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CP1336232-1 A Case Study Transforming Research Management Systems at Mayo Clinic Presented by: Steven C. Smith, Chair, Research Administration Leon G.

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Presentation on theme: "CP1336232-1 A Case Study Transforming Research Management Systems at Mayo Clinic Presented by: Steven C. Smith, Chair, Research Administration Leon G."— Presentation transcript:

1 CP 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

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

3 CP Presentation Outline Learning Objectives Learning Objectives Overview Overview Questions Questions

4 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. 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. 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. Describe the eight stages of changes, the critical action steps to take and the common problems to avoid. CP

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

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

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

8 Over 90% of Mayo physicians are involved in research-related activities Over 90% of Mayo physicians are involved in research-related activities $600 million research budget $600 million research budget Mayo Clinic research partnerships Research: Overview Bedside BenchPopulation Translational research ©2011 MFMER | slide-8

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

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

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

12 CRMS Key Strategic Objectives 1)Creating an Optimal Clinical Trials Management System 2)Implementing Quality Management Systems across all Research Business Units 3)Developing Scalable Infrastructure to serve MCHS, APN and clients globally

13 Research Services RESEARCH PROCESS Comprehensive Research Management System 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 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 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 ActivitiesStudy ActivitiesPost-study Activities

14 14 Research Management System Transformation CRMS Roadmap to Excellence Financial management systems Written policies and procedures Roles and responsibilities Compliance training and education NIH Response Circle Back Vision Strategic priorities Strategic initiatives Scorecard metrics 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 Management systems design Policy system Protocol management system Pre-award system Legal contracting system IRB process Quality Management Systems Comprehensive Training Program Phase 4 Research Infrastructure Service Excellence Phase 3 Research Infra- structure Process Improvement Phase 2 Research Infrastructure Compliance Phase I Research Vision and Strategic Priorities

15 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 The Stages of Change 8 Steps to Transforming Your Organization Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

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

17 CP Questions

18 CP Appendix

19 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 1 – Establish a sense of urgency Examine market and competitive realities Examine market and competitive realities Identify and discuss crises and major opportunities Identify and discuss crises and major opportunities Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

20 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 1 – Establish a sense of urgency Understanding difficulty of driving people from their comfort zones Understanding difficulty of driving people from their comfort zones Becoming paralyzed by risks Becoming paralyzed by risks Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

21 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 2 – Form a powerful guiding coalition Assemble a group with enough power to lead change Assemble a group with enough power to lead change Encourage the group to work together as a team Encourage the group to work together as a team Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

22 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 2 – Form a powerful guiding coalition No prior experience in teamwork at the top No prior experience in teamwork at the top Relegating team leadership to HR, quality, or strategic-planning executive rather than a senior line manager Relegating team leadership to HR, quality, or strategic-planning executive rather than a senior line manager Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

23 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 3 – Create a vision Create a vision to help direct the change Create a vision to help direct the change Develop strategies to achieve the vision Develop strategies to achieve the vision Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

24 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 3 – Create a vision Presenting a vision thats too complicated or vague to be communicated succinctly Presenting a vision thats too complicated or vague to be communicated succinctly Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

25 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 4 – Communicate the vision Use every vehicle possible to communicate Use every vehicle possible to communicate Teach new behaviors by leaders setting an example Teach new behaviors by leaders setting an example Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

26 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 4 – Communicate the vision Under communicating the vision Under communicating the vision Behaving in ways antithetical to the vision Behaving in ways antithetical to the vision Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

27 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 5 – Empower others to act Get rid of obstacles to change Get rid of obstacles to change Change systems or structures that seriously undermine the vision Change systems or structures that seriously undermine the vision Encourage risk taking and unconventional thinking Encourage risk taking and unconventional thinking Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

28 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 5 – Empower others to act Failing to remove powerful individuals who resist the change effect Failing to remove powerful individuals who resist the change effect Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

29 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 6 – Plan for and create short-term wins Plan for visible performance improvements Plan for visible performance improvements Create visible performance improvements Create visible performance improvements Recognize and reward employees involved Recognize and reward employees involved Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

30 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 6 – Plan for and create short-term wins Leaving short-term successes up to chance Leaving short-term successes up to chance Failing to achieve successes early enough Failing to achieve successes early enough (12-24 months into change effort) (12-24 months into change effort) Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

31 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 7 – Consolidate improvements Use increased credibility to change policies, systems and structures that dont fit new vision Use increased credibility to change policies, systems and structures that dont fit new vision Hire, promote and develop employees who can implement the vision Hire, promote and develop employees who can implement the vision Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

32 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 7 – Consolidate improvements Declaring victory too soonwith the first performance improvement Declaring victory too soonwith the first performance improvement Allowing resistors to convince troops that the war has been won Allowing resistors to convince troops that the war has been won Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

33 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 8 – Institutionalize new approaches Articulate the connections between the new behaviors and corporate success Articulate the connections between the new behaviors and corporate success Develop the means to ensure leadership development and succession Develop the means to ensure leadership development and succession Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

34 CP Establish urgency Institu- tionalize approach Produce change Short- term win Empower staff Convey vision Create vision Form coalition Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Step 8 – Institutionalize new approaches Not creating new social norms and shared values consistent with changes Not creating new social norms and shared values consistent with changes Promoting people into leadership positions who dont personify the new approach Promoting people into leadership positions who dont personify the new approach Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.

35 CP 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 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1 Source: Leading Change: Why Transformation Efforts Fail, Kotter, John P., Harvard Business Review, January, 2007.


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