Lean is an organizational redesign approach that is increasingly being used in health care. The term "Lean Production" was coined by an MIT research team studying leading automotive manufacturers around the world.1 At its core, Lean focuses on the elimination of waste, with waste defined as any activity that consumes resources (staff, time, money, space) without adding value to those being served by the process. Lean can be implemented in many ways. The world's leading example of Lean production is the Toyota Production System (TPS). Toyota, more than any other company in any industry, has established both the cultural and operational elements required to continuously drive waste out of its production processes. Some argue that Lean's focus on processes makes it especially appropriate for solving complex health care issues. Others argue that Lean's use in manufacturing as opposed to a service industry, and its focus on standardization and defining value from the customer perspective, renders it inappropriate for health care because patients have unique needs, and there are multiple customers (e.g., employers, insurers, patients).2
As Lean increases in popularity, the Agency for Healthcare Research and Quality (AHRQ) wanted to better understand if and how Lean works in health care, and, if it does work, what specific mechanisms make the redesign technique successful. To do so, AHRQ awarded a contract to the American Institutes for Research (AIR), a nonprofit research organization headquartered in Washington, DC, to study the application of Lean to health care. As part of this work, AIR conducted five case studies of individual health care organizations that implemented Lean.
Prior to the case studies, the AIR research team conducted a review of the literature to determine whether an evidence base exists for using Lean in health care. We found that the majority of studies about Lean lack data on key areas and domains important for understanding quality improvement, organizational behavior, and organizational change. In addition, the literature is largely anecdotal and devoid of theoretical frameworks, not comparative, authored by the individuals who have implemented the projects rather than independent investigators, and limited to those projects that were successful.a
Four major findings stemmed from the literature review:
- Information about Lean implementation in health care is unreliable and anecdotal. Peer-reviewed articles are relatively scarce, although there is a large volume of grey literature. Reports from peer-reviewed and grey literature were single case studies of limited validity. In addition, nearly all of the documents focused on one organization, department, and project, making it very difficult to determine what factors or features of organizations and the external environments in which they operate are important for successful implementation and maintenance of Lean. Finally, studies generally failed to use more rigorous quasiexperimental designs or comparative and longitudinal case study designs.
- Data are inconsistent or absent in many domains that research in other fields (e.g., quality improvement) suggests are important. There is little rigorous reporting about external impetus or context for Lean (e.g., market factors and conditions), key organizational factors (e.g., how culture affects who implements Lean), impact (e.g., economic, quality of care, outcomes of care), and sustainability. The outcomes measured were primarily efficiency and quality and, less frequently, safety and patient satisfaction.
- Lean studies are atheoretical. Few papers provided clear theoretical backgrounds or frameworks for reported findings.
- There is a positive publication bias in Lean literature. Nearly all documents included in our review reported positive outcomes and results from implementing Lean, and many were authored by consultants or individuals in the organizations implementing Lean.
In short, considerable gaps remain in the existing literature about Lean. These gaps make it very difficult, if not impossible, to discern which organizational characteristics and/or environmental conditions are critical for successful implementation and sustainability of Lean and its impacts on efficiency, quality/safety, and other important outcomes (e.g., patient satisfaction). This lack of research warrants additional investigation of the implementation of and outcomes related to Lean.
AIR developed a conceptual framework to guide the case study research, drawing on the results of the systematic literature review and, specifically, on the literature about health care quality improvement (including such related topics as implementation and diffusions of innovations) and on the literature about organizational learning, innovation, and change (Exhibit 1). This framework builds on and integrates theoretical/conceptual literature on organizational learning, innovation, and change and related work in health care, such as quality improvement. At the most basic level, hospitals, medical groups, and other health care organizations that attempt to use Lean are seeking to improve or fundamentally reconceptualize core administrative and/or clinical processes.
As shown in Exhibit 1, our theoretical/conceptual framework comprises five major elements, as follows:
- The local environment in which the health care organization is operating. According to the literature, the local environment is likely to be an important factor affecting the ability of health care organizations to successfully implement, disseminate, and integrate Lean. Specific aspects of the external context or local environment that previous research suggest are particularly important include: a) the extent to which health care purchasers are organized and able to put pressure on health care organizations to reduce spending or total costs and improve quality; b) the extent to which purchasers use any new, non-fee-for-service (FFS) payment methods (e.g., pay for performance, partial capitation) designed to provide a greater incentive to reduce spending or costs or improve quality; c) the competitiveness of the market, including whether other providers are using Lean; and d) sources of expertise in Lean, for example, universities, corporations outside the health care sector that have used Lean, or consultants.
Some schools of organizational theory point out that all organizations are dependent on their environment, because no organization possesses or can produce all the resources (e.g., inputs, distribution channels) required to fulfill their aims (refer to Scott and Davis, 2006,3 for an overview of resource dependency theory). In the case of Lean, one key resource is Lean knowledge and skills. Currently, most health care organizations lack this expertise in-house, so typically they are in the position of looking for this expertise from external individuals or groups that have experience in other industries. In addition, health care organizations often seek out this expertise locally, via linkages to university departments (e.g., engineering programs that use the technique with manufacturing firms) or local manufacturing firms or consultants. Therefore, the availability and capability of these entities with expertise in Lean, and the nature of the relationships they establish (e.g., frequent, positive interaction, "ownership" of the project taken by the organization versus remaining with the outside organization), may influence the ability of health care organizations to successfully implement, sustain, and disseminate Lean.
- The organization adopting Lean, particularly structures and processes (internal context) for implementing Lean. Building on the work of Donabedien4 and others, such as the Institute of Medicine's (IOM's) Crossing the Quality Chasm,5 it has long been understood that organizational structure has an impact on processes, and ultimately organizational (e.g., efficiency, effectiveness) and patient outcomes (e.g., mortality, morbidity, patient experience). In this study, the health care organizations' general structures and processes comprise the organizational context in which Lean is being implemented.
Several aspects of structure are likely to have an impact on the ability of health care organizations to successfully implement, disseminate, and sustain quality improvement initiatives such as Lean. At the most basic level, there are a variety of structural characteristics that have been shown to influence both positively and negatively a hospitals' desire to undertake and sustain initiatives like Lean (e.g., size, medical staff organization, such as employed or private practice physicians, profit and teaching status).
In addition to general structural characteristics noted above, four other aspects of structure have been found to be important for learning, innovation, and change and quality improvement. These include: culture,b existing knowledge and skills, information infrastructure, and slack resources. With respect to culture, Schein6 defines organizational culture as "a set of basic tacit assumptions about how the world is and ought to be that is shared by a set of people and determines their perceptions, thoughts, and feelings and, to some degree, their behavior." It involves the norms, values, beliefs, and behaviors of an organization reflecting how things are done within the organization. A culture conducive to quality improvement will encourage questioning and risk-taking at all levels, if not require double-loop learning and "meta-learning" in which an organization evaluates its basic operating assumptions, how it learns best, and makes efforts to improve its learning practices.7,8 Conversely, a very hierarchical culture emphasizing rules, regulations, and reporting relationships is negatively associated with implementation of quality improvement and related practices.
As noted, existing knowledge and skills about quality improvement more generally and the use of Lean by the Toyota Production System (TPS) more specifically, are also important factors influencing implementation. Health care organizations have varying degrees of knowledge and skills, as well as experience, in quality improvement more broadly. Those with greater expertise and experience with quality improvement can build upon them when beginning to use process redesign techniques like Lean. When it comes to expertise in Lean more specifically, many health care organizations have to seek out knowledge and skills from outside organizations, since the technique has historically been used in manufacturing. Therefore, an important concept related to existing knowledge and skills is an organization's absorptive capacity, which Greenhalgh and colleagues9 define as the ability to identify, capture, interpret, share, reframe, and re-codify new knowledge; to link it with its own knowledge base; and to put it to appropriate use. Precursors of absorptive capacity include the knowledge and skills of key staff and the organization overall, as well as some of the structures and processes described in this section.
Health care organizations also may vary considerably in terms of their information capability, including information technology (such as electronic health records) and the information they routinely have available or can readily produce. Without timely information that is not overly burdensome to collect, it is difficult to assess problems or assess what works to overcome them.
Finally, related to other general structural characteristics (e.g., profit status), health care organizations that have more slack resources (e.g., better profit margins, higher staffing levels) often are more likely to succeed in quality improvement. Individuals and teams need the time and other resources (such as education and training, ongoing assistance, information) to fundamentally re-examine and redesign processes, rather than creating temporary fixes. All of this requires at least an initial investment of resources before a return can be realized.
- The content or nature of the Lean Initiative and the degree to which it fits with existing organizational structures and processes. In addition to these general organizational features, several issues related to the approach to and uses of Lean at the organization-wide and specific project level are important. Increasingly, research on health care quality improvement highlights the need to: a) recognize the "nested" nature of health care organizations (e.g., individuals working in teams, teams in specific units, specific units in departments, and departments in organizations), and b) understand the relationship among these levels.5,10–12 For example, a lack of "alignment" of purpose, priorities, and incentives among these levels can hinder efforts to innovate and change.13
At the organizational level, this includes the vision for and goals of Lean. Different organizations have different visions of and goals for Lean.c For example, one key difference appears to be whether the health care organization views Lean as a specific "tool" and set of techniques to "refine" or improve existing processes in smaller, discrete organizational areas, or whether it views Lean as a mechanism for fundamentally transforming care delivery processes and the entire organization, including potentially its culture.
Other aspects of the Lean initiatives of importance at the organizational level are: scope and pace of Lean activity, locus of lean activity, and coordination of Lean activities and resources. A major decision that organizations must make is in how many areas and how quickly to try to implement Lean. Regardless of whether multiple areas of the inpatient or outpatient setting are being addressed or a single area and related value stream—that is, whether the locus of lean activity is broad or narrow—coordination of Lean activities is required.
At both the organizational and Lean project levels, a variety of other factors are important. These include: leadership, education/training, communication about Lean, Lean team composition, resources, and routinization. For example, the composition and size of the Lean team itself may be shaped by several organization wide sub-domains (vision of and goals for Lean, locus of Lean activity, resources); team size and resources also reflect the content of the specific Lean project. These team features, in turn, have a significant impact on the teams' overall effectiveness. A team is a type of formal group or collection of individuals who see themselves, and are seen by others, as a socially intact entity; share responsibility for tasks and outcomes; and operate within a broader organizational context, interacting with the larger organization or specific organizational subunits.14
A health care organization's ability to successfully implement, disseminate, and integrate Lean may also be affected by the content or nature of Lean, particularly the "fit" or "match" between the characteristics of the organization's social structure and the nature of Lean. Work on the diffusion and dissemination of innovations, including organizational innovations like Lean, suggest that some innovations are a better "fit" or "match" with existing organizational structures and networks, and that successful dissemination and integration is more likely when the degree of "fit" or "match" is greater. Aspects of Lean that are important for "fit" or "match" include: the perceived advantages relative to current practice (e.g., Lean results in superior efficiency and/or quality); compatibility with values, beliefs, and mission/vision; complexity (e.g., whether Lean is relatively easy to understand and use); trialability (i.e., the ability to experiment with Lean, on a limited basis, as opposed to an all-or-nothing approach); and observability (i.e., the extent to which the results are observable to key groups and stakeholders).15 For example, alignment between Lean and the organizational culture is likely to be poor when there is limited experience with or trust of multidisciplinary teamwork. Similarly, in organizations where physicians are used to high levels of autonomy, there may be resistance to Lean's stress on standardization of care processes.
Outcomes, both intermediate and ultimate. The next element of our conceptual framework is the outcomes associated with Lean implementation. The intermediate outcomes include employee satisfaction, culture change, increased knowledge of Lean, and routinization and diffusions of Lean methods and skills. For example, in the near or intermediate term, Lean can positively or negatively impact satisfaction among physicians and other clinicians and staff. The final outcomes include aspects of efficiency, quality, safety, and satisfaction. Further, in order for organizations to sustain Lean, there has to be a business and/or strategic case resulting from the initiative.
Integration of Lean into organizational routines. The final element of our conceptual framework is a feedback loop from the intermediate and ultimate outcomes to the internal context or organization. If organizations perceive and experience positive outcomes from their Lean efforts, they will be more willing and able to sustain their Lean efforts. In addition, as the organizations gain more experience with Lean, they will continue to learn about when and how to use it and how best to integrate it into their organizational structures and processes generally and, more specifically, with respect to quality improvement and Lean.
The purpose of the individual case studies, as part of the larger project, was to examine the ways in which each organization has implemented Lean and identify the factors that influenced progress within individual Lean projects and on the ultimate outcomes. At a practical level, these individual case study reports are designed to provide potential Lean users with information that will enable them to make informed decisions about implementing Lean, based on experiences that are relevant to their own situation.
The individual case studies contributed to goals of the project overall by providing evidence to answer study questions corresponding to each of the aims described here.
Aim 1. Assess whether Lean positively affects primary outcomes of interest to the participating hospitals. From the organization's perspective, does Lean improve quality, efficiency, costs, employee satisfaction, and organizational culture?
Aim 2. Identify internal and external factors that are associated with variations in outcomes and processes, so that potential users can understand which experiences are relevant to their own situation.
Aim 3. Identify challenges to implementing Lean, potential solutions to the challenges, and lessons learned.
To meet these aims, AHRQ and AIR conducted five case studies. The next section describes the methods of the case study approach.
To address the gaps in the Lean literature and examine the domains included in the conceptual framework, it was critical for our purposive sample of organizations to be diverse in nature and that it would expand the evidence base regarding the Lean method. These organizations—from single hospitals to entire systems composed of multiple hospitals and clinics—were considered to be the "cases" for this study. To qualify as a case, the organization must have implemented Lean in two or more projects (e.g., kaizens,d rapid cycle improvements, gembas,e and rapid improvement events).
Five diverse health care organizations were selected for the study:
- Critical access hospital.
- Academic medical center.
- Public safety net hospital.
- Tertiary care hospital.
- Organized delivery system (ODS).
Exhibit 2 presents factors considered in the selection of case study organizations.
Using the criteria described above, five diverse organizations were purposively selected for inclusion in our project. Exhibit 3 describes each organization, based on the selection factors for organizational selection, and indicates a pseudonym for each organization.
After determining the participating organizations, projects from each organization were selected for specific examination. "Projects" are defined by the organization but usually refer to specific Lean events in a department, unit, or segment of the value stream. The focus on specific projects allowed us to better understand how Lean works practically speaking at each organization, and how variation in the project target area may affect Lean success. This information allowed for a second level of detailed analysis to examine these factors and their influence on Lean implementation, sustainability, and success.
In sum, 13 distinct projects were studied across the five case study organizations. Nine of the projects were studied from a prospective analytic perspective, and data were collected at the beginning and during the course of the project. Four projects were studied from a retrospective analytic perspective, and data were collected after the conclusion of the project. Further, 10 projects focused on Lean implementation for a single department or operating unit within a health care organization. Three projects focused more broadly on the entire hospital's operations, including the construction of an entire hospital using Lean principles. The breakdown of projects based on the additional selection criteria are presented in Exhibit 4.
Exhibit 5 depicts the research design of the overall project.
Data collection activities included site visits with in-person interviews, digital diaries, collection of documentation, and telephone interviews. Data collection methods varied by analytic perspective (i.e., prospective and retrospective) and the stage of implementation of the Lean project (i.e., pre-implementation, implementation, post-implementation). Exhibit 6 shows the breakdown of data collection activities by both analytic perspective and stage of implementation.
Pre- and Post-implementation Data Collection Activities
Data collection methods during pre- and post-implementation were included in site visits with in-person interviews and collection of documentation.f
Site visits with in-person interviews. AIR collected qualitative data via site visits by conducting in-person interviews. The purpose of these interviews was to:
- Determine the organizational culture surrounding Lean.
- Assess the organizations' views of Lean and quality improvement in general.
- Gain a better understanding of the specific implementation strategies used by each organization and gather data about the local environment, structures, and processes with specific application to Lean implementation.
AIR visited each site twice. The first visit was to gain baseline information for prospective projects and to collect all of the information on retrospective projects. The second visit was to follow-up on the status and outcomes of all prospective case projects. The first visits occurred between November 2009 and May 2010, while the second visits occurred between September and December 2010.g
Each site visit lasted between 2 and 4our days and consisted of a series of individual and small group interviews. Each interview took 30-60 minutes. Interviews were conducted with the administrative and clinical personnel from each of the participating health care facilities as described in Exhibits 7 and 8.
Collection of documentation. The purpose of this activity was to solicit materials and data directly collected by the sites on the implementation and impact of Lean including:
- Internal reports or memos on Lean implementation or decisions surrounding Lean implementation.
- Materials promoting the adoption of Lean in the organization.
- Tools used when implementing Lean (e.g. value stream maps, checklists, guides, etc.).
- Press releases or other news media regarding the use of Lean in the organization.
- Data on the process evaluation for Lean (satisfaction surveys on Lean, use of Lean versus other methods).
- Materials disseminating information about Lean and its impact to others outside of the organization (speeches, presentations, posters, etc.).
Documentation from the organization also included quantitative data (e.g., Lean project metrics, patient satisfaction scores, cost savings, etc.) for review relevant to:
- Business case for Lean.
- Processes and outcomes of Lean projects.
Organizations provided data on indicators of quality, patient safety, customer service, efficiency (including costs), workforce development, and/or changes in the physical environment based on the type of Lean project(s) they implemented and the information they collected. The type of indicators and amount of data provided varied by organization. The most common indicators provided include quality/patient safety, customer service, efficiency, workforce development (including physician development), and architecture/physical environment.
- Quality/patient safety. Particularly for projects of a clinical nature, organizations provided documentation that they used to help measure outcomes for both quality and safety metrics. For example, a tracking sheet with monthly metrics on door-to-balloonh times was shared with the research team.16 On an organizational level, scorecards with results from all Lean projects were shared. These scorecards always included quality and/or safety metrics.
- Customer service. Documentation showing improvements in customer service were submitted by several organizations. Customer service documentation includes any information that affects the patient experience at the organization. For example, one organization sent documentation to show the reduction in wait time for an appointment. Others shared documentation with metrics related to the continuity of care between patients and their primary care providers.
- Efficiency. Documentation of efficiency was provided to illustrate the reduction of work for staff and the effects on specific processes. For example, one organization provided documentation regarding the reduction in preference cards (used by surgeons to specify equipment and supplies needed for an operation), a change that allowed for the surgical process to be more efficient. Additionally, documentation was submitted illustrating a reduction in the number of steps in a process for clinical staff to improve their efficiency and reduce the physical burden.
- Workforce development, including physician development. While Lean may have had impacts on employee satisfaction or culture, no documentation was collected or provided on these aspects.
- Architecture/physical environment. Many organizations combined spatial and organizational improvement with their Lean project. For example, we collected pictures from one organization on a 6S activity completed on a filing space that was part of a larger continuity of care case.
Implementation Phase Data Collection Activities
Data collection activities during the implementation phase were mainly qualitative, including recording of digital diaries, telephone interviews, and collection of documentation.
Digital diary. For prospective projects, the participating establishment assigned an onsite quality specialist or coordinator who worked closely with each department and Lean project. This onsite person kept a "digital diary," using a diary entry guide and a hand-held digital voice recorder to describe key aspects of the implementation process. The onsite coordinator dictated his or her answers to these questions into the digital recorder and sent the MP3 files to AIR researchers via email. The onsite coordinator made diary entries one to two times each month. In some situations, the individuals completing the digital diaries were uncomfortable completing these entries into the recorder. In these cases, we substituted short telephone interviews once or twice each month, in addition to those scheduled for all sites. This alternate method yielded similar information to the traditional digital diaries.
Telephone interviews. For each prospective project, we conducted telephone interviews with 1-3 individuals per department. The types of interviewees depended on the specific department and projects but largely included Lean champions, team leaders, or Lean process owners. The telephone interviews lasted approximately 30 minutes and were completed two to three times during the project implementation.
Collection of documentation. AIR collected qualitative documentation from each participating facility as described previously. The purpose of this collection of documentation was to assemble ongoing documents as they were being developed, used, and distributed. As available, quantitative data related to the cases in terms of process and outcome variables being collected by each organization for their Lean project were collected during this process.
Institutional Review Board (IRB) and Office of Management and Budget (OMB) Approvals
AIR received OMB approval to conduct the research presented in this document. AIR's IRB approved all protocols, recruitment, and interview procedures before any contacts were made or any data were collected.
All qualitative data from site visit in-person interviews, telephone interviews, and digital diaries were managed and analyzed using NVivo, a qualitative data analysis software program. NVivo can accommodate diverse types of qualitative data including text, audio, and video. All interviews and digital diaries were transcribed before uploading to NVivo. Print documents were also scanned and uploaded into NVivo.
We developed a coding system for the interviews and digital diaries based on an earlier but very similar version of the conceptual framework shown in Exhibit 1. To ensure a consistent application of the coding system across three coders, inter-coder reliability was tested after every 20 interviews. The average reliability for all coding was 92.8 percent.
After coding was complete, we analyzed the data for each individual case. We employed a variety of qualitative techniques to draw conclusions from the data (e.g., noting patterns and themes, plausibility, relationships between variables, and finding intervening variables). Other data provided by each organization were summarized as appropriate, for example, using descriptive statistics for quantitative indicators and integrating qualitative information from materials into the cases as needed.
The use of primarily qualitative data collection techniques presents some limitations. The freedom to tailor questions and probes to each respondent is the hallmark of the qualitative interviewing methodology. Because the interviewer does not adhere inflexibly to the written questions—by asking every question, using the exact written language, in the exact sequence—the study findings are limited by two potential sources of bias. First, if the language and sequence of the questions are associated with the responses, our conclusions might also vary in an unknown way. Second, because there are no rigid categories, aggregating responses requires interpretation by the analyst, and it is possible that one analyst's interpretation may differ from another's. However, the reliability of the coding noted above suggests that this was not a serious source of bias.
- Krafcik JF. Triumph of the lean production system. Sloan Management Review 1988;30(1):41–52.
- Boaden R, Harvey G, Moxham C, et al. Quality improvement: Theory and practice in healthcare. Coventry, England, UK: National Health System, Institute for Innovation and Improvement; 2008.
- Scott WR, Davis GF. Organizations and organizing: Rational, natural and open systems. Upper Saddle River NJ: Perspectives Prentice Hall; 2007.
- Donabedian A. The quality of medical care: Methods for assessing and monitoring the quality of care for research and for quality assurance programs. Science 1978;200(4344):856-64.
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a. An executive summary of the literature review is available separately at http://www.ahrq.gov/research/findings/final-reports/leanprocess.html.
b. Culture is often considered a process, instead of a structure, as it must continually be reinforced, and it can change. However, culture is relatively stable and changes slowly. In addition, some see Lean as a way of altering culture. So, we included culture in this model as part of the organizations' structure.
c. Some may also consider the vision for, and goals of, Lean as part of the organizational process rather than a structural feature of the organization. However, in more rational organizational theories, visions of and goals for something like Lean are viewed as occurring first and shaping the organization of the Lean work. So, we include this sub-domain here and also consider how the vision for and goals of Lean may be reinforced, refined, or changed through the implementation process.
d. A kaizen is a rapid improvement process that focuses on eliminating waste, improving productivity, and achieving sustained continual improvement in targeted activitiesand processes of an organization.
f. This activity solicited materials and data collected by the sites on Lean implementation and impact: internal reports/memos, materials promoting Lean adoption, tools used in Lean implementation (see Lean Healthcare Exchange at http://www.leanhealthcareexchange.com/?page_id=300), press releases, and data on process evaluation.
g. Note, as of January 27, 2011, one of the prospective projects had not begun data collection, and the second site visits had not occurred for two other prospective projects. The Lean hospital (LHC Horizon) is an ongoing prospective project on a different project schedule. Data for the Lean hospital are collected at every visit; an additional visit will occur after the hospital is opened.
h. Door-to-balloon (D2B) is a cardiac care time measurement for treatment of myocardial infarctions, specifically defined as the time from patient arrival at the hospital to the time of percutaneous coronary intervention.16