A 27-year-old female presents to the Emergency Department (ED) complaining of nausea and belly pain for the past 12 hours. The general surgeon on call is consulted after examination by the ED physician’s assistant (PA) confirms the presence of morbid obesity and active bowel sounds. The surgeon sees her and recommends discharge with use of over-the-counter laxatives. Six hours later, the patient returns with the same complaints. The ED PA finds nothing new, and the general surgeon elects not to see her again, recommending that she again be sent home, this time with codeine. She returns four hours later and precipitously delivers a baby in extremis, with Apgar scores 0 and 2. Asked later, the PA and consulting surgeon each admitted omitting a pelvic exam because pregnancy was of low probability and “it takes too long to get a pelvic tray up to the ED.”

Why would we care about process improvement in the medical center setting or any healthcare delivery system? In short, the reason is that healthcare delivery in the United States is too expensive, waste-filled, and dangerous. It is unsustainable. Donabedian (2003, pp. xxiii–xxiv), a doyen of quality improvement, once wrote:

Too many patients and providers would agree that the current level of quality in healthcare is not “fully satisfactory.” It must become more efficient, cost-effective, and conducive to higher-quality outcomes. And it must provide better value to patients and payers.

Process improvement is a business strategy with a long and positive history of successful boosting of efficiency and quality, as measured by structure, process, and outcome measures. The question “What should be measured, and with what frequency?” generates many different answers, particularly as the metrics have now become the purview of external regulatory and accrediting agencies. Even some of those metrics have value, however. A key determinant of process-improvement efforts is the definition of quality. Yet definitions of quality may alter with time and changes in patient, provider, and accreditation expectations as well as the economic exigencies that are ever more significant in healthcare delivery. Although the definition of quality is most useful and valuable when chosen by the local team engaged in its improvement, this short one has been effective for me: Quality care is ready access to effective healthcare.

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  By “ready access,” I mean that a patient can begin diagnosis, treatment, and preventative care as quickly as he or she deems desirable, in locations convenient to his or her home or work, without significant cost, pain, or disability incurred in doing so.

  
  
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  “Effective” means safely curing the curable, preventing the preventable, and bringing the chronic and incurably ill to the highest level of functionality, all while maintaining the dignity of and respect for the patient and her or his cultural beliefs and values, as well as those of the family and the rest of the social support network, all at the lowest possible cost to both the patient and society.

In the setting of modern healthcare policy, the advantage will generally be to those providers who can prove their value to the payer or to the consumer, or to both (in the US healthcare system, the patient and payer are rarely one and the same). Value, typically calculated with the formula Quality/Cost, can also be considered as a net equation that might be defined in part by using (Positive Outcomes, total) – (Negative Outcomes, total) = Net Benefit. Providers who reliably produce a positive net benefit in excess of the expected or average results achieved by their competitors will be attractive to payers, patients, and other providers as well as to regulators and accreditation agencies.

While we might consider it valuable to measure improved quality in terms of reduced length of stay or added years of life, an individual patient may find more value in other ways. For instance, a patient with chronic vascular disease and impaired lower-extremity circulation may value the avoidance of amputation over the risk of losing years of life span. He or she would definitely value both of those over length of stay. All quality is a personal matter.

Process improvement is a strategy with the ultimate goal of improving quality. There are several potential pathways to process improvement, including Six Sigma, Lean, and Lean Six Sigma (LSS), which is the most commonly used terminology in most healthcare locations now. LSS is a conflation of Lean management techniques, popularized by Toyota, and Six Sigma, the latter having been developed at 3M. I will use LSS as the model for the most part in this discussion, pulling from the techniques of Lean to reduce waste and from Six Sigma to improve reliability. At its most effective, LSS is a set of tools and a culture that is characterized by teamwork, a relatively flat hierarchy at the point of production of a good or service, and participatory pride by employees in efficiency and cost reduction. These cultural elements can be leveraged and channeled by healthcare leaders to improve efficacy and efficiency in the provision of healthcare. We will further focus on the potential use of rapid process-improvement events or workshops (known as Rapid Process Improvement Workshops, RPIWs, or Kaizens), which are team-based projects designed to identify and correct root causes of waste or error in order to improve quality and safety. It is also worth mentioning the use of Plan Do Study Act (PDSA) methodology both to accomplish improvement and to glean information about processes. More information about that technique can be found at https://deming.org/management-system/pdsacycle.

Lean Six Sigma provides a methodology of process improvement that is inherently participatory, allowing frontline staff to define hurdles and create and try out solutions, helping to ensure that outcomes are reality-based and that employee acceptance of change is enhanced. The Toyota Production System (TPS) may be considered the penultimate application of Lean principles. Its underpinning doctrines were applied in the 1880s by Sakichi Toyoda to reduce waste and inefficiency in the loom industry before being developed fully and implemented in the automotive industry by Taiichi Ohno, thereby leveraging the juxtaposition of automation and just-in-time production methodology. Ohno’s concept centered on asking “Why?” five times or more, in order to distill the causative factors in a process, thereby identifying and eliminating those that were unnecessary and removing waste from the process. It is a continuous technique, and its focus on the frontline worker’s participation can lead to a cultural change in which the employees are retrained as experts in the field of process improvement observation, now able to detect and uncover opportunities for improvement.

Lean reflects the principles of High Reliability Organizations (HROs), where all participants are expected and trained to observe for “the next error” to reduce the potential for system-enabled error. Inherent in the theory and practice of HRO methodology is that there must be a concern by all for the cost of error. This translates well into the obsessive elimination of waste in Lean.

The use of Lean is congruent with management by measurement, the review of outcome and process metrics to direct process improvement (using as short a cycle as possible between measurement and revision). It has been widely applied in healthcare, and outcome measurement is critical to quality improvement in providing patient care. For efficiency to be directed by the providers of care, measurement must be dependable and its findings distributed to those whose work is being measured.

The entry of Lean management principles into healthcare has been most successful, particularly on small-scale projects. Some institutions—such as the Virginia Mason Clinic—have implemented Lean as a widespread cultural change, primarily by educating leaders and managers as well as other staff through the repeated use of Kaizens or RPIWs. Lean’s introduction has been part of what may be termed the managerialization of healthcare, in the application of private business principles to the organization and delivery of healthcare in an effort—at its most basic level—to reduce its cost. In 2002, Virginia Mason was the first healthcare institution to introduce what is now the Virginia Mason Production System, modeled after the TPS.

THE SEVEN WASTES AND FIVE PRINCIPLES OF LEAN

Ohno construed Lean as the repeated effort to eliminate wasteful steps in a process. This has been adapted to healthcare in the identification of seven types of waste and five lean principles.

Seven Wastes

Here are the seven types of waste, with examples in healthcare situations:

1. 
   

   Transportation—If a nurse must walk to the central supply area to garner items used every day for procedures, rather than stocking those in the operating room.

   
   
2. 
   

   Inventory—Because there are not enough infusion pumps in the hospital to meet just-in-time needs of patients, nurses hide them in their lockers.

   
   
3. 
   

   Motion—Placement of computers outside patient rooms at fixed positions rather than allowing nurses and physicians to use computers on wheels (COWs) or tablets to bring data retrieval and entry to the point of service (e.g. the patient’s bedside).

   
   
4. 
   

   Waiting (Delay)—Requiring patient discharge to need a doctor’s specific orders for durable medical equipment (DME) and other supplies that are always needed after a routine total joint replacement, rather than creating an algorithm triggered by clicking a check box. This means that the physician must remember everything every time, and that patients are delayed by the inevitable errors introduced by reliance on human memory.

   
   
5. 
   

   Overproduction—Requiring that a lab test (e.g. hemoglobin) is drawn before every new mother is discharged, but not checking the tests prior to patient departure.

   
   
6. 
   

   Overprocessing—Requiring patients to fill out questionnaires repeatedly, regardless of the passage of time or lack of change in their condition since the previous time they filled them out.

   
   
7. 
   

   Defects and Correction—Failure to include social work evaluation ahead of elective admissions, leading to requirement for social worker “last-minute-rescue” work on days of discharge, leading to patient dissatisfaction and even re-admission.

The Five Principles of Lean

Here are the five principles of Lean:

1. 
   

   Specify the value desired by the customer.

   
   
2. 
   

   Provide a visual demonstration of the “value stream” (i.e. the processes required) for each product/service, noting the cost and waste of each step.

   
   
3. 
   

   Focus on making the production of the service flow continuously and with standard approaches to eliminate unnecessary variation and decrease wasted time.

   
   
4. 
   

   When continuous flow is challenging to achieve, place “pull” methodologies/triggers between all steps. Focus on the customer’s next need, reverse-engineering the steps of the value stream.

   
   
5. 
   

   Expunge nonvalue-added steps in the processes, eliminating waste of time and motion, unnecessary delays, and patient dissatisfiers, always reevaluating and reworking the value stream to continuously improve its efficiency and efficacy.

In healthcare, Lean principles are most often used in a single department rather than across an organization. This is because it is most easily implemented within point-of-care locations where designs do not require as much cross-unit coordination. The successful implementation of Lean requires scrupulous measurement of an entire process, but biting off a sizable chunk often deters managers from looking at processes outside their areas of authority.