Requisites and Best Practices in the Implementation of Lean Principles Applied to Hospital Quality Improvement Initiatives

Since the 1980s there has been an explosion in the use of formalized methodologies for increasing quality and efficiency. Methods outlined by philosophies such as Total Quality Management (TQM), Six Sigma, Lean, and ISO 9001 have yielded great returns in the manufacturing environment. These techniques have proven successful in reducing costs, increasing production, and improving quality in both manufacturing and service environments. After several generations of exposure to similar yet distinct philosophies of quality management, several hybrid methodologies have arisen to leverage the strength of two or more systems simultaneously (Dahlgaard and Dahlgaard-Park, 2006; Karthi et al., 2011). Since health care has become an area of continued attention in the pursuit of reducing government waste, it is a natural candidate for the application of the systematic and data driven techniques defined by TQM, Six Sigma, Lean, and ISO 9001 philosophies. The nature of healthcare as a service necessary for wellbeing, the presence of 3 party payers, and the non-employee relationship between hospitals and healthcare providers contribute to presenting unique challenges when implementing quality improvement initiatives. This paper performs a literature review of the relationship between quality management practices and their effects on quality outcomes focusing on the unique challenges to implementing quality improvement initiatives in a healthcare setting. An approach is suggested using elements of TQM to create a standardized management structure and organizational focus (Irani et al., 2004; Taveira et al., 2003), lean to identify waste, six sigma to reduce redundancy and monitor processes so that small tests of change can be effectively monitored via the Plan Do Check Act (PDCA) cycle, and ISO 9001 to ensure that monitored processes are documented and enforced. Previous studies have shown Baldrige Award (for Performance Excellence) winning hospitals to have better patient safety records than similar hospitals that have not won the Baldrige Award (Denney et al., 2009; Foster, 2011). We continue this investigation by comparing patient safety in hospitals that choose DNV accreditation to hospitals that choose another accrediting body. The DNV hospital accreditation organization “seamlessly introduces ISO 9001 quality methods into the hospital setting.” If the assumption is made that hospitals focused on standardization and process oriented quality improvement initiatives would choose the accreditation agency most closely aligned with its quality improvement philosophy, then DNV accredited hospitals would represent a more process-oriented population than their peers. This paper investigates whether a hospital’s investment in a formalized methodology of quality improvement translates into better performance on select AHRQ and SCIP measures of patient safety, patient satisfaction via the HCAPS survey, readmission rates for select conditions, and hospital acquired conditions by comparing DNV accredited to non-DNV accredited hospitals. Background Many cite the inception of total quality management with a specific publication such as ‘The Principles of Scientific Management’ by Frederick W. Taylor In 1911. Others would only include later more comprehensive works such as those developed in the 40s by Americans such as Deming, Juran and Feigenbaum using Japan as a laboratory and proving ground for their ideas. Still others would only consider incarnations of these principles arising from modern organizations present in the current market valid, such as the Six Sigma system developed by Motorola in the 1980s. The 1990s brought the Lean methodology stemming from the Toyota total production system, where even human intervention was pushed through the sieve of waste reduction. This paper seeks to bring the goal and tacit knowledge of each method under common roof referred collectively as Process-oriented quality management (PQM) . The principles underlying each of these techniques represent objective fundamentals in the goal of maximizing the ratio of reward to effort. The progression and refinement of explicit knowledge in these areas is not representative of competing philosophies, but rather a hill climbing toward a global maxima in fitting specific techniques to a hidden and highly dimensional ideal. For this reason, the management architectures discussed below are not considered distinct or even milestones, but rather a progression along a gradient with each of the methods having highly overlapping borders with the others. In this way PQM begins with the perfecting of the hand axe by Paleolithic man, progresses through the industrial revolution, and comes of age in the modern incarnation of precise analysis and disambiguation. Any system of quality management is implemented via the acquisition, acceptance, and dispersion of knowledge. At the core of successful business implementations of quality management philosophies are individuals with a common understanding, vocabulary, and motivation to effect change in their organization. Before the efficacy of a methodology can be evaluated, there must be a reductionist elucidation of the functional components that fall under a common moniker. We investigate TQM, LEAN, SIX SIGMA, and ISO9001 with the goal of understanding explicit knowledge of the practices and tools used in their implementation. Since adaptation of specific cases and generalization is needed for philosophies underlying the tools and methods to be applied across companies and industries with distinct cultural, economic, and organizational makeup, tacit knowledge is also addressed with the goal of providing a generalized framework for the application in the healthcare industry. Proponents of differing schools of quality management, often fueled by consulting firms specializing in one philosophy or another, often cite the differences in quality management regimens in order to bolster the results of the training or certification they have to offer over competing schools of thought. This out with the old in with the new sales pitch has left many who have been present for more than one quality paradigm shift with the feeling of being sold the “same old wine in new bottles” Since there is often a financial incentive to portray the system of guiding principles, techniques, and tools as being unique and novel, there is a force internal or external of company management to buy in whole heartedly to a single program. This paper views the common goals of customer focused reduction of waste through consistent executive and managerial goals by focusing on processes and implementing standardization and measurement to be the result of using a synthesis of PQM methods. TQM: The Primary strength of TQM is in the mature management structure developed by soliciting data and feedback from front line personnel. Successful implementation of a quality improvement initiative requires buy in from the top executive layer to provide the necessary human and capital resource. In fact, executive buy-in has been shown to significantly correlate with outcome measures of hospital performance in the Italian health system (Macinati, 2008). According Hayes (2007) “executive engagement is one of the most critical factors for Six Sigma to succeed.” There should also be substantial acceptance and contribution from the front line staff. This coherence of mission is fostered under TQM by setting “Core Values” that represent the shared observations and tacit knowledge of all levels in the corporation. TQM makes the assumption that employees want to do a good job, and will seek to find ways to better service the customer if they are empowered to do so. In TQM management feedback is solicited from those closest to the process. The involvement front line staff in quality improvement initiative decision making ensures that there is a homogonous dedication to the patient. The lack of such involvement can lead to the view that quality improvement is being forced upon staff by administrators that are out of touch with the reality of day to day operations. This can lead to poor staff compliance. The original 14 points made by Deming are summarized below. The 14 points. Summarized by the Edward Deming institute http://deming.org below 1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs. 2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change. 3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. 4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust. 5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs. 6. Institute training on the job. 7. Institute leadership (see Point 12 and Ch. 8). The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers. 8. Drive out fear, so that everyone may work effectively for the company (see Ch. 3). 9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service. 10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force. Eliminate work standards (quotas) on the factory floor. Substitute leadership. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership. 11. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality. 12. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective (see Ch. 3). 13. Institute a vigorous program of education and self-improvement. 14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job. Six Sigma Six Sigma seeks to bring about process change by focusing on the reduction of variation and redundancy. The goal of achieving a six standard deviation between the mean and the control limit is accomplished by making sure the process is performed the same way every time and that a steady flow of raw material or input information is supplied. In this way, the standard deviation is dramatically reduced allowing for scientific measurements to be observed. Testing the effects of change on a chaotic system do not yield meaningful results, Six Sigma empowers Deming’s plan do check act (PDCA) cycle with a standardized process that will react in a controlled way to change. These changes are monitored with simple statistical display tools such as the family of statistical process control charts (SPC). Six Sigma utilizes specially trained embedded personal certified to apply statistical techniques to process improvement. Summarized roles can be found below (Six Sigma Roles and Responsibilities WWW.Isixsigma.com)  Sponsor: Senior executive who sponsors the overall Six Sigma initiative.  Leader: Senior-level executive who is responsible for implementing Six Sigma within the business.  Champion: Middleor senior-level executive who sponsors a specific Six Sigma project, ensuring that resources are available and cross-functional issues are resolved.  Black Belt : Full-time professional who acts as a team leader on Six Sigma projects. Typically has four to five weeks of classroom training in methods, statistical tools and sometimes team skills.  Master Black Belt : Highly experienced and successful Black Belt who has managed several projects and is an expert in Six Sigma methods/tools. Responsible for coaching/mentoring/training Black Belts and for helping the Six Sigma leader and Champions keep the initiative on track.  Green Belt : Part-time professional who participates on a Black Belt project team or leads smaller projects. Typically has two weeks of classroom training in methods and basic statistical tools.  Team Member : Professional who has general awareness of Six Sigma (through no formal training) and who brings relevant experience or expertise to a particular project.  Process Owner : Professional responsible for the business process that is the target of a Six Sigma project. Lean Research shows that failure to recognize the overhead associated with quality improvement is a major barrier to successful quality improvement (Macinati, 2008). In the case of healthcare, strict rules surrounding data use and collection as well as the presence of large volumes of narrative and non-coded nominal data present significant overhead in providing feedback and analysis. Lean can be leveraged to free up resource that would normally be spent on wasteful tasks like unnecessary or redundant processing, waiting, or moving between distant work stations. The time saved due to reduced waste can be used to off-set the overhead incurred by quality improvement data acquisition and logging. The 7 wastes (Muda) eliminated by lean are 1. Defects: such as medication errors, wrong site surgery, miscoding, Pressure Ulcers 2. Over-production: Un-necessary lab work, duplicate charting, overly lengthy standards of care 3. Waiting: Lab work lead times, Patients waiting for imagery, nursing care bottlenecks 4. Confusion: No standard operating procedure, multiple conflicting standards of care, unnecessary variation, ambiguous orders 5. Transporting: Medications not located on the unit, Lack of electronic imagery, no central medical group building. 6. Inventory: Excess Bedding, More patient rooms than needed, expired meds 7. Motion: Lack of patient lifts, lack of bedside instruments, no in-room medications 8. Excess Processing: redundant charting, manual data abstraction, multiple disparate computer systems Integration of TQM, Lean, Six Sigma, ISO 9001: Companies embracing differing quality strategies leverage unequally the strengths of the chosen method. Fundamental tradeoffs do exist, such as the tradeoff between specificity and the degree to which a solution can be generalized as it manifests in interdepartmental standards. This is also the case with the implementation of one PQM strategy over another. There exist fundamental tradeoffs in the ability to standardize, prioritize, and document the flow of work which results in greater throughput via smooth queuing and the nimble efficiency gains that result from disruptive innovation. A solution to quality management utilizing the strengths of several systems is suggested below in figure 1. Figure 1. A suggested model for healthcare quality Improvement.