Improving Healthcare Monograph Series: Healthcare Technical

Committee, a joint development

Assessing Your Healthcare of the Healthcare and Quality
Quality Management System Management Divisions of ASQ

March 2019

1
 Improving Healthcare
Monograph Series
Assessing Your Healthcare Quality
Management System
Healthcare Technical Committee, a joint development of the
Healthcare and Quality Management Divisions of ASQ

Authors
Christine Bales serves as a technical expert in quality management
systems for blood centers and transfusion services for the American
Association of Blood Banks. In this role, she designs implementation
models for use as roadmaps to blood donor centers and transfusion
services facility accreditations. Bales has more than 20 years of
management experience in laboratory medicine, blood donor centers, and hospital-based
transfusion services where she has led through strategic planning, process improvement, and
facility accreditation processes. She can be reached via email at [email protected].

Tania Motschman is quality director for the Esoteric Business Unit of

Laboratory Corporation of America. She has 39 years of experience in
healthcare of which 30 years are in quality and regulatory management in
a large healthcare setting. Motschman has written numerous publications
on the design and implementation of a quality management system. She is
the chair of the Clinical and Laboratory Standards Institute’s Quality Management Expert
Panel and has served as chair of national and international committees on quality
management in laboratory medicine. Contact Motschman at [email protected].

Cheri Graham-Clark works for Kaiser Permanente, and her healthcare

positions have included quality director, patient safety officer, and director
of care management, as well as practicing as a Lean Six Sigma Black Belt.
Her current role involves overseeing and coordinating hospital and health
plan quality for over 600,000 members and more than 50,000 members in
the Geographic Managed Care-MediCal program. Graham-Clark is a registered nurse with
advanced credentials including multiple certifications from ASQ and healthcare professional
organizations. Her email address is [email protected].

1 HEALTHCARE TECHNICAL COMMITTEE October 2018

Susan Peiffer is the performance improvement specialist for the Hospital Sisters Health System,
Western Wisconsin Division. Peiffer has more than 30 years of hospital experience and served as
director of a variety of hospital departments including clinical laboratory, infection control,
radiation oncology, and palliative care. She is chair of the ASQ Healthcare Division, and her
email address is [email protected].

Grace L. Duffy is president of Management & Performance Systems where she provides services
in organizational and process improvement, leadership, and quality. She has authored several
books and articles on quality, leadership, and organizational performance. Duffy is an ASQ
Certified Quality Auditor (CQA), Certified Quality Improvement Associate (CQIA), Certified
Manager of Quality/Organizational Excellence (CMQ/QE) as well as a Lean Six Sigma Master
Black Belt. She was named Quality magazine’s 2014 Quality Person of the Year. Contact her at
[email protected].

Gene Barker serves as a Community Advisor on the EvergreenHealth Board Quality Committee
in Kirkland, WA, which was recognized by Healthgrades with a 2018 America’s 100 Best
Hospitals AwardTM. Before retirement, Gene lead the International Aerospace Quality Group
committee that developed the Aerospace Quality Management System standard. He as an ASQ
Fellow and a life member of ASQ and the Institute of Industrial and System Engineers. He can be
reached at [email protected].

Pierce Story is co-founder and vice president of concept development at Capacity Strategies, Inc.
A healthcare innovator and speaker, he is also the author of several books including, Optimizing
Your Capacity to Care: A Systems Approach to Hospital and Population Health Management;
The Good, Bad, and Ugly of Performance Optimization; and Maximizing Efficiency Through
Focus on Poly-Chronic Care Systems. Contact Story at [email protected].

Gregory Gurican is the founder, CEO, and lead consultant at GMG & Associates, LLP. He has
15 years of hospital-based quality management experience with clinical service lines, nursing,
patient safety, and risk management as well as 10 years of experience in quality assurance and
control in the nuclear power industry. An ASQ Senior member, Gurican is also the audit chair of
the ASQ Healthcare Division. Gurican can be contacted by email at [email protected].

Larry Timmerman has worked in the quality field for more than 35 years with experience in the
steel, aluminum, rubber, plastics, electronics, and healthcare industries. He is an ASQ Certified
Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman is
a founding member of ASQ Section 1528 in Ocala, FL, and he is currently the chair of that
section. Contact him via email at [email protected].

Deborah Hopen, Contributing Writer/Editor, is a past chair of ASQ and a leader in the
Healthcare Division. She is the editor of ASQ’s quarterly publication, The Journal for Quality and
Participation, as well as a columnist for Six Sigma Forum magazine. Hopen has over 40 years of
experience in quality management, including serving as a clinic manager for several medical
practices. Her current consulting practice includes many projects for hospitals and other medically
related organizations. She can be emailed at [email protected].

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 Table of Contents

4 Introduction
6 Overview of the QMS Model
Critical Quality System Elements … 7

11 Leveraging the QMS Model

Medical Clinics … 12
Other Human Healthcare Services … 12
Other Healthcare Organizations … 13

15 Organizational Assessment
Organizational Assessment … 16
Third-Party Assessments … 16
Self-Assessments … 16

18 Organizational Maturity
Developing a Maturity Model for the QMS Model … 18
Interaction of Learning and Mastery of Operational Conditions … 19
Integration of Process Application and Degree of Deployment … 19
QMS Maturity Model … 20

22 Initial Self-Assessments
Stage 1 Self-Assessment—QMS Model Adoption … 22
Stage 2 Self-Assessment—Alignment of Existing Processes Against 10 QMS
Elements … 25
Stage 3 Self-Assessment—QMS Pilot … 30

34 Ongoing Self-Assessments
45 Summary

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 Introduction

A Hospital-Based Healthcare Quality Management System Model1 was released to

organizations across the globe in April 2016. It was developed by a team of practitioners
from the ASQ Healthcare Technical Committee, who represented the Society’s Healthcare
and Quality Management Divisions. The model provides a conceptual framework for CEOs
and CMOs who are seeking to improve patient outcomes, safety, and satisfaction, as well as
cost savings, risk management, and regulatory compliance. The formalized quality
management system (QMS) shared in that monograph documented the structure,
responsibility, and procedures required to achieve effective quality management that is
focused on the quality policy and quality objectives to meet customer requirements. It
specifically describes the process for improving all aspects of patient outcomes and operating
performance.
Response to this breakthrough model has been extremely favorable. Individuals and
organizations across the globe have accessed the model through ASQ-affiliated websites, and
it already has been cited as a reference in many publications, conference presentations, and
webinars. The model’s non-prescriptive approach facilitates its adoption by hospitals of all
types, sizes, and locations.
Despite the steadily increasing interest in the model, its authors have received many
requests for additional information. In particular, three areas have emerged as warranting
additional attention. All are related to the way that healthcare organizations can apply the
model to improve patient outcomes. The current maturity of the organization’s QMS is one
factor that influences the model’s potential application. Hospitals that are beginning to
develop a QMS (or that just have recognized the need to develop one) will tend to have
different questions regarding the model’s use than those hospitals that have a well-
established QMS.
Furthermore, the potential for applying the model to non-hospital settings also has been
raised. The field of potential organizations that might be improved by use of a QMS model
includes medical clinics as well as a wide variety of other healthcare-related services, such as
pharmacies, dental clinics, radiology centers, laboratories, etc. Even veterinary clinics and
other non-human, health-related services might benefit from a QMS model.
Based on a growing understanding of those diverse needs, the ASQ Healthcare Technical
Committee decided to develop additional application-oriented monographs. Although they
all will support the successful implementation and sustainable operation of the QMS model
described in the initial monograph in this series, they are intended to provide notably
different resources to aid hospitals and other healthcare organizations.
Topics included in these additional monographs will include the following:
 Quality Management System Assessment. This information will present the rationale for
self-assessment and provide a standardized questionnaire and process that can be used
based on the maturity level of the organization’s current QMS. By conducting this self-
assessment, organizations can identify the strengths and opportunities for improvement
associated with their existing systems. For less mature organizations, leaders may decide
to pursue development of a new or substantially revised QMS that aligns with the
previously published QMS model. Organizations with more mature systems may find

4 HEALTHCARE TECHNICAL COMMITTEE October 2018

 specific areas that need focused attention or recognize the value of investigating best practices from other
organizations.
 Supporting Approaches and Tools. This information is intended to share a cross-section of data gathering,
analysis, and reporting approaches that a healthcare organization can use in conjunction with its QMS. Although
the practices presented will not represent an exhaustive list, they will demonstrate how selecting and applying
appropriate approaches and tools is instrumental for managing the QMS on a daily basis and ensuring that
reliable information that can be interpreted properly is readily available when decisions need to be made. The
expert panel that created the original QMS model will develop these approaches and tools and will include a
wide variety of options they gathered from global examples. The approaches and tools will be shared with
supporting instructions in formats that can be used off-the-shelf and applied immediately.
 Implementing the Healthcare Quality Management System. This topic has a much different purpose and will be
designed to provide a step-by-step process for organizations to use when initially developing their first
comprehensive QMS. It also will be useful for organizations that feel major revisions are required to improve
their QMS. The contents will provide a strategic foundation for the QMS’ development, as well as a project
management plan. This will be a process-oriented discussion and will focus on the steps needed to obtain support
from leaders and stakeholders, establish change plans, implement conformance audits, etc. The ASQ Healthcare
Technical Committee will develop a high-level process map with each step delineated in detail. The general
process steps will be supported with examples and case studies that describe the specific environment or
department associated with the implementation.
The QMS model offers a systemic structure that enables hospitals and other healthcare organizations to meet
both quality and value-based goals. Its design presumes the need for continuous improvement. Each organization
will need to understand its current situation and determine the actions that are required to raise its performance to the
necessary level and sustain that high performance on an ongoing basis. With these additional monographs,
healthcare organization leaders should have the necessary resources for meeting current and future requirements.

5 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Overview of the QMS Model

The ASQ Healthcare Technical 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 management fundamentals that had
been adapted specifically for the healthcare business environment. Its structure aligned well
with the ISO 9000 series of standards,2 Deming’s Plan-Do-Check-Act cycle,3 and other basic
quality-improvement tenets. The model was intended to be used for quickly diagnosing
business issues that impact effectiveness and efficiency in delivering exceptional quality,
safety, and patient outcomes. By recognizing the interactions of the key business processes
associated with this model, leaders can reduce negative impacts on results and promote
evaluation 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, and
they have a direct or indirect role before, during, and after the delivery of care and treatment.
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 that people have
following preventive care, or a survey of health indicators in a population that is accessing a
certain kind of care.4
The International Organization for Standardization (ISO) has a generic QMS model2 that
was used as the basis for
Figure 1: A High-Level Conceptual Representation of
developing the original
the Healthcare QMS1
hospital-based QMS model for
quality and safety, which is
shown in Figure 1. Figure 2
offers the more detailed
version. 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

6 HEALTHCARE TECHNICAL COMMITTEE October 2018

monograph, “A Hospital-Based Figure 2: The ASQ QMD/HCD Hospital-Based Healthcare QMS
Healthcare Quality Management Model1
System Model,” should be referenced
to obtain a deeper understanding of its
functionality.1
 The inner circle. The core of the
model delineates the results that are
expected—exceptional 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) survey’s
“willingness to recommend the
hospital.”5
 The middle circle. This circle details
four key components of the patient’s
care delivery—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 discharge. These components represent the
patient’s typical experiential path through the care-delivery process. They are described in more detail in the first
monograph.
 The outer circle. The 10 critical quality system elements that provide the infrastructure and framework for
supporting and influencing achievement of exceptional quality, safety, and patient outcomes are the process and
structures needed for overall business effectiveness and efficiency, and they have an interactive relationship with
each other, the four key components of care delivery, and ultimately the core of the model. These elements are
based on ISO 9001:20156 and the Baldrige Criteria for Performance Excellence,7 and they were adjusted to
reflect the hospital setting. The elements are summarized in broader terms that apply throughout healthcare in
Table 1.
 The overlay. The integration of continual improvement and innovation is critical throughout all the other aspects
of the model to ensure that better patient care and business efficiency are achieved. By superimposing these two
essential approaches over the three concentric circles, the model makes it clear that they must be applied to all of
the previously described parts. By determining, measuring, and analyzing the results of the organization’s core
processes, continual improvement and innovation are possible. Without this critical foundation, the model and
any advances it cultivates may become static and fail to allow for future change. The difference between these
two approaches is discussed in more detail in the original monograph.

Critical Quality System Elements

Of course, 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, attributes, 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 entire healthcare system and its ability to meet
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 actually engaging with the individual patient.

7 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 1: Critical Quality System Elements
Quality System Brief Description Key Factors
Element
Leadership commitment, Includes strategic planning for  Commitment to quality—Focusing on ensuring that
planning, and review governance, overall structure of effective processes are in place, directly engaging
the organization, and style of medical and administrative staff, and empowering
leadership required to best individuals by providing the appropriate responsibility
match the culture of the and authority needed to carry out their assigned duties;
community in which the leaders at all levels are aware of and support quality
organization serves efforts across the organization and have a personal
understanding of the intent of the operational model and
its results
 Planning—Strategic planning that is associated with
quality in both clinical and administrative processes,
starting with development of the mission, vision, quality
policy, goals, and objectives
 Quality policy—Comprehensive quality policy that
reflects the leadership style and culture of the
organization and the community it serves including
considerations for disaster planning, periodic risk
assessments, and frequent review of all the healthcare
system’s targeted product and service outcomes/results
 Review of quality plans—Occurs on a scheduled basis,
and annual reviews of the organization’s goals and
objectives set the stage for strategic planning
Feedback loops Verifies whether processes are  Linking processes and results—Relate process output
functioning as expected and information to the inputs and operational factors so that
facilitates a factual approach for the need for corrective action and/or transformation
decision making becomes evident
Environment of care Promotes a safe, functional, and  Physical environment—Includes building and/or space,
supportive environment to as well as their arrangements and special features
ensure that quality and safety are  Physical assets—Includes medical devices
attained and preserved to protect  Key practices—Disaster and recovery planning;
patients, visitors, and staff calibration, cleanliness, physical safety, and general
upkeep of the location and equipment
Management of finances Supports effectiveness and  Financial management—Focuses on budget
and support resources efficiency throughout the management and planning for resource utilization at the
organization and includes unit-, department-, division-, and corporate-levels
finances, people, equipment, and  Support of resources—Includes equipment utilization,
information systems (but does supplier qualification, and inventory control
not consider human resource
management, which is addressed
in a different element)

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Table 1: Critical Quality System Elements (continued)
Quality System Brief Description Key Factors
Element
Management of Assures that patient information  Reliable data—Includes coordinated care plans,
information is accurate and readily prescribed medications, laboratory test results, surgical
accessible to support patient summaries, electronic health records, and numerous
care and billing for services other types of information
 Data management—Involves data that both directly and
indirectly impact patients, assuring records are matched
to the correct patient, compiled properly from different
computer databases, are sorted appropriately, and can be
retrieved quickly
Communication, Provides the foundation for staff  Communication—Builds a connecting network to guide
education, and training members’ success in meeting all 10 quality system elements by fostering human
patient and administrative interaction to provide the necessary foundation for well-
requirements defined processes, including those associated with
managing the organization, obtaining and responding to
feedback, and building high-performing teams
 Education—Focuses on concepts and building
knowledge
 Training—Focuses on tasks/procedures and developing
skills
 Learning process—Instructional design and delivery,
present information in a well-organized manner, and
learning is validated by having students explain
underlying concepts and demonstrate that they can
perform tasks and apply tools at the level required in
their job descriptions
Risk management Associated with management  Risk sources—Involves all processes, as well as the
review and planning activities organizational structure, function, and resources (e.g.,
and primarily involves the facility and equipment, business continuity, etc.),
preventing risks associated with that may introduce risk, if they are not designed and
patients and their care—as executed properly
individuals or as a group  Risk mitigation—Focuses on managing clinical and
administrative processes and minimizing disruptions to
established procedures
 Opportunity management—Approaches the positive side
of risk management by using preventive techniques,
such as failure-mode-and-effects analysis and quality-
function deployment, to anticipate opportunities for
deflecting the risk before it is encountered.
Management of change Sponsors changes that fulfill a  Goal of change—Ensures that the organization is ready,
specific purpose or that are willing, and able to function appropriately in the
associated with process required environment
improvement efforts; they may  Change management process—Includes verifying that
impact one or more functions revised processes and equipment and other resources
and may involve multiple work as intended and that staff members have been
projects educated/trained appropriately and are competent to
perform the required functions and tasks

9 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 1: Critical Quality System Elements (continued)
Quality System Brief Description Key Factors
Element
Teamwork Involves all members of the  Purpose—Facilitates exceptional quality, safety, and
healthcare organization as well patient outcomes, as well as optimization of key
as organizations and individuals performance and financial metrics
within the broader care
community
Compliance with Addresses rules and regulations  Requirements—Takes both mandatory and voluntary
requirements that are set forth in requirements requirements into consideration and covers a wide range
from international, national, of areas
state, and local agencies

10 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Leveraging the QMS Model

As mentioned previously, this QMS model originally was developed with hospitals in
mind; however, its applicability to other healthcare settings was always considered to be
possible, as written in the first monograph, “Although this model is intended for hospital
application, its concepts also can be applied to other healthcare environments. It is hoped that
the committee’s future efforts will expand the model to include the many interrelated
processes used throughout a complete healthcare system.”
An analysis of feedback from the organizations that had reviewed the hospital-based
QMS model provided an impetus for the ASQ Healthcare Technical Committee to
investigate the QMS model’s extended application. For instance, a survey of division
members in mid-2017 indicated that they were associated with the diverse categories of
organizations shown in Figure 3. With only 33.2 percent directly working at patient-care
institutions, it was clear that there was a need for a QMS model that could be applied in non-
hospital settings.
Figure 3: Type of Organization That Best Describes Healthcare Division Member’s
Workplace
Number of Percent of
Rating Description Responses Responses

Academic Institution 32 16.1%

Association/Society 4 2.0%

Consulting 27 13.6%

Diagnostic/Testing 8 4.0%

Government 12 6.0%

Insurance 6 3.0%

Medical Technology 13 6.5%

Patient Care Institution 66 33.2%

Pharmacy/Pharmaceuticals 3 1.5%

Support Business 2 1.0%

Other 26 13.1%

All Respondents 199 0% 20% 40% 60% 80% 100%

On May 1, 2017, Grace Duffy, co-chair of the Healthcare Technical Committee, had the
opportunity to poll a cross-section of healthcare practitioners who were attending the ASQ
World Conference on Quality and Improvement in Charlotte, NC. She asked them to
consider whether or not the 10 quality system elements from the model could be used more
universally in healthcare. The results of that research supported extending the QMS model’s
application.8
The poll was divided into three sections—medical clinics; healthcare organizations that
focus on providing services to humans, such as independent laboratories and radiology
services, dental clinics, pharmacies, physical therapists, etc.; and healthcare organizations
that do not focus on providing services to humans, such as veterinary clinics, pharmaceutical

11 HEALTHCARE TECHNICAL COMMITTEE October 2018

manufacturers, medical device manufacturers, education/training institutions, etc. For each of the sections,
respondents were asked to indicate the applicability of the 10 quality system elements. A straightforward three-point
rating scale was provided—“applies very well,” “applies,” and “doesn't apply.” Then the participants were asked to
describe briefly any particular considerations that influenced their selected rating. A summary of the poll’s results
and comments is provided in the following three sections.

Medical Clinics
As shown in Figure 4, eight of the 10 quality system elements received high-level support from more than 80
percent of the respondents who
provided ratings of “applies very well.” Figure 4: Applicability of QMS Model Elements to Medical Clinics
Even the two least supported quality
system elements—“feedback loops”
and “communication, education, and
training”—received those high ratings
from more than 70 percent of the
respondents. Obviously, there was
substantial agreement that the hospital-
based QMS model would work
effectively in the medical clinic
environment.
A cross-section of comments was
provided regarding the efficacy of the
10 elements for medical clinics. One
respondent said, “Medical clinics have
very similar requirements and
considerations as hospitals,” and
another wrote, “All are applicable
based on regulatory requirements and
compliance as well as meeting patient
needs for best healthcare outcomes and
safety.” “There is large variation in
approaches used” also was mentioned.

Other Human Healthcare Services

This portion of the survey explored the applicability of the hospital-based QMS model for other human
healthcare services. This includes organizations such as independent laboratories and radiology services, dental
clinics, pharmacies, physical therapists, etc. All of the participants agreed that the “compliance with requirements”
quality system element applied to these organizations (see Figure 5). All nine of the other elements were rated
“applies very well” by at least 70 percent of the respondents. In addition to the generally supportive comments that
were received for medical clinics, there were some more specific comments for these organizations, including the
following:
 Leadership commitment, planning, and review. “It is the key to set direction and drive change,” and “Ensuring
the medical director is engaged; it is not uncommon to be delegated almost completely.”
 Feedback loops. “The ability to communicate effectively with established open lines of communication with
clinicians, pharmacy, nursing, imaging, etc.,” “This is needed for communication and sustainability,” and
“Independent reporting is needed.”
 Environment of care. “This is important to successful treatment” and “This drives meeting patient expectations
and safety requirements.”
 Management of finances and support resources. “Staying profitable equals staying alive” and “Organizations
must be fiscally responsible to stay in business.”

12 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Management of information. “New Figure 5: Applicability of QMS Model Elements to Other Human
speed requirements require effective Healthcare Services
information management” and
“Organizations often gather the
same data year after year without
looking for new areas of
opportunity and success that could
be accomplished and thoughtful
metrics.”
 Communication, education, and
training. “Clear effective
communication, as well as
continuing education, and training
are essential,”
“Competency/training specifics are
necessary,” and “Education and
training are required for everyone,
including patients!”
 Risk management. “Managing risk
and making everyone aware of risk
management is essential for an
organization,” “Introduce risk-based
thinking to lab preventive actions,”
and “This does not apply just to
preventing lawsuits.”
 Management of change. “Change management should start at the top and must be clearly communicated,”
“Administration should be proactive rather than reactive to change,” and “This is critical to be agile in today's
environment.”
 Teamwork. “This is essential to success,” “Eliminate the ‘us-against-them’ mentality and focus on patient
outcomes,” “Departments should be way more cooperative and work as true teammates rather than being
punitive and accusatory,” and “Teamwork helps facilitate the hierarchy of healthcare from MD to RN to others.”
 Compliance with requirements. “The heavily regulated environment requires compliance,” “Everyone has
ownership in this,” and “There are too many resources to check/inspect/audit.”

Other Healthcare Organizations

The results for this section, which evaluated the QMS model’s applicability for other types of healthcare
organizations, such as veterinary clinics, pharmaceutical manufacturers, medical device manufacturers,
education/training institutions, etc. These results were even more supportive of the original QMS model (see Figure
6). All respondents who participated in the poll agreed that every one of the 10 quality system elements would apply
very well. Here is a cross-section of the comments that were provided regarding the efficacy of the 10 elements.
 Leadership commitment, planning, and review. “Improvement solutions for medical device companies’
customers need to fit within the quality expectations of the purchasing healthcare organizations’ limitations” and
“These organizations need to create cultures to facilitate application of a QMS.”
 Feedback loops. “These are essential for control.”
 Environment of care. “This element may not apply to education/training organizations or virtual organizations”
and “Voice of the customer, customer/patient satisfaction, and safety all need to be monitored to understand
patient and staff issues.”
 Management of information. “Transparency is critical,” “IT and electronic medical records are involved in this
element,” and “Security, accessibility, user friendliness are important characteristics of the systems.”

13 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Communication, education, and Figure 6: Applicability of QMS Model Elements to Other Healthcare
training. “The focus needs to be on Organizations
competency development,”
“Competency assessment also is
required,” and “This element needs
to be integrated across clinical and
support services.”
 Risk management. “Integration is
essential—clinical, continuity of
operations.”
 Management of change. “Sustaining
improvements is very important.”
 Teamwork. “Ancillary departments
need to support patient diagrams
and care,” “Teamwork is needed for
safety issues also,” and “Cross-
functional teamwork is essential.”
 Compliance with requirements.
“Transparency is important in this
area, too.”

14 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Organizational Assessment

As described earlier in this monograph, the need for integration of continual improvement
and innovation is critical throughout all the aspects of the model to attain exceptional quality,
safety and patient outcomes. The fact is that there actually are two approaches to
improvement and the differentiation between them is not always recognized by practitioners.
Clearly, however, knowing when to apply each approach is an essential component of
successful management of the QMS.
 “Continual improvement is the
action taken throughout an Figure 7: Continual Improvement and Innovation
organization to increase the
effectiveness and efficiency of
activities and processes in order
to provide added benefits to the
patient, stakeholders, and
organization. It is a key aspect of
total quality management and is
based on the premise that there
are always opportunities for
improvement.”1
Many continual improvement
methodologies are used by
healthcare organizations to
address these issues, including Lean, Six Sigma, 8D, and other problem-solving
processes. Generally, these methods use a diverse set of tools in a structured series of
steps. They also rely on strong leadership from the top that emphasizes satisfying
customers and achieving required bottom-line financial results (profitability).
 “On the other hand, innovation also is needed for healthcare patient care and business
optimization—perhaps now more than ever. Innovative ideas will lead to leaps in
performance and bring healthcare organizations closer to their visions of a far better
delivery system. Healthcare innovators need to go beyond the status quo and develop
radical new ideas that break the mold. Changing steps in a process to yield the same
output with greater efficiency improves performance, but it is not innovation, which
yields an entirely new process with a radically new offering that addresses unmet
customer needs and makes patients’ lives much better.”9
“Innovation occurs when history, experience, and factors that are presumed to be obvious
are challenged. It requires consideration of a broader range of ways to solve problems—
particularly approaches that move results far beyond the current state and approach the
ideal situation.”1
Figure 7 provides a graphical illustration of the difference between continual
improvement and innovation. When the two approaches are combined, the healthcare
organization can make more definitive improvements to its QMS. Opportunities for
improvement are likely to exist in individual quality system elements, in various

15 HEALTHCARE TECHNICAL COMMITTEE October 2018

combinations of the elements, and even at the higher levels of the QMS model that represent more comprehensive
perspectives. With so many opportunities for improvement available within any organization—even those that are
high-performing, it is not surprising that one of the greatest challenges for leaders is to determine where to deploy
limited resources to gain the greatest benefits.10

Organizational Assessment
“An organizational assessment is a systematic process for obtaining valid information about the performance of
an organization and the factors that affect performance. It differs from other types of evaluations because the
assessment focuses on the organization as the primary unit of analysis.
Organizations are constantly trying to adapt, survive, perform, and influence. However, they are not always
successful. To better understand what they can or should change to improve their ability to perform, organizations
can conduct organizational assessments. This diagnostic tool can help organizations obtain useful data on their
performance, identify important factors that aid or impede their achievement of results, and situate themselves with
respect to competitors.”11
Organizational assessments fall into two primary categories—third-party assessments that are conducted by
specially trained external examiners and self-assessments that are conducted by members of the organization. In
both cases, the assessments usually are based on a comparison on the organization’s performance against an
established framework or specific set of criteria.
In a review of healthcare organizational assessments, the researchers noted, “As healthcare organizations look for
ways to ensure cost-effective, high-quality service delivery while still meeting patient needs, organizational
performance assessment is useful in focusing improvement efforts. In addition, organizational performance
assessment is essential for ongoing management decision making, operational effectiveness and strategy
formulation.”12

Third-Party Assessments
There are a wide range of third-party assessments available for healthcare organizations. Some of them are
associated with specific operational areas, such as security risks or HIPAA compliance, and these often are
conducted by consulting firms that have established practices in these specific areas.
At a higher-level, however, third-party assessments may not only be conducted by expert evaluators from
consulting firms, but they also actually may cross into the realm of accreditation organizations. In some cases, self-
assessments or third-party assessments by consultants serve as precursors for accreditation evaluations. In the U.S.,
the Joint Commission, the National Committee for Quality Assurance, the Utilization Review Accreditation
Commission, the Agency for Healthcare Research and Quality, and DNV-GL all have frameworks that frequently
are used for assessment of healthcare organizations—both by third parties and as the basis for self-assessment. Other
nations have similar accreditation frameworks that are used for organizational assessment.

Self-Assessments
Much has been written about the use of self-assessment tools for businesses and other organizations. In fact,
evaluations of this type are used to gather input on performance and behaviors for individuals, teams, departments,
business units, and even entire organizations. In some cases, the instruments are fairly simplistic and utilize short
questions whose answers are based on opinions and decisions. Other self-assessment instruments, however, may
have more complex frameworks that require the use of facts, data, and analyses to address the questions. In either
circumstance one of the greatest advantages of this approach is associated with the fact that they encourage
introspection.
Introspection can range from an informal process of reflection to a formalized experimental research approach.
On a personal level, introspection involves examining thoughts, emotions, and memories to examine their meaning
and effects on life.
Obviously, business-oriented self-assessments require the participants to consider their surrounding situations
introspectively. Unlike the original intentions of formal psychological research, however, one uniform result is not
being sought. Instead, there is much value to be found in the process of capturing diverse perspectives into a
consensus-based decision. The process of reaching the consensus involves discussion—and sometimes debate;

16 HEALTHCARE TECHNICAL COMMITTEE October 2018

however, the end result is a decision that all participants can support without trepidation. When conducting an
organizational self-assessment, the ultimate consensus-based decisions are significant, but often the process of
understanding and resolving the initially different perspectives may be even more significant because it builds
common insights and a unified approach for moving forward.
The use of a well-designed self-assessment tool that is based on a recognized framework can be especially
beneficial—particularly to organizations that are in the initial stages of implementing the associated criteria. For
instance, consider the positive results that have been reported about using self-assessment in association with the
Baldrige Performance Excellence Program criteria. Although the QMS model aligns with the ISO 9001 standard, the
self-assessment process associated with the Baldrige program is more consistently used by organizations in the
United States and as a foundation for other self-assessment programs across the globe. The program’s website lists
the following benefits of these internal evaluations:
 “Identify successes and opportunities for improvement
 Jump-start a change initiative
 Energize improvement initiatives
 Energize the workforce
 Focus your organization on common goals
 Assess performance against the competition
 Align resources with strategic objectives”13
Baldrige-based self-assessment has been such a prevalent practice that instruments were being developed by
academics, consultants, and practitioners for many years in an effort to provide options for organizations that had
differing intentions for the evaluation process. The use of the complete set of Baldrige criteria that is required for
award applicants actually involves a comprehensive self-assessment that must be supported by facts and data and
later is reviewed by trained examiners. More recently a simplified, but totally aligned, self-assessment tool, the
Baldrige Excellence Builder, was introduced to offer a less-detailed approach. In either case, however, the purpose
is the same—to generate a common understanding among decision makers regarding the organization’s performance
compared to the criteria.
Once the hospital-based QMS model was released in 2016, feedback quickly indicated that many organizations
would need a way to assess the efficacy of their existing QMS and/or to track progress associated with improvement
initiatives. The need for a self-assessment tool based on the model became apparent, and a decision was made to
develop an aligned instrument that could be used to prioritize next steps and differentiate between projects that
would benefit from continual improvement and those that would require innovation. The self-assessment process
and associated tool presented in this monograph is designed to fulfill this purpose.

17 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Organizational Maturity

Research on the efficacy of self-assessment has confirmed that another factor—

organizational maturity—impacts the value of framework-based evaluations. One study
examined the use of the Malcolm Baldrige and the European Excellence models, concluding,
“It is suggested that the original models might still be a useful guide to improvement but only
for organizations whose conformance quality is poor. More advanced organizations should
choose their own relevant dimensions and weightings rather than use any standard one-size-
fits-all model with more attention being paid to the processes by which their own business
models and strategy are developed.”14
In other words, as an organization becomes more mature in its conformance to a quality
system, its self-assessments need to move away from generic frameworks and focus more on
determining compliance with the organization’s specifically designed QMS. The use of facts,
data, and analyses to substantiate self-assessment findings would appear to be a necessity at
this point in an organization’s journey.
For instance, the Centers for Medicare and Medicaid Services (CMS) has developed the
Medicaid Information Technology Architecture Model, which is used by CMS, states, and
vendors. It is described as “A maturity model shows improvement and transformation of a
business over time. In the model, time is loosely associated with five milestones ranging
from the present to 10+ years from now. Predictions are well grounded at the five-year
marker but are dependent on new enablers in the future. Therefore, the time estimates are
less certain beyond the midpoint. It is a two-dimensional model showing change related to
time and space (see Figure 8). The temporal dimension shows a progression from the present
time to a realistic future time. The spatial dimension captures how the business looks and
what capabilities it exhibits at each progressively higher level.”15

Developing a Maturity Model for the QMS Model

Based on the research associated with self-assessment and other common maturity
models, the X-axis usually is based on a measurement of time or progressive operational
conditions. Benchmarks were not available to correlate specific operational conditions and
typical times because application of the model in real-life situations is relatively new. So, the
ASQ Healthcare Technical
Figure 8: Medicaid Information Technology
Committee decided to base this
Architecture Maturity Model15
maturity model on progressive
operational conditions.
The degree of deployment often
is used as the basis for the Y-axis for
maturity models. The MITA
maturity model calls this “space.”15
A similar approach was used to
develop the QMS maturity model,
where the deployment levels were
based on expanding application of
the organization’s QMS.

18 HEALTHCARE TECHNICAL COMMITTEE October 2018

Interaction of Learning and Mastery of Operational Conditions
In many ways, an organization’s ability to master progressively advanced levels of the QMS model are based on
the competencies of individuals and the organization as a whole to learn new concepts and their systematic
application. One commonly accepted model for learning involves four stages. Although this model often is
attributed to Abraham Maslow, it was not published until Noel Burch, an employee at Gordon Training International
published it, and it describes the four stages as shown below:
 “Level 1—Unconscious incompetence. The individual does not understand or know how to do something and
does not necessarily recognize the deficit. He or she may deny the usefulness of the skill. The individual must
recognize his/her own incompetence, and the value of the new skill, before moving on to the next stage. The
length of time an individual spends in this stage depends on the strength of the stimulus to learn.
 Level 2—Conscious incompetence. Though the individual does not understand or know how to do something, he
or she does recognize the deficit, as well as the value of a new skill in addressing the deficit. The making of
mistakes can be integral to the learning process at this stage.
 Level 3—Conscious competence. The individual understands or knows how to do something. However,
demonstrating the skill or knowledge requires concentration. It may be broken down into steps, and there is
heavy conscious involvement in executing the new skill.
 Level 4—Unconscious competence. The individual has had so much practice with a skill that it has become
‘second nature’ and can be performed easily. As a result, the skill can be performed while executing another task.
The individual may be able to teach it to others, depending upon how and when it was learned.”16
Although it is beyond the scope of this monograph to describe the large body of research and application of this
learning theory, these basic definitions provide a sufficient platform for understanding how the X-axis of the QMS
application maturity model discussed later in this monograph was developed.

Integration of Process Application and Degree of Deployment

The wide acceptance of the Baldrige criteria—not only in the United States but also as the foundation for many
other state and country’s quality award programs—supported the use of its scoring methodology for the
development of the QMS application maturity model development.
Scoring for Baldrige-based assessments uses two dimensions—process and results. Both the strategic approach
and the degree of deployment, as well as improvement (called learning), and integration are considered in the
process scores, as shown below:
 “Approach. How do you accomplish your organization’s work? How effective are your key approaches?
 Deployment. How consistently are your key processes used in relevant parts of your organization?
 Learning. How well have you evaluated and improved your key processes? How well have improvements been
shared within your organization?
 Integration. How do your processes align with your current and future organizational needs? How well are
processes and operations harmonized across your organization?”17
The deployment aspect is further described as follows:
 Definition. “Deployment refers to the extent to which an approach is applied in addressing the requirements of
the Baldrige criteria item. Deployment is evaluated on the basis of the breadth and depth of application of
approach to relevant work units throughout the organization.”18
 Features. Five characteristics are assessed—relevance, complete coverage, consistency, breadth across all work
units, and depth through multiple levels.18
The results dimension describes four methods of validating the organization’s performance, as shown here.
 Levels. What is your current performance?
 Trends. Are the results improving, staying the same, or getting worse?
 Comparisons. How does your performance compare with that of other organizations or with benchmarks or
industry leaders?

19 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Integration. Are you tracking results that are important to your organization and that consider the expectations
and needs of your key stakeholders? Are you using the results in decision making?
Healthcare organizations are complex, and their efforts to integrate a QMS take time and involve varying
approaches. Factors such as the services they provide, size, etc., impact their processes and results in all the ways
described by the Baldrige scoring system. Because research has shown that organizations require different
assessment information to support decision making, it makes sense to combine the concept of a maturity model with
a proven scoring system, such as the one used for Baldrige self-assessment.

QMS Maturity Model

Figure 9 illustrates a straightforward maturity model that reflects a typical organization’s journey to deploying
the QMS model systematically and comprehensively. The four stages of competence were used as the foundation for
the X-axis and the Baldrige scoring
methodology for the Y-axis. Note that Figure 9: QMS Maturity Model
the language associated with both of
these benchmarks has been adjusted to
reflect the application of the QMS
model.
This illustration also indicates when
the organization should shift from self-
assessments that are based on the
generic QMS model framework to the
specific organizational construct. The
areas that are shaded in red represent
the periods of less maturity when the
organization is more dependent on the
basic QMS model. Blue-shaded areas
show that the organization has
customized the QMS model into a
framework that specifically fits its
situation and should be used for
performance evaluations.
The X-axis reflects four operational stages that represent the organization’s growing understanding of the QMS
model, as follows:
 Initial awareness. The organization becomes familiar with the QMS model and seeks to determine if its existing
processes for attaining exceptional quality, safety, and patient outcomes are directionally appropriate.
 Increased understanding. The organization begins to delve more deeply into connecting the four key components
of the patient’s care delivery (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 discharge) and the 10 quality system
elements (leadership commitment, planning, and review; feedback loops; environment of care; management of
finances and support resources; management of information; communication, education, and training; risk
management; management of change; teamwork; and compliance with requirements).
 Metric-based application. The organization establishes clear metrics with targeted performance levels for all
QMS elements. Operational definitions exist for each metric and include sampling plans and reporting frequency
and distribution.
 Integrated application. Data associated with performance metrics is collected and analyzed. Results for the
metrics associated with the QMS elements are considered to be leading indicators. Correlation/regression
analyses have been used to determine how those metrics predict performance for the lagging indicators
associated with four key components of the patient’s care delivery, as well as the lagging indicators related to the
processes for attaining exceptional quality, safety, and patient outcomes. Results of these analyses are used to
drive continual improvement and innovation.

20 HEALTHCARE TECHNICAL COMMITTEE October 2018

 The Y-axis reflects six deployment stages that represent the organization’s growing understanding of the QMS
model, as follows:
 Stage 1—QMS model adoption. The organization officially adopts the QMS model as the relevant framework for
its system.
 Stage 2—Alignment of existing processes against 10 QMS elements. The organization determines how its
existing processes align with the 10 QMS elements, where there are redundant efforts, and where gaps exist.
 Stage 3—QMS pilot. The organization selects a department, function, clinic, location, or other subsidiary work
units as a pilot site for implementing the complete QMS model. Applicable existing processes are improved or
supplemented as necessary to fulfill the QMS model’s intentions completely. Initial metrics and performance
targets are adopted to track results. Learnings from the pilot are used to improve the QMS model’s application in
the initial work unit.
 Stage 4—QMS expansion. The organization develops a comprehensive expansion plan that applies the QMS
across all work units. Processes associated with the 10 QMS elements are customized as appropriate to meet
specific patient and business needs. Appropriate metrics and performance targets are adopted to track results for
each work unit. Learnings are monitored and used to improve the QMS model’s application in each work unit.
 Stage 5—Consistent application of the comprehensive QMS model. The organization’s focus moves beyond
determining if means and proportions of processes’ adopted metrics are on target. More attention is given to
consistent application by monitoring variances of the metrics.
 Stage 6—Understanding QMS drivers and interdependencies. The organization’s comprehension of relationships
among the QMS model’s levels are understood deeply. Continual improvement and innovation efforts associated
with the 10 QMS elements not only enhance attainment of target performance (for both means/proportions and
variances) but also ensure sustainable performance of the organization’s highest-level outcomes.
It is very important to note that the time required to complete each of these stages varies among organizations.
The level of leadership commitment is a key indicator of the speed associated with moving through these stages.
Because this is the case, self-assessments will not be conducted on a specifically recurring basis, such as quarterly or
annually. Each self-assessment should be administered when the organization’s leaders believe that the stage has
been completed or substantial progress has been made. This approach ensures that the deployment process can be
revised based on the results of the self-assessments to keep it moving forward optimally.

21 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Initial Self-Assessments

As described in the previous section, the more mature the organization’s application of
the QMS model is, the more it needs to switch from the use of a generic framework to one
that is customized to fit its specific situation. Initial self-assessments, however, are intended
to help the organization identify its strengths and opportunities related to alignment with the
generic model. In other words, at the beginning of its journey, the organization focuses more
on assessing whether or not it has processes in place to fulfill the 10 quality system elements
and how well the processes it is using are performing. Later as the organization becomes
more mature in its application of the QMS model, its self-assessment should become more
sophisticated, focusing on how well the processes associated with the elements combine to
generate organization-wide results that can be predicted and controlled so that patient and
business outcomes are achieved on a sustainable basis.
The worksheets provided for each self-assessment stage of the maturity model are
examples of simple forms that can be used. They are not intended to be used exactly as
presented by every organization that conducts a self-assessment of its progress in
implementing the QMS model. Instead, they offer a starting place for planning the self-
assessment process.

Stage 1 Self-Assessment—QMS Model Adoption

When conducting the initial self-assessment, the organization’s leader primarily needs to
consider the potential strategic application of the QMS model. Incorporating use of the QMS
model into the organization’s strategic plan positions it as a foundation for all operations
throughout the long term. Any other approach is likely to result in limited and/or inconsistent
application of the QMS model, which undermines its essence as a systematic means of
managing all aspects of quality.
Recognition of the importance of this initial stage of deployment led to the development
of a very specifically focused self-assessment instrument that is recommended only for use
when the organization is beginning its journey. The “Baldrige Organizational Profile for
Healthcare”19 was used as a benchmark for this first self-assessment instrument, and it is
described as “a snapshot of your organization, the key influences on how it operates, and the
key challenges it faces.” This instrument contains two sections—the organizational profile
and the organizational situation. Figure 10 displays the suggested process steps for
conducting this initial self-assessment, and Table 2 provides a simple form that captures the
key areas addressed in the Baldrige document. This tool can also be used to summarize the
results.

22 HEALTHCARE TECHNICAL COMMITTEE October 2018

Figure 10: Stage 1—Self-Assessment Process Map
The organization’s leaders perform all steps in this process.

23 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 2: Stage 1—Self-Assessment Instrument
Questions Related to Key Organizational Characteristics Summary of Leaders’ Consensus
Services
What healthcare-related services does your organization offer?
What are the relative priorities for those services from a patient’s
perspective?
What are the relative priorities for those services from a business
perspective?
Mission, vision, values, and quality policy
Does your organization have clearly documented mission, vision, and
values statements?
Does your organization have a formal quality policy that aligns with its
mission, vision, and values?
Workforce competencies
What are the key competencies that must exist for your workforce?
How do each of those competencies specifically impact quality in regard to
both patient and business outcomes?
Regulatory requirements
What are the regulatory requirements with which your organization must
comply?
How do those regulatory requirements specifically impact quality in regard
to both patient and business outcomes?
Organizational structure
What is your leadership and governance structure?
How is the attainment of quality managed within this structure?
Stakeholders
Who are your organization’s key stakeholders?
What expectations do each of these stakeholders have in regard to quality?
How have you determined their expectations?
Competitors
Who are your organization’s primary competitors?
What is their relative prioritized impact on your organization?
What are their greatest strengths and opportunities for improvement in
regard to quality when compared to your organization?
How have you determined their relative strengths and opportunities?
Challenges
What challenges is your organization expecting to face in the next five to
10 years?
How are those challenges related to quality?
Strategies and objectives/goals
How does your organization establish its strategies and objectives/goals?
Are metrics with specific targets established for the strategies and
objectives/goals?
How frequently are the strategies and objectives/goals updated?
How do the current strategies and objectives/goals impact quality?
How is performance against strategies and objectives/goals monitored?
What actions are taken when performance against strategies and
objectives/goals fall short of expectations?

24 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Note that this self-assessment is intended to stimulate discussion among the organization’s leaders and lead to
consensus decisions regarding the answers for each question. It does not require review of specific facts and data;
instead, it captures leaders’ existing perspectives, encouraging them to determine when their understanding of these
characteristics and the impact of quality on them is more diverse than needed to provide clear direction for the
organization.
By the end of this initial self-assessment, leaders should be able to recognize that a well-performing QMS
connects with all of the characteristics included in this instrument. They should understand that adopting the QMS
model is a strategic decision designed to improve the organization’s overall performance, and they should be ready
to accept the QMS model as a framework for the organization’s future efforts.

Stage 2 Self-Assessment—Alignment of Existing Processes Against 10 QMS

Elements
Once the organization adopts the QMS model as its framework, it needs to assess how well its existing processes
and components fulfill the 10 quality elements. Figure 11 shows the process steps associated with gathering and
analyzing the efficacy of those existing approaches. Table 3 includes a list of common processes and components
that are used for each of the 10 elements. It is in no way an exhaustive list, and it is not intended to imply that every
healthcare organization will have—or even should have—all of the examples in place. Instead, it was created to
support the investigation that precedes the stage 2 self-assessment.

Figure 11: Stage 2—Self-Assessment Process Map

25 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 3: Examples of Associated Processes and Other Components
Quality System Element Examples of Associated Processes and Other Components
Leadership commitment,  Quality commitment—agreement or pledge statement
planning, and review  Organizational structure
 Mission
 Vision
 Quality policy
 Strategic plan, including goals and objectives for strategic, tactical, and
operational levels
 Quality assurance monitoring
 Leadership review process of quality plan
 Leader engagement in oversight of quality and improvement work
Feedback loops  Plan-Do-Check-Act improvement cycles
 Lean and/or Six Sigma projects
 Results of quality assurance or management audits
 Joint Commission tracers (audits) and reviews
 Utilization and asset reviews to ensure effective use of resources
 Satisfaction/dissatisfaction surveys
 Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
scores
 Social media feedback, such as website reviews
 Comparative data including data from similar organizations or healthcare
industry benchmarks
 Patient/customer exit interviews
 Employee perceptions
 Performance outcomes/results
 Process assessments
 Patient, family, regulator, and other stakeholder complaints
 Patient inputs regarding care
 Internal tracers (audits)
 Near-miss events
 Unit nurse managers’ daily reviews of orders
 Employee suggestions
Environment of care  Physical environment—particularly the building and/or space, as well as their
arrangements and special features
 Physical assets, such as medical devices that support patient care, and are part of
the safe, functional, and supportive environment within the healthcare facility
 Disaster- and recovery-planning processes
 Practices associated with maintaining calibration, cleanliness, physical safety,
and general upkeep of the location and equipment
 Managing the risks associated with the safety and security, fire, hazardous
materials and waste, medical equipment, infection control, and utility systems
Management of finances  Resource concerns, including those associated with finances, people, equipment,
and support resources and information systems
 Budget management and planning for resource utilization
 Human resources—compensation and benefit costs of staff members; expenses
associated with recruiting, hiring, retaining, and educating/training
 Equipment utilization
 Supplier qualification
 Inventory control

26 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 3: Examples of Associated Processes and Other Components (continued)
Quality System Element Examples of Associated Processes and Other Components
Management of  Accurate, reliable, and confidential patient information
information  Processes for ensuring records are matched to the correct patient, compiled from
different computer databases, sorted appropriately, and can be retrieved quickly
 Inventory levels of and ordering documentation for supplies
 Coding and billing records
 Metrics’ tracking results
 Audit findings
Communication,  Connected network to guide all 10 quality system elements
education, and training  Identifying and effectively communicating the key information and data that
stakeholders must have
 Two-way flow of communication
 Organizational direction, policies, and procedures
 Instructional design and delivery
 Evaluation of learning process effectiveness
 Professional credentialing
 Patients’ and caregivers’ proficiency
 Operational performance
Risk management  Preventing risks associated with patients and their care (as individuals or as a
group), the environment as well as healthcare and support processes
 Managing clinical, environmental, and administrative processes and minimizing
disruptions to established procedures
 Interdisciplinary functional reviews of patient records
 Emergency department processes
 Standards and regulations
 Audits and reviews
 Opportunity management
Management of change  Assessing that the organization is ready, willing, and able to function
appropriately in the new environment
 Managing change to reduce resistance
 Communicating change rationales
 Stakeholder engagement
 High-reliability organization
 Parallel processes
 Risk management
 Corrective and preventive action (CAPA)
Teamwork  Team member selection and participation
 Cross-functional and broader involvement (internal and external stakeholders,
when appropriate)
Compliance with  Compliance with requirements from international, national, state, and local
requirements agencies
 Mandatory compliance
 Voluntary compliance

27 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Table 4 illustrates a simple instrument that can be used for documenting the existing processes and components
and using that information to assess whether additional efforts are required. Once again, the organization’s leaders
participate in the actual self-assessment process, but the organizational QMS process owners usually provide the
background information regarding the existing processes and components; therefore, they are often included in the
self-assessment process.
When this self-assessment is completed, the leaders and other participants should develop a prioritized action
plan that identifies specific improvements and/or innovations that are required. Responsibility and timelines should
be established 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 4: Stage 2—Self-Assessment Instrument

Quality System Element Compiled Internal Summary of Self-Assessment Participants’

Processes and Consensus
Components
Leadership commitment,  Do the compiled processes and components fulfill
planning, and review the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Feedback loops  Do the compiled processes and components fulfill
the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Environment of care  Do the compiled processes and components fulfill
the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?

28 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 4: Stage 2—Self-Assessment Instrument (continued)
Quality System Element Compiled Internal Summary of Self-Assessment Participants’
Processes and Consensus
Components
Management of finances  Do the compiled processes and components fulfill
and support resources the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Management of  Do the compiled processes and components fulfill
information the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Communication,  Do the compiled processes and components fulfill
education, and training the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Risk management  Do the compiled processes and components fulfill
the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Management of change  Do the compiled processes and components fulfill
the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?

29 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 4: Stage 2—Self-Assessment Instrument (continued)
Quality System Element Compiled Internal Summary of Self-Assessment Participants’
Processes and Consensus
Components
Teamwork  Do the compiled processes and components fulfill
the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Compliance with  Do the compiled processes and components fulfill
requirements the complete intentions of this QMS element?
 What, if any, revisions need to be made to the
existing processes and components to achieve
optimum results?
 What redundancies need to be eliminated with the
existing processes and components?
 What gaps need to be addressed with the existing
processes and components?
Findings for the existing  Should improvement initiatives be launched to
efficacy of the overall address the issues identified in this self-assessment?
QMS processes and  How will the leaders monitor those improvement
components initiatives and determine if the action plan needs to
be revised?

Stage 3 Self-Assessment—QMS Pilot

This stage represents the dividing line between the use of the generic QMS model as the self-assessment
framework and the use of an organizationally specific QMS framework. In effect, piloting involves an evaluation of
the organization’s efforts to transform the generic QMS model into its own terminology, processes and components,
metrics, and performance targets. If the self-assessment of the pilot results are favorable, the customized QMS
framework can be expanded across the organization, following the same process that was used to create the QMS for
the pilot unit.
Figure 12 provides a process map for developing the customized framework for the pilot unit and conducting the
self-assessment. Table 5 offers a self-assessment instrument that simultaneously captures the customized QMS
framework at a high level and summarizes the self-assessment findings.
Participants in the self-assessment should include the leaders who are championing the application of the QMS
model, as well as other members of the organization who work more directly with the processes and components at
either the organizational or pilot unit’s levels. At the end of this self-assessment, the following decisions should be
made:
 Was the pilot successful?
 What, if any, revisions need to be made to the pilot unit’s framework to achieve optimum results?
 How should the leaders conduct and monitor those improvement efforts?
 Should expansion of the QMS pilot begin? If so, what is the action plan (with responsibility assignments and
deadlines) for the expansion across the entire organization?
 How will the leaders monitor the expansion-action plan and determine if the action plan needs revisions?

30 HEALTHCARE TECHNICAL COMMITTEE October 2018

Figure 12: Stage 3—Self-Assessment Process Map

31 HEALTHCARE TECHNICAL COMMITTEE October 2018

Figure 12: Stage 3—Self-Assessment Process Map (continued)

32 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 5: Stage 3—Self-Assessment Instrument
Quality System Element Pilot Unit’s Processes Summary of Self-Assessment Participants’
and Components Consensus
Leadership commitment,  Was the pilot successful?
planning, and review  What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Feedback loops  Was the pilot successful?
 What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Environment of care  Was the pilot successful?
 What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Management of finances  Was the pilot successful?
and support resources  What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Management of  Was the pilot successful?
information  What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Communication,  Was the pilot successful?
education, and training  What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Risk management  Was the pilot successful?
 What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Management of change  Was the pilot successful?
 What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Teamwork  Was the pilot successful?
 What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Compliance with  Was the pilot successful?
requirements  What, if any, revisions need to be made to the pilot
unit’s framework to achieve optimum results?
Findings for the overall  Should expansion of the QMS pilot begin? If so,
customized QMS model what is the action plan (with responsibility
as applied to the pilot unit assignments and deadlines) for the expansion across
the entire organization?
 How will the leaders monitor the expansion action
plan and determine if the action plan needs to be
revised?

33 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Ongoing Self-Assessments

Once piloting has been completed and a decision made to expand application of the QMS
across the organization, the self-assessment process changes. At this point, individual
organizational units conduct self-assessments to monitor progress and identify strengths and
opportunities for improvement. The organization also conducts a comprehensive self-
assessment periodically to ensure that the QMS expansion is progressing as intended and that
the combined results being obtained are satisfactory.
Figure 13 illustrates the process used to conduct and integrate the ongoing self-assessment
of individual units, and Figure 14 displays the process map for the ongoing evaluation of the
entire organization’s performance against the customized QMS. Table 6 provides the self-
assessment instrument that can be used by individual units and Table 7 the organization-wide
self-assessment instrument. Note that individual units evaluate both processes/components
and results, but the organization-wide assessment focuses exclusively on results, which are
presumed to reflect successful operations at the individual unit level. In other words, it is
likely that poor organization-wide results will be associated with poor performance in one or
more individual units. These two self-assessment instruments can be applied during Stages 4,
5, and 6, and their results reflect a greater depth of understanding and integration of the
customized QMS model as the organization’s efforts mature.
Participants in the self-assessment processes will vary depending on whether individual
units or the entire organization is being evaluated. The organization’s leaders, however, need
to remain deeply engaged in the application of the QMS and see that its application
maintains a strategic focus if sustainable success is to be achieved. In most organizations, the
individual unit’s process owners will work with the organization process owners to conduct
the individual unit’s self-assessment. Those results are communicated to the organization’s
leaders who will take them into account when conducting the higher-level self-assessment. In
some organizations, one representative of each individual unit may be invited to participate
in the organization-wide self-assessment along with the leaders and the organization’s
process owners.
Note that the performance results assessments for both individual units and the entire
organization require an indication of the type of results being presented. The four results-
reporting methods are linked with those included in the Baldrige scoring framework, as
discussed previously.18 As the organization becomes more mature in its efforts to deploy a
customized QMS model, the type of performance results it has available will move from
simple summary values to more complex estimates of relationships among the system
elements and overall outcomes. It is only when this level of understanding regarding the
organization’s performance is achieved that continual improvement and innovation can focus
more explicitly on issues that will impact long-term sustainability.

34 HEALTHCARE TECHNICAL COMMITTEE October 2018

Figure 13: Stages 4 to 6—Individual Self-Assessment Process Map

35 HEALTHCARE TECHNICAL COMMITTEE October 2018

Figure 13: Stages 4 to 6—Individual Self-Assessment Process Map (continued)

Figure 14: Stages 4 to 6—Organization-Wide Self-Assessment Process Map

36 HEALTHCARE TECHNICAL COMMITTEE October 2018

Figure 14: Stages 4 to 6—Organization-Wide Self-Assessment Process Map (continued)

Table 6: Stages 4 to 6—Individual Unit Self-Assessment Instrument

Evaluation of Processes and Components
Individual Unit:
Quality System Element Individual Unit’s Summary of Self-Assessment Participants’
Processes and Consensus Regarding Processes and Components
Components
Leadership commitment,  Are the processes and components fulfilling the
planning, and review intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Feedback loops  Are the processes and components fulfilling the
intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Environment of care  Are the processes and components fulfilling the
intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Management of finances  Are the processes and components fulfilling the
and support resources intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?

37 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 6: Stages 4 to 6—Individual Unit Self-Assessment Instrument (continued)
Evaluation of Processes and Components
Individual Unit:
Quality System Element Individual Unit’s Summary of Self-Assessment Participants’
Processes and Consensus Regarding Processes and Components
Components
Management of  Are the processes and components fulfilling the
information intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Communication,  Are the processes and components fulfilling the
education, and training intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Risk management  Are the processes and components fulfilling the
intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Management of change  Are the processes and components fulfilling the
intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Teamwork  Are the processes and components fulfilling the
intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Compliance with  Are the processes and components fulfilling the
requirements intentions of this quality system element?
 What, if any, revisions need to be made to this
individual unit’s framework to achieve optimum
results?
Findings for the overall  Should individual unit improvement initiatives be
customized QMS model launched to address performance issues identified in
as applied to the pilot unit this self-assessment?
 How will the leaders monitor those individual unit
improvement initiatives and determine if the action
plan needs to be revised?

38 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 7: Stages 4 to 6—Organization-Wide Self-Assessment Instrument
Evaluation of Organization-Wide Results
Quality System Organization’s Description of Data Provided Summary of Self-Assessment
Element Metrics and to Document Performance Participants’ Consensus
Performance (Indicate all that apply) Regarding Performance
Targets, Including Results
Recent Results
(Indicate results
timeframe)
Leadership  Levels. What is your  Are the performance results
commitment, current performance? meeting expectations?
planning, and  Trends. Are the results  Are the performance results
review improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?
Feedback loops  Levels. What is your  Are the performance results
current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?

39 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 7: Stages 4 to 6—Organization-Wide Self-Assessment Instrument (continued)
Evaluation of Organization-Wide Results
Quality System Organization’s Description of Data Provided Summary of Self-Assessment
Element Metrics and to Document Performance Participants’ Consensus
Performance (Indicate all that apply) Regarding Performance
Targets, Including Results
Recent Results
(Indicate results
timeframe)
Environment of care  Levels. What is your  Are the performance results
current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?
Management of  Levels. What is your  Are the performance results
finances and support current performance? meeting expectations?
resources  Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?

40 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 7: Stages 4 to 6—Organization-Wide Self-Assessment Instrument (continued)
Evaluation of Organization-Wide Results
Quality System Organization’s Description of Data Provided Summary of Self-Assessment
Element Metrics and to Document Performance Participants’ Consensus
Performance (Indicate all that apply) Regarding Performance
Targets, Including Results
Recent Results
(Indicate results
timeframe)
Management of  Levels. What is your  Are the performance results
information current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?
Communication,  Levels. What is your  Are the performance results
education, and current performance? meeting expectations?
training  Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?

41 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 7: Stages 4 to 6—Organization-Wide Self-Assessment Instrument (continued)
Evaluation of Organization-Wide Results
Quality System Organization’s Description of Data Provided Summary of Self-Assessment
Element Metrics and to Document Performance Participants’ Consensus
Performance (Indicate all that apply) Regarding Performance
Targets, Including Results
Recent Results
(Indicate results
timeframe)
Risk management  Levels. What is your  Are the performance results
current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?
Management of  Levels. What is your  Are the performance results
change current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?

42 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 7: Stages 4 to 6—Organization-Wide Self-Assessment Instrument (continued)
Evaluation of Organization-Wide Results
Quality System Organization’s Description of Data Provided Summary of Self-Assessment
Element Metrics and to Document Performance Participants’ Consensus
Performance (Indicate all that apply) Regarding Performance
Targets, Including Results
Recent Results
(Indicate results
timeframe)
Teamwork  Levels. What is your  Are the performance results
current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?
Compliance with  Levels. What is your  Are the performance results
requirements current performance? meeting expectations?
 Trends. Are the results  Are the performance results
improving, staying the sufficiently driving required
same, or getting worse? patient and business
 Comparisons. How does outcomes?
your performance compare  What, if any, revisions need
with that of other to be made to this individual
organizations or with unit’s framework to achieve
benchmarks or industry optimum results?
leaders?
 Integration. Are you
tracking results that are
important to your
organization and that
consider the expectations
and needs of your key
stakeholders? Are you
using the results in decision
making?

43 HEALTHCARE TECHNICAL COMMITTEE October 2018

Table 7: Stages 4 to 6—Organization-Wide Self-Assessment Instrument (continued)
Evaluation of Organization-Wide Results
Quality System Organization’s Description of Data Provided Summary of Self-Assessment
Element Metrics and to Document Performance Participants’ Consensus
Performance (Indicate all that apply) Regarding Performance
Targets, Including Results
Recent Results
(Indicate results
timeframe)
Findings for the  Should organization-wide
individual unit’s improvement initiatives be
performance launched to address
performance issues
identified in this self-
assessment?
 How will the leaders
monitor those organization-
wide improvement
initiatives and determine if
the action plan needs to be
revised?

44 HEALTHCARE TECHNICAL COMMITTEE October 2018

 Summary

The application of the generic QMS model is useful for healthcare organizations of all
types. It establishes a fundamental framework for ensuring that patient and business
outcomes are attained consistently on a long-term basis.
The use of self-assessments provides an affordable means for organizations to evaluate
the state of their quality efforts and determine required improvements and innovations. The
self-assessment process, however, needs to be modified as the QMS implementation
progresses. By adjusting the self-assessment instruments used to fit the organization’s QMS
maturity, the findings will be more appropriate and actionable, supporting the organization’s
ability to meet or exceed its objectives/goals even as changes are made to the surrounding
environment. In other words, the self-assessment processes described in this monograph are
fairly robust, and they will work for most healthcare organizations regardless of the
conditions that are affecting their operations.

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46 HEALTHCARE TECHNICAL COMMITTEE October 2018