Title: A system-wide approach to implement lean strategies: lessons from a case-study Authors: Lega F.a, Marsilio M.b, Villa S.c a Associate Professor of healthcare and public management at Bocconi University (Milan, Italy) and Director of the Master of Science in Public Management and International Organizations (CLAPI) at Bocconi University (Milan, Italy). b Assistant Professor in management at University of Milano and research fellow at Centre for Research on Health and Social Care Management (CERGAS) at Bocconi University (Milan, Italy). c Assistant Professor at Catholic University, Department of Management (Rome, Italy) and coordinator of field research projects at CERISMAS (Research Centre in Health Care Management), Catholic University (Milano, Italy). 1 1. INTRODUCTION In recent years, with the aim to foster efficiency (‘doing more with less’) and improve quality, manufacturing and service industries have started to reorganize their production processes according to Lean principles (Radnor and Boaden 2008). As indicated by the extensive literature in this area (Ohno 1988, Fujimoto 1999, Womack et al. 1990, Womack et al. and Jones, 1996, 2003, Deming 2000, Womack et al. & Jones 2003, Hines et al. 2004 and Holweg 2007), Lean originates from the Toyota Motor Corporation production system, also known as the Toyota Production System (TPS), and it emphasizes the importance of continually improving processes in an effort to improve workflow, reduce waste and add value while involving a range of approaches and ‘tools’. Recent literature reports how, over the last decade, Lean methodologies have become widespread in the healthcare sector (Radnor 2010, Mazzocato et al. 2010, Brandao de Souza 2009). Brandao de Souza (2009) shows that the the USA has seen the biggest growth (57%), with the UK growing at a fast pace (29%), followed by Australia at 4%. The NHS Institute for Improvement and Innovation (NHSIII, 2007) translated Ohno’s (Ohno, 1988) seven wastes identified for a manufacturing environment into public healthcare wastes. Many studies have reported successful outcomes from Lean implementation in the healthcare sector, ranging from “quantifiable” benefits, such as: time-saving and timeliness of service, cost reductions, productivity enhancements and reduced mortality to more “qualitative” impacts, such as: reduction in errors or mistakes, improved staff, patient satisfaction, increased process understanding, staff engagement and willingness to collaborate. These studies reveal that Lean has been mostly used at the single process or ward/unit level rather than in the complete patient pathway or whole organization, with only some exceptions as seen at the Royal Bolton Hospital in the UK and the Virginia Mason Hospital in the US. (Radnor 2011, Mazzocato et al. 2010, Brandao de Souza 2009, Waring and Bishop 2012, Radnor et al. 2012, Spear 2005, Young et al. 2008). Moreover, it has been shown how Lean involves considerable variability in practice (Burgess et al. 2009) with some services adopting a system-wide approach or full implementation approach, while others tentatively adopt specific techniques from the Lean toolbox, known as the Rapid Improvement Events approach (Radnor and Walley 2008). Although scientific literature agrees that it is important to adopt a system-wide approach to Lean implementation, most of the studies and experiences have focused on single organizational processes and tools. Thereafter, the current paper aims to develop a sound and thorough analytical framework to understand what the most relevant critical factors are to sustain system-wide Lean programs in healthcare organizations. In order to address this research question, we used a two-step methodology. First, we developed a theoretical framework based on the results of a literature review on Lean implementation. Second, the framework was tested in a critical case widely recognized to have successfully adopted a system-wide Lean approach. 2. RESEARCH DESIGN The main goal of this article is to develop a thorough and sound theoretical framework to understand what the most critical conditions are to sustain system-wide Lean programs in healthcare organizations. To accomplish this goal, a two-step research protocol was followed. 2 First, an in-depth analysis of the scientific literature on Lean in the healthcare sector was conducted, with particular attention to challenges and critical success factors in the Lean implementation process. Analysis of the literature was conducted on EBSCO (MEDLINE, CINAHL and BSC), ISI Web of Science and Cilea. The chosen key words were: Lean management, Lean thinking, Lean process, Lean principle, Lean method and hospital, health, and healthcare. The searches took place between October 2012 and January 2013. Then, the theoretical framework was developed based on the results of this Lean implementation literature review. Secondly, a case study approach was used in order to test the framework (Eisenhardt 1989). The use of case study methodology allows a rich and in-depth empirical understanding of research issues. In the past, the majority of studies about Lean in healthcare, which were based on case studies focused on the tools and used to promote its benefits without a contextual understanding of factors determining successful implementation, were not as rigorous as other research (Lilford et al. 2003). As a matter of fact, these case studies were more similar to story-telling than to effective research protocol. In this respect, to avoid such a risk, we decided to adopt an approach similar to Radnor’s technique (Radnor, 2002) for analyzing and interpreting data collected through the case study. The technique follows six key steps: (1) topic ordering, (2) constructing categories, (3) reading for content, (4) completing coded sheets, (5) generating coded transcripts and (6) analysis to interpretation. This method enables a higher level of sensitivity to detail and context, as well as accurate access to information. Moreover, it enhances rigorous searching for patterns, helping the explanation of theories grounding them in data”. This technique seemed to be the most appropriate because the goal of this study is testing the theoretical framework build to understand what the most critical elements are to sustain Lean programs in healthcare organizations. The selection of the case study was based on the following criteria: 1. It should be a hospital with a long experience of Lean projects, for which academic literature, grey literature and anecdotal knowledge mainly based on conferences and presentations were available; 2. It should be a hospital where the Lean implementation was implemented with a system-wide approach not involving singles pieces (such as a unit, department or service line), but the whole organization. For the above reasons, we identified the critical case (Yin 2009) that best fit the research protocol and aim in the Galliera Hospital (GH) of Genoa. GH is a NHS-accredited private hospital run by a Foundation. GH adopts public regulations in its functioning processes and relies almost entirely on public funding for its survival. Employees, unions and citizens perceive GH as a public hospital and its internal mechanisms for: purchasing goods; investments and recruiting; and promoting and developing employees are based on public regulations. We collected all sorts of grey literature material, internal documents (archives data, official planning document, budgets plans, etc.) and published academic literature about the Lean program at GH. We interviewed five members of GH; in particular, the Chief Executive Officer (Dr. Lagostena), who was appointed at GH more than 10 years ago and has always firmly sponsored the Lean change program since the very beginning, and the Lean management coordinator (Dr. 3 Nicosia), who is widely recognized in Italy as one of the most prominent experts in Lean applied to healthcare settings. He has also published two books on these topics (Nicosia and Nicosia, 2008; Nicosia, 2010). Moreover, we interviewed two doctors, one from the surgical area and one from the medical area, a clinical tutor and a nurse manager. The interviews with the clinical tutor and the nurse were conducted directly on the shop floor in order to check facts and opinions that had been collected in previous interviews. Interviews were semi-structured and lasted about two hours each, during which two interviewers took notes which were later transcribed verbatim and, then, compared and processed according to Radnor’s technique. The interview was structured along the dimensions identified in the theoretical framework and tailored to the specificities of each interviewee. 3. LITERATURE ON LEAN IMPLEMENTATION IN HEALTHCARE SECTOR As in other sectors, some healthcare organizations have adopted a different set of tools and methodologies drawn from the vast menu offered by the Lean approach. Through a realist review of literature, Mazzocato et al. (2010, p 377) identified four methods supporting different Lean implementation phases in the healthcare sector: methods to understand processes in order to identify and analyze problems; methods to organize more effective and/or efficient processes; methods to improve error detection, relay information to problem solvers, and prevent errors from causing harm; and methods to manage change and solve problems with a scientific approach. Radnor and her colleagues (2012) identified three groups of tools according to the specific phase within the Lean implementation process: i. Assessment: to assess service delivery processes at the organizational level, e.g. value stream mapping and process mapping. ii. Improvement: to support and improve the processes of service delivery, e.g. Rapid Improvement Events (RIEs) and 5S (sorting, setting in order, sweeping, standardizing and sustaining, structured problem solving). iii. Monitoring: to measure and monitor the impact of the processes and their improvement, e.g. control charts, visual management, benchmarking, and workplace audits. Several authors (Mazzocato 2010; Radnor 2012; Radnor et al. 2012; Radnor et al. 2013; Bishop 2012) have focused their attention on the analysis of challenges and critical success factors of Lean implementation in healthcare. In fact, in the implementation of Lean, a typical manufacturing philosophy, it is of paramount importance to take the several specificities that characterize healthcare production processes into account (De Vries et al. 1999; Vissers and Beech 2005; Lega et al 2012; Villa 2012). First of all, healthcare production processes are subject to high levels of variability due to at least three different factors (Litvak and Long 2000, Noon et al. 2003): (i) clinical variability linked to the presence of different diseases, severity levels and responses to therapy; (ii) demand variability due to the unpredictability of certain typologies of patient flows (e.g., emergency department flows); and (iii) professional care variability due to differences in approaches, preferences and levels of ability. Second, healthcare organizations are characterized by several different types of production processes that are completely different under a technical perspective. This circumstance calls for the 4 need to integrate and coordinate different competencies and professions (Walley and Steyin, 2006; Lega et al., 2012; Villa 2012). Particularly, it is critical to take the special role played by physicians (the so called healthcare professionals) into account. In this regard, five aspects need to be considered: 1. The autonomy in the clinical decision making process; 2. The need to personalize therapies despite the presence of protocols and guidelines; in fact, patient clinical pathways sometimes need to be personalized to take into account the specific clinical, psychological and social conditions of each patient; 3. The increasing specialization of competencies and profiles; 4. The overlapping between supply and demand: the physician, who is in charge of the healthcare production process, is also the person that decides on behalf of the patients. Furthermore, clinical professionals often seem reluctant to respect organizational rules and procedures because they claim that their attention is devoted to patient management rather than to organizational performance and because they identify product standardization as jeopardizing the quality and personalization of treatment. For all these reasons, thus, it is critical to obtain the buy-in of clinicians in order to implement any strategic change in healthcare organizations. Finally, in the healthcare sector, unlike in manufacturing, the production process is iterative, relational and production and consumption occur contemporaneously (Radnor and Osborne, 2013). Osborne et al., (2013) highlight three core characteristics of services which differentiate them from manufacturing goods and which pose qualitatively different challenges for their management: their intangibility; simultaneous production and consumption; and the role of end-users as the coproducers of services. No service is ever produced identically for two people – a meal in a restaurant is as much a product of the interaction between the customer and the waiter as it is of the quality of the food, whilst a surgical procedure is influenced just as much by the individual pathology of a patient as by the skills of the doctor. At a fundamental level, therefore, co-production is not an ‘add-on’ to services but a core feature of them (Osborne et al. 2013). Consequently, due to these specificities, several authors (Radnor 2010; Mazzocato et al 2010; Waring and Bishop 2010; Radnor et al. 2012) have suggested different possible effective strategies to implement Lean techniques and methodologies in healthcare, particularly: ● Embrace a full and holistic program approach to Lean implementation, avoiding silos approach and prevalent short term implementation tools. ● Get the healthcare organizations “ready”, with a deep understanding of the principal assumption of Lean philosophy (prior to Lean tools), i.e. the processual nature of healthcare service delivery and the definition of “customer” requirement (internal staff and patient); the use of data to perform process analysis and diagnosis; and the engagement of staff through team working and structuring problem solving (Radnor 2012). ● Manage and steward the governance of interaction between Lean implementation with clinical practice and culture. In fact, in the case of re-design of a clinical process such as Lean, in which professionals (clinicians, nurses) are the principal actors of those changes, a service leader must be involved with a bottom up approach to avoid potential conflict that 5 can result in the failure of the innovation (Massey and Williams 2005; Cauldwell et al, 2005; Waring and Bishop 2010; Radnor et al. 2012). ● Avoid creating “ad hoc Lean teams” that risk to be isolated and confined in project rooms; this approach will not yield an organizational culture where quality improvement is everyone’s responsibility (Mazzocato et al. 2010, Waring and Bishop 2010) ● Engage senior management in problem solving; this is a pillar of TPS, with little evidence in healthcare Lean implementations. “Part of the challenge lies in helping senior management reject quick-fixes in favour of addressing root causes with a long term philosophy” (Mazzaocato et al. 2010, p 381) Enforcing these concepts, Brandao and Pinn (2011) analyzed the barriers to Lean implementation in the healthcare sector, identifying eight different types: perception, terminology, personal/professional skills of healthcare professionals, organizational momentum, professional and functional silos, hierarchy and management roles, data collection and performance measurement, and resistance to change/skepticism. As claimed in previous studies, they agree that many of those barriers are people-based or organizational-based and that they are common to other change programs. At the same time, they highlighted some specific barriers that are more critical in a Lean change program, such as “perception” and “terminology”. To overcome these barriers, they suggest clarifying the nature and goals of Lean implementation in healthcare, especially towards clinicians and nursing staff, using a vocabulary that cannot generate misunderstanding or resistance (e.g. reduce “non value” adding activities to increase to portion of “touch time” with patients; use “waiting time” instead of “lead time”). Finally, all the studies on Lean in healthcare go in the same direction identifying two conditions necessary to successfully implement Lean strategies: (i) a clear understanding of the impact of healthcare production specificities and (ii) the adoption of a system-wide approach. 4. A SYSTEMIC APPROACH TO LEAN MANAGEMENT Most of the scientific contributions summarized in the previous section agree that, since the Lean model entails a deep redesign of all the production processes, the adoption of a “Lean” approach must be considered as a system-wide business strategy. Consequently, there is emphasis on the concept that a whole system approach is vital to successfully implement Lean in healthcare organizations (Radnor et al., 2012). While there is a general consensus on the importance of adopting a system approach in the implementation of Lean approach, it is not clear from the existing literature what the most critical elements that need to be controlled are to successfully sustain such change programs. In order to achieve this goal, it is thus important to develop a theoretical framework capable of representing all the organizational components and their interdependencies within a systemic design. Other authors and studies also stress the importance of adopting a whole system approach in change management strategies. For example, the realistic evaluation approach sustains that the success of social interventions, such as business process re-engineering or quality improvement, depends on the specific organizational context (Pawson R., 2010). Butler et al. (2006) sustain that 6 any business strategy (either the development of a new medical area, the entry in a new market or the adoption of a new organizational care model) must be aligned with the overall strategic goals and be consistent with the different organizational functions (finance, marketing, operations and human resources). It must be noted that the concept of system theory was first developed by Boulding (1956) and Von Bertalanffy (1962) who sustained that any organization must be considered as a system that belongs to a wider system (the external environment) and it is characterized by a series of highly correlated subsystems. In the present study, in order to develop a theoretical framework to anticipate the impact of Lean strategies on organizational components, we refer to the mainstream of Italian management studies (Masini, 1979; Giannessi, 1979; Borgonovi, 1996) which show that an organization is not a mere summary of processes to optimize, but a highly integrated system. Any operational change does have an impact on the other organizational components and, ultimately, on the organization's capability of achieving its strategic goals. Here, we adopt a model first developed by Airoldi and colleagues (1994), but used also by other authors (Lega 2005; Anessi 2006; Villa 2012), to explain the impact of different management strategies or policies in the healthcare sector. As depicted in Figure 1, any organization is embedded in a given external environment that has a deep influence on the overall organizational functioning. The external environment is made up of different sub-environments, such as (Lega 2005: 45): (i) the institutional (expectations from external relevant stakeholders, e.g. Regions or Local Health Authorities for public hospitals); (ii) the socio-demographic (trends and behaviors of population and customers); (iii) the economic (recession vs. expansion period; financial resources availability, ecc.); (iv) the political (prevalent ideology that shapes the policy making process); and (v) the competitive (e.g. level of competition). Once an organization understands its position within the overall external environment, in order to implement its strategy (for example a Lean management strategy) and realize the expected goals, it needs to act effectively and coherently on six different components: 1. Production processes In the case of healthcare organizations, scientific literature (Lega 2001; Villa 2012) identifies three different categories of processes: (i) clinical processes (basically all nursing and physician activities performed directly on patients); (ii) ancillary clinical processes (they do not directly involve patients but they involve clinical professions such as drugs logistics or laboratory testing); and (iii) administrative processes (such as finance, purchasing and logistics). 2. Operations management It encompasses all the models, tools and approaches to better plan, manage and control the production processes and it entails choices and strategies on four different elements (Chase et 2004; Vissers and Beech, 2005; Villa 2012): (i) lay-out; (ii) scheduling and planning; (iii) process re-engineering; and (iv) information and technological innovation. 3. Organizational structure and support systems 7 It refers to the formal organizational chart that identifies the division of work between the different units and all the mechanisms to make the organization work, such as: planning, budgeting and controlling systems, rewards systems and information systems. 4. Human resources It refers to people motivations, beliefs, ideas, competences and culture. 5. Assets It refers to the technological, infrastructure and immaterial (e.g. knowledge, reputation) endowment of the organization. 6. Governance structure It defines the way and to whom the organization’s management is accountable for its actions. This is something particularly critical in the healthcare sector because of the important public trust and social accountability responsibilities of health service organizations (Lega, 2005: 51). The double arrow between the organizational components and the Lean strategy depicted in Figure 1 has a double meaning: i. any change in any of the six organizational components must be formulated within the Lean management strategy; ii. information on strengths and limitations from the analysis of the different organizational components might trigger a change in the development of the Lean program. The circular line that encompasses the six different organizational components represents the idea that the changes made on the organization triggered to implement Lean strategies should not be developed in isolation, but in a collaborative and integral fashion. Figure 1 – Lean strategy and organization system view 8 5. THE CASE STUDY The Galliera Hospital (GH) is a national highly specialized hospital in Genova, housing slightly less than 500 beds and 1760 employees (including administrative and clinical operators). The GH is part of the public regional healthcare system (Anessi et al., 2001), even though it has a relatively higher autonomy compared to other publicly owned hospitals and a strong relationship with the Genoa’s Catholic Church. In fact, the president of the Board of Directors is the Archbishop of the city and the other 6 members are elected from among the most representative institution of the city. The Board appoints the CEO, the Medical CO and the Administrative CO. In 2008, GH started a five-year working path on Lean Approach, labeled as Lean Genova (acronym of Galliera Empowerment by New Organization and Value Analysis) linked to: i) the implementation of the innovative organizational model of "intensity of care/care focused", which has been imposed by the regional government and is now gradually affecting an increasing number of areas and hospital services; and ii) an important restructuring project of the existing assets and buildings coherent to this innovative organizational model. In fact, many hospitals in Italy are under the pressure of regional laws and are looking at these new organizational paradigms with increased interest. This organizational innovation aims at reshaping hospital care delivery processes around patient needs and away from the traditional physicians-centered view. This means guiding hospitals beyond the rationale (and shortcomings) of the traditional organization based on the professional bureaucratic archetype. In fact, they can no longer sustain functional self-referential designs, in which resources are duplicated, economies of 9 scale are underexploited, clinical integration and clinical governance is nonexistent, and autonomy (in using the specialty’s resources) prevails over accountability. Hospitals can no longer support excessive specialization of staff or inefficiencies in how staff is used resulting from narrow functional areas and professional demarcations, nor can they allow the high rate of delay, cancellation of clinical procedures and waste of resources resulting from poor communication among departments and disciplines (Lega and De Pietro, 2005; Lega 2007; Villa et al., 2009). In the case of GH, the innovation process was led by the CEO of the hospital, Mr. Lagostena, and by the head of ICU (intensive care unit), Dr. Nicosia, a medical professional who is specialized in Anesthesia and Intensive Care. Actually, the project is not just an organizational logistics innovation for the hospital, but an attempt to apply tools and techniques within a reality redesigned to manage and work by flows and lines of activities. As the CEO frequently states, “a new hospital (meaning a new way of working) in a hospital new (referring here to the new future building)” Looking at GH’s Lean history, the first Lean project was the creation of the Department of Ortho Geriatrics in 2005 and particularly the redesign of the workflow for elderly patients with hip fracture. Literature evidence shows that timing incurred from the fractures to the surgical event is statistically correlated to mortality. It was still a “unit” Lean approach, not yet the embracement of a whole system approach, but very important to be used as a pilot case to highlight methods and results of Lean. As Nicosia always remarks “Lean at GH is the story of a standstill river flowing into a smooth-flowing stream, up to the whole hospital, in a realistic future vision”. Only at the end of 2008 did the CEO appoint Dr. Nicosia with the mandate to develop and spread a new model to manage patient flows through all GH departments and units, a patient centered approach that marked the beginning of the systematic Lean approach at GH. During the first stage in December 2008, Nicosia spent 10 days at the Royal Hospital of Bolton (UK), widely recognized as a hospital that embraced a whole system approach to Lean, to understand how the top management had implemented and improved the Lean philosophy. In 2009, a training program on Lean basic concepts and tools was launched with the aim to involve all employees. In 2010, a second step of executive training was implemented with the organization of Lean workshop (working groups) courses, identifying those pathways and processes that needed to be viewed and analyzed using the techniques learned in the first training step. Nowadays, the main results of this system Lean approach can be summarized in the following: ● the ongoing Lean training program, both at basic and executive levels; at the moment, 50% of employees have attended the courses; ● the creation of the Ortho Geriatrics department and the redesign of orthogeriatric flows helped in reducing the preoperative waiting time with a significant impact in terms of the reduction of mortality rate: the thirty-day mortality rate decreased by 50% from 7.1 to 3.7 (Nicosia 2010); 10 ● the extensive application of value stream mapping in the Intensive Care Unit 1 . The technique of Visual Stream Mapping (VSM) had been adopted as a tool for a real time monitoring of the patient stay and it consisted of a blackboard fixed in the corridor and updated daily with each patient’s health condition and its improvement or aggravation. The application of VSM led to significant implications in terms of: the reduction of long-term care and postoperative patients; greater chance of acceptance of new patients (annual basis); and the reduction of the average length of stay. ● A strong revision of patient flows in the operating theaters, through: ○ the centralization of the Day Surgery (short cycle surgery), with a transfer of almost 50% of the surgical activity to short cycle surgery and a total additional amount of hours in the operating theater of 10% less than the previous years, keeping the same volume of surgical activity; ○ the parallelization of the operating theaters to reduce the changeover times between one operation and another. The surgeon can, therefore, skip to the next service with a patient ready while the room in which the first operation took place can be sanitized and restored, resulting in substantial advantages in terms of time, especially for the nursing and medical staff recovery, with an increase of effective surgical time up from 50% to 70%; ○ the introduction of a Pre-admission Unit, centralized for all surgeries; ○ the definition of a standard of a maximum postoperative stay (5 days), beyond which a continuation of stay has to be provided in the rehabilitation level, or, in the event of complications, in the Intensive Care Unit. ○ the opening of the Recovery Room in the corridor next to the central main Operating Room’s structure, which led to a rationalization and standardization of patient flows. All these changes to the surgical patient flows brought a series of positive results, such as: (i) a 45% reduction of postponed cases; (ii) a 40% reduction of space within the surgical operating block; and (iii) a 90% reduction of extra work in Operating Theatres. Finally, it must be noted that GH is using an ABC (Activity Based Costing) system enabling them to define the cost for each service provided. In the recent years, the GH has performed a cut of 10% off production cost (with the same production level); moreover, GH resulted as the best performer on production cost in a benchmark with 20 other hospitals using the same ABC system (Nicosia, 2010). 6. ORGANIZATIONAL CONDITIONS FOR SUCCESS As explained in the section dedicated to research methods, we used a semi-structured interview designed around the six organizational components identified in Figure 1 in order to understand what the most relevant elements are for the successful implementation of Lean 1 The objectives of the Value Stream Map settled by Dr. Francesco Nicosia are: Keep the process rolling; Pull activities to a continuous flow delivery; Highlight the waste location to delete; Involve stakeholders in a common language; Develop work plans; Spelling out the priorities 11 strategies. The analysis of the GH case shows that the implementation of the Lean approach has been favored by coherent changes along four broad dimensions: 1. Institutional environment; 2. Production processes; 3. Organizational structure and support systems; 4. Human resources. i. Institutional environment In most western countries, the public sector plays a relevant role in terms of both provision and financing in the healthcare sector. In Italy, in particular, over the past few years, the Italian National Health Service has been undergoing an important process of decentralization with a significant transfer of powers and responsibilities from the central government to the Regions. Regions now have jurisdiction on all health-care issues and, since 2002, have been undertaking their own set of reforms based on different ideas and approaches to healthcare management and policy (Anessi et al. 2001; Villa et al., 2008). In this perspective, the fact that GH is located in the Liguria Region helped support the Lean program along two different dimensions: 1. Unlike other Italian Regions, Liguria is politically more stable. In fact, CEOs remain in charge for 5 years on average compared to an average of 4 years at the national level (Cantù, 2012). Furthermore, in the specific case of GH, the CEO has held his position for more than 10 years; this stability is essential in order to successfully implement and sustain long-run ambitious projects like Lean change strategies; 2. The Liguria Region has explicitly indicated to all its hospitals in the Region to adopt patientcentered models in the organization of hospital activities by April 2013. ii. Production process In recent years, as previously stated, several elements have forced GH to redesign healthcare production processes, particularly: ● In Italy, in the last decade, the ratio of the elderly has increased dramatically. This circumstance is particularly true for the Region (Liguria) where GH is located in an area where the percentage of the elderly (over 65) is nearly 30% compared to an Italian average of 20% (Cantù, 2012). This circumstance determines the necessity to redefine healthcare production processes for dealing with a demand characterized by chronic conditions, high-severity health problems and complex social situations; ● The Liguria Region, through a specific regional law, has provided indications to all the hospitals of the Region to redesign the organization of activities according to the principles of the patientcentered hospital models; ● There is a plan of relocating GH to a new site. The new hospital infrastructure will be much smaller in terms of production capacity (e.g. number of beds and operating rooms). This requires a complete rethinking of the organization of healthcare production processes. 12 A few years ago, GH began an ambitious project of hospital reorganization around the idea of a “care-focused” hospital to cope with these challenges and constraints. Particularly, GH has introduced a series of significant changes in healthcare delivery processes with the aim of creating multidisciplinary, horizontal and shared clinical settings. These changes have started to tear down the rigid barriers existing between the different hospital units. Some examples of these redesign projects are represented by: ● The design of the ortho-geriatric patient flow with the creation of a pooling of beds between these two units (geriatrics and orthopedics). The clinician in charge of frail patients, from the first evaluation to the discharge and even rehabilitation (even outside the hospital), is the geriatric doctor, while the orthopedic surgeon acts as a “specialist” in an acute piece of the entire patient journey; ● The construction of an outstanding site dedicated to day-surgeries, that is surgical procedures that need to stay in the hospital maximum one night. This unit is organized as a multidisciplinary area that serves all the surgical specialties of the hospital. This circumstance helped the introduction of Lean methodology under two different perspectives. First, many physicians were already used to thinking according to the key principles and concepts of Lean. Second, the Lean approach has been perceived as a way to facilitate the change process towards these new organizational models and as a mean to facilitate the daily clinical and nursing activities on hospital floors. This is an example of the presence of a bidirectional influence between Lean strategies and organizational components. In fact, the overall strategy to move to patient-centered and horizontal models in the organization of healthcare production processes was included in the overall Lean strategy. On the other hand, the ongoing implementation of the patient-centered models has actually further accelerated the development of the Lean program as a way to improve daily operations in these new hospital organizational models. In this scenario, Lean management and patient-centered models are actually parts of a single system-wide hospital redesign project. In other words, the implementation of Lean approach has been favored by the presence at GH of a new organizational model of healthcare production process, but, on the other hand, the long-term sustainability of these new organizational models has been reinforced by the adoption of Lean methodology. iii. Organizational structure and support systems As explained earlier, the innovation process at GH has moved along two directions: (i) the introduction of care-focused models and (ii) the reengineering of processes and activities according to the Lean approach. These two innovations, that have reinforced each other along the whole change process, have also called for a change in the organizational structure. First, the creation of multi-disciplinary settings according to the principles of care-focused models has required the creation of the new role of clinical tutor. 13 In the GH strategic plan, the tutor is defined as “the referring professional, for both the patient and their family, who takes care of clinical processes and monitors the compliance with clinical pathways through daily meetings with other colleagues (physicians and nurses)”. The creation of the clinical tutor is well explained by the words of the CEO: “… we want that any person (whoever he/she is) who steps in a hospital ward and asks “Who is the doctor that is following my father?” to be clearly directed to a person and this person should be the same the day after…” Tutors (or disease managers or caregivers) have been identified among doctors (especially internists). In the medicine department, the head has designated some clinicians to be tutors for a year on the basis of their professional and relational skills, with no other duties required. The organizational structure has been modified, with the acknowledgement of these new roles with three levels of seniority linked with their level of seniority in their clinical field (junior tutor, tutor, senior tutor). The engagement of nurses in tutoring roles is under examination, according to GH internal documents and interviews. Secondly, in order to guarantee a uniform methodology and the coordination of the increasing number of Lean projects, a Lean team was created. The goal of the team is to spread the idea of better management in the redesign of care and the improvement of the patient journey through the hospital areas and activities pipelines. The team has 20 members (including physicians, nurses and administrative staff) and it has a strategic role in supporting the CEO to identify the ongoing priorities and connect the different implementation projects. The team has not been deliberately formalized in an organizational structure (there is not any “Lean office” at GH!). The idea is for the team to develop methods and an approach that have to be then implemented in the units in which they usually work. No monetary incentives are provided to the Lean team members. Recently, the Lean team has been supported by a group of engineers to support the team more on the logistical aspects of patient flow management. Clinical tutors and the Lean team focus on slightly different aspects of the overall patient journey; in fact, the tutor is more focused on the clinical, nursing and social needs of each single patient while the Lean group is more concerned on aspects related to the management of patient flow logistics at hospital level. Despite having different focuses, clinical tutors and the Lean team are perfectly integrated. An effective tool that has helped and fostered this integration is the Value Stream Map. The Value Stream Map is the main tool used by clinical tutors and the Lean team to manage and control daily activities; in other words, the tool that allows everyone to see and understand the “sick rolling situation.” In the words of the clinical tutor in the medical wards, “The introduction of these tools (Lean system and Value Stream Map) helped us to become aware of resources and wastes and of benefits attainable through the constant following of patients along their flow. This is crucial in order to manage the capacity which the hospital can provide. This can ultimately bring the ward to have free beds, an option that is at the heart of our daily work. The goal is always to have the availability to accept patients and, currently, we aren’t in the condition to accept new cases on 10/15 days out of 365 days a year. Often, patients that need the Intensive Care Unit are very difficult to manage, resulting in high stress levels for professionals and the staff never increases”. 14 In terms of support systems, it must be noted that only few changes have been implemented in order to facilitate the implementation of Lean strategies. In fact, the top management decided not to introduce any specific software to support Lean management. This was coherent with the strategic vision than Lean asks for a continuous and active involvement of professionals in analyzing how to maximize the efficiency of a process. At this stage of Lean implementation at GH, the use of an ad hoc software has been seen as a threat to building capacity to develop a critical understanding of Lean approach, “do not pave the cow path”, “never automating a bad process: first, fix the process, then automate it”. Finally, as for the budgeting and performance measurement system, Lean has not actually been declined in specific targets and goals in the GH’s budget system. Nonetheless, the CEO stresses the Lean approach as the most important driver and facilitating condition to help the GH turn into a patient centered and intensity of care hospital in every budget meeting. Targets of the budgeting process are the output expected from Lean adoption, such as: for example, pooling and centralized scheduling of operating rooms, changing the role of the pharmacist from a logistic role in the central hospital pharmacy to a consultant role in the ward, increasing the surgical time in the surgical path, centralizing pre hospitalization activities, etc. iv. Human resources As commonly outlined in the scientific literature, the commitment and enthusiasm of people working in the organization is critical to successfully implementing any type of change. In the specific case of Lean, several authors (Mazzocato et al., 2010; Radnor et al., 2012) highlight the importance of top management as a critical condition to support these changes. This thesis is confirmed by the analysis of the case in which the role and commitment of GH’s top management has been crucial in all the stages of Lean implementation. Particularly, two different actors have played an influential role: Dr. Lagostena (the Chief Executive Officer) and Dr. Nicosia (head of Anesthesia and coordinator of the Lean program). Dr. Lagostena was essential in providing the project with the necessary institutional support and in promoting the rationale and objective of the project among the heads of the clinical directors sometimes reluctant in implementing this new way of working. His role was particularly effective in spreading a long-term view of continual improvement within the organization. On the other hand, Dr. Nicosia is responsible for the entire Lean program, from the organization of the training sessions up to the design and implementation of the single Lean change project. At the beginning Dr. Nicosia was supported by an external consulting company in order to strengthen the credibility of GH’s Lean program, especially among healthcare professionals (“… Nicosia is not an engineer!...”). Nowadays, Dr. Nicosia’s knowledge and competencies are widely recognized by employees and he has been called “Dr. Lean” or “Dr. Flow”. However, the efforts from GH top management to balance a top-down approach with a bottom-up one must be highlighted here. In fact, the Lean culture at GH is inspired by “looking for 15 a balance between a top down and bottom up approach”. At GH, the top management commitment is considered one of the most important critical success factors for Lean implementation, but we also recognize that without real involvement and commitment of the people asked to implement this improvement, little change can actually be achieved. This is the main reason the first implementation step of the Lean approach at GH was the launch of a pervasive training program, thus adopting a program approach rather than the rapid improvement events (Radnor 2011, 2012). The Lean training program has been the “core” of the Lean implementation strategy at GH, with the idea that it was necessary to pervasively improve the knowledge of Lean principles before starting with specific Lean innovation projects. A multilevel training program has been in effect since March 2009 with the aim to reach all the employees in a 5-year program. The program has been articulated in three main steps: i) a 9-hour “basic” course (split into three afternoons) on the basic principles of Lean and with a simulation of VSM (Value Stream Mapping) on the Ortho geriatric pilot case study; the participation is on voluntary basis up to 25 participants per class; up to date, 50% of the employees have followed the basic course which is held every 2 months; ii) an 18-hour executive/workshop course (split into 9 afternoons in order to leave time to participants to internalize and "digest" what has been discussed), with the aim of applying a VSM to a specific process within a working team approach. The value stream team, under the coordination of Nicosia, has identified those pathways and processes that need to be improved (ex. pooling together gastroenterology with general surgery), mapping the flow using the VSM technique. During these workshops, the VSM activity was applied to one singular DRG or a line of business to evaluate its current status, identifying and subsequently eliminating the weaknesses and the flaws in the process. In other words, it teaches the participants to see the process, to put it horizontally, to collect the series of actions, which are carried out to provide a service or to create value in the chain, in a set controllable and understandable to all. A key part of the training process is represented by the organization of a series of site visits to other hospitals that have implemented similar Lean projects. In this perspective, the ongoing relationship between GH and the Bolton trust, one of the first hospitals to have successfully adopted the Lean management approach (Nicosia, 2010) must be mentioned. Nicosia has organized several study tours at this hospital, always involving teams made up of different professionals, in order to grasp different possible perspectives and prompt the multidisciplinarily approach during these visits. Finally, the careful use of symbols from the top management to build support and foster enthusiasm towards the change process must be stressed. For example, the acronym GENOVA (Galliera Empowerment by New Organization and Value Analysis) has gained immediate success and is now known within the entire Italian healthcare system. Furthermore, the collaborative competition with the other healthcare delivery organization known in Italy for the implementation of Lean (the Local Health Authority of Florence) has helped maintain the commitment high among GH employees. 16 7. CONCLUSIONS While Lean theory emphasizes a holistic view, most of the studies reported in scientific literature narrow their attention to specific cases or to single technical applications with limited organizational reach. With this study, we aim to provide the basis for more enhanced refined research in the field of Lean applied to healthcare. We need to move quickly beyond the rhetoric as many healthcare systems and healthcare organizations are looking at implementing Lean projects with increased interest and although promised returns are attractive, there are extremely significant investments required. Nowadays, we can’t afford healthcare systems to waste financial resources on change initiatives without reasonable certainty that positive outcomes will follow. Lean seems to be a good way to approach the challenges of healthcare systems required to deliver better, quicker and lower cost services. However, the specificities of the healthcare industry make change more difficult, especially compared to all others industries, with Lean implementation being no exception. That is why we feel there is a gap in the research, as we have little, if any, evidence for what drives success in Lean implementation of a system-wide approach in logic. The framework we propose could be helpful to prepare new research that investigates the different organizational aspects on which Lean implementation impacts in more comprehensive ways. As rhetoric in the academic discourse states, system-wide approaches seem to be the best way to approach Lean, but no study has clarified or investigated what could be meant by a system-wide approach or how different components of the system interact and are aligned to produce change. Future studies based on case histories investigated through the framework could provide more in-depth evidence which is much needed to evaluate how to implement Lean in healthcare contexts. In this light, we identified and investigated the GH case, as it gave both the opportunity to validate the framework and added evidence to the literature debate about system-wide Lean implementation in hospitals. Within this system-wide approach adopted at GH, the importance of linking the Lean strategy with the redesign of clinical processes based on the concept of care-focused hospital model must be stressed. In fact, as outlined by other authors (Radnor and Osborne, 2012), clinical buy-in is critical to the success of the initiatives, as clinicians invariably have a strong-power base within the healthcare service and have the power and credibility to convince colleagues whether the initiatives can improve patient care or not. This circumstance helped gain the clinical buy-in under two different dimensions. First, many physicians were already used to thinking according to the key principles and concepts of Lean. Second, the Lean approach has been perceived by physicians as a way to facilitate the change process towards these new organizational models and as a mean to facilitate the daily clinical and nursing activities at hospital floors. In conclusion, we can say that the main findings from this case confirm that key actors perceived having a Lean system-wide strategy is of paramount importance for the success of the whole change. Obviously, there are limitations as the results obtained by GH are based on contextual factors (i.e. the long time appointment of the general manager, or the hybrid nature public-private of 17 religious hospitals in Italy) and it was not possible to thoroughly appraise the results with control factors (i.e. changes in medical and ancillary staff, roles of engineers recruited to sustain the process, external inputs from the institutional bodies, etc.). Nevertheless, we think the GH case is interesting in itself and because it shows the potential of the framework proposed in the text. We feel this framework is a positive contribution to filling a gap in the literature on Lean as it could advance the depth and comprehensiveness of research protocols and make future case histories that adopt it (or similar versions) more comparable. 18 BIBLIOGRAPHY Airoldi G., Brunetti G. e Coda V. (1994), Economia Aziendale, Bologna, Il Mulino Anessi Pessina E., Cantù E, Jommi C. 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