons of the cold boxes are listed in (Burstein et al., (2012). It

is recommended that the 25 percent of the facility purchase better quality cold boxes. An allocation

of the budget of these clinics should be set aside for this part of the immunization programme.It

was observed in 25 percent of the respondents that the temperature range of two degrees to eight

degrees Celsius was not maintained and in 75 percent the cold box temperature was correctly

maintained. In most of cases it was found that thermometers were present and working. In cases it

is not working, the EPI focal/cold manager was not able to identify if the vaccines were subjected

to heat or cold. While damage to vaccines due to overheating is gradual, freeze damage is almost

instantaneous. According to the EPI Guidelines (2010: 12) the temperature of vaccines should be

maintained between two degrees and eight degrees Celsius in the cold box and a dial thermometer

must be used. The correct thermometer should be included in the cold box for hourly monitoring of

the temperature. (Rogers et al.,2010: 339). The EPI focal/cold manager responsible for

immunisation programmes should be responsible for monitoring the cold box temperature hourly

31

to ensure that proper policy are adhered to. This finding is similar to that found by the (Burstein et

al., 2012) study conducted in Ghana, Kenya and Uganda.

The results of this study also revealed that in 75 percent of facility the cold box was incorrectly

packed and in 25 percent of the facility the cold box was correctly packed. It was observed in

facility that the ice packs used to line the cold boxes were too large and did not fit the cold box

well. With the result the lid of the cold box could not close and the correct temperature within the

cold box could not be maintained. This is not in keeping with the Proper Handling and Storage of

Vaccines Guidelines by (Rogers et al., 2010: 339). Rogers et al., state that the correct number and

placement of ice packs in the cold boxes is important because too few ice packs can fail to

maintain the internal temperature and too many ice packs can freeze the vaccines.

4.3. SELF-ADMINISTERED QUESTIONNAIRE

4.3.1. INTRODUCTION

The questionnaire was the primary tool used to collect data for this study. The questionnaire was

distributed to EPI focal persons/cold manager at Health center and woreda vaccine stores with in

N/S/L Sub city.

4.3.2. Response Rate

From all public health facilities (i.e. 10 woredas and 10 health centers), 18 facilities have been

participated in the study. Based on inclusion and exclusion criteria, a total of two facility (one

woreda and one health center) have been excluded from the study since the one wereda was not

managing vaccines and the health center is not available at the time of assessment. All 18 public

health facilities‟ respondents agreed and participated in the study.

Therefore, the overall response rate of the interview that was conducted was 100%.

32

4.3. 3.THE RESEARCH INSTRUMENT

The questionnaire was divided into two main sections which measured various themes as

illustrated below:

Section A : Biographical data

Section B : Vaccine Management

Question B1 : Policy

Question B2 : Vaccine Management

Question B3 : Vaccine Refrigerator

Question B4 : Cold Boxes

4.3.4. PRESENTATION OF THE RESULTS

This section presents the results of the self-administered questionnaire.

4.3.5. SECTION A – BIOGRAPHICAL DATA

This section summarizes the biographical characteristics of all respondents who participated in this

study. This included: age, gender and experience.

4.3.5.1. AGE AND GENDER DEMOGRAPHY

Table 4.5: assessment on age and gender demography

Age in years

Frequency Percent

20 to 25 5 27.8

26 to 30 9 50.0

31 years and above 4 22.2

Gender male 8 44.4

female 10 56.6

Work

experience in

years

0 to 5 9 50.0

6 to 10 7 38.9

11 years and above 2 11.1

Age, Gender, and experience at work of the participants were examined and their distribution is

summarized in the table. Regarding gender 44.4% (n=8) respondents were male and 56.6 % (n=10)

33

were female. The majority of participants were from 26 to 30 years old (50%, n=9). In addition the

majority of respondents i.e. 50% (n=9) were between 0 to 5 years of work experiences

4.3.5.2. TRAINING IN VACCINE MANAGEMENT

Table 4.6: Training in vaccine management and involvement in vaccine management

Training in vaccine management

Yes No

66.7 33.3

Involvement in vaccine management 100 0

Based on the results obtained from the assessment, 66.7% (n=12) cold chain managers and EPI

focal persons were participated in vaccine management training and participants who are trained in

vaccine management are involved in vaccine management whereas 33.3% (n=6) participants didn‟t

take any vaccine management training and participants who are not trained in vaccine management

are involved in vaccine management. These statistics tell us that more EPI focal/cold chain needs

to be encouraged to be trained and involved in vaccine management.

4.3.6. SECTION B – VACCINE MANAGEMENT

The section that follows analyses the scoring patterns of the participants per variable per section.

Negative statements were categorized as “Never” and positive were labeled “Always”. The results

are presented using percentages for the variables that constitute each section.

4.3.6.1. QUESTION B1: POLICY

This section deals with cold chain policies. The summarized scores are represented in Table 4.7

Table 4.7: Assessment on Policy

1. Policy

Never Sometimes Always

1.1. The cold room has an up to date cold chain policy 33.3 11.1 55.6

1.2. All staff are trained to follow policies that ensure cold

chain compliance for vaccines.

11.1 22.2 66.7

1.3. All new staff allocated to the cold room are oriented to

the vaccine policy and procedures.

16.7 22.2 61.1

1.4. There is at least one trained individual responsible for the

receipt, Storage of vaccines and the recording of vaccines

16.7 27.7 56.6

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Tables 4.7 shows that a large number of participants, 55.6% (n=10) agree that the cold rooms

always has an up to date cold chain policy while 33.3% (n=6) indicate that the cold rooms never

has an up to date cold chain policy and a small number 11.1% (n=2) have indicated that the cold

rooms sometimes has a cold chain policy that is up to date.The results show that 66.7% (n=12)

believe that all staff are trained to follow polices that ensure cold chain compliance for vaccines

whereas only 11.1% (n=2) believe that staff are not trained and 22.2% (n=4) believe that staff are

sometimes trained to follow these policies. The results further show that 61.1% (n=11) of all new

staff allocated to the clinic are always oriented to the vaccine policy and procedures, 22.2 (n=4)

indicated that staff are sometimes trained and 16.7% (n=3) stated that new staff are never oriented

to the vaccine policy and procedures. In addition to the above, the results show that 56.6% (n=10)

of participants indicate that there is one trained individual with at least one trained deputy

responsible for the receipt and storage of vaccines and the recording of vaccines while 16.7%

(n=3) state that this is never the case and 27.7% (n=5) indicate that this is sometimes the case.

Discussion on policy

The results revealed a positive finding in that most cold rooms always have an up-to-date cold

chain policy. Only few participants disagreed with this being in place in their respective cold room.

We also find that just over 66.7 percent agreed that all staffs are trained to follow policies that

ensure cold chain compliance for vaccines whilst 11.1 percent of the sample confirmed that this

does not occur. There is comprehensive literature available on cold chain policy such as the EPI

Cold Chain Standard Operating Procedure Manual (2009) that can enable the success of

implementing the cold chain policy. It is clear from the findings of the research that many staff

lack impending the trainings and cold chain policy. Furthermore, only 61.1 percent of all new

staffs allocated to the cold room are oriented to the vaccine policy and procedures. This is an

alarming statistic and further especially considering that 22.2 percent of the respondents agree that

this sometimes happens and 16.7 percent agreed that this never happens. To ensure the success of

vaccine management this must occur at far higher percentages say at 80 to 100 percent of the time.

Unfortunately, in this study setting it is not the case, highlighting an area attention that needs to be

addressed in order to ensure the effective management of the cold chain system for vaccines.

The EPI Ethiopia Policy (2012) has been specifically written for all health care professionals and

hence it is the responsibility of all health workers to educate themselves in the cold chain policy

specific to Ethiopia. This is also highlighted in other guidelines as well (Cold Chain Module 3

WHO, 1998, Vaccine Storage and Handling Toolkit, 2012 and National Vaccine Storage

Guidelines, 2005). According to the Vaccine Storage and Handling Guide (2011: 5) staff should be

35

knowledgeable regarding vaccine storage and handling and there should be at least two staff

members who are responsible for vaccine management. This is imperative for the success of the

cold chain policy, so there must be some accountability created and encouraged.

4.3.6.2. QUESTION B2: VACCINE MANAGEMENT

This section deals with management of vaccines as listed in the thirteen criteria below. The

summarized scores are shown in Table 4.8

Table 4.8: Assessment on vaccine management

2.Vaccine Management Never Sometimes Always

2.1. Stock cards for vaccines are kept. 0 11.1 88.9

2.2. Stock cards for vaccines are correctly filled in. 16.7 27.8 55.5

2.3. Vaccines are checked for discrepancies and leakage or

damage before receiving them.

11.1 11.1 77.8

2.4. Procedures are followed for recording the date and time,

vaccine types, brands, quantities, batch numbers and expiry

dates when received.

11.1 16.7 72.2

2.5. Staffs are aware of the urgency of storing vaccines

immediately on receipt.

0 11.1 88.9

2.6. Staffs are aware of how to read and check the cold chain

monitor when unpacking vaccines.

0 16.7 83.3

2.7. There are times when vaccines are out of stock. 16.7 66.6 16.7

2.8. Vaccines are ordered by a designated person. 5.6 16.7 77.8

2.9. Vaccine stock is monitored prior to ordering 0 16.7 83.3

2.10. There are more than four weeks of stock in the

refrigerator.

16.7 38.9 44.4

2.11. Vaccines are used when the inner square is as dark as

outer circle or darker.

0 0 100

2.12. The first in first out principle applies when using and

packing vaccines.

11.1 27.8 61.1

2.13. There is a record of vaccine batches in case of recall. 22.2 16.7 61.1

Tables 4.8 shows that A large majority of participants, 88.9% (n=16) indicate that stock cards for

vaccines are always kept with only 11.1% (n=2) indicating that this is sometimes the case.55.5%

(n=10) of participants assured that stock cards for vaccines were correctly filled in, while 27.8%

36

(n=5) stated that cards are sometimes correctly filled in and a small 16.7% (n=3) of respondents

stated that stock cards are never filled in correctly.77.8% (n=14) of participants agreed that

vaccines were always checked against the order for discrepancies and leakage. 11.1% (n=2)

indicated that vaccines are sometimes checked and only 11.1% (n=2) stated that vaccines are never

checked against orders.72.2% (n=13) stated that procedures for recording the date and time,

vaccine types brands, quantities, batch numbers and expiry are always followed when vaccines are

received, while 11.1% (n=2) stated that these procedures are never followed and 16.7% (n=3)

stated that these procedures are sometimes followed.88.9% (n=16) of participants indicated that

staff are always aware of the urgency of packing vaccines immediately on receipt. 11.1% (n=2) of

EPI Focal Person\Cold chain manager stated that staff sometimes pack vaccines on receipt. A large

majority of participants 83.3% (n=15) perceived that staff are aware of how to read and check the

cold chain monitor when unpacking vaccines. 16.7% (n=3) perceived that staff are sometimes

aware to go about doing this and a negligible. A small number of participants 16.7% (n=3) stated

that there are always times when vaccines are out of stock whereas 66.6% (n=12) stated that this is

sometimes the case and 16.7% (n=3) stated that this is never the case.77.8% (n=14) of participants

stated that vaccines are always ordered by designated person. 16.7% (n=3) stated that vaccines are

sometimes ordered by a dedicated person and 5.6% (n=1) stated that there is no dedicated person

to order vaccines. The majority of the participants, 83.3% (n=15) stated that vaccine stock is

always monitored prior to ordering. 16.7% (n=3) stated that vaccine stock is sometimes monitored

before ordering .44.4% (n=8) indicated that there is always more than a four week supply in the

refrigerator while 38.9% (n=7) stated that this is sometimes the case and 16.7% (n=3) stated that

this is never the case. The majority of participants, 100% (n=18), specified that vaccines are never

used when the inner square is as dark as the outer circle or darker. A large majority 61.1% (n=11)

indicated that the first-in first-out principle applies when packing and using vaccines. 27.8% (n=5)

stated that this principle is sometimes applied with a small percentage and 11.1% (n=2) stated that

this principle is never applied.61.1% (n=11) of participants stated that in the case of recall, there is

a record of vaccine batches, while 16.7% (n=3) stated that records are sometimes kept and 22.2%

(n=4) stated that records are never kept in case of recall.

Discussion on vaccine management

The analysis reveals that the areas of strengths within vaccine management include that stock cards

for vaccines are always kept; the first-in first-out principle applies when packing and using

vaccines; vaccines are never used when the inner square is as dark as the outer circle or darker; in

the case of recall, there is a record of vaccine batches; stock cards for vaccines were correctly

filled in; vaccines were checked against the order for discrepancies and leakage; procedures for

37

recording the date and time; staff are always aware of the urgency of packing vaccines

immediately on receipt; staff are aware of how to read and check the cold chain monitor when

unpacking vaccines, vaccines are always ordered by a designated person and vaccine stock is

always monitored prior to ordering since the majority of the respondents agreed that these policies

and procedures are being adhered to. Another area of attention is that there should always be more

than a four week supply in the refrigerator because 38.9 percent of the respondents indicated that

this is only sometimes the case. Thus there seems to be a lack of proper vaccine supply monitoring

amongst the surveyed facilities. Hence, it is recommended that a specific staff take the

responsibility of maintaining the vaccine stock control and inventory. The results of this study also

revealed that 66.6 percent of the respondents stated that vaccines are sometimes are out of stock.

Again, this highlights a stock control issue amongst the cold room and it is recommended that

stock be constantly monitored as well as access to stock. It is also recommended that the facilities

have some kind of a back-up plan if access to stock becomes unpredictable. Such a back-up plan

would be to consult a private retailer of the vaccines and to perhaps purchase the vaccines at a

reduced rate. Access to stock of vaccines and control thereof has been highlighted ( Wiysonge et

al, 2012: 578).

4.3.6.3. QUESTION B3: VACCINE REFRIGERATOR

This section is concerned with maintenance of the cold chain for vaccines in the refrigerator. As

listed below, 24 criteria were used in the questionnaire for the vaccine refrigerator. In order to

present these results the criteria was divided into different themes: criteria pertaining to the

refrigerator, signage on refrigerator, temperature monitoring, storage of vaccines, interruption in

electricity supply and power failure. The summarized scores are indicated in Table 4.9.

Table 4.9: Assessment on Vaccine refrigerator

3. Vaccine refrigerator

Never Sometimes Always

3.1. The refrigerator is in working order. 0 16.7 83.3

3.2. A dedicated refrigerator is used for the Storage of

vaccines only.

0 22.2 77.8

3.3. The refrigerator is situated in a well-ventilated area, away

from sunlight and heat.

0 5.6 94.4

3.4. The refrigerator type is correct for vaccines. 0 0 100

3.5. The refrigerator is the right size to store adequate

vaccines when the demand increases.

0 11.1 88.9

38

3.6. The refrigerator temperature is within correct range of (2 -

8ºC) all the time.

0 11.1 88.9

3.7. The responses to all deviations outside (2 - 8ºC) have

been documented and the recommended actions taken.

0 22.2 77.8

3.8. There is a “do not unplug the refrigerator” sign next to the

refrigerator.

0 0 100

3.9. Vaccines and are stored correctly. 0 16.7 83.3

3.10. Vaccines are stored on the door. 0 11.1 88.9

3.11. Food or cool drinks are stored in the same refrigerator

that is used to store vaccines.

0 16.7 83.3

3.12. The refrigerator is either lockable and locked or stored in

a locked room.

11.1 27.8 61.1

3.13. A refrigerator temperature chart is present with

recording.

0 11.1 88.9

3.14. The temperature chart is filled in twice daily. 0 5.6 94.4

3.15. Electricity supply to the refrigerator is safe examples-

switchless plugs, cautionary notices are in place.

44.4 16.7 38.9

3.16. Arrangements are in place in the event of a refrigerator

or power failure.

33.3 22.2 44.5

3.17. The refrigerator is correctly packed with air circulating

between the vaccines.

0 22.2 77.8

3.18. There are records of regular refrigerator servicing,

defrosting and cleaning available.

38.9 11.1 50

3.19. A working dial thermometer is present in the center of

the refrigerator.

0 50 50

3.20. There are no expired vaccines in refrigerator. 0 11.1 88.9

3.21. There is a sticker on the door to remind staff to open the

door only when necessary.

55.5 16.7 27.8

3.22. Vaccines are in their original packaging box and include

the information leaflet.

0 0 100

3.23. The Cold-rooms have a back-up system in case of power

failure.

44.4 16.7 38.9

3.24. The refrigerator has an alarm which is activated when

the temperature exceeds 8 degrees Celsius (8ºC) and falls

16.7 55.5 27.8

39

below 2 degrees Celsius (2ºC).

As it has been mentioned in the table 4.9,100 %( n=18) of participants agreed the correct type of

refrigerator is always used to store vaccines.88.9% (n=16) of participants agreed that the

refrigerator is the correct size for storage of vaccines, 11.1% (n=2) indicated that this is sometimes

the refrigerator is the correct size for storage of vaccines. A large majority of participants, 83.3%

(n=15) indicated that the refrigerator is always in working order, 16.7% (n=3) indicated that this is

sometimes the refrigerator is in working order.77.8% (n=14) of participants agreed that the

refrigerator is always dedicated for storage of vaccines only, with 22.2% (n=4) indicating

sometimes dedicated for storage of vaccines only.50% (n=9) of participants agreed that there are

always records of regular servicing, defrosting and cleaning of the refrigerator, while 11.1% (n=2)

agreed that this is sometimes the case and 38.9% (n=7) that this is never the case .94.4% (n=17) of

participants responded that the refrigerator is situated in a well-ventilated area, away from sunlight

and heat. 5.6% (n=1) agreed this is sometimes the refrigerator is situated in a well-ventilated area,

away from sunlight and heat.27.8% (n=5) of participants agreed that the refrigerator is always

fitted with an alarm to detect cold chain breaches, 55.5% (n=10) responded never and 16.7% (n=3)

responded sometimes.61.1% (n=11) of participants stated that the refrigerator is always either

locked or stored in a lockable room.27.8% (n=5) responded sometimes and 11.1% (n=2) responded

never. Based on the results obtained from the assessment, 88.9% (n=16) of participants responded

that the temperature chart is always placed on the refrigerator and recordings were kept. 11.1%

(n=2) responded sometimes.94.4% (n=17) of participants responded that the temperature of the

fridge is always documented twice daily on the temperature chart.5.6% (n=1) responded

sometimes.88.9% (n=16) of the participants responded that the refrigerator is always within the

correct temperature range of two degrees to eight degrees Celsius 11.1% (n=2) responded

sometimes.77.8% (n=14) of participants responded that deviations in the refrigerator are

documented and necessary actions are always taken. 22.2% (n=4) responded sometimes.50% (n=9)

of participants responded that there is a working dial thermometer in the center of the refrigerator.

50% (n=9) responded sometimes. Regarding on the signage of refrigerator, in 27.8% (n=5) of

participants responded that there is always signage on the refrigerator informing staff not to open

“vaccine fridge”.16.7% (n=3) of the participants responded sometimes and 55.5% (n=10)

responded never. In 100% (n=18) of participants responded that there is always a “do not unplug”

sign on the vaccine refrigerator. Regarding on interruption in electricity supply and power failure,

38.9% (n=7) of participants responded that the electricity supply to the refrigerator is always safe.

16.7% (n=3) responded sometimes and 44.4% (n=8) responded never.38.9% (n=7) of participants

40

responded that there is a backup system in place for vaccine management in case of power failure.

16.7% (n=3) responded sometimes and 44.4% (n=8) responded never.44.5% (n=8) of participants

responded that arrangement were in place in case of refrigerator failure or power failure. 22.2%

(n=4) responded sometimes and 33.3% (n=6) responded never. The majority of participants, 88.9%

(n=16) responded that there is always no vaccines stored on the door of the refrigerator. 11.1%

(n=2) of participants responded sometimes.83.3% (n=15) of participants agreed that no food or

cool drinks were ever stored in the refrigerator. 16.7% (n=3) responded sometimes.77.8% (n=14)

of participants responded that vaccines are always correctly packed in refrigerator with air

circulating in between vaccines while 22.2% (n=4) responded sometimes.88.9% (n=16) of

participants responded that there is always no expired vaccines in the refrigerator while 11.1%

(n=2) responded sometimes. The majority of participants, 100% (n=18) responded that vaccines

were always in their original packaging and included the information leaflet. The majority of

participants, 83.3% (n=15), responded that vaccines and diluents were always stored correctly

while 16.7% (n=2) responded sometimes.

Discussion on vaccine refrigerator

Many of the criteria‟s were being adhered to. The criteria not being adhered to in the surveyed cold

rooms will now be discussed. The study found that 50 percent of the respondents agreed that there

were always records of regular servicing, defrosting and cleaning of the refrigerator. The

refrigerator is the life of the vaccine and it must be well maintained in the clinics at all times.

Furthermore, it was evident in the surveyed cold rooms that only 27.8 percent of respondents

agreed that the refrigerator is always fitted with an alarm to detect cold chain breaches. Only 61.1

percent of the respondents agreed that the refrigerator is always either locked or stored in a

lockable room. These issues can be easily solved in the cold rooms by maintaining an efficient

refrigerator with proper principles and good technical staff with the training to fix issues early

(WHO 2005: 79; Vaccine Storage and handling Guidelines, 2011: 5). Furthermore, it was evident

in these cold-rooms that there was no regular inspection and quality control of their refrigerators.

This must now be implemented i.e. an inspection audit of the refrigerators where the vaccines are

being stored must be conducted regularly. The current study reveals that in 100 percent of the

participants responded that there was No signage on the refrigerator informing staff “DO NOT TO

OPEN VACCINE FRIDGE” as well as “DO NOT UNPLUG” sign on the vaccine fridge. These

percentages are below the norm indicating that signage on the refrigerators needs to improve. In

the observation study it was also highlighted that in all of the cold-rooms there was no “DO NOT

UNPLUGS” signage on the refrigerator plug and no signage on fridge door stating “DO NOT

OPEN VACCINE FRIDGE”. This is indicative of poor cold chain management for vaccines thus

41

indicating that signage on the refrigerators needs urgent improvement. The National Vaccine

Storage Guidelines Strive for Five (2005: 10) states that the vaccine fridge must be clearly marked

“DO NOT turn off or disconnect the vaccine fridge”. Accidental disconnection from the power

source can cause heat damage to vaccines, especially if this goes unnoticed for a long period. The

guidelines further state that vaccine refrigerators must have the sign “VACCINE

REFRIGERATOR DO NOT OPEN”. Reducing the number of times the fridge door is opened,

helps to maintain the internal temperature of the fridge (Nelson et al., 2004). It is recommended

that the signage be bold so that visibility is not a problem and hence the proper guidelines can be

followed. Lastly it is noted that at the cold rooms, only 38.9 percent indicated that there is a back-

up system in place for vaccine management in case of power failure. It is evident that the cold

rooms do not have generators or a contingency plan like solar power panels in case of a power

failure in order to protect their vaccines. Measures must now be implemented to deal with issues

such as power failure which is prevalent in Ethiopia). To address this, finances must be allocated

in order to purchase generators or solar panels to act as a back-up just in case of power failures.

4.3.6.4. QUESTION B4: COLD BOXES

This section deals with the management of vaccines in the cold box during an immunization

session. These results are presented in Table 4.10

Table 4.10: Assessment on Cold boxes

4. Cold boxes Never Sometimes Always

4.1. An adequate number of cooler boxes are available. 11.1 22.2 66.7

4.2. Cooler boxes are in a good condition and not damaged. 16.7 27.8 55.5

4.3. Are sufficient packs are available e.g. 6 and more 0 11.1 88.9

4.4. The temperature in the cooler box is between 2-8 degrees

Celsius (2 - 8ºC).

11.1 27.8 61.1

4.5. Records of regular checking of the cooler box are available. 33.3 27.8 38.9

4.6. Reconditioned ice packs are used. 5.6 11.1 83.3

4.7. Vaccines are correctly packed in the cooler box. 0 22.2 77.8

4.8. A dial thermometer is available for cooler boxes and is

working.

11.1 33.3 55.6

In regard to cold boxes, the results show that 66.7% (n=12) believe that there is always an

adequate number of cooler boxes available while 22.2% (n=4) believe that there is sometimes an

adequate number of cooler boxes available and 11.1% (n=2) believe that there is never an adequate

42

number of cooler boxes available. 55.6% (n=10) of participants believe that cooler boxes are in a

good condition while 27.8% (n=5) believe that cooler boxes are in a good condition sometimes and

16.7% (n=3) believe that cooler boxes are never in a good condition. A large number of

participants 88.9% (n=16) state that there are always sufficient ice packs available while 11.1%

(n=2) state that there are sometimes sufficient packs available. The majority of participants 61.1%

(n=11) indicated that the temperature in the cooler box is between two to eight degrees Celsius

while 27.8% (n=5) indicated that this is sometimes the case and 11.1% (n=2) indicated that the

temperature is never the case.38.9% (n=7) of participants state that records of regular checking of

the cooler box are available while 27.8% (n=5) stated that these records are sometimes available

and 33.3% (n=6) indicated that these records are never available.83.3% (n=15) of participants

indicated that reconditioned ice packs are always used, 11.1% (n=2) stated that reconditioned ice

packs are sometimes used and 5.6% (n=1) stated that reconditioned ice pack are never used.A large

majority 77.8% (n=14) of participants stated that vaccines are always correctly packed in the

cooler box, 22.2% (n=4) that they are sometimes packed correctly.The results show that 55.6%

(n=10) stated that a dial thermometer is always available for cooler boxes and is working, 33.3%

(n=6) stated that thermometer is sometimes available and 11.1% (n=2) indicated that thermometer

is never available.

Discussion on cold boxes

The surveyed facilities revealed that seven out of the eight criteria for the management of vaccines

in the cold box during immunization session were adhered to. The area that was not properly

adhered to is that of records of regular checking of the cooler box. In the current study 38.9 percent

of nurses stated that records of regular checking of the cooler box are available, 27.8 percent stated

that these records are sometimes available and 33.3 percent indicated that these records are never

available. To resolve the issue of regular checking of records of the cooler box it is suggested that

facilities appoint a member of staff who will perform this task efficiently (Cold chain and

immunisation manual, 2003; Vaccinators manual, 2012).

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CHAPTER FIVE: CONCLUSION AND RECOMMENDATION

5.1. CONCLUSION

The basis for any cold chain management activity is maintaining of the product with in

recommended storage condition to administer potent and quality vaccines to clients. Without

capable personnel to properly manage cold chain equipments guided by stipulated procedures, all

cold chain activities end in futility as sub-potent vaccines end up being administered to clients.

Cold manager/EPI staff plays a vital role in the maintenance of the cold chain to ensure the

efficacy and safety of vaccines administered. Maintaining cold chain standards is vital given the

large number of children they services and the cost attached to these vaccines.

The results of the study demonstrate that the cold chain for vaccines is not maintained effectively

thus vaccines are compromised. One of the most significant findings of the study is the need for in-

service training and refresher courses for Cold manager/EPI staff on cold chain management for

vaccines. These courses and in-service training must be based on National, Provincial and

Standard Operating Guidelines for vaccine management. Furthermore, there were no contingency

plans to deal with lack of equipment and electricity issues, no monitoring and evaluation systems,

poor recording keeping, poor management of the cold boxes and refrigerators and poor access to

stock. Some of the findings were similar to the observation study. These included issues

surrounding equipment and electricity, monitoring and evaluation systems, poor record keeping

and poor access to stock. It is recommended that ongoing training for staff on vaccine management

be conducted. Regular audits must be conducted by EPI coordinators/cold managers. Overall from

the findings of the study, it can be conclude that there were vaccine cold chain management

practice problems in maintaining the recommended temperature range, temperature monitoring,

well-functioning of the cold chain equipments and vaccine storage and handling practice in public

health facilities of N/S/L/Sub city, Addis Ababa, Ethiopia

5.2. RECOMMENDATIONS

In order to have an effective cold chain management practice three things are required. These are

personnel, cold chain equipment, policies and procedures. In addition there should be monitoring

and evaluation system of the cold chain. Hence the recommendations given will be:

Regarding the personnel; the cold chain will function well if there is a well trained professional. It

is expected to train the health professionals who are involved in the management of cold chain and

who didn‟t take the training on cold chain management practice

44

Regarding the cold chain equipments, as it has been observed from the assessment done, there are

a number of nonfunctional cold chain equipments at facilities. Therefore, there should be supply of

refrigerators for those who didn‟t have functional refrigerator. In addition the nonfunctional cold

chain equipments like refrigerators, generators, etc. should be repaired and maintained. For this to

be effective medical equipment technician should be assigned at least at woreda for immediate

response

Regarding the policies and procedures, there must be a written record of these reviews which

identifies problems and records actions taken.

Regarding the monitoring and evaluation system, there should be program specific regular

supportive supervision on vaccine cold chain management practice at facilities from N/S/L/Sub

city Health Department, Addis Ababa Health Bureau and EPSA and based on the findings from the

supervision, the required action should be taken.

One of the most significant findings of the study is the issue of education. Cold room staff needs

training and refresher courses with respect to the vaccine management. This education can be in

the form of training workshops. The access to and control of vaccine stock is an imperative issue

within the findings of the research. Although stock cards are available at the cold rooms in some

they are incomplete or incorrectly filled in. It is recommended that cold rooms appoint and train a

member of staff who will monitor and access the vaccine stock on a regular basis. Thus, there has

to be a proper inventory system in place in order to facilitate the usage of childhood vaccinations.

Another significant finding in the research is that of the signage on the vaccine refrigerator. There

has to be clear and concise signage on the vaccine refrigerator so that proper cold chain policy

guidelines can be followed. Thus, it is recommended that a member of staff take the responsibility

for placing the correct signage on the refrigerators. This will include signage on the fridge stating

“VACCINE FRIDGE DO NOT OPEN” and on the plug on the wall “VACCINE FRIDGE DO

NOT UNPLUG” (The National Vaccine Storage Guidelines Strive for Five 2005: 10).It was also

noted that facilities do not have a back-up plan in the event of a power outage. It is recommended

that facilities be supplied with generators or install solar panels, in order to ensure that the

refrigerators continue to keep running. Finally, the research also reveals that records of regular

checking of the cooler box should be visible. In addition, members of staff should be instructed to

take the responsibility of keeping these records and they should be constantly checking and

validating these records. A thermometer must be placed in the center of the cold box and the

temperature must be monitored and recorded hourly while on transport (Rogers et al., 2010).

45

APPENDIX 1 – Questionnaire for the Cold Chain Management of Vaccines

Instructions to be followed in completing this questionnaire

Section A: Demographic Information

Please select the most appropriate response

1.Date:__________

2. Your age:

20 to 25 years

26 to 30years

31 years and above

3. Work

Experience

0 to 5 years 6 to 10 years 11 years and above

4. Your Gender: Male Female

5. Training in vaccine management: YES NO

6. Involved in vaccine management: YES NO

SOMETIMES

Section B: Vaccine Management.

Please tick the option that best describes your response to the following statements

1. Policy

Never Sometimes Always

1.1. The cold room has an up to date cold chain policy

1.2. All staff are trained to follow policies that ensure cold

chain compliance for vaccines.

46

1.3. All new staff allocated to the cold room are oriented to

the vaccine policy and procedures.

1.4. There is at least one trained individual responsible for the

receipt, Storage of vaccines and the recording of vaccines

2.Vaccine Management Never Sometimes Always

2.1. Stock cards for vaccines are kept.

2.2. Stock cards for vaccines are correctly filled in.

2.3. Vaccines are checked for discrepancies and leakage or

damage before receiving them.

2.4. Procedures are followed for recording the date and time,

vaccine types, brands, quantities, batch numbers and expiry

dates when received.

2.5. Staff are aware of the urgency of storing vaccines

immediately on receipt.

2.6. Staff are aware of how to read and check the cold chain

monitor when unpacking vaccines.

2.7. There are times when vaccines are out of stock.

2.8. Vaccines are ordered by a designated person.

2.9. Vaccine stock is monitored prior to ordering

2.10. There are more than four weeks of stock in the

refrigerator.

2.11. Vaccines are used when the inner square is as dark as

outer circle or darker.

2.12. The first in first out principle applies when using and

packing vaccines.

2.13. There is a record of vaccine batches in case of recall.

3. Vaccine refrigerator

3.1. The refrigerator is in working order.

3.2. A dedicated refrigerator is used for the Storage of

vaccines only.

3.3. The refrigerator is situated in a well-ventilated area, away

from sunlight and heat.

3.4. The refrigerator type is correct for vaccines.

47

3.5. The refrigerator is the right size to store adequate

vaccines when the demand increases.

3.6. The refrigerator temperature is within correct range of (2 -

8ºC) all the time.

3.7. The responses to all deviations outside (2 - 8ºC) have

been documented and the recommended actions taken.

3.8. There is a “do not unplug the refrigerator” sign next to the

refrigerator.

3.9. Vaccines and are stored correctly.

3.10. Vaccines are stored on the door.

3.11. Food or cool drinks are stored in the same refrigerator

that is used to store vaccines.

3.12. The refrigerator is either lockable and locked or stored in

a locked room.

3.13. A refrigerator temperature chart is present with

recording.

3.14. The temperature chart is filled in twice daily.

3.15. Electricity supply to the refrigerator is safe examples-

switchless plugs, cautionary notices are in place.

3.16. Arrangements are in place in the event of a refrigerator

or power failure.

3.17. The refrigerator is correctly packed with air circulating

between the vaccines.

3.18. There are records of regular refrigerator servicing,

defrosting and cleaning available.

3.19. A working dial thermometer is present in the center of

the refrigerator.

3.20. There are no expired vaccines in refrigerator.

3.21. There is a sticker on the door to remind staff to open the

door only when necessary.

3.22. Vaccines are in their original packaging box and include

the information leaflet.

3.23. The Cold-rooms have a back-up system in case of power

failure.

48

3.24. The refrigerator has an alarm which is activated when

the temperature exceeds 8 degrees Celsius (8ºC) and falls

below 2 degrees Celsius (2ºC).

4. Cold boxes Never Sometimes Always

4.1. An adequate number of cooler boxes are available.

4.2. Cooler boxes are in a good condition and not damaged.

4.3. Are sufficient packs are available e.g. 6 and more

4.4. The temperature in the cooler box is between 2-8 degrees

Celsius (2 - 8ºC).

4.5. Records of regular checking of the cooler box are

available.

4.6. Reconditioned ice packs are used.

4.7. Vaccines are correctly packed in the cooler box.

4.8. A dial thermometer is available for cooler boxes and is

working.

Comments:

APPENDIX 2 – Observation Study Guidelines

Date: ________________________

1.Policies, procedures and guidelines

Yes No

1.1 Policies, procedures and guidelines available for vaccine management.

Examples- guidelines for vaccine management according to global, national

and standard operating procedures. Evidence of instruction and training on

policy and operating procedures on orientation and on-going. Researcher

will request this.

1.2. Are contingency plans in place for problems with equipment/electricity

used in the cold chain management of vaccines?

Examples: Power outages and the break-down of refrigerators. (Gas

49

cylinders, generators available) Policy on what to do if problems

encountered.

1.3. Is there evidence of maintenance to cold chain equipment available?

Example: Evidence of servicing and testing of equipment.

1.4. Is there evidence of filling in of stock cards for vaccines?

Example: Evidence of recording of stock.

1.5. Is there evidence of physical inventories of vaccine stock?

Example: Evidence of stock balances.

1.6. Is there evidence of dedicated room for vaccine Storage

1.7. Is vaccine wastage managed according to policy?

Example: Written evidence is available.

1.8. Are there vaccine wastage reports available?

Example: Reports are available.

1.9 Is there evidence of records of in case of recall /batch numbers for

vaccines

1.10 Is there evidence of good vaccine records i.e. temperature records,

training record, cold room service reports?

2. Vaccine arrival procedure Yes No

2.1. Does the EPI Focal Person\Cold chain manager respond immediately

when vaccines arrive in Cold-room?

2.2. Does the EPI Focal Person\Cold chain manager check vaccines for

discrepancies, leakage and breakage before receipt?

2.3. Are vaccines stored immediately on receipt?

2.4. Are vaccines packed according to the first-in first-out principle?

NB. This will be observed when vaccines arrive in the cold room. If no

vaccines arrive then the researcher will record not applicable.

3. Refrigerator Yes No

3.1. Is the refrigerator appropriate to store vaccine? Size, freezer

compartment for icepacks.

3.2. Is the refrigerator is dedicated for vaccines only? No other drugs

3.3. Is the refrigerator temperature between (2 - 8ºC)?

3.4. Is the temperature of the refrigerator recorded on chart twice daily?

3.5. Is the refrigerator packed correctly with vaccines and diluents?

3.6. Is the refrigerator overstocked?

50

3.7. Are there vaccines in the door?

3.8. Are vaccines frozen?

3.9 Is the refrigerator in a locked room or does the fridge have a lock and

key?

3.10 .Is there a working thermometer hanging in correct place?

NB. When the EPI Focal Person\Cold chain manager opens the

refrigerator to take out or pack vaccines the above will be observed.

4. Cold box Yes No

4.1. Is the cold boxes in a good condition and right size?

4.2. Is there a working thermometer in the cold box?

4.3. Is the temperature of the cold box between 2-8 degrees?

4.4. Is the cold box packed correctly i.e. 6 ice packs?

51

52

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