Department ofVeterans Affairs

On the Road to Excellence

October 2010

Stuart R. Warren, J.D., Pharm.D.Deputy Director

Leadership Strategy Tactics As a Small

Organization The Future

Our Context Our Motivations Progress Along Our

Journey Approaches to Quality Political-Competitive

Strategy Speed Bumps &

Roadblocks

Roadmap

Our Context

Pharmacy Center

5 Coordinating Centers

Our Mission

To provide creative and innovative pharmaceutical, scientific, technical, operational and educational support to clinical studies to improve the health and care of the Veteran and the Nation.

Our Vision

We are pioneers in developing and managing the pharmaceutical aspects of clinical trials, while setting industry standards and exceeding customer expectations.

What is a Clinical Trial?

An experiment in humans comparing the effect and value of an intervention (a therapy) against a control

Intervention can be a drug, device, or strategy intended to treat or prevent disease

Control can be active or placebo A highly regulated activity!

VA Cooperative Studies Program

National infrastructure for developing & executing:• Multi-site clinical trials• Epidemiological research• Genomic medicine research

38 year history of executing landmark studies

VA Cooperative Studies Program

First VA Cooperative Study: 1940s evaluated streptomycin for tuberculosis in WW II veterans • Program formally established in 1972

• Over 175 clinical trials and studies to date

• Landmark studies in cardiovascular disease, infectious diseases, surgery, gastroenterology, mental health, oncology, and endocrinology

What is a Cooperative Study?

A clinical trial involving investigators and patients at multiple sites

Investigators cooperate to try to answer a medical question

Conducted under a common protocol

CSP Study FindingsA few examples

Warfarin helps prevent stroke Blood pressure management reduces heart attacks

& strokes Aspirin helps reduce heart attacks & death Antiarrhythmic drugs should not be routinely used

post MI

CSP Study Findings

Increasing HDL cholesterol reduces the risk of heart attacks

Diabetics can have quality of life using an insulin pump

Shingles vaccine is effective in preventing shingles and reducing symptoms in patient with shingles

CSP in the News

CSP 403

CSP News Makers

A Recent CSP Study

Current CSP Studies• > 30 active – 5 mental health/substance abuse + NIDA– 4 cancer– 4 general and cardiac surgery – 4 neurology– 3 cardiovascular– 2 renal – Others: • infectious disease• diabetes• COPD• genetics• spinal cord injury• rheumatoid arthritis• nutrition in elderly

Our Business

Pharmaceutical expertise: Study design/protocol Investigational drugs Packaging and

distributing to study sites Patient safety Regulatory compliance—FDA

Our Business

Baldrige video clip

Our Motivations

Why embark on this journey?• Obstacles, opposition• “Good enough for

government work”• Scientist/academics• Risks

Major motivators• Our mission and vision• Survival

Progress: Where did We Start?

Progress: Our Starting Line

1978–1995 (18-year period) Emphasis on Regulatory Compliance

• Veterans Affairs • Food and Drug Administration• Drug Enforcement AdministrationNascent entrepreneurial mindset

Progress: New Approaches

1996–2009 (14-year period) Emphasis on Quality and Performance

Excellence Management• ISO 9001• ISO 15378• Baldrige Criteria

Approaches to Quality: Why Baldrige and ISO?

The obvious: synergy between • ISO requirements• Baldrige: Measurement and Process Management

The unexpected: ISO links regulations and Baldrige through process documentation

Structure and discipline

Two Major Quality Management Approaches

Quality Management System • Focus on Process Management

o ISO 9001

Performance Excellence Model• Focus on Results-Oriented Improvement

o Baldrige Award, Deming Prize, European Quality Award

Tsiakals, J.J., ASQ ISO 9000:2000 Handbook, edited by Cianfrani, Tsiakals & West 2002.

Quality Management and Performance Excellence

Relationships between Quality Management (ISO 9001) and Performance Excellence (Baldrige)

Analogy to Abraham Maslow’s Hierarchy of Human Needs

Used in leadership training for the USAF during WWII

Tsiakals, J.J., ASQ ISO 9000:2000 Handbook, edited by Cianfrani, Tsiakals & West 2002.

Maslow’s Hierarchy of Human Needs

Tsiakals, J.J., ASQ ISO 9000:2000 Handbook, edited by Cianfrani, Tsiakals & West 2002

Quality Hierarchy – Goals*

*Adapted from Tsiakals

Quality Hierarchy – Objectives*

*Adapted from Tsiakals

Albuquerque Journal, July 18, 2010; New York Times, July 16, 2010

Quality Hierarchy

Quality Goals

Competitive Advantage

Efficiency

Regulatory ManagementVA, FDA, DEA & EPA

Quality ManagementISO 9001 & ISO 15378

PerformanceManagement SystemBaldrige Criteria for Performance Excellence

Competitive & Political Strategy

External validation & quality benchmark Identified opportunities to increase:•Capability •Capacity•Effectiveness •Efficiency

Value-added for our Program

Competitive & Political Strategy

Consistency with DVA Guiding Principles*• Customer Focus on Veterans and Families • Employee Focus• Results measurement• Innovation and continuous improvement

*DVA Strategic Plan FY 2010-14 p. 21

Competitive & Political Strategy

Consistency with DVA Strategic Goals*• Improving quality of services• Optimizing value• Improving Veteran satisfaction•Improving internal customer satisfaction with Dept management and support services• Making the Dept an employer of choice

*DVA Strategic Plan FY 2010-14 p. 21

Speed Bumps & Roadblocks

External Traditional bureaucratic

mindset• Reactive vs. proactive

Lack of external support (resources)• “Laudable goals. Go for it. No

money.”

Speed Bumps & Roadblocks

Internal Struggles & Debates:

“What do you want me to do: my job or Baldrige?”

“Need time to work on OFIs.”“Won’t new visibility lead to criticism?”

“What if we fail?”

Leadership Strategy: Our MapA Culture of Excellence

Leadership Strategy (Our GPS)

A culture of excellence: Appeal to noble instincts Getting the right people

in the right positions Employee engagement Deployed the strategy and motivations Focus on external threats and survival• “Invasion from Mars”

Leadership Strategy

Flexibility: exploit opportunities Investments: strategic planning and training Unwavering optimism

It is amazing what you can accomplish if you do not care who gets the credit.”

–Harry S. Truman

It is amazing what you can accomplish if you do not care who gets the credit.”

–Harry S. Truman

“

Operational Strategy

Get better (and be recognized): Train in quality principles Exploit synergy between

Baldrige and ISO Staff involvement Apply, apply, apply…• 18 applications, 12 site visits in 14 years• “Accepts constructive criticism”

As a Small Organization

Advantages: • Easier to change direction?

Disadvantages:• Limited financial and human resources

o Can’t just start new departmentso People have to wear multiple hats—no “specialists”

Tactics Along the Way

It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is the most adaptable to change.”

–Charles Darwin“No one has to change. Survival is optional.”

– W. Edwards Deming

It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is the most adaptable to change.”

–Charles Darwin“No one has to change. Survival is optional.”

– W. Edwards Deming

“

Tactics Along the Way

Adaptability and flexibility: Rotated category champions Developed measures integration team Distributed the work

• Cross-functional ISO audit teams

Rewards

Key Decisions & Milestones

►

►

► ISO 9001

ISO 15378ISO Journey

Baldrige Journey

Regulatory Focus

National

Award

1978 ‘93 ‘96 ‘03 2009‘04

State Award

VA Carey Trophy

Quality Future: The Road Ahead

• Feedback report: 29 OFIs• Quality participation• CSP-wide ISO certification• Measures and benchmarks

Process and Attitude Quest for Excellence….

Arriving at one goal is the starting point to another.”

–John Dewey

Arriving at one goal is the starting point to another.”

–John Dewey

“

Who Should Get the Credit?

Special Thanks

Veterans video clip