A framework for Quality improvement in. Healthcare Information Systems. A Thesis Submitted in Partial Fulfillment of the Requirements of the

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1 A framework for Quality improvement in Healthcare Information Systems A Thesis Submitted in Partial Fulfillment of the Requirements of the Degree of Masters of Science in Software Engineering at the College of Computer and information Sciences at Prince Sultan University By Asma Suliman. Aloqail

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3 Acknowledgements First, I would like to present my deepest gratitude to Almighty ALLAH for the bounties and blessings and for giving me the ability to finish this thesis. I would like to extend my special gratitude to my beloved parents for their invaluable, constant, endless love, support and encouragement throughout my life. Thank you both for giving me strength to chase my dreams. My sisters and brothers deserve my wholehearted thanks as well. I am indebted to my first supervisor Dr. Afraz Syed and Prof. Dr. Ajantha Dahanayake as my second reader who deserve special thanks for their support and guidance throughout this study. Without their knowledge and valuable comments, it would have been impossible to finish my thesis. This thesis is only a beginning of my journey. 3

4 Abstract Nowadays, bringing improvements to the quality in healthcare industries is a major concern of the health institutions. The healthcare information systems are adapted to improve a number of healthcare complex processes such as complex patient flows, management of several healthcare units, and numerous human resources. Due to the high complexity in healthcare workflows and information processing, system analysis phase becomes the most difficult and complex phase in the Software Development Life Cycle. This research responds to the questions of how healthcare information systems could be improved by enhancing the workflow considering the factors (products, processes, services and resources) in the healthcare organization, this question was broken down to further questions which include: How do hospitals in the case practice quality improvement? What is the appropriate framework to practice quality improvement in HIS? Can the proposed framework be used to improve the quality process? Therefore, these research questions are to investigate the quality process model in HIS as practiced in several selected hospitals in Saudi Arabia. To propose as appropriate framework for HIS quality for application and testing and to test the applicability and the effectiveness of the framework in a single case environment. The suggested framework of the healthcare information systems improvement contributes in providing a structured problem solving approach that helps software engineers to analyze the current problem, and in providing an improvement-approach that helps software engineers to convert the existing system s workflow to an efficient one and improve its performance. Therefore, a framework for improving the healthcare information systems through studying the workflow factors (Process, Product, Service, and Resource) is presented. This framework has been applied in King Fahad Medical City (KFMC) in the outpatient department to improve the outpatient appointment workflow and to suggest solutions for late in date appointments and did not attend (DNA) situations. 4

5 The result of the framework application has been validated through simulation to examine the effectiveness of the framework results. Key words: Healthcare Information System (HIS), HIS improvement, HIS quality improvement, HIS workflow, HIS analysis, quality improvement framework. 5

6 البحث ملخص يعد تطوير الجودة في مجال الرعاية الصحية مصدر اهتمام كبير لدى المؤسسات الصحية, حيث يتم تكييف أنظمة المعلومات الصحية لتطوير وتحسين عدد كبير من العمليات الصحية المعقدة. وعلى سبيل المثال, إدارة إجراءات المرضى, إدارة الوحدات الصحية, وإدارة الموارد البشرية. ونظرا الى تعق د سير العمل في المجاالت الصحية ومعالجة المعلومات, فإن مرحلة تحليل النظام تمث ل المرحلة األكثر صعوبة وتعقيدا خالل دورة تطوير األنظمة. توضح هذه الدراسة كيفية تطوير وتحسين أنظمة المعلومات الصحية من خالل دراسة وتطوير المنتجات, والعمليات, والخدمات المقدمة والموارد. العمل المقترح إطار يسهم وسوف أنظمة المعلومات لتطوير الصحية في توفير نهج لتطوير األنظمة وحل المشكلة التي تواجهها, وذلك بمساعدة مهندسي البرمجيات على تحليل المشكلة الحالية وتحويل سير عمل النظام الحالي إلى نظام آخر أكثر فاعلية. وتقدم هذه الدراسة إطار عمل لتطوير أنظمة المعلومات الصحية من خالل دراسة عوامل سير العمل )المنتج, العملية, الخدمة, الموارد(. وقد تم تطبيق هذا النظام في قسم العيادات الخارجية في مدينة الملك فهد الطبية لتحسين سير عمل المواعيد الخارجية, والقتراح حلول لمشكلة المواعيد المتأخرة, وحاالت عدم الحضور. وقد تم التحقق من فاعلية النظام من خالل المحاكاة لدراسة فعالية نتائج تطبيقه. كلمات مفتاحية : نظام المعلومات الصحية, تطوير نظام المعلومات الصحية, تطوير جودة نظام المعلومات الصحية, سير عمل نظام المعلومات الصحية, تحليل نظام المعلومات الصحية, إطار تطوير الجودة. 6

7 Table of content Chapter 1: Introduction Introduction Healthcare workflow and quality Healthcare Systems What is Healthcare Information Systems Quality Improvement in Healthcare Healthcare quality problems Software engineering and Quality improvement Area of Research Research Question and Objectives Problem Statement Scope of the Thesis Thesis outline Chapter 2: Related Works Healthcare Information Systems (HISs) Impact of Healthcare Information System Complexity of the healthcare information system Information System Software Based Quality Model McCall s Quality Model: Boehm s Quality Model Dromey s Quality Model FURPS Quality Model ISO 9126 Quality Model Quality Models/ Frameworks in Healthcare: Six Sigma Lean Plan, Do, Study, Act (PDSA) Business Process Reengineering (BPR) Information System Workflows

8 2.4.1 Contextual Design Activity Theory Distributed cognition (Dcog) Healthcare Information System Workflows Relation with software engineering The suggested framework Summery Chapter 3: Research methods Research design Research strategy Research structure: Literature review Observation Interviews Propose a framework Case study Questionnaire Collecting a statistical data Simulation Chapter 4: Process, Product, Service, and Resource Framework Survey of the literature review Case study analysis Process, Product, Service, and Resource (PPSR) Framework Chapter 5: Application of (PPSR) Framework: King Fahad Medical City (KFMC) Case Study Problem definition What is the problem? What are we going to accomplish? Current situation What is the current workflow? SWOT analysis What are the Strengths of the current situation? What are the Weaknesses of the current situation?

9 5.3.3 What are the Opportunities of the current situation? What are the Threats of the current situation? Improvement How the weaknesses can be improved? What are the changes on the process? Changes on the product Changes on the service Changes on the recourse Summary Chapter 6: Validation Part 1: simulation Part 2: results of the questionnaires Summary Chapter 7: Conclusion Conclusion Future work Appendix A Staff questionnaire responses Patient questionnaire responses Weekly report from 30 November to 11 December in KFMC hospitals / centers provided by outpatient department Appendix B Case study request letter IRB approval Appendix C Related published papers References

10 List of tables Table 1: Comparison between five quality models Table 2: McCall Quality Model perspectives Table 3: Dromey s Quality Model principal Table 4: ISO 9126 product quality attribute Table 5: Selected framework to be tested Table 6: Process, Product, Service, and Resource (PPSR) Framework Table 7: workflow factors Table 8: the findings of each framework step Table 9: appointments data from 30 November to 11 December in KFMC hospitals / centers Table 10: Adjustment for cancelled appointments thru IVR by DNA patients Table 11: Number and percentage of DNA patients after the cancelation thru IVR Table 12: Patient questionnaire result Table 13: staff questionnaire result Table 14: PPSR framework

11 List of figures Figure 1: SDLC Phases Figure 2: Thesis chapters structures Figure 3: DMAIC steps Figure 4: PDSA steps Figure 5: Research Activities Figure 6 : Current outpatient appointment workflow Figure 7 : suggested appointment booking with waiting list workflow Figure 8 : moving the patient from waiting list workflow Figure 9: how the one-week schedule concept work Figure 10: percentage of DNA patients from 30 November to 11 December in KFMC hospitals / centers Figure 11: the percentages of patients' education levels Figure 12: Available appointments in each hospital Figure 13: percentage of DNA patients after the cancelation thru IVR

12 List of Acronym IS HIS OI PDSA SDLC KFMC PPSR IT DMAIC BPR SWOT DNA IVRS SMS Information System Healthcare Information System Quality Improvement Plan-Do-Study-Act Software Development Life Cycle King Fahad Medical City Processes, Products, Services, and Resources Information Technology Define, Measure, Analyze, Improve and Control Business Process Reengineering Strengths, Weaknesses, Opportunities and Threats Did Not Attend Interactive Voice Response System Short Message Service 12

13 Chapter 1: Introduction 1.1 Introduction Nowadays, bringing improvements to the quality in healthcare industries is a major concern of the health institutions. Quality assurance strategies and activities applied into software development determine the success of the software in the healthcare domain (Su & Talburt, 2011). Healthcare Systems are one of the most important segments of modern society. Improving the quality of health systems leads to providing effective care, and improving the quality of the care provided will improve the population's health (Teleki, Damberg, & Reville, 2003). Although, there are much research conducted in Healthcare systems quality improvement area there is still no comprehensive framework on how to improve the quality of healthcare information systems. This study proposes a framework to improve the healthcare information system s workflow quality, by focusing on the main components of the system processes, products, services, and resources. 1.2 Healthcare workflow and quality The Agency for Healthcare Research and Quality (AHRQ) define the workflow as the sequence of physical and mental tasks performed by various people within and between work environments (RHPI, 2012). Two factors Workflow analysis and future workflow redesign are cited as the main factors of successful implementations of technology in hospitals. Workflow analysis shows an important part in aligning people, processes and technologies. Healthcare organization outcomes can be achieved by analyze and align the workflow for a key business process before implementing a technology solution (HIMSS, 2010). Healthcare workflow challenges that have been identified in ( Lowry, et al., 2014) include: Dealing with multiple systems separately Missing functionalities 13

14 Difficulty in using the system Difficulties in switching between different paths 1.3 Healthcare Systems Infinite number of advances rapidly increased in medicine and technology field during the past two years. The healthcare systems are developed to reduce costs, provide high quality services, and address the patient needs in the complex medical environments (Varkey, Reller, & Resar, 2007). There are numerous amount of services provided in Health care sector. These services are quite different from other service sectors. Death of a patient might be a result of bad services (Akhade, Jaju, & Lakhe, 2013). Medical errors cause 44,000 to 98,000 deaths per year, and more than $9 billion in lost productivity and nearly $2 billion per year in hospital costs in the US population. (Varkey, Reller, & Resar, 2007). Roemer (1993) defines Healthcare System as the combination of resources, organization, financing and management that culminate in the delivery of health services to the population According to (HRSA, 2011) Healthcare system consists of three main components: Resources (inputs): People, Infrastructure, Materials, Information, and Technology. Activities (processes): What is done? And, how it is done? Results (outputs/outcomes): Health services delivered, change in health behavior, change in health status and patients satisfaction What is Healthcare Information Systems Today, Information System (IS) is a vital element in most fields of endeavor, whether it is healthcare, business, education, research or any other areas. An increasing number of daily live activities requires the use of information system. The ultimate success or failure of a business depends on 14

15 the following: offered services, increased productivity, reduce waste time, and achieved business objectives, and most importantly end user needs and expectations (O Brien, 2001). An Information System (IS) is a set of interrelated elements or components that collect (input), manipulate (process), store, and disseminate (output) data and information and provide a corrective reaction (feedback mechanism) to meet an objective (Stair & Reynolds, 2012). According to this definition the components of the Information system has been grouped as input, process, output, and feedback. Input: capturing and giving the raw data to the system activity. Process: Converting or transforming the raw data (input) by the IS into useful result (outputs). Output: Creation of the useful information which processed by the IS. Feedback: system gives an information to help make changes into the row data or process an activity through IS. (Stair & Reynolds, 2012). Currently, the use of Information Systems in Healthcare is significantly increased in both clinical and administrative processes where health related services are provided. The healthcare information system is adapted to improve a number of healthcare complex processes such as complex patient flows, management of several healthcare units, and numerous human resources (Augusto & Xie, 2014). There are different definitions of Health Care Information Systems based on the use of such systems. Wager et al. (2009), defined Healthcare Information System (HIS) as an arrangement of information (data), processes, people, and information technology that interact to collect, process, store, and provide as output the information needed to support the health care organization Regarding the information systems in an organization, the user is who uses the system on behalf of the organization, which in healthcare organization is one of the first two types. In this research we are going to determine the user 15

16 as the patient, the inevitable user of healthcare system (Paul, Ezz, & Kuljis, 2012). From the above, the research figure out the difference between healthcare system and healthcare information system. healthcare systems term refer to the complete network of agencies, facilities, and all providers of healthcare (healthcare system, 2015) while healthcare information systems term is refer to any system that capture, store, manage or transfer information related to the patient health or the tasks of organizations that work within the healthcare (Health Information Systems (HIS), 2015) Challenges that Healthcare Information System is facing: According to (Lippeveld, Rainer, & Bodart, 2000) HIS faces number of challenges as follows: Irrelevance of the information gathered Poor quality of data Duplication and waste among parallel healthcare information systems Lack of timely reporting and feedback Poor use of information 1.4 Quality Improvement in Healthcare Healthcare Quality has been defined by the US Agency for Healthcare Research and Quality as doing the right thing, at the right time, in the right way, for the right person and having the best possible results In addition, there are a number of quality improvement (QI) approaches such as plan-dostudy-act (PDSA), six-sigma, and lean strategies which are used to achieve the improvement goals in healthcare (Varkey, Reller, & Resar, 2007). QI process can get benefit into the healthcare industry by improve the patient s flow, experience outcomes, reduce the healthcare costs and improve the population healthcare in general (Weston & Roberts, 2013). 16

17 1.4.1 Healthcare quality problems According to (Chassin & Galvin, 1998) healthcare quality problems are divided into 3 categories, underuse, overuse, and misuse: Underuse: once the healthcare service which produces a favorable outcome, failed to deliver same to the patient. This leads to a major foregone of healthcare improvement chances. Overuse: overuse the healthcare service will negatively affect the patient and put the patient s health at risk. Misuse: if the healthcare service has been selected and provided to the correct patient, however the patient has not received the full service s benefit (Chassin & Galvin, 1998). 1.5 Software engineering and Quality improvement This section is to map the software engineering with the purpose of the research to improve the healthcare information systems workflow quality. Once the organization raises a problem in the current system and admits that it is no longer sufficient and effective, reengineering the system becomes a must. A proper analysis need to be done on the resources and the systems to get the benefits from the reengineering process, and find the gap between the current system and the new one. Otherwise, it is not cost effective. Reengineering is defined as the redesign of business processes to accomplish dramatic improvements in the performance, such as cost, quality, service and speed. (Neidhart, n.d.). The software development life cycle (SDLC) in system engineering process, consists of five main phases (Analysis, Design, Implementation, Testing, and Evaluation). This thesis focuses on the analysis phase, SDLC start with the analysis phase as shown in figure 1, in this phase team usually try to understand the problem and solution requirements. The Successful improvement of the system quality requires an efficient workflow analysis of the set of processes that must be achieved, the set resources and 17

18 tools available to perform those processes in order to provide the patient services (Cain & Haque, 2008). Analysis Evaluation Design Testing Implementation Figure 1: SDLC Phases 1.6 Area of Research This study suggests a way to improve the HIS workflow quality by understanding the entire process followed to provide services, and through which module and by whom. This knowledge will help to propose a framework to help software engineers in healthcare industries in order to improve the quality of software they develop by taking into account four aspects (processes, product, services, and resources) to reach the desired level of quality. The designed framework will be applied in King Fahad Medical City (KFMC) - outpatient department as a case study. 1.7 Research Question and Objectives The main research question is how to improve existing healthcare information system workflow by focusing on the product, process, service, and resources? This question was broken down to further questions which include: How do hospitals in the case practice quality improvement? 18

19 What is the appropriate framework to practice quality improvement in HIS? Can the proposed framework be used to improve the quality process? This thesis aims to propose a framework for quality improvement in healthcare information systems by studying the existing models and frameworks, also by understanding the current healthcare processes, produces, services, and resources. Therefore, the above research questions are to achieve the objectives of the thesis will be as follows: To investigate the quality process model in HIS as practiced in several selected hospitals in Saudi Arabia. To propose as appropriate framework for HIS quality for application and testing. To test the applicability and the effectiveness of the framework in a single case environment. 1.8 Problem Statement This thesis responds to the problem of how the healthcare information systems could be improved by analyzing and enhancing the products, processes, services, and recourses. The underlying principle behind the approach of selecting these four aspects (process, product, service and resource) (HRSA, 2011) (Health Information Systems (HIS), 2015). Process within a healthcare organization is a sequence of events that result in a particular outcome by define major concerns: what and how the value is done and provided? Product in healthcare refer to the technology that used to provide a service. Services refer to the healthcare services that will provided at the end of the process. 19

20 Resource referring to the one how will function and input the data to the product Based on several existing conditions: first, these four main aspects are the workflow s elements and it must be taken into consideration while developing or enhancing a system s workflow in healthcare industries (HIMSS, 2010). Second, based on the observation - which will be discussed in chapter four- of how systems has been improved in the hospitals, it is important to study these factors to determine the root cause of system s weaknesses or misuse. Historically, healthcare institutions has been interested to improve their services, and to provide quality healthcare to their clients. This can be achieved by verifying and evaluating products and services. It has been found out that such efforts were not sufficient to improve the desired healthcare outcomes. Enhancing certain aspects of the healthcare without recognizing the impact on the other parts can improve one process but negatively affect other system s parts (Varkey, Reller, & Resar, 2007). Due to the high complexity in healthcare workflow and information processing, system analysis phase becomes the most difficult and complex phase in the SDLC. To achieve high quality patient care, huge demand of requirements must be fulfilled. System failure can be a result of insufficient system analysis (Ammenwerth, et al., 2002). Moreover, in order to prevent poor patient healthcare outcomes; the concept of improving the system s workflow has been increased especially for emergency and elective care (Improving Patient Flow, 2013). 1.9 Scope of the Thesis The research will propose a framework for quality improvements in healthcare information systems. Four core factors from the healthcare domain; Processes, Products, Services, and Resources abbreviated as (PPSR) come under the scope of our research analysis. Moreover, this PPSR framework focuses on quality improvement metrics, standards, and existing practices from both healthcare and software industry. Findings in this thesis should add value to improve the quality 20

21 of healthcare information system, which in turn can improve the quality of healthcare outcomes. This framework is expected to be applied in the information technology (IT) department in healthcare industry Thesis outline Our thesis is structured as follows: 1. Introduction The aim of the introduction chapter is to review the proposed research area the Software Quality Improvements in Healthcare Systems This chapter will define the healthcare information system, state problems and challenges, scope, and objectives of this thesis. thesis. 2. Research Methods This chapter of the thesis should outline the design and methodology of the 3. Related Works The literature review chapter will present the information and theories found in the literature related to this thesis s selected area the Quality Improvement in Healthcare Systems including descriptions, summaries, evaluations, and clarifications of their literature. The aim of the literature review chapter is to give an overview of the Software Quality Improvement in Healthcare Systems area. 4. Process, Product, Service, and Resource (PPSR) Framework This chapter will discuss the research findings which will lead to the proposed framework. Furthermore, it will outline the proposed framework and its components. It defines the instructions on how to use the framework in order to improve the healthcare information system. 5. Application of PPSR Framework on KFMC Case Study This chapter describes the detailed application of the suggested framework into a case study that has been carried out in KFMC. 21

22 6. Validation This chapter aims to validate the results that were found in the application chapter. After that, the results of the validation study will presented. Also, the chapter will contain a full discussion and evaluation of the results with reference to the literature 7. Conclusions and discussion This chapter will summarize and conclude the work of this thesis, and provide recommendations. An overview of thesis chapters structures depicted in Figure 2. Thesis outline Introduction Research Methods Related Works PPSR Framework Application of PPSR Framework on KFMC Case Study Validation and discussion Conclusions Figure 2: Thesis chapters structures 22

23 Chapter 2: Related Works This chapter presents the research theories and concepts derived from various works in relevant literature. Healthcare quality improvement, Business process reengineering and Business analysis tools researches will be discussed in this chapter. 2.1 Healthcare Information Systems (HISs) Currently, the concerns over patient s safety and how to treat the patient efficiently are arising. The healthcare Information Systems and technologies have been evolved with the rapid development of ISs (Paul, Ezz, & Kuljis, 2012). As mentioned in chapter one, Healthcare information system defined as an arrangement of information (data), processes, people, and information technology that interact to collect, process, store, and provide as output the information needed to support the health care organization (Wager, Lee, & Glaser, 2009). High quality and efficient patient care are the main aim of HISs to enhance healthcare provision. These systems adopted towards the patient medical and nursing care and to handle the management and administrative aspects of this care (Haux, 2006). Adapting HISs is important for multiple potential reasons summarized by (Haux, 2006): The shift from paper-based to computer-based processing and storage, as well as the increase of data in health care settings. The shift from institution centered departmental and, later, hospital information systems towards regional and global HIS. The inclusion of patients and health consumers as HIS users, besides health care professionals and administrators. The use of HIS data not only for patient care and administrative purposes, but also for health care planning as well as clinical and epidemiological research. The shift from focusing mainly on technical HIS problems to those of change management as well as of strategic information management. 23

24 The shift from mainly alphanumeric data in HIS to images and now also to data on the molecular level. The steady increase of new technologies to be included, now starting to include ubiquitous computing environments and sensor-based technologies for health monitoring Impact of Healthcare Information System Healthcare information systems provide financial benefits as a result of identifying the potential bottlenecks in the management of care (Johnson, 2011). Sharing the healthcare information with the patient could result in diagnosis improvement, self-care build up and patient education growth (Perera, Holbrook, Thabane, Foster, & Willison, 2011). Healthcare information system effect positively on the safety and quality needs (Eslami, Abu-hanna, & DE Keizer, 2008) Complexity of the healthcare information system. Healthcare is a complex domain with respect to information management. It is unlike any other domain because the systems in health domain effect the human safety and patient care (Kohn, Corrigan, & Donaldson, 2000). HIS failure is a significant problem, and the solution for avoiding failure in health informatics projects is not discovered yet (Heeks, 2006). Risks in healthcare are higher for failure than other businesses, detrimental consequences can be a result of the minor disruption caused by HIS (Christensen, Grossman, & Hwang, 2009). (Teixeira, Ferreira, & Santo, 2012) Add that the lack of a systematic consideration of non-technical issues such as the lack in the requirements, process or design can cause a number of project failure. (Pai & Huang, 2011) Address the human factors such as the acceptance of computers by nurses, and the organizational support to improve the services. They confirm that, the productivity and the usefulness will be higher. Enhancing the services quality help the system to reach its potential full performance (Pai & Huang, 2011). 24

25 2.2 Information System Software Based Quality Model In this section, the Software Quality Models contributions will be discussed and brief outline of each of the models will be reviewed. From the 1960 s, software product development was perceived as an engineering discipline. Software quality measure is one of the most difficult measures. The first tries to define quality measure were in the 1970 s by McCall s and Boehm s. Azuma defines the Quality Model as the set of characteristics and the relationships between them which provide the basis for specifying quality requirements and evaluating quality (AL-Badareen, Selamat, Jabar, Din, & Turaev, 2011). Moreover, Quality model creates a framework in order to perform a measurement of the required specific software features. In addition, appropriate metrics for the quality attribute will be used to provide a measurement of that attribute with the numerical values (Singh I., 2013). Software engineering literature contain a number of software quality models; In each software quality model there are several number of quality characteristics and quality factors included which reflect the quality of the software product (Suman & Wadhwa, 2014). In general, software quality models provide the product development tracks. These tracks are to develop a quality product in states phases, time, cost and environment by following an organized manner. These models are useful tools, which help the management to achieve the determined quality product (Singh & Kannojia, 2013). This research will focus on the main five software quality models Literature, McCall quality model, Boehm quality model, Dromey quality model, FURBS quality model and ISO 1926 quality model. (Singh & Kannojia, 2013) Gives a comparative study and an estimation of various software qualitative models, McCall, Boehm, Dromey, and IOS 9126 based on various quality attributes. These models proposed for software applications by various researchers and their comparative viability. They conclude that any software model will satisfy the developers need to gain the required quality in their environment. Author in (Singh I., 2013) present an information about the quality metrics and the main characteristics of quality 25

26 models. An important factor among the findings of this work, is that the main important quality attribute is the reliability. Moreover, the good software specification requirements and project phases is important to achieve the required quality. The selected software quality models were studded in (Suman & Wadhwa, 2014), (Al-Qutaish, 2010), (Jamwal, 2010). These research papers observed the following comments: the FURPS quality model is a special model to fit the benefit of IBM Rational Software Company, ISO 9126 quality model is the most useful model because it is formed based on the international consensus and agreement and the metrics in the lower level of the McCall s, Boehm s, Doromey s and FURPS quality models are neither clearly nor completely defined and connected to the upper level of the quality models. The strength and weaknesses of those models are shown in (Waghmode & Jamsandekar, 2013) by applying a new method on a comprehensive comparison between the software quality models in order to develop and customize the closed model to the intended scope. This comparison method was basic on mathematical formula and consists of four main tasks: model selection, assigning values, factors comparison, and models comparison. Table 1 shows the Comparison between five quality models done by (Malhotra & Pruthi, 2012): Attributes/ Models McCall Boehm Dromey FURPS ISO 9126 Maintainability * * * Flexibility * Testability * * Correctness * Efficiency * * * * Reliability * * * * * Integrity * Usability * * * * Portability * * * * Reusability * * Interoperability * Human * Engineering Understandability * Modifiability * Functionality * * * 26

27 Performance * Supportability * Table 1: Comparison between five quality models McCall s Quality Model: In 1976, McCall and Joseph Ware proposed the first quality model McCall to identify the quality of a software product (Singh I., 2013). McCall Quality Model addresses three perspectives (Product operation, Product revision and Product transition) by dividing the external quality factors based on users point of view as shown in table 2. Product operation is the products ability and capability of understanding and operating the user queries. It covers correctness, reliability, efficiency, integrity and usability factors. Product revision is the ability to undertaking the products enhancements and changes including defects and errors correction. It covers maintainability, flexibility and testability factors. While Product transition covers portability, reusability and interoperability factors to measure the product ability of adapting to new environments, distributing the process together with the hardware situations (Suman & Wadhwa, 2014) Product operation Product revision Product transition Correctness Reliability Efficiency Integrity Usability Maintainability Flexibility Testability Portability Reusability Table 2: McCall Quality Model perspectives Interoperability The relationship established between the quality characteristics of McCall model is the main advantage, while the main disadvantage is that the functionality of software products is not included in the model. Therefore, setting the specific quality requirements is difficult in this model (Singh I., 2013) Boehm s Quality Model Boehm (1976, 1978) introduce the Boehm quality model to evaluate and measure the software quality. A set of metrics and quality attribute will be defined in order to determine the software quality level. In addition, this model consists of a 27

28 hierarchical structure of quality attribute (high level characteristics, intermediate characteristics, and lower level characteristics). The high level characteristics including the basic high level quality requirements which should be evaluated. It cover three questions, As-is utility: How well (easily, reliably, efficiently) can I use it? Maintainability: How easy is it to understand, modify and retest? Portability: Can I still use it if I change my environment?. The intermediate level characteristic covers seven quality characteristics Portability, Reliability, Efficiency, Usability, Testability, Understandability, and Flexibility (Suman & Wadhwa, 2014). Moreover, The primitive characteristics provides the foundation of qualities metrics definitions, In this model 17 attributes have been considered to define the product quality (Singh & Kannojia, 2013) Dromey s Quality Model. Recently R. Geoff Dromey present in 1995 a quality model similar to the McCall s, Boehm s and the FURPS quality models. This model concentrate on the connection between the software product properties and software quality attributes and the relationship between the quality attributes and its sub-attributes. in addition, Dromey model established based on the product, so the evaluation for each product will be different from the other, it s also a dynamic idea process modeling in order to apply it for different systems (Singh & Kannojia, 2013). Software s process properties classified into four categories (Correctness, Internal, Contextual, Descriptive). The first category Correctness measure some basic principles to check whether the software is violated. The second category Internal evaluate how well the software developed according to the requirement specifications. The third one is Contextual, measures the external effects the software usage. Lastly, the Descriptive evaluate the software descriptiveness (Singh I., 2013). The principal of Dromey s Quality Model shown below in table 3 (Singh & Kannojia, 2013): Software product Product proprieties Quality attribute Correctness Functionality Reliability 28

29 Implementation Internal Maintainability Efficiency Reliability Contextual Maintainability Reusability Portability Reliability Descriptive Maintainability Reusability Portability Usability Table 3: Dromey s Quality Model principal FURPS Quality Model The FURPS software quality model which presented by Robert Grady, it is stands for (Functionality, Usability, Reliability, Performance, Supportability). Functionality aspect including the feature sets, capabilities and security. While Usability includes human factors, aesthetics, consistency in the user interface, online and context sensitive help, wizards and agents, user documentation, and training materials. Reliability consists of the frequency and severity of failure, recoverability, predictability, accuracy, and Mean Time between Failures (MTBF). Performance includes conditions on functional requirements (FR) such as speed, efficiency, availability, accuracy, throughput, response time, recovery time, and resource usage. Supportability include testability, extensibility, and adaptability (Malhotra & Pruthi, 2012). The main drawback in FURPS is that one of the main quality attribute (Portability) does not considered in this model (Singh I., 2013) ISO 9126 Quality Model (Singh & Kannojia, 2013) Comparing two products will be easier by applying a universal model. In 1992, a Software Product Evaluation: Quality Characteristics and Guidelines for their Use was driven from the McCall model as the software quality measurement standard basis referenced by ISO 9126 standard. The 29

30 standard claims that the six attributes of product quality (Functionality, Reliability, Portability, Maintainability, Usability, and Efficiency) are comprehensive. Moreover, each of the six attributes is defined as a set of attributes that bear on a relevant aspect of software Every attribute can be divides to multiple levels of sub-attribute. Table 4 show the ISO 9126 six product quality attribute (Singh & Kannojia, 2013): Model Attribute Question Functionality Are the required functions available in the software? Reliability How reliable is the software? ISO 9126 Portability Maintainability Usability Efficiency How easy is to transfer the software to another environment? How easy is to modify the software? Is the software easy to use? How efficient is the software? Table 4: ISO 9126 product quality attribute 2.3 Quality Models/ Frameworks in Healthcare: Recognition of the essential deficits in healthcare quality was the most important reason behind the development of quality improvement models in the healthcare organizations (Powell, Rushmer, & Davies, 2009). Healthcare quality improvement models contributions will be under the scope in this section. A large number of research has recently been devoted to the development of healthcare quality improvement. There are number of quality improvement approaches widely used in healthcare industry, such as six sigma quality improvement model (Aguezzoul & Nyoungue, 2012), PDSA quality improvement model (Taylor, et al., 2013) and Business Process Re-engineering approach (Khodambashi, 2013). 30

31 2.3.1 Six Sigma Six Sigma improvement model and business strategy which allows organizations to improve their outcomes by continuous improvement, begun used in healthcare industries since around Define, Measure, Analyze, Improve and Control (DMAIC) methodology offered by six sigma to improve the system output and outcome by find the problem root causes to eliminate defects and reduce the variation in processes. Moreover, this approach consist of a set of steps to figure out the bottleneck which impact on the system components and guide specialist through problem-solving approach (Powell, Rushmer, & Davies, 2009). DMAIC steps consist of a key process to control the implementation of each step, we gather these keys shown in figure 3 below from (Ratnaningtyas & Surendro, 2013) Define Define the requirements and expectations Define the project boundaries Define the project boundaries Measure Analyze the process to satisfy the needs Develop a data collection plan Collect and compare data to determine issues Analyze Analyze the causes of defects Determine the variations in the process Prioritize opportunities for future improvements Improve Improve the process Develop creative alternatives and implement enhanced plan Control Control process variations Monitor and control the improved process Implement the improvements of systems Figure 3: DMAIC steps Dyah and Kridanto from the School of Electrical Engineering and Informatics created Information Quality (IQ) improvement prediction model based on the 31

32 method of Six Sigma for biomedical engineering, this model build to get solutions of the information quality problems by reduce variance information on the healthcare process. DMAIC methodology applied on a case study Immanuel Hospital in Bandung, Indonesia using key process and tools for each step in this methodology. The application end up with ten recommended solutions towards the case study (Ratnaningtyas & Surendro, 2014). In (Aguilar, Adaya, Castillo, & Posadas, 2011), six sigma methodology (DMAIC) has been applied at the National Institute of Respiratory Diseases of Mexico (INER) to improve the drug dispensing process. This study emphasized that six sigma is very useful in analyzing and improving the efficiency in drug dispensing process by the integration in medications systems (products). The Problems and opportunities have been defined in order to help optimizing the process, In conclusion, authors suggest to use Six Sigma methodology to solve and improve any problems in other health process. Authors in (Ratnaningtyas & Surendro, 2013) build an information quality improvement model for a Smart Hospital. This model consist of four steps that are: identification, analysis and solution planning, assessment and evaluation, and implementation. Six sigma methodology (DMAIC) adopted in the analysis and solution planning step to reduce variance information on the healthcare process Lean Lean approach to reduce waste and eliminate inefficiencies by focuses on customer value and improving processes. The application of lean is based on five defining principles (ULLLC, 2013): 1. Specify value: define the value from a customer s perspective. This can be done by learn what a customer values, and how to support the best outcome by improving their experience. 2. Identify value stream: deliver a seamless customer experience by evaluating how the steps of a process or procedure should be organized. And eliminate any steps that do not directly help to reaching the goal. 32

33 3. Flow without interruptions: Eliminate waste as much as possible between the process steps so that a product or service is delivered as efficiently as possible. 4. Customer pulls services: Allow the customer to receive or request products or services if needed and when the customer is ready to receive them. 5. Pursue perfection: in order to deliver a product or service with the highest possible quality, changing environment and customer needs must be adapt continuously. Moreover, the application of lean principles resulted in process changes to postoperative and medicine unit orders. The average amount of time required to process a medication order have been reduced to less than five minutes (ULLLC, 2013). Lean management strategy replies on many healthcare challenges (Radnor, 2010). Schwarz et al. (2011), present the A Lean project which was conducted at Centre Hospitalier Emil Mayrisch Clinic in Luxembourg. This study was conducted to reduce the change time per patient (extubation of patient "A" until intubation of patient "B") and throughput time per patient in order to improve the capacity utilization of operating room. This study result in optimizing the service organization and the efficient use of capacity of the operating room by the decreasing in waiting time per patient of 23%, and the improvement of more than 100% of the capacity of monitoring patients Plan, Do, Study, Act (PDSA) Plan-Do-Study-Act (PDSA) model proposed by Institute of Healthcare Improvement (IHI) to introduce the continuous quality improvement (CQI). This tool adapted from the 1970s (Powell, Rushmer, & Davies, 2009). PDSA quality improvement model answers three questions: 1. What are we going to accomplish? 2. How will we know if a change is an improvement? 3. What change can we make that will result in an improvement? 33

34 This model consists of four steps of the continuous improvement cycle. PDSA cycle contains four steps shown in figure 4. After all of the above steps completed, the PDSA cycle will continue and repeated over and over to ensure the product or process improvement (Varkey, Reller, & Resar, 2007): Start initiating the quality process improvement plan. Plan Do In this step the plan will be executed on a small scale Making future adjustments by make the plan permanent and study deviations Act Study In this step the plan will be executed on a small scale Figure 4: PDSA steps The performance improvement team in Akron Children's Hospital built a performance improvement plan to increase the nurse adherence to using medication safety software. Plan, Do, Study, Act (PDSA) model has been applied as a performance improvement method to address nurse adherence using a plan for change. The implementation of PDSA method successfully increased nurse adherence in using medication safety software to a rate above 85% with individual units intermittently reaching the 100% adherence rate goal (Gavriloff, 2012). In (Curran, 2012), the Plan, Do, Study, Act (PDSA) model implemented to reduce the incidence and impact of norovirus outbreaks in the National Health Service (NHS) Scotland. This is the first PDSA model applied to the preparedness and management of norovirus, it s led to reduce the incidence and impact of norovirus by design the system improvements. 34

35 2.3.4 Business Process Reengineering (BPR) BPR show up in the US in the 1990s, it is an approach of workflow redesign, defined as a management method which redesign and redevelop exist practices and processes in business and its interactions. It aims to improve the process efficiency by applying essential approaches by modifying or eliminating nonvalue adding activities. This approach use to analysis and redesign the processes in order to improve the workflow quality and services (Khodambashi, 2013). BPR consist of five main steps (Powell, Rushmer, & Davies, 2009): 1. Identify the BPR objectives 2. Analysis the As-Is process. 3. Identify weaknesses and opportunities. 4. Design To-Be process. 5. Improve the Process and analysis the new changes Moreover, many tools available to facilitate BPR process such as Unified Modeling Language (UML) and Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis tools. UML tool allow the engineer to model and design the workflow visually and help to understand and simplify the flowcharting of complex processes (Khodambashi, 2013). In the other hand, SWOT help the engineer to understand and analysis factors that influence the organization process. This tool will grant the engineer the ability to capitalize the strengths and opportunities and minimizing the weaknesses and threats (MSG, 2015). In (Bertolini, Bevilacqua, Ciarapica, & Postacchini, 2011), the business process reengineering (BPR) methods have been applied into the drugs management and distribution in an Italian Province to analysis the process as it is, identify any related problems and opportunities for improvement, and describe the reengineering of this process. This work consider the process has been changed, and the modification of product or service features which resources need to be aware and train for this change. 35

36 2.4 Information System Workflows Workflow consists of a sequence of activities in any environment, while practically workflow allows the activity assessment and the review of a sequence of work. Moreover, workflow is a pattern of processes for information processing (Whittenburg, 2010). In computer science, workflow has been defined as the independent jobs scheduling on a computer and all the relationships between the system activities, from start to finish (Dussart, Conseil, Benoit, & Paltry, 2004). In systems development, analyzing the workflow is important to define the problem clearly and to design a usable information systems. Moreover, to understanding the workflow features, several of systematic approaches proposed to guide the engineers in different directions depending on how work activities are conceptualized and to meet the needs of systems designers in healthcare settings. These approach such as Contextual Design, Activity Theory and Dcog. These approach highlight the interaction between people and systems (Sheehan & Bakken, 2012) Contextual Design Contextual design as an approach provides a framework and techniques used by designers to understand workflow practices. This approach describes the workflow at the organizational and individual levels. Moreover, it provides main points relevant to design by contextual inquiry method (Wixon, Flanders, & Beabes, 1996). As mentioned in (Beyer & Holtzblatt, 1999) contextual design consists of three phases: 1. Contextual inquiry: an interview with the worker that takes place in the determined field to understand the work-related tasks. 2. Work modeling: using the results of contextual inquiry to create models of work. 3. Consolidation: creating a single statement of the work practice Activity Theory Activity Theory suggests that human beings involvement in the determined activities is the goal. In addition, describing the activities and their target goals, actions, and the environment lead to develop an effective technology (Kaptelinin 36

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