Using Six Sigma to Improve Clinical Quality and Outcomes

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By Mark Van Kooy and Carolyn Pexton

Appropriately implemented, Six Sigma clearly produces benefits in terms of better operational efficiency, cost effectiveness and higher process quality. Perhaps less obvious -- and until recently less documented -- is the impact it can make in clinical areas such as infection control and medication delivery.

Clinicians are often receptive to Six Sigma given its familiar scientific and evidence-based foundation-adherents, however, must acknowledge the unique nature of patient care delivery requiring some translation of the methodology from manufacturing to medicine.

Defining Healthcare Quality and the Need for Improvement
Quality in healthcare has come to mean many things to many stakeholders -- from satisfaction with service to the clinical outcome of the patient's treatment. The most widely accepted definition was stated by the Institute of Medicine in the publication Medicare: A Strategy for Quality Assurance. The IOM defined quality of care as "the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge." The terminology is carefully chosen to include all points along the continuum of care. The IOM also identified three basic quality-of-care issues in medicine: overuse, underuse and misuse.

Defects in any business carry an associated expense, but medical errors also carry significant human costs. And the IOM report estimates that medical errors cost the nation approximately $37.6 billion each year, with roughly $17 billion of those costs associated with preventable errors.

For a multitude of reasons, improving healthcare quality is paramount. Communities today are not only demanding access to the best technology and treatment available, but also assurances that medical encounters will be both safe and effective. In this competitive, quality-driven and cost-conscious environment, one of the most effective solutions healthcare professionals have found has been the adoption of Six Sigma methodology and related change management techniques.

The Importance of Acceptance Often augmenting the basic framework of Six Sigma are change management techniques such as CAP (Change Acceleration Process) and Work-OutTM. Such techniques allow project teams and leaders to focus not only on the evidence indicated by the data, but also on the need to address cultural issues and build acceptance for change among a diverse group of constituents.

Mounting evidence illustrates that using Six Sigma to design and refine patient care processes eliminates the need to retrace steps, correct reporting errors, re-do examinations or re-schedule appointments. Such redundancies and waste are costly both in financial terms as well as discomfort and dissatisfaction to the patient.

A Better Approach
The use of statistical tools to measure and improve quality is not a new concept and certainly not exclusive to Six Sigma. Other quality initiatives, such as TQM (Total Quality Management) or CQI (Continuous Quality Improvement) also involve the use of statistics and data collection.

The edge that Six Sigma seems to enjoy, and the distinction the methodology has achieved can be attributed to several differentiating factors, in that it:

• Instills a common language and shared techniques
• Demands and provides a rigorous control mechanism
• Requires leadership support while driven by those closest to the process
• Targets process variability instead of aiming at averages
• Supports and aligns with organizational vision and strategy

Since people feel variability more than averages, Six Sigma focuses first on reducing process variation and then on improving the capability of that process. A logical healthcare example can be found in patient wait time. If a patient waits to be seen by the doctor 5 minutes one time and 50 minutes the next, they won't base their satisfaction level on the average of the two wait times, but the impact of the wide variability and corollary unpredictability of the process.

During initial phases, a key step involves scoping a project into manageable and measurable segments. For instance, a large-scale effort to improve the emergency department may break down into several smaller projects targeting specific areas such as admissions, charting, equipment availability and patients leaving without being seen (LWBS). Tackling all areas at once could make the initiative seem overwhelming and the obstacles to change insurmountable.

Once a project is selected, the contributing factors must be prioritized. Rather than viewing all factors as equal, it's important to identify and address critical to quality elements that drive the most variability or defects. In other words, although 15 potential causal factors could impact the safe, timely and appropriate delivery of medication, it may be determined that only three of those factors are responsible for 75% of the errors or defects. Concentrating on the critical few versus the trivial many will yield more significant results in a shorter timeframe.

Examples of Clinical Six Sigma Projects
The following offers a brief look at projects targeting patient safety, medical error reduction, clinical process improvement, patient satisfaction and outcomes.

Project #1: Addressing Chemotherapy Medication Errors Provider: Virtua Health, Marlton, New Jersey Note: This is a project in progress. The team is currently at the Analyze Phase. Project Goals: Reduce number of chemotherapy errors system wide Improve documentation of chemotherapy administration Reduce waste in product and time in chemotherapy administration Improve patient satisfaction with chemotherapy experience Improve bed flow for patients receiving chemotherapy Project Scoping Finds: Error reporting has increased as project brings visibility to the process There was no standard definition of an error. The team agreed that an error is any defect in the process that, if not detected, would lead to an error reaching the patient Anticipated Solutions: Develop standard process for chemotherapy administration Develop standardized order form and guidelines for chemotherapy use (completed) Develop standard operating procedure for communication between nursing units, physician practices and pharmacy Develop data collection process to identify and track medication errors using the above definition Anticipated Results: Possible increased productivity by improved bed flow and reduced process steps for chemotherapy administration Improved quality and patient satisfaction

Project #2: Defining 'Captain of the Ship' to Raise Quality and Patient Satisfaction Provider: Charleston Area Medical Center Project Goal: Ensure there is a physician identified to manage each patient's care Improve patient and family satisfaction regarding communication and coordination of patient care Project Scoping Finds: The need to redesign the care coordination process to promote the right care in the right setting and as a result reduce losses Improve non-progressive End of Life Care Solutions: Revised medical staff rules and regulations regarding the role of the attending and consulting physicians Established pre-scheduled conferences with attending and family on complex patients soon after admission to clarify "Who is in Charge" Improved process in identifying the patient's Advanced Medical Directives Results: Improved patient satisfaction and quality of care Total savings from Captain of the Ship Project: $790,000 Patient Satisfaction: $240,000 Care Coordination: $190,000 End of Life Care: $360,000

Project #3: Reducing Bloodstream Infections (BSIs) in one SICU Provider: Yale-New Haven Hospital Project Goal: Improve current operating metrics to meet CDC standards for catheter days between bloodstream infections Project Scoping Finds: Historical data consisted of the count of BSI's Input from SICU staff used to understand how catheter inspections and replacements were performed CAP and Work-OutTM contributed significantly to success, since staff and clinical teams developed process to improve infection rates Solutions: Created and implemented a barrier precautions 'kit' Developed standard operating procedures for dressing change and incorporated the new SOPs into educational videos Improved process for colonization of catheter tips Used control charts to monitor progress Results: Decreased LOS for selected patients Increased ICU capacity Project won a Hospital System quality award on basis of importance, interdisciplinary approach, and success Financial Potential ~ $450,000 over one year (savings in medical supplies, medication, bed availability and labor)

Project #4: Improving Infertility Rates Provider: Women and Infants Hospital Project Goal: Improve "take home baby" rates for infertility patients Project Scoping Finds: Obtained and/or collected data on possible factors Tested potential X's for significance in univariate analysis using Chi Square, then placed them into a logistic regression analysis to build a model describing the relationship between the probability of achieving a pregnancy and the "X's" Identified a modifiable critical X -- which physician performed the embryo transfer procedure Solutions: Developed standard operating procedures -- this reduced variation and raised overall pregnancy rates Results: Achieved a 24% increase in pregnancy rate (p=0.04) and a 46% (p<0.0001) increase in implantation rate Variation among implantation rates shrank dramatically, and has remained low, suggesting interventions in standardization and optimization of the embryo transfer procedure played an important role in the overall change

Summary: Confronting Barriers and Identifying Keys to Using Six Sigma for Clinical Improvement
Six Sigma is scalable to organizations of every size and demography and as the results above illustrate, it can be effectively applied to many areas and issues in healthcare, addressing clinical as well as operational challenges.

Data collection: One obstacle in bringing Six Sigma to healthcare has been the ability to collect the right data, due to insufficient IT infrastructures and a shortage of resources. Providers are often data-rich, but information poor -- lacking the ability to effectively analyze the data they have. Many processes that have been automated in other industries remain manual in healthcare. Such shortcomings must be addressed to achieve system-wide clinical quality improvement.

Medical error reporting: Given a litigious and punitive climate, providers are understandably hesitant to report medical errors. Peer protection and internal hierarchies also obscure such data and radical reformation is not impending. Some organizations, however, are moving away from a culture of blame and shifting the focus from the person to the process. Some have anonymous hotlines, and others use electronic programs at each nursing station to capture events as they occur without necessarily assigning individual responsibility.

Organizational Alignment: To produce positive, cumulative effects on the well-being of a community, Six Sigma projects must also align with the organization's mission and business imperatives. Leaders must be sure that a bloodstream infection project, for example, supports the hospital's mission for better patient safety. Establishing an equitable and harmonic balance across the organization is imperative. Projects should be weighed for their potential impact on other departments, using control measurements to ensure ongoing equilibrium in clinical quality, cost effectiveness, patient satisfaction and other key indicators.

Healthcare is still in the early stages of evolution with regard to Six Sigma. Clinicians should seek professional guidance for training and implementation, but must also rely on their own expertise to further extend the approach into true clinical applications. The horizon is nearly limitless…lessons learned through the successful execution of simpler projects will enable practitioners to tackle tougher initiatives in the future and create clinical change on a broad scale.

About The Authors
Mark Van Kooy, MD, Master Black Belt, Virtua Health
Carolyn Pexton, GE Medical Systems Performance Solutions

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