1. IS LEAN THINKING MAKING A DIFFERENCE IN HEALTHCARE? S TEPHEN S HORTELL, P H D, MPH, MBA Blue Cross of California Distinguished Professor of Health Policy & Management Co-Director - Center for Lean Engagement and Research (CLEAR) in Healthcare S CHOOL OF P UBLIC H EALTH UC, B ERKELEY T HOMAS R UNDALL, P H D Henry J. Kaiser Professor Emeritus Co-Director - Center for Lean Engagement and Research (CLEAR) in Healthcare S CHOOL OF P UBLIC H EALTH UC, B ERKELEY LEAN Healthcare Academic Conference at Stanford Palo Alto, California September 26-27, 2016

2. IS LEAN THINKING MAKING A DIFFERENCE IN HEALTHCARE? Answer: Not Much, Not Really. “Healthcare Lags far Behind the Manufacturing Industry’s Level of Excellence in Lean Application”.

3. WHY NOT? Answer: There is an over-emphasis on the tools and “one-off” projects as opposed to the realization that it is a radically new way of Leading and Managing a Healthcare Organization. Emphasis on The 4 E’s: Empowerment Engagement Execution Excellence

4. “It is important that the research community recognizes healthcare management is every bit as important as clinical medicine for research. In fact, it may be the most important research area from a patient safety standpoint. But until this research is done, forward looking organizations like the ones mentioned above will be pulling the healthcare industry into the 21 st century”. John Toussaint, President and CEO, ThedaCare Center for Healthcare Value “Sustained focus on removing barriers to reliable production of high-value care, optimizing data analysis and use, and reducing workflow waste will improve health more than pay-for-performance schemes”. CR Dale, M Myint, and AL Compton, “Counting Better - The Limits and Future of Quality-Based Compensation”, NEJM, August 18, 2016

5. WORKING DEFINITION OF LEAN The Development of a Culture that Enables an Overall Management System to Create Value for Customers by Eliminating Waste and Solves Problems Through the Daily Application of the Scientific Method in Creating Standard Work.

6. MOVING THE EVIDENCE BASE FORWARD DEVELOPING “ACTIONABLE” KNOWLEDGE T HE C ENTER FOR L EAN E NGAGEMENT AND R ESEARCH (CLEAR) IN H EALTHCARE  V ISION The vision of CLEAR is to transform healthcare delivery by helping organizations to eliminate waste and to create greater value resulting in the continuous improvement of patients’ outcomes and experience of care, population health, and reduced growth in the cost of care.  M ISSION CLEAR’s mission is to conduct timely, relevant, and actionable research on LEAN whole system transformation initiatives. CLEAR will work with organizations in the process of implementing LEAN transformation and with researchers studying the LEAN transformation process. The problems/topics to be studied will be selected by LEAN organizational leaders based on what is of most interest and likely impact for them. The research center will then identify a list of qualified researchers at leading universities and think tanks around the country to submit proposals. The winning proposals will be jointly selected by LEAN organizational leaders and Center directors.

7.  G OALS 1)Conduct in-house leading edge research on Lean in healthcare, beginning with the first national survey of Lean in hospitals; 2)Collaborate with specific healthcare organizations and other health services researchers on focused studies of the effects of Lean in particular organizations and departments; and 3)Facilitate research among other researchers and healthcare delivery organizations through resources and information available on our website.  W EBSITE www.Clear.Berkeley.edu

8. FOUNDING SPONSORS L EAN E NTERPRISE I NSTITUTE R ONA & A SSOCIATES T HEDA C ARE

9. STRATEGIC ADVISORY COUNCIL  A LICE L EE - LEAN E NTERPRISE I NSTITUTE  J OHN T OUSSAINT – T HEDA C ARE C ENTER FOR H EALTHCARE V ALUE  C RAIG V ERCRUYSSE - R ONA & A SSOCIATES  P ETER W ARD - O HIO S TATE U NIVERSITY  H ELEN Z AK - T HEDA C ARE C ENTER FOR H EALTHCARE V ALUE

10. SOME EXAMPLES OF TOPICS/QUESTIONS TO BE ADDRESSED 1)Do organizations that are further along in implementing Lean have better quality, patient satisfaction and cost outcomes? 2)What types/approaches to pre-work and leadership development are most effective in launching Lean transformation for given organizations? 3)What is the relationship between plan-do-study-act (PDSA) cycles and achievements in removing waste from the care delivery process? Or in improving the quality of care for patients? 4)What criteria should be used in the selection of model cells for beginning improvement work? How might early successes be more quickly spread to other parts of the organizations? Continue…

11. 5)What are the characteristics of the lean management system versus the traditional healthcare management system? What role does leader standard work play in the management process? 6)In what ways does the re-organization and re-purposing of the finance, human resources, and information technology functions contribute to Lean achieving successful performance outcomes? 7)What can be learned about the ability of Lean organizations to “hold gains achieved” over time and about continuous improvement over time? 8)Do organizations that apply Lean leadership practices and methods have less burnout of clinicians? …SOME EXAMPLES OF TOPICS/QUESTIONS TO BE ADDRESSED

12. CLEAR Center Annotated Bibliography Prepared by Justine Po, Summarizing 57 Primary Empirical Research Articles Published Since 2000 Reporting the Effects of Lean in Healthcare Organizations and 13 Systematic Reviews of Various Subsets of These Primary Studies.

13. FROM RECENT SYSTEMATIC REVIEW ¹ FINDINGS No significant association with patient satisfaction or health outcomes. Higher costs (taking into account money spent implementing Lean). Poorer worker satisfaction. Inconsistent association with process outcomes like patient flow and safety. CONCLUSION “The evidence to date does not support the belief that Lean leads to healthcare quality improvements”. Call for more rigorous, higher quality and better conducted scientific research. ¹ J. Moraros, M. Lemstra, and C. Nwankwo, “Lean interventions in healthcare – Do they actually work? A systematic literature review” International Journal for Quality in Health Care Advance Access, 2015, 28 (2): 150-165

14. WHAT IS NEEDED, WHAT WE PROPOSE  More Rigorous Evaluation Designs to Rule Out Alternative Explanation for Study Results -Experimental and Quasi-Experimental  Measures Relevant to the Intervention  Detailed Description of the Intervention  Thorough Examination of Contextual Effects  Assessments of Sustainability One Time – Longitudinal Study Designs  Studies of Spread – Diffusion to Other Units, Other Organizations will Require Effective Partnerships Between Lean Organizations and Researchers

15. A FRAMEWORK FOR CONSIDERING SUCCESSFUL LEAN IMPLEMENTATION FOUR DIMENSIONS S TRATEGIC  Is it an Organization Wide Priority?  Breadth of Involvement  Readiness Assessment C ULTURAL  Continuous Improvement Mindset  Empowerment Culture  Learning Organization  Reward Systems T ECHNICAL  Use Lean Tools/Processes  Training  Information Systems  Visibility of Data  Analytics S TRUCTURAL  Decentralization  Team Oriented  Relational Coordination  Social Networks  Forums for Learning

16. SCORE YOUR ORGANIZATION S TRATEGICCULTURALTECHNICALSTRUCTURALRESULT 0+1+1+1Minimal Impact; not a Priority 1+0+1+1Temporary Results not Sustainable; Culture does not Support it 1+1+0+1False Starts; Change Fatigue 1+1+1+0Sub-Optimization; no Spread 1+1+1+1Sustainable Significant Impact 0 to 1 = Probability that the Dimension Exists

17. T HANK Y OU S TEPHEN S HORTELL, P H D, MPH, MBA S HORTELL @B ERKELEY. EDU T HOMAS R UNDALL, P H D T RUNDALL @B ERKELEY. EDU C LEAR.B ERKELEY. EDU