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Third Edition

Q Solutions: Essential Resources


for the Healthcare Quality Professional

Healthcare Safety
chrisry L. Beaudin, PhD LCSW CPHQ FNAHA
Luc R. Pelletier, MSN PMHCNS-BC CPHQ FNAHQ FAAN

NAf,IONAt ASSOCI,ATION FOR HEALTHCARE QUATITY

Glenview,IL

Other titles in the Q So/utions Suite


Management
Q uolity and P erformance Improv ement
Info r m atio n Manageme nt
Regulation, Accreditation, and Con tf nuous Readiness

Le ader ship and

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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 @ 2005, 2008, 2}12by the National Association for Healthcare Quality.
All rights reserved. First edition published in 2005. Second edition published in 2008.
rsBN 978-0-9858 336-2-6
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 ProductAnalyst
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
l.

StrategicConsiderations.,..
A. TheHealthcareSafetylmperative..
t. Types of PatientSafetyand Harm..

..........,
...........

..........2

.
. . . . .. .z
HealthcareQuality
........5
B. CreatingandSustainingaHealthcareSafetyCulture
...........6
l.Aligning StructuretoSupportQuality
.,......6
C. Leadershipand Culture: lntegrating HealthcareSafety Concepts intothe Organization... ......10
D. HealthcareSafetyGoals.
.....17
2. Tiansforming the Healthcare Delivery System Through National Policy
g. Ethicsand

ll. OperationalConsiderations.

HealthcareSafetyProgramDevelopment......
B. HealthlnformationTechnology
C. Risk Management
D. lmplementing Safe Medication Practices
E. NQFNeverEvents
F. ConsumerEmpowerment, Engagement, andActivation ...
G. EvaluatingAdoption of Safety Practices
A.

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lll.

Tools

lV.

Summary

for lmproving

Safety

References
SuggestedReading.
Online

Resources

lndex.

.........17
.......17
.......19

..... 21
......24

..........26
....26

.......iO
....

.Zt

........92
.....25

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.....41

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45

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Q SoluEions

Ta bles
Table

1.

Table 2.
Table 3.
Table 4.

Gble

s.

lOPatientSafetyFacts

...........4

.
Safe PracticesforBetterHealthcare-2O10 Update
TheJointCommissionizotz HospitalNPSGs.
lnformation Technology Commonly Used by Healthcare Professionals.
Patient Safety Culture Composites and Descriptions.

...

10

........12
...........18
...

22

Table 6.

PotentialBenefitsandSafetyConcernsofHealthlTComponents.... ....22

Table

NQF, Consensus Standards Related to Disclosure of Error or

7.

Table 8.
Table 9.

lnjury.

.....

2s

NQF:SafePracticesRelatedtoMedicationAdministration..... .........26
NQF:SeriousReportableEventsinHealthcare-2Ot1Update..... ....... 27

Figures
Figure

1.

NationalQualityStrategyAims and

PriorityAreas..

.......

vii

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Foreword to thb 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 thiJ
essential time
qurtiay, safery innovation,
and the technology needed to bring higtrer levels
"..
of performance^*ith io*., costs. During
20ll and 2012, the National Association for Healthcare
eualiry (NAHO has been preparing for the transition by reenergizing our purpose
and vision and solidifuing our strategies
for meaningful work that beneiits our stakeholders.
our challenge is determining how to
provide the greatest value to our members,
certificants, and .orru-"r, of NAHe 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
eualiry certification commission
(HQCC) to ensure NAHQ products are
ready for the market p..riou, ,o *h., programs
are
offered. A prime example of the effort is the third
edition of e so/urions.
I take this opportunity to personally thank Luc R. pelletier,
MsN PMHCNS-BC CPHQ
FNAHQ FAAN, and christy L. Beaudin, PhD LCSW
cpHe FNAHe, for leading this major
revision to Q solutions with the most current information
available. By providing continuiry
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
.oo.d'inrt.s with the certified
Professional in Healthcare
(CPHO
content outline,s main divisions. I thank each of
Quality
them and the NAHQ stafffbr helpingto biingthis
valuable resource to market.
This edition of Q solutions features a new approach to presentating
content. By placing
the information within individual modules, pu..ir"r.rs
may obtain a module specific to his
or her needs' The availability 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 2013. I
am certain all of you will want ro 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. NAHe constituents are my network for identifiiing, learning
about, and understanding changes that
are happening rapidly and continuously within
lare delivery. They
their workplaces' and patients benefit from their commitment
"nhrn."
to achieving healthcare
improvement.
Promoting safe, effective, and efficient practices through
education, certification, and advocacy are key components. I encourage each
of you to identif,, ,t . ,ir*gths in the people
and the products of NAHe. Enjoy the third edition
of e so/urions.
Betty Brown, MBA MSN RN CpHe FNAHe
NAHQ President, 2}tt-2012

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Q SoluEions

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 quality and performance excellence? The healthcare qualiry
professional must successfully navigate the system to demonstrate quality and safety. The
application of sound theoretical and methodological practices is imperative. Q Solutfons
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 Quality Certification Commission's (HQCC's) practice analysis. The practice
analysis assesses the current functions and competencies for certified professionals in
healthcare quality. Organized under the HQCC detailed content outline, the following
modules were created:

.
.
.
.
.

Leadership andManagement

Quality and Performance Improyement


Healthcare Safety
InformationManagement
Regulation, Accreditation, and Continuous Readiness.

These modules feature critical components of healthcare qualiry the science and art
qualiry
of
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 experrs 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 quality 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 quality
challenges. This is accomplished in many ways including affiliations with professional
groups such as the National Association for Healthcare Quality (NAHO.
Q Solutions 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

ix
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 uirceasing efforts of our esteemed authors-Cathy E.
Duquette, PhD RN CPHQ NEA-BC; Robert Rosati, phD; susan v. white, phD RN cpHe
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
examination by our external review panel members-James B. Conway, MS LFACHE;
Gerald N. Glandon, PhD; John Hansen, MD MpH; Bernard J. Horak, phD FACHE cpHe;
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 successful 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 consrantly challenged to tell a qualiry 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 continuous readiness, including health
information technology that supports the continuous quality improvement paradigm
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 quality science by sharing evidencebased, outcomes-oriented quality techniques making a difference in the safery care,
and service embraced by forward-thinking, highly reliable organizations.
Our primary goal for this suite of Q Solutions modules is to provide NAHe members
and other quality and patient safety professionals with a product that is reliable, valid,
innovative, and timely. These updated modules reflect recent changes in national
healthcare safety 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 FNAHe FAAN
San Diego, CA

Christy L. Beaudin, PhD LCSW CpHe FNAHe


Los Angeles, CA

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About the Editors/Authors


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 Universiry 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 Universiry.
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
published several books and written numerous chapters and peer-reviewed articles. He
has delivered presentations on various nursing and healthcare qualiry topics and given
writing seminars to aspiring authors. He was the editor in chief of the Jounrul for Heakhcare
Quality from 1998 to 2007. During his tenure, the journal grew in prominence as a leading
healthcare qualiry 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
programs in behavioral health and patient engagement. He is also a Fellow of the American
Academy of Nursing and NAHe.

Christy L. Beaudin, PhD LCSW CPHQ FNAHQ is national director of qualiry 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
Care (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 Universiry and bachelor's degree in criminal justice from California State
Universiry San Bernardino. Dr. Beaudin is adjunct faculty at the Universiry of Redlands
and participates in state- and national-level qualiry 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 qualiry
behavioral health, and managed care.

External Review Board


This project could not have been completed without feedback from expert thought leaders
in the healthcare quality industry. We thank Jim Conway for providing feedback for this
module.

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James B. Conway, MS LFACHE


Principal and Head, Governance and Leadership Group, Pascal Metrics
Adjunct Lecturer, Harvard School of Public Health
Cambridge, MA

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Healthcare Safety

Facilitate assessment and ongoing development of the organization's healthcare safety culture.
2. Link healthcare safety goals and activities with the organization s strategic goals.
3. lntegrate concepts and evidence-based practices with the organization! healthcare safety program.
1.

+. ldentify applicablllty of external healthcare safety initiatives (e.g., regulatory accreditation, National Quality
Forum, World Health Organization IWHO]).
5. Determine mechanisms and tools to evaluate the success of healthcare safety activities and innovations.

6. Contribute to the development, revision, and enhancement of a written plan for a healthcare safety program.
7. Demonstrate technologys ability to enhance the healthcare safety program.
8. Perform, coordinate, and integrate enterprise risk management into the healthcare safety strategy.

l.

StrategicConsiderations

A. The Healthcare Safety lmperative


Eliminating medical errors is an urgent imperative in the healthcare industry. Healthcare
safery encompasses all healthcare settings and includes the patient and staff experience
as well as the clinical, environmental, and services aspects of safety. Whether the focus is
on medications or surgery the goals are the same-to ensure patients are being treated in
an absolutely safe environment. The current era heralds strategies such as "zero defects"
(Porche, 2006), "pursuing perfection" (Kabcenell, Nolan, Martin, & Gill, 2010), and "transforming healthcare" (The Joint Commission, 2011). Accreditation and regulatory agencies
such as The Joint Commission, the National Committee for Quality Assurance, and the
Centers for Medicare & Medicaid Services (CMS) are supporting the movement to reduce
errors. Proposed solutions to improving patient safety range from computerizing physician
order entry systems to having patients indicate on their bodies with markers the area upon
which to be operated. 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 (2004) suggested that approaching patient safety within an organization requires a review in six key areas: structure, environment, equipment/technologies, processes, people, and leadership/culture.
Evaluating structure involves reviewing whether facilities are designed to promote
safery the right supplies are being ordered, and policies and procedures address safety
considerations. Environmental factors such as lighting temperature, noise levels, surfaces,
storage, and ergonomics need to be assessed. Reviewing equipment/technologies involves
examining labels, instructions, and safety features to be sure potential errors can be
avoided when using a technology. Processes can lead to errors. Assessment determines
whether redesign would improve safety by looking at factors such as complexiry inconsistencies, time consffaints, and the amount of human intervention (i.e., lack of automation).
The effects of staff on patient safety are complex. For example, employee attitudes,
motivation, health (physical and psychological), education, training and cognitive functioning can influence the likelihood of a medical error. A healthy workplace supports safery.
Recently, the effect of healthcare professionals' disruptive behavior has been shown to
undermine a culture of patient safety (The Advisory Board, 2010). Further, an entire body
of research ("human factors" research) explores the ways in which humans interact with
machines and the potential for deadly accidents. The leadership and culture of an organization can drive safety when there is a willingness to allocate appropriate resources (e.g., staff
equipment), analyze processes, implement changes, support nonpunitive error-reporting,
and promote evidence-based practice.

Q SoluEions

Any improvement efforts focused on eliminating errors requires a just culture, detailed
analysis of the care delivery process, human factors that influence processes of care, and
the resources to bring about sustained systematic change.

1.

Types of Patient Safety and Harm


The Institute of Medicine (IOM) report, To Err Is Ifumon: Building a Safer Heakh System
(IOM, Committee on Qualiry of Health Care in America [CQHCA], 2o0o), and its subsequent reports, caught the attention of providers, payers, and consumers by illustrating the
direct relationship between quality of care and patient outcomes. Further, Becher and Chassin (2001) pointed out that patients can experience harm as the result of three types of
quality issues: underuse, overuse, and misuse of health services. Underuse occurs when patients do not receive beneficial health services (e.g.,5Oo/o of patients who have a heart attack
fail to receive beta blockers). Overuse occurs when patients undergo treatment or procedures from which they do not benefit (e.g., 50% of X rays performed on patients with back
pain are unnecessary). Misuse occurs when patients receive appropriate medical services
provided poorly, adding to the risk for preventable complicarions.
Underuse, overuse, and misuse are considered \Maste and waste is costly. Berwick and
Hackbarth QOl2) believe that the best healthcare reform and cost reduction strategy is to
eliminate waste. They have identified six categories where considerable costs are represented by waste. Below is a list of categories and the estimated wasteful spending to the U.S.
healthcare system. Total waste detailed below cost the United States $558 billion-$1,263
billion in 2011.
1. Failures of care delivery: waste from poor execution or lack of best practice adoption
resulting in injuries and poor outcomes ($tOz billion-$15a billion)
2. Failures of care coordination: waste related to fragmented care resulting in complications, readmissions, declines in functional status, and increased dependency of the
chronically ill (925 billion-$a5 billion)
3. Overtreatment: waste from rendering care that is not useful ($tSS billion-$226 billion)
4. Administrative complexity: waste from state and federal government, accrediting agencies, and payers creating inefficient or misguided rules ($tOZ billion-$389 billion)
5. Pricing failures: waste related to overpriced procedures and professional fees ($84
billion-$178 billion)
6. Fraud and abuse: waste from fraudsters and fake healthcare bills ($SZ bitlion-$272
billion (pp. E1-E2)

2.

Transforming the Healthcare Delivery System Through National Policy


The IOM continued to highlight problems in healthcare delivery and reported, "The American healthcare delivery system is in need of fundamental change" (IOM, CQHCA, 2001, p. 1).
The report stated that healthcare frequently harms and routinely fails to deliver its potential
benefits. In addition, it concluded that care was not being provided with the best scientific
knowledge. The IOM report suggested an agenda for "crossing the chasm" by changing the
healthcare delivery system. Its 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,
setting six aims for improvement to raise the quality of care to unprecedented levels.
Clinicians, patients, and healthcare organizations need to adopt a new set of principles
to guide the redesign of care processes.

Healthcare Safety

The government, through-the U.S. Department of Health and Human Senrices (HHS),
must identifi, 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 to foster and reward improvement in the context
of ever-expanding knowledge and rapid change. This is accomplished by creating an
infrastructure to support evidence-based practice, facilitating the use of information
technology, aligning payment incentives, and preparing the workforce to better provide care to patients.
As part of the agenda for change, the IOM proposed six improvement aims to address
key dimensions of healthcare qualiry. At a minimum, healthcare should be
. safe:Avoid injuries to patients from care that is intended to help them.
. effective: Provide care based on scientific knowledge regardingwho will likely benefit,
and restrain from providing care when it is not likely to benefit a patient.

patient-centered: Care should be respectful and responsive to patient preferences,

needs, and values. Furthermore, patient values should guide all clinical decisions.

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timely: Wait times and harmful delays for those who receive and provide care should
be eliminated.

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fficient: Care should be provided in ways that avoid waste, including waste of equipment, supplies, ideas, and energy.

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not vary in quality because of patients' personal characteristics


such as gender, ethnicity, geographic location, and socioeconomic status (IOM, CQHCA,
equito.ble: Care should

2001).

Organizations are challenged to maintain an infrastructure and dedicate enough


resources to continuously support these six aims and sustain high levels of performance
once desired levels of quality are achieved. A strong commitment to accelerated change is
needed and reflects focus, prioritization, alignment with mission and organizational goals,
and spread. These are evidenced by meaningful use of health information technology (IT),
developing effective multidisciplinary teams, and ensuring that the workforce is competent
to provide effective, safe care. Aligning reimbursement and incentives with quality also is a
critical component in meetingthe IOM's proposed aims.
The IoM has also defined the core competencies required for healthcare professionals
as they relate to quality and safety. These competencies include
. provide patient-centered care,
. work in interdisciplinary teams,
. employ evidence-based practice,
. apply quality improvement, and
' utilize informatics (IOM, Committee on the Health Professions Education Summit,
2OO3,pp.

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Various health professions have taken the charge to ensure quality and safery are integrated into academic curricula. An example of this is Qualiry and Safety Education for Nurses
(QSEN), a formal program to guide faculty in providing this core content to furure healthcare frontline staff.

International health enterprises such as WHO blaze the trail for healthcare quality. Since 2002 WHO has addressed patient safery as a public health issue and designed

Q SoluEions

programs to address 10 facts about patient safety in the world. These facts are detailed in
Table l. The Patient Safety Curriculum Guide (wHO, 20tt) presents an interprofessional approach in educating healthcare professionals about healthcare safety.
Several national imperatives emerged in the first decade of the 21st century. In 20Io
Affordable Care Act legislation directed the HHS National Quality Strategy (NeS) "to better
meet the promise of providing all Americans with access to healthcare that is safe, effective,
and affordable" (National Priorities Partnership [NPP], 2OLl, p.2). The development of the
NQS would occur with input from various stakeholders to influence a realistic, achievable
strategy. As a result, the National Qualiry Forum (NQF) convened the multistakeholder Npp
comprising a8 public and private-sector partners to provide input as HHS developed the
NQS goals, measures, and strategic opportunities (Nppr 2OlL, p.2).
The Nctional Strategy for Quality Improvement in Health Care (HHS, 20I1b) describes
three broad aims of an NQS: better care, healthy people/healthy communities, and affordable care (i.e., The Triple Aim). The report highlights six priority areas for an NeS, one of
which is to "make care safer." The goals include the following (Npp,201t):
' Improve patient, family, and caregiver experience of care related to qualiry safery and
access across settings.

Table 1. 1O Patient
1. Patient safety is a serious global public health issue. In recent years countries have increasingly recognized the
importance of improving patient safety. ln 2oo2 WHO Member States agreed on a World Health Assembly
resolution on patient safety.

2.

Estimates show that in developed countries as many as one in 10 patients is harmed while receiving hospital care.
The harm can be caused by a range of errors or adverse events.

3.

ln developing countries the probability of patients being harmed in hospitals is higher than in industrialized nations.

The risk of healthcare-associated infection in some developing countries is as much as 20 times higher than in
developed countries.

4. At any given time,

1.4 million people worldwide suffer from infections acquired in hospitals. Hand hygiene is the
most essential measure to reduce healthcare-associated infection and antimicrobial resistance.

At

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least 50% of medical equipment in developing countries is unusable or only partly usable. Often the
eguipment is not used due to lack of skills or commodities. As a resulE diagnostic procedures or treatments
cannot be performed. This leads to substandard or hazardous diagnosis or treatment that can pose a threat to the
safety of patients and may result in serious injury or death.

6.

ln some countries the proportion of injections given with syringes or needles reused without sterilization is as high
asTo%. This exposes millions of people to infections. Each year, unsafe injections cause .l.3 million deaths, primari!
due to transmission of bloodborne pathogens such as hepatitis B virus, hepatitis C virus, and HIV

7. Surgery is one of the most complex health interventions to deliver. More dran loo million people require surgical
treatment every year for different medical reasons. Problems associated with surgical safety ln developed
countries account for half of the avoidable adverse events that result in death or disability.

8. The economic benefits of improving patient safety are compelling. Studies show that additional hospitalization,
litigation costs, infections acquired in hospitals, lost income, disabihty, and medical expenses have cost some
countries between U.S. $o billion and U.5. $29 billion a year.
lndustries with a percelved higher risk such as aviation and nuclear energy have a much better safety record than
healthcare. There is a one in 1,oo0,Ooo chance of a traveler being harmed while in an aircraft. ln comparison, there
is a one in 300 chance of a patient being harmed while receiving healthcare services.
'10.

Patients' experience and their health are at the heart of the patient safety movement. The World Alliance for
Patient Safety is working with 40 champions who have suffered as the result of a lack of patient safety measures to
help make healthcare safer worldwide.

From l0 Facts on Patient Safery by World Health Organization, 2012. Retrieved from, www.who.int/features/factfitedpatient--safety/patient-safety-

facs/en/indexl.html. Copyright zOtZ by WHO. Reprinted with permission.

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Healthcare Safety

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In partnershiq with patients, families, and caregivers-using a shared decision-making


process-develop culturally sensitive and understandable care plans.
' Enable patients and their families and caregivers to navigate, coordinate, and manage
their care appropriately and effectively.
The HHS NQS's aims and priorities are displayed as Figure r (Npp, 2011, p. 11). The
NPP envisions "healthcare that honors each individual patient and family offeiing voice,
control, choice, skills in self-care, and total transparency, and that can and does ,drpt to
individual and family circumstances, and to differing cultures, languages, and social backgrounds" (NPP,2008, p.t7). The Npp partners vowed ro ensure
' all patients will be asked to provide feedback on their experience of care, which
healthcare organizations and their staffs will use to improve care;
' all patients will have access to tools and support systems that enable them to effectively
navigate and manage their care; and
' all patients will have access to information and assistance that enables them to make
informed decisions about their treatment options (Npp,200g, p. g).

Figrr"

1.

N"tion"l Qr"lity Str.t"gy

Ai-,

priority
"nd

Ar"",

Better Care

*eatthy Peonle,l
Healthy Communlfies

Affordable Care

From Input to the Secretary of Health and Human Services on Priorities for the National
Quality Strategy
washington, DC Nationa/ Qu ality Forum. Copyright zott. Reprinted with permission.

6y National

Priorities

p-r*6h,r*,

3. Ethics and Healthcare Quality


Healthcare quality professionals are obligated to stay abreast of current and pending legislation at the state and federal levels and to provide meaningful, data-driven feedback
to legislators. Frequently, well-intended legislation is proposed by special interest groups
without a full understanding of the complexity or lack of effectiveness of its implemeniation at the point of care delivery. In its Code of Conduct and Standards of practice jor Healthcare Quality Professioncls, the National Association for Healthcare
eualiry (NAHe, 201)
proposes that healthcare quality professionals agree to uphold and promote the
digniry of
the profession and be committed to

Q Soluuions

ractic ing the profe s sio n-with honesty, integritSl and accountabiliry;
maintaining the level of competency as outlined in the Standards of Practice for Health-

ar e Q uality Profess iona

Is ;

seeking the trust and confidence of all customers;


supporting the Stonda rds of Practice for Heakhcore Quality Professionals;
respecting all laws and avoiding involvement in any false, fraudulent, or deceptive

a
a
a

activity;
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 out.orn., of management decisions in an effort to facilitate informed decision making;
a
a
a

giving credit for the work of others to whom it is due;


aiding the professional development and advancement of colleagues;
usingthe Certified Professional in Healthcare Quality (CPHO)designation only after
p"rring the wrinen examination and adheringto standards established by the Healthcare
ilualiry Certification Board (now the Healthcare Quality Certification Commission), and
continuing to maintain those standards through the recertification process; and
maintaining membership in professional organizations as a means to promote quality
and professional growth, avoiding the use of such membership for the sole purpose of
solicitation of business or for personal financial gain.

B. Creating

and Sustaining a Healthcare Safety Culture

Structure to Support Quality


Designing an organization is similar to designing a house:

1. Aligning

Like the plrysical structure of a house, organizationo.l structure identifies and distin'
guishes the individual parts of an organization and ties these pieces together to define
in integrated whole. Organizational structure dffirs from the physical structure of a
house, howeyer, in thot it encompasses more than inanimate characterfstics of walls,
doors, and. windows. Organizational structure includes the interaction patterns thot
link people to people and people to work, and unlike ahouse, structural dimensions of
organizations frequently change and evolve. (Dunham & Pierce, 1989, p. 399)

Although everyone in the healthcare enterprise is responsible for healthcare quality and safery an organization's leadership must include safety as a core component of its
comprehensive healthcare safefy program. The most important patient safety issues facing
healthcare organizations today are
maintaining a culture of safety that supports a safe and just culture,

.
.
.
.
.

identifyingorganizationalchampions,
deploying and sustaining patient safety strategies,
determining key drivers for patient safety programs, and
ensuring the adoption of current and evolving safety-related technologies.
Botwinick, Bisognano, and Haraden propose that "leadership is the critical element
in a successful patient safery program and is non-delegable" (2006, p. 1). Providing for a
healthcare safety culture typically starts at the strategic planning stage when leaders develop their mission and vision statements, core values, and strategic goals. Whereas "do no
harm" was previously an individual responsibility, a paradigm shift makes "safety a system

Healthcare Safety

prioriry" (IOM, CQHCA,2001, p.67). The Institute for Healthcare Improvement (IHI) adds
the observation that when patients are harmed, the cause can be traced mostly to flaws in
the system of care (IHI,2008).
Among errors, 85%o rypically are the result of systems issues, and t5% are attributable to
human factors (Deming, 2000). According to fHI, 'The key to reliable, safe care does not lie
in exhorting individuals to be more careful and try harder. It lies in learning about causes of
error and designing systems to prevent human error whenever possible" (IHI, 2008, p. t9).
Those working in healthcare safety who are involved in identifying and acting on opportunities to improve safety must give attention to planning, development, implementation, and
evaluation, as well as to continuous improvement
Since the IOM started delivering reports on healthcare safety in 2000, various national
organizations, state and federal agencies, accreditation organizations, and professional associations have focused on the identification of safe practices and strategies for organizational or system-wide implementation. In addition, many states have established coalitions
to promote patient safety (Comden & Rosenthal,2OO2).
Addressing the need to improve the safe delivery of healthcare, Congress passed The
Patient Safery and Quality Improvement Act of zOOS (Patient Safety Act; Agency for Healthcare Research and Quality [AHRQ], 2005). To implement the Patient Safety Act, HHS issued
the Patient Safety and Quality Improvement final rule (AHRQ, HHS, 2008). The Patient
Safety Act and the Patient Safety Rule authorizedthe creation of patient safety organizations
(PSOs) to improve qualiry and safety through the collection and analysis of data on patient
events (Cartwright-Smith, Rosenbaum, & Sochacki, 20U).
PSOs are organizations that share the goal of improving the quality and safety of
healthcare delivery. Organizations that are eligible to become PSOs include public or private entities, profit or not-for-profit entities, provider entities such as hospital chains, and
other entities that establish special components to serve as PSOs. By providing both privilege and confidentialiry PSOs create a secure environment in which clinicians and healthcare organizations can collect, aggregate, and analyze data, thereby improving qualiry by
identifying and reducing the risks and hazards associated with patient care.
Eight patient safety activities are carried out by, or on behalf of PSOs or healthcare
providers:
. efforts to improve patient safety and the quality of healthcare delivery;
. collection and analysis of patient safety work product (PSWP);

.
.
.
.
'

development and dissemination of information regarding patient safety, such as recommendations, protocols, or information regarding best practices;

for the purpose to encourage a culture of safety and provide feedback


and assistance to effectively minimize patient risk;
use of PSWP

maintenance of procedures to preserve confidentiality with respect to PSWP;


provision of appropriate security measures with respect to PSWP;
use of qualified staff; and

activities related to the operation of a patient safety evaluation system and the provision of feedback to participants in a patient safety evaluation system (AHRQ, n.d.).

As of November 2009,27 states plus the District of Columbia had passed legislation or
regulation supporting adverse event reporting to a state agency. The new laws and regulations were intended to raise accountability in healthcare organizations. Public reporting
also has the potential to improve healthcare safety through event analysis and by examining and disseminating lessons learned (National Academy for State Health Policy, 2011).

Q SoluEions

Through the work of these various government, quasi-government, and voluntary


groups, different definitions, standards, and approaches emerged, such as
. Patient safety is *the absence of preventable harm to a patient during the process of

.
.
.
.

healthcare" (wHo, 2oL2).


Apatient safety practice is 'a type of process or structure whose application reduces the
probability of adverse events resultingfrom exposure to the healthcare system across a
range of diseases and procedures" (Shojania, Duncan, McDonald, &Wachter,2001, p.13).
Standards for patient safety practices include recommendations to improve accuracy
in patient identification, effectiveness of communication among caregivers, precautions when usinghigh-alert medications, and surgery safeguards (Farley et al., 2OO7).
Apatientsafety solution is defined as "any system design or intervention that has demonstrated the abiliry to prevent or mitigate patient harm stemming from the processes of
health care" (The Joint Commission, Joint Commission International, WHO, 2OO7,p.2).
Professionals should maintain good and defined standards of practice that identify
hazards that pose risks to patients, assess the risks associated with healthcare hazards
against the intended benefit, and eliminate or reduce risks to patients (National Patient
Safery Agency, 2OL2).

"Enhancement of patient safety involves a wide range of actions in the recruitment,


training, and retention of healthcare professionals, performance improvement, environmental safety and risk management, including infection control, safe use of
medicines, equipment safery safe clinical practice, and safe environment of care"
(World Health Professions Alliance, 2008).
Healthcare qualiry professionals facilitate assessment and development of an organization's safety culture. The first step in creating a culture of safety is to assess the readiness
of an organization to implement healthcare safety practices. Several tools are available to
assess an organization's readiness. ln 2OO4 AHRQ developed and distributed a valid and
reliable safety culture survey, the I{ospital Survey onPatient Safety Culture (AHRQ, 2008a), to
help hospitals, nursing homes, and ambulatory outpatient medical offices evaluate how well
they had established a culture of safety in their institutions.
Another goal of the AHRQ survey was to provide organizations with benchmark data.
A benchmarking database was created so organizations can determine how well they
are doing in establishing a culture of safety. The 2Ot2 version of the comparative report
represented 1,128 hospitals and 567,703 staff respondents (Sorra, Famolaro, Dyer, Nelson,
& Smith, 2OL2, p. l). The database included 650 hospitals to compare over time. Healthcare organizations can use these surveys to track changes in patient safety over time and
evaluate the effects of patient safety interventions (AHRQ, 2008b). AHRQ has developed
a comprehensive toolkit to assist organizations with their assessment and monitoring efforts. As part of its goal to support a culture of patient safety and qualiry improvement in
the nation's healthcare system, AHRQ developed its patient safety culture assessment tools
for healthcare. The Hospital Survey on Patient Safety Culture: 2012 tJser Comparative Database
Report (AHRQ, 2OL2) meets that need. Based on data provided voluntarily by hospitals, the
report provides an initial set of results that hospitals can use as benchmarks to establish a
culture of safety in comparison to similar hospitals or hospital units.
In 2008 AHRQ released its first benchmarking report (AHRQ, 2008b, chapter 5) based
upon an analysis of data from 400 voluntary participating hospitals. The results represented another cry for healthcare organizations to focus on their healthcare safety practices.
Areas of strength in the 2OL2 report included

Healthcare Safety
TeamworkWithinUnits (average 807o positive response)-the extent to which staffmembers support each other, treat each other with respect, and work together as a team;
2. Supervisorflllandger Expectations andActions PromotingPatient Safety (average 75o/o positive response)-the extent to which supervisors/managers consider staffsuggestions to
improve patient safety, praise stafffor following patient safety procedures, and do not
overlook patient safety problems;
3. Organizational Learning, Continuous Improvement (average 72o/o positive response)the extent to which mistakes lead to positive changes and changes are evaluated for
effectiveness; and
4. Management Support for Patient Sdfety (average 72o/o positive response)-the extent to
which hospital management provides a work climate that promotes patient safety and
shows that patient safefy is a top prioriry (Sorra et al., 2012, p.3).
Issues presenting the most potential for improvement for most hospitals (according to
survey responses) included
1. Nonpunitive Response to Error (average 44o/o positive response)-the extent to which staff
feel their mistakes and event reports are not held against them, and that mistakes are
not kept in their personnel file;
2. Handffi andTransirions (average 45o/o positive response)-the extent to which
important patient care information is transferred across hospital units and during shift
changes; and
3. Staffing (average 567o positive response)-the extent to which there are enough staff
to handle the workload, and work hours are appropriate to provide the best care for
patients (Sorra et al., 2OL2, p.3).
Each of the 12 areas, or composites, in the survey are described in Table 2. The University
of Texas Safery Attitudes Questionnaire (SAQ) is another tool that helps healthcare organizations measure caregiver attitudes about six patient safety-related domains, compare themselves to other organizations, prompt interventions to improve safety attitudes, and measure
the effectiveness of these interventions. The domain scales are teamwork climate, job satisfaction, perceptions of management, safety climate, working conditions, and stress recognition
(Sexton et al., 2AO6; Thomas, Sexton, & Helmreich, 2003). An organization can use the tool to
gather baseline data and test the effectiveness of various patient safety practices.
When the IOM published Crossing the Quality Chasm in 2001, the extent of preventable medical errors was far-reaching (IOM, CQHCA, 2001). Many initiatives focus on inpatient care and fewer focus on other settings such as ambulatory or nursing home care.
The Health Research and Educational Trust-in partnership with the American Hospital
Association, the Institute for Safe Medication Practices (ISMP), and the Medical Group
Management Association and its certifying body, the American College of Medical Practice
Executives-developed the Physician Practice Patient Safety Assessment (PPPSA) for the
medical practice setting (Health Research and Educational Trust, 2006). The PPPSA is an
interactive self-assessment tool for evaluating medication safery handoffs and transitions,
surgery and invasive procedures, personnel qualifications and competency, practice management and culture, and patient education and communication. Healthcare qualiry professionals in ambulatory settings can use the PPPSA to
gain specific ideas to improve patient safery

.
.
.
.

conduct data comparison to aggregate results for similar practices,


enhance organization and provider awareness of patient safety issues, and
track progress (Health Research and Educational Trust, 2006).

.T

Q SoluUions

10

Table 2. Patient Safety Cultuie Composites and Descriptions

Composite
l. Communication openness

Patient Safety Culture

2. Feedback and communication

error
3. Frequency of events

about

reported

Definition: The extent to which...


Staff freely speak up if they see something that may negatively affect
a patient, and feel free to question those with more authority.
Staff are informed about errors that happen, given feedback about
changes implemented, and discuss ways to prevent errors.
Mistakes of the following types are reported: (t) mistakes caught and

;: ff
+. Handoffs and transitions

T:l.i;lT : 6H:,:;: il:; :l Jl il: :tr ;:H: il:"f;

lmportant patient care information

is

*:

transferred across hospital units

and during shift changes.

5. Management support for patient safety Hospital management provides a work climate that promotes patient
safety and shows that patient safety is a top priority.

6. Nonpunitive

response to

7. Organizational

error

Staff feel their mistakes and event reports are not held against them,
and that mistakes are not kept in their personnel file.

learning-continuous

improvement
8. Overall perceptions of patient

Mistakes have led to positive changes and changes are evaluated for
effectiveness.

safety

Procedures and systems can prevent errors, and there is a lack of

patient safety problems.

9.

Staffing

There are enough staff to handle the workload, and work hours are
appropriate to provide the best care for patients.

10. Supervisor/manager expectations


actions promoting safety

11. Teamwork across

units

and

Supervisorsfmanagers consider staff suggestions for improving


patient safety, praise staff for following patient safety procedures,
and do not overlook patient safety problems.
Hospital units cooperate and coordinate with one another to provide

the best care for patients.


12. Teamwork within

units

Staff support each other, treat each other with respect, and work

together as a team.

C. Leadership and Culture: lntegrating Healthcare Safety Concepts into the


Organization
Leaders should commit at the organizational level to drive change and improvement in patient safety practices. An environmental scan is conducted to aid the organization in prioritizing and selecting practices needing improvement. The governing board and medical staff
should be included in the analysis and prioritization process. A key concept introduced recently is mistake-proofing. Mistake-prooTtng (also known as poka-yoke) is "the use of process
or design features to prevent errors or the negative impact of errors" (Grout, 2OO7). Grout's
Mistake-Proofingthe Design of Health Care Processes provides more than 150 real-world examples that can be applied in healthcare settings. The patient safery practices focus on design
features and mistake-proofing processes to help prevent medical errors or the negative impact of errors.
IHI also provides blueprints for leadership to use in developing comprehensive safety
programs. In building a safety culture, Botwinick and colleagues (2006) proposed that when
leaders begin asking what happened instead of. who made the error, the culture within their
healthcare institutions begin to change. NQF also provides leaders with consensus-driven
safety practices. In 2003 NQF endorsed a set of 30 practices that should be universally used
in applicable clinical care settings to reduce the risk of harm to consumers. In 2006 NQF

Healthcare Safety
undertook an update of the original set and endorsed pracrices with significantly expanded
specifications, supporting literature, and guidance for implementation. In 2009, the practices were updated to address pediatric imaging, organ donation, caringfor caregivers, glycemic control, and falls prevention. In 2010, NQF added evidence to the existing practices, and
more direction was given to healthcare professionals for implementation and patient and
family engagement. The resulting 34 safe-care practices are detailed in Table B (NeF, 2010).
Attention to infection prevention and control is growing as part of the national effort
to achieve "zero" preventable hospital infections. Public reporting of infection rates is the
"new clinical mandate" (The Advisory Board Company, p. 3). The 'Journey to Zero" includes
innovative strategies to eradicate hospital-associated infections through a process of laying
the foundation (sizing the burden), crafting a multipronged stratery (establishing frontline
awareness and minimizing pathogen opportuniry), and ensuring sustainable success (promoting long-term gains; The Advisory Board Company, 2008, pp. 18-19). Research shows
that employing nine best practices can reduce the burden of hospital-associated infections.
These practices include
. apresent-on-admissiontutorial,

.
.
.
.
.
.
.
.
.
.
'

an infectionomics primer,
a

prioritization compass,

a hand hygiene compliance assessment,

ahigh-touch objectspotcheck,
central line certification,
a dedicated insertion team,
a Foley validity check,
clockworkantibioticadministration,
automated data intelligence,
an off-protocol physician pilot, and

real-time accountabiliry enforcer (The Advisory Board Company, 2008, pp. 18-19).
The National Healthcare Safety Network (NHSN) also plays a leadership role in promoting patient safety by providing a secure, Internet-based safety surveillance system. It
collects and reports on national and state-specific standardized infection ratios for select
healthcare-associated infections.
Recently introduced in safe practices is the concept of fair and just culture (Marx,
2OO7).In a fair and just culture, everyone throughout the organization is aware that medical errors are inevitable, but all errors and unintended events are reported, even when the
events may not cause patient injury. This culture can make the system safer. A just culture
recognizes that competent professionals make mistakes and acknowledges that even
competent professionals develop unhealthy norms (shortcuts or routine rule violations);
nevertheless, this culture has zero tolerance for reckless behavior. Three principles of a just
culture are described as follows:
l. A fair and just culture is not an effort to reduce personal accountability and discipline.
It is a way to emphasize the importance of learning from mistakes and near misses to
reduce errors in the future.
2. In a fair and just culture an individual is accountable to the system, and the greatest error is to not report a mistake, and thereby prevent the system and others from learning.
Policies that would discourage any healthcare provider from self-reporting errors are at
odds with the goals of a fair and just culture.

11

Q SoluEions

12

Table 3. Safe Practices for Better Healthcare-2o10 Update


Practice Statement

Safe Practice

iafePractice't, ':

"I

Leadership Structures
and

Systems

-rt-..'

Leadership structures and systems must be established to ensure organizationwide awareness of patient safety performance gaps, direct accountabllity of leaders
for those gaps, and adequate investment in performance-improvement abilities,
and that actions are taken to g,nsure safe c;re of every patient served.

Culture Measurement,

Healthcare organizations must measure their culture, provide feedback to the


leadership and staff and undertake interventions that will reduce patient safety

Feedback, and lntervention

risk.

Safe Practice 2:

'rSafe Practice 3'

Teamwork Training and


Skill Building

Healthcare organizations must establish a proactive, systematic, organization-wide


approach to developing team-based care through teamwork training, skill building,
and team-led performance-improvement interventions that reduce preventable
harm to patients.

Safe Practice 4:

ldentification and
Mitigation of Risks and

Healthcare organizations must systematically identify and mitigate patient


safety risks and hazards with an integrated approach to continuously drive down
preventable patient harm.

Hazards

Safe Practice 5:

Informed Consent

Ask each patient or legal surrogate to "teach back," in his or her own words, key
information about the proposed treatments or procedures for which he or she is

'

being asked to provide informed consent.


Safe Practice 6:
Life-Sustaining Treatment
Safe Practice

7:

Ensure that written documentation of the patients preferences for life-sustaining


treatments is prominently displayed in his or her chart.

Following serious unanticipated outcomes, including those that are clearly caused
by systems failures, the patient and, as appropriate, the family should receive
timely, transparent, and clear communication concerning what is known about the
event.

Safe Practice

B:

Care of the Caregiver

Following serious unintentional harm resulting from systems failures and/or errors
that resulted from human performance failures, the involved caregivers (cllnical
providers, staff and administrators) should receive timely and systematic care to
include: treatment that is just, respect, compassion, supportive medical care, and
the opportunity to fully partlcipate in event investigation and risk identification and
mitigation activities that will prevent future events.
lmplement critical components of a well-designed nursing workforce that mutuatly
reinforce patient safeguards, including the following:

'

a nurse staffing plan with evidence that it is adequately resourced and actively

malaged

a1rd its

effectiveness is regularly evaluated with respect to patient

safety;

.
.

senior administrative nursing leaders, such as a chief nursing officer, are part of
the hospital senior management team;

governance boards and senior administrative leaders that take accountability for
ieducing patient safety risks related to nurse staffing decisions and the provision

of financial resources for nursing services; and

.
,i

"

'

Safe Practice lO:

Direct Caregivers

provision of budgetary resources to support nursing staff in the ongoing


acquisition and maintenance of professional knowledge and skills.

Ensure that nonnursing direct care staffing levels are adequate, that staff are
competent, and that they have had adequate orientation, training, and education
to perform their asslgned direct care duties.
continued

Y;'
I
I

Healthcare Safety

13

Table 5. Safe Practices for Better Healthcare-2OlO Update

(continued)

Safe Practice

Practice Statement

Safe Practice

All patients in general intensive care units (both adult and pediatric) should

11:

lntensive Care Unit Care

,.,rn"di.1T"
Safe Practice

Safe Practice

cetified') .

, :,

.,,

i,

timely manner and in a clearly understandable form to patients and all of the
patient's healthcare providers/professionals within and between care settings who
need that information to provide continued care.
a

lncorporate within your organization a safe, effective communication strategy,

13:

Order Read-Back
Abbreviations

(triticaf.care

Ensure that care information is transmitted and appropriately documented in

12:

Patient Care lnformation

Safe Practice

be

managed by physicians who have specific training and certification in critical care

and

''

structures, and systems to include the following:

'

For verbal or telephone orders or for telephonic reporting of critical test results,
verify the complete order or test result by having the person who is receiving
the information record and "read back" the complete order or test result.

'

Standardize a list of "do not use" abbreviations, acronyms, symbols, and dose
designations that cannot be used throughout the organization.

Studies

lmplement standardized policies, processes, and systems to ensure accurate


labeling of radiographs, laboratory specimens, or other diagnostic studies so the
right study is labeled for the right patient at the right time.

Safe Practice 15:

A discharge plan must be prepared for each patient at the time of hospital

14:

Labeling of Diagnostic

discharge, and a concise discharge summary must be prepared for and relayed

Discharge Systems

to the clinical caregiver accepting responsibility for postdischarge care in a


timely manner. Organizations must ensure there is confirmation of receipt of the
discharge information by the independent licensed practitioner who will assume
responsibility for care after discharge.
Safe Practice

Computerized Prescriber

lmplement a computerized prescriber order entry system built upon the requisite
foundation of reengineered evidence-based care, an assurance of healthcare
organization staff and independent practitioner readiness, and an integrated

Order Entry

information technology infrastructure.

Safe Practice i7:

The healthcare organization must develop, reconcile, and communicate an

16:

Safe Adoption of

lvledrcatron Keconcrlratron
Safe Practice

.accuratepatientmedicationlistthroughoutthecontinuumofcare
Pharmacy leaders should have an active role on the administrative leadership

18:

Structures and Systems

team that reflects their authority and accountability for medication management
systems performance across the organization.

Safe Practice 19:

Comply with current Centers for Disease Control and Prevention (CDC) hand

Hand Hygiene

hygiene guidelines.

Safe Practice 20:

Comply with current CDC recommendations for influenza vaccinations for


healthcare personnel and the annual recommendations of the CDC Advisory
Committee on lmmunization Practices for individual influenza prevention and

Pharmacist Leadership

lnfluenza Prevention

control.
Safe Practice

,i.Gke actiqls tg prevent central line-Qssociated bloodstream infection

21:

Central Line-Associated

by

implementing evidence-based intervention practices.

Bloodstream lnfection

Prevention

to prevent surgical-site infections by implementing evidence-based

Safe Practice 22:

Take actions

Surgical-Site lnfection
Prevention

intervention praciices.

continued

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I
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I

Healthcare Safety

15

3. A new culture of patient safety is successfully created when all serve as safery advocates
regardless of their positions within an organization. Providers and consumers will feel
safe and supported when they report medical errors or near misses and voice concerns
about patient safety.
Healthcare organizations committed to a fair and just culture identify and correct the
systems or processes of care that contributed to the medical error or near miss; they do not
assign blame. When feeling protected by a nonpunitive culture of medical error reporting,
more healthcare professionals will report more errors and near misses, which will further
improve patient safety through opportunities for improvement and lessons learned (California Patient Safery Action Coalition, 2008; Marx, 2OO7).
Senge's concept of the learning organization has been applied to heaithcare during the
past several years. His definition of a learning organization is one "where people continually expand their capacity to create the results they truly desire, where new and expansive
patterns of thinking are nurtured, where collective aspiration is set free, and where people
are continually learning to see the whole together" (Senge, 1990, p. 3). Alearninghealthcare
system "is designed to generate and apply the best evidence for the collaborative healthcare
choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, qualiry, safery and value in health care"
(IOM, Roundtable on Evidence-Based Medicine [ROEBM], 2007, p.ix).The most pressing
needs for change identified by the IOM roundtable are those related to
adaptation to the pace ofchange;

.
.
.
.
.
.
.
.
.
.
.
.

strongersynchronyofefforts;
culture of shared responsibility;
new clinical research paradigm;
clinical decision support systems;
universal electronic health records;
tools for database linkage, mining, and use;
notion of clinical data as a public good;
incentives aligned for practice-based evidence;
public engagement;
trusted scientific broker; and
leadership (IOM, ROEBM, 2oo7,p.

S).

Leaders must integrate healthcare safery practices as part of their organization's


strategic direction, and goals must be developed to ensure adoption and measurement of
safety practices. The patient safety program should be aligned with the mission, vision,
core values, and goals of the organization. National pressures mount, and new expectations emerge for leaders, including those of government agencies (e.g., CMS), public reporting groups (e.g., the Leapfrog Group and U.S. Ner.vs and World Report), accreditation
agencies (e.g., The Joint Commission and the Accreditation Council for Graduate Medical
Education), and third-pafty payers. Third-parry payers are just beginning the practice of
nonpayment for certain conditions that could have been reasonably prevented (e.g., pressure ulcers) and serious preventable events (e.g., leaving a sponge in a patient during surgery; see discussion of Nqf "never events," p.26). As consumers become more empowered
through consumer-directed healthcare, they will demand more from healthcare professionals and organizations.

Q SoluUions

16

As part of its duties, the governing body or board of directors holds responsibility to
promote quality of care and preserve safety. The heightened attention being given to
healthcare quality measurement and public reporting affects this responsibility. Quality
oversight is recognized more clearly as a core fiduciary duty relating not only to financial
health and reputation but to safety and quality of care. Ensuring and improving care cannot
be delegated to the medical staff and executive leadership. An activated board, in partnership with executive leadership and medical staff, can set system-level expectations and accountability for high performance, high reliabiliry, and the elimination of harm.
Qualiry and safety, which also can benefit financially stable and growing healthcare organizations, are of board interest and represent a fiduciary duty. Bond-rating agencies such
as Standard & Poor's and Moody's Investors Service stress the importance of healthcare
leaders' attention to clinical quality outcomes and safety as they make decisions about bond
ratings for hospitals. A recent Moody's publication noted,
From a credit perspective, a not-for-profit hospital's focus on a quality agenda can
translate into improved ratings through increased volume and market share, operational effi,ciencies, better rates from commercial payers, and improved financial
performance. Like mdny strategies, [Moody's] recognize[s] that realizing financial
returns from a quality strategy may require large capital costs and incurred operating
Iosses in the short term. However, over the long term, a hospital's focus on quality
will be viewed as a credit positite if greater patient demand and financial improvements materialize. Many not-for-profit hospitals are launching strategies to improve
evidence-based clinical outcomes and patient safety, which we view as the two key
to improve quality is a
facets of a strategy aimed at improving quality. The
major component of most hospitals' mission to provide the best patient care possible.
(Moody's Glob al Credit Rese arch, 200 8)

ffirt

Safety can be integrated into strategic planning. IHI QOOT) outlines six things all
boards should consider in their effort to improve quality and reduce harm.
1. Setting aims: Set a specific aim to reduce harm this year. Make an explicit public commitment to measurable quality improvement (e.g., a reduction in unnecessary mortality
and harm), establishing a clear aim for the faciliry or system.
2. Getting data and hearing stories: Select and review progress toward safer care as the
first agenda item at every board meeting; progress should be grounded in transparency
and a desire to put a "human face" on harm data.
3. Establishing and monitoring system-level measures: Identifii a small group of
organization-wide measures of patient safety (e.g., facility-wide harm, risk-adjusted
mortaliry), update the measures continually, and make them transparent to the entire
organization and all of its customers.
Changingthe environment, policies, and culture: Committo establishingand maintaining an environment that is respectful, fair, and just for all who experience pain and loss as
a result of avoidable harm and adverse outcomes (patients, their families, and the staff).
Learning, startingwith the board: Develop capability as a board. Learn how the best
boards work with executives and physician leaders to reduce harm. Set an expectation
for similar levels of education and training for all staff.
Establishing executive accountability: Oversee the effective execution of a plan to
achieve aims to reduce harm, including executive team accountabiliry for clear performance improvement targets.

't'
I

Healthcare Safety

With the convergence of clinical care, safety priorities, and economic stabiliry, board
members'interestwill increase over time and create opportunities for healthcare quality professionals to educate organizational leaders on the importance of paying attention to safety.

D. Healthcare Safety Goals


Various national organizations have employed consensus-driven processes to identify
healthcare safety practices that can be adopted by healthcare organizations. Because national efforts have yielded an abundance of consensus-driven standards, healthcare quality
professionals should be cautioned to not develop their own safety practices. Applicability of
various safety practices is dependent upon many factors, including the healthcare setting,
the populations served, high-risk processes, volume-driven practices, and previous performance data. Organizations should use quality tools such as a prioritization matrix to select
safety standards that are relevant to their population.
The NQF continues to vet voluntary consensus standards to measure healthcare organization performance. With the support of the Robert Wood Johnson Foundation, the NQF
developed a Quality Positioning System to assist organizations in selecting and "exploring
ways to use NQF-endorsed measures to achieve...measurement goals" (NQF, 20I1b). The
measures, through the NQF endorsement process, have undergone a rigorous review and
have gained the consensus of many stakeholders, including healthcare providers, consumer
groups, professional associations, purchasers, federal agencies, and research and quality
improvement organizations.
The Leapfrog Group is a voluntary initiative that serves to mobilize employer purchasing power to guide America's health industry in adopting "giant leaps" in healthcare
safety. The organization has distributed safety practices and identified four "leaps" (i.e.,
computerized physician order entry evidence-based hospital referral, intensive care unit
physician staffing, and the Leapfrog Safe Practices score). If hospitals implemented the
first three leaps, 52000 lives could be saved, up to $12 billion in healthcare costs could be
saved each year (Lewin & Shepard, 2008, p. 7), and 3 million medication errors could be
prevented (The Leapfrog Group, 2011). The Leapfrog Group's safe practices informed the
development of 34 NQF-endorsed safety practices (Table 3). These hospital practices, if
implemented, reduce harm in a number of areas. The practices comprise elements related
to leadership, care needs, information transfer and communication, medication management, healthcare-associated infections, and specific care processes.
The Joint Commission established National Patient Safety Goals (NPSG, for the nearly
15,000 healthcare organizations and programs in the United States that participate in its
accreditation programs. Currently, safety goals have been set for ambulatory care, assisted
living, behavioral healthcare, critical access hospitals, disease-specific care programs, home
care, hospitals, laboratories, long-term care, network programs, and office-based surgery
(The Joint Commission, 2011). The NPSGs are updated annually. Table 4 illustrates the
NPSGs for hospitals. It is written in a form that is user friendly for patients and their families.

Il.

Operational Considerations

A.

Healthcare Safety Program Development


Every healthcare organization needs a written plan for a patient safery program that
integrates patient safety goals (such as plans from The Joint Commission, IHI, and NQF)
into organizational activities. Patient safety requires an environment in which patients,
families, organization staff and leaders, and medical staff can identify and manage actual
and potential risks to safety. Consideration should be given to

17

Q SoluEions

18

Table 4. The Joint CommissiJn's2ol2Hospital NPSGs


The purpose of the NPSGs is to improve patient safety. The goals focus on problems in healthcare safety and how to
solve them.

ldentify patients correctly

NPSG.OI.Ot.O1

Use at least two ways to identify patients. For example, use the patienti name and date of
birth. This is done to make sure that each patient gets the correct medicine and treatment.

NPSG.ot.os.ol

Make sure that the correct patient gets the correct blood when they get a blood transfusion.

lmprove staff communication

NPSG.oz.os.Ot

Get important test results to the right staff person on time.

Use medicines safely

NPSG.os.o+.ot

Before a procedure, label medicines that are not labeled, for example, medicines in syringes,
cups, and basins. Do this in the area where medicines and supplies are set up.

NPSG.o:.os.oi Take extra care with patients who take medicines to thin their blood.
NPSG.oE.oo.ot Record and pass along correct information about a patients medicines. Find out what
medicines the patient is taking. Compare those medicines to new medicines given to the pa-

tient. Make sure the patient knows which medicines to take when they are at home. Tell the patient it is important to bring their up-to-date list of medicines every time they visit a doctor.

Prevent infection

NPSG.oz.ot.oi

Use the hand cleaning guidelines from the CDC or the WHO. Set goals for improving
hand cleaning. Use the goals to improve hand cleaning.

NPSG.oz.o:.0l

Use proven guidelines to prevent infections that are difflcult to treat.

NPSG.Oz.o+.ol

Use proven guidelines to prevent infection of the blood from central lines.

NPSG.oz.os.ol
N PSG.oz.oo.Ol

Use proven guidelines to prevent infection after surgery.


Use proven guidelines to prevent infections of the urinary tract that are caused by catheters.

ldentify patient safety risks

NPSG.1S.Ot.Ol

Find out which patients are most likely to try to commit suicide.

Prevent mistakes in surgery

UP.Ot.Ot.Ot

Make sure that the correct surgery is done on the correct patient and at the correct place
on the patients body.

UP.ot.OZ.Ot
UP.oi.o:.ot

Mark the correct place on the patient's body where the surgery is to be done.
Pause before the surgery to make sure that a mistake is not being made.

From "2012 Hospital National Patient Safety Goals," by The Joint Commission, 2012. Retrieved from wwwjointcommission.orgfassetsftfdfzotzNPSG-HAP.pdf. Copyright zotz by The Joint Commission. Reprinted with permission.

. planning and designing services,


. directing services,
o integrating and coordinating services,
. reducingandpreventingerrors,
. following clinical practice guidelines, and
. actively involving patients and families in care.
Human error is inevitable, even among the most conscientious professionals who are
practicing the highest standards of care. Identification and reporting of adverse events,
including those that result from practitioner error, are critical to an organization's efforts
to continuously improve patient safety and create a learning environment. Likewise,

Healthcare Safety

healthcare leaders have a dug to recognize the inevitability of human error, attempt
to design systems that make such error less likely, and avoid punitive reactions to honest
errors. Regardless of the setting or type of healthcare organi zation, the scope and oversight
of the patient safety program includes the following areas:

.
.
.
.
.
.
.

governance and leadership,

creation ofa culture ofsafety,


creation of a learning environment,

definition of objectives,
design ofsafe processes,
process implementation, and
measurement, monitoring, and improvement.
The patient safety program provides a coordinated and integrated system for hospitalwide assessment and improvement of interrelated safery support, and clinical care processes that affect patient outcomes, including standards compliance. Healthcare qualiry
professionals can develop a patient safery program by

.
.

.
.
.

using comparative data;

working collaboratively to improve compliance with the Joint Commission NPSGs,


Leapfrog Safe Practices, NQF-endorsed measures, and federal government-vetted
measures (e.g., AHRQ, NHSN);
assisting all services and programs across the continuum of care by identifying and
mitigating risks and hazards;

working collaboratively to enhance the adverse event, sentinel event, and peer review
processes; and

promoting transparency and dissemination of results across their organization.


An organization should determine which performance improvement methodolory
should be adopted and emphasize the improvement of systems and processes, retrospectively and proactively. A learningwork environment can be created that is just (nonpunitive
and accountable) and flexible, employing techniques such as root cause analysis, healthcare
failure mode and effects analysis, proactive risk assessment, evidence-based healthcare
methods, and the monitoring of measurements over time. An organization also can look
to build the skills of those working on improving patient safery such as avowing common
pitfalls when conducting a root cause analysis (ISMP, 20U).
Safety oversight should be provided by an organization's governing body, leadership,
and medical staff. Patients and their families should be involved in quality and performance
improvement activities, as appropriate.

B. Health lnformation Technology


Health IT holds the promise of making healthcare services safer and offers alternatives for
clinical decision support. If health IT is to work, the healthcare consumer must be at the
center of the healthcare system and be empowered to own his or her personal healthcare
data. If IT is to be effective in the care setting, it needs to be integrated with the patient
and clinical workflow and aligned with available resources and the expectations of the
end users. Some say not enough evidence exists to support the link benveen electronic
health records (EHRs) and patient safety (Parente & McCullough, zoog). The following
are questions for consideration: Is health IT easy to use? How quickly does it process
information? How functional is it? Health IT and interoperable systems are requisites
for healthcare delivery in the 21st century. Health IT potentially includes products such

19

Q SoluEions

20

as EHRs; patient engagement tools such as personal health records and secure, private
Internet ptrtals; and health information exchanges. A recent IOM report (IOM, 2Ol2)
that examined the state of the art in system safety and opportunities to build safer systems
concluded that
just the
Safety is an emergent property of a larger system that takes into account not
software but also how it is used by clinicians.
The'sociotechnical system" includes technology (software, hardware), people
(clinicians, patients), processes (workflow), organization (capacity, decisions about
how health IT is applied, incentives), and the external environment (regulations,
public opinion).
Safer implementation and use of health IT is a complex, dynamic process that
requires a shared responsibility between 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 improving clinical decisions and


patient safety.
A constant, ongoing commitment to safety-from acquisition to implementation and
maintenan..-ir 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 Network (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 information is available at the time and place of care;

.
.

.
.
.

.
.
o

ensuring that consumer health information is secure and confidential;


giving consumers new capabilities to manage and control their personal health records,
,r *.tt as providing access to their health information from EHRs and other sources;
reducing risks from medical errors and supporting the delivery of appropriate,
evidence-based medical care;
lowering healthcare costs resulting from inefficiencies, medical errors, and incomplete
patient information; and
prorloting a more effective marketplace, more competition, and increased choice
ihrough accessibility to accurate information on healthcare costs, qualiry, and
outcomes (HHS, ONC, 2008).

An exemplar of this strategy is the implementation of a Virtual Lifetime Electronic


Record (VLER) by the U.S. Department of Veterans Affairs (VA). The VLER program
with the
ensures that each veteran has an electronic health record that can be accessed,
pilot of
veterans permission, by public and private sector healthcare providers. The first
this program occurred in-San Diego, CA, betrveen the VA, the U.S. Department of Defense,
and Kaiser Permanente.
Any health IT discussion needs to address privacy protection and confidentiality in the
NHIN. A study at a major medical center involved l0o patients from six disease groups:

Healthcare Safety
breast cancer, colon cancer, cystic fibrosis, diabetes, HIV infection, and sickle cell anemia.
When the patients were asked about privacy protections, they ranked the following topics as
needing the most protection: abortion history, mental health history HIV/AIDS, genetic test
results, drug and alcohol history, and sexually transmitted disease history (Plantinga et al.,
2003).
W. Edward Hammond presented solutions to the interoperability dilemma. He
proposed the following to meet the goals for a single EHk (1) a unique identifier is needed
for each person in America; (2) all stakeholders need to agree on a common terminology;
(3) all stakeholders need to use standardized data elements with a single terminolory;
(+) the leaders of all types of healthcare organizations (practitioners, group practices,
healthcare enterprises, and health plans) need to be totally committed to modernizing care
delivery through health IT; (5) a national leader is needed who can articulate what needs
to be done at a national level to meet these goals; (6) vendors need to be brought into the
process of modernizing the healthcare infrastructure; (7) a sustainable funding model must
be developed; and (8) a feasible timeline should be developed (Hammond, 2OO7). EHRs
have the potential to capture data that can be reported for purposes of healthcare safety
performance and improvement.
Leadership plays a critical role in the adoption of health IT. But major barriers
to realizing its potential benefit exist. These barriers include the need for increased
standardization, funding regulatory relief, a single set of privacy and security laws, and a
uniform approach in matching patients to their records (Merritt, 2OO7).
Various technological solutions have been proposed to enhance patient safety
programs. The premise of these solutions is that if processes are standardized and the
potential for medical error is reduced by the automation of processes, errors will be
mitigated. Clancy (2005) proposed four health IT goals: (1) connect health records, (z) build
smart systems, (3) put the patient at the center of care, and (+) put prevention at the center
of treatment. In healthcare, technology can be applied to the work of nurses and other
healthcare professionals. Table 5 illustrates this point.
EHRs typically include four core components: electronic clinical documentation,
results reporting and management, electronic prescribing, results reporting and
management, and clinical decision support. Barcoding and patient engagement tools
have been added. Table 6 provides potential benefits and safety concerns of health IT
components.

C. Risk Management
Enterprise risk management is recommended as a strucflrred analyical process focusing on
identifying and eliminating the portfolio of risks rather than risk avoidance (Carroll, zOOa).
The portfolio includes the domains of operations (the organization's systems and practices),
financial resources (the earning, raising, or accessing of capital and the costs associated
with transferring risk), human resources (recruitment, maintenance, and management of
the workforce), strategic direction (the organization's ability to grow and expand), legal and
regulatory affairs (compliance with licensure, regulations, and accreditation standards), and
technological resources (biomedical, health Il equipment, and devices).
Using an enterprise-wide approach can help healthcare organizations manage risk.
Organizations also should have established mechanisms for reviewing potential incidents
of risk and safety concern. All members of the workforce are responsible for identifying,
reporting, and documenting risk management and potential quality-of-care problems
that can influence patient safety. Effective strategies for proactively reducing errors and

21

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Healthcare Safety

23

Table 6.Potential Bdnefits and Safety Concerns of Heatth lT Components (.ortinued)


Clinical Decision Support (CDS)
Monitors and alerts clinicians of patient conditions, prescriptions, and treatment to provide evidence-based clinical
suggestions to health professionals at the point of care
Potential

'

Benefits
in

SafetyConcerns

'

Reductions

errors,
- risk of toxic drug levels,
- time to therapeutic stabilization,
_ relative risk

of medication

'
'

- management

errors of resuscitating patients


adult trauma centers, and

- prescriptions of nonpreferred

in

Rate of detecting druo-drug interactions varies widely


among different vendors
lncreases in mortality rate

High override rate of computer generated alerts (alert


fatigue)

medications

'

Can effectively monitor and alert clinicians


adverse conditions

'

lmprove long-term treatment and increase the


likelihood of achieving treatment goals

of

Bar coding
Bar coding can be used to track medications, orders, and other healthcare products. lt can also be used to verify
patient identification and dosage.

Potential

'

Benefits

Significant reductions in relative risk of


errors associated with

medication

Safety Concerns
lntroduction of workarounds; for example, clinicians can

- transcription,
- dispensing, and
- administration errors

scan medications and patient identification without


visually checking to see if the medication, dosing, and
patient identification are correct;

- attach patient identification bar codes to another


object instead of the patient; and

- scan orders

and medications of multiple patients at once


instead of doing it each time the medication is dispensed.

Patient Engagement Tools


Tools such as patient portals, smartphone applications, e-mail, and interactive kiosks, which enable patients to

participate in their healthcare treatment

Potential

'
'

Benefits

Reduction in hospitalization rates in

S.f"ty

children
and

lncreases in patients' knowledge of treatment

illnesses

Concerns

Reliability of data entered by

- patients,
- families,
- friends, or
- unauthorized

users

Note:Ia6/e6r.snotintendedtobeanexhaustiVelistofallpotentialbenefitsandsafetyconcerns"
common potential benefits and safety concems.
From Health lT and Patient Safety: Building Safer Systems for Better Care, 6y lnstitute of Medicine, Committee on Patient Safery and Health
lnformation Technology, 2012. Copyright zotz by National Academr'es Press. Reprnte d with permission.

ensuring patient safety require an integrated and coordinated approach to synthesizing


knowledge and experience. Staff members should be encouraged to learn about errors and
permit internal reporting of information without blame.
Healthcare quality professionals should work with enterprise risk management and
legal counsel to
' improve the effectiveness and efficiency of the organization's processes and
operations through consistent identification of risks (threats) to the enterprise;

Q SoluEions

24

.
.
.
.
.

identifu, evaluate, and prioritize areas of risk that affect the operations of the
organization;
assess whether the identified risks are caused by internal (controllable) or external
(uncontrollable) factors;
develop and propose comprehensive strategies to minimize risks;
establish action plans to address problems when identified; and

maintain a periodic evaluation of feedback to monitor the progress of strategies and


actions.

Healthcare qualiry professionals can also work with their organizations to design educational programs to help healthcare executives and other organizational leaders address
serious events when they occur, respond effectively and learn to improve safety as a result
(Conway, Federico, Stewart, & Campbell,20fD.
Disclosing errors to patients and families is becoming more common practice in
healthcare organizations across the country, especially in the aftermath of the Josie King
incident in Maryland. In 20Ol King was 18 months old when she died in a hospital as the
result of medical errors. NQF (2009) identified disclosure as an important part of error
discovery in contrast to tactics of the past, which sprang from fear and blame. A just culture
supports the disclosure of successes and failures. Healthcare quality professionals rypically
are involved in the handling of errors and work with quality management, enterprise risk
management, and legal professionals to determine a course of action. Table 7 outlines NQF
consensus standards regarding the disclosure of error or injury to consumers.
More recent literature on disclosure highlights the "respectful management" of adverse
events (Conway et al., 2011). The aims of this group's work were to
. encourage and help every organization to develop a clinical crisis management plan
before they need to use it;
o provide an approach to integrating this plan into the organizational culture of quality
and safery with a particular focus on patient- and family-centered care and fair and
just treatment for staff; and
o provide organizations with a concise, practical resource to inform their efforts when a
serious adverse event occurs in the absence of a clinical crisis management plan and/
or culture of quality and safety (Conway et al., 2Oll,p.4).
Organizations also should look for ways to encourage reporting using innovations such
as the "Good Catch Awards" at Johns Hopkins Medicine in Baltimore, MD. This reporting
system encourages every clinician to report situations in which patients are at risk and
potentially lifesaving actions are warranted. Actions reflected system change and were
evaluated for sustainabiliry such as the national recall of improperly labeled drugs that had
caused look- alike medication errors (McCook, 2 011).

D. lmplementing Safe Medication Practices


Even though many treatment procedures involve some risk, by far the most common errors
occur with the use of medications. The frequency of medication use in the United States is
startling. More than four out of five U.S. adults take at least one medication (prescription
or over-the-counter drug, vitamin, mineral, or herbal supplement), and almost one-third
take at least five different medications (Aspden, Wolcott, Bootman, & Cronenwett, 2006).
It is estimated that the extra medical costs of treating medication-related injuries amounts
to $3.5 billion per year (Aspden et al). In healthcare facilities most errors occur in the
prescribing and administration stages of medication therapy.

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26

Q SoluUions

A healthcare safety culture should have as its foundation an atmosphere devoid of blame,
and a search for opportunities for improvement should be employed. The organization should
have systematic ways to welcome the reporting of medication errors. Because 857o of errors are
the result of system failures and traditionally only Llo/o are due to human error, the exploration
of systems issues should be primary in identif,ring a root cause of error (Deming 2000).
NQF has endorsed, through a consensus process, the adoption of safe practices related
to medication administration (Table 8). Other organizations such as the Leapfrog Group
have supported their endorsement. More specific recommendations are found in Sofe
Practices for Better Heakhcare: 2O1O tJpdare (NeF, 2010).
Table 8. NQF: Safe Practices Related to Medication Administration
For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test
result by having the person who is receiving the information record and read back the complete order or test result.

lmplement a computerized prescriber order entry system built upon the requisite foundation of reengineered
evidence-based care, an assurance of healthcare organization staff and independent practitioner readiness, and
an integrated information technology infrastructure.
Standardize a list of "do not use" abbreviations, acronyms, symbols, and dose designations that cannot be used
throughout the organization.

The healthcare organization must develop, reconcile, and communicate an accurate medication list throughout
the continuum ofcare.
Pharmacists should actively participate in medication management systems by, at a minimum, working with other health professionals to select and maintain a formulary of medications chosen for safety and effectiveness, being available for consultation with prescribers on medication ordering, interpretation and review of medication
orders, preparation of medications, assurance of the safe storage and availability of medications, dispensing of
medications, and administration and monitoring of medications.
a

Standardize methods for the labeling and packaging of medications.

ldentify all high-alert drugs and establish policies and processes to minimize the risks associated with the use of
these drugs. At a minimum, such drugs should include intravenous adrenergic agonlsts and antagonists, chemotherapy agents, anticoagulants and antithrombotics, concentrated parenteral electrolytes, general anesthetics,
neuromuscular blockers, insulin and oral hypoglycemics, and opiates.
Healthcare organizations should dispense medications, including parenterals, in unit-dose, or, when appropriate,
in unit-of-use form, whenever possible.
Adapted from Safe Practices for Better Healthcare-2010 Update: A Consensus Report (abndged version), by National Quality Forum,2otO.
Fo rum. Repinted with permission.

Copyright 2OlO by Natrbna/ Quaity

E. NQF'Never

Events"
In 2008 CMS announced a proposed rule that would update payment policies and rates
under the hospital inpatient prospective payment system for fiscal year 2009, beginning
for discharges on or after October 1, 2008. The proposed rule included a discussion of
candidates for addition to the list of hospital-acquired infections for fiscal year 2009,
including several conditions that have been identified by NQF as "serious reportable
adverse events' (also called "never events'). The complete list of 29 serious reportable
events that was updated in 2011 is shown in Table 9 (NQF, 2OlLa, pp. iii-iv). CMS withholds
payment to hospitals if any of these events occurs in an acute care faciliry.

F. Consumer Empowerment,

Engagement, and Activation


Healthcare leaders are not the only advocates for healthcare safety. Consumers are telling
their stories to the public, the most poignant of which concerns the Josie King incident.
Josie, daughter of Sorrel King died as the result of multiple medical errors including

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28

Q SoluEions

misused narcotics. Sorrel Kinglater went public with her findings of breakdowns that led
to her daughter's death at Johns Hopkins Hospital, a premier medical system in Baltimore,
MD. The Josie King Foundation was established with the mission "to prevent others from
dying or being harmed by medical errors" (Josie King Foundation, 2008). Together with
the hospital and provider groups, King also founded the Patient Safery Group in 2OO4,
which upholds the mission to 'encourage a culture of safety by providing tools that allow
healthcare organizations the ability to communicate, collaborate, improve, and share"
(The Patient Safety Group, 2008). The recent focus on safety also requires that clinicians
engage patienB in their care. Patients and their families need to understand their role
and responsibilities related to safery. Patient-centered communication has been shown to
improve clinical outcomes (Epstein & Street, 2oo7).Various public and private entities have
launched several initiatives to support consumer engagement. They are described below.
AHRQ: TalkingQuality. TalkingQualiry is a comprehensive resource and guide for organizations that produce and disseminate reports to consumers on the qualiry of care healthcare
organizations (e.g., hospitals, health plans, medical groups, nursing homes) and individual physicians provide. Consumer report sponsors share a common mission to improve the
quality of care consumers receive. They also share a common challenge on how to convey
comparative information about healthcare quality in a way that achieves the following objectives:

.
.
.
.

.
.

Consumers are motivated to use it.


Consumers can understand it.
Consumers can apply the information to their own healthcare choices.

TalkingQuality offers
innovative ideas for communicating complex information on healthcare quality to
consumers,

information on the latest research findings, and


real-world examples to illustrate various approaches and concepts.
While TalkingQuality focuses on the challenges and process of consumer reporting
much of the guidance applies equally well to organizations producing reports on healthcare
quality to drive quality improvement and to inform other audiences, such as providers of
care, payers, employers, and other stakeholders (AHRQ, n.d).
AHRQ: Communication and Patient-Centered Care Toolkits. These toolkits contain resources to enhance communication befween caregivers and patients.
. ImprovingHospital Discharge Through Medication Reconciliation and Education,
. Improving Medication Adherence,
. Improving Medication Safety in Clinics for Patients 55 and Older,
. ImprovingPatient Safety Through Enhanced Provider Communication,
. Multidisciplinary Training for Medication Reconciliation,
. ReducingDiscrepancies in Medication Orders and Histories at Handoffs,
. A Simulation-Based Safety Curriculum in a Children's Hospital ED,
. Testingthe Reengineered Hospital Discharge, and
. Using Military Simulation to Improve Rural Obstetric Safery
AHRQ: Consumers and Patients. AHRQ has developed exceptional tools geared toward
consumers and patients, providing "the latest evidence-based information for improving
your health." 'Getting Safer Care" includes resources in various forms, including written literature, podcasts, and videos.

Healthcare Safety

29

Americans for Quality Health Care Quality Tool Box Consumer Engagement. The National Partnership for women and Families (NPWF) believe that "no rir4. person, group
or profession can improve health and healthcare throughout a communiry-wiihout the
support of others" (NpWF,2OL2).
The partnership has also developed a Consumer Partnership for e-Health. Tools have
been developed for engaging consumers.
Patient-Centered Outcomes Research Institute (PCORI). According to its website, pCORI "is an independent organization created to help people rnake informed healthcare decisions and improve healthcare delivery. PCORI will commission research that is guided
by
patients, caregivers, and the broader healthcare communiry and will produce
high integriry
evidence-based information. PCORI is committed to transparency rrrd rigorous stakeholier-driven process that emphasizes patient engagement. PCORI will use" a variety of forums
and public comment periods to obtain public input throughout its work" (pCoRI, 20L2,
para.l-2).
In March 2012, the PCoRI Board refined its definition of patient-centered outcomes
research. "Patient-centered outcomes research (PCOR) helps people and their
caregivers
communicate and make informed healthcare decisions, allowing their voices to be heard
in assessing the value of healthcare options." This research answers patient-centered questions such as
1. Given my personal characteristics, conditions and preferences, what should I expect
will happen to me?
2. What are my options and what are the potential benefits and harms of those options?
3. what can I do to improve the outcomes that are most important to me?
4. How can clinicians and the care delivery systems they work in help me make the best
decisions about my health and healthcare? (PCORI, 2Ot2).
PCORI has established national priorities for patient-centered comparative clinical effectiveness, which are

'

Assessment of Prevention, Diagnosis, and Treatment Options: the research goal is to determine which option(s) work best for distinct populations with specific health problems;

'

Improving Healthcare Systems: focuses on ways to improve healthcare services, such


the coordination of care for patients with multiple chronic conditions;
Communication and Dissemination: looks at ways to provide information to patients
so that they, in turn, can make informed healthcare decisions with clinicians;
Addressing Disparities: ensures that research addresses the healthcare needs of all patient populations. This is needed as treatments may not work equally well for everyas

'
'

one; and

'

Accelerating Patient-Centered and Methodological Research: includes patients and


caregivers in the design of research that is quick, safe, and efficient (PCORI, 2OL2).
Partnership for Patients. Partnership for Patients: Better Care, Lower Costs is a new publicprivate partnership that will help improve the qualiry safety, and affordabiliry of healthcare
for all Americans. Using as much as $I billion in new fundingprovided by the Affordable Care
Act and leveraging a number of ongoing programs, the U.S. Department of Health and Human Services (HHS) will work with a wide variety of public and private parrners to achieve
the two core goals of this partnership: keeping patients from getting injured or sicker in the
healthcare system and helping patients heal without complication by improving transitions
from acute-care hospitals to other care settings, such as home or a skilled nursing facility. Its
mission is to help patients "take care into their own hands."

-'1

Q SoluEions

30

Beyond reducing harm caussd in hospitals, the Partnership for Patients is an important
test of what can occur when the nation acts as one to address a major national health problem.
The recently formed Innovation Center at the Center for Medicare & Medicaid Services
intends to dedicate more than $500 million to test models of safer care delivery and promote
implementation of best practices in patient safety. CMS will also provide $500 million for
a community-based care transition program created by the Affordable Care Act to support
hospitals and community-based organizations in helping Medicare beneficiaries at high risk
for readmission to the hospital safely transition from the hospital to other care settings.
More than Z3OO partners, including more than 3,200 hospitals as well as physicians and
nurses groups, consumer groups, and employers, have pledged their commitment to the
Partnership for Patients (HHS, 2011, para. 1-4).
The Joint Commission empowers consumers by providing educational materials and
tools as navigational aids for complex healthcare systems.In 2OO2 in response to a public
outcry regarding unsafe practices, the Joint Commission, in collaboration with CMS,

launched a national campaign to urge consumers to take an active role in identifying


and preventing healthcare errors. The goal of the initiative was to empower consumers
to become active, involved, and informed participants on the healthcare team (Joint
Commission,2OI2b). The "Speak Up" initiative encourages consumers to
Speok up if youhave questions

or concerns,

and

if you don't understand, askagain. It's

your body and you have a right to know.


Pay attentiontothe careyouare receiving.Make sureyou're gettingtherighttreatments
and medications by the righthealthcare professionols. Don't cssume anything.
Educate yourself about your diognosis, the medical tests you are undergoing and your
treatmentplan.
Ask

c trusted family member

or

friend to be your advocate.

Know what medicctions you take and why you take them. Medication errors dre the
mo st

co

mmo n he akhcar e mistake s.

Use a hospital, clinic, surgery center, or other type of heakhcare organization that has
undergone a rigorous on-site evaluation against established state-of-the-art quality

and safety standords, such as those proildedby The Joint Commission.

Participate in all decisions about your treatment. You are the center of the healthcare
team. (The Joint Commission, 2012b)

Roizen and Oz, in their book You the Smart Patient: An Insider's Handbookfor Getting the
BestTreatment Q,oo6), provide consumers with "everything from selecting the best physician
or hospital to avoiding all manner of therapeutic misadventures" (Soo Hoo, 2006 ,p.4).

G. Evaluating Adoption of Safety Practices


A RAND study (Farley et al., 2OO7) identified five components of an effective patient safery
system:
knowledge of the epidemiolory of patient safety risks and hazards,

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.
.

development of effective practices and tools,


establishment of an infrastructure for effective practices,

Healthcare Safety

.
.

broader adoption of effective practices, and


monitoring of progress and maintenance of vigilance.

Rogers's work on disseminating innovations is also applicable to the widespread


adoption of safety practices (Rogers, 2003). A comprehensive discussion of spread of chang"
and
innovation can be found in Q Solutions: Quality andPerformance Improvement.

lll.

Tools for lmproving Safety


Various statistical process control and quality improvement tools can be used in the
healthcare safety arena. Statistical process control techniques and p"rfor*rn..improvement tools (see Q Solution s: Information Managementj are applicable to the
deployment of healthcare safety practices throughout a healthcare enterprise.
A healthcare failure mode and effects analysis (HFMEA) can be ur"i to develop safety
program activities and provide continuous readiness for external surveys. HFMEA
is
described in detail in e solutions; Quoliry and performance rmprovement.
Only a small portion of healthcare errors (loo/o-2oyo) is reported. Of the errors that are
reported, 9oo/o-95o/o result in no harm to the patient (Griffin & Resar, 2OO7).IHI developed
a tool to determine which events cause harm to patients. An odyers e drug eyent is defined
as "an injury related to medical management, in contrast to complications of disease.
Medical management includes all aspects of care, including diagnosis and treatment, failure
to diagnose or treat, and the systems and equipment" (World Health Organization, 2005,
p. 8). IHI adapted the National Coordinating Council for Medication Error Reporting
and
Prevention to include only those errors that cause a patient harm. Categories of harm
include
' Category E: Caused temporary harm to the patient and required intervention,
' Category F: Caused temporary harm to the patient and required initial or prolonged
hospitalization,

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.

Category G: Caused permanent patient harm,


Category H: Required intervention to sustain life, and
Category I: Caused parient death (IHI,2OOT).

Organizations use root cause analysis to determine the cause of a variation in a process.
Human, environmental, equipment, policy, and leadership system factors .r. .*piored in
the analysis. Root cause analysis is described further in Soluti ons:
Q
Quality and performance

Improvement and Q Solutions: Information Management.


Another safety practice used by highly reliable industries-red rules-has sparked interest in healthcare (Griffith,2OOT; Scharf 2OO7). According to the AHRe patient Safety
Network (2008), red rules are those that must be followed to the letter; if there is a condition or situation that poses risk, red rules "stop the line." Red rules will always be supported
by an entire organization. In other words, when someone at the frontline calls for work to
cease on the basis of a red rule, top management must always support this decision. When
properly implemented, red rules foster a culture of safery because frontline workers will
know they can stop the line when they notice potential hazards. The most important aspect
of a red rule is its ability to "empower any worker to speak up when the rule is not being followed and to stop the line, regardless of rank or seniority" (ISMP, 200g, para.2). Red rules
are part of a just culture approach.

ISMP (2008) outlines the things that differentiate a red rule from other crucial rules
such as policies and procedures:

31

Q SoluEions

32

It must be possible and delirable for everyone to follow a red rule every time in a prounder all circumstances (red rules should not contain verbiage such as "except
when . . ." or "each breach will be assessed for appropriateness).
Anyone who notices that the red rule has been breached has the authority and responsibility to stop further progress of patient care associated with the red rule while
protecting the patient or employee from harm.
Managers and other leaders (including the board of trustees) always support the work
stoppage and immediately begin rectifying the problem and addressing the underlying
reason for breaking the rule.
The people who breached the red rule are given an opportunity to support their behavioral choices and are then judged fairly based on the reasons for breaking the
rule, regardless of rank and experience.
cess

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The red rules are few well understood, and memorable (para. 7).

Healthcare scenarios for which red rules can be beneficial include patient identification
(using rwo identifiers before administering tests of any kind), sponge-count reconciliation,
time-outs before an invasive procedure, timely alarm response, and correct labeling of
specimens.

lV.

Summary

This module includes a synthesis of current knowledge related to preventing errors and
reducing harm. Both strategic and operational components of developing a healthcare
safety program are presented. Beginning with the importance of leadership, the authors
discuss integrating healthcare safety concepts into an organization's vision, mission, strategic plan, goals, and objectives. Healthcare safery goals from various organizations are also
presented as well as national and global imperatives to reduce harm in healthcare. Finally,
the authors provide guidance in using performance-improvement tools to integrate safety
into enterprise's operations. Comprehensive references, resources, and suggested readings
from the Journalfor Heakhcare Quality also are provided.
In summary, consensus and the scientific literature support the following healthcare
safety tenets:

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.

Healthcare leaders must set the vision, mission, purpose, and direction and adopt
healthcare safety practices proven to prevent error.
Organizations should strive to create and maintain a fair and just culture emphasizing
learning from errors and near misses to reduce future errors. Instituting safe practices
decreases errors in healthcare.
Error prevention and reduction of harm are the job of everyone, including consumers.
Empowering and engaging patients leads to better outcomes and fewer errors.
Healthcare organizations must continue to adopt new and emerging evidence-based
safery practices.

Healthcare quality professionals possess unique experience and expertise to assist with
the advancement of safety practices in their organizations and the community at large.
Operational considerations for healthcare qualiry professionals include program development; technology to support the program; enterprise risk management; implementation
of safe medication practices; monitoring of errors and never events; consumer empowerment and engagement; and the adoption, spread, and evaluation of evidence-based safety
innovations.