Post on 31-Mar-2015
CP1336232-1
A Case Study
Transforming Research Management Systems at Mayo ClinicPresented 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
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DisclosureThe presenters do not have any relevant financial relationships with any commercial interests.
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Presentation Outline
Learning Objectives Overview Questions
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.
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Overview
Mayo Clinic Overview Mayo Quality Framework Comprehensive Research Management
System Stages of Transformation
©2011 MFMER | slide-6
Mayo ClinicLocations
Mayo Clinic Health SystemMayo Clinic Health System
Mayo Clinicin Arizona
Mayo Clinicin Arizona
Mayo Clinicin Florida
Mayo Clinicin Florida
Mayo ClinicMayo Clinic
©2011 MFMER | slide-7
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
Over 90% of Mayo physicians are involved in research-related activities
$600 million research budget
Mayo Clinic research partnerships
Research: Overview
Bedside
Bench Population
Translational research
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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
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; 2006.
• Quality Academy Leader Training• Champions training• Articulate roles and expectations• Commitment to transparency• Communications plan
CultureIII• 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)
EngineeringIV
InfrastructureII• Quality Academy• Systems implementation
• Enterprise Learning System• Spread simulation practices
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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
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
◄ R
esea
rch
Ser
vice
s
RESEARCH PROCESS
Comprehensive Research Management System
Planning & Strategy ServicesResearch 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 ProcessBusiness 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 ServicesIdentification of Funding Opportunities, Proposal Submission Services, Budgeting and Forecasting, Contracting,
Fundraising, Intellectual Property Disclosures & Licensing
Training & Education ServicesCompliance 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
TranslationAnalysis& Reporting
Protocol Execution
ProtocolReview
Protocol Development
Concept Development
Pre-award Activities Study Activities Post-study Activities
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 4Research Infrastructure
Service Excellence
Phase 3Research Infra-
structure Process Improvement
Phase 2 Research
Infrastructure Compliance
Phase I Research Vision
and Strategic Priorities
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
The Stages of Change8 Steps to Transforming Your Organization
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
Research Management System Transformation
CRMS Inflection Points
©2011 MFMER | slide-16
Resolved 72 compliance questions raised by NIH for continued federal fundingClosed 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 1-32006-2011
CRMS Phase 42012-2017
Eliminated industry research write-offs by $1.8M annually
Implement QMS in all Research business units
NIH Inquiry
DOJ Settlement
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Questions
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Appendix
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 1 – Establish a sense of urgency
Examine market and competitiverealities
Identify and discuss crises and major opportunities
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
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
Becoming paralyzed by risks
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 2 – Form a powerful guiding coalition
Assemble a group with enough powerto lead change
Encourage the group to work togetheras a team
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 2 – Form a powerful guiding coalition
No prior experience in teamwork at the top
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.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 3 – Create a vision
Create a vision to help direct the change Develop strategies to achieve the vision
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 3 – Create a vision
Presenting a vision that’s too complicated or vague to be communicated succinctly
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 4 – Communicate the vision
Use every vehicle possible to communicate
Teach new behaviors by leaders settingan example
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 4 – Communicate the vision
Under communicating the vision Behaving in ways antithetical to the vision
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 5 – Empower others to act
Get rid of obstacles to change Change systems or structures that
seriously undermine the vision Encourage risk taking and unconventional
thinking
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
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
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 6 – Plan for and create short-term wins
Plan for visible performance improvements
Create visible performance improvements Recognize and reward employees involved
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-30
Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
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
Failing to achieve successes early enough
(12-24 months into change effort)
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 7 – Consolidate improvements
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
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 7 – Consolidate improvements
Declaring victory too soon—with the first performance improvement
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.
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Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Step 8 – Institutionalize new approaches
Articulate the connections between the new behaviors and corporate success
Develop the means to ensure leadership development and succession
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-34
Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
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
Promoting people into leadership positions who don’t personify the new approach
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.
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The Stages of Changing8 Steps to Transforming Your Organization
Establishurgency
Institu-tionalizeapproach
Producechange
Short-term win
Empowerstaff
Conveyvision
Createvision
Formcoalition
Step 8Step 7Step 6Step 5Step 4Step 3Step 2Step 1
Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.