Historically, quality improvement (QI) has been a strategy employed to ensure consistency in business processes and products, with a primary goal of changing performance and improving outcomes. Early health services research proposed the examination of the quality of health provision from a QI perspective as aspects of structure, process, and outcomes.1 Since the classic work of Donabedian in 1966, an emphasis on quality healthcare has continued to evolve and is now an integral component of today's U.S. healthcare delivery system. Agencies, accreditation processes, and a variety of state and national resources have been created to ensure the delivery of quality healthcare with a particular focus on patient safety in response to the Institute of Medicine's (IOM) To Err is Human: Building a Safer Health System report.2 The U.S. Agency for Healthcare Research and Quality defines “quality” healthcare as “doing the right thing, at the right time, for the right person—and having the best possible results.”3
QI has also been defined as the combined efforts of all involved in patient care to ensure that changes will lead to improvements in patient outcomes (health), system performance (care), and professional development (learning).4 Continuous quality improvement (CQI) is a method for improving care that's characterized by the feedback of systematically collected data and the utilization of statistical methods for the purpose of limiting inappropriate process variation.5 The fundamental principles of CQI include the elimination of inappropriate variation and continuous improvement through a constant effort to reduce waste, repetition in work, and inefficient processes.6
Current evolving forces driving the improvement of the structure, process, and outcomes of nursing and the healthcare delivery system include regulatory and accreditation requirements of The Joint Commission and Det Norske Veritas legislation (enacted in 2010 with the Patient Protection and Affordable Care Act), the enactment of the Patient Protection and Affordable Care Act subpart II Health Care Quality Improvement Programs and its requirements, and the Magnet® recognition process.
The purpose of QI methodologies is to accomplish measurable organizational goals with performance improvement.7 The choice of which QI methodology to use within an organization depends on the nature of the improvement project because most methodologies share a common trait: repeatedly testing ideas and redesigning processes or technology based on previous errors or lessons learned. Clearly, QI is an evolving responsibility of hospital nurses today, and nurse participation is essential to hospital QI initiatives. Hospital nurses, from the frontline to management, however, may lack sufficient business background or academic preparation associated with QI specialization for effective participation and contributions to the process.
Industrial and business models
Industry-based and business models for quality management and measurement have been adopted by the healthcare industry over the past two decades and include Plan, Do, Study, Act (PDSA), Six Sigma, and the Lean process (including the rapid improvement methodology).8 These models have shaped and informed the way quality is understood, managed, and measured in healthcare settings across the continuum of care.
Plan, Do, Study, Act
The models of PDSA and Focus, Analyze, Develop, Execute (FADE) are the most commonly used approaches in healthcare settings.9 These methods involve a “trial and learning” approach in which a suggested improvement is tested on a small scale before changes are made to the whole system. The PDSA method allows for small tests of change with quick responses.
In the plan phase, an issue is identified and a process improvement plan is developed. In the do phase, the plan is implemented and any deviation from the plan is documented. These deviations are often called defects. The defects are then analyzed in the study phase. In this phase, results from the test cycle are studied, and questions are asked regarding what went right, what went wrong, and what will be changed in the next test cycle. In the act phase, lessons learned from the study phase are incorporated in the test of change, and a decision is made about continuation of the test cycle. If there's another test cycle, the steps are repeated.10
Six Sigma is a statistical modeling process originally used by Motorola that's now used in many hospital settings.11 The maturity and success of a process is described by a Sigma rating that indicates the yield of the percentage of defect-free products. A Six Sigma process indicates that products or services are statistically expected to be 99.99966% free from defects. The Greek letter Sigma is used in statistics to denote standard deviation (SD) from the mean. A SD of Six Sigma is equivalent to 3.4 defects or 3.4 errors per million opportunities. In applying these concepts to the patient care process, the provision of “perfect care” is achieved by reducing variation in care processes that contribute to errors. For example, when Six Sigma is achieved in the hospital setting, only 3.4 dose errors occur per million medication administrations, thus approaching “perfection.”
As a QI methodology, Six Sigma is mainly driven by projects designed to last 3 to 4 months. These projects are led and implemented by executive sponsors, project teams, and project owners. A Six Sigma approach follows five phases: define, measure, analyze, improve, and control. Each one of these steps involves statistical tools to assist with scoping the improvement opportunity, determining measurements of success, testing the hypothesis, evaluating solutions, and ensuring stability of the process.
The define phase includes tools such as assessing the perspective or “voice” of the customer, stakeholder analysis, project charter, definition of the problem statement, measurement of success, initial return on investment, and benefits to the customer and organization. The measurement phase strictly determines whether the opportunity for improvement is related to data validity or process opportunities using gage repeatability and reproducibility. Gage repeatability and reproducibility is a statistical technique that analyzes reproducibility and repeatability of a measurement system, which validates collected data. The analyze phase mainly focuses on identifying the biggest opportunities for improvement by creating and proving a hypothesis using more advanced statistical tools. The improve and control phases implement and monitor results from any changes put in place. One of the noteworthy advantages of this rigorous process is the identification of opportunities that may have been missed without a thorough investigation of process data.
The Lean process is evolving as an influential QI strategy in healthcare. Lean thinking and the Lean process are management strategies that originated in the automobile and manufacturing industries.12 The Toyota production system, often known as Lean, has been applied in many environments with impressive improvements in quality and efficiency. The underpinning values of Lean are to identify and remove nonvalue activities with an overarching goal to improve system processes by eliminating waste and maximizing value.13
Lean has the potential to reduce complexity and enhance the efficiency of patient care processes. This process is based on the following core principles:
* identify value from the customer's perspective
* identify and manage value stream processes used to provide a service to customers
* create flow process based on customers' demands
* create an environment of mutual responsibility
* strive for perfection.
In Lean hospitals, the patient is the primary customer, the one who justifies the existence and value of healthcare services. The second principle of Lean thinking—identifying and managing value streams to ensure the process is analyzed as a system and maximize opportunities to reduce waste—is the most frequently applied Lean tool in healthcare.14 The process involves visually depicting steps, delays, and information flows in delivering a product or service. This is accomplished by mapping every step or individual action involved in the process of delivering a specific healthcare service. For example, to streamline the discharge process, a value stream analysis may be used to identify each step involved from the time discharge is planned to the time the patient leaves the hospital.
Flow processes based on customer demand are known as “pull.” This principle relates to producing services or goods only when the customer asks for it, and lets the customer pull value from the company versus having the company “push” already designed products or services onto the market. An example of a push strategy can be applied to ordering the same lab tests for all patients admitted to the ED in an effort to save time knowing that not all patients will need certain tests (overproducing), versus ordering tests only when needed (pull strategy).
The final principle of Lean is excellence, which in healthcare can be translated to “do no harm.” Striving for perfection is undoubtedly the most important dimension in the provision of hospital services because the consequences of not doing the right thing the first and every time can result in adverse patient outcomes.2 Essential processes to achieve perfection are strategizing continuous improvements in the delivery of care and ensuring frontline staff involvement in identifying patient care systems that contribute to error. A Lean approach fosters interdisciplinary collaboration at the point of patient care by creating an environment of mutual responsibility and providing a framework for managing change inherent in hospital nursing care delivery.15
Kaizen, or Rapid Improvement Events (RIEs), is a Lean methodology that provides a mechanism for making radical changes to current processes and activities by rapidly closing the gap between desired and actual states of patient care delivery.13 The distinct benefit of RIEs is to reduce the time from problem identification to change implementation. A RIE typically involves the following stages:
* planning the event
* defining the current state
* defining the target state
* identifying waste
* designing improvements to eliminate waste
* improving process reliability and/or improving the patient care experience
* following up to ensure improvements are sustained over time.
The cycle is then evaluated and it's determined if further improvement is needed.
A fast and furious approach to problem solving and identification of solution training occurs in RIE processes. Team members are selected from diverse backgrounds and experiences to include experts in the current process and “fresh eyes,” or those with no knowledge of the current process. The “fresh eyes” are expected to contribute ideas for change and waste reduction without the bias of knowing the current practice. With the use of a trained facilitator, the team is expected to stay focused and close the gaps between current and future states of desired process changes. Outcomes of the RIE process are described in two broad areas: the performance of the healthcare system and leadership/educational development of employees and the work environment. RIE outcomes can provide a structure to evaluate the effectiveness of QI projects.
Leadership participation in RIEs is important so that implementation barriers, such as finance or resource issues, can be immediately addressed. Frontline or point-of-care staff involvement is equally essential in the process, particularly since they're responsible for implementing the change. The streamlined approach of RIEs requires minimal time commitment while facilitating immediate improvement.16
Examples of nonbusiness models include QI research, evidence-based practice (EBP) projects, and quality enhancement research initiatives. The following nonbusiness QI strategies provide problem-solving approaches while integrating research into the process.
QI can be translated into research, and the PDSA model's core methodology utilizes the scientific method for QI research. A QI project can be considered research if the tested intervention involves a change from established practices, individual patients are the subjects, randomization or blinding is conducted, and participants are subjected to additional risks or burdens beyond usual clinical practice to create generalized results. Randomized controlled trials, controlled studies, pre- and postintervention studies, and time series are commonly used methods in QI research. A notable advantage of QI research (with a robust study design) is that the findings from the study are more likely to be accepted for publication, thus contributing to future QI research.17
Conducting nursing research and using EBP are essential for Magnet recognition. The Magnet Recognition Program® promotes the use of new knowledge, innovations, and improvements to ensure quality patient outcomes, with EBP as a hallmark of nursing excellence in Magnet facilities. EBP is the use of the best evidence to guide and direct the delivery of healthcare services and includes the application of research findings, case reports, and expert opinion in making healthcare decisions.18
Although there are significant differences between EBP and QI, the goals of both processes are the same: to improve care processes and ultimately improve patient outcomes.7 Notably, the Iowa EBP model includes monitoring and analyzing structure, process, and outcomes—concepts that are foundational to the QI process. This model begins with the trigger of a clinical problem or new knowledge that can set an EBP project into motion and ends with the dissemination of project findings.19
Other commonly used models for EBP include Advancing Research and Clinical Practice Through Close Collaboration (ARCC) and the Johns Hopkins Nursing Evidence-Based Practice (JHNEBP) model. The ARCC model uses an EBP mentor to disseminate and implement EBP into the environment.20 This model first assesses the culture and cognitive beliefs of clinicians, which can be a major determinate for sustainable change. It then identifies the major barriers and facilitators to successfully navigate the implementation phase. EBP enculturation is the foundational element to the ARCC model and requires increased knowledge, interactive skill building, and strong mentorship.
The JHNEBP model is designed to guide clinical decision making by the hospital nurse and provide processes to answer administrative, operational, and educational questions. This model conceptualizes the core of nursing into research and nonresearch evidence within an open and dynamic organizational system providing strategies and guidelines to implement EBP. The JHNEBP process is broken down into three step-by-step phases:
* develop a practice question
* locate and appraise the evidence
* translate the evidence into practice.21
Implementation science is the study of methods to promote the integration of research findings and evidence into healthcare policy and practice. An example of implementation science is the Quality Enhancement Research Initiative (QUERI), a new discipline of implementation science and translation research. The Department of Veterans Affairs (VA) developed QUERI to allow optimal utilization of the VA health services, research expertise, and resources to improve the quality of care for veterans. The QUERI model is a six-step process to help turn research into practice. Specific steps include:
* identify high-risk/high-volume diseases or problems
* identify best practices
* define existing practice patterns and outcomes and current variation from best practices
* identify and implement interventions to promote best practices
* document the extent to which best practices improve outcomes
* document the relationship between outcomes and improved health-related quality of life.22
Business QI strategies are important models to improve hospital response when current systems don't work well or when improvement is needed in a system “just in time” to improve patient outcomes. Although there are many advantages associated with using business models in healthcare, a significant disadvantage is the lack of research evidence in the planning phase of many QI projects.16 Often, the objective is to address the need of a localized problem, such as an issue on one unit, making it fundamentally different from the aim of research, which is to address problems in a manner that yields generalized results applicable throughout an organization.
Literature reviews, the foundation to all scientific research, aren't typically incorporated in business models and the quasi-experimental design of QI projects and small sample sizes may not yield accurate results due the small scale of implementation. QI has inherent risks that include making changes too quickly without rigorous testing, and inadequate review and critique of published resources and studies.
Another QI limitation is that business methodologies use very specific language to identify and define processes that doesn't readily translate into the common scientific language used in hospitals. Nonbusiness models that involve research should be considered as a QI methodology when appropriate for the problem at hand. It's essential that hospitals continue to evaluate and conduct more research surrounding the utilization of business and nonbusiness models in the hospital setting while recognizing the foundational role that nurses can play in these processes. (See supplemental content on the Nursing Management iPad app.)
Hospital nurse practices
The American Nurses Association has developed a research agenda to require the use of research for EBP to identify gaps in evidence for nursing practice. Priority research areas include initiatives that contribute to processes, outcomes, and measures of safe, reliable, quality, and efficient nursing care. Endorsement of 15 nursing-sensitive measures by the National Quality Forum was an important advancement to standardize the measurement of nursing care and its relationship to quality and efficient healthcare. These measures provide the healthcare consumer with an assessment of nursing's quality contribution to inpatient hospital care, as well as identify outcomes and processes of care for continuous improvement influenced by nurses. The National Database of Nursing Quality Indicators,® a repository of nurse-sensitive indicators, allows for advances in quality care by providing a national comparison of nurse-sensitive indicators grouped by patient and unit type.
Nurses as direct care providers, educators, managers, and leaders share responsibility and accountability to ensure the quality and safety of the healthcare systems where they work. Nurses are essential to hospital QI efforts as direct caregivers because they can significantly influence the quality of care, timely treatment, and quality patient outcomes. Achieving the goal of providing quality care and ensuring the continuous improvement of care is particularly challenging in the complexity of today's healthcare system and requires a structured interprofessional approach to QI.
The IOM and the Robert Wood Johnson Foundation's visionary report on the Future of Nursing provides insight as to how nursing contributions to QI could be considered in planning and leading change.23 The four key messages in this landmark report provide a framework for QI recommendations related to prelicensure education, lifelong learning, and nurse involvement in leading QI projects and QI research. (See Table 1.)
Transforming healthcare, one project at a time
Important concerns and barriers for nursing staff involvement in QI activities include adequate time and resources. Notably, all nurses share QI responsibilities in their daily practice when catching errors, preventing harm, using keen assessment and critical thinking skills, and anticipating changes in a patient's condition. Requiring nurses to think about how they practice, what they practice, not taking shortcuts, providing QI tools, and documenting processes are foundational to the QI process. (See supplemental content on the Nursing Management iPad app.)
Hospitals may benefit from intentionally creating fun activities to engage staff in QI and offering opportunities for continued participation and training in QI activities.24 Communication, consistency, and collaboration need to be acknowledged and reinforced as key elements that contribute to quality outcomes. Doing things right and doing them well the first time reduces waste and rework and ultimately frees up valuable time for all healthcare providers.
Although QI and evidence-based methods are important practice strategies for hospital nurses, quality patient outcomes are equally important and dependent upon how the individual nurse practices. The professional dimension of the nurse is an essential contributing factor to excellent patient care, advances in nursing science, and hospital success. This professional dimension can best be supported by a hospital culture that engages nurse involvement in QI, EBP, and professional development through promoting education and lifelong learning opportunities.