A view of 21st century healthcare industry and software quality ...

Int. J. Networking and Virtual Organisations, Vol. 9, No. 2, 2011

A view of 21st century healthcare industry and software quality improvement practices Tien D. Nguyen*, Hong Guo and Raouf N.G. Naguib Biomedical Computing and Engineering Technologies (BIOCORE), Applied Research Group, Faculty of Engineering and Computing and Health Design and Technology Institute, Coventry University, CV1 5FB, UK E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] *Corresponding author

Nilmini Wickramasinghe School of Business IT and Logistics, RMIT University, G.P.O. Box 2476, Melbourne VIC 3001, Australia E-mail: [email protected] Abstract: In a rapidly expanding industry such as healthcare, information and communication technology is increasingly becoming a key role in supporting, maintaining and improving healthcare services. This paper discusses the impact and future development of software within the healthcare field. At the same time, it identifies the current state, challenges and solution of software quality improvement and assurance practices for this domain. Keywords: healthcare informatics; software process improvement; SPI; quality management and assurance. Reference to this paper should be made as follows: Nguyen, T.D., Guo, H., Naguib, R.N.G. and Wickramasinghe, N. (2011) ‘A view of 21st century healthcare industry and software quality improvement practices’, Int. J. Networking and Virtual Organisations, Vol. 9, No. 2, pp.155–168. Biographical notes: Tien D. Nguyen is a PhD graduate of the Biomedical Computing and Engineering Technologies (BIOCORE) Applied Research Group at Coventry University. His research focuses on healthcare informatics and software process/quality improvement models and methods which he has contributed numerous publications. Since 2004, he has been studying quality issues of large-scale software products and processes in the healthcare environment. Prior to his PhD, he received his BA and MSc from Coventry University. Hong Guo is a Senior Lecturer in Software Engineering and a member of the Biomedical Computing and Engineering Technologies Applied Research Group (BIOCORE) at Coventry University. She received her PhD from Copyright © 2011 Inderscience Enterprises Ltd.

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T.D. Nguyen et al. Nottingham Trent University in 2001. She has published many papers in journals and conferences on software quality management and process improvement, object oriented software engineering, and the application of software process improvement in teleworking environments. She is a Visiting Professor at Beijing Technology and Business University, Beijing, China. Raouf N.G. Naguib is a Professor of Biomedical Computing and the Head of BIOCORE. Prior to this appointment, he was a Lecturer at Newcastle University, UK. He has published over 290 journal and conference papers and reports in many aspects of biomedical and digital signal processing, image processing, AI and evolutionary computation in cancer research. He was awarded the Fulbright Cancer Fellowship in 1995–1996 when he carried out research at the University of Hawaii in Mãnoa, on the applications of artificial neural networks in breast cancer diagnosis and prognosis. He is a member of several national and international research committees and boards. Nilmini Wickramasinghe received her PhD from Case Western Reserve University, USA. She researches and teaches within the information systems domain. Her research work focuses primarily on developing suitable models, strategies and techniques grounded in various management disciplines to facilitate more effective design, development and implementation of IS/IT solutions to effect superior, patient centric healthcare delivery. She has collaborated with leading scholars at various premier healthcare organisations throughout the USA and Europe. She has published more than 200 refereed scholarly articles, ten books, numerous book chapters, an encyclopaedia and a well established funded research track record.

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Introduction

Software continues to be a major driver of economic and social modernisation. Businesses can no longer be imagined without software, neither can banks, insurance companies, government nor can other sectors operate without it. There is hardly any industry that is not touched or handled by one type of software or another. It is increasingly becoming a priority for the healthcare industry to invest in new software systems and IT infrastructure to help deal with the dramatic demands and, at the same time, close the gap with other sectors. In the near future, all the current investments and initiatives from healthcare organisations and governments will provide healthcare professionals a variety of automated tools such as tracking case notes, ordering test results, prescribing drugs and accessing comprehensive patient information on a real time basis and wider geographical boundary. However, as software plays a more critical role in healthcare delivery, it also brings many issues and concerns to its creators and users. This paper presents the latest development, future outlook and comparison of healthcare information and communications technology (ICT) initiatives between the UK and other developed nations. It also provides the current state of software quality management practices within the healthcare development environment from a recent survey. And finally, the paper concludes with some of the research work which devoted to address the current healthcare quality improvement challenges and demands.

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Healthcare ICT Overview

The healthcare sector has been slower than other industries to embrace business-sectorspecific automation technology (E-Health Insider, 2005). Many in the sector have been late adopters of information technology as a means of improving their organisation, increasing its efficiency, differentiating its services, and cutting its costs of doing business. Now technology is increasingly becoming a priority for the healthcare industry, especially to help deal with the dramatic changes in healthcare trends (towards prevention), and revenues and costs (effects of global recession). This section highlights the current role, future trend and comparison of ICT between the UK and other healthcare-developed nations.

2.1 The UK healthcare sector The healthcare software and services sector is one of the most rapidly growing markets in the UK, with an annual rate of growth of approximately 16% (Intellect, 2001). Over the longer term, the proportion of the National Health Service’s (NHS) £100 billion devoted to IT services is set to grow to 4%, more than double the 1.5% spent at the beginning of the decade. The biggest driver of the spending proportion is the NHS’s National Programme for IT (NPfIT), launched in 2002 and expected to be fully implemented by 2012 (Connecting for Health, 2010), with a central expenditure of over £12 billion which has made this IT scheme the world’s largest computer project (Brennan, 2005). This initiative was funded to support implementation of four major IT projects: computerised patient records, an online booking system, an electronic prescription system and a new broadband infrastructure. On completion, the new integrated software system will provide electronic medical records for all the UK population. They will also connect 30,000 GPs to 300 hospitals, providing secure and audited access to these records by authorised health professionals. They include many essential clinical, as well as sector-specific, products, systems and services that are used by health authorities, professionals and patients. Examples include electronic healthcare records, telemedicine services, health portal, picture archiving and communication system (PACS), and many others which can be use to prevent, diagnose, treat and monitor patients’ health. The scale of this IT change planned in the UK NHS over the course of this project is unprecedented. An enormous challenge is to introduce this change and the business changes necessary to exploit it fully without impacting the safe delivery of care. The commitment for the project nevertheless remains intact even when the timescales seem to be unachievable. As the UK is leading the world in healthcare IT investment, everyone is watching its healthcare system being transformed and supported by a range of new ICT systems. Failure to deliver high quality software systems despite vast spending will have a negative impact on the UK’s reputation and also, more seriously, lose taxpayers’ confidence, meaning there will be less support for similar future IT investment projects. The graph in Figure 1 shows the usage of ICT in each healthcare area. It also demonstrates that the UK is the European frontrunner in employing ICT among GP practices and hospitals. More comparisons will be discussed in the next section.

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T.D. Nguyen et al. ICT usage in the healthcare sector (see online version for colours)

Note: EU27 represents 27 member states. Source: European Commission (2008)

2.2 The EU and USA healthcare sector New technology has already brought an array of benefits that help tackle problems that the UK healthcare sector has struggled with for years (Brennan, 2005; Connecting for Health, 2007). Everyone from individuals to organisations to governments now appreciates the role of IT in maintaining and protecting their wellbeing. Other developed counties have already planned and followed the UK footsteps in investing and promoting IT implementations, as indicated in Table 1. Currently, these developed nations have largely focused their investments to improve infrastructure, patient administration, basic clinical applications and operational efficiency. Priorities in different countries vary somewhat depending on their individual organisational structure and strategy of their national healthcare system but they all show a strong commitment to E-Health applications which will be the key enabler for reforming and improving healthcare in the future. For instance: in Germany, a national electronic health cards (EHC) design is evolving which will be enabled by the issue of health ‘smart cards’ to all German citizens. This project will ultimately connect 21,000 pharmacists, 123,000 registered doctors, 65,000 dentists and 2,200 hospitals to provide patients and professionals access to medical information and to enable electronic prescribing (Federal Ministry of Health, 2007). Moreover, the European health insurance card (EHIC) is printed on the back of cards belonging to members of statutory health insurance providers that will allow the insured access to cross-border treatment in other EU countries if they fall ill. Gradually, the EHC will be given new functions and can be accessed securely in other EU countries. This extends well beyond the scope of administrative data, including doctors’ letters, x-ray images and digital data from various examinations. It is difficult to make comparisons in terms of priorities and trends between these countries because of their differences in organisational structure, funding and operational practice. For example, the USA focuses their IT spending on billing and entitlement management systems to improve its complex financing of the healthcare system. Electronic booking systems are less relevant in countries such as France and since their patients go directly to consult specialists without going through GP referrals, while the UK spends heavily on the choose-and-book system (a national electronic referrals

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service). Nevertheless, irrespective of the type of healthcare system, i.e., public, private or two tier, the table shows all the latest key ICT initiatives at national and international levels which serves to demonstrate a future trend in ICT development and investment and, at the same time, offer a clear direction for the rest of the world to follow. The development of new and advanced software applications in the healthcare sector, as shown in Table 1, not only brings about new benefits to healthcare professionals and patients, but also new risks. Poorly designed and implemented software systems can cause serious consequences in the healthcare environment. The next section explains the current state and challenges of software quality management and improvement within the healthcare software development environment. Table 1

EU and USA healthcare ICT overview

Country

Major projects

Goals

UK

The £12.6bn NPfIT project provides electronic patient records (EPR), digital x-rays, new internet broadband, electronic transmission of prescriptions, electronic booking sharing across country

Improving systems integration and her (electronic health record)

France

The CPS (Carte de Professionnel de Santé – health professional card); the SESAM-Vitale system for electronic reimbursement claims; EU NETC@RDS project for trans-European health services and health web portal

Optimising and reengineering of healthcare system

Germany

The electronic health card programme for national EHRs sharing and to integrate eEHIC (European Healthcare Insurance Card) in the future

Cost control and cross-border healthcare

Spain

Plan Avanza which includes e-health services such as EHRs, electronic medical appointments, e-prescribing, telemedicine and patient health cards

Improving quality of care and patient safety

Netherlands

The electronic medication record (EMR) and electronic general practitioners’ record (WDH) programme to provide a foundation for nationwide electronic communication and exchange of medical data

Developing a national EHR

Sweden

Several projects to facilitate E-Health applications include: CarelinkPLUS, CarelinkRIV, SITHS, e-Lak, InfoVU and national patient advice project

Facilitating system interoperability

USA

Two main IT initiatives from National Health IT Coordinator are: Consolidated Health Informatics Initiative (CHI) and Federal Health Architecture (FHA) to establish interoperability standards for data transfer between federal health systems and communities

Cost control and system interoperability

Source: European Commission (2008) and Anderson (2005)

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Healthcare software quality overview

There has been some improvement in software quality over the years, but according to the latest figures published by The Standish Group, it only shows about a third of

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software intensive project are successful with 32% of all projects succeeding which are delivered on time, on budget, with required features and functions, which represents a decrease in project success rates (The Standish Group, 2009). It further reveals that 44% were challenged which are late, over budget, and/or with less than the required features and functions and 24% failed which are cancelled prior to completion or delivered and never used. The result shows a backward trend in software success. It also shows the highest failure rate in over a decade, as summarised in Figure 2. Figure 2

Software development failure trend (see online version for colours)

In the healthcare industry, software systems have some characteristics in common with today’s ultra-large-scale systems with regards to: number of lines of code; number of people employing the system for different purposes; amount of data stored, accessed, manipulated, and refined; number of connections and interdependencies among software components; and number of hardware elements (Feiler et al., 2006; Maier, 1996). Their scale changes everything, which places even more demands on existing technologies and software engineering practices. In addition, the problems associated with quality in the healthcare setting also come from the end-users, as they usually acquire a bespoke system with very specific local requirement specifications. If the involvement of these primary stakeholders is neglected in this modern day programming, or they refuse to participate in the development process, this will become the biggest factor which prevents a new software system from operating to its full potential (Nguyen et al., 2008). With the current multi-billion pound investment, the UK healthcare sector has become the most rapidly growing sector of the software development industry. However, the ongoing UK NPfIT project has already faced many issues and challenges in terms of keeping up with the budget, timescale and technical requirements, which are well documented in many recent studies and reports (MORI, 2005; Medix, 2006; Nguyen et al., 2009a). Industry experts and software practitioners argue that the programme is at risk of breaking down due to the challenging integration of users’ working practices and organisational culture during the development process (Booth, 2003; Hendy et al., 2005). The author’s survey results further suggest that the problems are not just attributable to the size or technical challenges, but more frequently down to the management of software

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supplier-customer processes, mainly in the areas of requirement, change and implementation management (Nguyen et al., 2008). The survey also reveals other issues, ranging from specific technical concerns, such as security and interoperability, to wider organisational and people challenges. Not only is it unrivalled in scale; the complexities of the healthcare clinical processes and organisation mean that the development and management of such a project pose many more challenges for the healthcare industry, the UK NHS especially, than in other sectors. According to recent reports, the NPfIT project’s costs could eventually escalate to £20bn and it will be likely to take five years longer than expected for a full deployment (National Audit Office, 2008; O’Brien and Hayes, 2009). Beside the current NPfIT project’s concerns, the healthcare software industry has already been put under the microscope with some other well-known software disasters caused by poor design and implementation. For example, the Therac-25 (a machine used in radiation therapy for cancer patients) case which cost six people’s lives (Leverson and Turner, 1993), or the high-profile London Ambulance Service project failure (Field and Keller, 2002). These examples were some of the best-documented among many other unsuccessful healthcare IT projects. The designers of these failed to pay enough attention to the impact that new software systems could bring to working practices. These elements in combination suggest that the socio-cultural challenges to developing and implementing large-scale healthcare applications are as daunting as the technical and logical ones. Nowadays, software vendors within the healthcare industry are given the highest level of accountability because IT system defects and/or flaws not only result in huge financial loss but can also cause serious consequences to human lives. This is a warning for any creator of computer programs: software quality matters, application must be foolproof and, especially in this safety-critical and under-developed environment, a poorly designed, poorly implemented software system can kill. According to field experts, the healthcare sector is one of the ‘worst’ industries for employing good software engineering practices and in serious trouble (E-Health Insider, 2005; Anderson et al., 2007). The next section provides a brief overview of the current UK healthcare quality improvement and management practices from a recent survey.

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Current software quality and process improvement practices

4.1 Survey overview The author conducted a survey to investigate the current software process improvement (SPI) and quality management practices within the UK healthcare industry. The questions are designed to: a

elicit the perceived value of the SPI approach to quality management and improvement within the UK environment

b

identify process areas that are significant to develop a high quality product.

The survey questionnaire was sent to members of the software improvement group (SIG) and software engineering process group (SEPG) from healthcare development organisations. Overall, there were 29 organisations participated in the survey.

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4.2 Survey findings A significant number (93%) of surveyed software organisations stated that they have employed the SPI standard for managing their internal processes and/or for quality certification purposes (see Figure 3). The ISO 9001, in-house tailored and TickIT standards were the most popular choices among the UK healthcare sector with 69%, 41% and 34%, respectively. Others, such as CMM/CMMi and SPICE, are still at a low adoption rate in this domain (all are less than 10%), as shown in Table 2. Figure 3

Table 2

Current UK healthcare industry SPI standards adoption (see online version for colours)

SPI standards employed by the UK healthcare organisations

Standard

No.

% (Total = 29)

ISO 9001

20

69

Tailored

12

41

TickIT

10

34

Agile

8

28

SPICE

2

7

Others

2

7

CMM/CMMi

2

7

The majority of respondents agreed, just over 90% (see Figure 4), that the quality of their software product is largely governed by, and can be enhanced by, improving the process which is used to develop it. Thus, they acknowledged the advantage affiliation of SPI approach to quality improvement. Figure 5 shows a bar chart which clarifies the range of specific benefits from SPI standard implementation reported by software organisations. A large percentage (over 70%) of respondents agreed that SPI can help enhance their productivity, quality, communication, customer satisfaction and internal processes. However, there is some doubt about using SPI as a tool to help them win more contracts, with nearly half (41%) stating that they were not sure or disagreed, or to help them save costs (23% were not sure or disagreed). This finding could mean that the UK healthcare customers are still largely ignoring, unaware of and/or underestimating the advantages the SPI standard can bring to their software products. Thus, they might not have differentiated the software suppliers who had adopted SPI standard from those who had not. As for the cost factor, this may be due to the fact that SPI implementation demands significant resources which

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appear to increase rather than reduce cost, especially during the early stages of the initiative. It usually takes a long time for companies to realise the financial benefits of the SPI effort (McGibbon et al., 2007). Figure 4

Overall view of SPI approach to quality improvement within the UK healthcare industry (see online version for colours)

Figure 5

Benefits from SPI effort (see online version for colours)

The other main objective of the survey was to analyse specific processes that played a key role in achieving high product quality within the healthcare development

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environment. The answers ranked in Figure 6, showing around half of the respondents indicating that both the technical and management activities, ranging from problem resolution to project management, were regarded as key to help them develop and maintain a high quality software system. While ‘software design’ practice received the most votes with 69%, ‘process assessment’ and ‘process establishment’ got the least attention with 17% and 21%, respectively. Figure 6

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Critical process dimensions for the UK healthcare industry (see online version for colours)

Discussions

There is no doubt that software applications play a crucial part in the 21st century healthcare industry, as explained in previous sections. They can improve access to healthcare, reduce cost and increase the efficiency of care. Similar to other industries where software has made ‘mass customisation’ according to the highly personalised

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needs of individual customers possible (Institute of Medicine, 2001), it has also gradually transformed healthcare services to facilitate patient-centred and cross-border care. Nevertheless, this rapid introduction of new and advanced software applications in the healthcare sector not only brings about new benefits to healthcare professionals and patients, but also new risks. If software products and systems were poorly designed and implemented in this safety critical environment, they could cause array of serious consequences. Apart from ethical concerns and issues of data security and confidentiality, human lives are at stake. At present, the major challenge in the healthcare domain is to build software systems which meet quality requirements including safety, effectiveness, patient-centredness and timeliness and, at the same time, manage the effects of these interventions on other performance goals such as efficiency, security, interoperability and cost. The scale of the complexity of new large-scale healthcare systems will challenge all traditional development and management methods. For example: change management (how can the process for developing and maintaining a healthcare system be adapted to handle constant design change from different stakeholder groups?), adaptability to users (how can the needs of users and stakeholders be discovered and understood and how can developers create designs that are effective even as requirements and users’ expectations change continually?), implementation management (how to gain total buy-in and support from users in a change resistant prone environment?), quality maintenance (how can the overall quality be maintained while enabling the flexibility to satisfy each stakeholder group’s needs and demands?), and many more. In order to minimise risks to future healthcare system developments, one of the solutions is the development and adoption of best practices regarding data structure, quality standards, process improvement and new management approaches which are tailored specifically for this domain. It must happen quickly to avoid further failures currently experienced in the UK. Apart from this, software developers should spend time to understand complex and highly technical clinical processes and ensure that strict quality assurance practices are built into any system with zero tolerance for problems. Healthcare practitioners’ inputs and expertise are extremely important and therefore they must be involved in the design, implementation and maintenance of those systems in order to replicate specific user community’s needs, workflow and quality requirements. In addition, investments in training and education for healthcare practitioners and the public must also be of high priority in order to guarantee future success. Seeing the potential benefits from the SPI approach, many sectors, organisations and individuals have succeeded in tailoring several domain-based models to help them improve their products’ quality and avoid failure. Some examples are the AUTOMOTIVE SPICE (Automotive SIG, 2005), SPICE 4 SPACE (Cass et al., 2001) and Medi SPICE (McCaffery and Dorling, 2009) models, which have been derived from the ISO/IEC 15504 (SPICE) model and incorporate specific practices for the automotive, space and medical device industries, respectively. This initiative has grown swiftly within the SPI field across the world to accommodate the unique demands of each development and domain setting. SPI has become a driving force in the global software industry as more software organisations adopt this concept to improve the quality, productivity and predictability of their software development activities. The healthcare SPICE model which was developed by the author is yet another example (Nguyen et al., 2009b). It is based on the latest version of the ISO/IEC 15505-5 and introduces over 100 new healthcare-specific best practices which have developed from a combination of existing

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industry standards, guidelines and lessons learnt. This model aims to address current development and management concerns from the industry by introducing new best practices which are not covered by any existing SPI models. Furthermore, it provides detailed guidance on specific process areas which need to be addressed by the software supplier to achieve the minimum standard of conformance and quality requirements from the healthcare users, as illustrated in Figure 7. Adopting this new SPI model would ensure that the best software engineering and management practices are applied, managed and monitored rigorously throughout the development lifecycle of any future healthcare product. This approach, once again, emphasises that, if software practitioners get the process right, the end product will have a far better chance of satisfying the customer’s needs. Figure 7

The Healthcare SPICE model structure (see online version for colours)

Although, the sole focus of the healthcare SPICE model is on the UK healthcare development environment, its approach to quality improvement can provide a timely solution to overcome some of the key challenges experienced in the UK healthcare sector today. The additional tailored base practices and work products provide a comprehensive set of healthcare-centric practices and recommendations but they are still generic enough to be applied to other large-scale and safety-critical projects that require extensive supplier-customer collaborative activities.

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Conclusions

Today’s software systems are growing more complex by every dimension that we could imagine. The £12bn NPfIT programme for the UK healthcare sector will not be the first example of such scale. These systems will be developed and used by a vast number of people with different purposes. They will process millions of non-stop safety-critical processes. They will be interconnected by thousands of hardware and software components. Increasing the software’s scale and functionalities also enormously increases the significance of software quality assurance. Software suppliers wishing to remain competitive in the healthcare market will need to comply with all the strict contractor evaluation criteria, process models and quality standards. Cost competitiveness and time-to-market are dominant factors that will enable companies to survive and make a profit in the present economic situation. In the healthcare domain, however, the level of trust in the software creator’s capability to build and maintain foolproof healthcare IT products and systems for the customer will be the most important factor that ensure their survival and future success. For this reason, the adoption of new and innovative software engineering tools and techniques, the SPI methodology in particular, in ensuring high quality products is therefore even more imperative for software suppliers who wish to operate in this challenging industry.

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