Supporting Approaches and Tools

Improving Healthcare Monograph Series: Healthcare Quality and Improvement
Committee, a joint development

Supporting Approaches of the Healthcare and Quality
and Tools Management Divisions of ASQ
October 2020 Vol. 1, No. 3
Improving Healthcare
Monograph Series
Supporting Approaches and Tools
Authors Donna Gillespie

CAP 15189 Lead and Technical
Assessor, College of American
Grace L. Duffy
Pathologists
President,
Management & Performance
Systems
Rowena Chona Sano

Director, Performance Excellence
Memorial Hermann Greater Heights
Pierce Story
Hospital
VP Concept Development,
Capacity Strategies, Inc.
Maureen Washburn
Certification and Program Development
Lynn Loynes
DNV GL - Business Assurance,
Principal Business Analyst,
Healthcare Accreditation Services
DLMP Strategy Management
Services, Mayo Clinic
Tammy Allen
Director,
Susan E. Peiffer
DNV GL Program Development
Performance Improvement Manager
and Certifications
for the HSHS Wisconsin Division
2 Healthcare Quality and Improvement Committee October 2020

Ron Schulingkamp Douglas Dotan
Vice President, President, Pegwin
Louisiana Quality Foundation
Kelly Podgorny Gregory Gurican

Infection Prevention Specialist, Independent Healthcare Quality
Chicago Department of Public Health Consultant – Retired,
GMG & Associates, LLP
Christopher Kim
Project Manager, Pharmacy Operations
Sharp Rees-Stealy Medical Group
(Sharp Healthcare)
Next in This Monograph Series

The fourth monograph in this new series
from the Healthcare Technical Committee
will be released in 2021, and it will address
application of the Hospital-Based Healthcare
Quality Management System (QMS) Model.

Table of Contents
5 Introduction
7 Overview of the QMS Model
Critical Quality System Elements ... 9
Data and the QMS ... 9
Leadership Commitment, Planning, and Review ... 10
Feedback Loops/Measurement ... 11
Environment of Care ... 11
Management of Finances and Support Resources ... 12
Management of Information ... 12
Communication, Education, and Training ... 13
Risk Management ... 14
Management of Change ... 15
Teamwork ... 15
Compliance with Requirements ... 16
18 Appendix of Tools and Techniques

Leadership Commitment, Planning, and Review ... 18
Feedback Loops/Measurement ... 20
Environment of Care ... 22
Management of Finances and Support Resources ... 23
Management of Information ... 25
Communication, Education, and Training ... 26
Risk Management ... 28
Management of Change ... 30
Teamwork ... 33
Compliance with Requirements ... 35
38 References

Introduction
Health Care Quality Model conference presentations, and webinars.

The model’s non-prescriptive approach
A Hospital-Based Healthcare Quality
Management System Model1 was
released to organizations across the globe
facilitates its adoption by hospitals of all
types, sizes, and locations.
Due to increasing interest in the model,
in April 2016. It was developed by a team
its authors have received many requests
of practitioners from the ASQ Healthcare
for additional information related to the
Quality and Improvement Committee,
way the healthcare organizations can
who represented the Society’s Healthcare
apply the model to improve patient out-
and Quality Management Divisions. The
comes. Monograph 2 was issued in 2019
model provides a conceptual framework
to provide a tool for assessing the current
for CEOs, CMOS, and others who seek to
medical facility capabilities relative to a
improve patient outcomes, safety, and satis-
QMS.2 Use of this assessment tool to pro-
faction, as well as profitability, cost savings,
vide a gap analysis for improvement of
risk management, and regulatory compli-
the critical success factors to exceptional
ance. The formalized quality management
safety, quality, and patient outcomes sub-
system (QMS) shared in that monograph
sequently led piloting organizations to
documented the structure, responsibility,
request a set of tools to facilitate their
and procedures required to achieve effec-
efforts.
tive quality management focused on the
Furthermore, the potential for apply-
quality policy and quality objectives that
ing the model to non-hospital settings
can meet customer requirements. It specifi-
also has been raised. The field of potential
cally describes the process for improving all
organizations that might be improved by
aspects of patient outcomes and operating
use of a QMS model includes medical
performance.
clinics as well as a wide variety of other
The QMS model offers a systemic
healthcare-related services, such as phar-
structure that enables hospitals and
macies, dental clinics, radiology centers,
other healthcare organizations to meet
laboratories, etc. Even veterinary clinics
both quality and value-based goals. Its
and other non-human, health-related ser-
design presumes the need for contin-
vices might benefit from a QMS model.
uous improvement. Each organization
Based on a growing understanding of
will need to understand its current situ-
those diverse needs, the ASQ Healthcare
ation and determine the actions that are
Quality and Improvement Committee
required to raise its performance to the
decided to develop additional applica-
necessary level and sustain that high per-
tion-oriented monographs. Although they
formance on an ongoing basis.
all will support the successful imple-
Response to this breakthrough model
mentation and sustainable operation of
has been extremely favorable. Individuals
the QMS model described in the first
and organizations across the globe
two monographs in this series, they are
have accessed the model through ASQ-
intended to provide notably different
affiliated websites, and it already has been
cited as a reference in many publications,

resources to aid hospitals and other healthcare • Implementing the Healthcare Quality Management
organizations. System. This document has a much different
Topics in these additional monographs will purpose and will be designed to provide an
include the following: anthology of case studies for organizations to
• Supporting Approaches and Tools. This informa- use when initially developing and implementing
tion is intended to share a cross-section of data their first comprehensive QMS. It also will be
gathering, analysis, and reporting approaches useful for organizations that feel major revisions
that a healthcare organization can use in con- are required to improve their QMS. This will be a
junction with its QMS. Although the practices process-oriented document and will focus on the
presented will not represent an exhaustive steps needed to obtain support from leaders and
list, they will demonstrate how selecting and stakeholders, establish change plans, implement
applying appropriate approaches and tools is conformance audits, etc. The quality system ele-
instrumental for managing the QMS on a daily ments will be supported with examples and case
basis and ensuring that reliable information that studies that describe the specific environment or
can be interpreted properly is readily available department associated with the implementation.
when decisions need to be made. The expert This will constitute Monograph 4 in this series.
panel that created the original QMS model has
developed these approaches and tools as pre- With these additional monographs, health-
sented in this Monograph 3 of the Healthcare care organization leaders should have the
Series. The approaches and tools are shared with necessary resources for meeting current and future
supporting instructions in formats that can be requirements.
used off-the-shelf and applied immediately.

Overview of the QMS Model
T he ASQ Healthcare Quality and Improvement Committee developed the original

QMS model to provide the leaders of healthcare hospitals with a framework for
evaluating current business conditions against a set of commonly accepted quality man-
agement fundamentals that had been adapted specifically for the healthcare business
environment. By recognizing the interactions of the key business processes associated
with this model, leaders can reduce negative impacts on results and promote evalua-
tion of integrated improvement opportunities. Furthermore, the model facilitates the
attainment and maintenance of critical changes in operational environments so that the
demands of regulators and payers can also be met.
A broad range of disciplines support healthcare’s ultimate customer—the patient
who has a direct or indirect role before, during, and after the delivery of care and treat-
ment. When these disciplines work collaboratively and treat each other as customers, the
desired clinical results are more likely to be achieved along with patients’ satisfaction
related to their experiences with healthcare services. Ultimately, the goal of healthcare is
to provide medical resources of high worth to all who need them. The term “healthcare
quality” is determined based on measurements such as counts of a therapy’s reduction
or lessening of diseases identified by medical diagnosis, a decrease in the number of risk
factors which people have following preventive care, or a survey of health indicators in a
population that is accessing a certain kind of care.3
The ASQ QMD/HCD Hospital-Based Healthcare QMS Model

The International Organization for Standardization (ISO) has a generic QMS model2
that was used as the basis for developing the original hospital based QMS model for
quality and safety, which is shown in Figure 1 (see next page). The QMS model’s three
concentric circles and overlay illustrate the framework for integrating processes, measures,
and improvement activities into a smooth flowing, repeatable, and reliable QMS in order
to meet patient, community, and regulatory body requirements for improved results and
lower costs. The descriptions below summarize the QMS model’s content, but the first
monograph, “A Hospital-Based Healthcare Quality Management System Model,” should
be referenced to obtain a deeper understanding of its functionality.
• The inner circle. The core of the model delineates the results that are expected—excep-
tional quality, safety, and patient outcomes, the primary and secondary drivers of
exceptional patient and family inpatient hospital experience (defined as care that is
patient centered, safe, effective, timely, efficient, and equitable), as measured by the
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) sur-
vey’s “willingness to recommend” the hospital.”4
• The middle circle. This circle details four key components of the patient’s care deliv-
ery—identification and assessment, development of a treatment plan by all primary
and ancillary services, delivery of care, and transition of care to the next level or dis-
charge. These components represent the patient’s typical experiential path through the

Figure 1: The ASQ QMD/HCD Hospital-Based Healthcare QMS Model
Leadership commitment,
planning and review
e s
nc nt Fe
p lia reme e
loo dbac
m i
Co requ ps k
t h
wi
Patient
identification
and assessment
Env f care
work
iron
o
Team
men
t
Transition Exceptional quality, Development
of care safety and of treatment
Legend: patient outcome plan
sou ces
Interactions
rces
t re an
por f fin
Man chang
of
sup nt o
age e
men
and ageme
t
Delivery
Man
of care
Indicates nt
continual ma R
na isk e me tion
g
improvement ge na rma
and innovation me Ma info
nt of
Communication,
education and training
care-delivery process. They are described in more • The overlay. The integration of continual
detail in the first monograph. improvement and innovation is critical through-
•
The outer circle. The 10 critical quality system out all the other aspects of the model to ensure
elements that provide the infrastructure and that better patient care and business efficiency
framework for supporting and influencing are achieved. By superimposing these two essen-
achievement of exceptional quality, safety, and tial approaches over the three concentric circles,
patient outcomes are the process and structures the model makes it clear that they must be
needed for overall business effectiveness and effi- applied to all the previously described parts.
ciency, and they have an interactive relationship By determining, measuring, and analyzing the
with each other, the four key components of care results of the organization’s core processes,
delivery, and ultimately the core of the model. continual improvement and innovation are pos-
These elements are based on ISO 9001:20155 sible. Without this critical foundation, the model
and the Baldrige Criteria for Performance and any advances it cultivates may become static
Excellence,6 and they were adjusted to reflect and fail to allow for future change. The differ-
the hospital setting. ence between these two approaches is discussed
in more detail in the original monograph.

Critical Quality System Elements
The 10 critical quality system elements represent the operationally focused essence of the QMS model
from the perspective of a daily management system. They provide for the operational environment, attri-
butes, and activities that make up the patient experience, enable or constrain change, and lead to intended
clinical results. Poor performance of any of these elements may lead to the failure of the organization to meet
community expectations. The related activities and services associated with each of the elements may apply to
one or more of the four key components of care delivery affecting the patient experience. This is true because
setting up the ability to serve patients must happen strategically before engaging with the individual patient.
These elements are listed in Table 1. Another critical factor in supporting these system elements is the effective
use of data. This section begins with guidance on the proper use of data and analytics.
Table 1: 10 Critical Quality System Elements
Leadership commitment, Communication, education,

planning, and review and training
Feedback loops Risk management
Environment of care Management of change
Management of finances and Teamwork
support resources
Management of information Compliance with
requirements
Data and the QMS

Data is a foundational element to nearly every component and facet of the Hospital-Based Quality
Management System model. From Leadership Planning to the Management of Change to Compliance
with Requirements to Teamwork, the model’s components are enabled through the proper use of data and
analytics.
However, data in and of itself is relatively unhelpful. Data only begins to become useful as it is extracted
and put into graphic representations, reports, and summaries and then turned into actionable strategies for
change and the optimization of performance. Even when there is an abundance of data, without the trans-
formation into meaningful information and actionable strategies, it remains as lifeless as the computers and
paperwork in which it resides.
Furthermore, we often think of data only as the bits and bytes on computer hard drives. However, impor-
tant data also exists within the culture, attitudes, and philosophical underpinnings of an organization and its
participants and patients. While more difficult to measure and accurately extract, qualitative data can be as
important to the strategic direction of the organization as the quantitative data we typically gather and use.

To properly use the data at our disposal, we must The elements of the QMS model all require some
consider the accuracy and veracity of our data, the data. In order to make that data optimally useful,
validity of its source(s), and the processes by which we must be keenly aware of the limitations of our
it becomes information and strategy. The first step data, analysis, and reporting so that we can develop
is to evaluate the data itself. proper strategies for our quality and performance
Data only comes into existence as someone or improvement efforts.
something memorializes it as an input to a collec-
tion system, whether a piece of paper, a spreadsheet, Leadership Commitment, Planning,
or an Electronic Medical Record. This seemingly and Review
benign step becomes critical when data definitions The four areas within the Leadership Commit-
are needed or disputes about the validity and effi- ment, Planning, and Review are Commitment to
cacy of outputs and analysis arise. Thus, both the Quality, Planning, Quality Policy, and Review of
source and the collection methods must be consid- Quality Plans. Of these, the responsibility for stra-
ered when evaluating the efficacy of any available tegic planning is unique in that these actions set
data. organizational direction, create the roadmap to
Next, the means by which data becomes infor- success, and compel organizational members to
mation must be evaluated. For instance, reports act. Planning reinforces the organization’s mission,
generated by parties unfamiliar with the clinical keeping it alive and setting the vision.
operations being studied may produce errant or Optimal planning demonstrates a commitment
misleading results, leading to ill-informed actions to quality and reinforces a culture of collegiality
or remediation strategies. Likewise, reports and and support, and a culture that is patient-centered.
their results may be subject to interpretation when Planning specifies performance results and includes
several individual data points can be used for the critical links to action to achieve the best possible
same analytical data element. Because certain data patient safety, quality, and organizational outcomes
elements may not be readily available, analysts and and for measurements to sustain favorable out-
managers may need to resort to proxies, making comes. Ideally, the strategic plan is cascaded down
the analysis only “directionally correct” rather than to the front line and objectives are translated to
precise. meaningful and achievable goals. These actions pro-
Finally, data must become strategy if we are to vide a shared vision of organizational function and
use it to its fullest. Simply having pretty charts and line-of-sight for objectives from the top organiza-
graphs only makes us “Masters of the Obvious.” tional tiers to those directly creating and providing
But to take this step, objectivity and a deep under- products and services to the patient.
standing of both the data sources and its derivation Communication of the strategic plan is impor-
and manipulation is required. Without an objective tant for awareness and to engage organizational
evaluation of the information presented, we might members in actions to realize the strategic objec-
wrongly read our own preconceived ideas into the tives and move closer to the organizational vision.
analysis. Our strategies can become based on our Quality planning is an extension of the strategic
opinions or socially acceptable parameters rather plan and includes clinical, administrative, and edu-
than a “Spock-like” reading of the analysis. cational quality elements with considerations for
Errors, misinterpretations, or intentional manip- disaster planning and risk assessments. The quality
ulation in any of the three steps can lead to a policy stimulates periodic review of vital organiza-
mistrust of the data on which managers base many tional product and service outcomes and promotes
of their operational decisions. Thus, our data is effective reviews of clinical, administrative, and edu-
only as good as those inputting, extracting, and ana- cational quality functions.
lyzing it. Similarly, our strategies are only as good
as those consolidating and interpreting the analysis. Recommended Quality Tools
Therefore, we need specific tools and approaches to See the Appendix for a one-page description of
ensure data and output integrity such as data dic- the following tools:
tionaries, report construction documentation, and • The X-Matrix7 is based on the hoshin kanri
objective analytical rigor. strategic planning process. The matrix con-
nects the vital strategic objectives, aligned to

the organizational mission, vision, and values, is doing in a particular area. Each QSE must have
to the associated initiatives, tactical actions, at least one KPI that drives performance toward
and key metrics with targets. The matrix gener- the process goals related to that element. For
ally includes one to three tactical actions per example: KPIs for the Environment of Care ele-
initiative. Metrics are linked to organizational ment would include quantitative measures to assure
members with assigned responsibility. patient safety, HIPAA compliance, and process and
• System of Alignment and Accountability8 is a outcome requirements. The combination of all
visual tool to facilitate line-of-sight, the System operations, procedures, devices and other equip-
of Alignment and Accountability (SAA) steps ment, personnel and environment used to assign a
through the cascade of goals from high-level value to the characteristic being measured is called
tiers to the front line. The model depicts align- a measurement system.
ment of goals and connection to metrics that Recommended Quality Tools/Approaches
are reviewed monthly by multiple levels of the
Feedback Loops/Measurement
hospital system to track progress and stimulate
deeper analysis and improvement when needed. • Tri Metric Matrix is a tool that guides an
improvement team through identifying capacity
Feedback Loops/Measurement requirements, process expectations, and out-
Consistent and reliable feedback loops facilitate comes for a hospital-supplied process or service.
a factual approach to decision making. Feedback Capacity tells us whether we have the resources
loops verify whether processes are functioning as to meet current demand of the product or
expected. The loops relate process output informa- service. Process monitors the continuing effec-
tion to the inputs and operational factors to identify tiveness of activities performed. Outcome gauges
corrective action. Feedback loops can be highly the satisfaction of the end user with the product
interconnected to ensure exceptional quality, safety, or service once it is delivered or experienced.9
and patient outcomes, as well as better hospital per- • Gap Analysis Feedback Collection Tool is a
formance. Each of the 10 quality system elements table that captures feedback from the assess-
(QSE) may have leading and lagging indicators that ments performed by the healthcare organization
provide overall system feedback. Leading indicators against the 10 QSEs as identified in Healthcare
anticipate the probability of reaching the desired QMS Monograph 2.10 The Microsoft Word
result. Lagging indicators measure the performance table shown in the example in the Appendix is
of the completed activity. Examples of feedback intended to be expanded to address each of the
loops are: QSEs at least annually for the purpose of con-
• Information obtained from the patient, which tinuous quality improvement.
is the basis for care delivery, such as when the
patient self-assesses his/her pain level, and that
Environment of Care
rating is used to establish a treatment plan. The environment of a hospital or healthcare
system provides the basic infrastructure for care,
• Aggregated data collected for management review
including both physical systems and cultural.
that represents opportunities for improvement,
Utilities, buildings, systems, communication tools
support continual improvement projects, and
and support processes, and teams enable a system
assess the effectiveness of operational changes.
capable of delivering proper care; provide the busi-
• Non-patient qualitative and quantitative data ness infrastructure; and prepare the organization to
supporting allied health or administrative func- handle unusual events and emergencies.
tions also may be incorporated into feedback Safety, quality, and regulatory compliance aspects
loops. must be balanced with patient needs to support the
Measurement is the act or process of determining business and care processes and culture necessary
a value. Key performance indicators (KPI) are the to deliver high value care. The environment for
core measures set by the organization to identify care and business processes require unique system
strategic goals and objectives, along with the quan- designs, based on each organization’s scope of prac-
titative range of acceptable performance. A KPI is tice, vision and mission. The design will include the
a statistical measure of how well an organization organization’s service model, which will be framed

by the compliance approach and standards utilized. improvement (OFIs) are often identified by audi-
These processes will be framed by strategies, goals, tors, along with deficiencies, nonconformities, and
and measures, as part of the quality plan, to provide requirements for improvement during internal and
the basis for management control, compliance, and external audits. OFIs offer a continual and substan-
improvement activities. Likewise, an organization’s tial supply of resource allocation recommendations
culture is the combination of norms, behaviors, to hospital Quality Assurance and Performance
traditions, and roles that bring the processes to life. Improvement (QAPI) programs. QAPI programs
Common tools utilized in the establishment can efficiently compare improvement initiatives
of the environment of care include process maps and effectively identify viable projects by determin-
defining the organization’s processes and interac- ing the return on investment (ROI). Common ROI
tions and models built to enable a safe and engaged methods include the internal rate of return (IRR),
culture. Constructing the system of processes and net present value (NPV), and payback period.12
demonstrating the use of tools is a key part of IRR and NPV are capital budgeting techniques
management’s role in demonstrating leadership used by hospital accounting and finance profes-
behaviors to create a safe, team-based environment. sionals to determine the ROI. A Duke University
Failure to do so can lead to organizational confusion study of 392 Chief Financial Officers (CFOs) found
and politics, which result in lower organizational that nearly 57% of the survey respondents also
effectiveness. The following are examples of how used the payback period when evaluating capital
this has been approached. investments.13
Processes for communication and sharing of
Recommended Quality Tools for
organizational standards for use in the care envi-
Management of Finance and Support
ronment need to provide a system enabling the
multiple ways information can be defined, con- Resources
sumed, and maintained. These standards will be • Payback Period: The payback period is defined
evolving as new learning is achieved, balanced by as the number of years required to recover the
industry peer-reviewed science and the organiza- initial cash investment.14 The payback period is
tion’s knowledge base. Business improvement and an efficient and effective way for hospital QAPI
compliance needs will require key aspects of these programs to evaluate and prioritize projects for
processes have control metrics to demonstrate effec- CFOs.
tiveness. Attributes such as data accuracy, patient • Cost/Benefit Analysis: After project acceptance,
satisfaction with information, coding and billing a cost-benefit analysis is recommended to verify
accuracy, unauthorized user access events, etc., are that the benefits of a project will outweigh the
common traits used by organizations as KPIs, as costs. A cost-benefit analysis is a study to deter-
part of their quality plan. mine the relationship between the benefits and
the costs of changes to processes, policies, and/
or procedures.15 During a cost-benefit analysis,
Environment of Care
a financial measure such as a benefit-cost ratio
• Affinity Diagram: Graphical technique utilized (BCR)16 is used to determine project feasibility.
to group like themes to communicate relation- If a BCR indicates a positive change, then a proj-
ship/connections of sets of information. ect outcome is considered favorable. Hospital
• Process Flow: A process flow diagram indicates accounting and finance departments should be
sequence of work at a level of detail appropriate consulted before implementation to confirm a
for the concept being defined. project’s assumptions, limitations, cost-benefit
analysis, and BCR.
Management of Finances and
Support Resources Management of Information
Finances and Support Resources must be man- The information landscape of a hospital or
aged as a critical quality system element that healthcare system is complex and evolving. Security,
supports effectiveness and efficiency throughout the privacy, financial, and regulatory compliance
organization and includes finances, people, equip- aspects must be balanced with the need for timely
ment, and information systems.11 Opportunities for information to support processes and teamwork to

deliver effective care. The organization’s informa- information systems processes, as well as applying
tion system requires reliable data and effective data continuous improvement, based on the organiza-
management to achieve effectiveness. This includes tion’s needs, success criteria, and goals.
defining and deploying solutions which serve
patients, providers, support staff, and partnering
organizations with usable, appropriate information, Management of Information
with protections and limitations for unintended • SIPOC: is a visual representation of the Supplier,
access and usage, while monitoring and improving Input, Process, Output, Customer model for
system effectiveness. defining a process.
Processes for information management need to • Relationship Matrix: provides a way to organize
provide a system enabling the multiple ways infor- and compare two, three, or four attributes, and con-
mation can be defined, consumed, and maintained. vey the connections and relative strength visually.
This can include printed information, dedicated
electronic systems, websites, external applications, Communication, Education and
or data workflows used by the organization as well Training
as partner-hosted or cloud-based storage strategies. To ensure exceptional quality, safety, and
Business process, improvement, and compliance patient outcomes, hospitals must foster supportive
needs will require that key aspects of these processes work climates and high-performance work teams.
have control metrics such as data accuracy, patient Healthcare organizations must assess clinical and
satisfaction with information, coding and billing other competencies that staff members must possess
accuracy, unauthorized user access events, etc. These to meet patient and administrative requirements.
KPIs must be determined by the organization, as
part of its quality plan. Communication
From a system perspective, the real value of data Achievement of common goals occurs when
can be buried under mountains of well-meaning but communication is used to build a connecting net-
fruitless data analytics and data visualization. Fancy work to guide all 10 quality system elements. Human
data dashboards built for handling big data are interaction provides the foundation for well-defined
colorful renderings that risk conveying an illusion processes, including those associated with manag-
of progress without the reality of it. Leadership’s ing the organization, obtaining and responding
responsibility includes providing the system guid- to feedback, and building high-performing teams.
ance and modeling the behaviors associated with Identifying and effectively communicating the key
the appropriate use of data, while assuring safe- information and data that stakeholders must have
guards are in place to prevent misuse. ensures accomplishment of the hospital’s key per-
Trends in healthcare have included the push of formance indicators. There are many situations
big data and artificial intelligence into the care sys- and participants involved in a hospital’s quest to
tem models. The organization’s QMS responsibility communicate required information and data suc-
includes assuring its use is responsible, ethical, and cessfully. For example, communication may occur
valid. While demonstrating significant potential, among patients and their caregivers, members of the
machine learning and artificial intelligence (AI) caregiving team, different hospital departments, etc.
approaches cannot yet deliver real insight or knowl- A two-way flow of communication keeps informa-
edge about complex systems, entirely by themselves tion passing up, down, and across the organization.
without the use of conceptual models as frameworks Communications in a hospital setting primarily
with which to organize the data and to reason about relate to information that is exchanged to provide
it. Rational frameworks are needed for the kind of successful patient care or that helps staff members
reasoning that yields real insight. It is highly likely understand the organization’s direction and comply
that AI and machine-learning approaches will prove with its policies and procedures.
themselves invaluable in helping with the construc-
Education and Training
tion and optimization of conceptual models.
The purposes of education and training are
Key tools to support the evolution of Management
distinct but complementary. Whereas education gen-
of Information include the system design architec-
erally is conceptual and builds knowledge, training
ture and process mapping used to define their
is more task oriented and develops skills. Education

and training can be conducted in one-on-one or primarily involves preventing risks associated with
group settings. Effectiveness of the learning pro- patients and their care—as individuals or as a
cess can be determined by having learners explain group”.17 All processes, as well as the organizational
underlying concepts and demonstrate that they can structure, function, and resources (e.g., the facil-
perform tasks and apply tools at the level required ity and equipment, business continuity, etc.), may
in their job descriptions. Here are some hospital- introduce risk if they are not designed and executed
related examples of the application of education properly. In particular, the risk of sentinel events is
and training. a major hospital concern.
• Professional credentialing. Specific job respon- Auditing is an “on-site verification activity, such
sibilities and regulations may be connected to as inspection or examination, of a process or qual-
particular educational requirements, such as ity system to ensure compliance to requirements.18
professional instruction for physicians, nurses, An audit plan is a description of the activities and
technicians, and other caregivers necessary for arrangements for an audit. A hospital audit plan
licensure. Some credentials must be verified must be comprehensive, evaluating the entire QMS
prior to employment, and others involve con- in a specified time frame. It must also be flexible,
tinuing education to help staff members keep allowing for last-minute additions and deletions
current with developments in their field. that minimize disruptions in patient care, treat-
ment, and services. A competent, qualified QMS
• Patients’ and caregivers’ proficiency. The need for
auditor will send an audit plan to an affected hospi-
education and training also extends to patients,
tal area well in advance of the audit, allowing ample
their families, and other supporting community-
time for review, revision, and approval.19
care providers. This learning promotes better
Risk-based thinking makes preventive action part
understanding and implementation of home
of routine activity. Risk is often thought of only in
care and has a documented positive effect on
the negative sense. Risk-based thinking can also
patient outcomes. requirements, providing the
help to identify opportunities. This is the positive
education and training to ensure that staff mem-
side of risk. While auditing is a strategic and system-
bers maintain the highest standards of patient
atic approach to risk management, consideration of
care and safety.
daily risks to patients is also required. Visual con-
Recommended Quality Tools for trols, such as a “Patient Fall Risk” notice on room
Communication, Education, and Training doors or regular application of a Failure Modes
• SBAR (Situation, Background, Assessment and Effects Analysis20 to anticipate risks specific to
Recommendation): This is a communication patients currently occupying beds within the nurs-
tool introduced by the American military in ing care unit heighten awareness of caregivers.
the 1940s. Its use was targeted specifically for Recommended Quality Tools for
nuclear submarines where concise and relevant
Implementing Risk Management
information was essential for safety. Since then,
• Suggested Audit Plan Checklist for Managing
the SBAR communication tool has been used in
Risk to Healthcare Operational Key Processes:
a variety of industries including healthcare.
The self-assessment from the “Assessing Your
• Job/Task Analysis Summary Worksheet: This
Healthcare Quality Management System:
tool breaks a job into its component parts so
Monograph 2” provides a simple instrument for
they may be analyzed to identify what knowl-
auditing existing processes and components to
edge, skills, and abilities are required to meet
identify risks. This is an example of a preventive
desired product or process outcomes. The work-
approach to risk-based thinking.
sheet guides the analysis team through a series of
• The Failure Modes and Effects Analysis (FMEA):
considerations with the goal of developing and
Can be either a preventive or corrective tool.
delivering either education (for knowledge and
Used most effectively in anticipating disrup-
attitudes) or training (for skills).
tions to stable process operations, the FMEA can
Risk Management be scaled to strategic or operational situations.
Risk management is the QSE “associated with Used as a corrective action tool, it focuses on the
management review and planning activities and

immediate experience of those involved in the established to track the successful implementation
error to be analyzed. of the change and to monitor for sustainability.
Management of Change Recommended Quality Tools/Approaches for

The management of change focuses on people Implementing Management of Change
and organizational factors that both drive and • John Kotter’s 8-step Process of Change
obstruct change throughout the hospital. A criti- (Approach): The approach identified by Dr. John
cal part of any change is managing it in a way that Kotter who extracted the factors for successful
enables people to accept new processes, technolo- change and combined them into a methodology:
gies, systems, structures, and values. The ultimate the 8-Step Process for Leading Change. Kotter’s
goal of any change initiative is to ensure that the model helps managers deal with transforma-
organization is ready, willing, and able to appro- tional change. This is summarized in Kotter’s
priately function in the new environment. This 8-step change model.
includes verifying new processes and equipment • Gap Analysis/Crosswalk (Tool): A gap analysis
work as intended and that staff has been trained and is used to identify potential changes within an
is competent to perform new functions and tasks. organization, process, product, or service. Gap
Change management is required during normal analysis or as termed in healthcare, a crosswalk,
operations as well as during quality improvement is used by process improvement teams to priori-
efforts. tize and manage change.
Hospitals are a complex interaction of processes
that facilitate clinical, administrative, educational, Teamwork
and stakeholder outcomes. Projects are initiated to The Cambridge Dictionary21 defines teamwork
effect change for a specific purpose. Cross-functional as “the combined actions of a group of people
improvement efforts can affect multiple projects working together effectively to achieve a goal.” The
within the hospital that depend upon the impacted Business Dictionary states:
processes. Communicating the reason for change to “Teamwork is often a crucial part of a business,
all affected parties is imperative. The normal reac- as it is often necessary for colleagues to work well
tion of humans is to reject change. Effective change together, trying their best in any circumstance.
management reduces the anxiety associated with Teamwork means that people will try to cooperate,
change. Communication and involvement of those using their individual skills and providing construc-
who will experience the change provides two ben- tive feedback, despite any personal conflict between
efits. 1) Those who know the process or tasks being individuals.”22
changed are invaluable in providing suggestions for The Hospital-Based QMS model posits that
improvement and 2) involvement generates loyalty teamwork is crucial to building and sustaining
to the change when it is implemented. an effective healthcare QMS. Teamwork involves
Many healthcare organizations are now all members of the healthcare organization as
implementing process improvement programs well as organizations and individuals within the
to accurately define the current state, design an broader care community.23 Workforce engagement
appropriate future state in response to regulation (emotional and intellectual commitment to accom-
or population changes, and to identify the gaps plishing the organization’s work, mission, and
between the current and future states. The orga- vision24) plays a key role in successful teamwork.
nization has the responsibility to clearly define Effective leaders appreciate teamwork as being fun-
the future state so the affected individuals can damental to implementing a culture that leverages
align themselves with the new goals and expected the diverse ideas, knowledge, skills, and abilities of
outcomes. The management of change is critical the workforce.
to minimize disruption during the steps required To effectively implement a healthcare QMS, the
to close the identified gaps. Changes should be workforce at all levels of the organization must be
piloted on a small scale to validate the effectiveness committed to performing and supporting the activi-
of improvements before total roll out. Staff and ties needed for:
physician training on new activities or improve- • Care and treatment of patients25
ments may be necessary. Measures need to be
• Overall business effectiveness and efficiency26

The need for focused, functioning teams is Coordinator for Health Information Technology
essential to building the infrastructure, framework, (ONC).29 The requirements of these four agen-
and processes (the 10 critical QSEs) that allow the cies alone represent only a fraction of the federal
organization to realize the expected healthcare QMS regulatory burden impacting 21st-century hospitals
results of overall business effectiveness and effi- (see Figure 2 on next page). QMSs and quality
ciency, and exceptional quality, safety, and patient tools enable hospitals to efficiently manage regu-
outcomes. Similarly, a healthcare organization can- latory burden and effectively comply with federal
not expect to consistently achieve the HC QMS key regulations.
components of patient care delivery (e.g., develop
Recommended Quality Tools for Compliance
treatment plans, deliver quality care, and transition
patient care to the next level), absent high perform- with Requirements
ing teams. Teams are necessary to move strategy to • Checklists: A tool for organizing and ensuring
goals and objectives, goals, and objectives to reality. that all important steps or actions in an opera-
Leadership must not only participate in teamwork tion have been taken.
but also support and empower teams and their • Cause & Effect Diagram: A tool for analyzing
individual members. This includes allowing teams process variables. The diagram illustrates the
to participate in the consensus assessment of perfor- main causes and sub-causes leading to an effect
mance results to drive improvements and identify (symptom).
opportunities for breakthrough innovation.
Recommended Quality Tools for Teamwork

Decision-making tools are useful to teams in
moving through the process of understanding the
problem, generating possible solutions, narrowing
down possible solutions, and ultimately deciding
which solution to pilot. Common decision-making
tools include:
• Force-field analysis
• Brainstorming
• Nominal group technique
• Voting or multi-voting
A good tool for deciding what course of action
to take to address the problem is the Effort/Impact
Matrix. The ASQ Quality Resources site (https://asq.
org/quality-resources/learn-about-quality) offers a
comprehensive library of tools and references help-
ful to teams.
Compliance with Requirements

This is the critical quality system element that
addresses rules and regulations that are set forth
in requirements from international, national, state,
and local agencies.
U.S. healthcare organizations must comply with
a multitude of federal laws and regulations to
achieve “exceptional quality, safety, and patient out-
comes”27 In 2017, the American Hospital Association
(AHA) identified 341 hospital-related requirements
of the Centers for Medicare and Medicaid Services
(CMS),28 Office of Inspector General (OIG), Office
for Civil Rights (OCR), and Office of the National

Figure 2: Federal Agencies with Regulatory or Oversight Authority Impacting Hospitals.30

Appendix of Tools and Techniques
Leadership Commitment, Planning, and Review

Tool – X Matrix
Description: The X Matrix is a one-page strategy tool that aligns long- (3-4 years) and short-term (1-year)
objectives with the organization’s vision. Initiatives outline how the organization will achieve its objectives.
Finally, measures are set that identify achievement levels and resources, and accountabilities are identified
for the initiatives.
When to use: To create the organizational vision, strategy, and execution, communication, and accountabil-
ity plans.
Figure 3: Example of X Matrix Template

Basic procedure:
1. Develop the organization’s strategic intent: mission, vision, and strategies
2. Develop the vital few long- and short-term objectives
3. Define the breakthrough opportunities that will deliver the objectives
4. Determine the metrics and resources that align to the strategy
5. Show relationships or alignment in the X matrix
6. Review matrix and communicate the strategic plan to mid-level leaders for review, and to make recom-
mendations and pass back to senior leaders in an iterative process until all agree on a final strategy
(play catchball)
7. Cascade strategy to next level of management
8. Develop your execution plans
Figure 4: Example of Completed Strategy and Deployment Matrix

Tool – System of Alignment and Accountability
Description: The system of alignment and accountability tool assists in the alignment of the organization’s
strategic priorities, objectives, and goals with its mission and vision. Goals flow down to the front line and
action plans are formulated to achieve goals. Additionally, the model identifies accountability for each of the
annual initiatives and performance improvement projects by listing the executive champions and operational
owners on the visual tools that display KPIs as well as project metrics and results.
When to use: This tool guides the follow-up steps to the strategic planning process and achieves line-of-sight
throughout the organization for key organizational goals. It is used to align performance improvement proj-
ects to strategic priorities and track results.
Figure 5: Example of System of Alignment and Accountability Template
Mission and Vision Key Indicators

Strategic Priorities
Franciscan Stewardship:
Formation/ Quality/Care Develop Our Operations/
System BSC MI Scorecards
Mission Integration People Finance and
Integration Growth
Hospital SP Leader Goals
Hospital-Level Strategic Objectives and Goals
Dashboards Scorecards
Department Goals Department Scorecards
Colleague Goals Performance Reviews
Tactics/Action Plans Department Scorecards
Improvement Projects PI Scorecard
BSC: Balanced Scorecard

MI: Mission Integration
SP: Strategic Priorities
PI: Performance Improvement
Basic procedure:
1. Identify departmental goals, aligned to the organization’s strategic goals.
2. Identify colleague goals to support departmental and organizational goals and include as part of the
performance review process.
3. Create action plans to achieve goals at all levels.
4. List key indicators and improvement project goals with executive champions and operational owners
for each.
5. Communicate progress toward goals at set periodic intervals through dashboards and scorecards.
6. Follow up on goal achievement at performance reviews.
7. Undertake improvement projects identified to achieve organizational objectives.
Feedback Loops/Measurement
Tool – Tri-Metric Matrix
Description: The Tri-Metric Matrix guides the team to identify capacity requirements, process expectations,
and outcomes for a product or service. Capacity tells us whether we have the resources to meet current demand

of the product or service. Process monitors the continuing effectiveness of activities performed. Outcome
gauges the satisfaction of the end user with the product or service once it is delivered or experienced.31
When to use: Built when the process is defined.
Basic procedure: Ask the following questions for each measure that is proposed:
• What is the measure measuring: the population, the process or outcome? Provide a clear definition of
what is being measured (numerator and denominator, source of data, etc.) How difficult is it to gather
data for this measure?
• Is there a baseline for this measure? If not, can we obtain one? Is there a benchmark?
• Is the measure directly linked to our current strategy?
• Will the measure positively impact our patients or stakeholders if it is improved?
• Will employees have personal incentives to improve this measure?
• Are improvements in the measure likely to result in a better product, service, or outcome?
• Do we have the resources available for improving this measure?
Example: Capacity, process, and outcomes measures for a public health school dental check program.
Table 2: Example of Tri-Metric Matrix: Thunder Bay District Health Unit (TBDHU)
Tri Indicator Definition Baseline Improvement Target

Metric
Capacity Attain one qualified oral Total count of qualified oral health Varies by year; calculated as 100% coverage of
health professional per every professionals available to TBDHU to meet number schools selected for selected schools within
three schools to perform tooth process requirements for screening in all screening / number geographic each geographic area
check screenings district target schools within published time areas covered.
frame
Process Validate database of district Searchable database either shared with Lists of students per school exist 100% updated each fall
schools to current for number district education system or mirrored into for all schools, not 100% accurate in time for dental
of students to be screened and TBDHU with required data defined, input because of late enrollments and screenings
parent/ guardian addresses and validated before screening begins student movement from school to
school
Outcome Screen target population and All students in target district schools are % students screened from target 100% of target
deliver recommended successfully screened, parents informed of population per school and per population screened and
treatment to eligible students recommendations, eligible students received total population 98% of eligible students
recommended treatment, and database received recommended
properly updated treatment
Tool – Gap Analysis Feedback Collection

Description: This table captures feedback from assessment of the 10 QSEs as identified in Healthcare QMS
Monograph 2.32
When to use: When initially assessing the hospital or health facility’s processes relative to each of the QSEs.
Revisit the assessments in Monograph 2 and gather updated feedback using this gap analysis quarterly/annu-
ally or periodically as determined by the organization for the minimum amount of time before feedback is
required. Focus process improvement on the highest priority gaps in meeting patient and business outcomes.
Schedule and facilitate at least one improvement activity per quarter on a continuing basis.
Basic procedure: Use table below to drive discussion with process stakeholders. Assign facilitator to manage
scheduled improvement efforts.

Table 3: Example of Gap Analysis Feedback Collection
Quality System Percent assessment from Table 7 Which performance results or Prioritize which results or Date when
Element in Monograph 2 meets outcome measures are NOT driving measures must be improved to improvement team is
requirements (> 75% is minimum adequate patient or business meet patient or business chartered
acceptable level or as set by org.) outcomes? outcomes
rd
Leadership 25% 50% 75% 100% Quality assurance monitoring 2. Inventory of surgical supplies 3 Qtr 2020
th
commitment, X is not performed consistently 1. Patient EMR daily updates 4 Qtr 2019
nd
planning and (Add rows for additional items) 3. Terminal room cleaning cycle 2 Qtr 2020
review time
st
Feedback Loops / 25% 50% 75% 100% HCAHPS scores declining 1. meet % threshold for HCAHPS 1 Qtr 2020
st
Measures X Employee survey results 1. Relationship with Dept 1 Qtr 2020
Supervisor: (parallel and related
issues)
Environment of 25% 50% 75% 100% X All performance indicators N/A Sustain performance
Care meet requirements
(Expand table for 25% 50% 75% 100%
all 10 QSEs)
Environment of Care
Tool - Affinity Diagram
Description: Graphical technique utilized to group like themes to communicate relationship/connections
of sets of information.
When to use: The tool is often used when brainstorming, conducting data analysis, or needing to summarize
data. The approach can be useful when defining conceptual relationships, communicating organizational
design, system intent, or business architecture concepts.
Basic procedure:
• Plan approach to gather or evaluate the concepts, brainstorming input, or data to be organized, looking
for natural themes, patterns, or groupings.
• Organize data into groups and, if appropriate, subgroups, based on the concepts and categories.
• Utilize stakeholders to build consensus for final groupings.
• Formalize diagram in media appropriate for organization/team communication usage.
Figure 6: Example of Affinity Diagram: Environment of Care Control Factors
Environment of Care Control Factors
Manpower Methods Materials Machine Measurement Environment
Provider and Surgical

Vision, Mission, Care Process Safe & Learning
Allied Health Pharmaceuticals Equipment and
and Strategies KPIs Culture
Credentialing Robotics
Business & Linens, Scrubs,

Training & Financial and Radiology & Financial Facilities & Care
Development Planning & Environmental Imaging Reporting Readiness
Reporting Consumables
Care Scope,
Quality, Safety, Patient, Family
Leadership Guidelines, Best
Medical Devices Laboratory & Regulatory & Provider
Behaviors Practices &
Data Experience
Standards
Clinical, Business & IT

Payer Relations, Care process Infrastructure
Behavioral, and Infrastructure
Staffing Models Patient Access tools and Readiness &
Hospital Care Process
and Scheduling consumables Compliance
related Indicators
IP, Knowledge
Quality, Safety, Business
Roles & Management, Access, Service,
& Regulatory Technology &
Responsibilities and Brand and Utilization
Processes Infrastructure
Standards
Billing and Patient Handling

Coding and
Standards Transportation
Supply Chain &

Partnership
Contracting

Tool – Process Flow
Description: Process flow diagram indicates sequence of work at a level of detail appropriate for the concept
being defined.
When to use: The tool is often used when defining, designing, or capturing existing workflows. It can be done
to different levels depending on the intended use and needs of the audience, with the detail level varying
from broad concepts to detailed step by step activities, with swim lanes and symbols used to convey different
categories of actors and activities.
Basic procedure:
• Determine process model to represent.
• Identify starting and ending points of process
• Identify the steps, owner, and purpose
• Map the steps using Icon approach suitable for the intended level of detail
• Supplement with annotation to convey intended message
Figure 7: Example of Process Flow Diagram 33
Management of Finances and Support Resources

Tool – Payback Period
Description: The payback period is defined as the number of years required to recover the initial cash
investment.
Payback period in years = Initial cash investment

Estimated cash flow per year
When to use: The payback period is an efficient and effective way for hospital QAPI programs to evaluate
and prioritize projects for CFOs.
Basic procedure: The payback period of a project is easy to calculate and interpret. To calculate the payback
period, simply divide the initial cash investment by the estimated cash flow per year. For example, if the ini-
tial cash investment is $10,000, and if the estimated cash flow per year is $5,000, then the payback period

is $10,000 divided by $5,000 or two years. To interpret the payback period, simply accept a project if the
payback period is less than a prespecified maximum number of years.
Example: A hospital QAPI program is evaluating two projects for implementation. Project A requires an
initial cash investment of $150,000 and has an estimated cash flow per year of $22,000. Project B requires
an initial cash investment of $125,000 and has an estimated cash flow per year of $30,000. If all project
assumptions and limitations are the same, and if the hospital’s prespecified maximum payback period is five
years for capital investments, then which project should the QAPI program select?
Calculations:
The payback period for Project A is 6.8 years: $150,000
$22,000
The payback period for Project B is 4.2 years: $125,000

$30,000
Interpretation:
If all project assumptions and limitations are the same, then the QAPI program should select Project B.
The initial cash investment of $125,000 will be recovered within the hospital’s prespecified maximum
payback period of 5 years.
Tool – Cost-Benefit Analysis

Description: A cost-benefit analysis is a study to determine the relationship between the benefits and the
costs of changes to processes, policies, and/or procedures.
When to use: After project acceptance, a cost-benefit analysis is recommended to verify that the benefits of a
project will outweigh the costs.
Basic procedure:
1. Determine all costs associated with the processes affected by a proposed change.
2. Have these costs validated by accounting staff or by the appropriate financial group.
3. Identify the changes to the processes and calculate the costs to execute the new process going forward
(also known as the operational state).
4. Determine the costs of implementing the changes to the process. In addition to hard costs related to
hardware and equipment, capture costs related to information technology and operations, training,
documentation, running processes in parallel during the transition, office lease cancellation, and
relocation or severance costs for affected employees. There may be other costs related to implement-
ing the change.
5. Calculate the benefits projected from making these changes.
6. Determine the Benefit Cost Ratio (BCR) by dividing the total of the projected benefits by the total
costs. A higher ratio of benefits to costs indicates a positive change.
7. Communicate with management to obtain approval and implement the changes.
8. Periodically assess and calculate whether the benefits and costs forecasted were realized and recalcu-
late the BCR. Use this information for cost-benefit analyses of future projects.
Example: A proposed change would reduce the number of reviews required before approving an application.
The finance department provided a cost-benefit analysis template and guidance for using the template to
the project team by calculating the entire cost stream of an application by the underwriting and compliance
areas. The team presented this analysis to the accounting department for validation. The improvement team
redesigned the process and modeled the benefits:
• Bottom-line benefits consisted of increased sales and cost savings from reductions in staff and reductions
in office space.
• Costs resulting from the change included communicating changes, documenting changes, designing, and
printing new forms, and training staff on the changes. Costs would also include severance for affected
employees.

After the accounting and finance areas approved the financial analyses and projections, the team delivered
a presentation to senior management. Management approved the changes, the project team planned the
implementation, and the changes were executed. Six months after implementation, the project team and
stakeholders revisited the initial cost-benefit analysis and determined that actual results were consistent with
forecasted expectations. The cost-benefit analysis is maintained in a document repository and can be lever-
aged by project teams performing similar projects in the future.
Management of Information
Tool – SIPOC
Description: The SIPOC tool is a visual representation of the Supplier, Input, Process, Output, Customer
model for defining a process. The tool originated in the Six Sigma methodology and provides an approach
to define a system by identifying process steps utilized and supplier/input and customer/output relationships
involved with executing the process. It can be scaled to different altitudes to represent a variety of situations
and desired levels of detail. Variations of the tool include adding constraints and metrics, resulting in the
SIPOC+CM model.
When to use: The tool is used to define a process or system. It visually identifies the process components and
identifies their interactions with suppliers and customers. By mapping the relationships involved, it provides
context for the reader to understand the intended transformation, including inputs and outputs.
Basic procedure: Plan approach to gather or evaluate the relationships to be organized, looking for themes,
patterns, or:
• Determine process bounds/system
• Identify starting and ending points of process
• Identify the steps, owner, and purpose
• Identify the inputs/suppliers and outputs/customers for the systems
• Map the steps using icon approach suitable for the intended level of detail
• Supplement with annotation to convey intended message
Figure 8: Example of SIPOC of Management of Information Policies and Procedures
Supplier Input Process Output Customer
Management of Information
Policies & Processes
IMS-1.0 Mgmt of Info

System Arch Map Leadership,
IMS Sys - 1.1
Financial Shareholders,
Definition –Information
Management Systems
Info Operations, Compliance

Info Sys Compliance
IMS Sys - 1.2
& Regulatory
Best Practice
Clinical Practice Providers & External
& Std. Care Info Sys Sustainment Care Info &
Governance
Models & Event Mgmt Stds. Collaborative Partners
IMS Sys - 1.2
Patient & Patients & Clinical Practice
Research Research Care Providers (Internal &
Governance Methods EDM -1.0 Records
External )
Data Security
EDM – 1.1
Electronic Information and Data
Elec Data Sys Des & Coding & Business Offices (Internal &
Industry & Academic Collaborative Dev Billing Info External ), Payers, Regulators
Organizations Partners EDM – 1.2
Management
Elec Info & Data Research Research Community,

Finance Budget Change Mgmt Findings & Healthcare Industry, Patient
EDM – 1.3 Publications Population
Systems & Elec Info & Data

Information Technology Operations Security &
Institutional Governance
Infrastructure
DEV – 1.4 Operational and Compliance Reporting
Performance &
Reporting
Facilities BSM -1.0
Operations & Facilities Process & External Partner
Equipment Mgmt. Community, Organization,
BSM – 1.1 News & Public Researchers,
processes for information solutions
Assure business and care system
Business System Management –
Communications
are effective thru their lifecycle
Industry
Government, Industry, Compliance &
Info Delivery
Technical & Academic Regulatory
BSM – 1.2
Organizations Requirements
& Standards Industry, Academic, &
Operational Presentations Professional Organizations
Support
BSM - 1.3
Practice, Research,
Docs. & Records Memberships Industry & Academic
BSM – 1.4 &
Relationships Organizations

Tool – Relationship Matrix
Description: The relationship matrix tool provides a way to organize and compare two, three, or four attri-
butes, and convey the connections and relative strength visually. It provides a method to share a significant
amount of information in a way the audience can consume quickly.
When to use: The tool is used to define the connections, contrasts, and relative strengths of related entities,
such as requirements and processes, strategies and tactics, and organizational roles and responsibilities.
Basic procedure:
• Plan approach to gather or evaluate the relationships to be organized, looking for themes, patterns, or
groupings
• Organize information into the relationships, identifying primary, secondary, and minor relationships,
based on the concepts and categories intended to communicate, using icons to represent
• Identify the relative strengths of the comparative relationships
• Utilize stakeholders to build and validate relationships for final groupings
• Formalize diagram in media appropriate for organization/team communication usage
Figure 9: Example of Relationship Matrix for Organization and Regulatory Requirements
Org anizat ional Process
Information Sustainment & Disaster Recovery Process

QMS Business Process Design & Communication
Electronic Data Security & Exchange Process
Document and Record Control & Retention

Financial Planning and Reporting PRocess
Care Coding and Billing Stds. & Process

Patient Information Access System
Provider Care information system
Data Security and Privacy Policy
Org anizat ion/R egulatory Requiremnt s

1) HIPPA compliance for all patient data
2) Financial information protected from unauthorized access
3) Patient can access their information remotely
4) Provider can acc ess relevant case information
5) Provider can not ac cess case information for cases not relevant to their practice
6) Information transfer outside firewall is not usable by unauthorized 3rd party
7) C are c oding supports HL7 communications
8) C are c oding is compliant the HCD-10 standards
9) Information System Availability 24 /7
10) Electronic Information recoverable in event of multi site disaster event
P rima ry Re l at io ns h ip =
Se con da ry Re l at io ns h ip =
Min o r R e la ti on s h ip =
Communication, Education, and Training

Tool – The SBAR
Description: The “SBAR” (“Situation, Background, Assessment, and Recommendation”) communication
tool is simple in concept. The purpose is to provide essential, concise information usually during crucial
situations. It is a Communication Tool.

When to use: For clinical communication, such as between nurses and physicians, for leadership communica-
tion, or to submit project requests or recommendations such as for Information Technology or Performance
Improvement. The SBAR is an effective communication tool to and between leadership. In some cases, SBAR
can replace an executive summary in a formal report as it provides focused and concise information.
Basic procedure: When a situation occurs that requires data documenting the event:
1. Create a table as shown in the example below.
2. Gather data from participants of the event describing the 1) situation, 2) background leading up to
the event, 3) assessment of the situation and, 4) recommendations to address or resolve the situation.
3. Gain consensus of participants on concise wording of each of the SBAR communication categories
and fill in the table.
4. Share the completed table with others needing the information or as a final report to process owners
or leadership.
Table 4: Example of SBAR with a Written Healthcare Example to Leadership
Quality Improvement SBAR

1. S (Situation) In a drug dependency rehabilitation center, patients are
experiencing extreme dental pain not relieved with over-the-
counter medications.
2. B (Background) Many of the patients in this drug rehabilitation facility have long-
standing use of heroin and other narcotics since late childhood.
Additionally, numerous patients have not received ongoing dental
care. Dental exams indicate several caries and abscesses within this
population. Therefore, when patients are withdrawn from an
opioid, they experience extreme pain that is not relieved by over-
the-counter pain relievers.
3. A (Assessment) Medical and dental staff need to provide medications that will
relieve the pain. These patients require dental intervention as soon
as possible.
4. R 1. Patients need to be prioritized for dental pain intervention
(Recommendation) ASAP.
2. Dental and medical staff need to consult with state and
national organizations to determine medications that should be
used for this dental pain, as well as alternative treatments.
Tool – Job/Task Analysis Summary Worksheet

Description: The job/task analysis breaks a job into its component parts so they may be analyzed to identify
what knowledge, skills, and abilities are required to meet desired product or process outcomes. The work-
sheet guides the analysis team through a series of considerations with the goal of developing and delivering
either education (for knowledge and attitudes) or training (for skills).
When to use: The job/task analysis summary worksheet is used when business, performance, or learner
requirements change. The outcome of the analysis may NOT generate new education or training. It may
highlight the need to return to compliance with existing operating procedures or processes, which is a per-
formance issue, not a training or education issue.
Basic procedure: Questions to be asked before filling in the job/task analysis summary worksheet:
• Why offer a course (what Business Requirements would be met as a result of a possible course)?
• What does the organization want learners to be able to do as a result of the course (Performance
Requirements)?
• Are there any other Performance Requirements beside need for skills that prevent the business require-
ments from being met (e.g., procedure issues, product issues, lack of equipment, technology issues)?

• Who are the learners, how many are there, what special job context pressures do they face?
• What role will the “client” play during the analysis stage?
• What resources will the “client” commit to analysis and later development stages?
• What other key players would be involved?
• What will success look like?
• What is the time frame for implementing the course?
Table 5: Example of Task Analysis Summary Worksheet34
Do What (Job Terms) How Well (Job Terms)

Procedural steps and technical knowledge: Job criterion/standard: For at least the
List each procedural step and technical critical steps/skills, list how effective
knowledge required to perform the task from performance will be measured on the job.
start to finish on the job. Indicate critical
steps/skills with an asterisk.
Tools: (With what) List special tools, equipment, or materials needed to perform this task.
Job context: (With what) List critical factors (frequency, environment, difficulty,
prerequisites, outputs).
Information: (Know what) List knowledge areas (e.g. math, science) needed to perform
steps/skills of this task.
Values: (Believe what) List learner beliefs critical to performing this task competently on the
job.
Job Performance Requirement: List ‘With what, do what, how well’ in job terms.
Risk Management
Tool – QMS Sample Audit Plan
Description: An audit plan validates the capability of a specific set of processes and components to achieve
a specified result. The example illustrates a simple assessment tool that can be used for documenting existing
processes and components of the QSEs.
When to use: Audits are used to assure process owners that customer requirements or system specifica-
tions are met. Audits can be a preventive tool to anticipate gaps in processes or to identify opportunities for
improvement.
Basic procedure: Columns in the example guide the process owner to assess whether additional efforts are
required to meet desired levels of performance. Organizational leaders participate in the self-assessment pro-
cess, with the QMS process owners providing background information regarding the existing processes and
components. When this self-assessment is complete, participants develop a prioritized action plan to identify
improvements and/or innovations that are required. Responsibility and timelines are identified in the action

plan. It is important to note, however, that this action plan does not need to address every deficiency; it
should focus on the opportunities for improvement that represent the greatest benefits to the organization.
Table 6: Example of QMS Sample Audit Plan
Auditor comments: Auditor comments:

Answer the following four
Should improvement How will the leaders
questions:
For each of the 10 Quality System initiatives be launched to monitor those
(see Summary of Self-
Elements address the issues improvement initiatives
Assessment Participants'
identified in this and determine if the
Consensus)
assessment? action plan needs to be
revised?
1. Leadership commitment, planning, and
review
2. Feedback loops 1. Do the compiled processes and

components fulfill the complete
3. Environment of care intentions of this QMS element?
4. Management of finances and support 2. What, if any, revisions need to

resources be made to the existing processes
and components to achieve
5. Management of information optimum results?
6. Communication, education, and training 3. What redundancies need to be

eliminated with the existing
7. Risk management processes and components?
8. Management of change 4. What gaps need to be

addressed with the existing
9. Teamwork processes and components?
10. Compliance with requirements
Tool – Failure Modes and Effects Analysis (FMEA)

Description: A procedure in which each potential failure mode in every sub-item of an item or process is
analyzed to determine its effect on other sub-items and on the required function of the item or process. FMEA
can be either a preventive or corrective tool.
When to use: Used most effectively as a preventive tool in anticipating disruptions to stable process opera-
tions, the FMEA can be scaled to strategic or operational situations. Used as a corrective action tool, it focuses
on the immediate experience of those involved in the error to be analyzed. The FMEA is used for both clinical
and administrative processes.
Basic procedure: A FMEA team should have a carefully defined scope. Keep the team small; usually four to six
people consisting of persons with familiarity with the product or process being studied. The team leader must
be committed to the project and have experience with the FMEA process. Team members should be familiar
with continuous quality improvement (CQI) tools, particularly flow-charting, data analysis, and graphing.35
A well-orchestrated FMEA team works through 10 steps:
1. Process review: flow chart the process being studied.
2. Brainstorm and record all potential failure modes.
3. Brainstorm and list the effects of each failure mode.
4. Assign a severity rating to each effect. (Usually scale of 1-10)
5. Assign an occurrence rating for each mode.
6. Assign a detection rating for each mode and/or effect: the lower the likelihood of detection, the higher
the rating.
7. Calculate the criticality score for each mode and effect. A total criticality score for each mode can be
calculated from the sum of criticality scores for each effect of that mode and serves as a baseline mea-
sure used for comparison on remeasurement.
8. Prioritize the failure modes for action: perform a Pareto analysis and place priority on those failures
likely to be the most serious, regardless of the criticality score.

9. Perform a root cause analysis of why failure modes are occurring.
10. Take action to prevent those failure modes with the highest priority.
11. Calculate resulting criticality scores, as failure modes are reduced (proxies for ultimate outcome).36
Figure 10: Example of FMEA for Risk of Using Sporicidal Cleaning Products
Failure Modes and Effects Analysis (FMEA)

High Priority Failure Modes to Address
Test of new Sporicidal

Process or
disinfectant for cleaning/ Prepared by:G L. Duffy Page __1_ of 1
Product Name:
discharge rooms.
Responsible: Environmental Svcs FMEA Date (Orig) __6/19/19_____ (Rev) 7/28/19
S O D R S O D R
Process Actions
Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P Resp. Actions Taken E C E P
Step/Input Recommended
V C T N V C T N
What are the actions
detect cause or Failure

effect to the cusotmer?
How often does cause
Probability Number
How Severe is the
How well can you

for reducing the
Overall Reliability
Mode prior to the
What are the existing controls and Who is What are the completed
or FM occur?
What is the What is the impact on the occurrence of the
procedures (inspection and test) responsible actions taken with the
failure?
process step/ In what ways does the Key Key Output Variables What causes the Key Input to cause or improving
that prevent either the cause or for the recalculated RPN? Be
Input under Input go wrong? (Customer Requirements) or go wrong? detection? Should
the Failure Mode? Should recommende sure to include
investigation? internal requirements? have actions only on
include an SOP number. d action? completion month/year
high RPN's or easy
fixes.
Procedure update for
new sporicidal
Sporicidal disinfectant Proper wearing of personal New cleaning/ discharge
Room Frequent exposure to disinfectant to include Colleague
irritates eyes,and throat in Discomfort and potential protective equipment. Some procedure written
8 concentrate during full shift of 10 1 80 direction for colleague and 2 10 1 20
cleaning/dischar colleagues when preparing physical damage irritation was experienced using 7/25/19. Tested and
cleaning/discharges wear PPE every time supervisor
ges on the 5th product from concentrate previous disinfectant as well. approved 7 30/19
performing disinfecting
th
and 6 floor process
Use a separate grease Procedure updated to

Room Heavy duty grease from Fingerprints and other greasy
New Sporicidal disinfectant cleaning solvent include use of both
cleaning/dischar finger marks are not smudges are not removed Previous disinfectant mixture Environmenta
9 does not have grease cutting 3 4 108 already in inventory sporicidal disinfectant 1 3 4 12
during cleaning/ discharges included grease cutting cleaner l Services
ges on the 5th removed by sporicidal ingredients and approved for and, when necessary,
process
th
and 6 floor disinfectant patient rooms. grease cutting cleaner.
Management of Change
Technique – 8-Stage Change Process37
Description: The approach identified by Dr. John Kotter who extracted the factors for successful change and
combined them into a methodology: the 8-Step Process for Leading Change. Kotter’s model helps managers
deal with transformational change. This is summarized in Kotter’s 8-step change model.
From experience we learn that successful change occurs when there is commitment, a sense of urgency or
momentum, stakeholder engagement, openness, clear vision, good and clear communication, strong leader-
ship, and a well-executed plan.
When to Use: John Kotter’s 8-step change model comprises eight overlapping steps. The first three are all
about creating a climate for change. The next on engaging and enabling the organization. And the last, imple-
menting, and sustaining change.
When the status quo no longer works, start at the top of the 8 steps illustrated in Figure 11. Whether for a Page 1
corrective action or an opportunity for improvement, the project Champion must identify the priority of the
change and translate that into a burning platform for action.
Basic Procedure: Following the steps in figure 11 clockwise, the Champion gains senior leadership support
and charters a team which sets the vision and objectives that anchor the rest of the 8-step process.

Figure 11: Example of 8-Step Change Model Table 7: Example of actions and behaviors at each
of the 8 steps of the Kotter Process for Leading
Step Action New Behavior
Champions or senior hospital leadership

starts telling each other, “Let’s go, we
1 Increase urgency
need to change this!”
A group with enough power and respect

Build the guiding in the healthcare facility are named
2 to guide the change, and they start
team together well.
The project team develops

the right vision and strategy
3 Get the vision right
for the change effort.
Both clinical and administrative

Communicating for personnel begin to buy into the
4
buy-in change, and this shows in
their behavior.
More people feel able to act and are

Empower action motivated to drive toward desired
5
objectives and outcomes.
Momentum builds as clinicians and

Create short-term staff seek to fulfil the vision,
6 wins while fewer and fewer
resist change.
The hospital or facility makes wave

7 Don’t let up after wave of changes until the
vision is fulfilled.
New and winning behavior

Make change stick continues despite the pull of
8
tradition, turnover of change leaders etc.

Change Figure 12: Example of the gap analysis
Tool – Gap Analysis/Crosswalk process cycle38
Description: A technique that compares the exist-
ing state with its desired state (as expressed by its 1
Process Sensor Goal
long- term plans) to help determine what needs to
be done to remove or minimize the gap.
When to Use: To identify potential changes in an 5 2 3
organization, process, product or service. Gap analy-
sis or, in healthcare, a crosswalk, is used to prioritize
and manage change. Once the change has been 4
selected, other tools are used to design, measure, Actuator Comparison

effect, and sustain the change.
Basic Procedure: Figure 12 shows the steps for an
effective gap analysis.
1. The existing process or feature is defined. This
is performed by improvement teams through Table 8: Example of Crosswalk for Mgt of Change
flowcharting for a process. Characteristic for TJC Standards and Elements of Performance
tables or a crosswalk is used for features or
American Society for The Joint Commission. (2018, January). Comprehensive Accreditation Manual for
elements. Quality. (2016, April). A Hospitals [Patient Safety Systems Chapter]. Oakbrook, IL: Joint Commission Resources.
hospital-based healthcare
2. A sensing mechanism, either human or quality management
system model . Milwaukee,
electro-mechanical is used to compare the WI: ASQ Quality Press.
existing process or features with the desired Quality Element

LD.03.05.01
Standard
EP1
Elements of Performance
Leaders implement changes Structures for managing change and performance

or future state of the item under study. Management of Change
in existing processes to improvements exist that foster
improve the performance of the safety of the patient and the quality of care, treatment,
3. The goal is established through long term the hospital. and services.
planning in the case of organizational design EP3

The hospital has a systematic approach to change and
and process improvement or benchmarking performance improvement.
EP4
of product or service features. Leaders provide the resources required for performance
improvement and change
4. The comparison of the existing state with the management, including sufficient staff, access to
information, and training.
desired goal by means of the sensor provides EP5

The management of change and performance
a list of differences. Healthcare standards improvement supports both safety
and quality throughout the hospital.
or requirements analysis often identifies EP6

The hospital’s internal structures can adapt to changes in
differences through a crosswalk. Process or the environment.

EP7
breakthrough improvement is the term used Leaders evaluate the effectiveness of processes for the
management of change and
for process gap analysis. performance improvement. (See also PI.02.01.01, EP 13)
5. The actuator, also human or electro-mechan- LD.04.04.05

The hospital has an
EP1
The leaders implement a hospital-wide patient safety
organizationwide, integrated program.
ical drives the choice of what action to patient safety program
within its performance
PI.02.01.01
take. Three different decisions can be made: The hospital compiles and
EP13
When analysis reveals a problem with the adequacy of
analyzes data. staffing, the leaders
accept the current situation without change, responsible for the hospitalwide patient safety program (as
addressed at
adapt the current process or features to LD.04.04.05, EP 1) are informed, in a manner determined
by the safety
attain the goal, or abandon the existing pro- program, of the results of this analysis and actions taken to
resolve the identified
cess, product or service and perform a new problem(s). (See also LD.03.05.01, EP 7)
design to meet the goal.

Figure 12 illustrates the standards and elements of
performance set by The Joint Commission (TJC) for
Management of Change. The implementing organi-
zation would compare their actions to TJC elements
(Table 8) and set actions to improve processes to
meet TJC standards.

Teamwork
Tool – Brainstorming (unstructured)
Description: Brainstorming is an idea generation tool used by teams to generate ideas and present ideas in
an orderly fashion to the rest of the team. The output of brainstorming provides input for other tools.
When to use: Brainstorming is useful when:
• A broad range of options is desired
• Creative, original ideas are desired
• Participation of the entire group is desired
Basic procedure: Materials needed: flipchart, marking pens, tape, and blank wall space.
1. Review the rules of brainstorming with the entire group:
• no criticism, no evaluation, no discussion of ideas;
• all ideas are valid and worthy of consideration;
• all ideas are recorded; and
• piggybacking—combining, modifying, expanding others’ ideas—is encouraged.
2. Review the topic or problem to be discussed. Often it is best phrased as a “why,” “how,” or “what”
question. Make sure everyone understands the subject of the brainstorm.
3. Allow a minute or two of silence for everyone to think about the question.
4. Invite people to call out their ideas. Record all ideas, in words as close as possible to those used by the
contributor. Note: No discussion or evaluation of any kind is permitted.
5. Continue to generate and record ideas until several minutes’ silence produces no more
6. Brainstorming should be a rapid generation of ideas, so do it quickly; 5-15 minutes works well. If the
time limit has expired and ideas are still being generated, you can extend the time limit at five-minute
intervals.
Considerations:
• When possible, have a separate facilitator and recorder. The facilitator should act as a buffer between the
group and the recorder(s), keeping the flow of ideas going and ensuring that no ideas get lost before being
recorded. The recorder should focus on capturing the ideas.
• The recorder should try not to rephrase ideas. If an idea is not clear, ask for a rephrasing that everyone can
understand. If the idea is too long to record, work with the person who suggested the idea to come up with
a concise rephrasing. The person suggesting the idea must always approve what is recorded.
• Keep all ideas visible. When ideas overflow to additional flipchart pages, post previous pages around the
room so all ideas are still visible to everyone.
• The more ideas the better. Studies have shown that there is a direct relationship between the total number
of ideas and the number of beneficial, creative ideas.
• Allow for and encourage creative, unconventional, and out-of-the-box ideas.
• Don’t be afraid to piggyback or build on someone else’s idea.
Adapted from: https://asq.org/quality-resources/brainstorming.
Tool – Force-field Analysis

Description: A structured decision-making tool used to understand the factors (forces), both for (helping
forces) and against (hindering forces), that impact on a problem or goal. Using a force-field analysis allows
the team to identify implementation actions.
When to use: Use force-field analysis early in a team effort to identify the most effective ways to bring about
positive change.
Basic procedure:39
1. Clearly state what change you are looking to bring about (or perhaps it is an option for change that
you wish to explore). Write this at the top of your diagram.

2. Draw a vertical line down from the statement of change. On the right of the line, you can brainstorm
the driving forces; on the left of the line, you can brainstorm the restraining forces.
3. For each force, agree on a score between zero and five to reflect the extent of the impact (positive or
negative).
4. Draw an arrow where the length is equivalent to the score agreed and the thickness of the arrow is
used to represent the relative importance of the force.
5. Brainstorm (or use a problem-solving technique like Problem Solving Team Building) to generate
solutions for increasing driving forces and reducing restraining forces.
6. Create an action plan
Example:
A surgery center needed to uncover patients’ use of herbal supplements and instruct them to cease use some
time before surgery.
The center decided upon several different actions.
Some actions revolved around the preoperative telephone interview conducted days in advance of the
procedure:
Allocating two “silent rooms” in which to conduct these interviews.
Instructing the interviewers to press for clear answers to questions regarding patients’ use of supplements.
Developing an interview guide/checklist where the interviewer can check off responses obtained to record
the answers.
In the longer run, employing at least one nurse with language skills beyond English.
Realizing that some of these remedies might meet with resistance from staff or patients, the analysis team
decided to assess the implementation situation using force-field analysis. The analysis is shown below.40
The force-field analysis identifies patients’ embarrassment or reluctance to answer honestly as the most
serious obstacle. In favor of implementation, the much higher likelihood of avoiding supplement-related
complications should induce interviewers to be more persistent in obtaining answers.
Figure 13: Example of Force-Field Analysis of Patient Interviews

Table 9: Example of Action Plan after Force Field Analysis
How? What? Who? When? Where?

(Strategy) (Action) (Resp.) (Timing) (Location)
Accurate -Develop Nurse At time of Surgery

assessment interview conducting preoperative Center
of patients’ guide/checklist preoperative telephone
use of herbal that offers telephone interview
supplements neutral reaction interview
to use of herbal
supplements to
get accurate
behavioral data
-Train staff on
use of tool
-Interview
patient in a
language
he/she can
understand
(e.g., phone or
other
interpreter
services as
necessary)
Compliance with Requirements

Tool – Checklist
Description: A tool for organizing and ensuring that all important steps or actions in an operation have been
taken. Checklists contain items that are important or relevant to an issue or situation. Checklists should not
be confused with check sheets.
When to use: The goal of every healthcare organization is to comply with all rules, regulatory and accredi-
tation/certification requirements all the time. To determine ongoing compliance, inspections (tracers or
internal quality audits) are conducted using checklists. Different checklists can be developed depending on
the scope and objective of the inspection.
Basic procedure: Checklists can be in electronic app or in paper and may vary in the level of detail. The basic
format is having a list of the requirements on one side while the other side indicates compliance status and
notes.

Table 10: Example of IQA Checklist Developed for an Organization,
Using the ISO 9001:2015 Requirements41
IQA Checklist - General
Type of Audit: Initial / Follow-up Area Audited/Pavilion: __________________________________

Audit Criteria/Reference: _ISO 9001: 2015___________________ Date: ___________________________________
Question Evidence/Opportunities for Improvement NC? NC/CAP #

1. Do you have a documented procedure regarding __________?
(5.2)
• Documented statements of policy/ objective’
• Documents/records that ensure the effective planning,
operation, and control of the process. Any form or type of
medium
• Procedure is established, documented, implemented, and
maintained.
2. How do you know it is the latest revision? (4.4.2)
• How was this approved prior to use?
• How is it updated as necessary and re-approved?
• How is this available to staff at points of use?
• How do you ensure it is legible and readily identifiable?
• Do you use any documents external to the organization?
• How do you prevent the unintended use of obsolete
documents?
• Is there a procedure that defines the controls needed for the
identification, storage, protection, retrieval, retention, and
disposition of records?
3. What are the training requirements? (6.2.1)
• Who determines the necessary competence for staff?
• How do you provide training or take actions to achieve
necessary competence?
• How do you evaluate the effectiveness of the actions taken?
• How do you ensure staff is aware of the importance of the
activity, and how they contribute to the achievement of the
quality objectives?
Internal Quality Audit Work Product Table 10 IQA Checklist full copy one page for figure (rev. 2/4/2019)
1
Tool – Cause & Effect Diagram
Description: A tool for analyzing process variables. Figure 14 illustrates the main causes and sub-causes lead-
ing to an effect (symptom). Also known as the Ishikawa or fishbone diagram, it is a versatile problem-solving
tool that allows hospitals to objectively visualize the factors that contribute to a problem.42 One of the seven
basic quality tools, the cause and effect diagram, contributes to overall performance excellence by ensuring
sustainable process improvements.

After inspections (also known as tracers, surveys, audits, and assessments) (American Society for Quality,
2016), hospitals must thoroughly investigate all deficiencies, nonconformities, and requirements for
improvement. Cause analysis tools such as the cause and effect diagram help hospitals identify “many pos-
sible causes for an effect or problem.”43
The CMS Quality Assurance and Performance Improvement (QAPI) Process Tool Framework44 includes
problem-solving tools such as the fishbone diagram. ASQ offers a free fishbone diagram template on the
organization’s website at https://asq.org/quality-resources/fishbone.
Figure 14: CMS QAPI Fishbone Diagram45
This CMS QAPI fishbone diagram illustrates the four causes and associated sub-causes identified by a hospital
while investigating a fall-related injury.

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Improving Healthcare Monograph Series: Healthcare Quality and Improvement

Committee, a joint development

Authors Donna Gillespie

Rowena Chona Sano

2 Healthcare Quality and Improvement Committee October 2020

Kelly Podgorny Gregory Gurican

Next in This Monograph Series

3 Healthcare Quality and Improvement Committee October 2020

18 Appendix of Tools and Techniques

4 Healthcare Quality and Improvement Committee October 2020

Health Care Quality Model conference presentations, and webinars.

5 Healthcare Quality and Improvement Committee October 2020

6 Healthcare Quality and Improvement Committee October 2020

T he ASQ Healthcare Quality and Improvement Committee developed the original

The ASQ QMD/HCD Hospital-Based Healthcare QMS Model

7 Healthcare Quality and Improvement Committee October 2020

8 Healthcare Quality and Improvement Committee October 2020

Table 1: 10 Critical Quality System Elements

Leadership commitment, Communication, education,

Data and the QMS

9 Healthcare Quality and Improvement Committee October 2020

10 Healthcare Quality and Improvement Committee October 2020

11 Healthcare Quality and Improvement Committee October 2020

12 Healthcare Quality and Improvement Committee October 2020

13 Healthcare Quality and Improvement Committee October 2020

14 Healthcare Quality and Improvement Committee October 2020

Management of Change Recommended Quality Tools/Approaches for

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Recommended Quality Tools for Teamwork

Compliance with Requirements

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Leadership Commitment, Planning, and Review

Figure 3: Example of X Matrix Template

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Figure 4: Example of Completed Strategy and Deployment Matrix

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Figure 5: Example of System of Alignment and Accountability Template

Mission and Vision Key Indicators

Department Goals Department Scorecards

Colleague Goals Performance Reviews

Tactics/Action Plans Department Scorecards

Improvement Projects PI Scorecard

BSC: Balanced Scorecard

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Tri Indicator Definition Baseline Improvement Target

Tool – Gap Analysis Feedback Collection

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Figure 6: Example of Affinity Diagram: Environment of Care Control Factors

Environment of Care Control Factors

Manpower Methods Materials Machine Measurement Environment

Provider and Surgical

Business & Linens, Scrubs,

Clinical, Business & IT

Responsible: Environmental Svcs FMEA Date (Orig) 6/19/19___ (Rev) 7/28/19