asq orlando section 1509 - improving healthcare monograph … · 2017-01-29 · an asq certified...

22
Improving Healthcare Monograph Series: A Hospital-Based Healthcare Quality Management System Model April 2016 Vol. 1, No. 1 Healthcare Technical Committee, a joint development of the Healthcare and Quality Management Divisions of ASQ

Upload: others

Post on 05-Jul-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

Improving Healthcare Monograph Series:

A Hospital-Based Healthcare Quality Management System Model April 2016 Vol. 1, No. 1

Healthcare Technical Committee, a joint development of the Healthcare and Quality Management Divisions of ASQ

Page 2: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20162

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 ©2016

AuthorsTania 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 man-agement 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 qual-ity management in laboratory medicine. Contact Motschman at [email protected].

Christine Bales serves as a technical expert in quality manage-ment 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 stra-tegic planning, process improvement, and facility accreditation processes. She can be reached via 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, electron-ics, 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 cur-rently the chair of that section. He can be reached at [email protected].

Page 3: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20163

Grace L. Duffy is president of Management & Performance Systems where she provides services in organi-zational 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 maga-zine’s 2014 Quality Person of the Year. Contact her at [email protected].

Pierce Story is co-founder and vice president of concept develop-ment 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 con-tacted by email at [email protected].

ReviewersSusan E. Peiffer, MS, CSSBB, SSGB

Vicente “Alberto” Araujo, M.B.A.; P.M.P.

Cheri-Graham Clark, RN, MSN, CPHQ, CPHRM, CSSBB

Cathy Fisher, CQA, ISO Lead Auditor

Next in This Monograph SeriesThe second monograph in this new series from the Healthcare Technical Committee will be released later this year, and it will address application of the Hospital-Based Healthcare Quality Management System (QMS) Model.

Page 4: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20164

5 Executive Summary

7 IntroductionPurpose of the Model … 7Defining Quality … 7

9 The Model The Inner Circle—The Patient Experience: Exceptional Quality, Safety, and Patient Outcomes … 10 Quality and Safety … 10The Middle Circle: The Four Key Components of Care Delivery … 10The Outer Circle: The 10 Quality System Elements … 11 Leadership Commitment, Planning, and Review … 12 Commitment to Quality … 12 Planning … 12 Quality Policy … 12 Review of Quality Plans … 13 Feedback Loops … 13 Environment of Care … 14 Management of Finances and Support Resources … 14 Financial Management … 14 Support of Resources … 14 Management of Information … 15 Communication, Education, and Training … 15 Communication … 15 Education and Training … 16 Risk Management … 16 Management of Change … 17 Special Considerations for Hospitals … 17 Teamwork … 18 Compliance With Requirements … 18Continual Improvement and Innovation … 19 Continual Improvement … 19 Innovation … 20

21 Summary

Table of Contents

Page 5: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20165

This Hospital-Based Healthcare Quality Management System (QMS) Model is directed to the CEO and CMO who are seeking to improve patient out-

comes, safety, and satisfaction, as well as cost savings, risk management, and regulatory compliance. A QMS is defined as a formalized system that docu-ments the structure, responsibility, and procedures required to achieve effective quality management that is focused on the quality policy and quality objec-tives in order to meet customer requirements. In healthcare, a QMS specifically describes the process for improving all aspects of patient outcomes and operat-ing 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 health-care 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 reg-ulations and measures that drive priorities and decision making. International readers are encouraged to consider this monograph in terms of local regula-tions 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 out-comes. The framework is supported by four key components of care delivery

Executive Summary

Page 6: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20166

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 opera-tional 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 compli-ance will be the way the staff works at all times.

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

Underlying platformof continualimprovement andinnovation

Patientexperience

Components of care

Quality systemelements

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

Patient identi�cation

and assessment

Leadership commitment,planning and review

Feedbackloops

Environment

of care

Man

agem

ent of

�na

nces

and

supp

ort re

sour

ces

Managem

ent

of inf

ormati

on

Communication,education and training

Riskmanagement

Managem

ent

of change

Team

wor

k

Compli

ance

with re

quire

ments

Deliveryof care

Transitionof care

Developmentof treatment

plan

Exceptional quality,safety and

patient outcome

Indicatescontinual

improvementand innovation

Legend:Interactions

Page 7: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20167

Purpose of the Model

A quality management system (QMS), re-gardless 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 Com-mittee 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 fundamen-tals, which have been adapted specifically for the healthcare business environment. Its structure is based on the seven qual-ity 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 lead-ers 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 com-mittee’s future efforts will expand the model to include the many interrelated processes used throughout a complete healthcare system.

Defining QualityThe 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 mea-surement. Researchers use many different measures to determine healthcare quality, including, but certainly not limited to, counts of a therapy’s reduction or less-ening 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 indi-cators in a population that is accessing a certain kind of care.4

The sidebar, “Definitions of Quality,” provides a summary of some well-known

Introduction

Page 8: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20168

definitions for quality from a variety of sources and applications. There are two common themes in these definitions—a defined require-ment 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 per-form 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, interde-pendent system, the desired quality and, thus, the desired clinical results are achieved more effectively and efficiently.

Definitions of QualityQuality describes a subjective term for which each per-

son 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 excep-tional 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 fun-damental 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 deliv-ery systems that encourage improved quality and greater involvement of patients in their own care.16

Page 9: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 20169

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 fea-tures 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, mea-sures, and improvement activities into a smooth flowing, repeatable, and reliable QMS in order to meet patient, commu-nity, 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 rec-ommend” the hospital.”17

• The middle circle. This circle details four key components of the patient’s care delivery—identification and assessment, development of a treat-ment plan by all primary and ancillary services, delivery of care, and tran-sition of care to the next level or discharge. These components repre-sent the patient’s typical experiential path through the care delivery process.

• The outer circle. The 10 critical qual-ity system elements that provide the infrastructure and framework for sup-porting and influencing achievement of exceptional quality, safety, and patient outcomes are described in this circle. These are the process and structures needed for overall busi-ness effectiveness and efficiency, and they have an interactive relationship with each other, the four key compo-nents 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 con-tinual 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

The Model

Page 10: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201610

of the previously described parts. By determin-ing, measuring, and analyzing the results of the hospital’s core processes, continual improve-ment 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 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 entrust-ing 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 man-agement 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, met-rics 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 SafetyOf course in healthcare, patient safety is a central

aim of quality; thus, quality and safety are inter-twined 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 health-care.”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 concur-rent 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 1 summarizes the processes and the departments that are involved with performing those activities for each of the four key compo-nents 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).

• 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

Page 11: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201611

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 con-strain change, and lead to 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 9001:201520 and the Baldrige Criteria for Performance Excellence,21 and they have been adjusted to reflect the hospital set-ting. 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.

Table 1: The Patient Experience as a Process Approach

Patient Experience Processes Department Delivering Services

1. Patient identification and assessment

• Patient intake• Triage• Registration• Health assessment, leading to

admission or discharge

• Emergency • Admissions (Outpatient/Inpatient)• Medical staff• Nursing services• Ancillary services (e.g. blood, radiology,

anesthesia, surgery prep)

2. Development of treatment plan

• Care and treatment planning, provided either for inpatients or outpatients

• Medical staff• Nursing• Ancillary therapeutic services

3. Delivery of care • Delivery and coordination of care (treatment and ancillary services such as diagnostic, therapeutic, and custodial)

• Medical staff• Nursing services• Pharmacy services• 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 effectiveness

• Analysis of patient outcomes• Patient-status determination,

either continue treatment, change treatment, or discharge

• Patient feedback

• Medical staff• Nursing services• Consultations with any ancillary services• Discharge planning

Page 12: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201612

Leadership Commitment, Planning, and Review

This first quality system element includes strate-gic 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 QualityCommitment can be defined as an agreement

or pledge to do something in the future.22 Leaders exhibit commitment to quality by focusing on ensur-ing that effective processes are in place, directly engaging medical and administrative staff, and empowering individuals by providing the appropri-ate 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 per-sonnel through effective communication.

Additionally, leadership commitment to qual-ity 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 lead-ership 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 proj-ect’s successes was top management’s initial buy-in.

The vice president responsible for the respiratory care department attended every meeting of the qual-ity improvement task force. This participation eased implementation of the team’s solutions. Some deci-sions which historically had required many reviews were acted on directly.”24

PlanningHospital leaders are responsible for the strate-

gic 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 analyt-ics, 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 gen-eral standards and requirements established for national hospital health programs must exhibit equity among populations, their delivery and com-munication 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 PolicyQuality planning includes the development of

a comprehensive quality policy that reflects the leadership style and culture of the hospital and the

Page 13: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201613

community it serves. Considerations must be made for disaster planning, periodic risk assessments, and frequent review of all the healthcare system’s tar-geted product and service outcomes/results.

A defined quality policy sets the stage for effec-tive 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 orga-nization and in association with the partnerships it has established to support the overall health of the community it serves.

Review of Quality PlansThe leadership review process occurs on

a scheduled basis, and annual reviews of the organization’s goals and objectives typi-cally serve as the first phase of the strategic planning process. Monthly reviews of core process measures provide data-based oppor-tunities 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 LoopsThe intent of establishing consistent and

reliable feedback loops is to facilitate a fac-tual approach to decision making. Feedback loops verify whether processes are function-ing as expected, and they provide valuable information, which may suggest that pro-cess 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 effective-ness against established criteria. The leading indicators anticipate the probability of reaching

the desired result, and the lagging indicators mea-sure 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 the sidebar, “Feedback Loop Examples.”

• 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 rat-ing is used to establish a treatment plan.

Feedback Loop ExamplesExamples of processes used to generate feedback in organizations of all types

Plan-Do-Check-Act improvement cycles

Lean and/or Six Sigma projects

Results of quality assurance or management audits

Examples of common healthcare feedback systems

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

Examples of feedback data sources for healthcare organizations

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

Page 14: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201614

• 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 sup-porting allied health or administrative functions also may be incorporated into feedback loops.

Environment of CarePromoting a safe, functional, and supportive

environment within the healthcare facility is essen-tial for ensuring that quality and safety are attained and preserved to protect patients, visitors, and staff. This element addresses the hospital’s physi-cal environment—particularly the building and/or space, as well as their arrangements and special fea-tures. 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 fac-tors 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, equip-ment 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 organiza-tion. 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.

Financial ManagementManaging resources and assets drives business

results. One of the most critical responsibilities at all levels of hospital leadership is financial man-agement. Budget management and planning for resource utilization need to be constant focal points for unit-, department-, division-, and corporate-level 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 hospi-tal 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 encom-passes 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 becom-ing increasingly complicated as care-provision approaches shift, and more non-clinical resources become part of the process.

Support of ResourcesOf 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 main-tain the physical plant.

• Supplier qualification. High-performing materi-als that ensure exceptional quality, safety, and

Page 15: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201615

patient outcomes are achieved should be pur-chased 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 InformationAccurate 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 sum-maries, 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 appro-priately, and can be retrieved quickly. Additionally, other information that has an indirect impact on patients and their care also must be managed prop-erly. Examples of this type of information include inventory levels of and ordering documentation for supplies, coding and billing records, metrics’ track-ing results, and audit findings.

Hospitals often are challenged by the need to com-mit significant IT resources as both the sources of and demands for data and information continue to grow steadily. Documentation requirements are expand-ing 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 communica-tions to generate other critical documentation.

Ensuring that information is reliable and confi-dential are key concerns of modern hospitals, and they cannot be over emphasized as critical compo-nents 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.

Communication, Education, and TrainingTo 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 admin-istrative requirements. This quality system element provides the foundation for staff members’ success.

CommunicationAchievement 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 foun-dation for well-defined processes, including those associated with managing the organization, obtain-ing 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 partici-pants 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 informa-tion 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 care-givers from different specialties who are seeking to attain the optimum care for a particular patient is one illustration of this type of com-munication. In this case, there is an increased responsibility to consider the broader informa-tion and data flow to assure positive patient outcomes. Similarly, the “medical home” con-cept 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 poten-tially complex communication circumstances that rely on the interdependency of the involved disciplines before, during, and after the patient’s hospital stay.

Page 16: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201616

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 perfor-mance ratings, reputation, and reimbursements.

• Organizational direction, policies, and proce-dures. 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 commu-nication flow fosters a deeper understanding of the work environment and spotlights issues that require action and change.

Education and TrainingThe purposes of education and training are

distinct but complementary. Whereas education generally is conceptual and builds knowledge, train-ing 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 ben-eficial. 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 respon-sibilities and regulations may be connected to particular educational requirements, such as professional instruction for physicians, nurses, technicians, and other caregivers that are neces-sary 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 now are provided routinely to discharged patients, rather than the traditional verbal recommenda-tions given by the physician at the bedside, and well-educated caregivers can use them to con-firm 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 proce-dures. Developing the required competencies may involve not only classroom-led and/or computer-/Internet-based training but also just-in-time coaching, job shadowing, appren-ticeships, 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 ManagementThis 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 continu-ity, etc.), may introduce risk if they are not designed and executed properly. In particular, the risk of sen-tinel events is a major hospital concern.

Managing clinical and administrative processes and minimizing disruptions to established pro-cedures 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

Page 17: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201617

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, inter-action 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 regard-ing 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 infec-tion 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 situ-ations. 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 minimi-zation 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

Management of ChangeHospitals have a complex interaction of pro-

cesses that facilitate clinical, administrative, education/training, and stakeholder outcomes. Changes not only may be initiated to fulfill a spe-cific purpose, such as introducing new therapies, expanding hospital service offerings, implement-ing 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 func-tion appropriately in the new environment. This includes verifying that revised processes and equip-ment and other resources work as intended and that staff members have been educated/trained appro-priately and are competent to perform the required functions and tasks. Both the people and orga-nizational factors may drive or obstruct planned changes, and the key issues experienced when trans-formation 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 stakehold-ers 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 implementa-tion, but it also fosters loyalty to the new situation.

Special Considerations for HospitalsAchieving exceptional quality, safety, and patient

outcomes is particularly important during times of change, but fortunately these goals can be accom-plished through a variety of methodologies that address specific issues which may arise. As the fol-lowing points indicate, management of change also overlaps with the other 10 quality system elements.

Page 18: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201618

• High reliability organization (HRO). In recent years, the concept of an HRO has been intro-duced 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 organi-zation’s other priorities. Fortunately, some of the essential components of an HRO are read-ily 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 nonexis-tent. 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 prob-lems continues the quest for achieving the gold standard in healthcare.30

• Parallel processes. Special attention is required to manage resources and support of resources dur-ing 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 man-aging the risks that may arise as the revision is implemented. Typically, the greater the change required, the greater the risk of failure or occur-rences 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 deteriora-tion of operational metrics.

TeamworkExceptional quality, safety, and patient out-

comes, 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 focus-ing on the needs of the patient while managing task allocations through consistent and informa-tive 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 dis-position 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 community-wide level to include community health partners and organizations, it can minimize unnecessary hospital re-admissions and Emergency Depart-ment visits and broaden the base of potential patient interactions.

Compliance With RequirementsThe healthcare industry is governed by many

rules and regulations that are set forth in require-ments from international, national, state, and local agencies. In fact, compliance with requirements from government and licensing agencies is manda-tory. Furthermore, healthcare organizations have the option of seeking voluntary accreditation or certification, and when a decision is made to pur-sue 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:

Page 19: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201619

• 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, licen-sure, 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 inspec-tions (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 hos-pital 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.

Continual Improvement and Innovation

The need for improvement underlies and sup-ports 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 orga-nization. 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, admis-sions, 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-technol-ogy 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 solv-ing 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 ImprovementContinual improvement is the action taken

throughout an organization to increase the effective-ness and efficiency of activities and processes in order to provide added benefits to the patient, stakehold-ers, 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 opti-mizing resources; this method focuses on reducing cycle time (time from start to finish of an activ-ity) and waste. The Six Sigma method emphasizes

Page 20: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201620

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 empha-sizes 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.

InnovationInnovation 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 hos-pitals 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, hos-pital 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 dis-ease profiles has opened the door to innovation within hospital planning and operations, utiliza-tion of technologies and the Internet, and new approaches to wellness and population health management.

• 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 devel-oped 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

Page 21: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201621

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 activi-ties. 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.

References1. Centers for Medicare and Medicaid Services, “CMS Quality Strategy 2016,” https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/ qualityinitiativesgeninfo/downloads/cms-quality-strategy.pdf.

2. International Organization for Standardization, “Quality Management Principles,” http://www.iso.org/iso/pub100080.pdf.

3. ASQ, “Plan-Do-Check-Act (PDCA) Cycle,” http://asq.org/learn-about-quality/project-planning-tools/overview/pdca-cycle.html.

4. Avedis Donabedian, “The Quality of Care. How Can it be Assessed?” JAMA: the Journal of the American Medical Association, September 1988, p. 1,743-48.

5. ASQ, “Quality Glossary,” http://asq.org/glossary/q.html.

6. BusinessDictionary.com, http://www.businessdictionary.com/definition/quality.html.

7. Phillip B. Crosby, Quality is Free, McGraw-Hill, 1979, pp. 17 and 45.

8. Tirupathi R. Chandrupatla, “Quality and Reliability in Engineering,” Cambridge University Press, http://assets.cambridge.org/97805215/15221/excerpt/9780521515221_excerpt.pdf (based on the work of W. Edwards Deming).

9. Dictionary.com, http://www.dictionary.com/browse/quality?s=t.

Page 22: ASQ Orlando Section 1509 - Improving Healthcare Monograph … · 2017-01-29 · an ASQ Certified Quality Technician (CQT), Quality Engineer (CQE), and Quality Auditor (CQA). Timmerman

HealtHcare tecHnical committee April 201622

10. Peter F. Drucker, Innovation and Entrepreneurship, Harper & Row, 1985, p. 478.

11. International Organization for Standardization, ISO 9000:2015, Quality Management Systems—Fundamentals and Vocabulary, https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:en.

12. Joseph M. Juran and Joseph A. De Feo, “Attaining Superior Results Through Quality,” The Quality Handbook, 6th ed., McGraw-Hill, 1999, p. 5.

13. Noriaki Kano, “Attractive Quality and Must-be Quality,” The Journal of the Japanese Society for Quality Control, April 1984, pp. 39-48.

14. Gerald M. Weinberg, Quality Software Management: Vol 1: Systems Thinking, Dorset House, 1991, p. 7.

15. National Committee for Quality Assurance, “Accreditation Levels,” http://www.ncqa.org/Programs/Accreditation/AccountableCareOrganizationACO/ACOAccreditationLevels.aspx.

16. Harvard Vanguard Medical Associates, “Become a Patient: Quality You Can Trust,” http://www.harvardvanguard.org/become-a-patient/why-harvard-vanguard/quality-and-safety.

17. Institute for Healthcare Improvement, “Achieving an Exceptional Patient and Family Experience of Inpatient Hospital Care,” http://www.ihi.org/resources/pages/ ihiwhitepapers/achievingexceptionalpatientfamily experienceinpatienthospitalcarewhitepaper.aspx.

18. World Health Organization, “Patient Safety,” http://www.euro.who.int/en/health-topics/Health-systems/patient-safety.

19. American Hospital Association, “The Patient Care Partnership: Understanding Expectations, Rights, and Responsibilities,” www.aha.org/content/00-10/ pcp_english_030730.pdf.

20. International Organization for Standardization, ISO 9001:2015: Quality Management Systems – Requirements.

21. NIST, Baldrige Excellence Framework, http://www.nist.gov/baldrige/publications/criteria.cfm.

22. Webster’s New Collegiate Dictionary, “Commitment,” G. & C. Merriam Co., 1977, p. 226.

23. David Marks, “Patient Safety and the “Just Culture,” presentation,” The Just Culture Community, 2007.

24. Donald M Berwick, A. Blanton Godfrey, and Jane Roessner, Curing Healthcare Care, Jossey-Bass, 1990, p. 69.

25. Health Insurance Portability and Accountability Act Of 1996, https://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/downloads/hipaalaw.pdf.

26. Linda J. Vorvick, “Interprofessional Education in Team Communication: Working Together to Improve Patient Safety,” PubMed.gov, http://www.ncbi.nlm.nih.gov/pubmed/23293118.

27. Nancy R. Tague, The Quality Toolbox, 2nd ed., Quality Press, 2005. pp. 16 and 236.

28. Erin S. DuPree, “Zero Harm is the Goal,” Patient Safety and Quality Healthcare, Vol. 12, No. 6, November/December 2015, pg. 14.

29. The National Academies of Science, Engineering, and Medicine, “To Err is Human,” http://iom.nationalacademies.org/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx.

30. The Joint Commission Center for Transforming Healthcare, “High Reliability in Health Care,” http://www.centerfortransforminghealthcare.org/ hro_portal_main.aspx.

31. Donald M. Berwick, “Buckling Down to Change,” A presentation to the Fifth Annual National Forum on Quality Improvement in Healthcare, Orlando, FL, December 1993.

32. Raymond G. Carey and Robert C. Lloyd, Measuring Quality Improvement in Healthcare, Quality Press, pp. 15-16.

33. Peter Merrill, “Expert Answers: Integrating Quality, Innovation,” Quality Progress, July 2015, pp. 8-9.

34. Eric Hung Le, Michelle Le, and Grace Duffy, “Applying the Concept of Affordability to Strategic Cost Reduction,” Executive Insight, July 2013, p.13.

35. Praveen Gupta, “Innovation: The Key to a Successful Project,” Six Sigma Forum Magazine, http://asq.org/pub/sixsigma/past/vol4_issue4/ssfmv4i4gupta.html.

Next in This Monograph SeriesThe second monograph in this new series from the Healthcare Technical Committee will be released later this year, and it will address application of the Hospital-Based Healthcare Quality Management System (QMS) Model.