Third Edition

Q Solutions: Essential Resources

for the Healthcare Quality Professional
I

nformation Management

Robert J. Rosati, PhD

NATIONAL ASSOCIATION FOR HEATTHCARE @AIITY

Glenview;

IL

Other titles in the Q So/ufions Suite

and Manqement
Quality and P erformance Improv ement
Healthcare Safety
Regulation, Accreditation, and C ontinuous Reodiness

L e ader ship

Copyright @ 2OI2 by the National Association for Healthcare Quality. All rights reserved.
Except as permitted under the United States Copyright Act of 1976, no part of this
publication may be reproduced or distributed in any form or by any means, including but
not limited to the process of scanning and digitization, or stored in a database or retrieval
system without the prior written permission of the publisher.
Copyright O 2005,2008, 2Ol2by the National Association for Healthcare Qualiry.
All rights reserved. First edition published in 2005. Second edition published in 2008.
ISBN 978-0-9858 336-3-3
National Association for Healthcare Quality
47OO W. Lake Avenue
Glenview IL 60025
www.nahq.org
For the National Association for Healthcare Qualiry
Stacy Sochacki, Executive Director
Beth Zemach, Senior Programs and Product Analyst
Karen Schrimmer, Practice Content Manager
June Pinyo, MA, ManagingEditor
Monica Piotrowski, Associate Editor
Sonya Jones, Senior Graphic Designer
Printed in the Unitedstotes of America

ThirdEdition

Contents
I

l.HistoricalPerspective,Background,andCurrentlnitiatives
A. QualityManagementPhilosophy.
B. EarlyStrategiesof Managing forQuality
t. World War lland lts lmpact
z- The Japanese Quality Revolution and lts lmpact
C. QualityManagementPioneers.
l-Shewhart.
2. Deming.
5.Juran
4.Crosby.
s.lshikawa.
D. Healthcare Quality Management Pioneers.
1. The FirstEra: Nightingale, Codman, and theAmerican College of Surgeons

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1

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2.TheSecondEra,DonabedianandTheJointCommissioniMonitoringandEvaluationProcess.........T
5.TheThird Era: Berwick, Batalden, andJames "Discover" Deming, Juran, and'Japan,lnc." ..
E. Current and Evolving Healthcare Quality Management

Approaches

t.SixSigma
2. Lean Enterprise
5. Reenginee.ing ..
.
FocusonPatientSafety.
G. Patient-Centered Care..
H. TeamSTEPPS'".
a. Rapid Cycle lmprovement

F.

ll. IOM lmperatives, Priorities, and

A. PatientSafetyand

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Compefencies

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Harm

......12

System
C. PolicyandHealthcareQuality.
B. Changing the Healthcare Delivery

....

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Principles, Privacy, and Patients' Rights and

A. Conftdentiahty .
l.Releaseof lnformation.....

lnformation.....
B. MedicalPeerReview
C. Utilization Management
1. lnternal Review.
2. ExternalReview
D. MedicalRecords/ElectronicHealth Records(EHR,
l.lnformation Covered by Privilege
2. Patients'Billof Rightsand Responsibilities
2.Authorized Releaseof

12
13

........14

PublicReporting
B. RewardingforQuality

......14
........14

A.

lV Confidentiality

........

lll. PublicReportingandRewardingforQuality

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Responsibilities.

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Q SoluUions

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V. Evidence-Based Quality Management

A. TheQualityManagementResearch Continuum
B. Evidence-Based Practice . .

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..

C. Applying Epidemiological Principles to Ql

Vl. Measurement, Decision Support,

Risk

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Adjustment,

Benchmarking
A. DecisionSupport
B. RiskAdlusrment.

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.....24
.....25

..

Data lnterpretation, and

C. Analysis and Interpretation of Outcomes Data and Decision-Support

D.

Tools

Benchmarking...

Vll. Systematic Heahhcare

Quality

A. Developmentof a Quality lnformation System

B. StrategyforlnterpretationandUseof lnformation ..

Vlll.

. . . . .26

Systems
A. Purposesof lnformationSystems
t. Clinicallnformation Systems
2.AdministrativeSupportlnformationSystems.
3. DecisionSupportSystems
B. lmplementationof a QualityManagementlnformationSystem
1. EvaluatingSystems
2.Selecting a Quality ManagementSystem
C. FederalHealth lT lnitiatives.

.....27
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28

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Management lnformation

lX.QlStudyDesignandAnalysis
A. Getting Started on QPI Projects
B. DataandDataManagement
1. Categorical......
2.Continuous......
3. Statistical Power of Different Data Types
C. Data Collection Plan . .
D. BasicSamplingDesigns
1. Types of Sampling
a. Probability
b. Nonprobability ..
2.SampleSize..
E. DataAnalysis.
l. Reporting
2. lmportanceof Context
S.Variation
4.Tiend ldentification
F. StatisticalAnalysisand lnterpretationof Findings
1. MeasurementTools
2.Reliabiliry
a. ReliabilityCoefficient.
b. lnterraterReliability

...

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Validity
a. Content(Face)Validity.....
b. ConstructValidlty
c. Criterion-RelatedValidity .....
4.StatisticalTechniques
a. Measuresof Central Tendency
1) Mean.
2) Median.
3) Mode.
b. Measures of Variability.
1) Range,
2) StandardDeviation.
c. lnterpercentile Measures.....
S.Tests of StatisticalSignificance.
a. ParametricTests..
b. NonparametricTests
6. Concepts Related toTests of Significance.....
a. Confidencelntervals
b. Levelof Significance.....
G. PerformancelmprovementTools
1. Decision-Making MethodsandTools
2. Data Analysis and Process Improvement
3. Statistical Process Control
a.Typesof Variation

....

:.

X.

Summary

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70

References

71

Suggested Reading.

74

Online

Resources

lndex.

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viii

Q SoluEions

Tables
Comparison of Six Sigma Breakthrough Strategy and Juran! Problem-Solving

Table

1.

Gble

2.

Table s.
Table 4.

Table s.

Strategy

Process.
Projects.
StatisticalOptionsforDifferentDataTypes
Statistics ReferenceTable..

....

Research ProcessVersusQl

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Examples of Benchmarking

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28

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Figures
Figurel.

TheTiaditionalPlan-Do-Check-ActModel

Figure2. QualityMovementTimeline
Figure

3.

Figure4.

Health lnsurance Portability and Accountability Act of

Patients'Billof Rightsand

pga.

Responsibilities.

Figure6. Brainstorming
FigureT. Multivoting.
FigureS. NominalGroupTechnique.
Figure

9.

Activity Network

Diagram

Figure1O. DeploymentChartorPlanningGrid ..
Figure11. StratificationCharts
Figure12. HistogramorBarChart

Figurel5. ParetoDiagramorChart

Cause-and-Effect,lshikawa,orFishboneDiagram
ScatterDiagramorScatterPlot...
Healthcare FailureModeand EffectsAnalysis(HFMEA)
Figure lT. Affinity Diagram
Figure18. lnterrelationship Diagram.
Figure 19. Tree Diagram
Figure2o. MatrixDiagram.....
Figure21. PrioritizationMatrix.
Figure22. Flowchartor Process Flowchart.
Figure23. ProcessDecision ProgramChart(PDPC)
Figure24. RunChartorTrendChart.
Figure25. ControlChart.
Figure26. ForceFieldAnalysis
Figure27. Frequency Distribution.
Figure14.
Figure15.
Figure16.

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r'
ix

Foreword to the Third Edition

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Healthcare is at a transformative and exciting time as we embark on new models of delivering care. Prominent focal points during this essential time are quality, safety, innovation,
and the technology needed to bring higher levels of performance with lower costs. During
2otl and 2012, the National Association for Healthcare Quality (NAHQ) has been preparing for the transition by reenergizing our purpose and vision and solidifying our strategies
for meaningful work that benefits our stakeholders. Our challenge is determining how to
provide the greatest value to our members, certificants, and consumers of NAHQ products
while continuing to expand our reach.
We believe it to be of primary importance to coordinate the work of the NAHQ Board
of Directors, staff, and teams, as well as the Healthcare Qualiry Certification Commission
(HQCC) to ensure NAHQ products are ready for the market previotts to when programs are
offered. A prime example of the effort is the third edition of Q Solutfons.
I take this opportunity to personally thank Luc R. Pelletier, MSN PMHCNS-BC CPHQ
FNAHQ FAAN, and Chrisry L. Beaudin, PhD LCSW CPHQ FNAHQ, for leading this major
revision to Q Solurions with the most current information available. By providing continuity,
intellectual capital, and fortitude to this important NAHQ goal, we have the product ready
to deliver to you. The NAHQ Board called on a number of key people throughout the country to support the writing and review of the content, which coordinates with the Certified
Professional in Healthcare Quality (CPHO content outline's main divisions. I thank each of
them and the NAHQ staff for helping to bring this valuable resource to market.
This edition of Q solurions features a new approach to presentating content. By placing
the information within individual modules, purchasers may obtain a module specific to his
or her needs. The availabiliry of the first four modules (and fifth module soon after) of the
third edition coincides with updates to the United States regulation and accreditation content HQCC will begin using in January of ZOt3. I am certain all of you will \r/ant to share this
updated resource with your colleagues in the field of healthcare quality. These resources
will motivate you to excel even further.
My career development and leadership style have been enriched by many individuals,
especially those who have brought their best into this wonderful organization. NAHQ constituents are my network for identifying, learning about, and understanding changes that
are happening rapidly and continuously within care delivery. They enhance their workplaces, and patients benefit from their commitment to achieving healthcare improvement.
Promoting safe, effective, and efficient practices through education, certification, and advocacy are key components. I encourage each of you to identify the strengths in the people
and the products of NeHq. Enjoy the third edition of Q Solurions.
Betry Brown, MBA MSN RN CPHQ FNAHQ
NAHQ President, 2O|L-2OL2

Q SoluUions

Preface
Healthcare is complex and at times confusing to customers. Delivery systems, health plans,
solo and group practitioners, employers, and government agencies seek ways to achieve the
Triple Aim-ensure quality of care for the individual, improve the health of the population,
and control costs. Developing, deploying, and sustaining appropriate quality strategies
pose challenges and opportunities for healthcare quality professionals. Thoughtful
strategies employ effective, efficient, and evidence-based approaches to measure, monitor,
and determine outcomes. Did the actions and interventions yield intended goals and
objectives for improved qualiry and performance excellence? The healthcare quality
professional must successfully navigate the system to demonstrate quality and safety. The
application of sound theoretical and methodological practices is imperative. Q Solurions
covers the breadth and depth of critical areas for professional development and leadership,
including frameworks for quality management, the linking of science with practice, and
the translation of data into practical information that can be used and understood by any
customer, whether it is a practitioner, third-party payer, or consumer.
The development of the third edition of Q Solutions was informed by the most recent
Healthcare Qualiry Certification Commission's (HQCC's) practice analysis. The practice
analysis assesses the current functions and competencies for certified professionals in
healthcare qualiry. Organized under the HQCC detailed content outline, the following
modules were created:

,
.
.
.
.

Leadership andManagement

quality andPeformance Improvement

Healthcare Safety

Information Management
ReSu lat

ion, Accre ditation, and C ontinuous Readiness.

These modules feature critical components of healthcare qualiry the science and art
of quality and performance management, and environmental considerations such as
healthcare reform. In addition, Q Solutions was developed using feedback from healthcare
quality professionals and academic and policy experts in the field.
In our world of teeming technology, rapid innovation, and continuously expanding
science, we also rely on hope day in and day out. We hope that political agendas will reflect
the needs of patients, families, and other stakeholders; that resources will be available for
the work to be done; and that fear will not result in barriers to uncovering mistakes, flaws,
and failures. For healthcare qualiry to permeate the healthcare landscape, the cultures of
silence that still exist in institutions must be eradicated.
In addition to emerging technologies and techniques, the foundation of our work
involves the collaborative relationships we form and develop with various stakeholders.
Our work, after all, is relationship based. Mutual respect and accord lead to mutual
understanding and a sense of camaraderie as we face complex healthcare qualiry
challenges. This is accomplished in many ways including affiliations with professional
groups such as the National Association for Healthcare Qualiry (NAHQ).
Q Solurions is targeted to audiences across the care continuum and provides critical
knowledge to develop and enhance essential leadership skills in healthcare quality. In
effect, these tools and techniques are universal to any healthcare setting. The basic
principles can be adapted to your organization. When we embarked on the third edition
journey, there was no question about who the right people were to make these publications

xt

happen. We were humbled by the company we kept. Fortunately, these individuals made
time for what proved to be a fruitful endeavor. The product you hold in your hands would
not have been possible without the unceasing efforts of our esteemed authors-Cathy E.
Duquette, PhD RN CPHQ NEA-BC; Robert Rosati, PhD; Sr.rsan V. White; PhD RN CPHQ
NEA-BC FNAHQ; and Diane S. Brown, PhD RN CPHQ FNAHQ FAAN. Their vision
for NAHQ is depicted on every page. We thank them all for their thoughts and ideas
throughout the development process. In addition, we appreciate the thorough content
examinaticln by our external review panel members-James B. Conway, MS LFACHE;
Gerald N. Glandon, PhD; John Hansen, MD MPH; Bernarcl J. Horak, PhD FACHE CPHQ;
and Barbara G. Rebold, MS RN CPHQ. As always, we acknowledge the continuous support
of the NAHQ Board of Directors, which has resulted in the successflil launch of the third
edition of Q Solutions.
The work of healthcare quality professionals is noble indeed. Armed with a set of
advanced skills and practical tools, we are a force that can be boundless. Our nobiliry comes
from the fact that we are truth seekers. We are constantly challenged to tell a quality story
that is cogent, accurately depicts healthcare circumstances, and is understood by varying
audiences. To be able to tell the truth, we must demand that healthcare organizations
. provide resources necessary to conduct investigations and to maintain reporting
systems that use state-of-the-art information technologies;
. allow and support a solid infrastructure for continuoLls readiness, including health
information technology that supports the continuous quality improvement paradigrn
and doesn't disappear after an accreditation survey or regulatory audit;

.
.

ensure that all organizations are educated on the science of discovery (i.e., data,
methods, analysis, and application); and
contribute to the growing body of healthcare qualiry science by sharing evidencebased, outcomes-oriented qualiry techniques making a difference in the safety, care,
and service embraced by forward-thinking, highly reliable organizations.

Our primary goal for this suite of Q So/urions modules is to provide NAHQ members
and other qualiry and patient safety professionals with a product that is reliable, valid,
innovative, and timely. These updated modules reflect recent changes in national
healthcare safery as well as the transformation of healthcare as we know it. In the future,
NAHQ plans to supplement these modules with other relevant topics and learning
opportunities.
Luc R. Pelletier, MSN PMHCNS-BC CPHQ FNAHQ FAAN
San Diego, CA
Chrisry L. Beaudin, PhD LCSW CPHQ FNAHQ
Los Angeles, CA

Q SoluEions

xll

About the Editors

Luc R. pelletier, MSN PMHCNS-BC CPHQ FNAHQ FAAN, is an administrative liaison

at Sharp Mesa Vista Hospital, a core adjunct faculty member at National University, and
a healthcare consultant in San Diego, CA. He received a Master of Science degree in
nursing from Yale University and a bachelor of science in nursing from Fairfield University.
A healthcare quality professional for almost 25 years, Pelletier has participated in local
and national initiatives that ensure safe and equitable care for behavioral health patients
and has helped to shape systems of care and national standards of performance. He has
publishecl several books and written numerous chapters and peer-reviewed articles. He
has delivered presentations on various nursing and healthcare quality topics and given
writing seminars to aspiring authors. He was the editor in chief of the Journal for Heakhcare
journal grew in prominence as a leading
Quolity from 1998 to 2007. During his tenure, the
healthcare quality publication and was the recipient of various publishing awards. He has
served as a nurse expert with the U.S. Department of Justice and as a scientific consultant
to the National Institutes of Health. His current research focus is on nurse residency
progt ams in behavioral health and patient engagement. He is also a Fellow of the American
Academy of Nursing and NAHQ.

Christy L. Beaudin, PhD LCSW CPHQ FNAHQ, is national director of quality for AIDS
Healthcare Foundation in Los Angeles, CA. In her current role, Dr. Beaudin is responsible
for healthcare safety, accreditation, infection prevention and control, public reporting, and
education. At the executive level, she led healthcare safety efforts at Children's Hospital
Los Angeles, PacifiCare Behavioral Health, and Value Behavioral Health, and served as
vice president of research and development at Magellan Behavioral Health. Dr. Beaudin
supported hospitals and managed care organizations in preparing for and maintaining
state licensure and accreditation compliance including the National Committee for
Quality Assurance (NCQA), URAC, Accreditation Association for Ambulatory Health
Car.e (AAAHC), and The Joint Commission. Dr. Beaudin earned her doctorate in health
services from the UCLA School of Public Health, master's degree in social work from San
Diego State University, and bachelor's degree in criminal justice from California State
Universiry San Bernardino. Dr. Beaudin is adjunct faculty at the University of Redlands
and participates in state- and national-level quality initiatives for NAHQ, SNP Alliance, and
the California HealthCare Foundation. She is widely published, serves on several editorial
boards and review panels, and is a national subject matter expert on healthcare quality,
behavioral health, and managed care.

llii

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About the Author

Robert J. Rosati, PhD, is vice president of clinical informatics at the Center for Home
Care Policy and Research, Visiting Nurse Service of New York (VNSNY). At the Center, Dr.
Rosati is responsible for directing analysis and reporting of clinical ourcomes for patients
served by the VNSNY. He created and manages an Intranet website that allows all agency
staff to have access to reports and analyses provided by the Center's Informatics group.
The website provides detailed information on patient demographics, qualiry and outcomes,
referral sources, and utilization data. Dr. Rosati has more than 2O years' experience in
healthcare in varied research, qualiry management, educational, and administrative
roles. Dr. Rosati is currently on the faculty of Weill Cornell Nledical College and Hofstra
University. He has published many healthcare quality-related articles and made numerous
presentations at national meetings. Dr. Rosati has been an investigator on externally funded
research studies that include United Hospital Fund's Medicaid High-Cost Care Initiative,
Working Conditions and Adverse Events in Home Health Care, Patient Safety in Home
Care, and Improving Transitions and Outcomes for Heart Failure Patients through a
Hospital-Home Care Information Exchange. He also serves on the editorial board of the
J ournal for He akhcare Q

uality (JHQ).

External Review Board

This project could not have been completed without feedback from expert thought leaders
in the healthcare quality industry. We thank Dr. John Hansen for providing feedback for
this module.
John Hansen, MD MPH
Director of Quality Accreditation
Group Health Cooperative of South Central Wisconsin
Madison, WI

Acknowledgment
We would like to acknowledge Jacqr-reline F. Byers, PhD RN NEA-BC CPHQ FAAN, who
co-authored relevant content in the first two editions of Q .So/utions.

lnformation Management

Learning objectives
1.

Develop an understanding of activities required for the design and collection of data (e.g., activities,
records, reports and committee meetings).

2. Recognize tools and approaches useful in designing and constructing quality and performance

improvement activities (e.g., principles of qualitative and quantitative data collection).

5. Apply process analysis tools, basic statistical techniques and methods for statisticaI process control.
4. lnterpret data to support decision making and promote change to advance qLraliry- and performance

excellence in healthcare.

l.

Historical Perspective, Background, and Current lnitiatives

A. Quality Management Philosophy

The Institute of Medicine (IOM) defines healthcare quality as the extent to which health services provided to individuals and patient populations improve desired health outcomes.
Care should be based on the strongest clinical evidence and provided in a technically and
culturally competent manner characterized by good communication and shared decision
making (IOM, Committee on Quality of Health Care in America [CQHCA], 2001). As described later in this module, total quality management and continuous quality and performance improvement (QPI) are two strategies for achieving healthcare quality.
Total quality is best defined as an attitude or orientation that permeates an entire organization and the way in which an organization performs its internal and external business.
People accept individual responsibility for the quality of their work and elicit genuine commitment and active involvement from their organization's leadership. People who work in
organizations dedicated to the concept of total qualiry constantly strive for excellence and
continuous improvement in all that the organization does. Total qualiry integrates fundamental management techniques, existing improvement efforts, and technical tools through
a disciplined approach and focuses on continuous process improvement.
This definition of total qualiry is applicable to all healthcare settings. Regardless of the regulatory and accreditation standards to which an organization subscribes, leadership principles
remain as fundamental elements of the enterprise's strategic and quality planning. Leadership
is the driving force in creating and supporting the way people think about the things they do.
Leadership establishes the basis for procedures and focuses on customer needs, engagement,
and satisfaction. The leadership role must be genuine and visible, with active participation in
establishing, achieving, and rewardingthe attainment of qualiry objectives.

B.

Early Strategies of Managing for Quality

The need for quality has always existed. However, the means for meeting that need-the
processes of managing for quality-have undergone extensive and continuing change (Juran,1977). Before the 20th century managing for quality was based on ancient principles
that included product inspection by consumers, which is still widely used in today's villages,
and marketplaces concept, with which buyers rely on the skill and reputation of trained, experienced craftsmanship. Some craftsmen develop reputations that extend far beyond their
village boundaries. They are viewed as lirring national treasLlres.
As commerce expanded beyond village boundaries and with the $owth of technology,
additional methods and tools were invented to assist in managing for quality:
. Specifications by sample

Quality warranties in sales contracts.

Q Soluuions

In large towns, the craftsmen organized into monopolistic guilds, which generally were
strict in their enforcement of product quality. Their strategies included
. mandated specifications for input materials, processes, and finished goods;
. audits of the performance of guild members; and

o export controls on finished goods.

The early approach to managing for quality in the United States followed the prevailing practice in European countries that had colonized the North American continent. Apprentices learned a trade, qualified to become craftsmen, and in due course might become
masters of their own shops.
The Industrial Revolution, which originated in Europe, created the factory system,
which soon outproduced the small independent shops and made them largely obsolete. The
craftsmen became factory workers, and the masters became factory foremen. Quality was
managed as before, through the skills of the craftsmen, and supplemented by departmental inspection or supervisory audits. When the Industrial Revolution spread to the United
States, Americans again followed European practice. The Industrial Revolution also accelerated the growth of additional strategies, including
. written specifications for materials, processes, finished goods, and tests;
. measurement and the associated measuring instruments and testing laboratories; and

standardization in many forms.

1.

World War ll and lts lmpact

During World War II, U.S. industry was faced with the added burden of producing enormous
quantiiies of military products.Apart of thewar strategywas to shutdown production of many
civilian products such as automobiles, household appliances, and entertainment products.
A massive shortage of goods developed amid a huge buildup of purchasing power. It took the
rest of that decade (the 1940s) for supply to catch up with demand. In the interim, manufacturing companies gave top priority to meeting delivery dates, so quality of products suffered.
The practice of givingtop prioriry to delivery dates persisted longafter the shortages ended.
A new strategy emerged during World War II: statistical quality control (SQC). The War
production Board, in an effort to improve the qualiry of military goods, sponsored numerous training courses on the statistical techniques developed by the Bell System during the
1920s. (Interestingly, W. E. Deming, who became widely known during the 1980s, was one
of the lecturers at some of the War Production Board courses) Many training course attendees became enthusiastic and organized the American Society for Quality Control (now
known as American Sociery for Qualiry [ASQ). In its early years ASQ was strongly oriented
toward SQC, thereby stimulating further enthusiasm for the method.
As it turned out, most SQC applications in the manufacturing companies were tooloriented rather than results-oriented. As long as government contracts paid for everything,
the companies could not lose. In due course the government contracts came to an end and
the SeC proglams were re-examined from the standpoint of cost-effectiveness. Most of
them failed the test, resulting in wholesale cutbacks.

The Japanese Quality Revolution and lts lmpact

After World War II, the Japanese embarked on a course of reaching national goals through
trade rather than military means. The major manufactttrers, which had been extensively involvetl in military production, were faced with converting to civilian products. A major obstacle to selling these products in international markets was a reputation for shoddy

2.

merchandise, created by the export of poor-qualiry goods before World War

II.

lnformation Management
To solve their quality problems, the Japanese learned how other countries managed for
quality, sending teams abroad t6 visit foreign companies and study their approaches. They
also invited foreign lecturers to Japan to conduct trainingcourses for managers.
As the result of this educational process, the Japanese devised unprecedented strategies
to create a revolution in quality. Several of those strategies proved crucial:
Upper managers personally took charge of leading the revolution.

.
.
.
.

All levels and functions underwent training in managing for quality.

QPI was undertaken at a continuing, revolutionary pace.
The workforce was enlisted in QPI through the qualiry circle (QC) concept. QCs involve employee participation in decision making and problem solving to improve the
quality of work.
During the early postwar period, American companies logically considered competition from the Japanese to be based on price rather than quality. Their response was to
shift the manufacture of labor-intensive products to low-labor-cost areas, often offshore.
As time went on, price competition declined while quality cornpetition increased (Juran,
1981). During the 1960s and t970s, numerous Japanese manufacturers greatly increased
their share of the American market; a major reason was the superior quality of their products. Numerous industries were affected (e.g., consumer electronics, automobiles, steel,
and machine tools).
U.S. companies generally failed to notice the trend, continuing to believe that competition from the Japanese primarily was price-based rather than qualiry-based. Some observers sounded warning signals: "The Japanese are headed for world quality leadership and
will attain it in the next two decades because no one else is moving there at the same pace"
(Juran, 1967). The alarm was sounded at the conference of the European Organization for
Quality Control in Stockholm in June 1966.
The most obvious effect of the Japanese qualiry revolution was the massive export of
goods. The impact on the United States was considerable, especially in sensitive areas such
as manufacturing, steel, and electronics. The affected manufacturing companies were damaged by the resulting loss of sales. The workforce and their unions were damaged by the
resulting "export of jobs." The national economy was damaged by the resulting unfavorable
trade balance.

C. Quality Management Pioneers

Certain important figures in the QPI movement viewed process as a sequence of activities
and communications that fulfilled a service need for a client or customer (Gaucher & Coffey, 199I). The focus is on improving a process to improve the quality of an outcome.

1.

Shewhart
In the 1920s Walter Shewhart, a statistician at Bell Telephone Laboratories, developed the
Shewhart cycle, known as Plan-Do-Check-Act (PDCA; Figure f). This four-step process is
designed to continuously improve quality.
Plan. Question the capaciry or capability of a process. Pose theories on how to
improve the process and predict measurable outcomes.
Do.
Make changes on an experimental, pilot basis.
Check. Measure outcomes compared to predicted outcomes.
Act.
Implement the changes on a broad scale (Gaucher & Coffey, 1991).
The PDCA cycle later was adapted by Deming as the Plan-Do-Study-Act cycle; therefore, it also is referred to as the Deming Cycle or the Deming Wheel.

I
I
I

Q Solubions

1.

The Tiaditional Plafi-Do-Check-Act Model

3.
2.

4.

Measure and
analyze data

Describe the
current Process

Identifyimprovement
opportunities

P.AN\
'(

Identify root causes of

problems

1. Identify customer
needs,/expectations

11.

Monitor the change

and hold the gains

r')

5.

solutions

CHECK

?"/

\-/
10. Standardize the change

9. Draw

Generate and choose

8. Evaluate

Plan and implement

a pilot of the solutions
results of Pilot

conclusions

2. Deming

"gurus." A statisW. Edwards Deming is probably the most famous of the industrial quality
tician with doctorates in mathematics and physics, he ultimately became the "philosopher"
of qualitv and the learning organization. The story of post-World War II America's rejection of Deming's quality exhortations-and of his subsequent dealings with a receptive Japan-now is legend (Merry, l9g2).In the 1950s Deming had visited the Western Electric
Hawthorne plant in Chicago (while the Harvard University study regarding motivation of

workers was in progress). Following this experience he proposed replacing traditional

management techniques with a statistically controlled management process to determine
when-and when not-to intervene in a process. Statistical process control (SPC) techniques
allow management to determine a range of random variation that always occurs in a process. SpC describes two types of random variation causes: common cause and special cause.
Common-cause problems are rooted in basic processes and systems. Special-cause problems
stem from isolated occurrences that are outside the system. Deming said that 85% of the
problems detected are process- or system-related, and 157o are traceable to individuals; this
is known as the "B;f11theory" (Deming 2000a). Deming's management philosophy is based
on his t4 points for business to be competitive.
l. Create a constancy of purpose toward QPI.
2. Adopt a philosophy that expects good products and services.
3. Cease dependence on mass inspection and build qualiry into the product or service.
4. Do not award business solely on price tag.
5. Improve constantly the system of production and service6. Institute on-the-job training.
7. Institute leadership with an arm to help people and machines do better jobs.
8. Drive out fear.
9. Break down barriers between departments.
10. Eliminate slogans, exhortations, and targets.
[. Eliminate number quotas and management by objective, and substitute leadership.
12. Remove barriers to pride of workmanship.
13. Institute education and self-improvement.
14. Take action to accomplish the transformation (Deming, 2OOOa,2000b).

i-'
I

lnformation Management

3.

Juran
Joseph Juran's background was in errgireering and law. He followed Deming to Japan after
World War II, emphasizing the key role of top organizational leadership and the quality process in the organi zatior. (Merry, Lg92).In Juran on Leadership for Quality (1989), Juran states
that quality is "product performance that results in customer satisfaction; freedom from
product deficiencies which avoid customer dissatisfaction" (pp. 16, 31). This concept is known
as fitness for use and is explained in Juran's Trilogy@. Juran states that the cost of quality accoLu-rting means there is a break-even point of less than 1007o. Beyond a certain point, the
cost of providing quality exceeds the value of the incremental improvement in quality. Juran's
Trilogy is analogous to certain familiar financial processes. Quality planning is equal to budgeting, quality control (sometimes called measurement) is comparable to cost control, and
QPI relates to cost reduction and margin improvement (Gaucher & Coffey, 1991).

4.

Crosby

In the 1970s and t980s Philip B. Crosby developed an important concept known as the cost
of fpoorl quality. His work documented that high qualiry (what he terms "conformance to expectations') is less costly than the waste and rework that characterizes poor-quality processes. Crosby demonstrated conclusively that investment in qualiry can offer an enormous
financial return (Merry lg92). Five stages of management maturity are identified by Crosby in his book, Quality ls Free (tgzg). Crosby's underlying philosophy is "Do it right the first
time." The stages are
l. Uncertainty (when an organization is characterizedby the statement, "We don't know
why we have qualiry problemsJ')

2. Awakening
3. Enlightenment
4. Wisdom
5. Certainty (reserved for organizations in which top management proclaims, "We know
why we don't have quality problems." The mature company is equipped to initiate a
quality improvement (QI) program [Hunt, 1992])Crosby identifies 14 steps to improve qualify and move a company toward "certainty."
1. Management is committed to qt.
2. A QI team is formed to oversee actions.
3. Qualiry measurement is undertaken appropriate to the activities undergoing
improvement.
a. Qualiry cost is evaluated, using estimates as necessary'
5. Quality awareness is promoted through various methods and supervisor involvement'
6. Corrective actions are generated in response to steps 3 and 4.
7. Zero-defects planning is tailored to the company and its products.
8. Supervisory training is undertaken at all management levels.
9. A zero-defects day is held to celebrate a new performance standard.
10. Goals are set for individuals and groups.
11. Error cause is removed by management after notification.

D.

Goals are met and recognized.

13. The qualify council's experiences, problems, and ideas are shared.
14. The process is repeated. (QI is a never-ending process.)

Q SoluUions

5.

lshikawa
Kaoru Ishikawa \Mas'one of Deming's early Japanese hosts and inventor of the cause-andeffect, or fishbone, diagram and is credited with using the term total quality control to imply
not just the operational but also the total organizational commitment (marketing, finance,
research) needed to fully actualize all components of the modern quality-committed organization. The preferred American term is total quality management (TQM; Merry, 1992).

D. Healthcare Quality Management Pioneers

A timeline for the quality movement, which began in the lgth century and continues into
the 21st century, is described in this section and in Figure 2.

1863

Florence Nightingale calls for a systematic review of patient care.

1910

Codman proposes an end-result system of hospital standardization'

191 8

The American College of Surgeons develops minimum standards for hospitals and conducts its first

1950

Donabedian formulates a theoretical framework for patient care evaluation (structure, process, outcomes). The Joint Commission on Accreditation of Hospitals (now The Joint Commission) is
formed; accreditation of hospitals begins in 1953.

1960

Japan focuses on becoming a world quality leader; adopts the Deming management philosophy.

1970

Juran and Crosby build on Shewhart and Demingi work; Plan-Do-Check-Acti Plan-Do-Study-Act
cycles emerge.

1980

Berwick, Batalden, and James start applying Ql methods to healthcare.

1999

lnstitute of Medicine releases the report, To Err ls Human.

2000

Six Slgma, Lean Enterprise, rapid cycle improvements, safety, and pay for performance begin to have
an impact on healthcare quality.

2002

Medicare begins a series of quality measurement and reporting initiatives starting with nursing homes,
followed by home health care, and eventually hospitals and physicians.

2010

The Patient Protection and Affordable Care Act is signed into law.

1. The First Era: Nightingale, Codman, and the American

College of

Surgeons
In 1863 Florence Nightingale noted that patients seemed to fare better in some London
hospitals than in others. She was the first to call for systematic inquiry into the nature of
care processes that could be related to outcome variabiliry. Although there is little evidence
that Nightingale's qualiry vision came to fruition during her lifetime, Boston surgeon Ernest
Codman's early 2oth-century efforts had a more direct impact. Codman, who also observed
variability in patient outcomes among several hospitals, called for a systematic evaluation
process with a view toward improving care (Codman, 1916,1972). Although his efforts met
considerable rdsistance, Codman's ideas were embodied in the founding of the American
College of Surgeons in 1913. This body of work set about the task of establishing quality
standards. In l9l7 the College established a five-part "minimum standard" and the Hospital Standardization Program was born (Roberts, Redman, & Coate, 1987). The program was
based on Codman's end-result system of standardization in which hospitals would track every patient treated for long enough to determine if the treatment was effective. When treatment was fbund to be ineffective, the hospital would attempt to determine why such similar
cases could be treated with success in the future.

lnformation Management

2.

The Second Era: Donabedian and The Joint Commissioni Monitoring and
Evaluation Process
Accreditation standards evolved slowly throughout the 1950s and early 1960s. At the academic level, the Universiry of Michigan's Avedis Donabedian, MD, examined existing research, formulating a theoretical framework for patient care evaluation (Donabedian, 1980).
He is best recognized for his'structure, process, outcomes" model of quality evaluation.
This model suggests the importance of relating healthcare structures (qualifications
of practitioners and facilities and technology available to ttrem) and processes (activities involved in prevention, diagnosis, and treatment) to outcomes (how patients fare as a
result of their care). In the past Joint Commission standards mainly reflected the structure
and process elements of this model. Surveyors, who reviewed the structures and processes,
assessed hospital plans and technology, qualifications of clinicians and administrators,
and organizational structures against the annually updated requirements contained in the
Comprehensive Accreditation Manualfor.Flospitals. Specialized standards for behavioral health
and other services were also developed. Surveyors inferred process from documentation and
discussion. They reviewed minutes and interviewed clinical and administrative leaders to ascertain whether designated individuals were following proper quality evaluation processes.
As a matter of policy and practical considerations, accreditation standards did not address
patient outcomes directly. First, there were problems with the way "quality" was measured.
Second, no professional consensus existed on systematic measures of patient outcomes. Finally, uniform and comparable clinical databases were nonexistent. The problems of measuring and interpreting patient outcomes precluded their practical use in accreditation. As
a consequence, the accreditation process was necessarily built on an implicit assumption
that if proper structures and processes were in place, good outcomes were likely to follow.

3.

The Third Era: Berwick, Batalden, and James "Discover" Deming, Juran,

and'Japan, lnc."
The names of Donald Berwick, MD, Paul Batalden, MD, and Brent James, MD, stand out
in the field of healthcare quality management. Like many of their colleagues, these physicians were dissatisfied with traditional healthcare quality assurance (QA) practices. These
pioneering physicians, however, went beyond a mere critique of existing QA. Both Berwick and Batalden researched the industrial methods publicized by the Japanese experience. Arising from this research, Berwick's article describing healthcare QA as based upon
the "Theory of the Bad Apples' has become a classic (Berwick, 1989). Among his many contributions, Batalden translated Deming's famous 14 points (Crosby, 1979) into a healthcare
context (Batalden & Buchanan, 1989). InL987, these two physicians played key roles in linking with the Juran Institute and a variety of industrial quality consultants to create the National Demonstration Project on QPI in Healthcare. This multiyear project and its'original
21 forward-looking healthcare organizations conclusively demonstrated the applicability of
TQM processes to healthcare (Berwick, Godfrey, & Roessner, 1990).
James, of the Intermountain Health System, also was a pioneer in applying QPI processes directly to patients and clinical outcomes. The success of James and his team has
been measured not only in improved results in a single hospital, but also across the entire
multihospital system (James, 1990). James founded the Institute for Health Care Delivery and Research at Intermountain Health in Utah with a vision "to improve quality and
reduce the cost of healthcare services by providing technical support and education for
clinical research and process management within the Intermountain Healthcare system"
(Intermountain Healthcar e, 2Ol2).

tI

Q SoluUions

In 1991 Berwick established a not-for-profit organization, the Institute for Healthcare

Improvement (IHI), which b,jgan driving improvements in healthcare by supporting national projects that focus on safery effectiveness, patient.certeredress, timeliness, efficiency, and equity (the six primary areas identified in the IOM report; IOM, CQHCA, 2000).
One approach was to set up collaboratives involving many organizations that were attempting to affect the same issue and then use rapid-cycle improvement efforts to implement
change. A major benefit of this approach is that the collaborating organizations share their
experiences and improvements spread quickly. Projects that have been initiated include
improvements in chronic care, critical care, patient safery and end-of-life care. Berwick was
appointed administrator of the Centers for Medicare & Medicaid Services (CMS) in 2010
and served for 18 months in the Obama administration. While in office, he integrated the
"triple aim" into health policy: improving the patient care experience, improving population health, and reducing health costs (Berwick, Nolan, & Whittington, 2008), and was
responsible for initiating major changes under the new health reform legislation.
As more experience is gained in applying TQM to healthcare, the list of visionary leaders, both clinical and managerial, continues to grow.

E. Current and Evolving Healthcare Quality Management Approaches

1.

Six Sigma
In 1998 Mark Chassin, MD, (now the president of The Joint Commission) concluded, "\Me
can learn a good deal from industries that are working toward the Six Sigma goal. Let's try
it in healthcare and see how close we can get" (Chassin, 1998, p. 587). During the past several years this approach has taken hold in a number of hospitals and health systems. With
cost, qualiry, and regulatory pressures increasing within the healthcare industry, Six Sigma
is drawing increased attention from hospitals and health systems sceking a better approach
to achieving long-term results. The Six Sigma approach to improving quality can be used
to address many of the challenges facing healthcare, including resource utilization, patient
safery appropriate use of technology, and increasing market share. The Six Sigma strategy
(Harry & Schroeder, 2000) is remarkably similar to Juran's problem-solving stratery (Plsek
& Omnias, 1989), which has been applied to healthcare (Pelletier, 2000; Table f).
Six Sigma is a rigorous methodology that uses data and statistical analysis to measure
and improve performance. Quality is improved by eliminating errors in production and
service-related processes. Six Sigma is based on the concept of the normal distribution or
curve and the belief that there is 0.6 standard deviations from the mean at which there
should be almost zero defects. Accordingly, error rates shollld not exceed 3.4 defects per
million opportunities (DPMO). Six Sigma can be thought of as obtaining the right measures (or metrics) of quality, using rigorous statistical methods, and having a philosophy
that is customer-focused and data-driven. A Six Sigma project can address process redesign, a problem that needs to be solved, a change that needs to be instituted, or a process
that needs to be monitored. Six Sigma projects are managed by "Black Belts." Black Belts
are members of the organi zation who have been extensively trained in Six Sigma methods. Black Belts also must be experienced in statistical analysis and interested in teaching
others. Projects normally are carried out by "Green Belts" (organization members who
are knowledgeable about Six Sigma methods but who have received less training). For
major projects an organization also will assign a senior manager or executive to act as
a sponsor. Barry, Murcko, and Brubaker (2002) suggest that lo/o of the professional staff
within an organi zation be trained at the Black Belt level and 4o/o or 5o/o be trained as
Green Belts. Six Sigma has been successful in reducing emergency department wait times

lnformation Management

Table 1. Comparison of Six Sigrna Breakthrough Strategy and Jurani Problem-Solving

Strateqy

Strategy
Stage
Step [Objective]
ldentification Recognize
Define

Six Sigma Breakthrough

Jurani Problem-Solving Strategy

Phase

Step

Project definition and

organization

1. List and prioritlze problems

2. Define project

and team

(ldentify key business issues)

3. Analyze symptoms
Diagnostic journey
Measure
4.
Formulate theory of causes
Analyze
5. Test theories
(Understand current
performance levels)
6. ldentif,v root causes
Remedialjourney 7. Consider alternative solutions
Optimization lmprove
8. Design solutions and controls
Control
9. Address resistance to change
(Achieve breakthrough
10. lmplement solutions and
improvement)

Characterization

controls

lnstitutionalization

Standardize
lntegrate

Holding the

gains

11. Check performance

12. Monitor control system

(Tiansform how day-to-day

business is conducted)

and medication errors and eliminating duplicated tests (Barry, Murcko,

&

Brubaker,

2002).

2. Lean Enterprise
The Japanese automotive industry initiated the concept of lean manufacturing, whereby
great importance is given to reducing waste and focusing on activities that add value for
the custom er. Lean enterprise has in its roots the work of Deming but also includes a Japanese approach to business management. There has been growing interest in applying similar principles in service industry environments including healthcare. Lean enterprise includes the application of value stream analysis, a tool for exposing waste, and root cause
analysis, which is a method for pursuing perfection. Lean enterprise also includes the use
of new technologies to facilitate more efficient practices. Jones and Womack (2003) describe the philosophy in their book,LeenThinking.
The major focus in a lean enterprise is to eliminate waste in the following areas: production, waiting time, inappropriate processing, inventory, transporting, and defects (Jones &
Womack, 2OO3; Martin,2003). One of the major distinctions of the lean approach versus traditional QPI is its emphasis on investigatingnewways to get things done and makingchanges
in a short period of time. The basic idea is to identify new procedures that should be more
effective than existing systems in eliminating waste. QPI typically has used the incremental
change model, but lean enterprise is more about total redesign. A key element of success is
the commitment and involvement of workers in the change process. The typical project will
include cross-functional teams that have been trained in lean enterprise principles and tools.
It is probably better for an organization to implement lean methods before considering Six
Sigma because waste should be eliminated before fine-tuning the system to deliver excellence.

3.

Reengineering
In the 1990s reengineeringwas one of the major initiatives in hospitals. Most of these efforts
were focused on workforce redesign. There typically was a focus on restructuring systems

Q SoluEions

10

and departments into more efficient processes. For example, hospitals experimented with
creating new positions that combined work from several different areas. A focus on crossfunctional capabilities led to the dissolution of departmental "silos." A "patient services associate" or "technical associate" would deliver meals, clean patient rooms, stock supplies, and
provide patient transportation. Many hospitals thought that reengineering would increase
profit margins and create financial stability. The problem was that reengineering often
became associated with downsizing and layoffs. When this happened, employee morale
declined and productivity suffered. Because of these negative connotations, reengineering
has fallen out of favor and been replaced by other improvement models and initiatives.
The more contemporary approach is to consider adopting the lean enterprise method to
increase financial stability by eliminating waste.

4.

Rapid Cycle lmprovement

The IHI developed the "collaborative" approach, termed the "Breakthrough Series," to
bring about rapid cycle improvements. Fundamental to the collaborative approach is the
acceptance of a model and establishment of infrastructure through which collaborating organizations can identify and prioritize aims for improvement and gain access to methods,
tools, and materials that will enable them to conduct sophisticated, evidence-based QPI
activities they could not conduct individually. The key elements of success are enlisting a
broad range of "partners," using evidence-based practice (EBP) to improve quality of care,
and developing tool kits that contain essential information and resources for change. At the
core of the collaborative approach are PDCA cycles that build on incremental improvements.
The primary benefit to organizations that participate in the Breakthrough Series is they can
learn from other organizations' successes and failures. Another key principle to the IHI approach is the concept of spread. IHI has proposed that successful small-scale improvement
efforts initially will affect individual organizations and spread later to the industry (i.e., other hospitals) and eventually to the entire healthcare system. The spread is fostered through
learning sessions during which organizations share their experiences. The IHI approach also
can be adapted to a single organization (the work begins within a few units or teams and then
is spread to other units and, eventually, the entire organization).
The IHI also developed virtual support tools for improvement. For example, IHI recently launched expeditions, which are "topic-specific, action-focused program[s], lasting
3-5 months, designed to help frontline teams make rapid improvements in key components
of the Improvement Map" (a free, interactive, Web-based tool designed to bring together
the best knowledge available on the key process improvements that lead to exceptional
patient care; IHI, 2012, para.2).

F.

Focus on Patient Safety

In the 21st century eliminating medical errors has become the major push throughout the
healthcare industry. Whether the focus is on medications or surgery the goals are the sameto assure patients they are being treated in an absolutely safe environment. There also is a
regulatory component to patient safety, as identified in Joint Commission, federal, and state
mandates for the reduction of medical errors. There are many proposed solutions to improving patient safefy, from computerizing order entry systems to having patients indicate
on their bodies, using markers, the area to be operated on. To increase patient safery healthcare organizations need to conduct a thorough analysis of where and how patients are at risk
for potential medical errors. Byers and White QoO4) suggested that approaching patient
safety within an organization requires a review in six key areas: structure, environment,
equipment/technologies, processes, people, and leadership/culture.

nformation Management
Evaluating structure involves reviewing whether the general facilities are designed to
promote safety and if the righf supplies are being ordered and if policies and procedures
address safery considerations. Factors related to the environment include an assessment of
lighting, temperature, noise levels, surfaces, storage, and ergonomics. Reviewing equipment/
technologies involves an examination of labels, instructions, and safety features to ensure
potential errors can be avoided when using various devices. Processes can lead to errors and
there is a need to assess if redesign can improve safety by looking at some of the following
factors: complexity, inconsistencies, time constraints, and the amount of human intervention
(i.e., lack of automation).
Understanding the effect of people (specifically staff) on patient safery is complex and
requires attention to many factors. For example, employee attitudes, motivation, health
(physical and psychological), education, training, and cognitive functioning can impact the
likelihood of a medical error. Further, a body of research has explored the ways in which
humans interact with machines and the potential for deadly accidents. The leadership and
culture of an organization can drive safety issues when there is a willingness to allocate appropriate resources (staff and equipment), analyze processes, implement changes, support
nonpunitive error-reporting, and promote EBP.
In summary, any improvement efforts focused on eliminating medical errors will
require a detailed analysis of the care-delivery process and the resources to bring about
systematic change.

G. Patient-Centered Care
involving patients and their families in the design of new
care models and in decision making about individual options for treatment (IOM, CQHCA, 2000). The focus on patient-centered care has shifted the measurement of quality
to include whether patient expectations regarding their healthcare goals are being met
(Sepucha, Uzogarra & O'Connor, 2008). Data collection methods include traditional approaches such as patient surveys (such as the CAHPS'Hospital Survey) and, more recently, interviews and focus groups with patients, family members, and other informal caregivers. As an example, the Mayo Clinic in Arizona has developed a multiprong QPI model that states "the needs of the patients come first" (Kennedy, Caselli & Berry, 201I, p. 386).
One of their "prongs" is to collect data that address the things customers find important.
The measures include patient perception metrics that capture information related to listening, involving the patient in decisions, and explaining medical conditions. Undoubtedly,
these types of measures increasingly will becoming part of internal QPI and external public reporting.
Patient-centered care is defined as

H. TeamSTEPPS*
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS")
is a teamwork system developed by the Department of Defense (DoD) and the Agency for
Healthcare Research and Quality (A.HRQ). It is
. a powerful solution to improving patient safety within your organization,

.
.
.

an evidence-based teamwork system to improve communication and teamwork skills

among healthcare professionals,

for ready-to-use materials and a training curriculum to successfully integrate

teamwork principles into all areas of your healthcare system, and
scientifically rooted in more than 20 years of research and lessons from the application
of teamwork principles (AHRQ, n.d.).
a source

11

Q SoluUions

12

TeamSTEPPS is being rolled out nationally as an effective communications framework

with the aid of five technicaf resource centers. AHRQ provides exceptional training resoufces at http/ /teamstepps.ahrq.gov.

ll.

IOM lmperatives, Priorities, and Competencies

A. Patient Safety

and Harm

The IOM report, To Err ls Human: Building a Safer Health System (IOM, CQHCA, 2000),
caught the attention of providers, payers, and consumers by showing the direct relationship
between qualiry of care and patient outcomes. Further, Becher, and Chassin (2001) have
pointed out that patients experience harm because of three types of quality issues: underuse, overuse, and misuse. "Underuse" occurs when patients do not receive beneficial health
services (e.g., 50Zo of heart attack victims fail to receive beta blockers). "Overuse" would occur when patients undergo treatment or procedures from which they do not benefit (e.9.,
"Misuse" occurs when
5Oo/o of.X rays taken among patients with back pain are unnecessary).
patients receive appropriate medical services that are provided poorly, exposing them to
added risk for preventable complications.

B. Changing the Healthcare Delivery System

The IOM report highlighted the problems in healthcare delivery and stated, "The American healthcare delivery system is in need of fundamental change" (IOM, CQHCA, 2OOl,
p. 1). It stated that healthcare frequently harms and routinely fails to deliver its potential
benefits. In addition, it concluded that care was not being provided using the best scientific
knowledge. The IOM report suggested an agenda for "crossing the chasm" by changing the
healthcare delivery system. The agenda includes the following components:
All healthcare constituencies (e.g., purchasers, healthcare professionals, regulators,
consumers) should commit to a national statement of purpose for the healthcare system that sets six aims for improvement that can raise the qualiry of care to unprecedented levels.
Clinicians, patients, and healthcare organizations need to adopt a new set of principles

to guide the redesign ofcare processes.

.
.
.

The government, through the U.S. Department of Health and Human Services, must
identify a set of priorities to focus initial efforts, provide resources to stimulate innovation, and initiate the change process.
Healthcare organizations need to design and implement more effective support processes to make change in the delivery of care possible.
An environment needs to be created that fosters and rewards improvement. This environment should create an infrastructure to support EBP, facilitate the use of information technology (.IT), align payment incentives, and prepare the workforce to better
provide care to patients in the context of ever-expanding knowledge and rapid change.

As part of the agenda for change, the IOM's CQHCA established goals for the 21stcentury healthcare system. The committee proposed six improvements to address key dimensions of healthcare quality that were performing far below expected levels. Committee
members suggested that healthcare at a minimum should be
. safe-avoid injuries to patients resulting from care that is intended to help them;
. effective-provide care based on scientific knowledge demonstratingwho will likely
benefit, and restrain from providing care when it is not likely to benefit patients;

lnformation Management

13

'

patient-centered-care should be respectful and responsive to patient preferences,

needs, and values; further,"Ratient values should guide all clinical declsions;

'

timely-wait times and harmful delays for those who receive and provide care should
be eliminated;
efficient-care should be provided in ways that avoid waste, includingwaste of equipment, supplies, ideas, and energy; and
equitable-care should not vary in qualiry because of patients' personal characteristics
such as gender, ethniciry geographic location, and socioeconomic status (IOM, CQHCA,

'
'

2oo1).
Today's organizations are challenged to successfully meet these six aims. This challenge
translates into organizations establishing a new environment for care. At a minimum there
will be a need to make a strong commitment to change by starting to apply EBP, more fully
using health IT, developing effective multidisciplinary teams, and preparing the workforce.
External factors, such as aligning payment with qualiry also will need to change.

C. Policy and Healthcare Quality

In response to the IOM reports regarding patient safety and healthcare qualiry many private and public national initiatives have been introduced to improve patient care qualiry
across all disciplines and the continuum of care. In addition, federal and state legislation regarding healthcare qualiry is at the forefront of consumer and media attention. Not all of
these proposed regulations, however, are in the best interest of patients or consumers.
Healthcare qualiry professionals have an obligation to stay abreast of pending legislation at state and federal levels and to provide meaningful, data-driven feedback to legislators. Frequently, well-intended legislation is proposed by special interest groups that do not
have a full understanding of the complexity or lack of effectiveness of the proposed legislation's implementation at the point of care delivery. In its Code of Conduct and Standards of
Practice for Healthcare Quality Professionals, the National Association for Healthcare
Quality
(NAHQ, 2011) proposes that healthcare quality professionals agree to uphold and promote
the dignity of the profession and be committed to
practicing the profession with honesty, integriry and accountability;

.
'

maintaining the level of competency

c

.
'
'
'
'
.
.
.

ar e Q ttality Proless io na

as

outlined in the Standards of Practice for Health-

ls ;

seeking the trust and confidence of all customers;

supporting the Standards of Practice for Healthcare Quality Professionols;

respecting all laws and avoiding involvement in any false, fraudulent, or deceptive activiry;
promoting the right of privacy for all individuals and protecting the maintenance of
confidential information to the fullest extent permitted by law;
using expertise to inform employers or clients of possible positive and negative outcomes of management decisions in an effort to facilitate informed decision making;
giving credit for the work of others to whom it is due;
aiding the professional development and advancement of colleagues;
using the Certified Professional in Healthcare Quality (CPHQ) designation only after passing the written examination and adhering to standards established by the
Healthcare Quality Certification Board (now the Healthcare Quality Certification
Commission), and continuing to maintain those standards through the recertification
process; and

Q SoluUions

14

lll.

maintaining membership-in professional organizations as a means to promote quality

and professional growth and avoiding the use of such membership for the sole purpose
of business solicitation or for personal financial gain.

Public Reporting and Rewarding for Quality

A. Public Reporting
During the past decade there was a major shift in healthcare, with an emphasis on public
reporting of quality. Releases of public data began in the late 1980s when the Health Care
Financing Administration (now CMS) released case-mix-adjusted mortality rates for hospitals throughout the country. Eventually these reports were no longer issued because of hospitals' criticisms of case-mix-adjusted methodology. In the early 1990s New York State began releasing mortality data on patients who had undergone open-heart surgery by hospital and ranked hospitals according to how much they deviated from case-mix-adjusted values. Hospitals were then labeled as providing either "good" or "poor" care. Hospitals that
had poor outcomes were encouraged to improve their care processes. Eventually, New York
released data on individual surgeons and other procedures such as angioplasry. Examples of
these reports still are available on the New York State Department of Health website.
More recently several government and private initiatives have reported on a broader
range of outcomes that include the entire healthcare delivery system (i.e., continuum of
care). Today's emphasis is on reporting both outcome and process measures. Examples of
government-sponsored reporting include CMS efforts related to nursing homes (Nursing
Home Compare), home healthcare agencies (Home Health Compare), dialysis facilities (Dialysis Facility Compare) and hospitals (Hospital Compare). Private reporting groups include
HealthGrades (physicians, hospitals, nursing homes), the Leapfrog Group (hospitals, including process measures), and the Joint Commission Quality Check (hospitals). All of these reporting systems use basically the same approach, comparing healthcare providers to national
benchmarks and providing a rating as to whether care meets specific standards. It should be
noted that although not directly involved in reporting the National Quality Forum (NQF) has
as its mission the endorsement of consensus-based national standards for measurement and
public reporting of healthcare performance data. NQF has been involved in setting standards
for a broad range of healthcare issues. Many of these standards are being integrated into
provider reports on patient outcomes required by the federal government (i.e., CMS). For example, hospitals are required to publicly report on Joint Commission/CMS-developed, NQFendorsed measures related to their treatment of patients with acute myocardial infarction,
heart failure, and pneumonia. Evidence shows public reporting of performance data stimulates QPI activities at the hospital level (Fung, Lim, Mattke, Danberg, & Shekelle,2008).
In general, participating in public reporting is no longer voluntary and has become a
requirement for reimbursement. Further, CMS and state health departments are auditing
the accuracy of the data reported publicly when accreditation surveys are conducted.

B. Rewarding for Quality

The next step beyond reporting on qualir,v is rewarding organizations for having excellent
outcomes. One of the key principles behind the development of the Leapfrog Group was to
support value-based purchasing. Leapfrog's mission is to reward healthcare providers that
provide excellent care. Further, it suggests that the rewards for superior healthcare value
be based on four critical ingredients: reliable use of proven methods to ensure patient safety, improved clinical information systems, routine use of modern QPI methods in managing

nformation Management
and delivering care, and routine and active engagement of consumers in healthcare decision making. Purchasers are diiectly encouraged to shift their resources to better providers, to educate their employees about the importance of comparing the performance of
healthcare providers, and to assist them in using the measures to make informed healthcare
choices.
The federal government also is exploring the "pay-for-performance" benefits. CMS
has tested the link between direct Medicare payments to hospitals and qualiry of care. In
July 2003 CMS launched a 3-year pilot program with Premier, Inc., a large, nationwide
hospital alliance. The test provided financial awards to hospitals that showed high-qualiry
performance in a number of acute care areas. The hospitals used evidence-based clinical
protocols to treat patients with five conditions: heart failure, coronary artery bypass graft,
pneumonia, hip/knee replacements, and myocardial infarction. The hypothesis was that patients treated using these protocols would fare better, with fewer expensive complications,
postoperative infections, surgical wounds, readmissions, and other problems that occur as a
result of less than optimal care.
In the Premier pilot, CMS calculated the performance of participating hospitals in
treating these five conditions using established protocols. In total, 35 different measures
related to the five clinical conditions. Hospitals that ranked in the top lOo/o received a 2o/o
bonus for cases above the standard diagnosis-related $'oup (DRG) payment. Hospitals that
ranked in the top LOo/o to 2Oo/o received a 1% bonus.
The pay-for-performance initiative was extended to physician reimbursement. CMS
has implemented the Doctors' Office Quality (DOO project, designed to develop and test
a comprehensive, integrated approach to measuring the quality of care for chronic disease
and preventive services in physician offices. The goals of the DOQ project are to provide
information for informed decision making and to support adoption of QPI strategies by
physicians. The project measures clinical performance and patient experience. Ultimately,
CMS hopes the initiative will lead to new methods of service delivery, expanded coverage of
new types of service, and new payment approaches. Physicians will be directly rewarded for
improving the health outcomes of their patients by using EBPs.
In 2003 General Electric (GE), along with Ford, Proctor and Gamble, UPS, and Verizon,
started "Bridges to Excellence" (de Brantes, 2003). Using the framework established by
the IOM and creating a crosscutting group of healthcare professionals from the provider,
purchaser, and administrative sides, GE set out to develop programs that would encourage
leaps-not baby steps-in quality. The programs' objective is straightforward: Achieve a
certain level of performance and get a per-patient bonus. They work outside the current
scope of provider compensation so that incentives are visibly and clearly linked to QPI.
The programs also work across all purchasers regardless of their contractual or network
arrangements with health plans-self-insured or fully insured, health maintenance organization, preferred provider organization, point of service, or indemnity. Examples of pay-forperformance programs developed by GE include
Physician Ofice linlt-Physicians who demonstrate that they have adopted better systems and processes of care in their offices receive up to a $50-per-patient bonus every year for all patients who are covered by participating purchasers and plans. These
better processes are focused on clinical information systems that have evidence-based
decision guides, robust patient education and support, and appropriate care management for patients most at risk.

Link-Physicians who meet the performance measures defined in the existing Diabetes Physician Recognition Program (a program developed by the American
Diabetes Care

15

r
Q SoluEions

l6

Diabetes Association and the National Committee for QualityAssurance), which include
maintaining adequate blood sugar, lipid, and blood pressure controls in patients, receive
measures.
a $t00-per-diabetic-patient bonus every year they meet the performance
For programs that measure patient outcomes (Diabetes Care Link) rather than systems
(physician Offi." Link), allowances are made for physicians who care for sicker patients,

and incentives and rewards are deployed to patients who better manage their conditions.
The latter includes deploying comprehensive tools to help patients become more engaged
in their care, partnering with their physician. The goal is to align incentives of patients and
purchasers to focus their energy on achieving leaps in qualiry.
De Brantes, who developed these programs at GE, founded the Health Care Incentives
Improvement Institute, a not-for-profit organization, guided by a board of directors that inrange of
cludes physicians, employers, health plans, and others. They have created a broad
proglams to measure ou,aornar, reduce care defects, promote a team approach to caring for
pr,[rrar, realign payment incentives around quality, and reward excellence wherever they
iina i,. One of their programs, Bridges to Excellence, recognizes and rewards practitioners
who provide superior care (HCI3, 2010). The program is a component of CMS'S Center
for Medicare & Medicaid Innovation's (CMMI) Bundled Payments for Care Improvement
initiative, "a bold, broad and flexible approach to moving the country away from fee-forservice and into value-based payment" (HCI3, 2OLO,para' 1)'
Third-party payers also have started pay-for-performance initiatives. All the major payers (including BIue Cross, Aetna, Cigna, and United Healthcare) have begun testing some
form of linking reimbursement to quality. For example, in California a group of health plans
(Integrated Healthcare Association; www.iha.org) has taken the lead in pay for performance
and is proposing that indicators (such as preventive care, disease management, and patient satisiaction) based on the previous Health Plan Employer Data and Information Set
(HEDIS, now the Healthcare Effectiveness Data and Information Set; National Committee
for euality Assurance, 2011) be used to determine reimbursement. These payers have stated
that they are strongly committed to value-based purchasing and quantifiable results.
In 2010 the patient protection and Affordable Care Act (PPACA) was signed into law,
putting in place comprehensive U.S. health insurance reforms that will greatly impact
accountability (public Law, l[-I48, PPACA). The law creates new structures to support
.Accountable Care Organizations," "bundled payments;' "reductions in re-hospitalizations"
and other initiatives, which will foster future efforts that have pay-for-performance compoof
nents. There will be a fundamental shift to trying to "value" healthcare delivery in terms
effectiveness and cost control.

lV.

Confidentiality Principles, Privacy, and Patients'Rights and

Responsibilities

A. Confidentiality

Organizations are required by federal and state statutes to maintain the securiry integriry
plan
anJ confidentiality of patients' personal data and other information. An organizational
for health information management (HIM) should address the critical balance between
data sharing and data confidentialiry. Although timely, easy access to data and information is required, organizations also must ensure that data and information are safeguardtamed. The oiganization is responsible for protecting records against loss, defacement,
pering, ,nJ rnrrrhorized use. Each organization must determine the level of security, ini.Sriry, and confidentialiry for different categories of information. Access to each category

lnformation Management
of information must have a functioning mechanism designed to preserve the confidentiality of data and information identified as sensitive or requiring extraordinary means to protect patient privacy. The related Joint Commission standard is "RI.O1.O1.OI: The organization respects the rights of individuals served." Privacy of health information is addressed in
Information Management standards (I.M. 02.01.01 and Elements of Performance [nr] t-S)
and Environment of care privacy and securiry standards (EC.02.01.01, Ep 3; 02.06.01, Ep I;
The Joint Commission,2Ol2). The organization also must identifl, sanctions for employees
who breach confidentialiry. Other accreditation bodies have their own srandards.
Healthcare organizations must keep confidential all protected health information
(PHI) pertaining to medical peer review, QPI, and the monitoring and evaluation of patient
care. PHI is defined in the Health Insurance Portability and Accountabiliry Act (HIPAA)
of t990. All records that can be identified by patient or provider should be kept secure and
confidential so the patient's and provider's privacy can be maintained. This includes the
medical record (in any format, hard copy or electronic) and may also include reports, data
abstracts, and supplies. Effective infbrmation management security and confidentiality
policies and procedures in a healthcare organization should contain the following elements:
. identification of people with access to information;
. delineation of specific information as to which people have access;
' requirements for people with access to information to keep that information confidential;
. requirements for release of health information according to HIPAA;
' requirements for removal of medical records (a patient's medical record is the property of the healthcare facility); medical records should be removed from the organization jurisdiction and into safekeeping only in accordance with a court order, subpoena,
or statute;
' policies for protection of personal health information (U.S. Code of Federal
Regulations,2OO2);

'

'

a policy for handling the root cause analysis (RCA) reporting requirement if the organization is Joint Commission-accredited. (fhe Joint Commission has four options
for sentinel event reporting, with options ranging from mailing the information to the
Joint Commission to requesting that surveyors come to the healthcare organization to
review the medical records and RCA [The Joint Commission, 2Ot1].); and
mechanisms for securing information against unauthorized intrusion, corruption, and

damage.

Figure 3 lists the elements of PHI in the HIPAA regulations. Examples of information
management confidentiality and securiry methods include the following:
' Portions of medical records may be stored separately, for example, if the record contains information regarding certain types of psychiatric treatment. The complete
medical record would have to be available as needed for medical care and follow-up,
utilization review, or in quality- and performance-improvement activities.
' Organizations can restrict access to computer files or portions of computer files with
the use of security codes or by restricting certain computer operations to specific terminals or people.
' An organization that relies on computerized information should have an adequate
backup plan for each computer application and extensive security firewalls.

17

18

Health lnsurance Portabi

SoluEion.

Act of tgPo

Names

All geographic subdivisions smaller than

a state, including street address, city, county, preclnct, zip code, geocodes

(in some instances, the first three numbers of a zip code may be collected)
to 90 or older; only
Birth dates, admission dates, discharge date, date of death, all ages over 89 unless aggregated
year data may be collected
Telephone and fax numbers

protocol (lP) addresses/numbers

Electronic mail addresses, Web universal resource locators (URLr, and lnternet
Medical record, health plan beneficiary and account numbers
Certificate/ license numbers
Vehicle identification and license plate numbers
Device identifiers and serial numbers
Biometric identifiers, including finger and voice prints
Full-face photographic images and any comparable image

to identify
Any other unique identifying number, characteristic, or code that could be used alone or in combination
a person:

Patient name
Name of individual/organization requesting information
Reason for release of information
Anticipated use of information released
Exact material to be released, including reference to PHI
Period during which the release of information is valid
Documentation that information is released only to the individuaUorganization named above

Signature and date of the patient or legal representative (as defined by policy/state law)'
Fron U.S. Code of Federal Regulations. 2002. Available at www.gpo.gov/fdsys/pkg/CFR-20o2-title45-voh/xmt/CFR-zooz-title45-voh-secl64'514'xml

1. Release of lnformation
A written consent is required for an organization to release patient information to anyone
eloutside the organization. A rypical release of information form should have the following
ements:
. patient name,
. name of individu alf organization requesting information,

.
.
.
.
.

reason for release of information,

anticipated use of information released,
exact material to be released, including reference to PHI,
period during which the release of information is valid,
documentation that information is released only to the individual/organization named
above, and

signature and date of the patient or legal representative (as defined by policy/state
law).

2. Authorized

Release of lnformation
Information from medical records and studies may be released without written authorization from patients to individuals or groups who have a need for the information. Release of
information is regulated by national and state statutes. These people rnay include the
. governing body representatives,
. organization director (chief executive),
. healthcare personnel involved in the care of a patient,

nformation

.
.

Ma

nagement

19

people responsible for epl activities, and

people in the HlM/medical record department.

HIPAA requires healthcare providers (e.g., doctors and health plans) to obtain written
authorization from patients to share medical record information. 1.his may be for purposes
unrelated to treatment, payment, or routine healthcare operations. The authorization form
can originate from the hospital, physician, or health plan, or it can come fiom the organization requesting the data, such as a researcher, employer, or insurance company. There is
no mandated form but a valid form must include several core elements such as the name,
purpose of disclosure, and expiration date.

B. Medical Peer Review

The nature of tl-re data contained in a medical recorrJ is highly conficlential. policies and
procedures clearly define who may have access to a meclical recorcl ancl under what circumstances in accordance with medical staff bylaws, hospital policy, and applicable laws and
regulations. Because of the complexity of those issues, consultation from general counsel
regarding national and state statutes is critical. Practitioner profiles can be maintained as
a part of the credentials file or in a separate locked file. Most states have laws governing
medical peer review and its activities. When applicable, files, their cont"ntr, ,rrd meeting
minutes should be marked as "Confidential-peer review according to statute X." A simple
"Confidential" stamp also will suffice.
A mechanism should be developed to track activiry on each practitioner profile. A log
or signout sheet attached to each file should contain the date of request, reason foruequest/
review, name of person(s) reviewing and any pertinent notes such as requests for copies
of the contents. Policies and procedures define the circumstances under which copiei of
contents are made, such as individual physician request. In accordar-rce with medical staff
bylaws and rules and regulations, a mechanism for release of information with specification
of contents to be disclosed should be developed. This mechanism is in place in ,.rponr.
to the need to evaluate a practitioner's competence for appointment and reappointment to
other healthcare institutions.
Committee minutes of QPI activities usually are protected under medical peer review
statutes. Consequently, maintaining confidentialiry of records extends beyond credentialing
to the entire QPI program within an organization.

C. Utilization Management
Numerous issues surround preservation
management function.

1.

of patient confidentiality within the utilization

lnternal Review

Policies and procedures should ensure confidentiality during the medical peer review process. They should be consistent urith organizational policies and procedures (usually within the HlM/medical records department) and may include completion of a confidentialiry
statement signed by staffand practitioners involved in the peer review process.
Mechanisms also should be established to inform patients of utilization management
review policies and procedures. A common method to inform and obtain consent is to include a statement on the admission consent form or consent for treatment form.

2. External Review
Review by telephone is a legally risky aspect of external review. The utilization management program should have written policies governing how a telephone review is conducted. These policies should address such things as methods to verify caller identiry

Q SoluEions

20

mandetermination of who in the organization may provide information to utilization/care

Of particular
agement entities, limits on the lnformation provided, and HIPAA compliance.
or abuse, menconcern is provision of the reason for hospitalization, such as substance use
comtal health, iffVTefOS, and other PHI as identified by HIPAA. These policies must be
process'
municated to the insurance company as part of the managed care contract review
of,
Onsite review by external agencies also requires development and communication
proper identification
and adherence to, poli.l"r and piocedures. Areas to be covered include
areas,
of the on-site reviewer (photo narne badge), issuance of passes to enter patient care
notification of the utilization management program representative on arrival and departure,
teiephonic review, these
and what information can and cannot leave the premises. As with
and
protocols should be discussed with the third-party payer during contract negotiations
in.o.po.",ed into the conffact. The issue of patient consent to allow review by an insurDuring hospita/
ance company generally is covered in healthcare coverage contract terms.
provider negotiations, hlalthcare quality professionals should confirm that this process occurs'

D. Medical Records/Electronic Health Records (EHR,

adequate
Healthcare facilities and clinical staff who treat patients are required to maintain
about pamedical records/xHRs to serve as a basis for planning care and communicating
rients' conditions and treatments with other healthcare providers' The medical record
by administrative
serves other purposes as well. For example, medical records are reviewed
physicians enstaff perfo.*irrg qualiry utilization, and risk management functions and by
gaged in peer review. Outside organizations also use the medical record for matters relating
,o pryrn*t and accreditation. In malpractice cases, the medical record serves as the major
in medical
source of evidence about the care p"ti.nt has received. Information contained
"
privarecords aiso is used in retrospective clinical research. If PHI is collected for research,
cy or institutional review board approval is needed.
Healthcare organizations should have a clear policy about who may have access to medical records and whether those records are written, computerized, or otherwise maintained.
policy statements also should make clear which elements other than actual medical records
constitute a portion of the record. For example, with the advent and frequent use of video(based on
taping of procedures or fetal heart monitoring strips, it is important to address
record.
state law and legal advice) whether such things as videotapes are part of the medical
The legal basis for confidentialiry derives from the physician-patient privilege, set forth
by statute in almost all states. This is one of several relationships recognized as special by
the relalaw. The preservation of confidentiality is viewed as essential to maintenance of
gives
rise to a
tionship. The need for confidentiality in the physician-patient relationship
legal piivilege. This means that, in the absence of a patient authorization or waiver or an
o*.riding law or public policy, medical information about a patient is protected from the
dir.or.ry, through which parties to a lawsuit normally can compel discloprocess known
",
sure of relevant evidence. In certain states the physician-patient privilege extends beyond
physicians to protect a patient's relationship with other healthcare practitioners such as
,o.irl workers, clinical nurse specialists, and nurse practitioners.
psychologirtr,

1.

"lir,i.rl

lnformation Covered by Privilege

This information extends beyond oral communication between practitioner and patient to
cover written entries in the patient's medical record, as well as X rays, cardiograph, or fetal monitoring strips; laboratory results; and other information concerning a patient's condition that is kept by an individual provider or healthcare institution. Information that is
privileged must satisfy the following conditions:

I
I

nformation Management
a
a
a

21

It must have been commun-icated in the context of the physician-patient relationship.

It must have been given with the expectation that it remain confidential.
It must be necessary for the diagnosis and treatment of the patient.

2.

Patients' Bill of Rights and Responsibilities

Although specific wording may vary by state, a patient has both rights and responsibilities. A summary of the federal version of the Patients' Bill of Rights and Responsibilities is
shown in Figure 4. A recent change in this area is the inclusion of patients' responsibilities
to actively participate in promoting health, decision making, and care.

V.

Evidence-BasedQualityManagement

A. The Quality Management

Research Continuum
QPI activities and research exist on a continuum of rigor, as seen in Table 2. Both are based
on the scientific method and are used to better understand phenomena. The scientific approach is the most sophisticated method of acquiring knowledge. This approach involves
inductive and deductive reasoning to define a process that self-evaluates in an attempt to
reach conclusions superior to those arrived at through reliance on tradition, authority, and
experience. Integrating the "right pieces" of data and information into a research-based
framework for the study of people was a contribution of the earliest pioneers in the field of
healthcare quality.
The underlying assumptions of design, measurement, and interpretation are the same.
Healthcare qualiry professionals should use the level of research rigor that best answers the
specific performance-improvement question. There needs to be a balance between rigor
and practicality (Byers & Beaudin,2OO2). Research studies and systematic reviews can be
evaluated for usefulness to a practice setting trsing critical appraisal tools. These tools guide

Ql Process

Table 2. Research Process Versus

Scientific Process/Research

Process

Ql Process

ldentifo information need(s) or ask the question to

investigatedDefine the variable(s) or the elements for which

are required.
Formulate a plan of study or

data

hypotheses.

Choose or design the research design and

collection

tools/instruments.
Collect the data.
Analyze the data.
Display the data.
Report the data and findings.
Draw conclusions.
Act upon recommendations deduced from

conclusions.

ldentify the process improvement, survey the literature,

and flowchart the process'
Deflne the customers and problem.

Formulate a plan'
Choose one or a combination of basic or qualitymanagement and planning tools.

Collect the data.

Analyze the data and look for root causes.
Display the data'
Report the data and findings.
Draw conclusions'

the

process.
Evaluate and communicate conclusions.

Continue to monitor the

be

Act upon recommendations deduced from the

conclusions.

Continue to monitor the process'

Evaluate and communicate conclusions'

Hold the improvement'

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sueld Pue sraP!^ord ro a)rotl)'ll

'suolsllap etelqllpaq paur,ro1ur e)eLu uel no,( os paprno.rd aq 1p,r,r aluelslsse'6urqleulos PuelsJaP
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arnsol)s!o uolleurorul'l

-a;1;;qlsuodsa6 pue sl{6!U

,o !llg ,s}ua!}ed

suotSnlos

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zz

lnformation

Ma

nagement

23

healthcare quality professionals- through the research critique process, allowing effective
evaluation and synthesis of research findings for use in performance-improvement activities (Byers & Beaudin, 2001), Additional online resources provided at the end of this book
provide websites that facilitate searching for evidence relating to a particular topic.

B. Evidence-Based Practice
the "conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients" (Sackett, Rosenberg,
Muir-Gray, Haynes, & Richardson, 1996, p. 71). Because multiple disciplines are involved
in healthcare delivery, however, the term evidence-based practice is more appropriate than
evidence-based medicine from a healthcare quality perspective. Clinicians should base their
care not only on experimental evidence but also consider experiential evidence, physiologic principles, patient and professional values, and system features in their decision making
(Tonelli, 2o0l). This practice allows individualized application and diffusion of aggregate
research evidence (Greenhalgh, 1999; Tonelli).
EBP promotes patient safety through the provision of effective and efficient healthcare
resulting in less variation in care and fewer unnecessary or nontherapeutic interventions
(IOM, CQHCA, 2001). EBP and outcomes measurement are iterative; one facilitates the
other (Deaton, 200D. EBP complements the principles of continuous QPI (CQD. Outcomes
evaluation at the individual and aggregate level is an essential step in evaluating the influence ofEBP.
Evidence-based clualiry management is based on clinical research and health services
research. Clinical research evaluates the impact of interventions on patient outcomes. Outcome measures may include clinical outcomes, functional outcomes, and patient satisfaction. This type of research helps healthcare quality professionals determine clinical
evidence-based best practices. Health services research evaluates the health system at the
micro and macro levels. Results from this type of research guide healthcare quality professionals in improving work processes and systems of care.
To promote research utilization, healthcare quality professionals must collaborate with
organizational leadership to promote a culture of excellence. Healthcare providers must be
motivated to provide the best possible care and use the best system processes based on the
evidence in the literature or data obtained within their own organizations. A key strategy is
to base all discussions on improving patient experiences and outcomes, and to keep personality conflicts out of the conversation (according to previously established ground rules).
Research utilization is a key aspect of the QPI process and critical to achieving healthcare
quality as defined by the IOM.
Evidence-based medicfne is

C. Applying Epidemiological Principles to Ql

The influence of QPI can be enhanced through the application of clinical epidemiology (e.g., case control studies, cohort studies, propensity score matching) to data collected
on a large number of patients for relatively little cost. This comports to a recent emphasis
in the healthcare industry related to "population health." Comprehensive linked databases
have enormous potential to provide information on the influence of tests and treatments on
health. The potential value of these data can be realized if (1) actual receipt of these interventions, health outcomes, and potentially confounding variables can be ascertained accurately for individual patients; and (2) selection bias can be minimized by identifying an appropriate basis for comparison (Weiss, 2011). For example, it is possible to assess changes in
patient outcomes after an "improvement intervention" on a specific nursing unit by comparing those outcomes to a matched gfoup of patients from other units in a hospital or over

Q SoluEions

24

a prior period of time for the-same unit when adjusting for any confounding variables. Using data available in electronic records and appropriate statistical methods makes it possible to test for statistical differences related to a QPI initiative compared to current practice.
This level of analysis generally makes the results found more robust, lending to wider acceptance across an organization and broad adoption of the improvement effort.

Vl.

Measurement, Decision Support, Risk Adjustment, Data lnterpretation,

and Benchmarking

A.

Decision Support
Performance outcomes measurement or decision support systems can provide a primary focus to determine the quality of healthcare services provided to consumers. By analyzing data and information generated by an effective performance outcomes measurement
system, healthcare qualiry professionals will be able to help identify areas in which to improve quality and resources in their organizations. Other uses for outcomes systems include helping to identify how an organization measures up in relation to its competitors,
identifying individual providers and practitioners who meet acceptable levels of qualiry allowing providers to respond more rapidly to market changes, and paying for exceptional
performance.
Organizations should use available decision support systems to develop an outcomes
information management plan, which includes evaluating performance outcomes measurement systems. Outcomes are viewed in terms of variotts clinical topics including mortaliry
complication rates, infection rates, Cesarean section (C-section) rates, and other clinical
outcomes measurement categories. categories may or may not reflect the resources (cost,
charges, length of stay [LOS]), associated with a given outcome.
To analyze and interpret such outcomes data, healthcare quality professionals start
with the rype of system: EHR-based and code-based. With EHR-based systems, nursing or
medical record analysts review the medical records/EHRs of all discharged inpatients to
capture and input diagnostic, procedural, and detailed clinical findings such as laboratory
results. This is done to identify severity- and risk-adjusted information from the time of a
patient's admission and at different points throughout his or her hospitalization.
Code-based systems are based on retrospective administrative data such as data in the
Uniform Bill documentlgg2 (UB-92) or claims data. These systems include clinical information spanning the patient's entire stay but not identifying the specific timing of certain
conditions. This additional type of information can be available in an EHR system. There
are significant benefits to using a code-based system, including much lower costs. Another
benefit of a code-based system is that it is more likely to contain a sample size sufficient
to develop more reliable models and output and provide sufficient and meaningful groups
for data comparison. Most states require hospitals to submit all payer data that are deemed
public information. These data can be purchased by interested organizations and analyzed
and interpreted using statistical tools in a search for key variables that can predict the like-

lihood of a desired outcome.

Both BgR-based and code-based systems allow healthcare providers to identifi,
positive and negative outcomes so appropriate action can be taken. Both types of systems
serve to focus users on areas of concern regarding outcomes performance. Cost savings
occur because energy can be focused on analyzing and controlling deviations from the
baseline.

lnformation Management

B.

25

Risk Adjustment
Risk adjustment is a technique used to take into account or to control the fact that different
patients with the same diagnosis may have additional conditions or characteristics that can
affect how well they respond to treatment. Risk-increasing variables reflect that a patient
has a high probability of dying. Analysis of outcomes data using statistical techniques can
take into account and control for patients' characteristics or conditions that are clinically
meaningful, and have demonstrated a statistical effect on the rates for each condition. This
removes the bias effect that can result when practitioners prirnarily treat patients who are
more likely to experience desirable outcomes, such as those with fewer risk factors or cooccurring illnesses (morbidities).
Some outcomes measurement systems define the differences between rislt adjustment
and severity, whereas other systems use the terms interchangeably. However, there is a
difference. Patients in a particular study population may respond with either "yes" or "no"
when asked if they have had certain outcomes; the outcomes variable in this case is binary.
The probability of a "yes" answer is the risk of the outcome. Statistical methodologies to
adjust for risk are applied to the outcomes data to predict patient-specific variables such
as certain diagnoses that are risk factors. The validity of each risk adjustment model is assessed on the basis of the choice of risk factors, including both potential risk factors and
those acttrally included in the model, and through measures of how well the predictions
match overall experience. This assessment includes indicators such as measures of patient
subpopulations, including patients with more than one risk factor, and the concordance
statistic, which shows, in perccntages, how accurate the model is at predicting the outcome.
The yes-or-no nature of outcomes data means that outcomes can refer to clinical outcomes, such as inpatient C-section complication rates. Outcomes also can be defined by
using LOS and charges or cost, such as when an LOS exceeds a certain number of days and
results in a "yes" or "no" answer. When the categories are in two or more groups, a set of
outcomes can be defined and the risk adjustment methoclologies can be applied to the full
set of outcomes at the same time.
An important distinction must be made between the statistical analysis of binary and
continuous data. Risk adjustment methodologies do not apply to dependent variables that
are continuous, like cost or LOS. The answer cotrld be any number on a continuum, not
"yes" or "no." Severity adjustment methodologies are applied to the cost of LOS data to
predict severity by using patient-specific variables, called severity factors. Frequently, the
presence of additional diagnoses helps to define the severity of a group of patients within
a DRG, on an individual patient level, or both. Both risk-adjusted and severity-adjusted data
are extremely important outcomes system tools.
Using unadjusted or raw data means that all patients in the clinical topic category, regardless of their health status or the existence of varying clinical conditions, are included in
the rate calculation. Both raw and risk-adjusted data can be made available on the same outcomes topic because payers frequently use risk-adjusted data in their initial decision making.
Healthcare quality professionals also must be familiar with the ways in which their decision-support databases handle statistical "outliers." Are all patients included, or are patients
more than two standard deviations from the mean removed from data analysis? Most decision-support databases have a consistent approach regarding patients who are outliers. It is
critical during data comparisons to make sure that all data sources have managed patient
outliers in a consistent fashion. For example, a hospital physician group was trying to compare its performance on resource utilization and LOS for community-acquired pneumonia.
One patient was hospitalized for more than 100 days because he was ventilator-dependent

Q SoluUions

26

l'
I

and did not have adequate resources to be placed in an extended care faciliry. This patient's
record needed to be removed fiom the data before a fair comparison could be made.
Another factor to consider in the analysis and interpretation of outcomes data is the
level of detail. The best system includes every payer's, practitioner's, and patient's clinical
and financial information. This integrated data repository can mine data for
benchmarking qualiry performance against established standards;

.
.
.
.
.
.

comparing physician performance within given outcome topics;

examining details at the patient level;
viewing patients'diagnoses, procedures, and other information;
determining the impact of managed care on costs and outcomes; and
analyzing product lines to evaluate their effectiveness and to increase or downsize service offerings.

C. Analysis and lnterpretation of Outcomes Data and Decision-Support Tools

Healthcare qualiry managers facilitate analysis and interpretation of outcomes and decisionsupport data for an organization. The reference point for the outcomes data must always be
kept in mind whenever the results of such data are analyzed. The overall goals for use of
outcomes and decision-support data are to improve qualiry reduce costs and resource consumption, increase organizational profitabiliry and develop an information-based strategic
plan. Comparisons of LOS, costs, complications, and mortality cannot be made legitimately
without adjusting severity at the patient level. Severity adjustment and clinical case mix permit effective analysis and eliminate practitioners' concerns that "their patients are sicker."
Decision-support data facilitate cross-functional analyses to improve patient care
processes and outcomes. These data integrate financial and clinical data and provide the
opportunity to perform highly sophisticated data analysis involving predictive outcome
management. These data help healthcare quality managers and executive staff evaluate
current operations and the feasibility of the development of new product lines and services.
Healthcare quality managers coordinate outcome and decision-support data by posing
the following pertinent questions:
. What kinds of comparative analyses will be most important?

.
.
.

with whom should we compare

ourselves?

How can we be sure the data are really comparable?

What do we do when the data reveal significant differences in our outcomes and the
outcomes of the peer or benchmark?
Bright and colleagues (2012) assessed healthcare process measures and clinical outcome measures associated with commercially and locally developed clinical decision support systems (CDSS). This study found that a CDSS is effective in improving healthcare
process measures across diverse settings. "Effect of Clinical Decision-Support Systems:
A Systematic Review" explained the benefits of CDSS and suggested more research is required to promote the use of CDSS and to increase the clinical effectiveness of the systems.
However, evidence is limited about the impact on certain outcome measures (i.e., economic
and financial). This research expands on the 20f2 AHRQ evidence report "Enabling Health
Care Decisionmaking Through Clinical Decision Support and Knowledge Management,"
which discusses key features for successful CDSS implementation.

lnformation Management

D. Benchmarking
When comparison reveals differences, the healthcare organization's management staff can
begin to ask questions internally to determine the cause of these variances. The challenge
for QPI staff is to display outcomes data in a meaningful way that will be used by the involved departments or teams. Graphic display of the data enhances the understanding and
use of results.
Benchmarking is the comparison of an organization's or individual practitioner's results against a reference point. Ideally, the reference point should be a demonstrated best
practice. Healthcare quality professionals assist an organization and its practitioners in interpreting benchmarking results. It is important to clarifii two important aspects of benchmarking. The organization or practitioner's actual performance or outcomes always stay
the same. However, depending upon to whom the organization or physician is compared,
the expected value can change. For instance, an organization's complication rate may only
be 60/o higher than expected when compared to a selected market. However, the same organization may have an llo/o higher-than-expected complication rate rvhen compared to the
U.S. average. In other words, the comparison value and the magnitude of difference change.
Healthcare quality professionals need to ask the right questions to learn how their organization works and then ask more questions to compare it to the best performers. The
goal is to identify how to improve an organization's outcomes, not to identify the differences between it and the benchmarking partner. It is important to be able to take benchmarking data and provide pertinent results to the right audience. When variance is identified,
the department or service involved must ask the following questions:
. What are we doing?

.
.
.

How are we doing it?

What is the measure of howwell we do it?
Why are we looking for improvement?

Directed and focused questions help managers identify performance gaps. Benchmarking needs to be an essential element of clinical pathway development to ensure the
highest-cost, highest-opportunity DRGs are prioritized. Data-driven internal and external
comparisons help to set best practices and also appeal to healthcare professionals by providing objective data for clinical pathway development. In general, three steps must be
followed when be nchmarking clinical pathways.
1. Identify high-resource-utilization DRGs.
2. Assess internal variabiliry.
3. Benchmark against external sources.
Table 3 illustrates examples of benchmarking projects. Benchmarking enables an organization to set a target or goal for its performance improvement activities. It is up to the
performance improvement team to determine whether it wants to be "average" (the industry
standard) or raise the bar to a much higher level of performance. To improve performance,
the goal depends on the level of current performance and the commitment of the performance team and healthcare providers. One of the most critical decisions an organization
makes when launching a benchmarking initiative is selecting the source of its benchmarking comparative data. Healthcare quality professionals often coordinate an organization's
benchmarking efforts. Most healthcare regulatory agencies require benchmarking as part of
a comprehensive QPI program.

27

-Y
I

Q SoluEions

28

Table E. E*r-Pl"t of
Type of

Benchmarking

lnternal

B"n.h-*king
Example Topic

Measures

Cesarean section rate

Physician A versus B versus C, etc.;

physician grouP
Practice A versus B, etc.; physicians versus

midwives
lnternal

Time to antibiotic

forXYZ

infection

Emergency department versus unit A versus

unit

B, etc.

Emergency department versus urgent care

setting
External

Use of angiotensin-converting

enzyme (ACE) inhibitors with

acute myocardial infarction

Health system or proprietary database

performance of all hospltals versus region
versus similar-size hospital versus your

hospital
External

Zero-incidence

Central-line-associated blood

Your unit versus National Healthcare

stream infection rates

Safety Network data for similar units;

can compare by quartile or median rates
(industry standard).

Wrong site/wrong procedure/

Your hospital's incidence versus zero

wrong Person surgery

incidence

Potential data sources for benchmarking include the following:

o govflment data available from CMS and state government agencies;
. alliances such as large healthcare systems (partnership organizations often provide
for internal and
data extrapolation for their members, frequently providing databases

.
,

Vll.

external benchmarking);
that offer free benchstate peer review organizations and state hospital associations
marking opportunities for hospitals within their state; and
for-profit database companies that offer software that helps hospitals or organizations
data
extrapolate and compile their own benchmark data or provide benchmarking
reported
are
also
through a centralized database compiled by the company. These data
ORYX and Core
to regulatory agencies upon request such as the Joint Commission's
Assurance's HEDIS.
Measures, CMS'OASIS, and the National Committee for Quality

Systematic Healthcare Quality

A. DeveloPment of a Quality lnformation System

interpret the vast amount of

Healthcare professionals are constantly challenged to sift and
what is irrelevant to plan a course
Jata availabie and then distinguish what is relevant from
may be monitoring a patient's elecof action. For example, a nurse in an intensive care unit
her interpretation of the reltrocardiogram readings and vital signs, and, based upon his or
a course of action that will
ative importance of tf,ose ongoing data, the nurse must choose
functional status. so,
ultirnrtely have an effect on the patient's opportunity for improved
related to qualiioo, qrrtiy-of-care data must be interpreted to make informed decisions
of meaningful data and
ry-of-care outcomes. The keys to a[ QrI activities are the collection
the right informathe communication of useful information. The trick is to communicate
tion the right way at the right time to the right people'

nformation Management

.
.

29

There is a distinction between data and information.

Dataare the abstract.epr"Sertrtion of things, facts, concepts, and instructions that
are stored in a defined format and structure on a passive medium (e.g., paper, computer, microfilm).
Information, on the other hand, is obtained when data are translated into results and
statements that are useful for decision making. For information to be meaningful, data
must be considered within the context of how they were obtained and how they are to
be used (Qualiry Measurement and Management Project, 1991).

An information distribution system must be developed through which effective processes are identified for information gathering and dissemination (Tweed-Weber, Inc.,
1992).An organization must
identifi, who needs to know the information (this may include various stakeholders
such as senior management, board members, customers, physicians, etc.);

.
.
.

determine which information stakeholders need to know to make decisions related to

improving the quality of care; and
develop a system that ensures the right people receive the right information at the
right time in the right way.

The Qualiry Measurement and Management Project (t99t, p. 28) developed the following seven basic concepts related to quality management information:
. Healthcare data must be carefully defined and systematically collected and analyzed
in their full context before they can be useful in quality management.

.
.
.
.

Tremendous amounts of healthcare data and information are available, but not all of
is useful for qualiry management.

it

Mature quality management information revolves around clearly established patterns

of care, not individual cases. Patterns identify a consistent process that can be studied
and improved.
Most quality indicators currently available are useful only as indicators of potential
problems and not as definitive measures of qualiry.

Multiple measures of quality need to be integrated to provide a clear picture of quality

of care in an institution or managed care organization.
. Developing outcomes information without monitoring the process of care, when warranted, is inefficient because it cannot lead directly to QIs.
. Cost and quality are inseparable issues.
Chassin, Loeb, Schmaltz, and Wachter (2010) have suggested that QPI programs should
focus explicitly on maximizing health benefits to patients and, to achieve the goal, measures
must be included that advance knowledge about whether the goal is being achieved. They
suggest four criteria for accountability measures (i.e., process measures; if met, there will be
a higher likelihood of improving patient outcomes). The criteria include the following:
. A strong evidence base shows that the care process leads to improved outcomes.
. The measure accurately captures whether the evidence-based care process has, in
fact, been provided.
. The measure addresses a process that has few intervening care processes that must
occur before the improved outcome is realized.
. Implementing the measure has little or no chance of inducing unintended adverse
consequences.

Q SoluUions

30

B. Strategy for lnterpJetation and Use of lnformation

Based upon the seven concepts, the Quality Measurement and Management Project devised
a seven-step strategy for the interpretation and use of quality-of-care information (Bader &

Bohr,1991).
Step l. Planningand Organizingfor Data Collection,Interpretation, and Use
Advance planning for collection and utilization of internally and externally generated data
leads to a higher likelihood of success. Anticipating barriers, identifuing responsibilities,
and laying the groundwork for multidisciplinary collaboration can more smoothly guide the
process toward improvement. Consideration needs to be given to whether the data will be
quantitative (e.g., clinical values) or qualitative (e.g., a review of clinical notes). Qualitative
data will require a rigorous process that delineates exactly where to look for the data and
what needs to be captured. In addition, a data dictionary that defines all data elements and
calculations of indicators can be an invaluable element to improve the communication of

information.
Step 2. Verifring and Correcting Data
The purpose of verifiring data is to identify data limitations and opportunities to improve
internal systems that lead to better data, provide an opportunity to correct data (e.g., find
missing data), and to review data to become familiar with it. For qualitative data, it is necessary to establish interrater reliability to ensure staff who reviewed clinical records consis-

tently captured the same information.

Step 3. Identifoing and Presenting Potentially Important Findings
The first step in this process is to perform preliminary data analysis, often descriptive analyses. When conducting this type of analysis, Bader and Bohr (1991) recommend that several
questions be addressed.
How do these data compare with other organizations' (as with mortality rates) or with
previously trended internal data (for example, nosocomial [now healthcare-associated

infection] rates)?
. What is the trend over time? Is it static, improving, or worsening?
. How are data likely to be interpreted (or misinterpreted)?
. Is there an opportuniry for improvement?
. Who should receive the data? For what purpose?
Data must be translated into meaningful information. Several techniques are used to
present information in a clear and concise manner. Bader and Bohr (1991) describe the use
of tables, graphics, and visuals.
Tables are the most common format to present information. By highlighting the most
pertinent information, readers can quickly and efficiently hone in on key information. For
tables to be most effective they should be understandable and use minimal abbreviations or
jargon. They should have columns clearly identified, with specific findings highlighted with
boldface type, underlining, or other distinguishing marks.
Graphics and visuals provide a snapshot of an organization's status; where the variations lie; the relative importance of identified problems; and the impact, if any, of changes
that have been instituted (Brassard & Ritter, 1994).
Common graphical techniques include
Pareto diagram/chart: prioritizes a series of problems or possible causes of problems;
histogram: illustrates the variability or distribution of data;

.
.

lnformation Management

'
.
'

scatter diagram: displays possible cause and effect, illustrates whether one variable
might have an impact upot another variable, and can illustrate the strength of that
impact;

run chart: used to monitor processes over time;

control chart: used to statistically illustrate upper and lower limits of a process and the
variation of an organization's process within those limits ; and
' stratification: breaks down single values into meaningful categories or classifications
to focus on improvement opportunities or corrective action (nrassard & Ritter, 1994).
In recent years organizations have developed "dashboards" to represent key management and performance indicators (Rosati, 2oog). They can be used asdata-mining toolsto
synchronize and synthesize vast amounts of data into visual representations. Dashboards
can be used to analyze and forecast various organizational systems. These dashboards
frequently incorporate external benchmarks, which allow organizations to compare performance to national, state, or regional norms. These benchmarks are available frtm CMS,
state health department websites, medical specialty groups, published literature, and organizations such as Leapfrog.
step 4. continuingto study and Develop Recommendations for change

If further study of the data is warranted, a variery of methods are available. These include
variation analysis, review of additional data, retrospective medical reviews, and process
analysis (Bader & Bohr, 1991). Variation analysis seeks an explanation for statistically significant differences in the data. Thcse differences may reflect clinical factors, patient characteristics, data collection (such as sampling characteristics), or organizational characteristics
(such as staffing).
Additional data may need to be collected and reviewed to completely understand variations in data. For example, a hospital may show a steady increase in mortality rates. Additional data related to hospital case mix, diagnostic categories, mortality within a specified
time from date of hospital admission, and other hospital characteristics may be used to fully
interpret the data.
Focused/intensive retrospective review refers to an activity for which processes or outcomes use pre-established criteria or indicators. Findings may be presented in peer review
or other settings.
Process analysis refers to a method of analyzing data using industrial
QpI techniques.
Process analysis occurs when a $oup diagrams a healthcare process. The gloup then measures process variations and looks for ways to improve the process and the administrative
or clinical outcome.
Step 5. TakingAction

"Taking action" implies that people, teams, departments, and committees are empowered
to make decisions and implement changes based on information discovered through data
analysis. Actions may occur in several forms: education and training of stafl education and
reporting of findings to outside vendors or the public, changes in organizational or departmental policies and processes, and changes in practice patterns.
Step 6. Monitoring Performance

Monitoring performance entails monitoring the influence and effectiveness of a QPI action
and involves the collection of additional data.

31

-T

Q SoluUions

32

.
.
.
.

following (Bader & Bohr- 199I):

Questions to be considered include the
Hrr. the proposed changes been implemented? To what extent?
How could compliance with the changes be enhanced?
these desirable effects?
What effect are the changes having on patient outcomes? Are
on a wider
Should the changes be modified and then tested further, communicated
conclusions' or ended because
scale, tested fo. i lo.rger period of time before drawing
they are ineffective?

Step 7. Communicating Results

the interpretation and use of inforBader and Bohr (I99D delineate three basic barriers to
factors'
mation: human factors, statistical factors, and organizational
data; unrealistic expecexternal
Human factors include fear of the data; resentment of
perfect); and lack of traintations about data (includingthe myth that all data mustbe
ing related to planning, organizing, and analyzing data'
poorly displayed data' and data
Statistical factors include flawed data, untimely data,
that are difficult to integrate with other organizational data'
system; lack of reorganizational factors include data overload; a poor data retrieval
among administration' physisources (time, people, money); and poor relationships
cians, and staff.

previous steps' Striving for

Communication is an integral component of each of the
of where an organizahealthcare qualiry is a journev.hpr begins with the communication
providing information to the
tion is and where it is going. Bffective communication requires
should be given to which audiences
appropriate staff so thly can take action. Consideration
in bringing about change' Depending
and methods of communication will be most effective
patient issues, administration for
on the findings, audiences may include clinical staff for
for staffing concerns' The final
service delivery failures, or the human resources department
that can be shared across the
product of every QPI project should include three do.,rrrl.rrtt
first document should be a high-level
organization and u" used with different audiences. The
overall findings and outline suggespresentation that can be used in meetings to discuss the
be a a one-page executive summary
tions for improvements. The second document should
and improvement recomthat can be shared broadly and summarizes the project, findings,
report that describes what was done;
mendations. The third clocument should be a deiailed
the findings; and offers the specific
features all of the analyses, tables, and figUres; interprets
would be sent to chairs of departments'
details about what needs to be done next. This report
of communication to consider is
quality leaders, and senior administrators. Another avenue
posters on recent QPI projquarterly or semiannual events that include presentations and
audience and widely publicized. other opects. These events should be offered to a broad
newsletters and e-mails to staff'
tions for disseminating epl findings include monthly

Vlll. Management lnformation Systems

I
I

I
I

both the manual and the automated

A management information system (MIS) can contain
making. other names-for an MIS' which are
methods that provide information for decision
medical information system' hosused interchangeably, include data-processing structure,
as it commonly is used' repital information system, or decision support system' The term'
plays a key role in decision makfers to an automated or computerir"d ,yri.-. information
a staff member or manager is trying
ing in each stage of the management piocess. whether
evaluate a QPI process' or monitor
to establish goals, estimate resources, allocate resources,

Ii

lnformation Management
a system, access

33

to accurate and timely information is an ongoing requirement of any MIS.

The qualiry ofjudgments and dicisions directly correlates with availabiliry and reliability
of
data and its synthesis into information.
Choices for the design or flow of information are so important that
they can be a determining factor in the survival of a patient or organization.
Although accurate and timely healthcare information should provide the rationale
for
management decisions, this often is not the case. Information, according
to O,Rourke and
Bader (rggg), often is incomplete, confusing, and not sufficiently relevant
to the organization's mission, strategic goals, or customer and stakeholder needs when it is presented
in
many governing body reports. These authors make a strong point that
organizations should
clarify the difference between data and information, and that data mu.st be carefully
selected, validated, and formatted to make them useful. This often is easier
to mandate than
accomplish. However, the goal remains that governing body reports contain
only the critical information needed for effective decision making-Achieving this goal would
eliminate
healthcare data being presented as a pile of computer printouts and various fragmented
reports.
According to O'Rourke and Bader (1993), the information contained in data helps leaders to
' assess how well the mission and values are being achieved by applying quantitative
measures to the ideals espoused in their mission and vision statements;
' understand changes in community needs, financial resources, and technology;
. develop a vision and evaluate program achievements;
. identifii the need for policy implementation effectiveness;

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prioritize strategic goals, including programs, to support or discontinue;

judge progress toward strategic goals and objectives;
weigh long- and short-term financial viability;
weigh the impact of budgetary decisions on quality of care/services;
determine priorities for continuous improvements;
monitor aspects of organizational performance and take corrective action;
understand the mechanism for physician appointment and recredentialingwhile
knowing their performance review process is effective;
decide on individual credentialing recommendations effectively;
determine goals for improving the health status of the communify;
evaluate the effectiveness of programs designed to improve health;
defend an organization's resources, efficiency, and effectiveness based on accurate information; and

help the governingbody evaluate and improve its performance.

A.

Purposes of lnformation Systems

Information systems can be used to support a variety of activities within healthcare organizations. Areas commonly supported include
QPI, cost control, and productivity; patient registration; utilization management; program planning and evaluation; external reporting; research; and education. An MIS can identify problems, provide evidence to lead to solutions,
and evaluate the results of implemented strategies (Burton & Hoy, Lg93).
Information systems can be grouped into the following: clinical information systems,
administrative support information systems, and decision support systems.

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1.

Clinical lnformation Systems

Designed to support direct patient care processes, automated clinical information systems
have great potential for analyzing and improving the quality of patient care.
Barriers to healthcare leaders' and healthcare organizations' implementation of MIS
include normal resistance to change, the mindset that patients can best be tended to by the
human mind, lack of exposure to information science and computers in healthcare educational and training pro$ams, and inadequate resources. One study found that, on average,
Florida hospitals use only 38o/o of available clinical healthcare informati<ln technologies associated with the six IOM care aims (Burke, Menachemi, & Brooks, 2005).
Currently, expanded clinical information systems in use include electronic medical
records and their retrieval systems; computer-assisted medical decision making for history and physicals and antibiotic selection; clinical application progtams for health-risk
progfr-r, health maintenance organization encounter data, clinical algorithms, predictive
modeling, and simulation.
From a managed care perspective, Rontal (1993) outlined the following criteria as being
needed for an MIS: appropriate use, place of service, specific procedures, preventive care,
cost-effectiveness, patient satisfaction, chronic illness management, access to care, and
patient education. Also needed are outcomes of care for mortaliry morbidity, complications,
readmissions, quality of life, and disability. Clinical information systems often depend on
integration with administrative information systems for some data.

2. Administrative Support lnformation

Systems
Aclministrative support information systems aid day-to-day operations in healthcare organizations, including
1. Financial information systems
. payroll

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accounts payable

patient accounting
cost accounting

forecasting
budgeting

2. Human resources information systems

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employee record

position and performance management

labor analysis

turnover and absenteeism

3. Office automation systems
. word processing
. e-mail
. scheduling
. facsimile/scanning
' electronicspreadsheets.

3.

Decision Support SYstems

Decision support systems deal with strategic planning functions (see Section VI, Decision
Support, niskedlustment, Data Interpretation, and Benchmarking). Included in this area are

lnformation Management
strategic planning and marketing,
resource allocation,

performance evaluation and monitoring,

product evaluation and services, and
medical management (e.g., EBP, clinical guidelines and pathways).

B. lmplementation of a Quality Management lnforrnation System

1.

Evaluating Systems
The following is a checklist of issues to consider when evaluating r-arious computerizarion
options:

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Does the system provide for capture, storage, and retrieval of clinical and financial information from a variety of sources (e.g., HIM, medical records, admission, discharge,
transfer, billing,laboratory pharmacy, blood bank, operating room schedule, and radi-

ology}
Does the system interface with the organization's existing information systems?

Does the system allow for the establishment of "triggers" or thresholds for important measures of performance and signal an alert when these thresholds have been
exceeded?
Does the system have critical alerts such as abnormal laboratory values, drug interactions, and others to promote patient safety (e.g., identifying "never events')?
Does the system have "rules-based" processing or an algorithm (i.e., the system automatically provides a complete list of cases that meet or fail criteria)?
Is the system flexible enough to allow for both concurrent and retrospective reviews?
Does the system support Joint Commission and other accreditation and regulatory
reporting requirements?
Does the system have the capabiliry for data mining reporting or statistical analysis?
Does the system allow for multiple users to access the same programs at the same
time?

Is it an "open operating system" (a system that enables users to operate on a variety of

different hardware platforms)?
Does the system have networking capabilities?

Will the system display data in graphic form?

Is there the capability for drill-down analysis of underlying causes of outcomes?
Does the system allow access to reports via a secure Intranet website within the
organization?

2.

Selecting a Quality Management System

Rarely do organizations build their own quality management systems. The following are
things to consider when developing and implementing a quality management system:

What expertise does the organization have in-house to develop the system, database
soffware, analytic tools, and hardware? How much money and time will have to be invested to procure this expertise?
Do either HIM or quality management staffhave the full industry knowledge required
to develop and deploy the information system to support clinical and financial needs
of the organization (architecture, nomenclature, and other national standards)?

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Q SoluEions

36

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Can staff provide necessary documentation, training, support, and maintenance for
the system on an ongoing basis? If so, will changing priorities interfere with the sus-

tainability of the program?

How will the organization be able to sustain the system? Are resources available to
keep the program up to date in an ever-changing environment?
Is there atrue understandingof the future data demands of accreditation organizations,
regulatory agencies, third-party payers, employers, and other external data demands?
Will there be long-term dedicated resources to enhance such an application for QI (including various functions such as credentialing, profiling, etc.)?
What would be gained by being part of an established vendor network or user group
addressing the needs of credentialing and QI?
Is it more cost-effective alternative to develop such applications in-house or would
the faciliry be better served by purchasing softu.are dedicated to these needs?

C. Federal Health lT lnitiatives

The need to accelerate the adoption of health IT has been widely recognized and was singled out as a key goal by the Health Care Delivery and Information Technology (HCpff)
Subcommittee of the President's Information Technology Advisory Committee (200a).
Studies have suggested that the qualiry of healthcare can improve with the appropriate
use of technology (Bates & Gawande,2OO3; Weiner, et al., 2OO3). These studies specifically highlight the need to facilitate the transmission of clinical information contained in the
medical record benreen healthcare providers. A second goal identified by the HCDIT subcommittee is use of health IT to achieve substantial economic and social benefits (such as
reducing medical errors, eliminating unproductive healthcare expenditures, and improving
quality of care).
A lack of standards has hindered the adoption of IT tools in the healthcare industry
(Bates & Gawande, 2003). However, an effort by the National Committee on Vital and
Health Statistics (NCVHS) to standardize formats and data for the electronic exchange of
patient health record information is encouraging (NCVHS, 2OO2).In addition, other organizations and taskforces are working on international protocols and frameworks for data
exchanges between heterogeneous systems in the healthcare industry. The industry Health
Level 7 (HL7; www.hlZ.org), the Systemized Nomenclature of Medicine (SNOMED), and
Extensible Markup Language (XML) special interest groups have been leaders in defining
EHR standards. As these standards evolve, it is more likely that comprehensive EHRs will
be developed and shared among all the providers in the healthcare system. It should be
noted that EHRs sometimes are referred to as personal health records (PHR$. There is a
distinction between the two types of records; PHRs are geared more toward consumers and
EHRs pertain to records used by healthcare providers.
Federal suppoft has been increasing since the 2OO4 announcement of the U.S. Department of Health & Human Services I0-year plan to create a new national health information infrastructure that will include an EHR for every American and a new network to link
health records nationwide.
Health IT and interoperable systems are requisites for healthcare delivery in the 21st
century. Health IT potentially includes products such as EHRs, patient engagement tools
such as PHRs and secure, private Internet portals, and health information exchanges. A
recent IOM reportQOL2) that examined the state of the art in system safety and opportunities to build safer systems concluded that

lnformation Management

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Safety is an emergent property of a larger system that takes into account not just the
software but also how it is used by clinicians.

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The'sociotechnical system" includes technology (software, hardware), people (clinicians, patients), processes (workflow), organization (capacity, decisions about how
health IT is applied, incentives), and the externalenvironment (regulations, public
opinion).
' Safer implementation and use of health IT is a complex, iiynamic process that requires a shared responsibility benveen vendors and healthcare organizations.
' Poor user-interface design, poor workflow, and complex data interfaces threaten patient safety.
' A lack of system interoperability is a barrier to irnproving clinical decisions and patient safety.
' A constant, ongoing commitment to safety-from acquisition to implementation and
maintenance-is needed to achieve safer, more effective care (IOM ,2ol2,pp. S2-Sa).
The HHS office of the National Coordinator (oNC) was charged with developing a
Nationwide Health Information Nenryork (NHIN) to "provide a secure, nationwide, interoperable health information infrastructure that will connect providers, consumers, and others
involved in supporting health and healthcare" (HHS, oNC, 2008). The NHIN's purpose
is to allow health information to be accessible to healthcare providers regardless of where
patients are treated. NHIN will achieve this goal by
' developing capabilities for national standards-based, secure data exchange;
' improving the coordination of care information among hospitals, laboratories, physician offices, pharmacies, and other providers;
' ensuring that appropriate infbrmation is available at the time and place of care;
' ensuringthat consumer health information is secure and confidential;
' giving consumers new capabilities to manage and control their personal health records, as well as providing access to their health information from EHRs and other
sources;

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reducing risks from medical errors and supporting the delivery of appropriate,
evidence-based medical care;

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lowering healthcare costs resulting from inefficiencies, medical errors, and incomplete patient information; and

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promoting a more effective marketplace, more competition, and increased choice

through accessibility to accurate information on healthcare costs, quality, and outcomes (HHS, ONC,2008).
Advances in health IT will facilitate an evolving quality agenda in coming years. Health
IT provides the infrastructure to enhance patient safery transparency, public reporting, and
pay for performance. An exemplar of this strategJ is the Veterans Affairs (VA) implementation of a Virtual Lifetime Electronic Record (VLER). The VLER Health program ensures
that each veteran has an electronic health record that can be accessed, with the veteran's
permission, by public and private sector healthcare providers. The first pilot of this program occurred in San Diego, CA, between the VA, the U.S. DoD, and Kaiser Permanente.
The program is now being implemented nationwide.

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