Can Six Sigma Methods Meet the Demanding Rigors of Local Public Health Practices?

Introduction
It has been said by many that quality drives innovation and vice-versa. This is evidenced by the growing literature on the utilization of Six Sigma methodology within health care institutions (7, 6, and 9). In contrast, the local public health community may have been slow to respond to innovative quality methods often utilized by the private sector, due to a barrage of legal and ethical considerations regarding the distinction between the actual practice and research. As medical communities begin to confront quality improvement with increased vigor, so should the public health community. This study will examine the difference between public health practice and research; and why it may be appropriate for local health departments to embrace Six Sigma methodology in their respective operations.

The Dilemma of Public Health Practice
Public health refers to the organized efforts of society, both government and others, to assure the population’s health (12). Local public health practice is quite complex. Understanding the difference between public health practice and research has perplexed the local public health community for years. Local (in the context of this article) will be defined as relating to a city, town or distinct rather than larger area. What drives this unique distinction, are primarily three features: Common Rule, Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the Tenth Ammendment. Common Rule refers to how the federal government interprets the utilization of human subject research. HIPAA another federal mandate protects how the use and privacy of health information. “The provision of public health services in the United States has its basis in the U.S. Constitution 11 (p22).” What this means, is that ultimately, states have the primary responsibility of protecting its public health and the Tenth Amendment allows states to exercise this broad and extensive power. Further, as states define their scope and definition of public health. The comprehensive “Model State Public Health Act” (11, 4) recently completed the “Turning Point Statutory Modernization Collaborative” (11, 4) which continues to build a universal definition of public health. As a result, local public health practice refers to protecting the public’s health in a city or town. Local public health officials have questioned whether a certain activity may be defined as research or activity, but this is where states have influence on determining what is a public health activity or research. Further, discerning what “identifiable” health information is, has plagued many local health offices as it relates to determining appropriate funding sources. This vague statement encompasses a great deal of activity. Epidemiological investigations, surveillance, programmatic evaluations and clinical care for the populations; are the primary endeavors that comprise public health practice (11).

As public health issues offer more complexity in the 21st century, it may behoove the public health community to further enhance their toolbox, with more efficient methods to manage internal and external operations. As the medical community continues to embrace Six Sigma: Can Six Sigma meet the demanding rigors of the public health community at the local level?

What Six Sigma Means?
In 1988, Motorola Corporation became one of the first companies to receive the Malcolm Baldrige National Quality Award (16). The award strives to identify those excellent firms that are worthy role models for other businesses. One of Motorola’s innovations that attracted a great deal of attention was its Six Sigma program. One of Motorola’s most significant contributions was to change the discussion of quality from one where quality levels were measured in percentages (parts per hundred) to a discussion of (parts per million) or even (parts per billion). Motorola correctly pointed out that modern technology was so complex that old ideas about acceptable quality levels were no longer acceptable (16, 13, and 10).
Six Sigma means a measure of quality that strives for near perfection (13). Six Sigma is data driven approach and methodology for eliminating defects. Six Sigma is utilized in manufacturing to transactional products and services. In particular, Six Sigma quantifies how a particular process is performing (driving towards six standard deviations between the mean and the nearest specification limit). Quality improvement continues to be an important ingredient in the medial and public health communities.
Six Sigma and Medical Care
Recently, several studies (15, 5, and 18) have cited quality concerns in health care in the United States. As a result, health care organizations began to increase their efforts on quality improvement, by aligning improvement goals with mission and vision statements of respective organizations. In order to do this, a number of quality improvement processes had to be established, implemented and monitored (particularly in medical institutions) to accommodate this lofty goal and consequently, Six Sigma gained traction nationwide. Considering that Six Sigma methods evolve around how defects impact a process; one may consider how a defect should be defined in public health practice? Particularly, on the local level. In general, a defect may be described as anything that results in customer dissatisfaction (9). Furthermore, would the Six Sigma process be the same for eliminating a defect in a public health practice or process compared with other industries? Based on available research, the answer may be yes (9, 2).
Considering the Centers for Disease Control (CDC) has been at the forefront of providing training and resources to the state and local levels. Hence, is Six Sigma transferable to public health, knowing the legal and operational constraints of the local public health community? In this particular case, looking to the CDC for additional guidance in which processes can be considered eligible for Six Sigma by referencing the National Pubic Health Performance Standards Program (NPHPSP) is a start in the right direction.
The purpose of this program is to provide information and resources concerning performance and systems improvement. Performance improvement is a critical piece of NPHPSP mission statement. “Performance improvement can be achieved through the practice of “performance management.” As defined by the Turning Point Performance Management Collaborative, performance management is the practice of actively using performance data to improve the public’s health. This practice involves the strategic use of performance measures and standards to establish performance targets and goals, to prioritize and allocate resources, to inform managers about needed adjustments or changes in policy or program directions to meet goals, to frame reports on the success in meeting performance goals, and to improve the quality of public health practice (2, 3).” Moreover, The Office of Chief of Public Health Practice (OSEIP) has created four additional offices that support public health practice. State and Local Public Health Agency Accreditation, co-funded by the Robert Wood Johnson Foundation recently completed a 14-month effort to explore the components of a model voluntary national accreditation system. It was determined that The Steering Committee reached a consensus decision in August 2006 that a national voluntary accreditation program for state and local public health departments is both feasible and desirable, and that implementation should proceed (2).
In this spirit, it seems reasonable to assume, until national reform is taken more seriously of the standardizing local public health practice, questions will remain concerning the distinction with public health research and practice. Until then, quality assurance should not take a back seat in public health and local agencies must be increasingly proactive.

What Is Public Health Practice at the Local Level?
“Public health practice involves the application of proven methods to monitor health status of the community, investigate unusual occurrences of diseases or other conditions, and implement preventive control measures based on current understanding within public health sciences 11 (p20). “ At the state and local levels, public health practice activities are not delegated to Institute Review Boards (IRB), due to a robust and transparent process that manages local public health officials. For example, the State of New Jersey Department of Health and Senior Services adopted “Practice Standard of Performance for Local Board of Health in New Jersey (14). The goal of these practice standards was to modernize New Jersey’s local public health system. This lofty goal would take a number of years to accomplish. Questions to consider in this multi-year endeavor as it related to Six Sigma methods:
• Are the most “current” practice and service delivery models being utilized or proposed?
• From an assessment approach, how does existing work flows measure up to this new endeavor?
• How thorough is the project management lifecycle process in local public health?
• From a quality assurance approach, can new methods be introduced, embraced and maintained?

Six Sigma Methods Can Complement Local Public Health Practices
Six Sigma provides the framework to ask the right questions, depending on the process and desired outcome. Understanding the power of how a defect affects a process, operation or practice is critical to the success with any Six Sigma initiative. In public health practice, defects can refer to birth, genetics or topological. But the scope of the defects would have to be expanded in public health practice to meet operational standards. Public health practice, (particularly public health program development, analysis and oversight functions) may be enhanced with Six Sigma sub methodologies such as Define, Measure, Analyze, Implement, Control (DMAIC) or Design for Six Sigma (DFSS). DMAIC (Figure I) is an improvement system for existing processes that may fall below specification. “Existing” public health practice processes that may benefit from Six Sigma include:
• General administration (reducing the “lifecycle” of repetitive processes)
• Understanding risk and burden in local public health practice standards*
• Development of strategies to master core public health competencies*

*Proposed process can also be considered a new process, if not established. In that event, DFSS methods (Figure II or III) would apply.

Each of these processes has the potential of being broken down further by utilizing DMAIC Methodology. Six Sigma methods share similarities with other evidence (quantitative) based projects: Specifically, the measure and analysis functionality of DMAIC Methodology. These particular caveats of DFSS not only support the quantitative scrutiny that is already recognized in public health. This systemized approach also complements and also challenges current paradigm which relate to the development of public health practice operations and procedures. DMAIC may also be crucial when local health departments perform statewide roll-outs that may synchronize with Department of Health and Human Services (DHHS) initiatives. The redesign feature in DMAIC (Figures I & II) also affords project teams to re-evaluate root cause analysis and implement alternative solutions during the lifecycle.

Figure I (The DMAIC Methodology)
The DMAIC Methodology
Improvement teams use the DMAIC methodology to root out and eliminate the causes of defects:
D Define a problem or improvement opportunity.
M Measure process performance.
A Analyze the process to determine the root causes of poor performance; determine whether the process can be improved or should be redesigned.
I Improve the process by attacking root causes.
C Control the improved process to hold the gains.
Permission from ASQ to reproduce. © Copyright 2007

Figure II (DFSS Methodology)
DFSS Analyze (Finding the Balance)
Voice of the Customer Voice of the Business
Functionality delivered* Size delivered*
Value characterization* Value Characterization*
Lead time Schedule compression*
Cost* Cost*
Quality* Warranty cost
Usability* Risk*
*DFSS attributes applicable to local public health offices when designing new product or process.
Permission from Six Sigma Advantage to reproduce. © Copyright 2003

Figure III (Innovation Model based on DFSS Methodology)

Permission from Strategyn to reproduce. © Copyright 2007

DFSS (Figure II) is the acronym for Design for Six Sigma. Unlike the DMAIC methodology (Figure I), the phases or steps of DFSS are not universally recognized or defined — almost every company or training organization will define DFSS differently. Many times a company will implement DFSS to suit their business, industry and culture; other times they will implement the version of DFSS used by the consulting company assisting in the deployment. Because of this, DFSS is more of an approach than a defined methodology.
DFSS is used to design or re-design a product or service from the ground up. The expected process Sigma level for a DFSS product or service is at least 4.5 (no more than approximately 1 defect per thousand opportunities), but can be 6 Sigma or higher depending the product. Producing such a low defect level from product or service launch means that customer expectations and needs-critical to quality (CTQ) must be completely understood before a design can be completed and implemented. Examples of “new” public health practice processes for DFSS:
• Establishing a work flow process for funding sources which relate to public health practices
• Application of the HIPAA Privacy Rule to “identifiable” health information and prospective public health practices standardized database
• Establishment of performance instruments for local partners in regards leveraging resources on collaborative projects

Conclusion
The premise of this study was to explain the distinction between research and practice; along with incorporating Six Sigma methods in local practice. What is important to realize, is that Six Sigma can complement existing research methods often used in public health practice. For example, effective public health practice projects may comprise selection bias, confounders, data collection method and blinding. Six Sigma sub applications of DMAIC and DFSS: share a commonality with these research methods, particularly with data collection methods.

As the public health community moves closer to clarifying the distinction between research and practice, it will be easier for local departments to implements new methods into their operations like Six Sigma. Consequently, understanding how a defect should be defined in public health practice and the implications of eliminating these defects (if appropriate) will allow for local departments to realize the full potential of Six Sigma. Incidentally, this would be further reason for dialogue.

Local public health practice has a great deal to gain in terms of the application of Six Sigma methodology and the sub applications of DMAIC and DFSS. With these benefits, there are also consequences of the implementation of new methods like Six Sigma. If Six Sigma is not embraced and supported by those at the executive level, the magnitude of failure in a new environment is possible. Scarce resources and (limited) manpower are ingredients that seem to motivate Six Sigma initiatives to thrive (if launched and managed correctly). Especially, in a challenging environment such as a local public health practice. The National Public Health Performance Standards Program and the State and Local Public Health Accreditation Agency could be the vehicles to initiate Six Sigma dialogue at the local level.

Not addressing the culture within local public health communities was one of the primary limitations of this study as it relates to incorporating Six Sigma methods. Local agencies are confronted with significant challenges. Among these challenges, is the privatization of some public health activities. The outcome of this privatization has created some tension in some local public health departments across the country. This is often the challenge of introducing a new innovation. Perhaps, future studies could further examine privatization effect of local health departments and the possible relationship to quality assurance. Other challenges may include; how to acquire the methodology, cost benefit analysis, training and the actual effects that Six Sigma may have on the operational bottom line.

References
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3. Centers for Disease Control and Prevention. National Public Health Performance Standards Program. Available at http://www.cdc.gov/od/ocphp/nphpsp/ Accessed on February 14, 2007.

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13.Six Sigma. Six Sigma-What is Six Sigma? Available at http://www.iSix Sigma.com Accessed on February 12, 2007.

14. New Jersey Department of Health and Senior Services. 2003. Practice Standards of Performance for Local Boards of Health in New Jersey. Adopted February 18, 2003.

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