Six Sigma and Dmaic Approach Peer Reviewed Articles

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J Investig Med. Writer manuscript; available in PMC 2010 Mar ix.

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PMCID: PMC2835466

NIHMSID: NIHMS174869

The Applicability of Lean and Half dozen Sigma Techniques to Clinical and Translational Research

Abstract

Groundwork

Lean and Six Sigma are business management strategies ordinarily used in production industries to improve process efficiency and quality. During the by decade, these procedure comeback techniques increasingly have been applied exterior of the manufacturing sector, for example, in wellness care and in software development. This article concerns the potential use of Lean and Six Sigma to improve the processes involved in clinical and translational enquiry. Improving quality, avoiding delays and errors, and speeding up the time to implementation of biomedical discoveries are prime objectives of the NIH Roadmap for Biomedical Research and the NIH Clinical and Translational Science Laurels (CTSA) program.

Methods

This article presents a description of the main principles, practices, and methodologies used in Lean and Six Sigma. Available literature involving applications of Lean and 6 Sigma to health care, laboratory science, and clinical and translational research is reviewed. Specific issues concerning the use of these techniques in different phases of translational research are identified.

Results

Examples are provided of Lean and Vi Sigma applications that are existence planned at a current CTSA site, which could potentially be replicated elsewhere. Nosotros describe how unlike process comeback approaches are all-time adjusted for particularly translational research phases.

Conclusions

Lean and Six Sigma process improvement methodologies are well suited to help achieve NIH'south goal of making clinical and translational research more efficient and cost-effective, enhancing the quality of the research, and facilitating the successful adoption of biomedical research findings into practice.

Keywords: Lean, Six Sigma, procedure comeback, translational research, quality, TQM, CQI

Introduction

Various business management strategies have been developed to improve the performance of organizations by improving the processes by which they carry out their work. These strategies, which include Lean and Vi Sigma, aim to implement procedure improvements through a coordinated set up of principles and practices that promote greater efficiency and effectiveness, with fewer wasteful practices or errors. Evolving from their original application in manufacturing industries, these process improvement strategies have been extended to other settings including construction, software development, fiscal services, wellness care delivery, and laboratory sciences.

The creation of the Clinical and Translational Science Awards (CTSA) initiative as role of the National Institutes of Health (NIH) Roadmap for Medical Research is aimed at creating a clinical and translational research enterprise that assures maximal value is obtained from biomedical enquiry investments. While the definition of clinical and translational inquiry is nevertheless being debated, at that place is broad consensus that formal and sustained processes are needed to improve the timeliness and efficiency of research along the biomedical continuum. Reducing the fourth dimension between biomedical research discoveries and their adoption into clinical practice requires increased coordination, systematic planning, and new types of connections within biomedical research organizations. This commodity suggests that better coordination, timeliness, efficiency and value of clinical and translational research tin be achieved by applying the set of principles, practices and methods represented by Lean and Six Sigma.

What is Lean?

Lean (also known as Lean Production, Lean Enterprise, and Lean Thinking) involves a fix of principles, practices and methods for designing, improving and managing processes. The development of Lean is attributed to Taiichi Ohno's articulation of the Toyota Production System.¹ Ohno aimed to better efficiency by eliminating particular kinds of waste material (called muda, in Japanese) which absorb fourth dimension and resources only do not add value. Examples include mistakes which need rectification, unneeded procedure steps, move of materials or people without a purpose, unnecessary waiting because upstream activeness was not delivered on fourth dimension, and the creation of appurtenances or services that are non actually needed past cease users.²

A Lean process reflects the goal of continually reducing waste material and improving work menses to efficiently produce a production or service that is perceived to be of high value to those who use it. Implementation of Lean involves systematic procedure cess and analysis. The preliminary stages of Lean assessment include "value stream mapping" in which central people, resources, activities and information flows required to deliver a product or service are made explicit and depicted graphically. The value stream map is a key tool for identifying opportunities to reduce waste product and more tightly integrate process steps, thus improving process efficiency.

Comeback approaches such as Lean and Six Sigma abound out of a long tradition of quality and process improvement efforts in manufacturing. For example, Frederick Winslow Taylor'due south scientific management and Frank Gilbreth's "time and motion" studies were among the earliest prescriptions for improving the quality and efficiency of product processes. Current thinking virtually process improvement draws heavily on the ideas of W. Edwards Deming, Joseph Juran and other statisticians whose information analysis tools and management philosophies were initially adopted past Japanese manufacturers, and take come to exist known as Total Quality Management (TQM) or Continuous Quality Comeback (CQI).^{three , four}

What is Six Sigma?

6 Sigma, like Lean, is a business management strategy used to better the quality and efficiency of operational processes. While Lean focuses on identifying means to streamline processes and reduce waste, Six Sigma aims predominantly to make processes more uniform and precise through the application of statistical methods.⁵ Six Sigma was originally developed by Bill Smith of Motorola in 1986 as a fashion of eliminating defects in manufacturing, where a defect is understood to exist a product or process that fails to come across customers' expectations and requirements. The name Six Sigma refers to a quality level defined every bit the near-perfect defect rate of 3.4 defects per million opportunities. As a process comeback strategy, Six Sigma gained much attention through its association with General Electrical and its onetime CEO Jack Welsh.

A variety of systematic methodologies for identifying, assessing and improving processes accept been developed equally part of the Six Sigma approach. The Half-dozen Sigma improvement model, Define, Measure, Analyze, Improve, and Command (DMAIC) specifies the following sequence of steps for understanding and improving a process: i) defining the project goals and customer (internal and external) requirements; 2) measuring the process to decide current performance; iii) analyzing and determining the root cause(south) of relevant defects; 4) improving the process past eliminating defect root causes, and 5) controlling future process performance. Another Half-dozen Sigma methodology, Design for Six Sigma (DFSS), is used to systematically design new products and services that encounter client expectations and can exist produced at Six Sigma quality levels.^six

Six Sigma likewise involves the preparation and certification of designated process specialists (called black belts, greenish belts, or other like titles) inside organizations to help guide Half dozen Sigma improvement efforts. Other distinctive Half dozen Sigma features include the expectation that process quality improvements be translated into financial metrics to assess value and the active interest of height direction in all Six Sigma initiatives.

Diverse combinations of Lean and Half dozen Sigma techniques take been developed, which frequently are described as Lean Half-dozen Sigma approaches. The composite approach points to the common process-centered and data-driven foundations of both Lean and Six-Sigma. Proponents of a combined arroyo assert that organizations can benefit from utilizing both the customer-orientation and focus on eliminating waste inherent in Lean forth with the statistical tools and systematic defect reduction strategies featured in Six Sigma.^{vii , 8}

Lean and Six Sigma are simply 2 of numerous approaches that are in use for systematically analyzing and improving process catamenia and efficiency within industries. Other similar approaches include Business Procedure Modeling (BPM), Business organisation Procedure Reengineering (BPR), and Workflow Mapping (WM), as well every bit a variety of TQM and CQI-oriented techniques such as management accounting systems, Kaizen, and Shewhart cycles (PDCA). The pick of a particular process improvement approach will depend upon the specific circumstances and needs existing in a working environment, including the type of processes, the improvement objectives, and the skills, noesis, and resources bachelor in that setting. For example, some approaches may b better suited to statistical analysis of defects (e.1000., Six Sigma), some to layout planning and production flow (east.k., BPM and WM), and some to optimizing transitions betwixt process steps (eastward.g., Lean). We chose to focus primarily on Lean and Half-dozen Sigma in this article because of literature suggesting their applicability to biomedical and research settings (reviewed below).

Awarding of Lean and Six Sigma to Health Care

Health care organizations, specially large health systems, began studying and adopting industrial quality management methods in the belatedly 1980'southward including TQM and CQI approaches^{ix - xi} Early applications focused primarily on establishing programs and infrastructure to mensurate quality and enhancing organizational culture surrounding quality issues.¹² Some hospitals used TQM methods to implement procedure improvements and redesign both non-clinical and clinical work flows.^xiii Examples of specific TQM interventions included the formation of cantankerous-disciplinary teams to examine and improve piece of work processes, training employees to identify quality improvement opportunities, and the utilise and application of statistical methods for process comeback.¹⁴

Nether the banner of TQM and CQI (hereafter we will use "TQM" every bit short-hand for both TQM and CQI) health care institutions began to evaluate and make changes to a variety of care practices. For example, selected service functions such as bones laboratory, pharmacy, admitting and discharge, medical records, housekeeping, and fabric support services were relocated to patient care areas to ameliorate organizational efficiency.^fifteen Applying TQM principles, hospitals restructured processes to brand intendance more patient focused. In one TQM application, the turnaround of radiology reports was improved by revising work flow to feature electronic signature by radiologists, elimination of a trainee signature requirement, accelerated transcription, structured reports, faster picture delivery to reading desks, and training about the importance of radiology reports for clinical decision making.¹⁶ Many health care organizations, inspired by TQM, established broader and more client-focused quality measurement systems including patient questionnaires, quality and ceremoniousness reviews, performance appraisals, patient monitoring reports, infection rate surveillance, and other quality-oriented metrics.¹⁷

Although TQM approaches became quite mutual in health care during the 1990s, many authorities expressed skepticism and reservations about the effectiveness of TQM and its ultimate effect on improving wellness care delivery and patient outcomes. Several critics characterized TQM as a vague and indistinct fad, with niggling tangible content.^{18 , 19} Shortell et al. (2000) found that whether or non a hospital adopted TQM had footling issue on multiple outcomes of intendance for patients receiving coronary avenue bypass graft surgery. ²⁰ Blumenthal and Kilo (1998) have summarized the shortcomings of early applications of TQM to health intendance quality comeback.²¹

Equally described by Black and Revere (2006), Lean and Six Sigma "emerged from the fertile environment" created past TQM.²² Contempo applications of Lean and Six Sigma in wellness intendance attempt to amend on previous experiences with TQM by making project deliverables more detached and measurable, retaining a strong customer (rather than organizational) focus, quantifying results, and attempting to deliver specific quality improvements within a designated time frame.

Since 2000, in that location have been a variety of projects applying Lean and Six Sigma strategies to wellness care quality improvement. For example, pilot programs utilizing Lean approaches at Intermountain Healthcare resulted in essentially reduced turnaround fourth dimension for pathologist reports from an anatomical pathology lab.²³ Other Lean-facilitated improvements at Intermountain Healthcare included reducing IV backlog in the pharmacy, reducing the time needed to perform glucose checks on patients, decreasing fourth dimension to enter new medication orders and consummate nautical chart entries, and streamlining electronic payment for large vendor accounts.²³

De Koning et al. (2006) describe several applications of an integrated Lean Six Sigma approach instituted at a Dutch hospital that led to reducing the complexity of hiring function-time clinical staff, optimizing operating room scheduling by designing a new pre-surgical admissions process, and developing a new work planning organisation to expedited completion of equipment maintenance requests.²⁴ The U.K.'s National Wellness System adopted a diverseness of Lean strategies, including redesigning the number of steps, and hence the time, needed for collection and processing of blood samples at Bolton Hospital.²⁵ Successful applications of Lean and Six Sigma have been reported at numerous other health care settings.^{26 - 31}

Application of Lean and Six Sigma to Laboratory Science

Lean and Six Sigma methodologies are well suited for application to laboratory settings considering of the inherent demand for statistical precision and quality command in laboratory testing and measurement activities, equally well equally the highly repetitive nature of laboratory piece of work. Most laboratory applications of Lean and Half-dozen Sigma take occurred in clinical environments. A recent review article past Gras and Phillippe (2007) describes many of these applications.³² Nevalainen et al. have advocated using a Six Sigma scale (based on six standard deviations in variance representing a defect rate of iii.4 per one,000,000 opportunities) as a fashion of tracking on laboratory quality, establishing benchmarks, and measuring changes in laboratory functioning over time.³³ Applications of Lean and Six Sigma in clinical laboratories have included efforts to reduce auto-verification errors in a laboratory data system,³⁴ ensure sufficient volume of blood samples for apply in a clinical microbiology laboratory,³⁵ assure the repeatability and reproducibility of warfarin anticoagulation testing among different laboratories within a customs,³⁶ and establish continuous and efficient work flow within a hospital-based histology lab.³⁷

In that location is substantially less research literature describing Lean and Half dozen Sigma applications in basic scientific discipline laboratories every bit compared to clinical laboratory settings. This difference may reflect the greater access to process improvement expertise available to clinical laboratories, equally these facilities are generally role of larger wellness care delivery systems. Nonetheless, Lean and 6 Sigma approaches are potentially applicative in both clinical and non-clinical laboratory settings. For example, Six Sigma techniques have been recommended as a means to avoid cross contamination of prison cell lines.³⁸ Hollensead et al. (2004) outline potential uses of Lean, Six Sigma, and other quality assurance practices to reduce laboratory errors in a host of disciplines including molecular biology, cytology, microbiology, and pathology.³⁹ Lean and 6 Sigma accept besides been directed towards quality assurance in pharmaceutical laboratories and production facilities.^twoscore

Quality and Process Comeback in Clinical & Translational Inquiry

The NIH'south Roadmap for Medical Enquiry calls for "re-engineering the clinical research enterprise." This initiative aims to develop new partnerships among organized patient communities, community-based wellness care providers, and academic researchers. The NIH envisions a clinical research process that becomes more efficient and constructive by improving linkages betwixt system components and meliorate integrating the continuum spanning basic science, clinical studies, and the uptake of new practices past medical practitioners and their patients. The NIH calls for "new and more efficient approaches to discovery and clinical validation of research results . . .[that will] . . . contribute to accelerating and strengthening clinical research by adopting a systematic infrastructure that will better serve the evolving field of scientific discovery."⁴¹

To reach its vision, the NIH in 2006 initiated a program of Clinical and Translational Science Awards (CTSA) for major medical research institutions throughout the United States.⁴² As of early on 2009, 38 sites accept been awarded CTSA funding. The NIH has charged the CTSA sites with 4 primary goals:1) to ameliorate the way biomedical inquiry is conducted across the country, 2) to reduce the time it takes for laboratory discoveries to get treatments for patients, 3) to engage communities in clinical research efforts, and 4) to railroad train the adjacent generation of clinical and translational researchers.

Underlying the NIH's Roadmap is the belief that the clinical research enterprise is not currently as efficient or coherent as it ought to be. The NIH has identified a variety of impediments plaguing the current research environment, particularly the lengthy timeframe needed for conducting research, testing approaches in patient populations, and getting effective approaches accustomed into clinical practice. The NIH hopes that establishment of the CTSA sites will address important problems, such as poor coordination between existing inquiry networks and lack of data sharing among researchers. The CTSA awards comprise funds for training of new researchers who will exist expected to piece of work collaboratively in a transdisciplinary surroundings that fosters new ideas and creates more than efficient processes for moving novel practices and technologies into the health care delivery setting.

The NIH's vision for the CTSA sites is clearly aligned with the objectives represented by Lean and Six Sigma approaches. These management strategies for process improvement, quality measurement, and reduction of errors and waste hold the potential for facilitating the transformation of the clinical and translational research enterprise envisioned by NIH. The residuum of this article volition depict the specific components of clinical and translational enquiry, as currently understood, and provide examples of ways in which Lean and Six Sigma methodologies can exist applied to help reach the specific goals of NIH's clinical and translational research program.

What is Clinical and Translational Research?

The NIH has defined clinical and translational science equally follows: "'Clinical Enquiry' comprises studies and trials in human subjects. Translational research includes ii areas of translation. One is the procedure of applying discoveries generated during research in the laboratory, and in preclinical studies, to the evolution of trials and studies in humans. The 2nd expanse of translation concerns research aimed at enhancing the adoption of best practices in the customs. Cost-effectiveness of prevention and handling strategies is also an of import part of translational science."⁴³

Several scholars have proposed conceptual models of clinical and translational research as consisting of multiple linked phases. The Establish of Medicine's Clinical Inquiry Roundtable, which met from 2000 to 2003, distinguished two types of translational research domains, designated as T1 and T2. The "bench to bedside" T1 enterprise is concerned with transferring the discoveries and advances of basic laboratory science to clinical testing in human subjects. The T2 sphere extends the results of clinical studies into everyday clinical exercise and health decision making.⁴⁴ Woolf (2008) has commented on the inherent ambiguity in calling both types of activity "translational research," and he has advocated a stronger governmental commitment to supporting T2 studies examining the uptake and use of new clinical intendance practices in customs-based settings.⁴⁵ Other researchers have recommended alternative nomenclature for describing these ii domains including preclinical research and discovery research for T1 studies and applied clinical inquiry and cognition translation for T2 studies.^{46 , 47}

Attributable to the complication of translational research and its continuum over a wide scope of activities bridging laboratory experiments, preclinical testing, clinical trials, knowledge transfer, adoption into accustomed clinical practice, and ultimately assessing the effects on individuals and communities, some authorities have recommended more finely detailed conceptual models of translational inquiry. Several theorists have adult translational research models with three or more stages.

Westfall et al. (2007), for example, have distinguished 3 domains of translational enquiry: T1, in which preclinical and fauna testing is shifted to homo subjects; T2, in which the results of initial testing in human being subjects migrates to patients, and T3, involving implementation and dissemination of research discoveries into accepted clinical practice.⁴⁸ Dougherty and Conway's (2008) model shares Westfall's formulation of a linear process bridging the boundaries of discovery to broad-scale implementation, with T1 representing demote to bedside inquiry, T2 designating clinical trials to test rubber and efficacy, and T3 involving transfer to practices settings and populations.⁴⁹ A iv-phase model has been proposed past Khoury et al. (2007) in which the T1 phase concerns transfer for laboratory to potential wellness application, the T2 phase from health awarding to testify-based guidelines, the T3 phase from guidelines to health care practise, and T4 from health care exercise to furnishings in individuals and populations.^l

The picture emerging of clinical and translational enquiry is that of a complicated multi-phase process involving numerous participants including laboratory scientists, researchers, clinicians, patients, academic institutions, external funding sources, health care organizations, manufacturers and suppliers of wellness care technologies, communities, and others. The end goal of clinical and translational science initiatives sponsored by NIH is to make this procedure more rationale, coordinated, efficient, cost-effective, and timely, with fewer impediments and less wasted effort. NIH'southward goal is to support integrated inquiry efforts across the broad spectrum of phases in order to advance the entire process and increase the likelihood that research will identify effective clinical treatments and practices.

Application of Lean and 6 Sigma to Clinical and Translational Inquiry

In that location is a clear correspondence betwixt NIH's vision of a more than integrated and efficient clinical and translational science enterprise and the process-focused strategies embodied by Lean and Half dozen Sigma. These direction strategies, imported from the industrial surround, can exist practical to help systemically clarify and improve the assortment of procedure steps involved in most clinical and translational research projects. The CTSA construction that NIH has adopted facilitates the selection and introduction of process direction techniques that can be practical to clinical and translation inquiry programs. Nosotros are not aware of whatsoever published articles to date describing Lean or Six Sigma approaches to redesign the clinical and translation inquiry enterprise at whatsoever of the CTSA sites. This is an opportunity that is waiting to exist tested.

A few applications of Lean and Half dozen Sigma techniques at other clinical and translational research sites have been reported. Ablowitz et al. (2008) draw a complex systems engineering assay of the translational enquiry process at the University of Virginia. In that analysis, the investigators adult and utilized a Translational Research Performance Index to quantify performance measures of translational research, such as the number of researchers in various cross-functional teams and the number of existing enquiry partnerships.⁵¹ Based on their assay, various "solution strategies" for enhancing the translational research process were proposed, including incentives to stimulate trans-departmental collaboration, blueprint recommendations for facility infrastructure, and the recruitment of a specialist in Lean/Six Sigma to undertake studies of boosted process changes.

Liu (2006) describes an application of Six Sigma methods to achieve a reduction of 70% in bike time for entry of case record forms in a phase III clinical trial, while maintaining a statistically acceptable mistake rate requirement.⁵² The procedure redesign involved such steps as implementing an optical mark technique to convert study data into optically recognizable binary characters for processing data directly into data direction systems without human intervention. Marti (2005) reported on an awarding of Lean Half-dozen Sigma in which the time needed to complete a phase 1 clinical trial was improved by redesigning standardized case tape forms, setting upward a dashboard organisation for monitoring key functioning indicators, and acquiring new hardware and software systems for reducing cycle time for data analysis.⁵³ Lean techniques have been applied to streamline the drug discovery procedure in the preclinical phase of research. For example, Lean techniques were used by a contract inquiry system to improve analysis turnaround times and reduce analysis outcome variance.⁵⁴ In another preclinical pharmacologic inquiry setting, Lean and Vi Sigma were used for redesigning laboratory layout to align better with workflows, grouping work by assay blazon, and repositioning equipment and instrumentation to exist in closer proximity to their eventual indicate of use.⁵⁵

The Centre for Clinical and Translation Science at The Ohio State University, a CTSA site, is planning to pursue various procedure improvement projects using Lean and Six Sigma methods. Some of the projects that are now beingness designed and initiated include:

• A process comeback study using Lean and Six Sigma techniques to review, assess, and improve the procedure for establishing clinical enquiry contracts between a sponsor (typically a pharmaceutical company) and the university's clinical enquiry middle. This process is often prolonged and burdensome owing to the need to develop appropriate disclosure agreements, arrange and conduct sponsor qualification visits, and develop the language and attain legal review for the clinical research contract.

• Studying the circuitous bug involved in transforming NIH'south former model of a "General Clinical Inquiry Heart" (GCRC) every bit a nexus for organizing and conducting clinical trials to the new paradigm of clinical and translational enquiry units. There are questions about whether the GCRC should exist retained as is, modified, or merged into the new "Center for Clinical and Translational Research" that was established at the university. A Lean analysis is being considered to examine these issues.

• A related process study is being designed to aggrandize a charge-back process for the clinical trials unit by which costs for different services volition exist compared (e.chiliad., overnight stays, multiple blood draws), with charges being applied and routed back to advisable cost units. Similar "accuse-back" processes are beingness considered for other services offered by the Center for Clinical and Translational Science including biostatistical support and services existence offered through biomedical informatics and their information warehouse.

• Vi Sigma and Lean methods are being used to investigate the process steps and issues involved in establishing reciprocal IRB agreements between affiliated bookish and non-academic research institutions. The goal is to enact a new "fast-runway" process to expedite the time needed to obtain terminal IRB approval.

• The review procedure for soliciting, evaluating, and awarding of pilot projection awards, clinical research traineeships, and test-bed projects for novel technologies will exist examined using Six Sigma and Lean techniques, with the goal of making the procedure quicker, more efficient, and fair.

• Faculty and doctoral students from the university's systems applied science department are conducting work flow assessments in the clinical trials unit in which acuity factors are calculated estimating the time required to perform specific functions and procedures. This will outcome in time simulations for optimal process period. Some changes have already been fabricated as the result of preliminary investigation, such as revising patient scheduling procedures.

Because the nature of clinical and translational inquiry activities varies considerably between the different research phases described previously (T1, T2, T3, T4), the application of process comeback strategies utilizing Lean and Vi Sigma tin can be expected to also differ amongst the research phases. Adopting a four-phase model of translational research based loosely on Khoury et al. (2007), information technology is possible to distinguish the general type of Lean and Six Sigma approaches that may be well-nigh relevant and applicable to each of the four research phases. Tabular array 1 details some of the specific practices associated with Lean and Six Sigma, and illustrates how applications of these two approaches could be relevant to each translational research phase.

Table ane

Examples of Lean and Six Sigma Strategies Applied to the Phases of Translational Research

Management Strategies	T1 Basic Laboratory Enquiry Animal Testing Pre-Clinical Testing	T2 Initial Application to Human being Subjects Clinical Trials	T3 Implementation Adoption in Clinical Practice Practise Guidelines	T4 Outcomes Assessment Dissemination Bear on on Populations
Lean
Determine "value" as defined  by CTR customers	Novel research ideas Qualified researchers	Research grant funding Protocol approval	Payer reimbursement Evidence-based handling	Positive efficacy results Findings published
Assess customer pull: need  for products and services	Advisable instrumentation Assistance with IRB	Biostatistical consultation Bailiwick recruitment	Treatment protocols EMR and IS adjustability	Outcomes measurement Health policy implications
Place and understand  procedure steps	Testing protocols Investigational new drug appl	Availability of pilot data Clinical trial protocol accepted	Postal service-marketing testing Inclusion in guideline	Follow upwards with patients Social network assay
Conduct value stream mapping  to evaluate work flow	Transfer of samples in lab Regulatory requests	Advertising for patients Informed consent	Distribution of guidelines Specific clinical preparation	Data acquisition methods Methods to de-place data
Eliminate waste product (steps that practice  not add value)	In vitro testing when possible Assure compounds bachelor	Minimize protocol subpoena Are placebos really needed	Unexplained variation in care Misuse of drugs & treatments	Appropriate sampling strategy Is pilot projection necessary
Integrate steps and test results  on efficiency and goals	Fast turnaround of tox. results Validation of assays	Strict patient monitoring Consider database recruitment	Quality balls program Doctor performance incentives	Research commission oversight Experienced PI
Six Sigma
Define project goals and  customer requirements	Employ advisable animal model Select best target agents	Select best endpoints Have qualified research team	Increment physician awareness Standardizing intendance	Appraise health status Improve patient compliance
Designate resource specialists  ("black belts")	Pharmacological expertise Bioinformatics capabilities	Bioethics/informed consent Clinical trial role	Clinical leaders in organization Specialists with care arroyo	Health economists Health services researchers
Measure the procedure to  make up one's mind current operation	Monitor side furnishings Analyze scheduling organisation	Treatment scheduling Statistical analysis of defects	EMR nautical chart review Communication with MCOs	Research team germination Patient cocky-reporting
Analyze and decide the  root causes of relevant defects	Identify reasons for compunction Inadequate number of samples	Inadequate enrollment patient safe jeopardized	Cooperation of nursing staff Incompatible IS systems	Depression response rates Inability to contact patients
Improving the process by  eliminating defect root causes	Ready new condom standards Replace defective instruments	Reasons for protocol deviation Early phase design errors	Improve patient education Strengthen clinical leadership	Utilise updated accurate data Ensure adequate sample sizes
Control future process  functioning	Ameliorate lab recording system Plant biological endpoints	Address disharmonize of interest Enhanced patient self-reports	Guideline review periodically Peer-review committee	Validated measurement tools Customs participation

Case Report

The following instance report provides an instance of how Lean and Six Sigma principles were used in a recent procedure comeback project involving redesign of the scheduling system at the Clinical Trials unit of measurement of the Ohio State University. Historically, scheduling of patients inside the unit of measurement was done using a conventional paper-based calendar organization. This led to inefficiencies in matching staff and room availability with protocol requirements and patient needs, as measured by utilization of staff and rooms equally well as patients waiting for their services to be completed. A process improvement project was undertaken to develop a more coherent and data-driven scheduling organization based on multiple factors and assisted by specialized computer software. The project began with efforts to clearly empathise each pace of the existing scheduling process. Next, the process improvement team began to consider different scheduling approaches that incorporated the salient factors identified as important for an efficient schedule. Using repeated comeback cycles, scheduling algorithms were tested in the field and evaluated. A key upshot of this endeavor was development and validation of an "vigil table" that assigns an acuity guess (in minutes per activity) for each of 89 specific activities. For example, the activity of "arterial line set-upwardly" was assigned an vigil score of 15 (minutes) and the activity of "simple specimen collection" was given an acuity score of 5. A scheduling algorithm matched the vigil scores with other factors (such as the number of available nurses per shift, room availability, number of protocols underway, visit sequence in the protocol, protocol requirements, etc.) to optimize both patient and staff scheduling on any detail solar day. By developing a computerized model based on this scheduling approach and then preparation staff to employ the model, the projection squad helped assure that the process comeback would be adopted equally the new way of scheduling patients. A diagrammatic depiction of the process steps analyzed and relevant factors considered are shown in Figure 1.

Example of a process improvement projection at a clinical trial unit of measurement using Lean techniques

This process improvement project illustrates many of the steps typically involved in Lean and Vi Sigma analyses. The analysis started with determining customer needs, systematically evaluating each process pace in particular, and and so identifying sources of inefficiency and waste material, while also assessing organizational structure, culture, and management. The analysis was informed by on-site observation and acquisition of process data, for example, relating to patient load, nurse staffing needs, and protocol requirements. This led to the development of proposed strategies to optimize the process. Subsequently repeated comeback cycles and field testing, the improved scheduling strategy was incorporated into an integrated calculator assisted scheduling arrangement. Training and related support procedures were developed to assure staff understood how to utilise the new system and to address any concerns they might have with the revised process.

Conclusion

The traditional biomedical enquiry model ofttimes features individual research projects that are merely loosely linked by discipline and performed in distinctly separate piece of work settings by specialized staff. Traditional research practices at clinical research centers too frequently suffer from poor coordination, inefficient use of resources, and crushing authoritative requirements. In that traditional model, there is considerable potential for process comeback. In manufacturing and business settings, the transformation of similarly disjointed and disconnected production processes has been enhanced significantly past the introduction of Lean and Six Sigma management strategies.

The NIH Roadmap envisions a new era of clinical and translational research characterized by expanded interconnection between preclinical discovery, clinical trials, and adoption of novel and constructive treatments into do. This new model demands that investigators piece of work outside their organizational boundaries in transdisciplinary teams with greater sensation of the circuitous intertwined relationships among basic laboratory science, preclinical testing, clinical trials, adoption into practice, and the ultimate furnishings on individuals and communities.

Information technology is naïve to believe that such a comprehensive view of biomedical research can be accomplished without systematic tools and conceptual models for planning, agreement, analyzing, and implementing the various processes required for constructive clinical and translational research. That is exactly the potential part that Lean and Six Sigma are intended to serve. Those methodologies have been developed and honed in the equally complex environment of manufacturing and systems engineering, where quality, precision, and customer uptake are equally critical to overall project success as they are in biomedical research. The rational for the institution of CTSA sites is rooted in the aforementioned underlying philosophies of lean product, customer orientation, toll effectiveness, and procedure efficiency.

It is of import to notation that mere application of Lean or Vi Sigma techniques is generally not, in itself, sufficient to ensure a successful process improvement project. Achieving improve efficiency and procedure flow also requires a receptive organizational climate, active management support and engagement, sufficient financial and other resources, and articulate communications channels inside the organization about the process alter. Equally pointed out by Deming and other management theorists, implementing a truly transformative alter takes time and shifts in organizational beliefs that establish a foundation for process improvements to be accepted and fully integrated into the organization's routine operations and expectations.^{55 , 56} Recognizing the importance of the "softer side" of organizational behavior in process change is a critical component for making a Lean or Six Sigma project succeed.

In this article, we have attempted to illustrate how high-level Lean and Six Sigma principles tin be applied to clinical and translational research. The value of these approaches, ultimately, will exist measured by whether new and effective treatments become widely used and population health is improved as a result. We look that within the next two years, the first results of initial applications of these techniques in clinical and translational research will be attained. The results will be of groovy importance, not only to the NIH, but also to the long-term sustainability of America'southward biomedical research enterprise.

Acknowledgments

The projection described was supported by Laurels Number UL1-RR025755 from the National Center For Research Resource. The content is solely the responsibility of the authors and does not necessarily stand for the official views of the National Heart For Research Resources or the National Institutes of Health..

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2835466/

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