EPR exchange system: conceptual business process model development using design science

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EPR exchange system: conceptual business process model

development using design science

Master Thesis Technology and Operations Management

L. Stephana

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EPR exchange system: conceptual business process model development using design science

L. Stephana

University of Groningen Faculty of Economics & Business

&

Hospital Nij Smellinghe Drachten

Cardiology department and Vascular Surgery department

Master Thesis Technology and Operations Management Groningen, June 2013

First Supervisor: Dr. H. Balsters Second Supervisor: Dr. ir. D.J. van der Zee

Supervisor at the hospital Nij Smellinghe Drachten: M. van der Linde

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PREFACE

The report you just started to read is my Master Thesis, which is the final project of my study Technology and Operations Management at the University of Groningen. This report is also the final document for Nij Smellinghe at Drachten, the hospital for which I performed the research for my Master Thesis. This research has been an exciting journey full of challenges, but also with achievements. Finishing this Master Thesis project would not have been possible without the support of people to whom I wish to express my appreciation and gratitude.

First, I would like to thank Nij Smellinghe for the experience and the opportunities I have had during my research period at the hospital. I would like to thank Marcel van der Linde, Marald Wikkeling, Wim Loman, Christiaan Ybema, Pieter Buwalda and Marinka Zwier at Nij Smellinghe, for your useful support and feedback during the several meetings, and e-mail contact we had. Furthermore, I would like to thank you all for the critical questions during meetings, and sharing your point of view on several aspects of the business’ playground.

Secondly, I would like to thank my supervisors at the University of Groningen, my first supervisor professor Balsters, and my second assessor assistant professor van der Zee. I would like to thank professor Balsters for his useful feedback on my research, and helping me with the academic writing. Also, I would like to thank him for providing me different surprising views on the subject for this research. I would like to thank professor assistant van der Zee for the effort and time he spent at assessing my Master Thesis.

Finally, I would like to thank my family, especially my sister Lana Stephana, and friends for supporting me during this period!

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ABSTRACT

This report is the result of a design science research performed at the cardiology, and vascular departments of the hospital Nij Smellinghe Drachten (NSD). The research presented in this report, is a sub-project with a context of a larger project. This larger project analyzes systematically a proof of concept for the design of an Electronic Patient Record Exchange System (EPRES). In the first sub-project, which will be presented in this report, a basic set of business requirements are inventoried, and detailed business process models are generated using Business Process Modeling Notation (BPMN). The central research question of this research was:

Which factors are relevant in making a complete and consistent design of a business process describing data exchange between hospitals?

To make complete and consistent business process models, the regulative cycle of Van Strien (1997) was used. This regulative cycle has five basic process steps; design problem, diagnosis/analysis, design solution, validation, and implementation. This regulative cycle is passed through the following steps: design problem, diagnosis/analysis, design solution, and validation. The Implementation phase is excluded in this research.

The following factors are relevant to identify, to inventory a basic set of business requirements, and make a complete and consistent design of business process models:

1. Who are the stakeholders involved in an EPRES?

2. What are the goals and requirements of these stakeholders?

3. What are the Critical Success Factors (CSF’s)when implementing an EPRES?

From the identified stakeholders, their goals and requirements, and the CSF’s, a set of business requirements are generated, and complete and consist conceptual business process models are developed for the exchange of patient’ data by an EPRES.

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1. INTRODUCTION

This introduction is setting the scene for this Master Thesis. The Master Thesis of Technology and Operations Management is the final project to demonstrate that a student is able to perform academic research in the field of Technology and Operations Management. A proof-of-concept for a design of an Electronic Patient Record Exchange System (EPRES) is the subject of this research, and one of the research topics in the field of Technology and Operations Management. In this report different abbreviations will be used, to enable the understanding of the different concepts in the context of this research. A list with the abbreviations could be found in appendix I.

1.1 Introduction of the subject of research

Nowadays, the cooperation between smaller and larger hospitals is increasing. Several arguments can be found for the increasing cooperation. First of all, there is a minimum volume standard for hospitals to perform a certain operation. If the hospital does not reach the minimum volume standard, they are not allowed to perform the operation anymore. Second, every hospital provides different types of high-complexity care to patients. Over the past years, it turned out to be very costly that every hospital provides all different types of complexity care to patients. The government came up with a covenant to bundle high-complexity care, which should reduce the healthcare expenses (rapport Staat der Gezondheidszorg (SGZ), 2011).

Further cooperation between smaller and larger hospitals, will have as a result that patients can be treated in different hospitals. When a patient is referred to another hospital, information about the patient has to be transferred as well. In order to transfer patient data, systems, like the Electronic Patient Record (EPR) or the Health Care Information Infrastructure (HCII), facilitating this patient data exchange is envisioned.

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healthcare staff (rapport SGZ, 2011). The importance of correct and actual information is crucial. With this information, mistakes in healthcare could be eliminated (rapport SGZ, 2011).

However, the EPR and other healthcare exchange systems developed so far have been criticized heavily. The subject EPR has been discussed in Dutch media very much. In 2012 almost four hundred Dutch newspapers included articles about the EPR/HCII. The EPR/HCII has been discussed, because of the approach that is taken to develop such a system. Till now, the current EPR/HCII have been developed from a purely a technical perspective. These EPR/HCII systems are technologically perfect designed systems. However, taking a business perspective, these systems have failed (Van Twist et al., 2012; Balsters, 2012). The current designed EPR/HCII systems do not pay attention to the business needs, like the goals and requirements of the organizations (i.e. hospitals). The healthcare staff of hospitals, which are the users of the EPR/HCII systems, are currently not given enough opportunity to contribute to the development process of such an EPR/HCII system. The requirements of these stakeholders were not taken into account by the development of an EPR/HCII system. The result is that the designed system does not fit their workflow.

1.2 Research objective, research question and sub questions

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generated in this project serves as input. See Appendix II for details of the second and third projects. The outputs of this reports (the BPMN-models), are used as input in both the second- and third sub-project. Thus, outcomes of the three projects have many interdependencies. That’s why the larger project will be performed in a collaborative way. The results and concepts from the first project will be shared with the researchers responsible for the second and third projects. This way, early input will be provided and the results could be verified and validated. The result of performing this project in a collaborative way allows for greater responsiveness towards potential changes in the business environment, and will provide opportunity to identify problems early in the design process. This project is conducted at the hospital Nij Smellinghe Drachten (NSD), the Netherlands, at the cardiology, and the vascular surgery departments. Surgeons of these departments are interested in the development of an Electronic Patient Record Exchange System (EPRES), that is technically as well as strategically a success.

The objective of this research is to take a business perspective when generating business requirements, and designing conceptual business process models for a design of an EPRES for NSD. This will be performed on the basis of identifying and analyzing the goals and requirements of the stakeholders of such an EPRES at the cardiology, and vascular surgery departments of NSD. From the analysis of these goals and requirements, business will be inventoried, and conceptual business process models will be generated in BPMN. BPMN will result in producing Business Process Diagrams (BPD). These BPD’s are flowcharts that mention all tasks in a process, illustrating the sequence in which the tasks are executed and showings the events that can happen in a process (Balsters, 2012). A more detailed description of BPMN will be given in chapter 6.

From the research objective the central research question can be formulated and will therefore be:

To answer this central research question several sub questions for the analysis part of this research have to be answered:

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3. What are the critical success factors when implementing an EPRES?

These sub questions will be identified and answered in the following chapters of this report, after theoretical and empirical research is done.

1.3 Academic and practical relevance

The EPRES is an example of an information system. Information systems have gained considerable importance in academic research. Nowadays, many organizations, not only healthcare organizations, are implementing such an information system. It is crucial to organizations to do this in a successful way. This research contributes to the existing base of theory to implement information systems, in particular EPRES’s, by taking an organizational perspective.

Practically, this research gives organizations more insight in their business processes, both formal and factual processes. Understanding these processes will provide the hospital valuable insight into the hospital’ efficiency, and could provide for an increase in patient’ health. For managers, this report could be helpful to gain insight in analyzing the business processes, by using our BPMN-models. BPMN allows us to define a multitude of business scenarios, ranging from internal process choreographies to inter-organizational process adaptations, service interactions, and workflow exceptions (Recker, 2008). With BPMN models, the organization gets a better understanding of their business processes; BPMN models have been designed to be easy to use, and understand the complex business processes (Owen & Raj, 2003). Because of this, we get a better understanding of the data that is needed to support the process.

1.4 Structure of this report

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2. THEORETICAL BACKGROUND

As mentioned in the introduction the cooperation between smaller and larger hospitals is increasing. The increasing cooperation is the result of the minimum volume standard for hospitals to perform a certain operation. If the hospital does not reach the minimum volume standard, they are not allowed to perform the operation anymore. The government came up with a covenant to bundle high-complexity care, which should reduce the healthcare expenses (rapport SGZ, 2011). In order to transfer patient data, systems, like the Electronic Patient Record Exchange System (EPRES), or other healthcare exchange systems, facilitating this patient data exchange is envisioned. In an electronic patient record exchange system all medical and administrative data of the patient is recorded and coupled digitally (rapport SGZ, 2011).

Primarily, the EPRES is a database with patient information, which healthcare professionals can easily retrieve and store patient information (Berg, 2004). The EPRES has many benefits, but is has also their difficulties. The remainder of this theory background is as follow: first the benefits of an EPRES will be illustrated (i.e. why do we need an ERPES). Next, the current developed EPR systems will be discussed and what is needed to design an EPRES system that is technically and strategically a success. Furthermore, the laws and regulations around the EPRES are discussed. Last, the sub questions mentioned in the introduction will be answered after literature research is performed. The sub questions are:

1. Who are the stakeholders involved in an EPRES, and what are the goals and requirements of these stakeholders?

2. What are the critical success factors when implementing an EPRES?

2.1 Benefits of an Electronic Patient Record Exchange System

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for specialists and other healthcare staff to find the patient information anywhere and anytime. Moreover, with the EPRES the quality of the medical information increases, because there are no missing fragments of information (Christensen & Grimsmo, 2008; Miller & Sim, 2004). International studies have shown that centralization of a complex treatment can yield more efficient medical care (Forshaw et al., 2006). Additionally, the EPRES ensures improving quality of care, improving clinical workflow and reducing medical errors (Vest, 2008; Miller & Sim, 2004). The productivity can be increased with the use of the EPRES (Christensen & Grimsmo, 2008). Specialists and healthcare staff can glance over the medical history of the patient before the consult process begins (Desrochet et al., 2008; Benson, 2002).

2.2 Difficulties of an Electronic Patient Record Exchange System

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knowledge is needed in order to create a single consistent.

The design and implementation of information exchange systems in health care is a complex process. It is important to take into account the problems of information exchange systems, the future users, and the organizational context and adequacy (Aarts & Peel 1999). According to Aarts et al. (2004) is "fit" an important factor for a successful implementation of information systems. With 'fit' they mean that the system must be connected to the working practice. Similarly, for Stoop et al. (2007), is the lack of fit between the technology and the context an explanation for the failure of information exchange systems. From the study by Scott et al. (2005) also a number of organizational factors, like culture and leadership, emerged that both encouraged and hampered the implementation both. Besides, the ideals of healthcare professional played a complex role in the whole process of implementation.

2.3 Laws and Regulations

In healthcare exchange systems, like and EPRES, the functionalities of the system must comply with the existing law and regulations in the Netherlands. These laws and regulations are mainly about security and privacy issues of patients and its users. During the design and development phases of a new system issues regarding security and privacy are of highest importance.

Security

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L. Stephana 8 Privacy

Beside security, privacy is seen as one of the main barriers for the development of an EPRES, or other healthcare systems. All new EPR exchange systems or (any other healthcare systems) should comply with Dutch privacy laws and regulations. The EPRES (or any other healthcare systems )should comply to the following law (in Dutch: wet):

Wet geneeskundige behandelingsovereenkomst (WGBO): This law regulates the relationship

between a patient and a therapist (i.e. healthcare staff). A treatment relationship between the patient and a therapist arises when a patient invokes the help of that therapist. This law implies:

 The right to information by the therapist  Consent for medical treatment

 The right to inspect the medical file by the therapist  The right to a second opinion

 Representation of patients who are not able to decide  Right of privacy

Wet bescherming persoonsgegevens (WBP): This law regulated the patient’ personal data. It

states what can and cannot be done with patient’ data. Some examples of the regulations are:

 Patients have the right to see their personal data, and possibly correct them.

 The healthcare organizations must be able to explain why certain data is captured. These organizations may only capture necessary data.

Wet gebruik Burgerservicenummer (BSN) in de zorg’: This law regulates the use of the

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2.4 Stakeholders and their goals of an Electronic Patient Record Exchange System

Stakeholders are those persons (organizations or systems) that have an interest, directly or indirectly, by the introduction of an information exchange system (Boonstra & Goover, 2009), like an EPRES. These stakeholders can be categorized in different groups, and have besides a different view of the EPRES, a different perception of the success of an EPRES (Scott et al., 2005). In order to explain the stakeholders of an EPRES in a better way, these stakeholders will be divided in two different groups: the internal- and external stakeholders. Internal stakeholders are members of the project or research (Kalmann, 2013). External stakeholders are stakeholders who are interested in the business, a research or a project, but are not part of the research or project team (Boonstra & Goover, 2009). These stakeholders will be explained in more depth below.

Internal stakeholders

Internal stakeholders are persons or groups of persons (or organizations or systems) – with a specific role and responsibility – who are directly influenced by a healthcare exchange system (Scott et al. 2005), such as the EPRES. The main internal stakeholders are: medical specialists, nurses, medical assistance, admission support, and laboratory staff (i.e. healthcare staff). Furthermore, the management of the hospital play also a direct role, and are operated from inside of health provider organizations, thus these groups will also be included into the internal stakeholders. Besides the healthcare staff and the management of the hospital, IT developers are also an internal stakeholders. They will develop the exchange system, like the EPRES. The internal stakeholders will be discussed now in more detail.

Healthcare staff

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 Reduction of mistakes in healthcare. Having data available can induce more efficient operations and will improve the quality of treatments.

 Easy transfer and retrieval of patient data. For the healthcare staff it is essential to make well informed decisions for the treatment of patients. Furthermore, with the EPRES, the specialists would reach a decrease in workload and take away unneeded handling.

 Improved performance. Having data available, the healthcare staff could treat the patient faster. Besides, the time and effort needed to exchange medical data between health providers will decrease.

 Easiness of the system. The EPRES should be easy to use and should be understandable.

Hospital (IT) Management

The hospital management are also internal stakeholders. The hospital management have to decide whether to implement such an EPRES (Boonstra & Goovers, 2009). They are most concerned about the quality of care, efficiency of work process, and total costs of their organization (Boonstra & Goovers, 2009). With an EPRES the hospital management would like to decrease the time needed to gain medical data from partnering organizations, but at the same time they would like to improve the quality of healthcare (Boonstra & Goovers, 2009). The input of these groups is mainly important during the implementation phases of a new system. These are the main goals for the hospital management:

 The reduction of the costs in healthcare.  Improved service to patients.

 Improved quality of care.

IT Developers

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desire, but that is also technically feasible (Velde et al., 2006). The IT company would like to satisfy the customer, which is in this case a healthcare provider.

External stakeholders

External stakeholders are all groups of people that are outside of the health organization. These groups include several interest group of the medical specialists and patients (Boonsta & Goovers). Practically, in this case almost all groups that operate or are located outside the organizations border, are considered as external stakeholders. The external stakeholders that are included in this report are: patients, the health insurance companies and the governmental organizations (Dijkstra, 2012). The external stakeholders will be discussed now in more detail.

Patients

The patient can be categorized as external stakeholder, because they are not part of the research or project, but the patient is the most important stakeholder. To make a regional EPRES work, the patient need to approve the fact that their confidential personal information is stored inside this central database (Dijkstra, 2012). The main goal of the patient is the maintenance of their privacy. Furthermore, the patient would like to have improved service provided by the healthcare providers, like hospitals (Dijkstra, 2012).

Health insurance company

One of the largest clients of hospitals in the Netherlands is the health insurance company. The health insurance companies have very high interest in the exchange of medical patient data. They are mostly interested in reducing the healthcare costs (Dijkstra, 2012). They would like to exchange medical treatment data in order to control and reduce the costs that are related with the medical treatments (Dijkstra, 2012).

Governmental organizations

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privacy issues (CBP, 2012). CBP has a coordinating and execution role to protect privacy of the nations, according to the privacy laws in the Netherlands (CBP, 2012). Ministry of Health, Welfare and Sport is one of the main forces of the development of the national EPR. The ministry tasked a subdivision for supervising the healthcare industry. The IGZ regulate the quality of healthcare of all healthcare providers. The care provided by hospitals is dividable into two categories: low- and high-complexity care. High-complexity is of high risk to the patients that receive the treatment. The IGZ is pushing for volume requirements (in Dutch: volumenormen) in order to increase the quality of high complexity care. Hospitals failing to meet these volume requirements, having the risk of revoking their license. NICTIZ, the National IT Institute for Healthcare in the Netherlands is the coordination point, and information center for IT and innovation in the healthcare sector in the Netherlands (NICTIZ, 2013a). This organization provides all needed knowledge and technical assistance to health providers to encourage them to improve regional exchange systems. NICTIZ has introduced different publications about the exchange of medical data (NICTIZ, 2013a). The goals of the governmental organizations are to protect the privacy of the patients, to reduce the healthcare costs in the Netherlands, to reduce mistakes in the healthcare in the Netherlands, and having a EPRES that meet the legal requirements and privacy laws.

2.4 Critical Success Factors of an Electronic Patient Record Exchange System

In this section the Critical Success Factors (CSF’s) of every stakeholder with their goals will be defined. These CSF’s are factors that the EPRES system must meet to speak of a successful solution. If the EPRES does not meet the defined CSF’s, the solution is by definition a failed solution (Balsters, 2012). The CSF’s of the internal- and external stakeholders find from literature (Balsters, 2012; Boonstra & Goovers 2009; Scott et al., 2005; Malloch 2007; Mäenpää et al. 2009), laws and regulations in the Netherlands (WGB, WGBO, WBPG, NICTIZ) and previous performed studies (Dijkstra, 2012; Haarsma, 2012; Wijma, 2012) will be summed up below.

CSF’s of the users (i.e. healthcare staff)

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 The exchange system must be easy to understand and to use. The users with little knowledge of computers should handle the system.

 The EPR exchange system should include the ability to share documents; this means that the system must be able to exchange medical files.

 Information of patient is clear to all healthcare staff.  Information should be complete and accurate.

CSF’s of the hospital management

 The EPRES must be safe; this means that the system must meet the legal standards of the law ‘protection of personal data’. (in Dutch: ‘wet bescherming persoonsgegevens’ ).

 Unauthorized access to patient’ data is not possible. The user needs to login into the exchange system, to get access to patient’ data.

 The EPRES must distinguish between the competences of users to get access to patient data. The user should only be able to recover data he or she is authorized to.

 The EPRES should be reliable and the storage of data should be reproducible. Patient’ data should be available when it is needed and where it is needed all the time.

 The system must have audit trails and access to these audit trails. All operations in the system must be registered according to the format dd:mm:yyyy hh:mm:ss (NEN ISO NORM 8601)

 The EPRES must have a shared ownership of the central registry. This means that each hospital that participates must have a say on the central register.

 The EPRES must be flexible (i.e. scalable) in the number of users (healthcare providers). Multiple users should be added to the system easily.

CSF’s of IT Developers

 The EPR exchange system project should be profitable, and technically feasible.

CSF’s of Patients

 The patient will be registered in the EPRES only if, a patient has explicitly given consent to make his or her records available to the EPR Exchange System.

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 The EPRES should not provide access to private patient data for health insurers.  Patients should have access to their own patient data. The patient data must be

available when it is needed and where it is needed.

 The EPRES must be safe; this means that the system must meet the legal standards of the law of protection of personal data. (in Dutch: wet bescherming persoonsgegevens’ ).

CSF’s of Health insurance companies

 The EPRES must be able to provide access to treatment programs to health insurance companies. They should be able to see what actions have been carried out in which hospital.

CSF’s of governmental organizations

 The EPRES should adhere the law ‘Use of the social security number in healthcare act’ (in Dutch: ‘Wet gebruik burgerservicenummer in de zorg’). This law mandates that all communication between healthcare providers should include the unique citizen number (BSN) to prevent medical errors. The BSN may only be used once the patient is identified through an official document.

 The EPRES should adhere the law ‘protection of personal data’ (in Dutch: ‘Wet bescherming persoonsgegevens’).

 For hospitals who want to implement an EPRES, it should adhere to the ‘Law concerning agreement on medical treatment’. (in Dutch: ‘Wet op de geneeskundige behandelingsovereenkomst’, WGBO).

 The EPR exchange system should adhere the law ‘Medical treatment contracts’ (in Dutch: Wet op de geneeskundige behandelingsovereenkomst’).

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3. THE CASE

The purpose of this chapter is to describe the central case of this thesis. First a general introduction of the hospital Nij Smellinghe Drachten (NSD) will be given. Subsequently, the cardiology and vascular surgery departments of NSD and its core activities are described. The current progress of activities in these two departments will be illustrated, and the desired situation will be explained, which is the purpose of this research.

3.1 General description NSD

The hospital Nij Smellinghe Drachten (NSD), is a regional hospital located in the southwest of the province Friesland in the Netherlands. Following a recent expansion, all medical specialists are represented in NSD (Haarsma, 2012). The hospital features 339 beds, which makes it a medium sized hospital in comparison to other Dutch hospitals (Lijst van Nederlandse Ziekenhuizen, 2012). All medical specialties are represented at the hospital. The organizational structure of NSD is presented in figure 1 shown below. For the organizational structure of NSD in more detail see Appendix III.

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NSD is a partner with other neighboring hospitals in the north of the Netherlands, to provide high complexity healthcare to patients. These hospitals are: Medical Center Leeuwarden (MCL), hospital ’De Tjongerschans’ at Heerenveen, Antonius hospital at Sneek, hospital ‘De Sionsberg’ at Dokkum, Universitair Medical Centrum Groningen (UMCG), and the hospital Martini Ziekenhuis at Groningen (Haarsma, 2012). Figure 2 illustrated the hospitals mentioned yet.

Figure 2: Hospitals partnering with NSD

3.2 Cardiology and vascular surgery departments

The research presented in this report is performed with collaboration of the cardiology and the vascular surgery departments of NSD. These two departments will be described in more detail.

Cardiology department NSD

Cardiologist are specialized physicians engaged in research and treatment of patients with cardiovascular disease. For the treatment of patients with cardiovascular disease different treatments could performed, depending on the disease of the patient. The core activities one can find at the policlinic cardiology are:

 EGC

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L. Stephana 18 Vascular surgery NSD

The medical specialty vascular surgery is mainly concerned with diseases of the blood vessels in the neck, chest, abdomen and legs. The blood vessels could be divided in two categories; diseases of the arteries and disorders of the veins. Each category has different treatment activities. For the diseases the following treatments are possible:

 aortic aneurysm

 Intermittent claudication of the legs.  Thoracic outlet syndrome

 Narrowing of the carotid arteries  Treatment of varicose

 Treatment of veins.

3.2.1 The current situation at NSD

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3.2.2 The desired situation at NSD

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4. METHODOLOGY

4.1 Type of research

In this chapter the methodology is discussed. This master thesis Technology and Operations Management is performed during an internship at the Nij Smellinghe Hospital Drachten (NSD) in the Netherlands. The subject of the larger research is a proof-of-concept of an EPR Exchange System (EPRES) design, that satisfies the stakeholders involved in the implementation process, and take into account the critical success factors (CSF’s) of an EPRES. The desired outcome of this research is to create value rather than determine a reality. Therefore, this research is a business problem-solving project instead of a literature study: there is a gap between the way stakeholders at this time perceive the world, and the way they would like to perceive the world. Research that addresses practical-knowledge problems is commonly called design research.

4.2 Research framework

Van Aken, Berends and van der Bij (2007) developed a research methodology for business problem-solving projects. This research at NSD fits the quality criteria of a problem-solving project of Van Aken et al., (2007) which are:

 performance focused: the research is initiated to improve the performance of the two departments cardiology and vascular surgery at NSD. The research is about a proof-of-concept of an EPRES design, that satisfies key stakeholders involved, and take into account the critical success factors (CSF’s) of an EPRES.

 design-oriented: the activities during this research are controlled through a research methodology.

 theory-based: knowledge from scientific literature is used for analysis and design activities.

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L. Stephana 21 Figure 3: Regulative Cycle (Van Strien,1997)

The design problem phase give answer to the following questions:

1. Who are the stakeholders?

2. What are the goals for each stakeholder?

3. What are the Critical Success Factors (CSF) for each goal?

The Diagnosis/Analysis phase has the focus on the following:

1. What are possible causes of the difficulty resolving a CSF?

2. What are the quality attributes of CSF’s? 3. What are the CSF interdependencies?

Design solutions phase:

1. Which alternative solutions are available?

2. Can we assemble old solutions to build a new solution?

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The implementation phase then should deliver a construct according to the designed solution. Finally, the validation phase give answer to the following questions:

1. How to design test methods for each CSF?

2. Were all CSF’s met?

3. Is there a trade-off between CSF’s?

4. How scalable is the solution/implementation?

5. How well does the solution/implementation perform relative to previously established CSF quality attributes?

(Balsters, 2012)

This regulative cycle will be passed through as the following: Design Problem, Diagnosis/Analysis, Design Solution and Validation, in this research to come through a well-developed design. The Implementation phase will be excluded in this research.

4.3 Scope of the research

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process. Due to limited resources available, the key stakeholders considered in this research are:

 The healthcare staff (i.e. the users of the system)  The (IT) management of the hospital

4.4 Data collection

This research will provide the goals and CSF’s for each stakeholder, as well as give an indication of the quality attributes and causes for difficulties to resolve these CSF’s. For this research different sources of data are used. First, other previously performed studies at the NSD can serve as input. These studies are: Dijkstra, 2013; Haarsma, 2012; Kalmann, 2013; Wijma, 2013. Furthermore, knowledge and viewpoints of stakeholders (employees of NSD) are obtained by performing semi-structured interviews. Data will be gathered by means of written correspondence and interviews. For the theoretical foundation of this thesis scientific literature is used from Scientific Journals found in the electronic library “Business Source Premier”.

4.5 Evaluation

The business requirements, and the resulting business process models (BPM-models) for NSD, which will be identified in this research, are the output of this research. These outputs should be evaluated, because when requirements are inadequate it will have consequences for the project (Robertson & J. Robertson, 2006). Thus, the identified requirements should be verified (i.e. are the requirements correct?) and validated (i.e. are the requirements justifiable?). For the evaluation of the requirements in this research, we will use of Key Performance Indicators (KPI’s). In the context of requirement specifications in this research, KPI’s can be established concerning:

1. Quantifiability – the quality of being measurable

2. Feasibility - capable of being accomplished

3. Accuracy – conformability to fact and precision

4. Completeness – having all necessary or normal parts, components or steps.

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6. Validity – the quality of being purposeful, justifiable and well grounded.

The stakeholders involved in this research, will play a role in this evaluation process. The business requirements identified, and the conceptual business process models developed, will be linked back to the stakeholders, so that the stakeholders can give feedback. They have greater knowledge about the environment, and can make a better judgment on whether a CSF is fulfilled.

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5. ANALYSIS

5.1 Data analysis

In this chapter of this report, the analysis and results are discussed. It is important to investigate the viewpoints, goals and interests, and Critical Success Factors (CSF’s) of different mentioned stakeholders of an EPRES. The knowledge about the viewpoints, goals, interests, and CSF’s, can help to collect the most important requirements from stakeholders. The basis of this analysis, is to identify the most important requirements, and the associated CSF’s of different stakeholders. In this report, the focus is on only the identification of the viewpoint and goals of medical specialists and assistants at the cardiology, and vascular surgery departments. All other stakeholders mentioned in section 2.4 are not included. Furthermore, the focus in this analysis is limited to only one function of the EPRES, being the exchange of the medical data of the patients. Another detail to mention, is that the business requirements composed in this analysis include only a set of user requirements, and hence the technical system requirements are excluded in this report, because in this report the focus is on the business analysis. The technical system aspects of the project is delegated to the third sub-project (See report of Hijlkema, 2013). In the analysis of this report the term business requirements will be used, even though these requirement do not cover all the business requirements.

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verified and validated see section 5.3 of this report. As noticed, the IT management of NSD was also asked for feedback. The reason for this, is to see if the business requirements composed from the goals of the medical specialist, fits into the ICT of NSD. Besides this reason, the business requirements were verified and validated from more stakeholders, which it makes it more reliable. Additional, the list of business requirements was verified and validated by my mentor, Mr. Balsters and the researcher who is responsible for the second sub-project of the larger project, Stefan Post.

5.2 Stakeholders, their goals and the CSF´s for analysis

As mentioned before, only surgeons from two departments were interviewed, and feedback was given by these surgeons. As described in section 2.4, these stakeholders belong to the category internal stakeholders. Internal stakeholders are persons or groups of persons (or organizations or systems) – with a specific role and responsibility – who are directly influenced by a healthcare exchange system (Scott et al. 2005), such as the EPRES. The internal stakeholders in this analysis are: medical specialists, and medical assistance (i.e. healthcare staff) of NSD.

Healthcare staff (i.e. users of the EPRES)

For this analysis, the healthcare staff are two surgeons (i.e. medical specialist) from the cardiology, and vascular surgery departments. The healthcare staff (like medical specialists) comprise the main users of an EPRES. These medical specialists are responsible for the diagnosis of diseases and treatment of the patients. Before the implementation of an EPRES, it is important to take into account their viewpoint, goals and advice. Knowing their important goals will reduce the risks of failure, and will help to increase their wiliness to corporate with the development of the new system (Boonstra & Goovers, 2009). These are the main goals of the medical specialists of NSD:

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 Improved performance. Having data available, the healthcare staff could treat the patient faster. Besides, the time and effort needed to exchange medical data between health providers will decrease.

CSF’s of the healthcare staff

 The EPRES must have a fit with the current workflow. This means that the system should have a fit with the processes at the two departments of NSD.

 The EPRES must have a fit with the goals and requirements of the healthcare staff. This means that the system must meet the wishes of the healthcare staff to improve the performance.

 The EPRES must be easy to understand and to use. The users with little knowledge of computers should handle the system. If the system is not easy understandable, the workload would not decrease.

 The EPRES should include the ability to share documents; this means that the system must be able to exchange files.

 The EPRES should include the ability to share visual diagnostics; this means that the system must be able to photos and images.

 Information of patient is clear and understandable to all healthcare staff. When information is not clear or understandable to healthcare staff, the performance will not improve, but will decrease.

 Information should be complete and accurate. The patient’ information in the EPRES system should be complete and accurate, to improve the performance.

To set up a list of CSF’s seems to be an easy case, but the realization of these CSF’s is a difficult task. There are many aspects to take into account to meet the CSF’s in a successful way. Moreover, some CSF’s should be given a higher priority. Below, some possible causes will be described why it is difficult to solve the CSF’s.

The Dutch privacy laws and regulations

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(BSN) in de zorg’. For the detailed description of these laws see section 2.3 of this report. There is a risk that not all these laws are met when a healthcare organization decides to implement a healthcare exchange system, such as the EPRES.

Security standards with regard to patient’s safety and privacy

The EPRES must adhere the security standards (NEN 7510, NEN 7511, NEN 7512, and NEN 7513) that are related to the security of personal data, and authorization and access of the users. The complexity of the safety rules in combination with the increased technical capabilities ensures that it is difficult to develop a very safe system.

Patients permission to register EPRES

Patients must give permission to exchange their patient data with third parties. The registration of the patients in the EPRES should be organized in a controlled manner. Furthermore, patients are allowed to refuse to give permission.

Reliability of the EPRES

The patient’ data should be available all the time, where it is needed and when it is needed. This is difficult to maintain. These are mainly technical issues, and are referred to the third subproject of the larger project. For details of these technical issues, see the report: EPR exchange system: prototype development using design science (Hijlkema, 2013).

Uniformity of patient’ data

The patient’ data should be uniform to all the users of the EPRES. Different healthcare providers have their own patient’ file, and their own way of processing the data in the Hospital Information System (HIS). Exchanging these patient’ data with the EPRES, these data should be converted in an easy manner, so the data is uniform. How the heterogeneous data in the HIS of each hospital will be converted to homogeneous data in the EPRES is part of the third sub-project (Hijlkema, 2013).

Patients should have access to their own patient data

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patient given the possibility to login? These questions should be designed in a thoughtful way.

Emergency procedure

With an emergency intake the specialist should have access to the EPRES without the authorization checks, and without permission of the patient. This emergency procedure allows for the possibility that patient data can be obtained without an authorization check. The risk behind this is that users can make abuse of the emergency procedure. To prevent this large risk, everything in the EPRES must be logged in an controlled manner.

Easy and quick implementation process of EPRES

The implementation process of an EPRES is a complex process. Often several things that come into play were not assessed in advance. Also, some problem could arise with the coordination between the different authorities sharing an EPRES. Furthermore, the system should be tested several times, before the actual implementation process.

Easiness of the EPRES

The EPRES system should be easy and intuitive to the user. The users of the system should all agree with the interface of the system. This is difficult to reach, because every user experience easiness in another way.

5.3 Business requirements

From the analysis of the data gathered from NSD, a list of business requirements is composed. The list of business requirements is composed from the medical specialist of the cardiology and vascular surgery departments of NSD. From the feedback received from NSD, the list of business requirement consists of three additional requirements obtained from the IT management department of NSD.

Business requirements from medical specialists of cardiology and vascular surgery department of NSD

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 A session starts when a user logs into the electronic patient record exchange system. A session can be terminated by the user or logout after xx minutes of inactivity on the workstation.

 When requesting information about a patient by means of the electronic patient record by the user, the retrieval process requires no more than three user actions. Provided that the information about the patient for the user is accessible, an act can be: the activation of a control by using a pointing device, using a touch screen, filling in a text field.

 The user interface should only have one control element for each function with the underlying aim to keep the interface simple and clear.

 The user interface should work on an efficient workflow, and to be attractive (to work with) with respect to graphics, color and resettlement aspects.

 The display of an electronic patient record for a specialist as a user, must contain administrative, personal and medical data of a patient.

 The display of an electronic patient record for a secretary / assistant to a specialist as a user, must contain administrative, personal and medical data of a patient.

 Viewing, modifying and adding information concerning a patient in the electronic patient file, must be doable by the user within one screen, provided that the user is authorized for these operations. The aim underlying this is an efficient workflow. Working with composite screens should also be allowed, for an efficient workflow, in particular, partition of dual data per patient into two screens (per user) should be feasible.

 The EPRES must be able to handle high resolution photos. The high resolution images, for example MR images must be able to be transferred in a good way to the other user.  The EPRES should not be complex, with many features. The users should be able to

work with the system.

 A patient in the electronic patient record must be identified on the hand of his Citizen Service Number (BSN), as prescribed in the Act using citizen service number in care.  The rights to access, type and extent of access permitted with respect to the user and

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 The start time and end time of a session must be recorded in the system in the format dd: mm: yyyy hh: mm: ss according to DIN ISO 8601.

 A patient file in the electronic patient record must contain all information and meta-data can contain as prescribed in the standard HL7 CDA 2.0.

 A patient in the electronic patient record must be identified on the hand of his Citizen Service Number (BSN), as prescribed in the Act using citizen service number in care

or alternative for an extra check to find the right patient by his/her birth name, birth

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6. RESULTS/DESIGN

In this section, the results will be illustrated and described. The results of this research are conceptual business process models. These conceptual business process models are designed in Business Process Modeling Notation (BPMN), which will be described in more detail later on in this section. The BPMN-models are established from the data analysis, the business requirements described in the previous section, and the information from the theory background. These BPMN-models are verified and validated by several stakeholders: two surgeons of cardiology and vascular surgery departments of NSD, three stakeholders from the IT management of NSD, my mentor Mr. Balsters, and the researchers which are responsible for sub-project two and three, Stefan Post and Hans Hijlkema. The BPMN-models are verified and validated by showing the stakeholders the BPMN-models, and give a detailed explanation of how to read the models. Additional to this verification and validation method, the BPMN-models are verified and validated by means of the conceptual user interfaces designed by Hijlkema (2013). As mentioned before in this report, the BPMN-models are direct input to make a conceptual design of user interfaces. As these user interfaces are verified and validated by the stakeholders, it can be concluded that the conceptual business process models are correct.

The BPMN-models, visualize the processes of an EPRES. As mentioned before in this report, the focus of this research is on only one function of the EPRES, and is on the exchange of medical data of patients. For this reason, only for this function of the EPRES, conceptual business process models are designed. For the exchange of medical data of patients, the following processes are required:

 Registration process of a patient at a hospital: When a patient is referred to a hospital, the patient is required to register in that particular hospital. If the patient is already registered in the EPRES, the hospital could retrieve the patient data, and could make a file for this patient in the hospital. This, will save time and effort for the user to fill in the personal data of the patient. Also, for the patient it is more user-friendly; the patient does not have to give their personal data again. If the patient is not registered in the EPR ES, the patient could be asked to give consent whether or not to register in the EPR ES, during the registration process at the hospital.

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from one healthcare organization to another healthcare organization, a referral process is required.

 Viewing patient data by healthcare staff: The function of the EPRES is, to exchange patient’ data between healthcare providers, and hence, the healthcare staff should be able to view the data that is exchanged.

 Emergency procedure: When there is an emergency intake, the healthcare staff should be able to view the data of that particular patient in the EPRES.

The processes that are required for the exchange of medical data between healthcare providers, as described above, are designed in BPMN-models (see pages 36-39 for the designs). BPMN is the current international standard for process modeling, and provides a basis to make the transition from the business process to business data. With BPMN models, the organization gets a better understanding of their business processes. Using BPMN, someone is writing Business Process Diagrams (BPD). These BPD’s are flowcharts, that mention all tasks in a process, illustrates the sequence in which the tasks are executed, and shows the events and activities that can happen in a process. In other words, the business process models visualizes the stakeholders involved in the EPRES, their goals and requirements, and the CSF’s. The Business process diagrams, represents the context of the process. The BPD’s in this case, represents the context of these processes: the registration process of a patient in a hospital, the referral process of patient’ data by the healthcare staff, the viewing process of patient’ data by the healthcare staff, and the emergency procedure. The swim-lanes, indicate the stakeholders involved in the process that is. As mentioned in the section theory background, stakeholders can comprise people, organizations, and systems. The process presented in a BPD, starts with an ‘start event’, and shows the subsequent tasks, and control points of the process. The process ends with an ‘end event’. When the process reaches the ‘end event’, the goal of the stakeholders involved in the process is achieved. The control point, are the Critical Success Factors (CSF’s) of the goals of the stakeholders involved in the process, which is illustrated in an BPD. Some examples are given to clarify this. In both the registration process of a patient at a hospital, and in the process of viewing patient’ data by the healthcare staff, the first control point is ‘Registered in EPRES?’. This control point belongs to the CSF of a patient, and is:

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explicitly given consent to make his or her records available to the EPRES.

In the referral process of patient’ data by the healthcare staff, the control point is ‘Write access authorized?’. This control point belongs to the CSF of the hospital management, patients and the governmental organizations, and is:

 Unauthorized access to patient data is not possible.

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Swim lane. A swim lane represents a stakeholder in the process. A stakeholder can be a person or group of persons, an organization or a system.

Start event. A start event indicates where a particular process will start.

End event. An end event indicates where a particular process will end.

Task in the process. An task is an atomic activity that is included within the process. The short name of the activity indicates what needs to be performed.

Control point in the process. These control points are in the process where the process flow split in two possible ways to the next step of the process.

Data object. A data object provide information about how documents, data and other objects are used and updated during a process.

Sequence flow. A sequence flow is used to show the order that activities will be performed in a process.

Annotation. A text annotation is a mechanism for a modeler to provide additional information for the reader of a BPMN diagram.

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7. CONCLUSION AND DISCUSSION

In this concluding chapter some core elements of the outcome of this study are addressed. Subsequently, limitations of the study are addressed, together with recommendations for further research. The research question of this report, where in this section, answer is given to is:

For the exchange of patient’ data between hospitals, systems like an Electronic Patient Record Exchange System (EPRES) is envisioned. To make complete and consistent business process models, the following factors are relevant to identify:

2. What are the goals and requirements of these stakeholders?

3. What are the Critical Success Factors (CSF’s)when implementing an EPRES?

From literature research, we found that the most important stakeholders involved in an EPRES are: healthcare staff, hospital (IT) management, IT developers, patients, healthcare insurance companies, and governmental organization. Each of these stakeholders has their own goals and requirements related to the EPRES. The case for this research were the cardiology and the vascular surgery departments. As a consequence, the stakeholders involved in this research are the healthcare staff (i.e. two surgeons). The goals of these stakeholders are: transfer and retrieval of patient’ data easily, transfer and retrieval of patient’ visual diagnostic, like photos and images, and improved performance. The CSF’s of these goals are:

 The EPRES must have a fit with the current workflow.

 The EPRES must have a fit with the needs of the healthcare staff.  The EPRES must be easy to understand and to use.

 The EPRES should include the ability to share documents.  The EPRES should include the ability to share visual diagnostics.

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From the identified stakeholders, their goals and requirements, and the CSF’s, a set if business requirements, and complete and consist conceptual business process models are developed for the exchange of patient’ data by an EPRES.

7.1 Limitations of research

This research was limited to the departments cardiology and vascular surgery of Nij Smellinghe Drachten (NSD). As a result, the data used for this research is only obtained from two stakeholders of these departments. It is not so clear to what extent the findings are extendible to other departments of NSD or other hospitals. Furthermore, the focus of this research was only on one function of the Electronic Patient Record Exchange System (EPRES), which is the exchange of patient’ data between departments/hospitals. Without further research, the conclusion of this research, and the recommendations for NSD are only appropriate for the departments cardiology and vascular surgery.

7.2 Recommendations for further research

Further research could be done on the data completeness, and reliability. This could be achieved by expanding the number of stakeholders involved in this research. More healthcare staff could be involved, to make the research more reliable. Besides healthcare staff, other stakeholders, such as patients, IT developers, or governmental organizations, of the EPRES could be involved in the research. Appendix VI, show some scenarios of Business Process Models (BPM), which are already developed for governmental organizations as stakeholder. However, these BPM’s are neither verified nor validated. Moreover, more hospitals could be included as stakeholders. Another suggestion for further research is, focusing on more functions of the EPRES. Research could examine how data in the EPRES should be processed. Another investigation could be, which data exactly should be processed.

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