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Chapter 1: concepts and principles of quality management.


Study of the information presented in this chapter will enable the learner to:

1. Define quality.

2. Discuss the basic principles and concepts of continuous quality improvement.

3. Describe a tested continuous quality improvement model for use in the nephrology setting.


The basics of quality management with a focus on continuous quality improvement (CQI) will be highlighted in this chapter. Quality, total quality management, and CQI will be defined, and an easy-to-implement CQI model will be presented.


When faced with the need to do and document quality improvement activities on a formal basis in busy work settings, it is tempting for practitioners to say, "Why bother? We are far too busy taking care of patients to do more 'busy work!'"

Continuous quality improvement (CQI), if done correctly and with input from an interdisciplinary team, is not busy work. Nor is it optional when it comes to people's health and welfare. Striving to continually improve patient outcomes is mandatory, and ultimately, when CQI is practiced daily by the entire team, it saves time, since problems and suboptimal outcomes are reduced or eliminated.

Formal CQI does not need to be overwhelming, time consuming, or focused on paperwork. A simple process that can be implemented in any setting will be outlined in this chapter. Furthermore, while the principles of CQI apply to most structures and processes in any given setting, the application of CQI in this chapter will focus primarily on patient care and clinical outcomes.

What Is Continuous Quality Improvement?

CQI is a component of a broader concept called quality management (see Figure 1-1). Quality management encompasses all activities related to improving the quality of products or services as well as customer satisfaction with those products or services. The four components of quality management are quality leadership, quality planning, quality control and quality improvement (Hradesky, 1995).

Quality leadership provides the opportunity and guides the effort. Simply stated, quality leadership makes sure that quality improvement is pursued and provides the resources needed.

Quality planning involves 1) developing a plan for incorporating quality improvement efforts into everyday practice or activities, 2) identifying short-term and long-term quality needs, and 3) ensuring that resources, including knowledge, are available for CQI activities. An example of quality planning is establishing quality goals and projects for the year.


Quality control involves monitoring actual performance to see if expectations are being met. Data collection and analysis of the key indicators of quality are central to effective quality control. Monitoring and reporting water quality and clinical performance measures are two examples specific to the dialysis setting.

CQI, called quality assessment and performance improvement (QAPI) by some, is generally to describe, in the aggregate, the ongoing monitoring, evaluation and improvement of processes (Joint Commission on Accreditation of Healthcare Organization [JCAHO], 1992). Said another way, it is a formal process that 1) identifies improvement needs; 2) determines the causes of problems, needs, or gaps; 3) develops solutions; 4) implements those solutions; and 5) determines if the solutions work. There are many CQI methods or models to guide the process, but the one that is used in this chapter is an adaptation of the Shewhart Plan-Do-Check-Act (PDCA) Model promoted by W. Edwards Deming (Walton, 1986). The model will be discussed later in this chapter.

There are a number of formal definitions of quality improvement:

* A mind set, commitment, and process used in business in which teams continually improve all processes throughout the organization, with the intent of meeting and exceeding expectations, whether internal or external (Schroeden 1994).

* A set of principles, policies, support structures, and practices designed to continually improve the efficiency and effectiveness of what is valued.

* Intelligent, focused teams making sound decisions about important issues in an organized, timely manner.

* Knowledgeable, caring people doing the right thing, the first time, and for the right reason in an organized manner (Hunt, 1992).

However it is defined, quality improvement identifies and solves real or potential problems. Problems are either 1) off-target (such as hemoglobins below an established target or parathyroid hormone [PTH] greater than an established upper limit target) or 2) unwanted (such as patients being hospitalized for preventable conditions). Another way of looking at problems is to say there is a gap between what is desired and what currently exists. For example, if the unit currently has 30% of its patients with a TSA < 20%, and the goal is 10%, that is a problem or a gap. When outcomes or situations are off-target or unwanted, or a gap exists, a quality improvement project to narrow the gap or resolve the problem is indicated.

What is Quality?

Quality means different things to different people, depending on their focus, values, and responsibilities. From a healthcare perspective, in the classic publication, Medicare: A Strategy for Quality Assurance, Lohr (1990) defines quality as "the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge" (p. 4).

In Quality in America, Hunt (1992) discusses quality in two contexts: quality in perception and quality in fact. Examples of quality in perception include:

* Delivering the right service(s).

* Identifying and satisfying customers' needs.

* Meeting customers' expectations.

* Treating all customers with integrity, courtesy, and respect.

Hunt (1992) continues to define "quality in fact" as doing the right thing, doing it the right way, doing it right the first time, and doing it on time. From the perspective of nephrology, examples of doing the right thing include:

* Using aseptic technique for catheter, fistula, and graft care.

* Providing adequate dialysis--correct dialyzer, full treatment time, full blood flow rate.

* Preventing or at least minimizing complications of dialysis, such as hypotension.

* Correcting the anemia of chronic kidney disease.

* Striving to improve patient compliance with the treatment regimen, whether it is transplantation, hemodialysis, or peritoneal dialysis.

* Collecting all billable charges.

* Being in regulatory compliance at all times.

Examples of doing it the right way include:

* Following accepted standards and practice guidelines.

* Using products, supplies, and devices correctly.

* Using aseptic technique consistently.

* Removing fluid without hypotension.

* Capture and collection of all billable charges in a timely fashion.

Doing it right the first time might include:

* Having practices and processes in place that prevent complications.

* Using needle insertion techniques that ensure consistent, adequate blood flow and no infection.

* Consistently administering the appropriate dose of erythropoietic stimulating agent (ESA) and iron.

* Preparing claims so that they are accepted and processed the first time.

* Using the structures, processes, and practices in place consistently so that survey is passed without deficiencies.


Doing it on time includes:

* Training patients for home therapy in an acceptable number of days.

* Monthly clinic visits for patients on home therapy.

* Safety and vital sign checks per policy.

* Obtaining target weight each dialysis.

* Billing cycle of 30 to 45 days.

* Comprehensive patient assessments by the interdisciplinary team within the first 30 days of treatment or the first 13 treatments.

What Is Needed for CQI to Be Effective?

For quality efforts to be successful, regardless of setting, a of factors must be present (Hunt, 1992; Schroeder, They are:

* Leaders committed to quality and a formal CQI/QAPI process.

* Knowledgeable and dedicated employees committed to real time (daily) quality improvement.

* Accessible information, including data to help identify/prioritize projects and needs, upon which to base decisions and actions.

* Benchmarks.

* Easy-to-use tools for decision-making and documentation.

* Interdisciplinary team involvement in and accountability for quality outcomes.

* Ability to see the "big picture" of caring for a patient with kidney dysfunction, not just one specific treatment.

* Standards, guidelines, and evidence to guide practice and decisions.

* A formal CQI/QAPI structure and process used by all disciplines.

Potential Problems or Issues in the Nepbrology Setting to Explore for Improvement

Processes and outcomes conducive to quality improvement fall into the broad categories of clinical, administrative, financial, technical, and regulatory. Improvements to explore are listed in Table 1-1.

Identifying Improvement Needs

If sound information and data collection and trending tools are in place, improvement needs can be easily identified and prioritized. Benchmarking or comparing one's self to others is frequently used in the nephrology setting for clinical issues. Examples of this include clinical performance measures, and the National Quality Forum (NQF) endorsed quality measures and internal corporate standards. Additionally, quality improvement teams often study the use of time as well as conduct surveys to identify customer needs and concerns. For example, do adverse occurrences, such as vascular access clotting, frequently occur? Is the facility being cited for regulatory issues? Do anemia and bone/mineral outcomes compare favorably to state and national benchmarks? Once identified, the top three or four problems or issues can be prioritized using the following criteria: 1) high risk, 2) high volume, 3) problem prone, and/or 4) high costs. While it is not practical to address all improvement needs at once, current projects and their status should be easily identifiable, and timelines should be set for future projects.

Basic Components of a CQI Program

Basic components of a CQI program include:

* Quality indicators based on internal and external expectations.

* Processes--clinical, managerial, or systems-oriented--to achieve outcomes.

* Data collection calendar.

* Trending tool, typically with 3 to 6 months of data.

* CQI model.

* Quality improvement meeting agenda.

* Meeting minutes that document analyses, discussions, actions, and results.

* Action plans focused on addressing the specific causes of problems or issues.

CQI Models

CQI methods or models simply provide a consistent set of steps to use in all improvement processes and projects. Documentation of quality projects and initiatives should follow the model or process used by the facility. While there are numerous CQI models available for use, such as the Shewhart PDCA cycle, FOCUS-PDCA, FADE, and IMPROVE models (JCAHO, 1992), the CPDCA model will be used in this chapter to explain the steps in CQI.

The CPDCA Model

The Check-Plan-Do-Check-Act (CPDCA) model (see Figure 1-2) is a modification of the Shewhart PDCA cycle developed by Walter Shewhart. Shewhart pioneered the application of statistical methods for controlling quality in manufacturing (Walton, 1986). His cycle has been modified to include the first check to emphasize the ongoing need to collect, trend, and analyze information. This cycle, as with any established CQI model, provides a structured and organized approach to evaluate how we are doing, what needs to be improved, how to improve, and if we succeeded.

Steps in the CPDCA Model


1. Collect, trend, and analyze information on a consistent basis to monitor internally and externally established quality indicators. Information includes observations and patient symptoms/circumstances, as well as laboratory data.

2. Discuss the information at each monthly quality improvement meeting using a pre-established calendar. High-risk, problem-prone issues, such as those affecting patient health and safety, may need to be addressed on an accelerated basis.

3. Identify and prioritize projects using the "high-risk, high-volume, problem-prone, and/or has a negative effect on the mission of the facility and company" criteria. (JCAHO, 1994, p. 12).

4. Issues that cross all categories should receive top priority.


1. Select a quality improvement project team. Members should be knowledgeable of the process being studied as well as committed to a formal CQI process.

2. Analyze each process by using tools, such as cause and effect (fishbone) diagrams, flow charts, pareto charts, run charts, brainstorming, and the literature. Use observation, interviews, and audits to collect additional information on the possible causes or factors in the outcome. For efficiency, use automated reports as much as possible.

3. Based on the information, identify and document reasons for the problem or gap.

4. Develop a CQI action plan that:

* Clearly states the improvement needed.

* Identifies the specific goals of the project.

* Includes what will be done, who will do it, the time frame involved, and how and when the outcome(s) will be measured or checked.

Brainstorming, flow charts, literature review, and communication with colleagues can be used to develop a "best practice" plan.


1. Educate and train everyone who will be involved directly or indirectly in implementing the plan. Remember to include the patient and patient's family if the project is patient-centered.

2. Implement the plan on a small scale if it involves major policy or practice changes.


1. Monitor the results of the action or improvement plan to see if the desired results have been achieved.

2. Share the information at the monthly quality improvement meeting, at staff meetings, and during patient rounds.


1. Weigh the results against the desired outcome. If satisfied with the results, incorporate the changes into the facility's everyday policies, procedures, and/or practice, as well as the patient's plan of care.

2. If the outcome has not been achieved, make any necessary changes, modifications, or adaptations to the action or care plan and implement.

3. Communicate the outcomes and any procedure, practice, or policy changes to all appropriate parties.

4. Monitor outcomes on a regular basis to ensure that desired outcomes continue.

Application of this model is demonstrated in the Chapter 5, "Clinical Application: CQI in Anemia/Iron Management."

CQI Responsibilities

The commitment of work place leaders is essential to the success of a quality improvement program. The program should be comprehensive yet flexible enough to permit innovation and variation in assessment approaches. Regardless of its exact structure, it should contain all the necessary components discussed earlier in this chapter.

The Conditions for Coverage for End Stage Renal Disease Facilities, effective October 2008 (Centers for Medicare and Medicaid Services [CMS], 2008) are part of CMS' effort to "modernize regulations and improve the avail ability of quality-of-care information; to promote transparency; and to move toward a patient outcome-based system that focuses on quality assessment and performance improvement" (p. 20371). In keeping with this intent, the role of the medical director was expanded and clarified.

The medical director is responsible for the delivery of patient care and outcomes in the facility, which includes responsibility for the QAPI program, staff education, training, and performance, as well as policies and procedures of the end stage renal disease (ESRD) facility. To further strengthen the responsibilities of the medical director, the first paragraph of [section]494.150 (CMS, 2008) states, "the medical director is accountable to the governing body for the quality of medical care provided to patients" (p. 20483). While the medical director is ultimately responsible for the quality or QAPI program, physicians, nurses, dialysis technicians, social workers, dietitians, biomedical technicians, and secretaries are all potential members of CQI teams. These members and other staff serve on teams/committees to apply CQI techniques (such as CPDCA) to opportunities for improvement as they are identified via information review. In the case of outpatient dialysis clinics, quality improvement committees are accountable to the medical director of the facility, and ultimately, the governing board. Hospital-based programs will have their own reporting/accountability structure.

Although the frequency of quality improvement meetings is not mandated, they are routinely held monthly or more often as necessary to oversee quality initiatives. Based on issues identified, the quality improvement committee develops appropriate recommendations for changes to existing facility processes using a CQI model. These meetings are documented in minutes housed in the work setting. The quality improvement committee conducts assessments of action plan results and documents meaningful changes in service delivery as a result of the quality improvement activities.

Functions of the Quality Improvement Committee

The functions of a quality improvement committee generally fall into seven categories. These are:

* Coordinating the collection, review, and analysis of information to include outcome data.

* Identifying and prioritizing improvement opportunities.

* Selecting and preparing quality improvement teams.

* Overseeing the development of quality improvement projects and action plans; providing feedback.

* Assisting in the development and implementation of quality-related educational/training programs.

* Communicating quality initiatives and their outcomes to internal and external customers.

* Evaluating the overall quality improvement program at least annually.

What Should Happen if CQI/QAPI Is Being Practiced Consistently and Correctly?

If CQI/QAPI principles are being practiced consistently and correctly, both internal and external customers (patients, patients' families, doctors, staff, surveyors, payers) are more satisfied with the services and care provided. The ability to comply with federal and state regulations and to meet renal community standards is increased, and the likelihood of lawsuits is lessened. Patient complaints to the ESRD Network and State Department of Public Health are few to none. Most importantly, patient outcomes improve over time and are sustained.

From a practical perspective, less time is spent on dealing with problems and crises. Patient care is less fragmented, while at the same time, caregivers experience greater job satisfaction as they see their efforts improve care.


Quality and continuous quality improvement play a key role in health care. The specialty of nephrology is no exception. Quality and its ongoing improvement is the right thing to do because of the human lives at stake. It is also the business thing to do because of regulatory compliance and pay-for-performance expectations.

Quality improvement in health care is not a new concept. CQI, however, has at times been misunderstood, under used, and even misused. It is not simply paperwork to be completed for regulatory or corporate compliance. It is a time-tested, common-sense approach to quality that really works in helping to identify improvement needs, develop solutions, and assess results of actions taken, both in the short and long term. When all is said and done, CQI is a mindset--a way of thinking about and practicing for quality.


Editor's Note: ANNA's latest publication, Applying Continuous Quality Improvement in Clinical Practice, offers nephrology nurses the knowledge and tools to successfully integrate continuous quality improvement into clinical practice. This chapter is provided to offer our readers a preview of the book.


Centers for Medicare and Medicaid Services (CMS). (2008). Medicare program; Conditions for coverage for end-stage renal disease facilities. Washington, DC: Federal Register.

Hradesky, J.L. (1995). Total quality management handbook. New York: McGraw-Hill, Inc.

Hunt, V.D. (1992). Quality in America. Homewood, IL: Business One Irwin.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO). (1992). Using quality improvement tools in a healthcare setting. Oakbrook, IL: Author.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO). (1994). Forums, charts, and other tools for performance improvement. Oakbrook, II: Author.

Lohr, K.N. (Ed.). (1990). Medicare: A strategy for quality assurance in Medicare. Washington, DC: National Academy Press.

Schroeder, P.S. (1994). Improving quality and performance: Concepts, programs, and techniques. St Louis: Mosby.

Walton, M. (1986). The Deming management method. New York: Putnam Publishing Group.

Gail Wick, MHSA, BSN, RN, CNN
Table 1-1
Improvements in the Nephrology
Setting to Explore

Access function and type     Nutrition

Adequacy of dialysis         Patient adherence
Adverse occurrences          Patient knowledge and
Anemia and iron management   Patient employment
Bone and mineral disorders   PD complications
Diabetes control and         Quality of life
Exercise                     Re-use of dialyzers
Falls and patient safety     Rehabilitation
Family abuse                 Regulatory compliance
Hospitalizations             Social functioning and support
Hyperlipidemia               Sodium/fluid/BP control
Machine maintenance          Staff attrition or job
Missed treatments            Transplantation
Mortality                    Water treatment

Source: Used with permission from Gail Wick.
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Title Annotation:Applying Continuous Quality Improvement in Clinical Practice
Author:Wick, Gail
Publication:Nephrology Nursing Journal
Geographic Code:1USA
Date:Sep 1, 2009
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