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

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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CP1336232-5

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


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



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

©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

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


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.


CRMS Inflection Points


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


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 1 – Establish a sense of urgency

Examine market and competitiverealities

Identify and discuss crises and major opportunities


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 1 – Establish a sense of urgency

Understanding difficulty of driving people from their comfort zones

Becoming paralyzed by risks


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 2 – Form a powerful guiding coalition

Assemble a group with enough powerto lead change

Encourage the group to work togetheras a team


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


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


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 3 – Create a vision

Create a vision to help direct the change Develop strategies to achieve the vision


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 3 – Create a vision

Presenting a vision that’s too complicated or vague to be communicated succinctly


CP1336232-25

Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 4 – Communicate the vision

Use every vehicle possible to communicate

Teach new behaviors by leaders settingan example


CP1336232-26

Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 4 – Communicate the vision

Under communicating the vision Behaving in ways antithetical to the vision


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


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


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 5 – Empower others to act

Failing to remove powerful individuals who resist the change effect


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 6 – Plan for and create short-term wins

Plan for visible performance improvements

Create visible performance improvements Recognize and reward employees involved


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


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)


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


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


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 7 – Consolidate improvements

Declaring victory too soon—with the first performance improvement

Allowing resistors to convince “troops” that the war has been won


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


Step 8 – Institutionalize new approaches

Articulate the connections between the new behaviors and corporate success

Develop the means to ensure leadership development and succession


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Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition


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


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The Stages of Changing8 Steps to Transforming Your Organization

Establishurgency


Producechange

Short-term win

Empowerstaff

Conveyvision

Createvision

Formcoalition



Documents

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