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Personalized Medicine vs. Lean Health Care

Short Version:

The application of lean to healthcare is most reasonable when healthcare is viewed from a broad perspective.  The analogy between “making cars” and “caring for patients” becomes less valid as one delves into the more-granular aspects of healthcare.

Lean  =   Healthcare (broadly)

Lean  X=X  Healthcare (at the microlevel)

Long version:

Personalized Medicine vs. Lean Health Care

There is growing interest in personalized medicine.  Patients are increasingly being told that their care can be tailored to their specific situation.  Enthusiasm for this approach is fueled in part by advances in genetics (e.g. defining tumor-specific abnormalities in the genome) and therapeutics (e.g. targeted therapies that exploit unique biochemical/genetic abnormalities in tumors).  Further, this approach “sounds good” and plays well to our sense of individualism and empowerment.

Concurrently, lean health care is being promoted as a means to improve clinical operations and efficiency through standardization and the reduction of waste.  Lean approaches gained much credibility as they were successfully applied by Toyota to generate uniquely reliable automobiles.  Similar lean-based improvements have been seen by other manufacturers as well as in other industries such as aviation.

Lean has been less vigorously embraced by healthcare.  There are several well-known successes (e.g. Virginia Mason, Thedacare) where lean has helped to improve operational efficiencies, increase financial performance and improve clinical outcomes.   The standardization that comes with lean reduced inter-patient variations in care, appears to reduce errors, increases efficiency, and improve outcomes.  In other words, exactly what was seen by Toyota.   Nevertheless, it is very challenging to implement lean principles in healthcare.  Indeed, the successes at Virginia Mason and Thedacare took many years to be attained, and were hindered by much resistance from providers and staff alike. This is all well described in the books “Transforming Healthcare” and “On the Mend” from these institutions.  The popularity of these books, and manner in which these institutions are so widely admired for their achievements, is a reflection of the difficulties in bringing such lean-based change to healthcare.

Physicians and other care-providers are typically strong-willed and opinionated.  The concept of standardization (fundamental to lean) is often seen by providers as an affront to their medical judgment, competence and professionalism.  “We are not making cars, we are curing cancer” is a representative refrain voiced by opponents of lean.

Who is right?  Like most things, the truth is somewhere in the middle.  Health care providers indeed are not making cars, and inter-patient differences are almost certainly larger than the inter-car differences.  Nevertheless, viewed from a fairly high level, patients and cars are very similar.  In our radiation oncology clinic, we typically evaluate and care for over 100 patients per day, with a wide variety of ailments.  There are many inter-patient differences that need to be considered on an individual basis, with corresponding modifications to their radiation doses, field sizes, etc.  Nevertheless, there are many commonalities that span across all patients.  At the time of initial consultation, essentially all patients will have (in the same order) an evaluation by a nurse, a history and physician examination by a physician, review of pertinent medical records, a recommendation for treatment (or not), and a series of appointments made for future activities.  Sure there are differences in the details of these various components, but the broad structure can be readily standardized.  Similarly, just prior to receiving a radiation treatment, essentially all patients will disrobe, get onto a table in the radiation treatment room, be positioned and aligned as needed, imaged to assume correct positioning, and then treated.

Therefore, lean concepts such as standardizaton can usually be readily applied to the broad aspects of patient care.  However, as one delves more deeply into the details of any individual patient’s treatments, the presence of (necessary) inter-patient variation makes the application of standardization more challenging.

The successful implementation of lean in healthcare requires that we accept that there are inter-patient differences and that the provider’s input as to how to address these differences is still needed.  Indeed, the goal of lean in healthcare is to standardize what can be standardized, so that the providers can spend their time focusing on those important inter-patient differences.  In fact, it is those inter-patient differences that makes healthcare so interesting, challenging, and rewarding.  Used properly, lean can liberate providers to relish the most interesting aspects of their work.  Personalized medicine and lean healthcare are synergistic.

Creating Performance Excellence through Understanding and Developing Your People

6 Comment(s) | Posted | by Lukasz M. Mazur, Ph.D. |

As you might know, recently, a number of hospitals have responded to the challenge by using lean methods to help solve their quality and efficiency related problems. However, if a hospitals turn out to have a similar trajectory to manufacturing, the percentage of failed lean implementation efforts could run as high as 90%. One important reason for the high failure rate in lean implementation is that most organizations revert to old habits without successfully making the transformation to lean thinking and behaviors. Repeatedly, experts point to the failure to develop lean as an operating philosophy, as opposed to an application of tools. Perhaps, healthcare administrators and managers may be unprepared to provide their employees with the learning and experience necessary to develop a lean culture and mindset. What do you think?

Most of the learning occurring on the hospital floor can be defined as detection and correction of error, but without addressing the underlying values that drive action and govern behavior. This is called single-loop learning (SLL). In SLL, importance is placed on the efficiency and effectiveness of localized problem solving techniques, but not system-wide analysis to remove the root-causes of problem. The focus is on fixing what is wrong and moving on. Unfortunately, using such a model, healthcare professionals often suppress their negative feelings about emergent problems and continue to operate using comfortable, safe routines to achieve productivity standards. Literature shows that such behavior hinders individuals’ psychological safety to engage in team learning and negatively affects perceptions on organizational trust. 

So, how do hospitals contribute to SLL? In general, job complexity and productivity demands create double-bind conditions in which professionals must choose between abiding by failing policies and procedures, or resorting to workarounds that are adequate in the short term but not the long term. This choice is made more difficult and stressful by hospital administrators and managers who allow frontline professionals to justify workarounds because the existence of faulty systems interferes with good productivity. In this sense, workarounds are seen as a reasonable way to meet productivity objectives and are often considered to be of little threat to the healthcare professional, patient, or organization. Moreover, workarounds can even be seen as positive because they reduce costs, save time, and allow employees to stay on time with daily routines. Once justified and legitimized, workarounds become embedded in the culture as a group norm and are very difficult to monitor, control, or eliminate. Therefore, in the long term SLL can lead to disruptive behaviors and employee burnout.

Well, what should hospitals do? Perhaps, develop double-loop learners. Compared with SLL, double-loop learning (DLL)  is more reflective and considered. Where SLL tends to address problem symptoms, DLL leads to the identification and elimination of root causes of problems. To accomplish this, DLL requires an environment where problems can be examined in an open and honest manner, using valid information, with problem stakeholders being free to express opinions and recommend actions. In addition, effective DLL requires an internal commitment by those involved to investigate and remove root causes of problems. Healthcare professionals operating in this manner feel empowered to emphasize patient safety and operational performance as critical components of care, and often initiate problem solving with stakeholders through the use of acceptable language, behavior, and available data. 

But, how to develop double-loop learners? My research and detailed observations in hospitals lead me to offer some concluding recommendations for hospital leadership teams that are considering developing DLL. 

  1. First, make sure you have appropriate human resources to mentor and develop double-loop learners. Specifically, err on the side of broader frontline participation in DLL, versus building a smaller team of experts that can drive localized improvements. The investment of time and effort to build a broad base of double-loop learners in the hospital is an indispensible part of the learning organization. Without it, the change initiative runs the risk of losing momentum after the initial level of excitement naturally fades.
  2. Second, leadership must make the financial commitment to adjust staffing levels for areas that have employees working on projects requiring DLL (i.e., Kaizen events). Typically, the expenditures for supplemental staffing will come in advance of any associated savings from improvement projects. Therefore, leadership must trust that DLL will succeed over the long term, even though the expenses will often occur in advance of any realized cost savings.
  3. Third, leadership must focus on the role they can play in fostering the informal spread of DLL. In any organization, there is a formal structure and an informal structure. The formal structure is captured through the organization chart and the clearly defined reporting relationships, roles, and responsibilities of all employees. Conversely, the informal structure of an organization is the ad hoc, evolving relationships of employees across the organization as they self-organize to get work done. While leadership cannot directly manage the informal social networks in their organizations, they can recognize that informal networks exist and strive to understand who are and can become the informal DLL leaders.

Finally, I wish to conclude by stating an observation that may be apparent but bears repeating. Double-loop learning is much more than a set of tools and methods. The challenge is not to teach employees the tools and methods. Rather, it is to go beyond this level of training and into a deeper learning cycle of applying tools and methods, making improvements, reflecting and internalizing the insights and lessons of lean improvement, and building personal commitment – in other words, developing double-loop learners. As hospitals become more proficient at this, we will continue to see more success stories.

Engaging Physician in Lean Transformation

Immersed as I am now in Lean literature and methodology, it is sometimes hard to recall my first reactions as a physician to the words Standardization and Compliance. I am reminded, however, of my negative reflexes when I see the responses of physicians who attend Lean educational sessions. Those who are following along contentedly through Value Stream Mapping and A3s suddenly throw up walls of defensiveness when they hear Standardization and Compliance.

The response of Quality Assurance staff and facilitators often is to become frustrated and critical of us physicians for being too conservative and wedded to our autonomy. They may proceed with improvement efforts without physician participation. I'd like to explore the physician context and in so doing, suggest means for introducing Standardization and Compliance in ways that physicians can accept because physician engagement is critical to the success of the majority of Lean Healthcare transformations.

Lean has only been aggressively adapted to the healthcare market for about a decade. We promoters understand it to be an integrated approach to improving processes and systems using the innovations of all of the workers who touch the process, top to bottom and bottom to top. Prior to Lean, quality initiatives came strictly from the top and often from outside the hospital walls. Regulatory agencies developed and imposed "standards" and only negative indicators of poor outcomes such as infection rates, low APGAR scores and returns to OR without the input of those who provided the care.

Enforcement of "standards" or compliance was given to the Quality Control Officer (intimidating language) whose job it was to comb through charts finding the omissions, failures and faults in order to display them for the Medical Staff for review and report to the Board. Such statistical methods applied to very small sample sizes and minimally meaningful indicators created anger and rejection of the process among medical staff. For example, a physician who had saved a life by diagnosing a post-operative bleed, who took the patient back to the OR was "dinged" and judged as culpable by the indicators. Many of these practices continue today. If an error is caught in a non-Lean regulatory environment, what are the incentives to identify and disclose it if you are going to be penalized?

Physicians work with many sharply competing incentives. Reduce costs, see more patients, make no errors, document to satisfy even the harshest malpractice lawyer, be compassionate, spend more time with all patients, screen for seatbelt or tobacco use, complete required authorizations for HMO's, coordinate care with all providers, and be prepared to respond to any emergencies. We will resist Standards if they feel like another burdensome injunction to "remember to do" one more thing that is going to be measured.

On being introduced to Lean, physicians are likely to think of it is a means of meeting current reporting requirements while we know it can have much greater impact. I saw a recent example at Scotland Memorial Hospital in Laurinburg. Surgeons began using Lean to investigate why they had deficiencies in meeting SCIPS DVT prophylaxis indicators and why orders for heparin were omitted. When they went on a Gemba walk they discovered the many wastes in their whole pre-operative admission process. They discovered how Lean methodology could be used to simplify, not burden their practices. They discovered how standardization is about having resources, routines and safeguards in place that protect their practice of medicine. Simple examples of standards and routines include having laboratory results reported in an accurate and timely manner, for having outside records available prior to consults, for medication refills ready for signing after checking for allergies, for check lists for pre surgical authorizations and registrations. These examples and others can demonstrate how standardized work can avoid errors, redundancy, waiting, and rework while simplifying medical practice but not constraining it.

To engage physicians, emphasize that Lean Methodology is devoted to establishing processes throughout an organization that reliably support the physician’s efforts. Demonstrate how standardization links the physicians' work to those who come before and after in the sequence. Compliance with standard work is a means of confidently controlling the mundane work and focusing the physician's efforts on the exceptional and unusual cases. Physicians will see that the processes associated with standard work assist them to provide individualized care and responsiveness to unpredictable need.

For assurance, we should emphasize what Lean is not - it is not a means of controlling, policing or punishing. It is not a set of Do's to remember. It is not a denial of individual patient or physician needs. It is not strictly an efficiency tool. And it is not the enemy of innovation. Atul Gawande, MD, in his outstanding book "Better" examines several stories of clinics and practitioners whose outstanding outcomes are many percentage points above the expected. He challenges us to look at that variability for the sources of true excellence. Compliance with standards by everyone in the workflow is not going to eliminate all variability or stifle innovation but it will provide an unprecedented level of support and stability to highly competent physicians who will be able to focus on excellence.

We physicians are not necessarily resistant or obstructionist when it comes to Lean or quality improvement efforts. The Lean transformations of Virginia Mason and Theda Care were led by physicians. Engaging physicians is critical for success in Lean Healthcare. As a facilitator, sensei or change agent, success will be when you find the ways to align the Lean principles with the physicians' goals - they are not incompatible. The true transformation in the medical culture will be achieved when this alignment results in trust and cooperation among all providers of patients' care.