A Case Study Transforming Research Management Systems at Mayo Clinic Presented by: Steven C. Smith, Chair, Research Administration Leon G. Clark, Vice-Chair, Research Administration Gary C. Cseko, Operations Administrator, Research Administration Susan M. Uhlenkamp, Chair, Research Finance NCURA Annual Conference, Washington DC Washington Hilton, Washington, DC 11:00 – 12:00pm, November 7, 2012

Disclosure The presenters do not have any relevant financial relationships with any commercial interests.

Presentation Outline Learning Objectives Overview Questions Describe the Mayo quality improvement framework and how this framework can be applied in their own organizations to improve the quality and transform business processes. Explain that transformation is a process that advances through a series of stages that build upon one another. Describe the eight stages of change, the critical action steps to take and the common problem to avoid. Select a change of strategic importance currently underway in your own organization and complete a brief assessment tool to identify critical action steps to take and common problems to avoid enhancing the likelihood of a successful transformation. Summarize a Mayo Clinic Case Study highlighting the transformation of Research Management Systems at Mayo Clinic currently underway.

Learning Objectives Describe the Mayo quality improvement framework and how this framework can be applied in their organizations to improve the quality and transform business processes. Explain the transformation is a process that advances through a series of stages that build upon one another. Describe the eight stages of changes, the critical action steps to take and the common problems to avoid.

Overview Mayo Clinic Overview Mayo Quality Framework Comprehensive Research Management System Stages of Transformation

Mayo Clinic Health System Mayo Clinic Locations Mayo Clinic Mayo Clinic Health System Rizza Mayo Clinic in Arizona Mayo Clinic in Florida ©2011 MFMER | slide-6

Mayo Clinic Research is… National research program Arizona, Florida, Minnesota In top 20 NIH-funded AMC’s 365 awards from 27 institutes Over 8,000 active human studies Over 3,000 staff employed in research ©2011 MFMER | slide-7

Research: Overview Mayo Clinic research partnerships Translational research Bedside Bench Population Over 90% of Mayo physicians are involved in research-related activities $600 million research budget Mayo Clinic research partnerships

Mayo Clinic Research is… Enterprise-wide governance Enterprise-wide leadership & management Physician/administrator partnership Committed to creating ‘world-class’ systems Continuing growth of programs Evolution from ‘cottage industries’ to systems approach Infrastructure not up to Mayo standards Recognition of risks Commitment to implementing quality systems ©2011 MFMER | slide-9

Mayo Clinic Quality Framework The best care for every patient every day I Quality Academy Leader Training Champions training Articulate roles and expectations Commitment to transparency Communications plan Culture III Practice (e.g. - pressure ulcers, right-site surgery) Education (e.g. – Ask Mayo Expert) Research (e.g. – IRB, OSPA,etc) Engineering IV Demonstrate business case Active visible leadership Process owners Frontline empowerment Common scorecard + targets 100-day discipline Execution V Infrastructure II Quality Academy Systems implementation Enterprise Learning System Spread simulation practices December 6, 2007 Adapted from Bisognano, Plsek. 10 More Powerful Ideas for Improving Patient Care. Chicago: Health Administration Press & Institute for Healthcare Improvement; 2006. ©2010 MFMER | 3065532-10

Research Management System Transformation CRMS Vision Imagine we will… Create optimal research administrative services to advance research from knowledge generation through delivery to our patients …that is our vision

CRMS Key Strategic Objectives Creating an Optimal Clinical Trials Management System Implementing Quality Management Systems across all Research Business Units Developing Scalable Infrastructure to serve MCHS, APN and clients globally

Comprehensive Research Management System New Treatments New Lab Procedures New Analysis Capabilities New Care Delivery Methods End of study report Drop out, screen failure, outcomes reporting Produce publications Present discoveries Assign staff/resources Patient search, screening, scheduling Patient treatment & education Collect/test/track samples data analysis Meeting preparation Meeting execution Document/forms review Scientific review Establish study plan Create protocol Complete/initiate docs and forms Qualify staff and/or organizations Creation of aims Literature search Preliminary reviews Create concept docs Identify teams Translation Analysis & Reporting  Protocol Execution  Protocol Review  Protocol Development  Concept Development  Pre-award Activities Study Activities Post-study Activities RESEARCH PROCESS  Planning & Strategy Services Research Governance, Research Leadership, Strategic Planning, Operational Planning, Portfolio Management, Quality Planning, Financial Planning & Analysis, Benchmarking, Competitive Intelligence, Research Collaborations & Partnerships, Research Funding Model, Research Review Process Business Management Services Research Policy Management, Process and Procedure Management, Quality Management and Process Improvement, Administrative Support Activities, e-Research – (Research Web, Clinical Trials Management System, Lawson), New Process Design, Performance Management & Reporting, Business Analysis, Project Management ◄ Research Services  Funding Services Identification of Funding Opportunities, Proposal Submission Services, Budgeting and Forecasting, Contracting, Fundraising, Intellectual Property Disclosures & Licensing Training & Education Services Compliance Training & Education, A.H. Staff Education & Development, Leadership Development, Change Management Scientific Support Services Pharmacy Support, Study Coordination, Direct Scientific Support for Cellular-Animal-Human Studies, Biostatistics, Informatics, Computing, Epidemiology, Bio-repository, Health Services Research, Bio-specimens, Survey Research Regulatory Support Services Billing Compliance, Human Subjects Protection, Animal Care and Use, Research Safety, Conflict of Interest

Research Management System Transformation CRMS Roadmap to Excellence Phase I Research Vision and Strategic Priorities Phase 2 Research Infrastructure Compliance Phase 3 Research Infra- structure Process Improvement Phase 4 Research Infrastructure Service Excellence Vision Strategic priorities Strategic initiatives Scorecard metrics Financial management systems Written policies and procedures Roles and responsibilities Compliance training and education NIH Response Circle Back Management systems design Policy system Protocol management system Pre-award system Legal contracting system IRB process Quality Management Systems Comprehensive Training Program Research strategic planning Research policy management Research compliance Research management system Research contract management Research financial management Sponsored projects administration Research information services Research communication Research web services Human subjects protection Animal care and use Research career development Science and technology Research Service Excellence Cycles Research Service Center BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location.

The Stages of Change 8 Steps to Transforming Your Organization Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Research Management System Transformation CRMS Inflection Points Create optimal research administrative services and systems Advance entrepreneurism to the benefit of our patients and society Accelerate the translation of discoveries to our patients CRMS Phase 4 2012-2017 Develop a scalable global Affiliated Research Network Optimize Clinical Trials Integrate research administrative services and systems Implement QMS in all Research business units Implemented QMS in selected Research business units Reduced pre-award cycle time by 351 days Increased federal indirect revenue by $8M annually CRMS Phases 1-3 2006-2011 Reduced administrative costs by 10% Eliminated industry research write-offs by $1.8M annually Eliminated need to outsource IRB savings $16M annually Reduced NIH annual audit findings from 14 to 0 for last 3 years Mitigated $65M in risk exposure Closed 27 major research compliance gaps Resolved 72 compliance questions raised by NIH for continued federal funding NIH Inquiry DOJ Settlement ©2011 MFMER | slide-16

Questions

Appendix

Step 1 – Establish a sense of urgency Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Examine market and competitive realities Identify and discuss crises and major opportunities BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 1 – Establish a sense of urgency Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Understanding difficulty of driving people from their comfort zones Becoming paralyzed by risks BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 2 – Form a powerful guiding coalition Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Assemble a group with enough power to lead change Encourage the group to work together as a team BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 2 – Form a powerful guiding coalition Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 No prior experience in teamwork at the top Relegating team leadership to HR, quality, or strategic-planning executive rather than a senior line manager BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 3 – Create a vision Create a vision to help direct the change Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Create a vision to help direct the change Develop strategies to achieve the vision BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 3 – Create a vision Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Presenting a vision that’s too complicated or vague to be communicated succinctly BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 4 – Communicate the vision Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Use every vehicle possible to communicate Teach new behaviors by leaders setting an example BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 4 – Communicate the vision Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Under communicating the vision Behaving in ways antithetical to the vision BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 5 – Empower others to act Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Get rid of obstacles to change Change systems or structures that seriously undermine the vision Encourage risk taking and unconventional thinking BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 5 – Empower others to act Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Failing to remove powerful individuals who resist the change effect BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 6 – Plan for and create short-term wins Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Plan for visible performance improvements Create visible performance improvements Recognize and reward employees involved BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 6 – Plan for and create short-term wins Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Leaving short-term successes up to chance Failing to achieve successes early enough (12-24 months into change effort) BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 7 – Consolidate improvements Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Use increased credibility to change policies, systems and structures that don’t fit new vision Hire, promote and develop employees who can implement the vision BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 7 – Consolidate improvements Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Declaring victory too soon—with the first performance improvement Allowing resistors to convince “troops” that the war has been won BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 8 – Institutionalize new approaches Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Articulate the connections between the new behaviors and corporate success Develop the means to ensure leadership development and succession BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

Step 8 – Institutionalize new approaches Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 Not creating new social norms and shared values consistent with changes Promoting people into leadership positions who don’t personify the new approach BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

The Stages of Changing 8 Steps to Transforming Your Organization Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8 Step 7 Step 6 Step 5 Step 4 Step 3 Step 2 Step 1 BPO (Business Process Opportunities)/ Quality Sponsored Management Systems Design – Refine supervisory structure in research. Policy System – Mechanism to standardize research policies and store in a common location. Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.