Improving Healthcare Monograph Series:

Healthcare Technical
A Hospital-Based Committee, a joint development
of the Healthcare and Quality
Healthcare Quality Management Management Divisions of ASQ
System Model
April 2016
 Improving Healthcare
Monograph Series
A Hospital-Based Healthcare Quality
Management System Model
Healthcare Technical Committee, a joint development of the
Healthcare and Quality Management Divisions of ASQ
Authors
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 motscht@labcorp.com.

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 cbales@aabb.org.

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 lptimmerman@gmail.com.

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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
Grace683@outlook.com.

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 pbstory@capacitystrategies.com.

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 gmgurican@comcast.net.

Reviewers
Susan E. Peiffer, MS, CSSBB, SSGB
Vicente “Alberto” Araujo, M.B.A.; P.M.P.
Cheri-Graham Clark, RN, MSN, CPHQ, CPHRM, CSSBB
Cath Fisher, CQA, ISO Lead Auditor

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 Table of Contents

4 Executive Summary
6 Introduction
Purpose of the Model … 6
Defining Quality … 6

8 The Model
The Inner Circle—The Patient Experience: Exceptional Quality, Safety, and Patient
Outcomes … 9
Quality and Safety … 9
The Middle Circle: The Four Key Components of Care Delivery … 9
The Outer Circle: The 10 Quality System Elements … 10
Leadership Commitment, Planning, and Review … 11
Commitment to Quality … 11
Planning … 11
Quality Policy … 12
Review of Quality Plans … 12
Feedback Loops … 12
Environment of Care … 13
Management of Finances and Support Resources … 13
Financial Management … 14
Support of Resources … 14
Management of Information … 14
Communication, Education, and Training … 15
Communication … 15
Education and Training … 15
Risk Management … 16
Management of Change … 17
Special Considerations for Hospitals … 17
Teamwork … 18
Compliance With Requirements … 18
Continual Improvement and Innovation … 19
Continual Improvement … 19
Innovation … 19

20 Summary

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 Executive Summary

This Hospital-Based Healthcare Quality Management System (QMS) Model is directed to

the CEO and CMO who are seeking to improve patient outcomes, safety, and satisfaction, as
well as cost savings, risk management, and regulatory compliance. A QMS is defined as a
formalized system that documents the structure, responsibility, and procedures required to
achieve effective quality management that is focused on the quality policy and quality
objectives in order to meet customer requirements. In healthcare, a QMS specifically
describes the process for improving all aspects of patient outcomes and operating
performance.
These imperatives are being driven within the United States in part by the 2016 Centers
for Medicare and Medicaid Services (CMS) Quality Strategy, which ties reimbursement to
quality and value metrics as described below:
● Thirty percent of Medicare payments will be tied to quality or value through alternative
payment models by the end of 2016, and 50 percent by the end of 2018.
● Eighty-five percent of all Medicare FFS payments will be tied to quality or value by the
end of 2016, and 90 percent by the end of 2018.
The CMS Quality Strategy envisions health and care provisions that are patient-centered,
provide incentives for the right results, are sustainable, emphasize coordinated care and
shared decision making, and rely on transparency of quality and cost information.1 In order
for providers to achieve these results, however, there must be an overarching program
capable of enabling and maintaining the necessary operational and structural changes. In
most industries, a QMS provides this structure by creating a framework for defining and
delivering quality results, managing risk, and continually improving performance and
processes.
To help achieve the CMS Quality Strategy requirement and enable healthcare providers to
meet the future demands of care delivery, the Healthcare Technical Committee (a joint effort
of the ASQ Healthcare and Quality Management Divisions) has developed the Hospital-
Based Healthcare QMS Model. Other countries’ healthcare systems undoubtedly have
equivalent regulations and measures that drive priorities and decision making. International
readers are encouraged to consider this monograph in terms of local regulations and
measures.
This model offers a systemic structure focused on the patient and the patient’s experience,
aiming to generate exceptional quality, safety, and patient outcomes. The framework is
supported by four key components of care delivery and 10 quality system elements. When
fully integrated, this structure enables hospitals to meet both the quality and value-based
goals imposed by the CMS Quality Strategy. Figure 1 is a high-level conceptual
representation of the model, and Figure 2 provides a more detailed view of its parts.
By enacting this structure in hospitals of all sizes, managers will be able to create the
operational environments required to support and comply with CMS’ ever-expanding
demands. Hospitals with a properly functioning QMS will not need to ramp up for
inspections because the requirements will be so integrated into the organization’s processes
that compliance will be the way the staff works at all times.

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 Figure 1: A High-Level Conceptual Representation of the
Healthcare QMS

Figure 2: The ASQ QMD/HCD Hospital-Based Healthcare QMS Model

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 Introduction

Purpose of the Model

A quality management system (QMS), regardless of its industry or focus, should achieve
the following major objectives:
● ensuring reliable processes,
● decreasing variation and defects, (waste),
● focusing on achieving better results, and
● using evidence to ensure that a service is satisfactory.
The ASQ Healthcare Technical Committee developed the Hospital-Based Healthcare
QMS Model to provide the leaders of healthcare organizations with a framework for
evaluating current business conditions against a set of commonly accepted quality
management fundamentals, which have been adapted specifically for the healthcare business
environment. Its structure is based on the seven quality management principles associated
with the ISO 9000 series of standards,2 Deming’s Plan-Do-Check-Act cycle,3 and other basic
quality-improvement tenets.
This model can be utilized for quickly diagnosing business issues that impact a hospital’s
effectiveness and efficiency in delivering exceptional quality, safety, and patient outcomes.
By recognizing the interactions of the key business processes associated with this model,
hospital leaders can reduce negative impacts on the hospital’s 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 also can be met.
A broad range of disciplines support healthcare’s ultimate customer—the patient—the
reason for the healthcare organization’s existence. These disciplines transcend the walls of
the hospital, 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 the hospital’s healthcare services. 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.

Defining Quality
The goal of healthcare is to provide medical resources of high worth to all who need
them. The term “healthcare quality” refers to a level of value of any healthcare resource as
determined by some measurement. Researchers use many different measures to determine
healthcare quality, including, but certainly not limited to, counts of a therapy’s reduction or
lessening of diseases identified by medical diagnosis, a decrease in the number of risk factors
which people have following preventive care, or a survey of health indicators in a population
that is accessing a certain kind of care.4
Table 1 provides a summary of some well-known definitions for quality from a variety of
sources and applications. There are two common themes in these definitions—a defined

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requirement that is meeting or exceeding expectations and conformance to those requirements. In the healthcare
sector, the safety of the customer and value of provided services and products are paramount; there is little or no
margin for error. As such, quality in healthcare could be defined with a third theme of achieving the best possible
outcomes in the safest manner.
To achieve quality in healthcare, people at all levels of healthcare organizations must perform and support the
activities needed for care and treatment of patients. In order to enable the maximum use of healthcare professionals’
skills and abilities for the benefit of the patient and the healthcare organization, managing activities and resources as
part of interrelated processes is essential. When these interrelated processes are managed as a holistic,
interdependent system, the desired quality and, thus, the desired clinical results are achieved more effectively and
efficiently.

Table 1: Definitions of Quality

Quality describes a subjective term for which each person or sector has his/her/its own definition. In technical
usage, the following may apply:
● The characteristics of a product or service that bear on its ability to satisfy stated or implied needs.
● A product or service free of deficiencies.5
● Free from defects, deficiencies, and significant variation.6
● Conformance to requirements.7
● A predictable degree of uniformity and dependability with a quality standard suited to the customer.8
● Native excellence or superiority.9
● What the customer gets out and is willing to pay for.10
● Degree to which a set of inherent characteristics fulfill requirements.11
● Fitness for use.12
● Products and services that meet or exceed customers’ expectations.13
● Value to some person.14
Ultimately, quality is in the eye of the beholder, so exceptional quality must be defined through the voice of
the customer and represent patients’ perceptions. At the same time, however, the healthcare industry also relies on
more tangible definitions of exceptional quality. For instance, the National Committee for Quality Assurance
(NCQA) recognizes healthcare organizations as having exceptional quality when they receive the highest
attainable ranking, which demonstrates they are not only meeting all the fundamental requirements but also are
demonstrating strong performance or significant improvement in performance measures across the triple aim of
better patient experience, better health, and lower per capita cost.15 The NCQA confers this prestigious national
distinction for healthcare delivery systems that encourage improved quality and greater involvement of patients in
their own care.16

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 The Model

Many industries have developed a QMS model, and the International Organization for
Standardization (ISO) has a generic model that represents all industries.2 These models have
many features in common—even if represented in a slightly different manner or having some
unique aspects. Figure 1 presents the high-level model for hospital quality and safety that
serves as the basis for this monograph and that could be expanded to support any part of the
healthcare sector, and Figure 2 offers the more detailed version.
The Hospital-Based Healthcare QMS Model can be used most effectively once its
overarching structure is understood completely. Its three concentric circles and overlay
illustrate the framework for integrating the hospital’s 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 inner circle. The core of the model delineates the results that are expected—
exceptional quality, safety, and patient outcomes. The use of the term “exceptional” in
this model stems from work of the Institute for Healthcare Improvement, which noted,
“Our aim was to identify 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.”17
● 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.
● 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 described in this circle. These 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. If any of these elements is not well-defined and/or well-implemented,
there may be a negative impact on the process’ results, patient’s experience, and/or the
hospital’s business results. Such breakdowns can be very costly when they cause harm to
a patient, damage the hospital’s reputation, or generate financial loss.
● 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 hospital’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.

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The Inner Circle—The Patient Experience: Exceptional Quality, Safety, and Patient
Outcomes
The inner circle of the Hospital-based Healthcare QMS Model depicts the relationship between two factors. First,
the patient experience and the quality of service delivered throughout the continuum of care is considered. Then, the
system attributes most important to the patient—specifically exceptional quality, safety, and patient outcomes—are
taken into account. These are the basis of patients entrusting the hospital’s system to provide their care. The core of
the model, therefore, involves those critical factors that are most important to the health and well-being of patients.
By focusing on exceptional quality, safety, and patient outcomes, the model appropriately aligns processes,
resources, and management attention on those attributes of system performance that will yield the required results.
Patient outcomes include a wide variety of measurements that focus on the patient’s health and well-being. For
instance, the standard metrics used by the medical community and researchers include measures related to the
patient’s survival and physiological condition—in other words, metrics associated with the efficacy of the patient’s
treatment. Quality of life is another common metric included in this category, and it involves the patient and
associated support groups’ perceptions of the care experience and how well their expectations and concerns have
been addressed.

Quality and Safety

Of course in healthcare, patient safety is a central aim of quality; thus, quality and safety are intertwined and
inseparable. Patient safety cannot be guaranteed confidently without quality.
The World Health Organization defines patient safety as, “the prevention of errors and adverse effects to patients
that are associated with healthcare.”18 Similarly, the American Hospital Association (AHA) establishes the
following expectations for hospital stays:
● high quality hospital care,
● a clean and safe environment,
● involvement in your care,
● protection of your privacy,
● help when leaving the hospital, and
● help with your billing claims.19
Patient safety is tantamount to good care and, therefore, clinical results. It is the most likely reason for the
hospital’s healthcare system to focus on quality.

The Middle Circle: The Four Key Components of Care Delivery

Each of the four key components of care delivery is described in this section. The middle circle flows clockwise,
describing the processes involved in the patient’s experience.
Note that all four components revolve around the model’s center—exceptional quality, safety, and patient
outcomes—because they always should be aligned with achieving the patient-centered goals. Furthermore, the four
components also have concurrent interactions with the 10 quality system elements in the outer circle, which are
depicted by the double arrows connecting the middle and outer circles. The interconnectedness of this approach
fosters easier and faster staff and management understanding and buy-in because each component clearly influences
and is influenced by the other factors.
Table 2 summarizes the processes and the departments that are involved with performing those activities for each
of the four key components of care delivery, which appear in the “Patient Experience” column. Here are some of the
main features of these components.
● Patient identification and assessment. The patient is identified properly, and assessment of the patient’s
condition is conducted by the care provider.
● Development of treatment plan. A specific plan is developed for the care and treatment of the patient, which
may include some standardized activities (e.g., protocols).

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Table 2: The Patient Experience as a Process Approach
Patient Experience Processes Department Delivering Services
1. Patient ● Patient intake ● Emergency
identification and
● Triage ● Admissions (Outpatient/Inpatient)
assessment
● Registration ● Medical staff
● Health assessment, leading to ● Nursing services
admission or discharge ● Ancillary services (e.g. blood, radiology,
anesthesia, surgery prep)
2. Development of ● Care and treatment planning, ● Medical staff
treatment plan provided either for inpatients or ● Nursing
outpatients
● Ancillary therapeutic services
3. Delivery of care ● Delivery and coordination of ● Medical staff
care (treatment and ancillary ● Nursing services
services such as diagnostic,
● Pharmacy services
therapeutic, and custodial)
● Radiologic services
● Laboratory services
● Dietetic services
● Surgical services
● Anesthesia services
● Behavioral health services
● Nuclear medicine
● Rehabilitation services
● Respiratory services
● Oncology services
● Skilled nursing and treatment services
● Therapies (physical, occupational, speech)
4. Transition of care ● Assessment of treatment plan ● Medical staff
effectiveness ● Nursing services
● Analysis of patient outcomes ● Consultations with any ancillary services
● Patient-status determination, ● Discharge planning
either continue treatment,
change treatment, or discharge
● Patient feedback
● Delivery of care. The care and treatment plan is implemented, including any coordination among the various
healthcare specialties and the delivery of any required ancillary services.
● Transition of care. Following delivery of the care and treatment plan, the patient’s care may be transitioned to
another care provider or specialty, if necessary. This cycle repeats until the patient’s care and treatment plan is
completed, and the patient is discharged or transferred.

The Outer Circle: The 10 Quality System Elements

The outer circle of the QMS model shows the 10 quality system elements that provide for the operational
environment, attributes, and activities that make up the patient experience, enable or constrain change, and lead to

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intended clinical results. Poor performance of any of these elements may lead to the failure of the entire hospital
healthcare system and its ability to meet expectations. These elements are based on ISO 9001:2015 20 and the
Baldrige Criteria for Performance Excellence,21 and they have been adjusted to reflect the hospital setting. A more
detailed discussion of each element is provided in the following sections.
The related activities and services associated with each of the 10 quality system 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.

Leadership Commitment, Planning, and Review

This first quality system element includes strategic planning for governance, overall structure of the organization,
and style of leadership required to best match the culture of the community in which the hospital serves.

Commitment to Quality
Commitment can be defined as an agreement or pledge to do something in the future.22 Leaders exhibit
commitment to quality by focusing on ensuring that effective processes are in place, directly engaging medical and
administrative staff, and empowering individuals by providing the appropriate responsibility and authority needed to
carry out their assigned duties. Furthermore, this means that hospital leaders at all levels are aware of and support
quality efforts across the organization, and it requires that the leaders have a personal understanding of the intent of
the hospital operational model and its results. Characteristics of a leader who is committed to quality include the
following:
● Displays a passionate interest in performance results and obtaining the best possible patient outcomes. Expects
all hospital activities to utilize the QMS model and comply with regulatory and accreditation requirements.
● Provides the necessary resources to carry out the daily activities for delivery of care.
● Remains consistently engaged and encourages engagement of other staff members.
● Networks with clinical and administrative personnel through effective communication.
Additionally, leadership commitment to quality includes establishing a non-punitive culture in which staff can
express concerns, including those related to errors and failures in compliance. “Just Culture Models,” which are used
to address human error prevention in healthcare, are one approach that addresses this aspect of leadership.23
Don Berwick, A. Blanton Godfrey, and Jane Roessner share observations about the value of leadership support to
healthcare quality teams: “The value of the visible participation of the executives, whether as members of teams or
of the steering committees, was stressed repeatedly in the project reports. Butterworth Hospital, for example,
reported the following, ‘One of the main reasons for the project’s successes was top management’s initial buy-in.
The vice president responsible for the respiratory care department attended every meeting of the quality
improvement task force. This participation eased implementation of the team’s solutions. Some decisions which
historically had required many reviews were acted on directly.”24

Planning
Hospital leaders are responsible for the strategic planning function, including that associated with quality in both
clinical and administrative processes. Planning starts with developing (or refreshing/reaffirming) the mission, vision,
quality policy, goals, and objectives. Goals and objectives are set for strategic, tactical, and operational levels of the
hospital. These goals and objectives must be consistent with the quality policy, mission, and vision of the
organization.
Quality planning includes goal setting for quality metrics and clinical results and is associated closely with risk
management, which is covered later in this monograph. Quality assurance involves monitoring process and
outcome-related metrics, data analytics, reporting, process/quality improvement, and continuing attention to
improving performance. It is a short-term implementation process that assures the outcomes/results identified in the
quality plan are achieved.
It is important to note that planning criteria may differ substantially. For instance, rural health service approaches
are likely to diverge from those designed for inner-city populations. Although general standards and requirements

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established for national hospital health programs must exhibit equity among populations, their delivery and
communication vehicles should be tailored to the geographic populations and markets served.
Excellence does not happen by accident; it requires a well-thought-out, well-communicated plan that is embraced
by everyone. That plan must be based on a shared vision of how the organization will function to provide what the
patient perceives to be exceptional quality and how the quality of work will be measured and improved. Hospital
leaders have the final responsibility for the plan, along with its supporting quality vision, policy, and ongoing
reviews.

Quality Policy
Quality planning includes the development of a comprehensive quality policy that reflects the leadership style
and culture of the hospital and the community it serves. Considerations must be made for disaster planning, periodic
risk assessments, and frequent review of all the healthcare system’s targeted product and service outcomes/results.
A defined quality policy sets the stage for effective reviews based on the mission and vision of the organization.
Reviews are appropriate for both the physical infrastructure and assets of the healthcare facility, including the
clinical, administrative, and educational functions performed within the organization and in association with the
partnerships it has established to support the overall health of the community it serves.

Review of Quality Plans

The leadership review process occurs on a scheduled basis, and annual reviews of the organization’s goals and
objectives typically serve as the first phase of the strategic planning process. Monthly reviews of core process
measures provide data-based opportunities for leaders to assess the outcomes/ results associated with the 10 quality
system elements. The review findings should be shared with all affected stakeholders at the earliest possible time
and be used to indicate required adjustments.

Feedback Loops
The intent of establishing consistent and reliable feedback loops is to facilitate a factual approach to decision
making. Feedback loops verify whether processes are functioning as expected, and they provide valuable
information, which may suggest that process improvement actions are necessary. The loops relate process output
information to the inputs and operational factors so that the need for corrective action and/or transformation
becomes evident.
Feedback loops can be highly interconnected as they work together to ensure exceptional quality, safety, and
patient outcomes, as well as better overall hospital performance results. Each of the 10 quality system elements may
have leading and lagging indicators that provide feedback to the overall system. Furthermore, each of those elements
may consist of multiple underlying processes, which can have their own feedback loops for measuring effectiveness
against established criteria. The leading indicators anticipate the probability of reaching the desired result, and the
lagging indicators measure the performance of the actual activity after it is completed. Both are important for the
ongoing evaluation of the overall system.
Here are some examples of how feedback loops can be used. A cross-section of approaches that are used by
many organizations, as well as healthcare-specific systems and commonly collected data, are shown in Table 3.
● Information may be obtained from the patient and used as the basis for care delivery, such as when the patient
self-assesses his/her pain level, and that rating is used to establish a treatment plan.
● Aggregated data collected for management review that represents the bigger picture and is used to identify
opportunities for improvement, support continual improvement projects, and assess the effectiveness of
operational changes.
● Non-patient qualitative and quantitative data supporting allied health or administrative functions also may be
incorporated into feedback loops.

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Table 3: Feedback Loop Examples
Examples of Plan-Do-Check-Act improvement cycles
processes used to
generate feedback in Lean and/or Six Sigma projects
organizations of all
Results of quality assurance or management audits
types
Examples of Joint Commission tracers (audits) and reviews
common healthcare Utilization and asset reviews to ensure effective use of resources
feedback systems 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
Examples of Patient/customer exit interviews
feedback data Employee perceptions
sources for Performance outcomes/results
healthcare Process assessments
organizations 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
Promoting a safe, functional, and supportive environment within the healthcare facility is essential for ensuring
that quality and safety are attained and preserved to protect patients, visitors, and staff. This element addresses the
hospital’s physical environment—particularly the building and/or space, as well as their arrangements and special
features. Additionally, physical assets, such as medical devices that support patient care, are part of the safe,
functional, and supportive environment within the healthcare facility. Disaster and recovery planning processes are
included in this element, along with 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 is an integral aspect of the environment of care element. These
risks are quite different than those related to the provision of care, treatment, and services—regardless of the
hospital’s size and location. When staff members understand the factors that ensure a safe environment, they are
more likely to follow processes for identifying, reporting, and taking action on environmental risks. Some examples
of projects that can impact this quality system element include patient fall studies, equipment sterilization, storage
room organization, and use of traction mats in stairwells.

Management of Finances and Support Resources

For the hospital’s healthcare system to work effectively and efficiently, both its financial and support resources
must be managed appropriately. This quality system element is one of the most critical and complex activities within
the organization. It involves a broad range of resource concerns, including those associated with finances, people,
equipment, and information systems. These all can have direct impacts on the ability of the medical and nursing
staff, as well as other personnel, to fulfill their duties in a way that ensures exceptional quality, safety, and patient
outcomes.

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Financial Management
Managing resources and assets drives business results. One of the most critical responsibilities at all levels of
hospital leadership is financial management. Budget management and planning for resource utilization need to be
constant focal points for unit-, department-, division-, and corporatelevel attention. There are many worthwhile areas
that compete for the limited financial resources that are available to hospitals—salaries, new equipment purchases,
maintenance of existing equipment, technology upgrades, physical plant operational costs, expansion needs, etc., are
just a few. As federal and clinical requirements demand more of hospital organizations, the financial resources
become scarcer and planning how to obtain the required funds needed to meet future needs becomes an even more
challenging, but critical, activity.
One particularly important aspect of financial management links to human resources. This encompasses not only
the compensation and benefit costs of staff members but also expenses associated with recruiting, hiring, retaining,
and educating/training. Work must be performed at the level necessary to meet ever-changing government
regulations, as well as population health and demographic changes within the community. This situation is
becoming increasingly complicated as care-provision approaches shift, and more non-clinical resources become part
of the process.

Support of Resources
Of course, resource management concerns extend far beyond finances and people. That is why this hospital-
based QMS model specifically considers resource management separately. Here are a few examples.
● Equipment utilization. Staff members should be trained to use equipment wisely. Emphasis should be placed on
extending the life of these assets and maximizing the investment made in their acquisition. Equipment should be
used solely to support patient care and safely maintain the physical plant.
● Supplier qualification. High-performing materials that ensure exceptional quality, safety, and patient outcomes
are achieved should be purchased from suppliers whose processes and ability to meet specifications have been
validated.
● Inventory control. It is essential for hospitals to have documented processes for tracking and maintaining
appropriate inventory levels that are based on patient load and care profiles. Effective communication among
operating units and purchasing must be established to reduce any disruption in the flow of supplies.

Management of Information
Accurate patient information is paramount in the care of patients and billing for services where error-free
documentation is required. Both federal and healthcare-industry programs call for reliable data, such as coordinated
care plans, prescribed medications, laboratory test results, surgical summaries, electronic health records, and
numerous other types of information. The process associated with this quality system element must assure that
records are matched to the correct patient, compiled from different computer databases, sorted appropriately, and
can be retrieved quickly. Additionally, other information that has an indirect impact on patients and their care also
must be managed properly. Examples of this type of information include inventory levels of and ordering
documentation for supplies, coding and billing records, metrics’ tracking results, and audit findings.
Hospitals often are challenged by the need to commit significant IT resources as both the sources of and demands
for data and information continue to grow steadily. Documentation requirements are expanding as new federal and
other regulations increase. Internet and social media, as well as patient input submitted via portals and secure email,
are combined with the hospital’s internal electronic communications to generate other critical documentation.
Ensuring that information is reliable and confidential are key concerns of modern hospitals, and they cannot be
over emphasized as critical components of successful communication. For instance, confidentiality of patient and
other medical records must be compliant with HIPAA (The Health Insurance Portability and Accountability Act of
1996).25 Information also must be readily available in a user-friendly format, so data supporting the daily care of
patients must be managed continually and aggregated to support organizational goals and operational improvements.

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Communication, Education, and Training
To ensure exceptional quality, safety, and patient outcomes, hospitals must foster supportive work climates and
high-performance work teams. Healthcare organizations must assess the clinical and other competencies that staff
members need to possess so that they can meet patient and administrative requirements. This quality system element
provides the foundation for staff members’ success.

Communication
Achievement of common goals occurs when communication is used to build a connecting network to guide all 10
quality system elements. Human interaction provides the necessary foundation for well-defined processes, including
those associated with managing the organization, obtaining and responding to feedback, and building high-
performing teams. Identifying and effectively communicating the key information and data that stakeholders must
have ensures accomplishment of the hospital’s key performance indicators.
There are many diverse situations and participants involved in a hospital’s quest to communicate required
information and data successfully. For example, communication may occur among patients and their caregivers, the
members of the caregiving team, different hospital departments, etc. A two-way flow of communication is necessary
to keep information passing up, down, and across the organization. Communications in a hospital setting primarily
relate to information that needs to be exchanged to provide successful patient care or that helps staff members
understand the organization’s direction and comply with its policies and procedures.
● Patient care. The collaboration of multiple caregivers from different specialties who are seeking to attain the
optimum care for a particular patient is one illustration of this type of communication. In this case, there is an
increased responsibility to consider the broader information and data flow to assure positive patient outcomes.
Similarly, the “medical home” concept intuitively includes the family physician as well as all specialists who are
consulted as part of the patient’s care plan. Clear and concise communications are essential for these potentially
complex communication circumstances that rely on the interdependency of the involved disciplines before,
during, and after the patient’s hospital stay.
A lack of communication between clinical units can affect a patient’s outcome negatively by increasing risk,
delaying care, and/or creating unnecessary work. Furthermore, the effectiveness and presentation of patient
communications can have a profound impact on HCAHPS (Hospital Consumer Assessment of Healthcare Providers
and Systems) scores for both physicians and nurses, which can undermine the hospital’s overall performance ratings,
reputation, and reimbursements.
● Organizational direction, policies, and procedures. Key messages need to be communicated by hospital leaders
to all staff members, and those leaders need to hear the input of all stakeholders of the organization. This
communication flow fosters a deeper understanding of the work environment and spotlights issues that require
action and change.

Education and Training

The purposes of education and training are distinct but complementary. Whereas education generally is
conceptual and builds knowledge, training is more task oriented and develops skills. Education and training can be
conducted in one-on-one or group settings. Thoughtful instructional design and delivery that present the information
to students in a well-organized manner is most beneficial. Effectiveness of the learning process can be determined
by having students explain underlying concepts and demonstrate that they can perform tasks and apply tools at the
level required in their job descriptions.
Here are some hospital-related examples of the application of education and training.
● Professional credentialing. Specific job responsibilities and regulations may be connected to particular
educational requirements, such as professional instruction for physicians, nurses, technicians, and other
caregivers that are necessary for licensure. Some credentials need to be verified prior to employment, and others
involve continuing education that helps staff members to keep current with the latest developments in their fields.
● Patients’ and caregivers’ proficiency. The need for education and training also extends to patients, their
families, and other supporting community-care providers. This learning helps promote better understanding and
implementation of home care and has a documented positive effect on patient outcomes.26 Written guidelines

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 now are provided routinely to discharged patients, rather than the traditional verbal recommendations given by
the physician at the bedside, and well-educated caregivers can use them to confirm that required actions are being
followed. Training on how to give an insulin shot, change a dressing, or other similar tasks also fall into this
category.
● Operational performance. Staff members are expected to understand and carry out the appropriate policies,
processes, and procedures. Developing the required competencies may involve not only classroom-led and/or
computer-/Internet-based training but also just-in-time coaching, job shadowing, apprenticeships, and a variety of
other approaches.
Education and training for clinical staff can impact staff member retention and the hospital’s reputation in the
community. When hospital leaders are willing to invest in education and training both the individuals and the
organization gain increased value. This is the reason that high-performing hospitals go beyond the minimum
credentialing requirements, providing the education and training to ensure that staff members maintain the highest
standards of patient care and safety.

Risk Management
This quality system element is closely associated with management review and planning activities. In the hospital
setting, it primarily involves preventing risks associated with patients and their care—as individuals or as a group.
All processes, as well as the organizational structure, function, and resources (e.g., the facility and equipment,
business continuity, etc.), may introduce risk if they are not designed and executed properly. In particular, the risk of
sentinel events is a major hospital concern.
Managing clinical and administrative processes and minimizing disruptions to established procedures requires an
ongoing effort. Interruption and/or non-conformance to expected protocols waste money and resources, increasing
the risk of not meeting the intended patient and operational outcomes. Furthermore, the potential for injury to a
patient must be deliberated carefully when changes to procedures, facilities, use of medical equipment, or personnel
transition are considered.
The following examples not only demonstrate hospital activities where risk management is a major
consideration, but they also show how this area links with some of the other 10 quality system elements:
● Interdisciplinary functional reviews of patient records. Trained staff members are responsible for reducing risks
to patients that might be caused by miscommunication among specialists, interaction of medications, or other
exposures made more feasible by fast-paced hospital schedules. Observations made during functional reviews
flow into the feedback loop to suggest process or procedure improvements in future treatments.
● Emergency department processes. Minimizing the risk of liability during triage and in deciding which patients
will receive care first is essential. Then a determination must be made regarding the order of treatment of the
multiple medical conditions exhibited by the patient. Next, intense effort is invested to choose among treatment
options in order to select the best alternative for that particular patient.
● Standards and regulations. HIPAA and other similar documents provide structured guidance on risk
management in a targeted healthcare context. Similarly, federal requirements for infection control and response
to epidemic situations are well established and include standardized risk protocols.
● Audits and reviews. The opportunity for data corruption, facility and safety issues, and other infrastructure risks
require specific designs that uniquely fit circumstances. Some hospitals charter hazard-vulnerability teams to
assess the system’s risk continuously against a checklist of potential service disruptions and/or harmful
situations. The involvement of external auditors and review bodies, such as The Joint Commission or DNV, is
useful for identifying levels of risk and establishing consistent and reliable responses to risk situations.
The concept of opportunity management recently has been introduced to healthcare as part of ongoing process
management and the minimization of disruptions to established and optimized procedures for both clinical and
administrative functions. 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.27

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Management of Change
Hospitals have a complex interaction of processes that facilitate clinical, administrative, education/training, and
stakeholder outcomes. Changes not only may be initiated to fulfill a specific purpose, such as introducing new
therapies, expanding hospital service offerings, implementing recent regulations, and modifying other daily
activities, but they also may be associated with process improvement efforts. These initiatives may impact one or
more functions and may involve multiple projects.
The ultimate goal of any change is to ensure that the organization is ready, willing, and able to function
appropriately in the new environment. This includes verifying that revised processes and equipment and other
resources work as intended and that staff members have been educated/trained appropriately and are competent to
perform the required functions and tasks. Both the people and organizational factors may drive or obstruct planned
changes, and the key issues experienced when transformation is underway are process disruptions and pushback
from those who are impacted as processes are modified.
Many changes are accompanied by resistance, which often is associated with the anxiety and fear of the unknown
that affected participants face. Managing change reduces the likelihood of this issue because it assures that the future
state and expected outcomes are defined more clearly and that the newly proposed processes have been validated to
work as intended. Communicating the reason for the change and engaging key stakeholders in the initiative gives
them a sense of control and increases their willingness to accept the change. This combination of communication
and involvement of people who will be affected by the modification not only incorporates their invaluable
knowledge, experience, and suggestions related to the changing process or task into the planning and
implementation, but it also fosters loyalty to the new situation.

Special Considerations for Hospitals

Achieving exceptional quality, safety, and patient outcomes is particularly important during times of change, but
fortunately these goals can be accomplished through a variety of methodologies that address specific issues which
may arise. As the following points indicate, management of change also overlaps with the other 10 quality system
elements.
● High reliability organization (HRO). In recent years, the concept of an HRO has been introduced to healthcare.
Although many healthcare leaders have a genuine interest in this area, they do not know exactly what it means in
a hospital setting or how to integrate it with their organization’s other priorities. Fortunately, some of the
essential components of an HRO are readily attainable when deploying the QMS model described in this
monograph. For instance, teaching and learning are at the core of an HRO. Also, in an HRO, everyone from the
frontlines to the boardroom takes responsibility for safety, which requires trust across the organization and a
relentless focus on improvement. Furthermore, HROs focus on prevention, rather than reaction, and the
identification of errors and/or close calls are valued for the lessons that can be extracted from them. 28 Attaining
recognition as an HRO is a lofty target for hospitals in today’s environment of increased regulation, reduced
funding, and expanded CMS oversight; however, all hospitals should strive to ensure that accidents, such as
those described in the Institute of Medicine’s To Err is Human Report,29 become almost nonexistent. Similarly,
the Joint Commission Center for Transforming Healthcare has adopted a mission “to transform healthcare into a
high reliability industry by developing effective solutions to healthcare’s most critical safety and quality
problems continues the quest for achieving the gold standard in healthcare.30
● Parallel processes. Special attention is required to manage resources and support of resources during periods of
transition. Many hospital processes have limited availability and must be optimized at all times. Generally, a
current process remains operational while the new or improved process is being validated, and this can generate
issues if the change is not managed properly.
● Risk management. Another component of change management encompasses identifying and managing the risks
that may arise as the revision is implemented. Typically, the greater the change required, the greater the risk of
failure or occurrences of errors. Even when these seem relatively inconsequential, these change-related issues
may lead to other more serious risks, such as those related to patient harm, loss of data, or deterioration of
operational metrics.

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Teamwork
Exceptional quality, safety, and patient outcomes, as well as optimization of key performance and financial
metrics, such as length of stay and hospital discharge times, are predicated on effective teamwork among the many
participants in the care-delivery system. Teamwork can and should involve all members of the healthcare
organization as well as organizations and individuals within the broader care community.
These examples illustrate different hospital-related situations where teamwork is instrumental to success.
● Consider a hospital’s inpatient unit that is focusing on the needs of the patient while managing task allocations
through consistent and informative communication of the patient’s health status and clinical goals. Teamwork in
the Emergency Department would ensure proper management of the case, including efficient diagnosis and
disposition to other appropriate care areas, settings, and/or functions.
● Teamwork among clinicians and support staff, such as Environmental Services, Nutrition, and Physical Therapy,
helps to achieve important goals related to patient care and avoid risk.
● When teamwork expands to the communitywide level to include community health partners and organizations, it
can minimize unnecessary hospital re-admissions and Emergency Department visits and broaden the base of
potential patient interactions.

Compliance With Requirements

The healthcare industry is governed by many rules and regulations that are set forth in requirements from
international, national, state, and local agencies. In fact, compliance with requirements from government and
licensing agencies is mandatory. Furthermore, healthcare organizations have the option of seeking voluntary
accreditation or certification, and when a decision is made to pursue that path, the associated requirements become
mandatory. Healthcare organizations, therefore, must accept that compliance with requirements is one of the 10
quality system elements.
The external requirements with which hospitals must comply can be quite diverse, including, but not limited to,
the following:
● Conditions necessary for the hospital to receive reimbursement from the government.
● Patient and employee safety criteria.
● Discipline-specific standards of practice, research, security, and confidentiality.
● Leadership guidelines, including its role in achieving quality.
Other sources of requisites are based on patient/ customer expectations and internal policies and procedures.
Although it is not always possible to provide exactly what the patient/customer would prefer, those needs and
desires should be solicited and thoughtfully considered. Ultimately, it is of utmost importance that the patient always
be treated with dignity and respect and that his/her care and treatment be performed as efficiently and effectively as
possible. Additionally, policies and procedures should be developed based on carefully designed processes that are
consistent with regulatory, licensure, accreditation, and certification requirements. Providing easy-to-understand and
readily available documentation, as well as appropriate education/ training on the concepts associated with and how
to follow the policies and procedures, are critical aspects of ensuring compliance with these two types of
requirements.
Adherence is evaluated by the regulatory agency or its assigned representative, and these inspections (which also
are known as tracers, surveys, and assessments) determine whether compliance with the specified requirements
exists. In some cases, the inspections also verify whether the hospital complies with its own policies and procedures.
This conformance monitoring may be performed on an announced or unannounced basis, and the latter approach is
used more frequently, so the healthcare organization always must be ready. When a hospital has properly
implemented the QMS model, no special preparation is necessary prior to these inspections because the
requirements are integrated thoroughly into the organization’s processes, and compliance with the requirements is
the way the staff members work all the time.

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Continual Improvement and Innovation
The need for improvement underlies and supports the entire QMS model, and it is integral to all processes in
which the hospital engages. These efforts involve two approaches—continual improvement, the process of
incremental changes, and innovation, the process of breakthrough changes. Improvement opportunities can be found
in all areas of the organization. Dr. Donald Berwick31 provided the four general categories below, as well as the
indicated suggestions for improvement that lead to a better healthcare system:
● Health status outcomes. Improvements in this area increase the appropriateness of practice (e.g., reducing the
use of inappropriate surgery, admissions, and tests), increase effective preventive practice (e.g., reducing causes
of illness, such as smoking, hand-gun violence, and alcohol/drug abuse), reduce cesarean-section rates without
compromise in maternal or fetal outcomes, and streamline pharmaceutical use—especially for antibiotics and
drug prescriptions for the elderly.
● The experience of care. These opportunities emphasize increasing the frequency with which patients participate
actively in decision making about therapeutic options and decrease waiting in all its forms.
● The total cost of care and illness. Reducing the total cost of care by consolidating high-technology services into
regional and community-wide centers offers great potential, and it leads to reduced waste and duplicative
recording, as well as minimized inventory levels throughout the supply chain.
● Social justice and equity in healthcare. By solving some of these issues, healthcare providers can reduce the
differences in infant mortality and low birth weight between the black and white populations.32

Continual Improvement
Continual improvement is the action taken throughout an 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.
Many continual improvement methodologies are applied by hospitals. Lean techniques are designed to provide
the maximum health services at the lowest operational cost while simultaneously optimizing resources; this method
focuses on reducing cycle time (time from start to finish of an activity) and waste. The Six Sigma method
emphasizes reduction of variation in service delivery by using a diverse set of tools in a structured series of steps; it
relies on strong leadership from the top and emphasizes satisfying customers and achieving required bottom-line
financial results (profitability). These two approaches can be combined, offering a fact-based, data-driven
philosophy of improvement that values defect prevention over defect detection and attains all the improvements
associated with the two independent methods. Finally, the Plan- Do-Check (or Study)-Act process is based on a
structured, four-step continuous process for quality and continual improvement that reflects the way people
generally tackle problem solving.

Innovation
Innovation in healthcare business and care models, therapies, and population health is needed—perhaps now
more than ever. 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.33 New ideas foster greater innovation that leads to leaps in performance
and brings hospitals closer to their visions of a far more optimized delivery system.
The medical community constantly is looking for innovative ways to improve patient treatment through
evidence-based sharing. Furthermore, hospital operations and finance are fertile grounds for innovative planning.
This Hospital-Based Healthcare QMS Model, therefore, is designed to support innovation and innovative thinking.
Here are a few examples of innovations that have been adopted.
● Variation based on geographic, market, and disease profiles has opened the door to innovation within hospital
planning and operations, utilization of technologies and the Internet, and new approaches to wellness and
population health management.

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● The cost of care delivery is a primary concern for many in healthcare, so cost control is a worthy area for new
ideas. An approach developed by the U. S. defense industry has led to the introduction of a conceptual model for
healthcare affordability to guide the planning for new programs and anticipating benefits/costs for improvement
projects.34
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. Some common techniques for fostering innovative
thinking include the following:
● Visualizing the problem in different ways and from different angles.
● Representing thoughts in visuals.
● Thinking fast and frequently.
● Trying different combinations.
● Investigating the opposite side.
● Thinking beyond what is known.
● Looking for disconnects.
● Looking for ignorance.
● Thinking in teams and building on others’ ideas.35

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 Summary

The Hospital-Based Healthcare QMS Model presented here takes the following aspects
into consideration:
● The results that are expected to be achieved—exceptional quality, safety, and patient
outcomes.
● The patient experience—patient identification and assessment, development of treatment
plan, delivery of care, and transition of care.
● The 10 quality system elements that provide the critical infrastructure and framework
needed to support and influence the patient experience and the hospital’s results.
● The importance of continual improvement and innovation in all aspects of the model to
ensure that better patient care and business effectiveness and efficiency are achieved.
● The hospital or healthcare organization should not be based on functional siloes with
independent activities. Similarly, the components of the Hospital-Based Healthcare QMS
Model represents a holistic framework with fully integrated activities. When the hospital
plans for and manages quality throughout the organization and its processes, not only are
better results achieved, but they also are accomplished in a more cost effective, efficient,
and safe manner. As hospitals relentlessly pursue these goals, they will become HROs
and their patients will experience exceptional quality, safety, and other outcomes.

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