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Health Policy 119 (2015) 1197–1209

Contents lists available at ScienceDirect

Health Policy

journa l h om epa ge: www.elsev ier .com/ locate /hea l thpol

eview

ean in healthcare: A comprehensive review

ntonio D’Andreamatteoa,∗, Luca Iannia, Federico Legab,assimo Sargiacomoa

Department of Management and Business Administration, University “G. d’Annunzio”, Via Pindaro, 42, 65127 Pescara, ItalyDepartment of Policy Analysis and Public Management, CeRGAS Public Management & Policy SDA - Bocconi University,ia Roentgen, 1, 20136 Milan, Italy

r t i c l e i n f o

rticle history:eceived 13 June 2014eceived in revised form 30 January 2015ccepted 4 February 2015

eywords:eanean Six Sigmaean thinkingealthcareperational excellenceontinuous quality improvementeview

a b s t r a c t

Background: Lean seems to be the next revolution for a better, improved, value-based heal-hcare. In the last 15 years Lean has been increasingly adapted and adopted in healthcare.Accordingly, Lean healthcare has been developing into a major strand of research sincethe early 2000s. The aim of this work is to present a comprehensive overview of the mainissues highlighted by research on implementation of Lean in a complex contest such as thehealthcare one.Method: Comprehensive literature review was conducted in order to identify empirical andtheoretical articles published up to September 2013. Thematic analysis was performed inorder to extract and synthesis data.Findings: 243 articles were selected for analysis. Lean is best understood as a means toincrease productivity. Hospital is the more explored setting, with emergency and surgery asthe pioneer departments. USA appears to be the leading country for number of applications.The theoretical works have been focused mainly on barriers, challenges and success factors.Sustainability, framework for measurement and critical appraisal remain underestimatedthemes. Evaluations of “system wide approach” are still low in number.Conclusion: Even though Lean results appear to be promising, findings so far do not allow todraw a final word on its positive impacts or challenges when introduced in the healthcaresector. Scholars are called to explore further the potentiality and the weaknesses of Lean,

above all as for the magnitude of investments required and for the engagement of thewhole organization it represents increasingly strategic choice, whilst health professionals,managers and policy makers could and should learn from research how to play a pivotalrole for a more effective implementation of lean in different health contexts.

. Introduction

The investigation of Lean healthcare has been devel-ping into a major strand of research since thearly 2000s (e.g., [1–3]), attracting many researchers

∗ Corresponding author. Tel.: +39 0854537593; fax: +39 0854537917.E-mail addresses: adandreamatteo@gmail.com (A. D’Andreamatteo),

ianni@unich.it (L. Ianni), federico.lega@unibocconi.it (F. Lega),sargiacomo@unich.it (M. Sargiacomo).

http://dx.doi.org/10.1016/j.healthpol.2015.02.002168-8510/© 2015 Elsevier Ireland Ltd. All rights reserved.

© 2015 Elsevier Ireland Ltd. All rights reserved.

worldwide. Accordingly, a growing number of books (e.g.,[4,5]), well-known and oft-quoted papers (e.g., [2,3,6]) andgray literature (e.g., [7,8]) have been disseminated, high-lighting different cases, topics, methodologies, countries,etc.

Organizations in the United States, such as the Insti-tute for Healthcare Improvement, and the United Kingdom,

such as the NHS Confederation and the Institution for Inno-vation and Improvement, advocated the use of Lean in2005–2007, respectively, as Lean had proved itself usefulin other sectors and began to show promising results in

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healthcare [7–9]. These organizations recognized the con-tribution of Lean in both maximizing value and eliminatingwaste [7] and suggested it as a possible answer to the needfor change perceived in the sector [9].

One of the first papers published about Lean in health-care, the study by Young et al. [2] addresses the useof industrial processes to improve patient care. Funda-mentally, the authors describe three established industrialapproaches, i.e., Lean thinking, the theory of constraintsand Six Sigma, and explore how the concepts underly-ing each relate to healthcare. These authors conclude thatthe three methodologies have common features, as eachemphasizes the concept of production as a complex inter-action of individual activities, and each recognizes that forproduction to be efficient and effective, it is fundamentalto identify weak links or bottlenecks and take appropri-ate remedial action. However, in order for them to work,all approaches would require strong leadership, the adop-tion of algorithmic methods to problem solving based oniterative improvement, and employee participation in allcomponents of the system.

Widely cited is the study by Spear [3] published inthe Harvard Business Review in 2005 in which the authordiscussed how health professionals could ensure that thequality of their service matched their knowledge and aspi-rations. Spear claims that learning how to improve thework one does while actually doing it can deliver extraordi-nary savings in lives and dollars. According to Spear, somehospitals are making enormous short-term improvementsthat are not based on legislation or market reconfigurationand with little or no capital investment. Instead of waitingfor sweeping changes in market mechanisms, these insti-tutions take an operations approach to patient care. Speardescribes how doctors, nurses, technicians, and managersradically increase the effectiveness of patient care and dra-matically lower its costs by applying the same capabilitiesin operations design and improvement as those that drivethe famous Toyota Production System.

In 2006, Kim et al. [10] claimed that the readiness toact by hospitalists that use the new principles of Leanwithin hospitals can deliver high-quality and efficientcare to patients. The authors also underlined the culturaland practical barriers to overcome to spread the use ofLean techniques. Among these barriers is the suspicionagainst management tools imported from a context otherthan healthcare, a misunderstanding of what Lean aimsto achieve by cuts and layoffs, and the difficulty to act asa whole by units that are accustomed to functioning asautonomous “silos”.

The flourishing [11] of this new area of study has alsoprompted the publication of several literature reviews.For example, de Souza [12] sought to illuminate generalemerging trends in and approaches to Lean healthcare andevaluate the research status quo by proposing a taxon-omy primarily based on differentiating between theoreticalpapers and case studies. Poksinska [13] provided a por-trait of how Lean has been implemented in healthcare,

simultaneously presenting barriers, challenges and out-comes. Mazzocato et al. [14] produced a “realist review”that emphasizes the general mechanisms involved in theapplication of Lean. Conversely, Holden [15] crafted a

licy 119 (2015) 1197–1209

critical review that deployed an analytical framework tofocus on emergency care settings.

Other literature reviews evaluate Lean applications inspecific settings or compare various process improvementapproaches, analyzing the academic, the practitioner andthe gray literature. Radnor et al. [16] highlighted some criti-cal features of Lean in the public sector that remain sparselyinvestigated (i.e., how it works, its outcomes, barriers tochange, and success factors for sustainability), highlight-ing that Lean principles were adapted for its application.Boaden et al. [17] demonstrated an increasing emphasis onLean in healthcare, with Lean sometimes being integratedwithin the Six Sigma framework. The report also indicatesthat there are some difficulties in identifying guidelines forthe implementation of Lean and in identifying additionalstudies with findings that are more comparative, indepen-dent, or critical.

Although all the precedents reviews offer importantinsights on the topic, they are based on narrow researchquestions (e.g. [18,19]) and different inclusion criteria (e.g.[20–25]). Some of them need to be updated (e.g. [12,13]),as well. Consequently, the aim of the current paper is topresent a comprehensive overview of Lean in healthcareas well as describing emerging important issues about itsimplementation. Accordingly, this work focuses on twomain research questions: which is the diffusion of Lean inhealthcare, so far? which are areas in need of further research?

The paper is organized as follows. The next sectionshows the methodological approach to the review; Section3 synthesizes the principal themes drawn from the body ofresearch reviewed; and Section 4 discusses the main issuesto future research on Lean healthcare and challenges in itsimplementation.

2. Methods

A thematic analysis [26] was conducted to identify themain themes and concepts of the selected literature. Theprocess followed the guidelines proposed by the Centrefor Reviews and Dissemination [27], with some exceptionsdetailed in the following subparagraphs to take account ofthe variety of research approaches (quantitative or quali-tative) and consequent methodologies as well as differenttraditions of research (social sciences and health sciences).The review protocol was designed around the intent to gaina wide comprehension of the phenomenon of Lean, whereLean has been applied in healthcare, in which countriesand with which outcomes, and what issues are inherent toits implementation. The protocol includes sources of data,criteria for inclusion and the organization of the results.

2.1. Data sources, inclusion/exclusion criteria and dataextraction

Papers published in peer-reviewed journals up toSeptember 2013 were selected by exploring the Sco-pus and Pubmed databases, which are two platforms

relevant to the social sciences (primarily the Scopusdatabase), and the life and health sciences database(mainly the Pubmed database). Papers were searchedin the databases by combining the following keywords:

ealth Policy 119 (2015) 1197–1209 1199

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Table 1Organizations of findings from analysis.

Empirical applications papers Theoretical papers

Whole or partial approachLevels of care, countries andother improvement techniques

Lean and the change processLean and other processimprovement techniques

A. D’Andreamatteo et al. / H

Lean approach”, “Lean process”, “Lean methodology”,Lean method”, “Lean transformation”, “Lean philoso-hy”, “Lean principles”, “Lean practices”, “Lean process

mprovement”, “Lean management”, “Lean healthcare”,Lean thinking”, “Lean production”, “Lean Six Sigma”, “Toy-ta management system”, “Kaizen”, “Rapid improvementvent”, “Rapid improvement workshop”, “health system”,hospital”, “acute care”, “primary care”, “secondary care”,tertiary care”, “rehabilitation”, “home care”, and “commu-ity care”. Articles were included if they were published inhe English language and contained the search terms in theitle, abstract or keywords when available. Furthermore,hey must be published in peer-review journals. Accord-ngly, books, reports, proceedings and gray literature werexcluded. Journals should not be report, magazine or tradeublications. The potentially relevant records were scru-inized independently by two of the authors to eliminateuplicates, errors and to ensure the retention of peer-eviewed papers. The only exception was Spear’s article3], which was published in the Harvard Business Reviewn 2005. This paper is one of the first and most cited ofll selected publications, and it was included because theournal is a widely respected resource in the academic andractitioner community. Additional papers were identifiedy reading the papers included in the review.

Next, according to the method chosen for the review the thematic analysis – the papers were scrutinized toring out the main concepts. To facilitate the full-textnalysis process, each paper was examined using a dataxtraction sheet. The data extraction sheet contained theollowing items: title; author(s); year of publication andournal details; abstract; keywords; type of paper (theo-etical and empirical); significant details about each type ofrticle (healthcare setting; outcome data; issues about leanmplementation); reasons for exclusion from the review;nd space for possible comments and notes. A paper wasxcluded if, contrary to indications in the title or thebstract, it did not address the topic. Furthermore, editori-ls and letters to the editor were excluded from the reviewlong with papers aimed to educational use or facility man-gement. Each author examined a group of papers, and twof them checked all of the data added in the sheets. Doubtsegarding any features noted in the sheet were resolvedy discussions among all the authors. A graphical word-rocessing and an electronic spreadsheet program weresed to collect and analyze the data.

.2. Cluster of works

Studies were clustered into two main groups depend-ng on the type of paper: empirical or theoretical. Theategories were borrowed from de Souza [12], who distin-uished the Lean healthcare literature among theoreticalnd case studies, with the former based on methodologicalnd speculative works and the latter on practice-based dis-ussion. In this work, the empirical cluster included paperseporting documented data on the process of implementa-

ion and its outcomes, and the theoretical cluster included

ore conceptual reflections about specific issues related toean. Accordingly, in the first group, data where gatheredith regard the effects of Lean on healthcare performance;

Impacts on performanceCore or support services

Critical assessment

cross-comparative analyses between organizations withina country or between different countries; types of clinicalspecialty, auxiliary services or support activities; joint orparallel implementation with other quality-improvementapproaches and techniques; and the extent of the Leanimplementation (if systematic – at an organizational orcross-organizational level – compared to a micro-contextfocus). For all empirical papers, the country of implemen-tation was recorded. The second group (theoretical papers)focused on theoretical reflections on specific issues withinLean healthcare. Drawing on Radnor et al.’s report “Eval-uation of the Lean approach to business management andits use in the public sector” [16], key areas were identified:barriers and challenges to Lean implementation; organiza-tional readiness to implement Lean (i.e., the required stateof an organization to introduce Lean) [16]; the implemen-tation process itself; the factors of success; the outcomes ofLean; and discussions of Lean or related techniques, toolsand approaches. Narrative reports regarding Lean projectslacking an in-depth explanation of the aim, context, ratio-nale, methods and findings as well as papers with the firstaim to explain Lean and spread its use were included inthe theoretical group and referred to as speculative. Paperswith empirical contents, but at the same time with a focuson frameworks, definitions and conceptual discussion wereincluded in the theoretical cluster. The following table(Table 1) summarizes the organization of findings concern-ing key aspects from the empirical and theoretical papers,as they emerged at the end of the full-text review. The fol-lowing section shows the main themes that stemmed fromthe literature.

3. Results

Following the method underlined in the previous sec-tion, 622 potentially relevant records were identified bysearching in the databases. 40 papers were added subse-quently after reading the full text of selected papers (e.g.reference lists of studies included). Next, by excluding somerecords, 306 articles were assessed for eligibility. Finally, byexcluding some papers, 243 articles were included in thethematic analysis. Fig. 1 shows the selection process of thestudies [28].

The findings were organized as follows: (a) a cumulativefrequency analysis of included papers intended to show thetrend of publications since the first studies on Lean health-care up to September 2013 (Table 2; Fig. 2); (b) an analysis

of the empirical and theoretical literature according to thedimensions depicted in the second stage.

Beyond the possible “bandwagon effect,” this resultmost likely means that various journals (especially

1200 A. D’Andreamatteo et al. / Health Policy 119 (2015) 1197–1209

on proce

Fig. 1. SelectiAdapted from Moher et al. [28].

medical and nursing journals) show an increased interest

in the Lean approach as a means of improving opera-tional efficiency, the clinical outcomes of care processesand well-being at work, even though criticalities remain inits implementation

Fig. 2. Accumulated frequency analysis of

ss of studies.

3.1. Empirical works

A total of 109 papers of the 243 were categorizedas empirical and contained an in-depth description ofLean interventions and documented outcomes. Table 3

the papers included in the review.

A. D’Andreamatteo et al. / Health Po

Table 2Accumulated frequency analysis of the papers included in the review.

Year Frequency Accumulated frequency

2003 1 12004 3 42005 6 102006 11 212007 13 342008 15 492009 32 812010 36 1172011 39 156

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2012 51 2072013 36 243Total 243

ummarizes the primary results from the review in a data

atrix. The papers were further grouped according to their

iscussion of Lean’s levels of care, joint implementationith other techniques, effect on performance and the activ-

ty involved. All of these features were also related to the

able 3ata matrix analysis of empirical papers.

Focus/countries Rest of the world (or notwell-specified country)

Levels of careSecondary and tertiary point of care 10

Disease prevention and control and othersettings

1

Home, community and primary point of care

Subtotal 11

Cross Comparative AnalysisWithin countries

Between countries 1

Subtotal 1

Lean and other techniqueSix Sigma 2

Other process improvement techniques,theory or approaches

1

Subtotal 3

Documented impacts on performanceProductivity and cost efficiency 9

Clinical quality

Patient safety 2

Staff safety

Staff satisfaction

Patient satisfaction 1

Financial outcomes 1

Subtotal 13

ApproachSeveral projects or Systemic implementation

Basic medical or surgical servicesSurgery 1

Emergency 4

Other specialties 1

Subtotal 6

Ancillary servicesHospital pharmacy 1

Laboratory (pathology) 1

Other AS 1

Subtotal 3

Support activitiesSupport activities 1

ean in healthcare: a comprehensive review.

licy 119 (2015) 1197–1209 1201

country of implementation; the US had the highest num-ber of interventions, likely because only English languageliterature was considered.

3.1.1. Whole or partial approachDespite the rich literature, only a few papers addressed

an entire organizational approach. Examples were iden-tified in the Netherlands, Australia, the US and the UK,with the US accounting for the majority of the cases (e.g.[29–35]). When Lean was implemented within a plan ofactions aimed to improve the whole organization per-formance, the organizations appeared to become moreprocess-oriented, reduce costs and increase quality [32,35].One major effect was that employees were stimulatedto become change agents and work using a team-based

approach [32,35]. Important outcomes were also achievedin the areas of safety and the accessibility of care [30]. Ona smaller scale, similar results were achieved with projectsimplemented in a single ward, in other specific units or

Rest ofEurope

Australia USA UK Total

25 6 54 13 1081 2

3 3 625 6 58 16 116

2 5 73 1 3 2 105 1 8 2 17

7 12 1 224 1 2 1 9

11 1 14 2 31

17 5 50 13 944 1 6 3 142 1 12 1 181 1 2

2 1 32 4 8 2 175 13 19

31 13 90 20 167

2 2 9 2 15

8 1 7 5 223 3 5 2 175 1 16 4 27

16 5 28 11 66

1 5 72 7 10

5 4 103 0 17 4 27

1 7 9

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addressing only one organizational process, even thoughthese results does not allow to appreciate improvement ofthe overall organizational performance.

3.1.2. Levels of care, countries and other improvementtechniques

With regard to the level of care and countries amongthe empirical papers, nearly all (more than 90%) wereconcerned with projects implemented in a hospital, witha few exceptions for primary care. Only 11 papers weregrounded on cross-comparative analyses, four of whichwere between different countries (e.g. [36,37]) and theothers within the same country (e.g. [38–40]). The USand the UK saw the majority of interventions (58 and 16cases, respectively), whereas in the rest of Europe, theNetherlands was second in the number of cases studied(e.g. [34,35,39,41–45]). Furthermore, projects were identi-fied, among others, in Canada (e.g. [46,47]), Taiwan [48],and New Zealand [49].

In terms of the joint implementation of differentimprovement techniques, Lean and Six Sigma were theapproaches most often combined, with advocates primar-ily in the US (e.g. [31,50,51]) and in the rest of Europe(i.e., Germany, Sweden, Italy and the Netherlands) (e.g.,[41,52,53]), where particular attention was also paid tobenchmarking, Queuing Theory and the Theory of Con-straints (e.g. [39,42,52,54]).

3.1.3. Impacts on performanceWith reference to the impacts on performance, differ-

ent documented outcomes were observed, both tangibleand intangible, which demonstrated the positive influenceof Lean on performance. In particular, positive outcomeswere observed related to productivity and cost efficiency,clinical quality, patient and staff safety, patient and staffsatisfaction, and financial result. A total of 167 findingswere documented, and over 50% referred to increased pro-ductivity and cost efficiency. Broadly speaking, the resultssuggested a reduction in different categories of waste,one of the fundamental features of Lean. The other twoprincipal outcomes were patient safety (18 cases) andfinancial outcomes (19 cases). Only a few papers [55–57]documented an increase in staff satisfaction, and onlytwo papers demonstrated an improvement in staff safety[53,58]. No negative effects were reported, except for somecases in the emergency department (e.g. [59]).

3.1.4. Core (clinical specialties and ancillary services) orsupport services

Finally, in terms of which services applied Leanprojects, the healthcare community, clinicians andespecially nurses were particularly proactive in exper-imenting with Lean projects within the sector. Nearlyall of the clinical specialties tried to implement Leanand analyze the corresponding results. Surgery (e.g.,[30,41,60]) and emergency care (e.g., [6,41,61]) accountedfor more than half of the included studies. Among

ancillary services, hospital pharmacies and laborato-ries were the principal contexts for experimentation,followed by radiology (four cases). Only nine empiricalpapers showed that the application of Lean improved

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support activities such as information technologyprocesses, meal delivery and supply chain management[29,30,51,62–67].

3.2. Theoretical papers

A total of 134 of the 243 papers were considered theo-retical according to the criteria highlighted in the previoussection. Of these, 62 were classified as speculative, becausenarrative reports concerning Lean without a complete andwell explanation of projects or intended to just disseminatethe related concepts and ideas in different settings. Amongthe remaining papers, 13 were literature reviews. 63 arti-cles addressed crucial elements of Lean, such as barriersand challenges, success factors, outcomes and conditionsof organizational readiness. Only 8 theoretical studies werebased on a cross-comparative analysis [68–75]. 26 papersconcerned other specific features related to Lean imple-mentation. Overall, three main themes were identified thatcan represent the field: (i) Lean and the change process,(ii) Lean and other process improvement techniques and (iii)critical assessment. Within the first group the followingsub-themes, among others, were acknowledged: barriersand challenges, success factors, implementation process,sustainability and measurement framework. This sectionexamines each perspective.

3.2.1. Lean and the change process3.2.1.1. Barrier and challenges. Many included studieshighlighted specific critical features that affect the Leanjourney, i.e., barriers, challenges and success factors. Theexistence of barriers in the healthcare setting may explainthe slower adoption of Lean in this context [76]; someobstacles would be evident in specific sectors of health-care and must be appropriately managed, such as obstaclesto mental health services [77]. Accordingly, there wouldbe varied challenges that affect its successful implemen-tation, such as the receptivity of staff, the complexity ofthe adoption process, the evidence of innovation sharingand the embedding of change [78] as well as high processvariability, a lack of understanding of Lean, problems indefining waste [12] and a poorly defined focus [79]. Someof these challenges are triggered by a narrowly focusedLean approach that causes or shifts problems to other partsof the organization [13]. Sustaining momentum once theprogram begins and initial enthusiasm wanes would becritical [80]. A more significant issue is posed by the adapta-tion of Lean from the private to the public sector, requiringthat specific managerial and organizational “breaches” beaddressed [74]. Furthermore, a paradigm shift would benecessary in public services reform to establish Lean withina “public service-dominant business logic”, where the focusis the end-user, rather than internal efficiency [81]. Simul-taneously, especially in hospital environments, key sourcesof tension must be resolved when implementing serviceimprovements; i.e., as the NHS would show, tensions mightarise between the need to demonstrate efficiency and

achieve performance targets (derived from governmen-tal financial pressure) and the need to invest time andresources in embedding a culture of continuous improve-ment [82].

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A. D’Andreamatteo et al. / H

.2.1.2. Success factors. To address these barriers and chal-enges, the literature stresses a number of factors. Supportrom managers at each level would be required [13],nd leadership should be secured [15]. However, scholarsdvocate framing Lean in a manner that creates an emo-ional connection between the program and the peopley including central resourcing (also at a national level),enior executive- and board-level backing and supportrom external change agencies [78]. Significantly, creatingultural change, adapting Lean to the local context, learningrom previous experiences [15], fostering a long-term viewf continuous improvement [14], arranging high-impactraining courses and providing rewards and incentives tochieve greater involvement at all levels [83] would beurther key suggestions for Lean implementation. In addi-ion, in several instances, it is possible to observe how theindustrial” concept of “Lean thinking” is applicable to aealthcare setting, thereby identifying key performance

ndicators that measure change toward the “conceptualramework” in this context. Hence, Lean thinking should beerceived as a component of “the larger management shifto plan for changes in mindset and in the workplace” [84].he quality of project definitions would be another criti-al success factor in pursuing improvements in healthcareelivery; project definitions should be related, for instance,o patient safety, patient satisfaction, and the business-conomic performance of the hospital [85].

Strictly linked to success factors, organizational readi-ess conditions are prerequisites of the launch of theroject and its subsequent implementation. For Lean to beuccessful, the following should be present: a clear defini-ion of the quality targets, an increase in the availabilityf data, an understanding of customers and what theyalue, the knowledge of processes and stakeholder involve-ent before initiating the change [78]. Furthermore, key

nablers of the implementation process are the presencef an information-led organizational design [73], the basictability of the organization [86] and links between imple-entation attempts and an improvement strategy [72].

.2.1.3. Implementation process. The implementation pat-erns highlighted in the literature include key steps suchs conducting Lean training, initiating pilot projects andmplementing changes [13]. A standard Lean transforma-ion process should proceed through understanding theurrent state, defining the future state, implementing Leannd sustaining the implementation [87]. Essentially, oneould distinguish the Lean implementation (as experi-ented by the NHS) as “tentative,” “productive ward only”,

few projects”, “program” or “systemic” [88]. To achieveean’s potential, a full implementation approach would beecommended [69]: “full implementation” – or systemic –ould be an approach the embed Lean in the organization’s

trategic vision for the long term; this model would prefermployee development, continuous process improvementnd sustainability of change over short gain through costavings. Accordingly, a learning environment should be

eveloped for both staff and management to address theelivery of care, and Lean would be powerful to build such

context [86]. External pressure to improve the care pro-ess, the staff’s willingness to accept change, and changes

licy 119 (2015) 1197–1209 1203

in patient volume appear to influence which Lean tools areimplemented and how changes are sustainable over time[89]. One fundamental lesson that should be learned is thatLean is a “translated” idea when adopted in contexts otherthan manufacturing [68]. Furthermore, when implemen-ting Lean, an awareness of the dynamic association of actorswould be critical to the design of the process if the inter-vention is challenged [90,91]. Further, the processes andoutcomes of Lean would depend not only on the technol-ogy itself but also on the negotiation context in which theplanning and implementation of the Lean project occur,especially when the context is the public sector. Conse-quently, Lean is not a neutral and value-free activity, but itis fluid and open to multiple interpretations, interests andlogics [71]. Many outcomes of the implementation processhave been reported in the literature [14]. Briefly, Lean hasbeen shown to affect patient care indirectly and employeesboth directly and indirectly, improving or worsening careprocesses and patient outcomes [15]. Attention should bepaid to leadership and management tasks in leading theprocess of change (e.g. [92,93]).

3.2.1.4. Sustainability. Another critical theme mentionedby nearly all studies but explicitly addressed only in afew is the sustainability of improvements over the longterm. Generally, there is a lack of evidence of sustainedresults, i.e. improvements that maintain the achieved levelover the time [22]. Linking together approach, readi-ness and sustainability, a healthcare organization mightprogress toward a ‘generative’ state, one in which it pro-mote an organization wide, self-sustaining approach, withimprovement as a continuous condition [72].

3.2.1.5. Measurement framework. The literature reportsattempts to elaborate upon the measurement frameworksto assess the implementation of Lean. The implementa-tion scheme may concern the approach or the definitionof Lean itself and permits an evaluation of where short-comings exist. In the first case, organizations may evaluatetheir implementation process as ‘tentative,’ ‘productiveward only,’ ‘few projects,’ ‘program’ or ‘systemic’ and trackthe Lean journey over time, monitoring changes from oneapproach to another [88]. In the second case, one shouldconsider Lean as an attitude of continuous improvementthat creates value, organizations clarify priorities and guidestaff accordingly, enhances respect for the people who dothe work, is ‘visual’ and creates flexible regimentation [75].The distance from these poles can measure the gap towarda ‘full’ Lean implementation. When adopting Lean thinkingprinciples, it is important to design a measurement sys-tem that reflects the initiatives taken and also reflects theefficiency and effectiveness of healthcare organizations. Acomparison shows [84] that the flow model, which is arather simple process model that measures time parame-ters, is an appropriate model for indicating changes toward

by other measurements to provide a complete pictureof Lean performance (e.g., patient satisfaction, referralmanagement, process mapping and fulfilment of targetsand policies).

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3.2.2. Lean and other process improvement techniquesOther papers address using Lean in combination with

other techniques and provide a deeper understanding ofsome of the tools of interest, implying that some tech-niques may work better than others in specific healthcareorganizations [94]. More broadly, some authors suggestthat interest should be focused on bringing Lean and SixSigma together, giving rise to the Lean Six Sigma approach[95]. In addition, when Lean and Six Sigma are blended,it appears that statistical tools are used less often thanthey are in other contexts [96]. In this respect, some worksdemonstrate the benefit of using the Healthcare Lean SixSigma System model, combining the two approaches. Thiscombination would fill the service gap between health-care providers and patients, balance the requirements ofhealthcare managers, and deliver healthcare services topatients by combining the benefits of Lean’s speed andSix Sigma’s high-quality principles [97]. Notably, Aleem’spaper [98] focuses on primary care and the existing chal-lenge to providing high-value care along with improvedconsistency and reduced waste to reap financial benefits inincreasingly popular patient-centered medical homes andin an Accountable Care Organization model of care. Aleemobserves that the transfer of various quality-improvementtechniques such as Lean Six Sigma from the manufactur-ing industry to a service industry such as healthcare wouldprovide an opportunity for healthcare organizational sys-tems and practices to objectively improve the value of thecare they provide.

3.2.3. Critical assessmentFinally, in terms of critical assessment, there was a

claim of methodological development stemming from aproblematic definition of an important driver of Leanimplementation, i.e., the understanding of customer valuein healthcare [99]. Although different areas of improve-ment, such as time savings and the timeliness of service,cost reduction or productivity enhancement, the reduc-tion in errors or mistakes, staff and patient satisfaction,mortality, and intermediate outputs (i.e., reduction ofsteps in a process), were observed [14], some papersalso confirm a gap in the literature, which offers evi-dence of the poor quality in reporting the outcomes ofbusiness-process improvement methodologies, thus stip-ulating more rigorous studies to spread evidence-basedmanagement practices (e.g. [20–23]).

Furthermore, there is some discussion regarding therisks of an uncritical adoption of Lean thinking into work-design processes in hospitals, whose effect would be thecreation of a fundamental tension between the produc-tion of healthcare and the protection of the patient [100].Besides, Lean should not be regarded as a cornerstone ofNHS policy without a deeper preliminary understandingof how to balance utilization and waste when match-ing demand with the capacity of healthcare services[101].

4. Discussion

Drawing upon the themes underlined in the previoussections, this section highlights the main challenges and

licy 119 (2015) 1197–1209

issues about Lean in healthcare, identifies possible futurestrands of research and notes the limitations of the currentreview.

First of all, it appears in literature to exist a lack ofuniformity in the theoretical conceptualization of Lean.By reviewing the literature, it seems that everything maybe Lean; on the contrary, a common definition should beestablished to distinguish what Lean is and what Lean isnot to properly analyze future projects and to strengthenboth research and practice. Other terms for Lean used inthe healthcare sector, such as “The Henry Ford Produc-tion System” [102], the “ThedaCare Improvement System”[103], and the “Virginia Mason Production System” [104]for health system and “The productive ward” and “Theproductive operating theatre” [105] for specific programs,while anchored to Lean principles, might be confusing aswell.

The term Lean, first introduced in 1988 by Krafcik[106] to explain the Japanese system of success, was laterspread by Womak, Jones and Ross in their leading bookThe Machine that changed the world [107] and by Womakand Jones through Lean thinking: banish waste and createwealth in your corporation [108]. Lean is currently under-stood [109] as a combination of basic principles (specifyvalue; identify the value stream; avoid interruption invalue flow; let customers pull value; start pursuing per-fection again) and other principles such as committedmanagement, respect for people and the involvement ofsupply chain management. At a more abstract level, Leancould be conceptualized as “an operation strategy that pri-oritizes flow efficiency over resource efficiency” [110].

Accordingly, a critical issue that emerged by reviewingthe literature is the prevailing focus on single processes,units or departments as well as specific principles or toolsof Lean. To the contrary, Lean should be viewed and appliedas a strategy to reach a holistic transformation and 360◦

efficiency (e.g. [111]). Despite the usefulness of an in-depthcomprehension of specific aspects of the phenomenon,this state of art impedes the generalizations of the resultsthat have emerged so far. Indeed, the inability to eval-uate more cases of the system-wide implementation ofLean in healthcare settings with a great deal of experi-ence allows only quasi-anecdotal appreciations of Lean’sgoals and results. However, it should be recognized thatLean is a dynamic state [110] characterized by a continuousimprovement approach, and an a priori rejection of earlieror narrower experiences might lead researchers and practi-tioners to lose useful insights. Creating a shared frameworkor protocol for research would be rather important for thedevelopment of the field, with a primary focus on clari-fying what is being investigated in accordance with theconcept of “Lean healthcare”. According to the authors ofthe paper, this is especially important to allow future sys-tematic and sound evaluations of the evidence about Leanprograms. This lack of a definition is reflected in the qualityof the reported evidence. Indeed, several authors call for abetter assessment of Lean’s outcomes (e.g., [15,96,98]). For

Lean to obtain the commitment of healthcare professionalsbeyond a “bandwagon effect,” its effects must be shown byimproved studies in terms of its design, analysis of resultsand, in particular, assessments of clinical outcomes and

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ther overlooked benefits (i.e., financial results and staffnd patient satisfaction and safety).

Furthermore, the analysis of the benefits and the crit-cality of a joint implementation with other techniquesemain undervalued. In this work, the most importantnd cited process improvement techniques for evaluatingublic services [112,113] were searched when proposed

n combination or the concurrent implementation ofean, including Six Sigma, benchmarking, business re-ngineering, Total Quality Management and the Europeanoundation Quality Model. To date, it has not been deter-ined whether Lean has been implemented because of

new “bandwagon effect” or because of a disappoint-ent with the previous process improvement techniques.

onsequently, before rejecting other approaches, more in-epth research is needed about the relationships amonghe different techniques in the healthcare setting. In theeviewed literature, it seems that the most often experi-ented way is the Lean Six Sigma (e.g., [114]), in which it

s shown that a joint implementation could overcome eachystem’s respective points of weakness. It would be usefulo deepen the intrinsic nature of Lean Six Sigma in relationo both Lean and Six Sigma and analyze the appropriateays to integrate them.

Drawing upon “empirical cluster” papers in particular, itan be stated that more healthcare settings require inves-igation. The acute level of care is the most investigated,ut more analyses are required for home care and com-unity and primary points of care as well as throughout

he healthcare supply chain. Furthermore, there exist fewross-comparative and multi-site analyses. New cases –specially concerning different countries – would allowor an appreciation of the extent of the phenomenon and,imultaneously, a better evaluation of the possible cul-ural influences on the choice to adopt and adapt Lean.

promising subfield of research may be the analysis ofhe similarities and differences between the implementa-ion of Lean in private healthcare organizations and in theublic sector. As Radnor and Osborne state, the “genealogyor Lean raises [. . .] important challenges for its imple-

entation in public services” [81]; therefore, it would beorthwhile to better understand the way to overcome

hese challenges and the specific features of the imple-entation of Lean in the private compared to in the public

ector.The implementation process itself and sustainability

emain key and underinvestigated issues. With referenceo the first issue, as suggested by Hoss and ten Caten, itould be interesting to know more about the influence

f roles, rules and values as well as how Lean practicesre structured by social actors [115]. For sustainability,ore longitudinal studies regarding new or well-known

rograms would be useful (e.g., [59]), especially those char-cterized by a holistic approach.

Despite the many recognized and well-proven benefitsf Lean, a few papers are critical of using Lean in healthcarer of the manner in which Lean is used. In fact, we know

ore regarding the drivers of success than the causes of

ailure. Indeed, many scholars assert that the literature ispecifically built on positive cases (e.g., [15]). In reality, aew cases in the literature reviewed showed impacts other

licy 119 (2015) 1197–1209 1205

than positive (e.g. [59]). On the contrary, it would be impor-tant to learn from unsuccessful projects and, generally, toapply a more critical view to evaluate Lean in healthcare.

Eventually, the cost effectiveness of Lean interventionsmust be shown. An evaluation framework for measuringLean healthcare performance should be developed to com-pare the amount of resources invested (often described asnull) and financial and non-financial benefits that resultfrom its implementation.

The current study has various limitations. Despite thedifferent degrees of methodological rigor among the stud-ies reviewed, the papers were intentionally not assessed fortheir quality. The aim of the authors was to avoid excludingpapers for which not relevant mistakes could have affectedthe overall quality of the articles despite their importantfindings [116]. Indeed, with reference to the general scopeand related research questions for the current review, aconventional method of systematic review could not haveallowed the authors to catch all of the significant issuesrelated to the implementation of complex quality improve-ment programs [117]. The exclusion of papers for theirlow quality could have resulted in ruling out themes thatare potentially good and relevant. On the contrary, a lowthreshold might be set to “maximize the inclusion and con-tribution of a wide range of papers at the level of concepts”[118]. Furthermore, the study characteristics (principallythe study design) varied significantly according to dif-ferent traditions of research, namely, the life and healthsciences compared to social sciences, with the latter hav-ing a different tradition of evidence-based research (e.g., inthe management literature [119]). Hence, the exclusion ofsome of the papers by using assessment criteria that arefairly general for all papers but do not fit the purpose withreference to a specific group could have affected the com-pleteness of the review. Nevertheless, we mitigated thiscriterion by acknowledging the existence of a specific cate-gory (conceptual/speculative) in which we grouped paperswith a low quality of reporting about any aspect of theresearch (i.e. its aim, context, rationale, methods and find-ings) and/or with a principal aim to explain Lean and spreadits use in healthcare. These criteria allowed the authors toextract meaningful concepts from this group of papers.

Another limitation of the study is that it examinesonly English-language studies, although relevant insightsmay stem from papers published in languages otherthan English. In addition, there may be influential booksby scholars or practitioners that may provide a soundunderstanding of the phenomenon but that did notmeet the inclusion. Finally, although a careful searchapproach was deployed, some papers from journalsnot indexed in the searched databases may have beenoverlooked.

5. Conclusion

Lean is an improvement approach increasingly appliedin the healthcare field. Healthcare professionals and

managers in many countries are experimenting withLean tools and techniques to improve efficiency, clini-cal outcomes, satisfaction and safety for both staff andpatients and ultimately to enhance financial performance

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1206 A. D’Andreamatteo et al. / H

and sustainability. In the USA, Lean experiences seemedto have significantly increased over time, and the UKgovernment has primarily chosen Lean as a means toreform its public sector [81]. Tough, despite the inter-esting results, only few organizations appear to haveattempted to implement a system-wide approach. Further-more, notwithstanding the great number of publicationsin peer-reviewed journals, the research and implemen-tation in the field appears to be at an early stage ofdevelopment if a system wide view of Lean is to beacknowledged.

Therefore, even if we now know much more regardingLean in healthcare than we did at the beginning of thiscentury – particularly regarding its underlying principlesand tools, enablers, barriers and outcomes, as described inthe previous sections – there is nevertheless much to learnregarding some under-investigated or overlooked issues.Particularly, the following could be some directions forfuture investigations:

(a) a common definition should be established to distin-guish what is Lean and what is not in order to properlyanalyze future attempts to introduce Lean in healthcareand to strengthen the literature;

(b) the analysis of benefits and challenges or drawbacks ofa joint implementation with other techniques remainundervalued; it would be useful to analyze futuretrends utilizing blended approaches such as Lean SixSigma;

(c) to obtain the commitment and engagement of health-care professionals beyond a “bandwagon effect” Leanimpacts and consequences must be the focus of morerobust studies in terms of design, methods and analy-sis of findings. In particular, specific attention shouldalso be paid to the assessments of clinical outcomesand other overlooked benefits (i.e., financial results andstaff and patient satisfaction and safety);

(d) more settings require investigation. The acute levelof care is the most investigated. Further researchis required for Lean introduction in home care andcommunity and primary care contexts as well asthroughout the whole healthcare supply chain;

(e) there are few cross-comparative and multi-site anal-yses. New cases – especially concerning differentcountries – would allow an appreciation of the extentof the phenomenon and, simultaneously, a better eval-uation of possible cultural influences on the choice toadopt and adapt Lean;

(f) the implementation process and sustainability remainkey issues. More longitudinal studies regarding newor well-known programs would be useful, especiallythose characterized by a systemic approach;

(g) the literature is specifically built on cases of success.Many scholars advocate learning from both positiveand negative cases; generally, it is important to apply

a more critical view to evaluate Lean in healthcare;

(h) the cost-effectiveness of Lean interventions must beaddressed. An evaluation framework for measuringLean healthcare performance must be developed.

licy 119 (2015) 1197–1209

These unexplored issues imply it is difficult to drawa last word or unquestionable implications. Neverthe-less, some preliminary insights emerge. First, findingsshow that Lean, no matter if implemented with a ‘sys-tem wide approach’ or not, would ensure a range ofbenefits. When managers are committed and secure lead-ership and enhance organizational readiness conditions,changes toward a ‘leaner healthcare organization’ wouldbe more likely. Furthermore, in sector as complex asthe healthcare one, policy makers should play a piv-otal role in allowing a more precise implementationsof this strategy, through the adoption of guidelines andframeworks that help professionals to be more comfort-able with ‘industrial’ process improvement techniques.Also, other policy-making implications stem from thisreview. They have no claim to be exhaustive, still pro-vide some interesting directions for future policies, suchas:

- provide stronger incentives to spread Lean initiativesoutside the hospital setting. Assuming the scarcity ofresearch so far conducted in settings different than hos-pital it is an index of the relative low development ofLean projects in community and other healthcare sett-ings. Therefore, much more can be done to spread theLean approach toward those contexts;

- given the magnitude of the phenomenon, an higher pri-ority in terms of funding could be allocated to researchproject that address issues connected with Lean introduc-tion in healthcare, further with the aim of making easiercross-national learning and dissemination of findings;

- competences and skills on Lean health could beintroduced – obviously with different intensity – inexecutive management training initiatives dedicated tohealth professionals, in study curricula of doctors andnurses, in training schemes for health organizationsadministrators and managers.

Finally, as experiences such as the NHS one highlight,to introduce Lean in national plans for development andimprovement and sustain it with central sourcing couldbe an advisable (or necessary) – even though not suf-ficient – condition to foster the use the spread of theLean approach. Certainly, to avoid just a ‘bandwagoneffect’, evidence to advocate for national plans shouldbe based on evaluation of ‘system wide approach’ cases,in which Lean is implemented as an overall organiza-tional strategy, rather than a means to reach short gainsin limited areas. Especially this last issue should receivemore attention from the academic community in the nearfuture.

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