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Development of a computerized provider order entry system for laboratory

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par Gérard Bisama Mutshipayi
University of Ghana - Master of Science (MSc) 2015
  

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SCHOOL OF PUBLIC HEALTH

COLLEGE OF HEALTH SCIENCES

UNIVERSITY OF GHANA, LEGON

DEVELOPMENTOF A COMPUTERIZED PROVIDER ORDER ENTRY SYSTEM FOR LABORATORY

BY

GERARD BISAMA MUTSHIPAYI

(10509422)

A PROJECT WORK SUBMITTED TO

THE SCHOOL OF PUBLIC HEALTH, COLLEGE OF HEALTH SCIENCES, UNIVERSITY OF GHANA, LEGON, IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE AWARD OF MASTER OF HEALTH INFORMATICS

JULY 2015

DECLARATION

I Gérard Bisama Mutshipayi the author of this dissertation, do hereby declare that with the exception of references to the literature and works of other researchers which have been duly cited the work in this dissertation is the result of my original work.

Gérard Bisama Mutshipayi ........................................

(Student) (Supervisor)

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

Date: ......................... Date: ...........

DEDICATION

For my family, the reason I wrote this dissertation and the raison I was able to. Francine Kukamba Kawesi, my lovely wife and Ethan Mutshipayi Bisama, my son. My parents Alphonse Mutshipayi and Josée Bakafua, I can barely find the words to express all the wisdom and support you have given me.

This work is dedicated to you.

ACKNOWLEDGEMENT

I am very grateful to all individuals and groups who contributed to making this study a successful one.

First and foremost, all my thanks to God. You have given me the strength to believe in my passion and pursue my dreams. I could never have done this without the faith I have in you, the Almighty.

A special thanks to my supervisor Mr. Seth K. Afagbedzi, for his guidance, assistance and counsel. Without his continuous support and assistance it would not have been possible to finish this dissertation.I also thank all lecturers for the knowledge imparted to me.

Thanks to all MHI course mates for their contribution and advices.

I would like to thank all my friends, especially Mary Anita Quist, for her support in the academic work.Thanks to Patrick Tshibangu, my friend, roommate and compatriot for listening, offering me advices.

Finally, we are extend our most sincere gratitude to the BEBUC (Bourse d'Excellence Bringmannaux Universités Congolaise) scholarship program and The Holger-Poehlmann-Foundation for supporting this master program financially and morally, particular thanks to Prof. Gerhard Bringmann and Prof. Mudugo Virima respectively the president and the vice-president of BEBUC. To all members of the BEBUC panel I express also my gratitude.

1. ABSTRACT

The laboratory services play important role in health care provision since it provides clinicians and other health care professional information that will help them to detect disease and to confirm or reject the diagnostics. (McPherson & Matthew R. Pincus, 2011). Managing the follow up of radiological as well as diagnostics test is a complex process since it requires information exchange between different health care practitioners across different services within the health facilities. (Callen, Georgiou, Li, & Westbrook, 2011). Error in the management of laboratory result can carries a risk of harm of patient life and these errors are more present to the pre and post-analytical steps of the total testing process then during the chemical analytical phases inside the laboratory. (Plebani, 2009)

In this study, we havedevelopeda Computerized Provider Order Entry (CPOE) systemto capture and shared laboratory data of the patient across clinical services in the district hospital by the automation of the main pre and post analytical process that are main source of errors. We have focused a particular attention of the modelling of the workflow to identify business process that involve communication between different services and the laboratory. Through the analysis of business process we have identify the main actors and describe the system requirements. A particular attention has been paid to improve patient communication in the proposed workflow.

The system was designed using C# programming language over .Net Framework 4.0 and PostgresSQL to capture patient and laboratory order data from the Out-patient department to patient assignment in clinical services. The result of lab test also has been captured andShort Message Service (SMS) and email notification features have been integrated to send information to both patient and clinician where the lab result was available.

TABLE OF CONTENTS

DECLARATION

DEDICATION ii

ACKNOWLEDGEMENT iii

ABSTRACT iv

TABLE OF CONTENTS vi

LIST OF FIGURES ix

LIST OF TABLES xi

LIST OF ABBREVIATIONS xii

CHAPTER 1 1

1. INTRODUCTION 1

1.1. Background 1

1.2. Problem statement 5

1.3. Framework of the laboratory test order management system 7

1.4. Justification of the study 9

1.5. Objectives 11

1.5.1. General objectives 11

1.5.2. Specific objectives 11

CHAPTER 2 12

2. LITERATURE REVIEW 12

2.1. The use of automated laboratory data management with an EMR 12

2.2. The benefits of improving laboratory data management on the patient safety in care delivery 13

2.3. The importance of laboratory data for public health monitoring of diseases and epidemics 14

2.4. The benefits of Electronic Health Record and problems associated with their implementation. 15

2.5. The mobile Health (mHealth) 16

2.5.1. Cell phone text messages for communication of lab results in Uganda 16

2.5.2. The Mobile Technology for Community Health (MoTeCH) Initiative in Ghana 17

2.6. The common categories of Computerized Provider Order Entry (CPOE) 18

2.7. Works on the design and implementation of Health Information system 19

2.7.1. Design of the Open Medical Record System (OpenMRS) to support HIV treatment in Rwanda 19

2.7.2. The LabPush system in Swaziland 21

2.7.3. Design of an application for the chemotherapy treatment process at University Hospital of Geneva 22

2.8. Conclusion 24

CHAPTER 3 26

3. METHODOLOGY 26

3.1. Data collection 26

3.2. System development life cycle 28

3.3. The planning phase 29

3.4. The analysis phase 30

3.4.1. The existing situation 30

3.4.2. Improvements identification 31

3.4.3. Requirements definition 31

Business requirements 32

Functional requirements 32

Nonfunctional requirements 34

3.5. System design 35

3.5.1. System Architecture 35

3.5.2. The process modelling 36

Activity Diagrams 37

Use case diagrams 38

Class diagrams 41

Sequences diagrams 43

3.5.3. The data modelling 45

Conceptual data design 45

Logical data design 48

Physical data design 52

CHAPTER 4 53

4. SYSTEM DEVELOPMENT 53

4.1. The users and system administration module 54

4.2. The medical staff management module 56

4.3. The patient management module 57

4.4. The appointment and consultation module 58

3.1. The laboratory test order management module 59

4.5. The laboratory test result management module 61

4.6. The report module 65

CHAPTER 5 67

5. DISCUSSION 67

5.1. The design consideration 67

5.2. Benefits of the system 68

5.3. Limitation 69

5.4. Future works 69

6. CONCLUSION AND RECOMMENDATION 71

6.1. Conclusion 71

6.2. Recommendation 72

Reference 74

LIST OF FIGURES

Figure 1.1:Adapted framework of CPOE system in the district hospital 2

Figure 3.2: System architecture 36

Figure 3.3: Activity diagram 38

Figure 3.5: Use case diagram for patient and medical staff management subsystem 39

Figure 3.6: Use case diagram for the laboratory test order management subsystem 40

Figure 3.8: Use case diagram for the lab order result management subsystem 41

Figure 3.9: Class diagram for the user's management package 42

Figure 3.10: Class diagram for the location package 42

Figure 3.11: Class diagram for the order and result management package 43

Figure 3.12: Sequence diagram for order laboratory test scenario 44

Figure 3.13: Sequence diagram for record lab test result scenario 45

Figure 3.14: First ER diagram 47

Figure 3.15: Final ER diagram 50

Figure 4.2: System login form 55

Figure 4.3: Main form of the system 55

Figure 4.4: Users security system access configuration 56

Figure 4.5: User change password form 56

Figure 4.6: Medical staff personal details registration 57

Figure 4.7: Patient search form 58

Figure 4.8: Patient registration form 58

Figure 4.9: Patient assignment to clinician 59

Figure 4.10: Laboratory test group order for a patient. 60

Figure 4.11: List of order place by a clinician 60

Figure 4.12: Laboratory specimen deposit record 62

Figure 4.13: Lab result record and notification 62

Figure 4.14: SMS lab result notification format for the patient 63

Figure 4.15: SMS lab result notification format for the clinician 63

Figure 4.16: E-mail lab notification format for the patient 63

Figure 4.17: E-mail lab result notification format for the clinician 64

Figure 4.18: Lab result view and treatment registration form 64

Figure 4.19: Resend of lab result notification to patient and/or clinician 65

Figure. 4. 20: Patient lab history report 66

Figure. 4. 21: Case-based surveillance reporting form 66

LIST OF TABLES

Table 3.1: List of laboratory tests for malaria, tuberculosis and HIV based on WHO IDSR and CDC.(CDC, 2015a, 2015b)(CDC, 2014a, 2014b)(WHO & CDC, 2010)(CDC, 2012)(Caminero, 2005) 2

Table 3.2: Recommended minimum data element of patient identification based on WHO RSS. (WHO, 1999) 28

Table 3.3: List of attributes of the first ER diagram 48

Table 3.4: List of attributes of the final ER diagram 52

LIST OF ABBREVIATIONS

AFB

:

Acid-Fast Bacilli

API

 

Application Programming Interface

ARV

:

anti-retroviral

CDC

:

Centers for Disease Control and Prevention

CPR

:

computerized patient record

CPOE

:

Computerized Provider Order Entry

DBDL

:

Data Base Definition Language

DST

:

Drug susceptibility testing

EHR

:

Electronic Health Record

eLAB

:

electronic Lab order Entry Management

ELR

:

electronic laboratory reporting

e-mail

:

electronic mail

EMR

:

Electronic Medical Record

ER

:

Entity relationship

ELISA

:

Enzyme-linked Immunosorbent Assay

GHS

:

Ghana Health Service

HIS

:

health information system

HL7

:

Health Level 7

HIV

:

human immunodeficiency virus

ICT

:

Information and Communication technologies

IS

:

information system

IDSR

:

Integrated Disease Surveillance and Response

IHE

:

Integrating Healthcare Enterprise

IIBA

:

International Institute of Business Analysis

LOINC

:

Logical Observation Identifiers Names and Codes

MOH

:

Ministry of Health

MDR

:

Multi drug resistance

NAA

:

Nucleic acid amplification

OpenMRS

:

Open Medical Record System

PC

:

personal computer

PIN

:

Personal Identification Number

PCR

:

Polymerase Chain Reaction

RDT

:

Rapid diagnostic test

RSS

:

Recommended Surveillance Standard

RDBMS

:

Relational Database Management System

SMS

:

Short Message Service

SQL

:

Structured Query Language

SNOMED-CT

:

Systematized Nomenclature of Medicine-Clinical Terms

SDLC

:

systems development life cycle

HUG

:

the University Hospitals of Geneva

TB

:

Tuberculosis treatment

UML

:

Unified Modeling Language `

USA

:

United States of America

USB

:

Universal Serial Bus

WB

:

Western blot tests

WHO

:

World Health Organization

CHAPTER 1

2. INTRODUCTION

2.1. Background

The laboratory services play important role in health care provision and an estimation of 70% of all medical decisions made by clinicians are based on the results of laboratory test. The laboratory provides clinicians and other health care professionals information that will help them to detect disease or predisposition to a certain disease, to confirm or reject as diagnostics, to establish prognostic and to monitor efficacy of therapy followed by a patient.(McPherson & Matthew R. Pincus, 2011)

Managing the follow up of radiological test as well as diagnostics test is a complex process since it requires information exchange between patients, doctors, nurses and laboratory technician using a combination of information systems, including paper-based, telephone and electronic systems. This environment with multiple steps, players and information systems increases the risk of errorswhich could lead to suboptimal clinical outcomes. It is also shown that the rate of missed results test is highin hospitals which used entirely paper-based systems and in those which used amixture of paper and electronic systemsdue to the error in the communication workflow between actors within the health care setting. (Callen et al., 2011)

In a qualitative study conducted in United States of America (USA) in 2010 by Nancy C. Elder and al, practicingfamily physicians confirm that the implementation of an Electronic Medical Record (EMR) was the most important achievementdone to decrease testing process errors. Custom results management information systems have been reported to improve both physician and patient satisfaction then a standard EMR.(Elder, Mcewen, Flach, Gallimore, & Pallerla, 2010).

Computerized providerorder entry (CPOE)allows medical staff to enter electronically orders for medications, diagnostic tests, and regiments as well as procedures before a surgery, with the objective to improve the clarity and specificity of physician orders, to facilitate the rapid communication of orders, and to providesignificantly enhanced decision support capabilities compared to traditional handwritten orders.(Maslove, Rizk, & Lowe, 2011)

Continuous quality audit requirementssuch as electronic system that providescapacity for clinicians to acknowledge that they have viewed test results and document their follow-up actions in the systemhasbeen advocated to improve the communication workflow in the management of test result. But many facility still continue to use the traditional practice in the laboratory result management andone of the most used is to telephone results for urgent or critical tests to clinician. It has proved to be time-consuming with potential for errors and the one of using mobile phone calls has also been proved to be expensive.(Callen et al., 2011)

The computerized system for managing the laboratory test result do not solve the communication process problem between actor involved in patient care even if some improvement has been recognized. A systematic review conducted in 2011 on the implication of missed test result for hospitalized patient, reveals that by replacing the telephone call notification of urgent laboratory result with a computer system,28.8%(529/1836) of the urgent biochemistry lab results during a six-month period were never accessed. The radiology follow-up assessment using an email alert system for important radiology investigation reported that 20.0% (10 598/52 883) of email were not viewed by the referring physician.(Callen et al., 2011)

The communicationbetween health care providers and patients isalso an essential component of the patient care. Traditionally, face-to-face and telephone communication have been the primary means for the patients to interact with their health providers. However, with advances in technology, internet applications for communications, particularly electronic mail (e-mail) or mobile technology like Short Message Service (SMS) can be also used as viable media for patient communication. While benefits of e-mails in enhancing communication were recognized by both patients and providers, concerns about confidentiality and security were also expressed.(Ye, Rust, Fry-Johnson, & Strothers, 2009)

In rural and resource-limited settings area of Africa, where internet still present some logistic problems, the widespread availability of mobile communication, along with its ease of use and relatively low cost make it a promising medium to improve health related communications.(Siedner, Haberer, Bwana, Ware, & Bangsberg, 2012)Recently severalinitiatives has been conducted to Internet connectivity to a growing number of remote locations within the rural area but the internet traffic demands was not able to deliver basic quality services needed for simple web application due to the poor infrastructure, lack of economic interest from telecommunication providers and lack of the governmental support result in a relatively disconnection in large part of rural area.(Johnson, Pejovic, & Belding, 2011)

Cell phone text message (SMS) is been demonstrate to be an important tool to improve communication with patient and to solve challenges related to transportations and access to clinicians in rural area. In a study conducted in southwestern Uganda in 2012 to assess the acceptability of using SMS for communication with human immunodeficiency virus (HIV)-infected patients, all participants expressed interest to receive information about laboratory results by cell phone text message, stating benefits of increased awareness of their health statusand decreased transportation costs due to the reduction of movement between the house and the health facility.(Siedner et al., 2012)

Even though issues related to privacy and confidentiality of information has been raised, some measures like the use of the Personal Identification Number (PIN) code and deletion of the message after receiving the notification have been retained as measures to protect confidentiality.(Siedner et al., 2012)

Despite of EHR benefits, in most African country, public and private hospitals are still running paper based system for laboratory order or semi-automated system combining stand alone or web application and use of email to share result between clinicians and laboratories technician. Only a few established ones has implemented an Electronic Medical Record (EMR) or a Computerized Provider Order Entry system for radiology, pharmacy and laboratory department.(Jiagge, 2007)

In Ghana thereare four main categories of health care delivery systems:«the public, private-not-for-profit, private-for-profit, and traditional systems» centered on the Ministry of Health (MOH). The MOH is the policy maker body and all the health sector actors are responsible to it. MOH uses the Ghana health service for the implementation of the policies. Established by the Ghana Health Service and Teaching Hospitals Act 525, 1996, the Ghana Health Service (GHS) is responsible for the administration and management of the hospitals owned by the government and excluding teaching hospitals and quasi-state institutions such as the universities and security services (Military and police hospital).(MOH Ghana, 2009)

The health services are organizedon a three-tier system of care; from primary through secondary to tertiary services. They are run at five levels from bottom to top: community, sub district, district, regional and national. The community and sub-district levels health facility provide primary care. Thedistrict and regional hospitals provide secondary health care. The teaching hospitals are the top inproviding tertiary services and they are responsible for the most specialized clinical and maternity care. (MOH Ghana, 2009)

Clinical care at the district level are assured by the district hospital and they are supposed to serve an average population of 100,000-200,000 people in a clearly defined geographical area. District hospital contains between 50 and 60beds and should provide the following services: «Curative care, preventive care, and promotion of heath of the people in the district. Quality clinical care by a more skilled and competent staff than those of the health centers and polyclinics.Treatment techniques, such as surgery, laboratory and other diagnostic techniques appropriate to the medical, surgical, outpatient and in-patient services». (Ghana Health Service, 2015)

The aim of this project is to use information system approach to improve the management of the laboratory orderwithin the district hospital by taking into account the data workflow between clinical services and improve patient communication experience using notification alert based on SMS and email capabilities provide by mobile technology and internet.

2.2. Problem statement

Clinicians rely heavily on laboratory data to make medical decisions. Even though there is evidence that the Electronic Medical Record (EMR) introduction in the clinical setting has improved the management of patient related medical record, there is still some problem to solve. One of them is the follow up of the laboratory test result by both the referring clinician and the patient and the exchange of information between care givers in the facilities.(POON, KUPERMAN, FISKIO, & BATES, 2002)

Although the CPOE for laboratory result has improved the management and access to the test result, many studies have shown that passive retrieval of information in CPOEsystem since the clinician have to use the computer to pull the information from the test management system has created a loss of follow-up of the lab result, especially for outpatient comparing to inpatient and those in emergency department.(Callen et al., 2011)

Another commonly cited problem in lab information management, is the breakdown of communication between actors that are involved in the patient care. The traditional practice of telephoning results to the referring clinicians is time-consuming with potential for errors, and left other actors like nurse out of the communication process meanwhile they are those who gave treatments to the patient based on the guideline recommended by the clinician. Most of laboratory management information system also do not take into account the cross-boundary communication process with integration of the actorsinvolved. The patient should also be associated by getting informed on the action that should be taken for his care. Thus, sharing the right information in time between actors involve in the patient care allow to improve the outcome of patient care since critical test result will be shared between actors and serviceswithin the health facility (Callen et al., 2011)

Provision of reliable internet connectivity to support use and deployment of web based EHR as well as integration of web based Application Programming Interface (API) is a challenge in rural area due to the lack of interest of internet provider to invest in expensive equipment for area of low economics opportunity.

A desktop computerized provider order entry system that will provide an effective and efficient managementcapabilities of laboratoryorderand facilitates the exchange of lab test information across clinical service boundary, can be used as part of solution to this problem. Patient and physician interactions and communication experience with the laboratory in the proposed solution are based on the use of SMS over GSM and email to send alert and notification.

2.3. Framework of the laboratory test order management system

The Integrating Healthcare Enterprise (IHE) initiative defines the laboratory order schedule workflow based on a description of interaction processes and exchange of information in the form of use-cases, actors, transactions. The IHE schedule workflow provide international standard of software requirement in radiology, imaging and laboratory diagnostic techniques.Itinvolves intensive collaboration and communication among actors by using transaction to meet the identified process management in clinical setting. (Spronk, 2012)

The IHE schedule workflow identified actors in term of their applications roles in the system and the interaction between them is based on exchange information protocol like Health Level 7 (HL7).According to the IHE, the mains transaction identified are: patient registration and update management, order place management, order fill management, test result management, work order management, order result management. (Spronk, 2012)

The transactions between different actors across the clinical setting ensure the laboratory data workflow and failed to establish one the transactions in the system requirement implies breakdown communication of workflow that lead to the problems cited above such as: patient misidentification, specimen misidentification and collection error, lost to follow up of order, poor communication between clinical services and poor patient communication with the health facility(Plebani, 2010).

According to the requirement of a district hospital in Ghana, the following adapted workflow (Figure 1.1) will be used as the study framework. The framework of laboratory order in the district hospital identifies different interactions between actors involves in the test management processes.The Computerized Provider Order Entry (CPOE) system is the hub of the flowchart diagram and aims to establish link between actors in term of process management. The actorswho are involved in the lab test management of the proposed workflow are: the patients, the nurses, the physicians, the laboratory technicians and the public health departments.

The interaction of patient is done in the system in term of visit at the Outpatient department and in term of reception of notification of laboratory result. The patient can also interact with the laboratory service without passing through the OPD in case that the laboratory order come from another health facility. Physician, nurse and lab technician interactions are done through the test order, the lab test management and patient appointment with the physician inside the specific department. Public health department receives periodic report for decision making and to produce report on disease surveillance event (Ghana Health Service).

Figure 1.1:Adapted framework of CPOE system in the district hospital

2.4. Justification of the study

The laboratory play an important role for medical decision, and clinician rely on it to provide better treatment to patient. The clinicians therefore need to have a tool that will assist them to make laboratory test order, to check if the result of the lab test ordered are available and if neededto be notified by the laboratorywhen results are available. The laboratory service should be able to record accurate data on disease diagnosed and to produce efficient report for the disease surveillance. The patient also as the most concerned person should have the possibility to know if his/her laboratorytest results are available so he can schedule a meeting with the clinician.

Since the use of mobile devices in healthcare has been proven to facilitate coordination of patient care, care standardization, communication between patient and health care providers.(Hao et al., 2015) Using this technology in the proposed solution will allow patient and medical staff to improve their communication experience with the health facility. Since internet is still a challenge in a lot of African rural area to support a good quality of service (QoS) for the use of web application, the system architecture will be based on a client-server desktop application with alert notifications based on SMS over GSM network instead of using internet API. The email notification will be based on the use of internet but no component will be hosted on internet.

In Ghana, the district hospital is one of the five functional levels of health care distributionthat provide the first level of advance clinical care, laboratory and diagnostic techniques. And we think that there is need to provide this facility with heath information system that will allow to manage their laboratory data with good coordination and exchange between different services. Developing a Computerized Provider Order Entry system for a district hospital will allow:

1. The Outpatient Department (OPD) to manage efficiently patient information

2. The different clinical servicesto keep accurate information on patient and their related laboratory test history

3. To provide better access to patient laboratory result test by sharing the treatment guideline and the lab result between attending medical practitioners (nurses, laboratory technician and physician)

4. To establish fast and timely notification of the laboratory result by SMS and /or email to both patient and clinician.

5. To provide accurate information to the public health department for disease surveillance

2.5. Objectives

2.5.1. General objectives

The main objective of the study is to developa Computerized Provider Order Entry (CPOE)to capture, to track and exchange patient laboratory order and related test result across the clinical services in a district hospital.

2.5.2. Specific objectives

- To develop a Computerized Provider Order Entry (CPOE) systemto capture information on the laboratory order and related test.

- To propose an adapted workflow that will facilitate the exchange of patient laboratory information between the patient management system, the clinical services and the CPOE.

- To establish anautomated and an efficient communication of laboratory result between the patients, medical practitioners and the laboratory technicians using mobile technology and internet.

CHAPTER 2

3. LITERATURE REVIEW

To help understanding the most recent development and achievement on the capability of a laboratory test management information systemto improve patient communication within the health facilities, the communication of medical practitioners within the clinical setting, and the efficiency and the health care quality, we will conduct the review onthe use of automatedlaboratory data management within an EMR, on the benefits of improving laboratory data management on the patient safety in care delivery, on the importance of laboratory data for public health monitoring of diseases and epidemics, on the benefits of the Electronic Health Record (EHR) and their implementation problems, and then on the mobile health (mHealth). The review on the common categories of CPOE and a particular focus on the laboratory order and lab result management automation will be also be done, then we will conclude with the review on some cases on the design and implementation of health information system (HIS)that involve the automation of management of the laboratory data.

3.1. The useof automated laboratory data management with an EMR

Laboratory, radiology results serveclinicians in healthcare for screening, diagnosis of the disease and medication management.In the study conducted by Nancy Elderand others in 2010, focused on «the documentation of results management steps in patients charts at eight primary care offices in the southwest Ohio region» (Elder et al., 2010)in USA.The research team assessed whether results managed by an Electronic Medical Record (EMR)or by a specialized lab management system improve the lab test documentation comparing to manual and paper based practices. Observations, interviews with clinical staff, and chart audits of twenty five (25) patient in each offices as been used to assess the efficiency of the two systems. In this study, the clinicians have expressed concern that EMR for managing test results just as part of patient medical record are not satisfactoryeven if they have recognized a significance improvement, compared to in-build system focus on laboratory data management. (Elder et al., 2010)

Since, there are multiple steps involved in the management of test results, beginning with offices tracking their orders and the return of results to the clinician's office,one of the concern expressed is related to the breakdown of communication process between clinician, lab technician and nurses.The lost to follow up of laboratory test result by the practitioner involved in patient care is also cited as a major problem in lab result management. The research team has found that 64% of results managed with the laboratory data management system had a follow-up plan documented compared to only 40% of paper managed results. They find also thathaving two or more standardized results management steps did not significantly improve documentation of any stepsince there are not take into account in the standard EMR. Instead all offices fall short in notifying patients and in documenting interpretation of the laboratory result. (Elder et al., 2010)

3.2. The benefits of improving laboratory data management on the patient safety in care delivery

Qualitymeasurement inhealthcare is going to be focused on accountability for patient care outcomes and not onlyon quality assurance sinceevery step in the process of patient care carries a risk of harm.In relation to the quality assurance within the clinical laboratory, recent improvements have been done to significantly decrease the rates of errors, but the procedures before and after the clinical test are more prone to the introduction of errors.(Plebani, 2009) In the study conducted by Mario Plebani in Italy, to assess quality indicator of laboratory test. The author mentioned that event if a lot ofefforts have been donein the last decade to implement quality indicators for laboratory tests focused on the analytical performance, a systematic framework for laboratory quality measurement is still not available. The evaluation is based on the laboratory capability to provide service that is safe, timely, efficient, effective, equitable, and patient-centered. This study demonstrates that pre and post-analytical steps of the total testing process are more error-prone than the analytical phase inside the laboratory since the diagnostic process, which consists of numerous clinical steps, stretches across multiple care providersin the hospital. Some of the identified error are:the inappropriate test request from clinician, error in patient identification and specimen collection, lost to follow up the lab test. (Plebani, 2009)

3.3. The importance of laboratory data for public health monitoring of diseases and epidemics

The improvement of laboratory result management does not only improve patient care but it is also essential for disease monitoring and surveillance. The reports of disease notifiable conditions from laboratories and health care providers to public health authorities, is fundamental to the prevention and control of population health related problems.(Overhage, Grannis, & McDonald, 2008)

In the study conducted by J.Marc Overhage and others in 2008 in Mario County in Indianapolis, the research team examines whether the information produced by the automated electronic laboratory reporting of notifiable-diseases are more complete, accurate and timely produced than those produced by the paper based reporting procedure. Two source of data has been compared: the first source is an automated electronic laboratory reporting (ELR) system, the Indiana Network for Patient Care (INPC) notifiable condition database that link laboratories, radiology centers, and public health departments in central Indiana in a shared database, and he second source the Marion County Health Department usespaper-based records. (Overhage et al., 2008)

After 3month study period, the team found that the ELR identified 4.4 times as many cases as traditional spontaneous reporting methods which show that automated system more-timely report the notifiable diseases conditions than does traditional spontaneous reporting. And the data produced by the electronic reporting of notifiable conditions can be easily mapped and scale with the Logical Observation Identifiers Names and Codes (LOINC) for laboratory test result and the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) clinical condition according to the Centers for Disease Control and Prevention (CDC). (Overhage et al., 2008)

3.4. The benefits of Electronic Health Record and problems associated with their implementation.

Electronic Health Record (EHR), «has the aimof providing comprehensive, cross-institutional, longitudinal records of patients health and healthcare data», it provides the following benefits: cost reduction explained by future increases in revenue and cost savings, reducing errors in pharmacy, laboratory and in medication order as well as in finance and accounting. The improvement of coordination can be also cited as a benefit since it improve organizational coordination within the health care facility and between health care providers like health insurance.(Kimble, 2014)

But the organizational coordination can result to the cross border interoperability problem between stakeholder information systems. Instead of all these benefits a lot of EHR implementation program failed, the EHR-IMPLEMENT program under the auspices of a European Union initiative can be cited as an example of the large EHR implementation failure. In the study conducted by Chris Kindle in 2014, to underlying problems that prevent EHR systems from delivering its benefits, mains causes of failure has been identified using the ethnographic studies of EHR systems to assess the waythat such systems are used within the clinical setting .The problems ofpaper persistence information exchange between services and organizations after the introduction of the automation, the breakdown of coordination and communication across the professional boundary in health care, and limited share of knowledge between medical professional group since the documentation of patient actions and treatment is managed separately by each specialty services within the hospital are the main causes of the failure apart of those who are related to all information system. (Kimble, 2014)

3.5. The mobile Health (mHealth)

The widespread availability of mobile communication, along with its ease of use and relatively low cost make the mobile technology an improvement tools in health data management.(Siedner et al., 2012) According to the International Telecommunication Union, mobile phone subscriptions in developing country have increased over 4-fold globally to nearly 1213 to 5,400 million subscriptions during the period 2005-2014. The most substantial increases in cell phone access have occurred in sub-Saharan Africa.(ITU, 2014)

3.5.1. Cell phone text messages for communication of lab results in Uganda

A study conducted in Uganda in 2012 by Mark J Siedner and Others, to assess the acceptability for SMS to improve communication of laboratory results with HIV-infected patients, the cell phone use practices and literacy among them, and the issues about privacy and confidentiality of receiving private health related information by Short Message Service on their cell phone. The interview techniques to assess their understanding of the subject as defined in the study objectives.(Siedner et al., 2012)

The researcher's team finds that a significant proportion of patients preferred the SMS notification of laboratory results to the existing system of learning laboratory results at the next clinic visit. Participants also cited secondary benefits like improvement of relationship with clinic staff and providers, and decreased of transportation costs when using SMS to communicate laboratory result information, even thoughaconcern has been raised about the confidentiality. According to the privacy and confidentiality issuean interest of using Personal Identification Number (PIN) code activation and deletion of SMS message after reading has been recognized to be efficient. As such, it is important that patients understand and accept these risks prior to receivingsensitive SMS information. (Siedner et al., 2012)

3.5.2. The Mobile Technology for Community Health (MoTeCH) Initiative in Ghana

In Ghana, in 2009, Columbia University, the Grameen Foundation, and the Ghana Health Service launched a program of technology development and research designed to evaluate the potential uses of mobile technology in supporting community health operations, known as the Mobile Technology for Community Health (MoTeCH) Initiative. In the study conducted by Bruce Macleod and others to describe the software architecture of a system that is designed in response to the health development potential trend of the rapid expansion of community health worker deployment and the global proliferation of mobile technology coverage; and their use in poor countries, the research team analyzes the problem of the need of high quality and accurate information in the management of pregnant woman and labor information in the health administration.The awareness of the young pregnant women in the follow up of the antenatal and postnatal care has been also analyzed. One of the method they used to address the issues cited above is the integration of the mobile phone into the rural health system to bridge key health information gaps. (Macleod, Phillips, Stone, Walji, & Awoonor-Williams, 2012)

In the solution proposed by the MoTech system, some of the particular scenariorelated to the use of mobile phone that illustratethe potentials of mobile health (mHealth) benefits are: the reception of voice messages in health education by pregnant woman,the collection of patient data using low cost mobile phone and the reception of a weekly SMS message onwomen who are delayed for routine schedule care by nurses.(Macleod et al., 2012)

3.6. The common categories of Computerized Provider Order Entry

In the study conducted by Timothy Huerta and others in 2013, to evaluate the contribution of an automated laboratory test order management system (eLAB)on the duplication and unnecessary ordering of laboratory and diagnostic tests within U.S hospital, they have identified three major class of CPOE prior the analysis. The first and the most frequently discussed in litteratre is the electronic prescribing (ePrescribing or eRx).due to the focus on patient safety, and the significant role that medication errors play in compromising care quality. The second isthe CPOE involves the standardization of clinical order set entry that describe the activities of care that a patient should receive prior or after an intervention. We can cite the dietary restrictions, physical therapy and wound care. The use of the second class CPOEhas been the slowest due to the complexity and workload to manage that category of data.(Huerta, Thompson, Ford, & Ford, 2013)

The third class of CPOE, and the subject of our study, is the use of electronic Lab order Entry Management(eLAB )systems for ordering of diagnostic tests that are conducted in a controlled manner such as imaging and microbiology test. eLAB systems provide a structured and auditable framework in which laboratory data may be captured and communicatedthrough the establishment of a single point of contact for laboratory ordering and results.The basic principal of eLAB systems is that redundant tests can be minimized and clinical decision-making is further supported.(Huerta et al., 2013)

3.7. Works on the design and implementation of Health Information system

3.7.1. Design of the Open Medical Record System (OpenMRS) to support HIV treatment in Rwanda

In the study conducted by Chritian Allen and others in Rwanda in 2007, to support the process of patient registration, therapy initiation and treatment monitoring' of HIV-affected person, the research team has developed and implemented the OpenMRS system to support their user's requirements. Open Medical Record System (OpenMRS) is a web-based electronic medical record system that has been developed to address the problem of configuring EMR systems to suit new sites, languages and diseases after the deployment. (Allen et al., 2007)

The user's requirements of Rwanda was based on the management of HIV patient on active anti-retroviral (ARV)treatment and Tuberculosis treatment (TB). In their methodology to find the system that will meet the need to support new HIV and Multi drug resistance (MDR)-TB treatment projects, the research teamneeded a system that isvery flexible and scalable andthat will not require expert programming skills to add new forms or tailor it to new sites, languages or diseases requirements.The system should alsoshould be web based andshould allow local «offline» data entry. (Allen et al., 2007)

After looking for an existing EMR systems,they found thateven though some commercial EHR system could fulfill a part on their requirements, they areclosed, proprietary and, typicallyexpensive and not designed to be extended on the sites after the system deployment. And, the small number of open source EMR available do not have the characteristics required for the project. So the team decided to develop a new system architecture called openMRS.(Allen et al., 2007)

The OpenMRS system is built in Java using the Spring application framework and the Hibernate for back-end data persistence over MySQL database or any Relational Database Management System (RDBMS) that support hibernate. The originality of OpenMRS comparing to other open source system is the integration of a comprehensive data dictionary for all clinical data that allow new data model to be added without programming and altering the database structure.(Allen et al., 2007)

The laboratory data collection and management system was not part of the initial project and the specific need of order entry system did not allow the integration of this module in OpenMRS. To solve this problem, a Java standalone systemhave been developed as asimple laboratory data collection application using MySQL database to meet thestandard needs of the country.This module willallow to search the patient, to register lab orders and results, to send sent alerts as an SMS message to a clinician's mobile phone using the Skype™ Application Programing Interface (API). The lab data can be synchronized with openMRS using health level 7 (HL7). Other functional modules as Report module and pharmacy data management have been also integrated later easily with the use of HL7. (Allen et al., 2007)

But the main challenge in the openMRS system architecture is the data synchronization of all local site with the main server on line, since OpenMRS need reliable internet connection to correctly synchronize the data.(Allen et al., 2007)

3.7.2. The LabPush system in Swaziland

Mobile technologies are widely available and can play an important role in health care at the regional, community, and individual levels. In Swaziland, although National laboratoryis usually able to accomplish the requested test and produce the result within two days after receiving the samples, the time for the results to be delivered back to clinics is quite variable depending on how often the motorbike transport makes trips between the clinic and the laboratory. (Hao et al., 2015)

In the pilot study conducted by Wen-Rui Hao and others in 2014, to assess factors facilitating and hindering the adoption of mobile devices in the Swaziland healthcare through the evaluation of the end-users experiences, the Taipei Medical Universityperform a feasibility studyfor the development of a system that will allow the physicians to receive laboratory test result on the mobile phone through SMS. The research team conductsinterview with medical staff and come out with a software requirement document that serve as input to the software development team.According to the users' requirement, ten laboratories test has been considered the most urgent to be communicate by the medical staff. Those one should be notify to clinicians prior the receptions by the traditional ways (Motorbike mail) of the full report details on paper.(Hao et al., 2015)

Due to the limitation of internet access in health facility the SMS has been chosen as the better way of notify lab result through the country. The system will be installed at the national laboratory and the notification are sent to the remote clinic through SMS. The SMS should also contains the patient information and the code number for the laboratory test which should be enter in the system and submit after the validation. A mobile phone with a SIM card was provided to each participating clinic, and the use of this mobile phone was restricted to only receiving laboratory results via SMS. Missing lab result can be requested to the National laboratory that can be resend by SMS that improve follow up of missing lab result(Hao et al., 2015)

At the end of the pilot study, the participant has recognized the improvement of communication of laboratory result between the National laboratory and the clinics. But the participant has expressed the concern about the workloadwith the introduction of the labPush system since they have to transcribe the result from the phone to the paper based log book to keep thehistory of the patient result test.(Hao et al., 2015)

3.7.3. Design of an application for the chemotherapy treatment process at University Hospital of Geneva

Decision support, order entry, drug and care administration with their respective documentation cannot be seen as independent actions, especially in term of medical approach and patient safety. Chemotherapies errors in the process cited above can have dramatic effectson the patient life. In this study, Stéphane Spahni and otherspresent the overall approach leading the computerization of order entry, drug and medication administration.The research team conduct also the first evaluations about the potential benefits of the computer-aided controls during the care administration phaseat the University Hospitals of Geneva (HUG). (Spahni et al., 2007)

In an effort to minimize the potential for chemotherapy-related errors, the HUGinitiated a project that start with the centralizationofthe pharmacy and the laboratorydata to manage the preparation of the right chemotherapies provide to the patient. All the related actions involved the laboratory test and the preparation of the right chemotherapies arecalled the protocol. HUG as already at the time of the study an in-house developed computerized patient record (CPR) systemdeployed in thirtyfacilities and runs on more than 4,500 personal computers.After setting up a global database, an application has been developed over this data repository for managing the request of new preparations, for organizingthe concrete preparations and managing the traceability before, during and after the production process. The Application has 3 main modules: the prescription side, the pharmacy side and the drug administration or the nursing side.(Spahni et al., 2007)

The prescription side is the features of the system that help the oncologist to follow their patients and the current status of all running protocols.It is a powerful feature that allow the management of the patient treatment and the following up of the associated side effects through the production of alert such as the overlapping dates, regimens and some anomalies in the laboratory results. The pharmacy side allow the management of most of the logistics needed to produce drugs from raw substances since some regiment are produced specifically by the HUG's central pharmacy.The protocol production for a patient is computerized during the drugs validation and laboratory analyses.(Spahni et al., 2007)

The Drug administration side, is the complex side of the system, it gives for each patient the treatment to follow, the side effects of the treatment and the precaution to follow. The bedside traceability of patient in the ward and the nurse who gives treatment is also managed by this module. . This module is deployed on the pocket personal computer (PC) The patient, the nurse and the treatment are both identified using an international numbering of objects code called GS1 that can be read by the Pocket PC.(Spahni et al., 2007)

After the evaluation of the impact of the introduction of the system, the benefits in patient safety, the acceptance by the users and the integration of the system in the workflow process of the hospital has been observe as positive outcomes.However, it must be emphasized that the formalization and the validation of all processes, including each protocol, require a significant amount of time, especially from oncologists.(Spahni et al., 2007)

4. Conclusion

During the review of the literature, we have identify the following key point that will be considered in our study as guideline in the solution we are seeking to provide on the computerization and automation of the laboratory test order and result:

1. The testing process is complex since it involve many actors from the order to the identification of the patient and the management of laboratory test data.

2. The difference between clinical services creates a breakdown of communication of flow of information of the test orders and results since each specialties has a specifics group of diagnostics investigation and, documents the patient record in a particular way that can create duplication of patient information in the same hospital.

3. The automation of the management of the laboratory and related diagnostics with a standard EMR has been proven to bring significant improvement comparing to the paper based method. But specific health information tools like CPOE has been proved to be more efficient for laboratory data management than the customization of an EMR.

4. Even though some success stories has been cited and the benefits of the electronic medical record has been proven after a lot of implementation, the case of failure has also been recognized since the deployment of the system does not provide the expected satisfaction. Those challenges should be solve prior and during the deployment of the all health information system.

5. A participatory involvement of medical stall in the system requirement is an important step in the deployment of any health information system and a qualitative assessment should be conducted to have feedback of the medical practitioner on their user experience to avoid the case of abandon of health system observed in some project.

6. The patient satisfaction should be key factor when developing any health information system and the impact of the information system on the medical staff workload should be minimized as possible.

7. theavailability and low cost of mobile phone even in poor setting area makes mobile technology a viable medium to improve patient and clinician communication experience in health care .

CHAPTER 3

5. METHODOLOGY

In this chapter, we describe the method used to analyze and design the CPOE. We describe the mains source of the data used to build the system starting from the chosen workflow to the business requirement definitions. The workflow has been adapted to fit the need of a district hospital in Ghana. We also describe the various stages in the system development process as well as tools and techniques used to model and design the system.

5.1. Data collection

The study was focused on the laboratory test used in the diagnosis ofthree infectious diseases: malaria, tuberculosis and Drug susceptibility testing (DST), and human immunodeficiency virus (HIV).(M'ikanatha, Lynfield, Beneden, & Valk, 2013). For each of these three diseases cited above the laboratory tests technique was based on the criteria used by laboratory to confirm diseases, as described in case definition for Integrated Disease Surveillance and Response in Ghana which is based on technical guide for Integrated Disease Surveillance and Response (IDSR) in the African region edited by World Health Organization (WHO) and Centre for Disease Control and Prevention (CDC).(WHO & CDC, 2010) the table 3.1 shows for the chosen infectious disease the common laboratories test that are used for diagnosis.

Diseases

Specimen

Laboratory tests

Malaria

Blood

Rapid diagnostic test (RDT).

Polymerase Chain Reaction (PCR) test.

Detection of parasites in thick or thin peripheral blood films

Tuberculosis and related drug resistance test

Sputum

Sputum specimen positive for Acid-Fast Bacilli (AFB) by microscopy.

Sputum specimen positive on culture forAFB.

No specimen

The Mantoux tuberculin skin test.

Sputum

Isolation of M. tuberculosis

Nucleic acid amplification (NAA) tests

Drug susceptibility testing (DST)

HIV

Blood

Enzyme-linked Immunosorbent Assay (ELISA)

Western blot tests(WB)

P24 HIV antigen based testing.

Table 3.1: List of laboratory tests for malaria, tuberculosis and HIV based on WHO IDSR and CDC.(CDC, 2015a, 2015b)(CDC, 2014a, 2014b)(WHO & CDC, 2010)(CDC, 2012)(Caminero, 2005)

The identification of patient information was based on the recommended minimum data element, data analyses, report and presentation as described in WHO Recommended Surveillance Standard (RSS) document. Phone number and email of the patient will also be collected to allow the reception of SMS and email notification.The identification information of the clinicians ordering the laboratory test has beenalso collected with his/her phone number and email, to allow the system to send laboratory results alert to the clinicians. The Table 3.2 contains the set of data for the patient and clinicians based on the WHO RSS

Disease

Minimum set of data

All (Malaria, Tuberculosis, HIV)

- Names of Patient

- Date of birth

- Sex

- Patient ID number or folder number (if available)

- Patient cell phone number (Compulsory)

- Patient e-mail (optional)

- Names of clinician who ordered the test

- Licence number of the clinician who ordered the test

- Cell phone number of the clinician who ordered the test

- Email address of the clinician who ordered the test

- Specimen condition

- Final lab results

- Notification type chosen by the clinician

- Date at which the clinician ordered the test

- Date Lab receive the specimen

- Date of final lab results

- Date of notification of the result to the patient

- Date results sent to the clinicians

- Location of patient ( at least at the District level)

- Location type (Urban/Rural) of patient

Malaria

- Pregnancy status

Tuberculosis

- Is it the first test for TB

- Reason: diagnosis, follow-up

- Date of the first diagnosis

- Treatment failed

- Treatment interrupted

HIV

- Pregnancy status

Table 3.2: Recommended minimum data element of patient identification based on WHO RSS. (WHO, 1999)

5.2. System development life cycle

The systems development life cycle (SDLC)was applied to provide a descriptive or prescriptive characterization of how the CPOE systemwas developed. The SDLC describes phases of the software cycle and the order in which those phases are executed. (Ragunath, Velmourougan, Davachelvan, Kayalvizhi, & Ravimohan, 2010).

According to the SDLC approach, we followed the phases cited below for the design of the system (Parsons & Oja, 2014):

1. The planning phase

2. The analysis phase

3. The design phase

4. The development and testing phase

5. The implementation phase

6. The maintenance phase

The implementation and the maintenance phase involve the installation of the new information system and the conversion of the organization procedures to use it. In this study the deployment of the new system in a hospital is not planned so the implementation and the maintenance phase was not part of the study.

5.3. The planning phase

The planning phase is the fundamental process of understanding the main reason for building the new information system (IS).Itdetermines how the project team will proceed to achieve the goal. It has two steps: the project initiation and the project management (Dennis, Wixom, & Roth, 2012).

During project initiation, we have to identify the task performed by different actors in the lab order management and the challenges of using manual system or no optimized system to manage lab test data. The structured interview technique is one of the efficient way of collecting information on the user needs. Based on the information found in the literature reviewrelated to our study, the laboratory order communication between medical staff within the hospital, the risk of miss to follow-up of the patient lab results and the notification of the test results to both referring clinicians and patients are the main problems identified at the health facility that provide advance clinical care, laboratory and diagnostic techniques to a lot of people in a clearly defined area. Thus, these problems could correspond to the problems found at the district hospital based on the functional levels of health care distribution in Ghana. Since we did not work with a particular district hospital due to time constraint and the limited budget we have consider the district hospital structure in Ghana as study setting, and the information used at this step are based on existing literature as stated in the background section of the work. The project management step plan correspond the research study plan and the deliverable is the CPOE system.

At the end of this phase, the recommendation done to the hospital management can be formulated in the terms of designing a Computerized Provider Order Entry System for laboratoryorder management with notification capabilities using SMS and Email.

5.4. The analysis phase

5.4.1. The existing situation

According to the study, a district hospital with a manual and paper laboratory based system constitute our study setting, and the aim of the project is to create a new automated system for laboratory order management. The loop-holes found in the manual system according to the literature reviews are: inappropriate test request from clinician, error in patient identification and specimen collection, failure in communicating laboratory result to both patient and referring clinician (Plebani, 2010) and breaking in the workflow communication process between clinical staff within the hospital setting.(Maslove et al., 2011)

5.4.2. Improvements identification

Based on the proposed framework for the district hospital illustrate in the Figure1.1 (Chapter 1), we have identified five business processes to automate for the improvement of the laboratory test order management:

1. Patient administration management: provides patient demographics information to the system. This process involves the management of patient identification information such as names, record number, ID number and patient location. The patient is uniquely identified with the medical record number.

2. Staff administration management: provides basics information on the profile of the medical staffs in terms of their working categories or the duties they are supposed to perform to provide care to the patient. The medical staff are identified by their professional identification number such as license number.

3. Place order management: provides information on the laboratory order requested by clinician for patients. Each order created by the clinician should be identified with an Order Number.

4. Test result management: provides information on the specimen collection for an order, their identification and management. Result entry is also included in this process.

5. Order result management: provides information on the follow-up and the tracking of the order result.

5.4.3. Requirements definition

A requirement is simply a statement of what the system must perform or what characteristics it should have. During a systems development project, requirements are created to describe the business needs (business requirements), what the software should do (functional requirements), the characteristics that the system should have (nonfunctional requirements).

Business requirements

The business requirements are the statements that describe the reasons for proposing the system development project. This section refer to the justification of the study.

Functional requirements

A functional requirement relates directly to a process that the system has to perform to support the user tasks. The International Institute of Business Analysis (IIBA) defines functional requirements as «the product capabilities, or things that a product must do for its users». By the analysis of main user tasks that should be performed from the five business processes to be automated, the functional requirements listed below have been identified.

§ Patient administration management:

The system will allow the clerk:

- To record new patients

- To subscribe the patient to receive notification of laboratory result by SMS and/or e-mail

- To search a patient using his/her identification information

- To update demographic information of the patient

- To view the list of the patient of the hospital

§ Staff administration management:

The system will allow the clerk:

- To record new medical staff

- To update identification information of the medical staff

- To view the list of the staff of the hospital

§ Place order management

The system will allow

- The clinician to request laboratories test for the patient

- The clinician to choose to receive the lab result by SMS and/or email

- The clinician to view the ordered laboratory group test for a patient;

- The nurse to refer a patient to a clinician

- The nurse to view laboratory test request by the clinician for a patient.

§ Test result management

The system will:

- Allow the laboratory technician to record the reception of specimen;

- Allow the laboratory technician to identify the referring clinician and patients;

- Allow the laboratory technician to record result of lab test

- Allow the laboratory technician to record new external laboratory order

- Send automatic SMS and/or email notification to both patient and referring clinicianwhen the result are validated.

§ Order result management

The system will allow:

- The referring clinician to view the result of the lab tests ordered

- The referring clinician to view laboratory test that have been performed or not

- The referring clinician to enter treatment guideline for a patient after viewing the lab result

- Any clinician who is authorized to access the system to view lab order requested by another clinician and to enter treatment guideline

- Any clinician who is authorized to access the system to view on the work station the alert notification of new results available

- The nurse to view the treatment guideline and the laboratory test request for an identified patient and referring physician.

Nonfunctional requirements

The IIBA defines the nonfunctional requirements as the quality attributes, design, and implementation constraints, and external interfaces which a product must have. The followings requirements have been identified:

§ Operational

Defines the physical and technical environments in which the system will operate:

- The system should run on a PC (Windows 7 Operating system or above, 1 Gb of RAM, and at least 1Gb of Hard Disc) used by medical and administrative staff;

- The system should work in the existing wired or wireless intranet network

- The system should use the existing internet connection

- The system should use available GSM network for SMS notification

§ Performance

- The system should support 5 users in minimum

- The system should allow to resend notification when the GSM network or the internet network is down.

§ Security

- No clinician can cancel the laboratory order requested by another clinician

- Only the referring clinician can choose to be notified by e-mail and SMS

- The patient should give his/her agreement for being notified by e-mail and SMS when the laboratory result is available

- Laboratory test details should be sent to the clinician only, the patient receive just the notification on the availability of the result

§ Cultural and political requirement

- Patient medical record information should be protected by local or regional law related to Data Protection Act

- Policy on confidentiality and privacy of the patient record should be implemented and disseminated prior to the system deployment

5.5. System design

The following step consist on the technical modelling of therequirements. In engineering discipline model is crucial and is used to describe the shapes or actions of any construction that must be built. The benefits of the model are the requirement clarification and performance of a construction. The main objectives of design model is to support system complexity and reduce the error in the software development processes.(Ali, Shukur, & Idris, 2007)

5.5.1. System Architecture

In the study the client-server architecture is the base system architecture, since it attempts to balance the processing between client devices and one or more server devices. In the client-server architecture, the client is responsible for the presentation logic, whereas the server is responsible for the data access logic and data storage.(Dennis et al., 2012) We will use thick or fat client approach wherethe client contains most of the application logic and the server contains the data repository so the proposed system will be a stand-alone application.

Figure 3.2: System architecture

5.5.2. The process modelling

Unified Modeling Language `(UML) is increasingly used as the standard for software modelling and design. The most recent version (UML 2.0 under OMG 2004) includes 13 distinct modelling notations ranging from high-level use case diagrams, which illustrate the scenario of the interactions between actors and major business tasks, through to low-level object diagrams which capture instances of individual data objects. The various modelling notations are essentially divided into three main views: the behavior, the structure and the interaction views.(Russell, Aalst, Hofstede, & Wohed, 2006)

The behavior views contains diagrams that describe the set of functionality of the software at a relatively high level of abstraction. The structure view, contains diagrams that capture the data structure of objects involve in task performance. And, the interaction view contains diagrams that illustrate the interactions between objects involve in the execution of a business function.(Blanc & Mounier, 2006)

Activity Diagrams

The activity diagram notation is the most detailed form of flowmodelling within UML. (Russell et al., 2006)Activity modeling focuses on the execution and flow of the behavior of a system.It will be used to represent the workflow of laboratory order process in the district hospital according to the framework of CPOE system in Figure 1.1.

Figure3.3: Activity diagram

Use case diagrams

Since one of the goals in the systems development project is to create usable software, it is important to clearly determine the user's needs. Use cases help to understand and clarify the users' required interactions with the system by illustrating the interactions between users and business function to perform an activity in the workflow process. (Dennis et al., 2012) To allow the better view of the use case diagram we will split the use case diagram into three subsystem:

1. The authentication subsystem

2. The patient and medical staff management subsystem

3. The laboratory order management subsystem

4. The laboratory result management subsystem

Figure 3.4: Use case diagram for authentication subsystem

Figure3.5: Use case diagram for patient and medical staff management subsystem

Figure 3.6: Use case diagram for the laboratory test order management subsystem

Figure 3.7: Use case diagram for the laboratory test result management subsystem

Figure3.8: Use case diagram for the lab order result management subsystem

Class diagrams

The structure view of UML language is the most used to specify an application requirements. The main objective of this view is to model the structure of different classes of an object oriented (OO) application and their interaction.(Blanc & Mounier, 2006)The main building block of a class diagram is the class, which stores and manages information in the system. The classes refer to the people, places, events, and things about which the system will capture and process data. Later, during coding phase, classes can refer also to coding-specific component like windows, forms, and other objects used to construct the system.(Dennis et al., 2012)

To make the diagrams easier to read and keep the models at a reasonable level of complexity, the classes is grouped into packages. In our diagrams, only mains attributes are illustrates to make the diagram as simple as possible and classes methods are not illustrates since they are more useful during the coding phase. We will devise the class diagram to three package:

1. The user management package

2. The location package

3. The laboratory order and result management package

Figure3.9: Class diagram for the user's management package

Figure3.10: Class diagram for the location package

Figure3.11: Class diagram for the order and result management package

Sequences diagrams

The behavioural aspect of an OO application is defined by the way the objects of the system are interacting between them. The execution of the program is essentially the exchange of the messages between application objects to perform a particular treatment. (Blanc & Mounier, 2006)Since sequence diagrams emphasize the time-based ordering of the interactions that takes place among a set of objects, they are very helpful for understanding real-time specifications and complex use cases.(Dennis et al., 2012)

We will focus on sequence diagrams of the most important use cases to make our design simple: Order laboratory test and record laboratory test result. The others sequences diagrams are also important but they will not be illustrated to simplify the process modelling as they are more related to the coding of system features.

Figure3.12: Sequence diagram for order laboratory test scenario

Figure3.13: Sequence diagram for record lab test result scenario

5.5.3. The data modelling

The data model presents the logical organization of data without indicating how the data are stored, created, or manipulated. Entity relationship (ER) diagram will be used for the data model.(Dennis et al., 2012)The database modelling approach in the study, will be based on the three main phases of the database design methodology: conceptual, logical, and physical database design.

Conceptual data design

The conceptual data design is the process of constructing a model of the data independent of all physical considerations. This process involve building the first ER diagram based on the functional requirements. The following steps are used in the conceptual data modelling: (CONNOLLY & BEGG, 2005)

§ Entity identification: In this step, we have identified the main objects that the users are interested in, based on business and functional requirements. The attributes of each entity are also identified.

§ Attribute domain determination: A domain is a pool of values for an attributes. The objective of this step is to determine domains for all the attributes in the model. Simple, composite, single, multi-valued, and derived attributes are also identified.

§ Relationship identification: we search for the relationship that exist between entities and we determine the cardinality constraints for each relationship. The cardinality constraints are used to check and maintain data quality since it precises how many instances of each entity participate in the relationship.

§ Design the first ER diagram showing entity and their relationship

The figure 3.15 below shows the first ER diagram. The different attributes of the entities are listed in the table 3.3.

Figure 3.14: First ER diagram

Entity set

Attribute name

1

Disease

Name

2

Laboratory_test

Name

Description

3

Specimen

name

4

Patient

Id number

Names

Date of birth

Sex

Phone

email

5

Clinician

Names

License number

Phone

email

6

Address

Suburb

Town

District

Region

7

Notification

Type

8

Laboratory order

Date of order

Date reception specimen

9

Laboratory result

Date of final result

Date notification clinician

Date notification patient

Treatment guideline

Table3.3: List of attributes of the first ER diagram

Logical data design

The logical data model provides the physical database designer with a vehicle for making tradeoffs that are very important to the design of an efficient database. The main objective is to translate the conceptual data model into a logical data model and, then to validate this model bychecking whether it is structurally correct and able to support the required transactions. The following steps are used in the logicaldata modelling: (CONNOLLY & BEGG, 2005)

§ Relationship derivation for logical data model: We identify many to many relationships to derive new entity followed by foreign key identification. At this step parent and child entities are determined to manage the foreign key mechanism.

§ Normalization: The purpose of normalization is to ensure that the set of relations has a minimal and yet sufficient number of attributes necessary to support the data requirements of the enterprise.The relations should have minimal data redundancy to avoid the problems of update, delete and insert anomalies. The third Normal Form (3NF) rules has been chosen as sufficient level of optimization of the database schema.

After going through the conceptual and logical design, we have obtained the final ER diagram shown in the Figure 3.16 below, only primary and foreign keys will be represented to make the diagram simpler, other attributes are illustrated in the Table3.4.

Figure 3.15: Final ER diagram

Entity set

Attribute name

1

Disease

Disease id

Name

2

Laboratory_test

Test id

Name

Description

Specimen id

3

Specimen

Specimen_id

Name

4

Patient

Patient_id

Id number

First name

Las tname

Date of birth

Sex

Phone

email

Notification_id

5

Clinician

Clinician_id

Licence_number

Firstname

lastname

Phone

email

6

Referring_list

Clinician_id

Patient_id

date

7

Suburb

Suburb_id

name

8

Town

Town_id

name

9

District

District_id

name

10

region

Region_id

name

11

Notification

Notification_id

type

12

Laboratory_order

Order_id

Clinician_id

Patient_id

Date

Notification_id

date_of_order

13

Order_test_list

Order_id

Test_id

Date_specimen_reception

14

Laboratory_result

Lab_result_id

Order_id

Date of final result

Treatment guideline

15

Result_test_list

Result id

Test id

Date notification clinician

Date notification patient

notes

Table3.4: List of attributes of the final ER diagram

Physical data design

The physical design translate the logical data model for target Relational Database Management System (RDBMS) to produce a relational database. After selecting the RDBMS on which the relational database will be implemented, the main step in logical design is the definition of different relations using the Data Base Definition Language (DBDL). A relational database is principally the collections of tables, each of which has a primary key, and in which the tables are related to each other by the placement of the primary key from one table into the related table as a foreign key. (Dennis et al., 2012). As the DBDL is more related to the implementation of database relations in the RDMS, we will not illustrate the Structured Query Language (SQL) definition of each relation in PostgreSQL since the main objective of the DBML is to implement the entity in the RDMS.

CHAPTER 4

4. SYSTEM DEVELOPMENT

The development or the coding phase has been performed using two mains tools: the Visual Studio 2010 IDE and PostgreSQL 9.0. Visual Studio 2010 was used for the programming of the client side (front end) of system using the C# programming language. The physical design step of the database was performed using SQL over PostgreSQL RDMS. The GSM modem is connected on the Universal Serial Bus (USB) port of the PC that will be used to send the alert and notification, according to the workflow the GSM modem can be installed either on the lab computer or on the clerk work station.

The CPOE is designed to meet the system requirement of lab order management within a district hospital in Ghana. It hasseven functional modules:

1. The users and system administration module

2. The medical staff management module

3. The patient management module

4. The appointment and consultation module

5. The laboratory test order management module

6. The laboratory test result management module

7. The report module

Figure 4.1:The CPOE system information form

4.1. The users and system administration module

To access the system, the user should have a valid user name and password. The user is created by the system administrator. The system administrator is a super user and his account is created during the system installation. The user of the system are physician, nurses and administrative staff. To access the system any staff member should be first registered in the system.

The first task of the system administrator is to register the medical staff and to associate a credentials (user name and password) to them. During the user creation, the system suggest a username and generate randomly a password for each associated staff. Those credentials should be communicated to each user by the system administrator and then the user can change the generated to ensure the security of their account. Each user should be assigned to the group system which is associated to a collection of features that a user can access in the system. So each user access only the information associated to his role within the organization. By this mechanism the system ensure the confidentiality of the patient information. The user registration and management processes are shown in figures 4.2 to 4.5.

Figure 4.2: System login form

Figure 4.3: Main form of the system

Figure 4.4: Users security system access configuration

Figure 4.5: User change password form

4.2. The medical staff management module

All staff should be first registered prior of being associated to a credential. Medical personnel like physician, nurses and laboratory technicians will provide their license number that will serve as their primary identification. For other administrative categories, they will provide their national identification number (ID) or any other type of identification number. Phone numbers and e-mails are not required for all group of system users but for the purpose of receiving laboratory notification, clinicians are required to provide their cell phone numbers and/or email to be able to subscribe to SMS and email notification of laboratory result (Figure 4.6).

Figure 4.6:Medical staff personal details registration

4.3. The patient management module

During the patient registration the national ID number can be entered if available. The system generate for each patient a new record number to allow identification for patients without the national ID numbers. For the purpose of receiving the laboratory notification by SMS and/or email, the phone number and e-mail information should be entered in the system after the patient subscription. To prevent the duplication of the patient information, the system have a search module that uses multi criteria variables to check if the patient is already in the system prior to his registration. The patient registration processes are shown in Figure 4.7 and Figure 4.8

Figure 4.7: Patient search form

Figure 4.8: Patient registration form

4.4. The appointment and consultation module

Before having access to the consulting room to see a physician the patient should be received at the nurse station and then being assigned to the right clinician according to his/her case (Figure 4.9).

Figure 4.9: Patient assignment to clinician

3.1. The laboratory test order management module

After assigning a patient to a physician for the consultation, the physician can only order a group of lab test for the patients that are assigned only to him. During this step, the physician can decide to receive the laboratory test results by SMS or e-mail. A laboratory test order can contain many tests and the system issue a lab order number to allow unique identification of the test order. The physician can also track his orders or the lab orders requested by other clinicians. The figures 4.10 to 4.11 illustrate the lab order management process.

Figure 4.10: Laboratory test group order for a patient.

Figure 4.11: List of order place by a clinician

4.5. The laboratory test result management module

After requesting order for the patient by the clinician during the consultation. The Laboratory technician can consult the requested lab orders and record the information on specimens deposit, and enter the lab result for each tests performed. As all test cannot be done at the same time, for example the RDT for malaria comparing with to the culture of sputum test which can take more time, the laboratory technician can decide during the record of test results to send notification for only one or a group of test, or to send the notification after all test has been performed (Figure 4.12 to 4.18). To send notification by SMS, a GSM modem should be connected to the work station reserved for that. For the e-mail notification, the system should be also be connected to an internet network. If one of the connections is not available, an error message appears at the status bar to inform the user on the absence of the connection. But the network problem does not prevent the result to be saved in the system.

The system also allow the message to be send/resend later if necessary, since the email or the SMS could not reach the clinitian or the patient due to the network provider service errors (Figure 4.19). The clinician can consult the result for each lab order requested at the workstation and give the treatment guide line for the patient which can also be viewed by the nurses. The clerk or the administrative personnel can also check if the lab result of the patient is available or not, without accessing to the details of the laboratory test which are exclusively reserved to medical personnel. When some results are available the system show a message at the status bar to alert the clinician.

Figure 4.12:Laboratory specimen deposit record

Figure 4.13: Lab result record and notification

Figure 4.14: SMS lab result notification format for the patient

Figure 4.15: SMS lab result notification format for the clinician

Figure 4.16: E-mail lab notification format for the patient

Figure 4.17: E-mail lab result notification format for the clinician

Figure 4.18: Lab result view and treatment registration form

Figure 4.19: Resend of lab result notification to patient and/or clinician

4.6. The report module

The report module provide the laboratory history and treatment guideline for a specific patient across the time. It provides detailed information on all lab exam requested, the clinicians in charge, the result of the lab test as well as patient detailed information. This report can be exported in word, excel and pdf document format. Additional report on such as the case-based surveillance report form and the notifiable disease report form are also produced. (Ministry of Health of Ghana, 2002)

Figure. 4. 20: Patient lab history report

Figure. 4. 21:Case-based surveillance reporting form

CHAPTER 5

5. DISCUSSION

The CPOE for laboratory test management design provides capabilities to clinician to automate the order of lab test and performed the follow up of the result in a district hospital. The automation of the pre and post diagnostics task reduces errors such as identification of patient and specimen, redundant ordered test, lost to follow up.

According to the proposed framework which is based on the HIE laboratory order schedule workflow, the CPOE as the hub of lab order system ensures a improvement in workflow by establishing the connection between the patient management system, the medical history management of patient within the clinical services and the laboratory order in a centralized architecture.

By using SMS and email notification of laboratory result, the patient communication experience is improved as well as the referring clinician, since they can receive respectively the notification and the result of the laboratory tests on their phone and by email.

5.1. The design consideration

After conducting a literature review of main topic related to our study subject, we have found that the lack of health information system integration in the clinical workflow and the clinical relationship between services has been cited as one of the main raison of abandonment of a medical record after his deployment. (Maslove et al., 2011)

To take into account this limitation observed in others study on the design HIS, we first start our study by identifying the important workflow in data exchange between clinical services and the main actors involved in lab order management. We analyzed the circulation of information between the outpatient department, the laboratory service and other clinical services prior to the identification of system business requirements. Business process management approach has been used to identify different actors involved in the circulation of information and the tasks to automate. We think that this methodology provide the system more flexibility to be integrated in the hospital workflow and to introduce organization change without breaking communication between actors.

5.2. Benefits of the system

- The CPOE provide clinicians at the district hospital with a tools to easily order a group of laboratory test for a patient with a relatively simple users friendly interfaces where most of the task are selection based.

- The CPOE allows the clinician to perform the follow up of the laboratory test by visualizing the test that has been performed and those in pending status.

- Provide laboratory service in the district hospital with a tools to organize and managed all the result as well as specimen reception information on patient.

- The CPOE has the potential to enhance clinician'sawareness of the patient situation by receiving alert and notification of the laboratory result on the mobile phone and by email.

- The CPOE has the potential to improve patient communication experience with the district hospital by receiving by SMS and email notification when the lab result is available.

- The system use the existing GSM network for SMS notification instead of internet API that make it most adaptable at limited setting area where the internet access is a challenge.

5.3. Limitation

Despite of the benefits of the CPOE system, the study has some limitations. We can cite:

- The feasibility study was not conducted on the field to get real input on a district hospital using data collection technique like a structured-interview. We have based our system and user requirement on existing literature.

- Due to the time constraint the implementation of the system on the field could not be conducted as well as the system assessment to get users feedback

- The system used synchronous mode to send notification of SMS and e-mail, that can create a delay with a relative long time of waiting when sending the notification if the GSM network and the internet connection are not good.

- To view the patient treatment guide line, the nurse has to access the computer. Knowing that they are moving within the ward to provide treatment to patient, this module should be deployed on mobile device such as mobile phone or pocket PC and linked to the system through the wireless intranet network.

5.4. Future works

Several work can be done in future to make the system more efficient.

System interoperability

To allow the system to be very scalable and allow the exchange of information with others system (OpenEMR, DHIS2), we have planned to use HL7 data exchange standard for communication between the client and the server instead of simple SQL request based. With data exchange standard new module (web or mobile) client can be added and deployed easily without the need to reinstall or update the all client and server module.

New nurse interface module

The nurse has to be connected on the workstation to view patient laboratory treatment guideline which is not a very friendly solution. We have planned to develop a mobile application for cell phone or pocket PC that will allow the nurses to access patient treatment guideline anywhere in the hospital.

New specimen identification module

To allow an efficient identification of the specimen bring by the patient, we have plan to update the specimen deposit feature in such a way that a the patient ID and the associated bar code can be print and paste to the specimen container to avoid physical error in patient identification.

CHAPTER 6

6. CONCLUSION AND RECOMMENDATION

7. Conclusion

Information and Communication technologies (ICT) used to manage, generate and communicate health-related information have been widely proved to be used as the way to improve the quality, safety, and efficiency of health care delivery in both developed and developing countries. Health Information Technologies tools provide a significant enhanced capabilities to the traditional manual system. (Maslove et al., 2011)

Some common challenges has been recognized as obstacles to the success of the implementation of the electronic medical record like the limited computer literacy among the medical practitioners, lack of unique identification numbers for patient, lack of skilled health information system analyst. (Blaya et al., 2006) But a very important aspect to take into account when a health information system is designed, is the integration in the clinical workflow between services and the clinical relationship between actors. (Maslove et al., 2011).

We have developed a computerized provider order entry system for laboratory order data management that take into account the workflow of information related to the laboratory data within a district hospital to help the hospital to manage efficiently and effectively data related to laboratory test. Adding the SMS and the e-mail notification of laboratory result to both patient and clinician have the purpose to improve their communication experience.

This study is the initial step of building a CPOE for the district hospital in Ghana, we believe that the developed system will allow medical staff in the district hospital to improve the laboratory order management and provide satisfaction to patient.

5.5. Recommendation

To implement the system and get full benefits of it, the following recommendations are necessary for the health informatician (implementation team), the hospital administration and other health related institutions:

1. The hospital administration and the implementation team should plan a working meeting that will involve the laboratory techniciansand the physicians, to identify the practical terminology used on the field to order and record laboratory test, and map them to the standard terminology used in the system, to allow smooth introduction and use of the system.

2. The hospital administration and the medical staff should put in place a team to decide on the format and the content of information send by email and SMS, to both patient and medical staff ;

3. The hospital administration should put in place a security policy to ensure confidentiality of data inside and outside the clinical setting, by implementing a Security Education Training and Awareness Program (SETA) for both patient and medical staff. National Institute of Standards and Technology (NIST) Special Publication (SP) 800-50 can be used to design and implement the security program and it should be based as possible on National Data Protection Acts.

4. The hospital should acquire a network environment (wireless or wired) to get the full benefit of the system and, appoint a network and system administrator to provide technical support in the health facility.

5. Since the system used bulk SMS technology, the implementation team should contact a GSM provider to allow the hospital to acquire a short telephone number format and optimize the time out of SMS to avoid the lost laboratory notification message with SMS.

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