The Case for Change

In December 1999, the Institute of Medicine (IOM) released a report that made health care providers and consumers alike sit up and take notice. The study by the IOM estimates 98,000 people die every year in the United States from medical mistakes made by healthcare professionals. In addition to the troubling death toll, the study suggests the nation’s price tag for these errors could be as high as $29 billion a year, and lists medical mistakes as the fifth leading cause of death in the country…behind heart disease, cancer, stroke and lung disease.

Further evidence of the need to address medical errors may be drawn from a benchmark study conducted by Harvard University for the state of New York. This study, extrapolated to the national population, suggested that 1.3 million people are injured each year in hospitals, and of that number, 180,000 will die from the injuries. Providing additional cause for alarm, the report also suggested that most of those injuries were actually preventable.

Another study in 1997 used trained observers to monitor care in an urban teaching hospital and documented discussions between physicians and nurses in clinical conferences for patients. The observers identified one serious adverse event in approximately 18 percent of the patients (ranging from temporary disability to death).

The statistics collectively speak for themselves. Clearly, though one may quibble over percentage points, the bottom line is that decisive action needs to be taken – sooner, rather than later.

Six Sigma’s Potential for Error Reduction

“Sigma” is a statistical measurement reflecting how well a product or process is performing. Higher sigma values indicate better performance, while lower values indicate a greater number of defects per unit. At Six Sigma – a rigorous and exacting approach to quality – defects are limited to just 3.4 per million opportunities. Organizations take aim at this lofty target by carefully applying Six Sigma methodology to every aspect of a particular product or process. This approach allows the redirection of time, energy and resources toward activities that bring real value to customers instead of forestalling and fixing defects in order to perform at a minimally acceptable level.

While Six Sigma has been steadily revolutionizing a diverse range of corporations, the approach is relatively new to the healthcare industry. Given the ominous and widely reported backdrop of medical mistakes, however, it’s evident that the healthcare setting provides distinct and vital opportunities for the application of this methodology to reduce errors at the clinical process or project level. Mounting evidence of success in other industries suggests definite patient/caregiver rewards to be reaped by deploying Six Sigma strategies and techniques within hospitals and health systems. If error reduction is warranted within industries such as plastics or electronics, it should be considered even more crucial to the delivery of healthcare. The exigency here is dictated by the fact that this particular line of work deals with nothing less than the precarious balance between life and death.

Charting a Course Toward Improved Patient Care

Once Six Sigma is introduced and begins to take hold within the realm of patient care, initial efforts will likely focus on existing processes that appear to be dysfunctional or more often prone to error. The Six Sigma approach to this type of process is referred to as DMAIC: Define, Measure, Analyze, Improve, Control. This may sound somewhat like previously tried operational improvement processes, and it also sounds like the nursing process itself which requires caretakers to assess, plan, implement and evaluate. Despite superficial similarities, Six Sigma is unlike any initiative formerly introduced to improve the quality of healthcare delivery.

The approach goes above and beyond other initiatives by removing guesswork and half-hearted implementation. At each step of the review process, the methodology forces participants to rigorously test assumptions and to document those tests. The methodology itself encourages the reduction of variability not only in the process immediately under investigation, but also in the overall approach to the investigation and improvement of processes throughout the organization.

Six Sigma healthcare projects currently underway in a few locations have already begun to reduce the number of defects in specific areas, including the nurse charting process and patient throughput in radiology. But there are many other patient care processes that seem to be begging for immediate attention and initiation of a Six Sigma review. It’s conceivable and reasonable to expect that the error rates cited in the IOM report could be reduced by process implementation in the following areas:

• Medication administration
• Site-marking for surgical or other procedures
• Assignment of patient caregivers
• Case management
• Patient falls
• Patient restraints
• Emergency department triage

Six Sigma alone may not be heralded as the savior of healthcare delivery in this country, but its judicious application along clinical lines, combined with the best treatment, technology and expertise available, will certainly improve care for the patient and diminish uncertainty for caregivers. Time will bear witness to the efficacy and extent of the transformation.