Quality Improvement

Models
Presented by: Donna M. Daniel, PhD
Atlantic Health
Morristown, New Jersey

Quality Basics Series

Taught by quality experts for staff in
Quality Improvement Organizations,
Quality Basics focuses on the
fundamentals of quality in areas such as
the history of quality improvement,
methods and models, performance
measurement and other key topics.

Quality Basics:

Quality Improvement Models

Presented by Donna M. Daniel, PhD
September 25, 2007

Quality Improvement Models

Organizational Frameworks / Quality Management Models

Quality Improvement Methods

Baldrige Evaluation Process

ISO 9001 Certification
Balanced Scorecard Approach
Six Sigma
Human Factors
Lean or TPS (Toyota Production System)
PDSA Cycles or Model for Improvement

Quality Improvement Theories

Reliability Theory
Spread Theory

Main Concepts
Baldrige: Performance Excellence
(value/quality service)

ISO 9000: Performance Excellence

(internal processes)

Balanced Scorecard: Performance Excellence

(measurement of business processes and external
outcomes)

Baldrige Award
The Malcolm Baldrige National Quality
Award is an award given, by the
President of the United States, to
applying organizations that meet
designated criteria.
Managed by U.S. Commerce
Departments National Institute of
Standards and Technology (NIST)
Award As Quality Model

Malcolm Baldrige
1922-1987
26th Secretary of
Commerce

"More than any other program, the Baldrige Quality Award is

responsible for making quality a national priority and
disseminating best practices across the United States."
--The Private-sector Council on Competitiveness

Criteria for Performance Excellence

The Baldrige Criteria is a framework that organizations can use to
improve their overall performance.

Leadership
Strategic planning
Customer and market focus
Measurement, analysis, and knowledge
management
Human resource focus
Process management
Business results

Key Tools
The Baldrige Criteria does not instruct organizations to
use any specific improvement tool, but allows the
organization to select the tool appropriate to their
improvement efforts.

In Healthcare
Baldrige Award Recipients

2006 North Mississippi Medical Center - Tupelo, MS

2005 Bronson Methodist Hospital Kalamazoo, MI
2004 Robert Wood Johnson University Hospital
Hamilton Hamilton, NJ
2003 - Baptist Hospital, Inc. - Pensacola, FL; Saint
Lukes Hospital of Kansas City - Kansas City, MO
2002 - SSM Health Care - a health care system in
four states IL, MO, OK and WI

ISO 9001 Certification

ISO 9001 is a series of international standards initially
published in 1987 by the International Organization for
Standardization (ISO), Geneva, Switzerland.
The standards specify requirements and
recommendations for design and assessment of a
management system, the purpose is to ensure products
and services meet customer requirements.
ISO 9000 registration determines whether a company
complies with its own quality system.

Criteria for ISO Certification

Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Relationships
Hoyle, David. ISO 9000 Quality Systems Handbook. Butterworth-Heinemann LTD, Oxford, 1998

Key Tools of ISO 9000

Flowcharting
Process mapping
Cause and effect diagrams
Plan-Do-Check-Act Cycles
and more

Healthcare applications of ISO 9000

Companies and health care organizations registered to ISO
9000 have reported significant reductions in customer
complaints, improved client relations, decreased employee
turnover and reductions in operating costs.1
It supports the business while assisting with safety, quality and
improvement on a continuing basis. 2
Leelanau Memorial Health Center improved overall financial
performance by 10 %, reduced annual employee turnover from
+ 40 % to 12 %, and their long-term care facility now meets 100
% of their customers expectations.3
1 & 3. Dillon, L. Rad, Healthcare and ISO 9000. An interview with Dr. Michael Crago. Quality
Management, Sept/Oct 2002. 43-47.
2. Quality Drives Business Improvement in Healthcare.
http://www.standards.org.au/STANDARDS/NEWSROOM/TAS/200310/HEALTHCARE/HEALTHCARE
.HTM

Balanced Scorecard
Developed in the early 1990's by Drs. Robert Kaplan
and David Norton
Distinguishing feature is based on what companies
should measure in order to 'balance' the financial
perspective
More than a measurement system a management
system

Components
For each of the four perspectives, objectives, measures,
targets and initiatives are outlined.
Learning & Growth To achieve our vision, how will we
sustain our ability to change and improve?
Customer To achieve our vision, how should we
appear to our customers?
Financial To succeed financially, how should we
appear to our shareholders?
Internal Business Processes To satisfy our
shareholders and customers, what business processes
must we excel at?

Improvement Methodologies

Lean
Human Factors
Six Sigma
Model For Improvement

Main Concepts
Lean: Waste; Efficiency (internal processes)
Human Factors: Performance; Variation (staff
abilities)
Six Sigma: Performance; Variation (cost saving,
business goals)
Model For Improvement: Processes

Lean Thinking
Definition
Lean Thinking is a way to do more and more work
with less and less-less human effort, less
equipment, less time, and less space-while coming
closer and closer to providing customers with
exactly what they want.
The aim of lean is to eliminate waste.

Defining characteristics: 14 Principles

Base your management decisions on a long-term philosophy, even at the expense of shortterm financial goals.
Create continuous process flow to bring problems to the surface.
Use pull systems to avoid overproduction.
Level out the workload.
Build a culture of stopping to fix problem, to get quality right the first time.
Standardized tasks are the foundation for continuous improvement and employee
empowerment.
Use visual control so no problems are hidden.
Use only reliable, thoroughly tested technology that serves your people and process.
Grow leaders who thoroughly understand the work, live the philosophy, and teach it to
others
Develop exceptional people and teams who follow your companys philosophy.
Respect your extended network of partners and suppliers by challenging them and helping
them improve.
Go and see for yourself to thoroughly understand the situation.
Make decisions slowly by consensus, thoroughly considering all options; implement
decisions rapidly.
Become a learning organization through relentless reflection and continuous improvement.

The Toyota Way: 14 Management Principles From The World's Greatest Manufacturer. by Jeffery Liker, J. McGraw-Hill. 2003.

Key Tools of Lean Thinking

Tools include, but are not limited to the
following

Value Stream Mapping

Process Mapping
Poka-Yoke (error-proofing)
Pull Systems (Kanban signal)
Visual workplace (5S - Sort, Straighten, Shine,
Standardize, Sustain)

On Lean Enterprise and Its Potential Healthcare Applications, by Martin, K. Journal for Healthcare
Quality. Vol 25. No 5. Sept/Oct 2003.

Healthcare Applications of Lean Thinking

Hospitals that are employing Lean Thinking

Denver Health

Johns Hopkins

Allegheny General

University of Iowa Hospitals and Clinics

University of Washington Medical Center

Virginia Mason

Atlantic Health

And many more

Jeff McAuliffe, Tom Moench and Joan Wellman, The Lean Enterprise Meets Health Care, Hospitals
and Health Networks, January 15, 2004.

Hospital Example
Steps
Value-Added Steps
Total Time
% Value-Added Time
Queues
Orders in Process
Handoffs
Inspection Steps
Variation in Methods
Variation in Cycle Time
2002 Corporate Strategies and Development, LLC
2002 Joan Wellman and Associates, Inc.

Before
25
4
70 min.
9% - 17%
11
132
10
4
High
High

After
9
4
20 min.
32 - 42%
3
39
5
2
Low
Low

Human Factors
Definition
Human Factors is the science of designing tools, tasks,
information, and work systems to be compatible with the
abilities of human users.
This includes both physical and cognitive abilities.

Mike Silver, MPH, An Introduction to Human Factors - Design for Use by Humans.
HealthInsight, Las Vegas NV, 2003.

Defining characteristics
Diagnosing the type error (execution errors, planning
errors, violations )
Execution errors - Correct Plan failure in
execution of the plan
Planning Errors Flawed Plan
Violations Intentionally deviated from plan
negative consequence not intended
Design interventions based upon the error type

Key Tools of Human Factors

Tools include, but are not limited to the following:
Analysis Tools (e.g. Analytic Hierarchy Process, Technique for
Human Error Rate Prediction, Decision Matrix for the Allocation of
Functions)
Assessment Tools (e.g. Situation Awareness, Global
Assessment Technique, Situation Assessment Rating Technique,
Situation Present Assessment Method, Situation Awareness
Verification and Analysis Tool)

For a listing of Human Factor Tools please see, http://www.hf.faa.gov/Portal/ToolsByTypeTally.aspx)

Healthcare applications
HealthInsights pilot project and Quality and Safety Series
Iowa Health System (IHS) Des Moines, IA is applying human
factors to their health system. Quote from Gail Nielsen, IHSs
Patient Safety Administrator, Human factors engineering touches
nearly every aspect of patient care, from equipment use and the
physical environment to staffing, workload, and patients ability to
use devices prescribed by their clinicians.

Human factors engineers/engineering (HFE) is recognized

as useful in critiquing medical device design, conducting
usability testing, and is credited with aiding remarkable
improvements in some areas of patient safety.
http://www.qualityhealthcare.org/ihi/Topics/PatientSafety/MedicationSystems/Literature/ImprovingPatien
tSafetyByIncorporatingHumanFactors.htm
http://ase.tufts.edu/mechanical/EREL/Publications/A-1.pdf

Six Sigma
Definition
Six Sigma is defined as a comprehensive and flexible
system for achieving, sustaining, and maximizing business
success.
Six Sigma is uniquely driven by close understanding of
customer needs, disciplined use of the facts, data, and
statistical analysis, and diligent attention to managing,
improving and reinventing business processes.

Pande, P, Neuman, R, and Cavanagh, R. The Six Sigma Way. McGraw Hill 2000

Defining characteristics
Six critical elements
Genuine focus on the customer
Data-and fact-driven management
Processes are where the action is
Proactive management
Boundary less Collaboration
Drive for perfection

Key Tools of Six Sigma

Tools include, but are not limited to the following:
Brainstorming
Affinity
Diagramming
Statistical Process Control
Tests of Statistical Significance
Force Field diagram
Balanced Scorecards

Healthcare application of Six Sigma

Bed discharge process
Reduction of external, temporary employees
Radiation oncology treatment planning
throughput
Cycle time to diagnose breast cancer

Luc Pelletier, Beth Lanham on Six Sigma in Healthcare. Journal for Healthcare Quality. Vol
25. No 2, March/April 2003.

Model for Improvement (MFI)

Definition

The MFI is based on a trial and learning approach. This trial

and learning approach revolves around three questions.
What are we trying to accomplish? (AIM)
How will we know that a change is an improvement?
(Criteria or Measures)
What changes can we make that will result in improvement?
(Testing Changes)

Focusing on these questions accelerates the building of

knowledge by emphasizing a framework for learning, the use of
data and the design of effective tests or trial.

Defining characteristics

Address the 3 fundamental questions

PDSA Cycle
Plan Change or Test
Do Carry out plan
Study Summarize Learnings
Act Determine Action

To address the items mentioned above this methodology

includes the following steps: Setting Aims, Establish
measures, Select Changes, Test Changes, Implement
Changes, Spread Improvement

Key Tools of MFI

Tools include, but are not limited to the following:

IHI Breakthrough Series Collaborative

PDSA Cycle

Run Charts

Control Charts

Measures: Balance, Process, Outcome

Flowcharts

Comparison Charts

Standardization

Healthcare applications of MFI

The Model for Improvement has significantly affected
healthcare through the IHI Breakthrough Series
Collaborative which incorporates the Model for
Improvement.
- www.qualityhealthcare.org
- www.improvingchroniccare.org
- www.ihi.org

Review of the Main Concepts

Baldrige: Performance Excellence (value/quality service)

ISO 9000: Performance Excellence (internal processes)

Balanced Scorecard: Performance Excellence

(measurement of business processes and external

outcomes)

Lean: Waste; Efficiency (internal processes)

Human Factors: Performance; Variation (staff

abilities)

Six Sigma: Performance; Variation (cost saving,

business goals)

MFI: Processes

Comparison of staff involvement across

methodologies
SL

Mid-Level

Front-Line

Baldrige

High

High

High to Med

ISO 9000

High

Med

Low

Balanced
Scorecard

High

Med

Low

Lean

High

High

High

Human
Factors

Med

Med

High

Six Sigma

Med

High Belts

Med

MFI

Med

Med

High

*Clearly varies by organization

Shared Concepts
Similar concepts for the six methodologies include:
Leadership
Measurement/Analysis base decisions on
knowledge
Product business/customer/market
People - human resources/management/staff
involvement and or satisfaction
Processes

IHI Spread Theory: A Framework for Spread

Leadership
-Topic is a key strategic initiative
-Goals and incentives aligned
-Executive sponsor assigned
-Day-to-day managers identified

Measurement and Feedback

Social System

Set-up
Better Ideas
-Develop the case
-Describe the ideas

-Key messengers
-Communities
-Technical support
-Transition issues

-Target population
-Adopter audiences
-Successful sites
-Key partners
-Initial spread plan

Knowledge Management

From IHI, Boston, Massachusetts

Com

mu

nic
atio
n

(aw

ar e

nes
s

& te

c hn
i ca

l)

On Better Ideas
CURRENT WAY

BETTER IDEA

Wait for cardiologist

ED activate Cath Lab

Reliance on memory

Standing ASA, beta blocker

order for AMI

Reliance on memory, lack of

ability to recognize failure

Pharmacist in ED

ED on divert

No OR blocking

Thanks to Qualis Health/Sharon Eloranta, MD.

On Set-Up: Adopter Categories

Innovators
Early
Adopters
2.5%
From Rogers,
1995

13.5%

Late
Early
Majority Majority
Traditionalists
34%

34%

16%

7 Leadership Leverage Points

1. Establish and oversee system-level aims for
improvement at the highest Board and leadership level
2. Align system measures, strategy and projects in a
leadership learning system
3. Channel leadership attention to system-level
improvement
4. Get the right team on the bus
5. Make the CFO a quality champion
6. Engage physicians: Avoid monovoxoplegia or
paralysis by one loud voice
7. Build improvement capability
IHI White Paper by James L. Reinertsen, MD, Michael D. Pugh, Maureen Bisognano, Seven
Leadership Leverage Points For Organization-Level Improvement in Health Care.

On Communication:

Campaign concept
Practice, Passion, Pull
PRACTICE: What people actually do and how
they do it. You must get to this level of change.
PASSION: Figure out how to attach the
energies of the people who are passionate
about what you are trying to do.
PULL: An effective campaign attracts people
rather than exhorting them to join!

Thanks to CFAR/Tom Gilmore and Qualis Health/Sharon Eloranta, MD.

Seven Spreadly Sins

1.
2.
3.
4.

Start with large pilots!

Find one person willing to do it all!
Be vigilant and WORK HARDER!
If a process worked in the pilot, then it should be spread
UNCHANGED!
5. Require the person who drove the pilot team to be
responsible for hospital-wide spread!
6. Look at defects on a QUARTERLY basis!
7. Early on, expect marked improvements in outcomes
without regard to process improvements!
Thanks to IHI and Qualis Health/Sharon Eloranta, MD.

IHIs Reliability Theory

IHI White Paper by Thomas Nolan, PhD, Roger Resar, MD,
Carol Haraden, PhD, Frances A. Griffin, RRT, MPA, Improving
the Reliability of Health Care.

Defining Reliability
Highly Unreliable

<80%

10-1 (1 or 2 failures in 10 cases)

~80-90%

10-2 (5 failures or less in 100 cases)

95%

10-3 (5 failures or less in 1000 cases)

99.5%

10-4 (5 failures or less in 10,000)

99.99%

Appropriate Care Measure

July 2005 through June 2006

201 High

352 High

487 High

272 High

1505 Low

1035 Low

636 Low

702 Low

National averages as reported to the QualityNet data warehouse. Slide provided by Dale W. Bratzler, DO, MPH, OFMQ, Hospital
Interventions QIO Support Center.

10-2 (95%) is the ONLY goal for.

Non-catastrophic processes
Definition: failure of the process does not lead to death or
severe injury within hours of the failure
10-1 performance or worse is commonly seen in these
processes

Why are we operating at 10-1 despite all of our talents and

resources?

Three-tier Design Strategy

Prevent initial failure using intent and standardization
Identify defects (using redundancy) and mitigate
Measure and then communicate the learning back into
the design process

CHF Reliability
Level 1 changes only (Step 1)

CHF Protocol For All

Admitted Patients

50-80%

10-25%
All items
on protocol
done

Protocol
Not Used

10-25%
Portions
of
protocol
not used

Standardization mostly structure

Reminders
Awareness and training
Feedback of data
Hard work

Usual Strategies
Level 1

Best
Effort
10-1

CHF Reliability
Level 1 and Level 2 changes (Step 2)

CHF Protocol For All Admitted Patients

50-80%
All items on
protocol done

Every patient
getting lasix
reviewed by
pharmacy for a dx
of CHF

10-25%
Protocol Not Used

10-25%
Portions of
protocol not used

Pharmacy starts
the protocol if dx
CHF

Reminders built into system

Default desired action
Redundancy
Standardize process

Level 2 changes at
individual process level

Best Effort
10-1

Best effort
barely 10-2

CHF Reliability
Level 1 and 2 + global changes (Step 3)

CHF Protocol For All Admitted Patients

50-80%
All items on
protocol done

Every patient getting lasix

reviewed by pharmacy for a dx of

10-25%

10-25%

Protocol Not Used

Portions of
protocol not used

Pharmacy starts the protocol

if dx CHF

CHF

Smoking
advice (all
patients counseled
about smoking and
risk of second hand
smoke)

Portions of protocol not

used (highest failure modes)
Detailed D/C
instructions (If
protocol on chart clerk
prints out DC instruction
sheet at discharge)

ACEI use (If

protocol on chart
pharmacy checks for use
of ACEI and calls MD if
not ordered)

Best Effort
10-1
Best effort
barely 10-2

Best effort
10-2 to a
barely 10-3

Reliability Design
1-Specify the steps
2-Use both level 1 and level 2 changes to attain 10-1
3-Segment population to test the design

Standardization to achieve
10-1 (Tier 1)
10% only
partially done

10% not done at all

1-Utilize a system level redundancy

2-Measure failure rates from step 1
3-Do not use unless step one is at least 10-1

1-Redesign only if articulated goal not

reached
2-Tackle one failure mode at a time

Identify Failures and Mitigate

failures if possible to achieve
10-2 (Tier 2)
Prioritize failure modes and
redesign steps 1 and or 2 if
articulated goal has not been
reached (Tier 3)

Concepts associated with 10-2

Decision aids and reminders built in
Desired action the default
Redundant processes utilized
Scheduling used in design
Habits and patterns
Falls in radiology

Standardization of process is the norm

Where can you go from here?

(or How to succeed in spite of the Options)

These tools allow you to construct what you wish:

Better trained work force
Focused attention to objectives/goals
It is about:

Measuring
Recognizing
Accountability
Achievement

THANK YOU!!
Donna M. Daniel, PhD
donna.daniel@atlantichealth.org
973-660-3272

Thank you for your participation!

For additional questions or resources
contact the Performance
Improvement QIO Support Center at
piqiosc@waqio.sdps.org
A recording of this session will be
posted on www.MedQIC.org