Chapter 44. Tools and Strategies for Quality 

Improvement and Patient Safety 

Ronda G. Hughes 

Background 

The necessity for quality and safety improvement initiatives permeates health care.1, 2 Quality 

health care is defined 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”3 (p. 1161). According to the Institute of Medicine (IOM) report, To Err Is Human,

4

the majority of medical errors result from faulty systems and processes, not individuals. 

Processes that are inefficient and variable, changing case mix of patients, health insurance, 

differences in provider education and experience, and numerous other factors contribute to the 

complexity of health care. With this in mind, the IOM also asserted that today’s health care 

industry functions at a lower level than it can and should, and it put forth the following six aims 

of health care: effective, safe, patient-centered, timely, efficient, and equitable.2 The aims of 

effectiveness and safety are targeted through process-of-care measures, assessing whether 

providers of health care perform processes that have been demonstrated to achieve the desired 

aims and avoid those processes that are predisposed toward harm. The goals of measuring health 

care quality are to determine the effects of health care on desired outcomes and to assess the 

degree to which health care adheres to processes based on scientific evidence or agreed to by 

professional consensus and is consistent with patient preferences. 

Because errors are caused by system or process failures,5 it is important to adopt various 

process-improvement techniques to identify inefficiencies, ineffective care, and preventable 

errors to then influence changes associated with systems. Each of these techniques involves 

assessing performance and using findings to inform change. This chapter will discuss strategies 

and tools for quality improvement—including failure modes and effects analysis, Plan-DoStudy-Act, Six Sigma, Lean, and root-cause analysis—that have been used to improve the 

quality and safety of health care. 

Measures and Benchmarks 

Efforts to improve quality need to be measured to demonstrate “whether improvement efforts 

(1) lead to change in the primary end point in the desired direction, (2) contribute to unintended 

results in different parts of the system, and (3) require additional efforts to bring a process back 

into acceptable ranges”6

 (p. 735). The rationale for measuring quality improvement is the belief 

that good performance reflects good-quality practice, and that comparing performance among 

providers and organizations will encourage better performance. In the past few years, there has 

been a surge in measuring and reporting the performance of health care systems and 

processes.1, 7–9 While public reporting of quality performance can be used to identify areas 

needing improvement and ascribe national, State, or other level of benchmarks,10, 11 some 

providers have been sensitive to comparative performance data being published.12 Another 

audience for public reporting, consumers, has had problems interpreting the data in reports and 

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has consequently not used the reports to the extent hoped to make informed decisions for higherquality care.13–15

The complexity of health care systems and delivery of services, the unpredictable nature of 

health care, and the occupational differentiation and interdependence among clinicians and 

systems16–19 make measuring quality difficult. One of the challenges in using measures in health 

care is the attribution variability associated with high-level cognitive reasoning, discretionary 

decisionmaking, problem-solving, and experiential knowledge.20–22 Another measurement 

challenge is whether a near miss could have resulted in harm or whether an adverse event was a 

rare aberration or likely to recur.23

The Agency for Healthcare Research and Quality (AHRQ), the National Quality Forum, the 

Joint Commission, and many other national organizations endorse the use of valid and reliable 

measures of quality and patient safety to improve health care. Many of these useful measures that 

can be applied to the different settings of care and care processes can be found at AHRQ’s 

National Quality Measures Clearinghouse (http://www.qualitymeasures.ahrq.gov) and the 

National Quality Forum’s Web site (http://www.qualityforum.org). These measures are generally 

developed through a process including an assessment of the scientific strength of the evidence 

found in peer-reviewed literature, evaluating the validity and reliability of the measures and 

sources of data, determining how best to use the measure (e.g., determine if and how risk 

adjustment is needed), and actually testing the measure.24, 25

Measures of quality and safety can track the progress of quality improvement initiatives 

using external benchmarks. Benchmarking in health care is defined as the continual and 

collaborative discipline of measuring and comparing the results of key work processes with those 

of the best performers26 in evaluating organizational performance. There are two types of 

benchmarking that can be used to evaluate patient safety and quality performance. Internal 

benchmarking is used to identify best practices within an organization, to compare best practices 

within the organization, and to compare current practice over time. The information and data can 

be plotted on a control chart with statistically derived upper and lower control limits. However, 

using only internal benchmarking does not necessarily represent the best practices elsewhere. 

Competitive or external benchmarking involves using comparative data between organizations to 

judge performance and identify improvements that have proven to be successful in other 

organizations. Comparative data are available from national organizations, such as AHRQ’s 

annual National Health Care Quality Report1 and National Healthcare Disparities Report,9

 as 

well as several proprietary benchmarking companies or groups (e.g., the American Nurses 

Association’s National Database of Nursing Quality Indicators). 

Quality Improvement Strategies 

More than 40 years ago, Donabedian27 proposed measuring the quality of health care by 

observing its structure, processes, and outcomes. Structure measures assess the accessibility, 

availability, and quality of resources, such as health insurance, bed capacity of a hospital, and 

number of nurses with advanced training. Process measures assess the delivery of health care 

services by clinicians and providers, such as using guidelines for care of diabetic patients. 

Outcome measures indicate the final result of health care and can be influenced by 

environmental and behavioral factors. Examples include mortality, patient satisfaction, and 

improved health status. 

Twenty years later, health care leaders borrowed techniques from the work of Deming28 in 

rebuilding the manufacturing businesses of post-World War II Japan. Deming, the father of Total 

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Quality Methods, Benchmarking

Quality Management (TQM), promoted “constancy of purpose” and systematic analysis and 

measurement of process steps in relation to capacity or outcomes. The TQM model is an 

organizational approach involving organizational management, teamwork, defined processes, 

systems thinking, and change to create an environment for improvement. This approach 

incorporated the view that the entire organization must be committed to quality and improvement 

to achieve the best results.29

In health care, continuous quality improvement (CQI) is used interchangeably with TQM. 

CQI has been used as a means to develop clinical practice30 and is based on the principle that 

there is an opportunity for improvement in every process and on every occasion.31 Many inhospital quality assurance (QA) programs generally focus on issues identified by regulatory or 

accreditation organizations, such as checking documentation, reviewing the work of oversight 

committees, and studying credentialing processes.32 There are several other strategies that have 

been proposed for improving clinical practice. For example, Horn and colleagues discussed 

clinical practice improvement (CPI) as a “multidimensional outcomes methodology that has 

direct application to the clinical management of individual patients”33 (p. 160). CPI, an approach 

lead by clinicians that attempts a comprehensive understanding of the complexity of health care 

delivery, uses a team, determines a purpose, collects data, assesses findings, and then translates 

those findings into practice changes. From these models, management and clinician commitment 

and involvement have been found to be essential for the successful implementation of change.34–

36 From other quality improvement strategies, there has been particular emphasis on the need for 

management to have faith in the project, communicate the purpose, and empower staff.37

In the past 20 years, quality improvement methods have “generally emphasize[d] the 

importance of identifying a process with less-than-ideal outcomes, measuring the key 

performance attributes, using careful analysis to devise a new approach, integrating the 

redesigned approach with the process, and reassessing performance to determine if the change in 

process is successful”38 (p. 9). Besides TQM, other quality improvement strategies have come 

forth, including the International Organization for Standardization ISO 9000, Zero Defects, Six 

Sigma, Baldridge, and Toyota Production System/Lean Production.6, 39, 40

Quality improvement is defined “as systematic, data-guided activities designed to bring about 

immediate improvement in health care delivery in particular settings”41 (p. 667). A quality 

improvement strategy is defined as “any intervention aimed at reducing the quality gap for a 

group of patients representative of those encountered in routine practice”38 (p. 13). Shojania and 

colleagues38 developed a taxonomy of quality improvement strategies (see Table 1), which infers 

that the choice of the quality improvement strategy and methodology is dependent upon the 

nature of the quality improvement project. Many other strategies and tools for quality 

improvement can be accessed at AHRQ’s quality tools Web site (www.qualitytools.ahrq.gov) 

and patient safety Web site (www.patientsafety.gov). 

Table 1. Taxonomy of Quality Improvement Strategies With Examples of Substrategies

QI Strategy Examples 

Provider reminder systems • Reminders in charts for providers 

• Computer-based reminders for providers 

• Computer-based decision support 

Facilitated relay of clinical data to providers • Transmission of clinical data from outpatient specialty clinic 

to primary care provider by means other than medical record 

(e.g., phone call or fax) 

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QI Strategy Examples 

Audit and feedback • Feedback of performance to individual providers 

• Quality indicators and reports 

• National/State quality report cards 

• Publicly released performance data 

• Benchmarking – provision of outcomes data from top 

performers for comparison with provider’s own data 

Provider education • Workshops and conferences 

• Educational outreach visits (e.g., academic detailing) 

• Distributed educational materials 

Patient education • Classes 

• Parent and family education 

• Patient pamphlets 

• Intensive education strategies promoting self-management 

of chronic conditions 

Patient reminder systems • Materials and devices promoting self-management 

Promotion of self-management • Postcards or calls to patients 

Organizational change • Case management, disease management 

• TQM, CQI techniques 

• Multidisciplinary teams 

• Change from paper to computer-based records 

• Increased staffing 

• Skill-mix changes 

Financial incentives, regulation, and policy Provider directed: 

• Financial incentives based on achievement of performance 

goals 

• Alternative reimbursement systems (e.g., fee-for-service, 

capitated payments) 

• Licensure requirements 

Patient directed: 

• Copayments for certain visit types 

• Health insurance premiums, user fees 

Health system directed: 

• Initiatives by accreditation bodies (e.g., residency work hour 

limits) 

• Changes in reimbursement schemes (e.g., capitation, 

prospective payment, salaried providers) 

Note: Reprinted with permission from AHRQ38 (pp. 17–18).

Quality improvement projects and strategies differ from research: while research attempts to 

assess and address problems that will produce generalizable results, quality improvement 

projects can include small samples, frequent changes in interventions, and adoption of new 

strategies that appear to be effective.6

 In a review of the literature on the differences between 

quality improvement and research, Reinhardt and Ray42 proposed four criteria that distinguish 

the two: (1) quality improvement applies research into practice, while research develops new 

interventions; (2) risk to participants is not present in quality improvement, while research could 

pose risk to participants; (3) the primary audience for quality improvement is the organization, 

and the information from analyses may be applicable only to that organization, while research is 

intended to be generalizable to all similar organizations; and (4) data from quality improvement 

is organization-specific, while research data are derived from multiple organizations. 

The lack of scientific health services literature has inhibited the acceptance of quality 

improvement methods in health care,43, 44 but new rigorous studies are emerging. It has been 

asserted that a quality improvement project can be considered more like research when it 

involves a change in practice, affects patients and assesses their outcomes, employs 

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Quality Methods, Benchmarking

randomization or blinding, and exposes patients to additional risks or burdens—all in an effort 

towards generalizability.45–47 Regardless of whether the project is considered research, human 

subjects need to be protected by ensuring respect for participants, securing informed consent, and 

ensuring scientific value.41, 46, 48

Plan-Do-Study-Act (PDSA) 

Quality improvement projects and studies aimed at making positive changes in health care 

processes to effecting favorable outcomes can use the Plan-Do-Study-Act (PDSA) model. This is 

a method that has been widely used by the Institute for Healthcare Improvement for rapid cycle 

improvement.31, 49 One of the unique features of this model is the cyclical nature of impacting 

and assessing change, most effectively accomplished through small and frequent PDSAs rather 

than big and slow ones,50 before changes are made systemwide.31, 51

The purpose of PDSA quality improvement efforts is to establish a functional or causal 

relationship between changes in processes (specifically behaviors and capabilities) and 

outcomes. Langley and colleagues51 proposed three questions before using the PDSA cycles: (1) 

What is the goal of the project? (2) How will it be known whether the goal was reached? and (3) 

What will be done to reach the goal? The PDSA cycle starts with determining the nature and 

scope of the problem, what changes can and should be made, a plan for a specific change, who 

should be involved, what should be measured to understand the impact of change, and where the 

strategy will be targeted. Change is then implemented and data and information are collected. 

Results from the implementation study are assessed and interpreted by reviewing several key 

measurements that indicate success or failure. Lastly, action is taken on the results by 

implementing the change or beginning the process again.51

Six Sigma 

Six Sigma, originally designed as a business strategy, involves improving, designing, and 

monitoring process to minimize or eliminate waste while optimizing satisfaction and increasing 

financial stability.52 The performance of a process—or the process capability—is used to 

measure improvement by comparing the baseline process capability (before improvement) with 

the process capability after piloting potential solutions for quality improvement.53 There are two 

primary methods used with Six Sigma. One method inspects process outcome and counts the 

defects, calculates a defect rate per million, and uses a statistical table to convert defect rate per 

million to a σ (sigma) metric. This method is applicable to preanalytic and postanalytic processes 

(a.k.a. pretest and post-test studies). The second method uses estimates of process variation to 

predict process performance by calculating a σ metric from the defined tolerance limits and the 

variation observed for the process. This method is suitable for analytic processes in which the 

precision and accuracy can be determined by experimental procedures. 

One component of Six Sigma uses a five-phased process that is structured, disciplined, and 

rigorous, known as the define, measure, analyze, improve, and control (DMAIC) approach.53, 54

To begin, the project is identified, historical data are reviewed, and the scope of expectations is 

defined. Next, continuous total quality performance standards are selected, performance 

objectives are defined, and sources of variability are defined. As the new project is implemented, 

data are collected to assess how well changes improved the process. To support this analysis, 

validated measures are developed to determine the capability of the new process. 

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Six Sigma and PDSA are interrelated. The DMAIC methodology builds on Shewhart’s plan, 

do, check, and act cycle.55 The key elements of Six Sigma is related to PDSA as follows: the plan 

phase of PDSA is related to define core processes, key customers, and customer requirements of 

Six Sigma; the do phase of PDSA is related to measure performance of Six Sigma; the study 

phase of PDSA is related to analyze of Six Sigma; and the act phase of PDSA is related to 

improve and integrate of Six Sigma.56

Toyota Production System/Lean Production System 

Application of the Toyota Production System—used in the manufacturing process of Toyota 

cars57—resulted in what has become known as the Lean Production System or Lean 

methodology. This methodology overlaps with the Six Sigma methodology, but differs in that 

Lean is driven by the identification of customer needs and aims to improve processes by 

removing activities that are non-value-added (a.k.a. waste). Steps in the Lean methodology 

involve maximizing value-added activities in the best possible sequence to enable continuous 

operations.58 This methodology depends on root-cause analysis to investigate errors and then to 

improve quality and prevent similar errors. 

Physicians, nurses, technicians, and managers are increasing the effectiveness of patient care 

and decreasing costs in pathology laboratories, pharmacies,59–61 and blood banks61 by applying 

the same principles used in the Toyota Production System. Two reviews of projects using Toyota 

Production System methods reported that health care organizations improved patient safety and 

the quality of health care by systematically defining the problem; using root-cause analysis; then 

setting goals, removing ambiguity and workarounds, and clarifying responsibilities. When it 

came to processes, team members in these projects developed action plans that improved, 

simplified, and redesigned work processes.59, 60 According to Spear, the Toyota Production 

System method was used to make the “following crystal clear: which patient gets which 

procedure (output); who does which aspect of the job (responsibility); exactly which signals are 

used to indicate that the work should begin (connection); and precisely how each step is carried 

out”60 (p. 84). 

Factors involved in the successful application of the Toyota Production System in health care 

are eliminating unnecessary daily activities associated with “overcomplicated processes, 

workarounds, and rework”59 (p. 234), involving front-line staff throughout the process, and 

rigorously tracking problems as they are experimented with throughout the problem-solving 

process. 

Root Cause Analysis 

Root cause analysis (RCA), used extensively in engineering62 and similar to critical incident 

technique,63 is a formalized investigation and problem-solving approach focused on identifying 

and understanding the underlying causes of an event as well as potential events that were 

intercepted. The Joint Commission requires RCA to be performed in response to all sentinel 

events and expects, based on the results of the RCA, the organization to develop and implement 

an action plan consisting of improvements designed to reduce future risk of events and to 

monitor the effectiveness of those improvements.64

RCA is a technique used to identify trends and assess risk that can be used whenever human 

error is suspected65 with the understanding that system, rather than individual factors, are likely 

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Quality Methods, Benchmarking

the root cause of most problems.2, 4 A similar procedure is critical incident technique, where after 

an event occurs, information is collected on the causes and actions that led to the event.63

An RCA is a reactive assessment that begins after an event, retrospectively outlining the 

sequence of events leading to that identified event, charting causal factors, and identifying root 

causes to completely examine the event.66 Because it is a labor-intensive process, ideally a 

multidisciplinary team trained in RCA triangulates or corroborates major findings and increases 

the validity of findings.67 Taken one step further, the notion of aggregate RCA (used by the 

Veterans Affairs (VA) Health System) is purported to use staff time efficiently and involves 

several simultaneous RCAs that focus on assessing trends, rather than an in-depth case 

assessment.68

Using a qualitative process, the aim of RCA is to uncover the underlying cause(s) of an error 

by looking at enabling factors (e.g., lack of education), including latent conditions (e.g., not 

checking the patient’s ID band) and situational factors (e.g., two patients in the hospital with the 

same last name) that contributed to or enabled the adverse event (e.g., an adverse drug event). 

Those involved in the investigation ask a series of key questions, including what happened, why 

it happened, what were the most proximate factors causing it to happen, why those factors 

occurred, and what systems and processes underlie those proximate factors. Answers to these 

questions help identify ineffective safety barriers and causes of problems so similar problems can 

be prevented in the future. Often, it is important to also consider events that occurred 

immediately prior to the event in question because other remote factors may have contributed.68

The final step of a traditional RCA is developing recommendations for system and process 

improvement(s), based on the findings of the investigation.68 The importance of this step is 

supported by a review of the literature on root-cause analysis, where the authors conclude that 

there is little evidence that RCA can improve patient safety by itself.69 A nontraditional strategy, 

used by the VA, is aggregate RCA processes, where several simultaneous RCAs are used to 

examine multiple cases in a single review for certain categories of events.68, 70

Due the breadth of types of adverse events and the large number of root causes of errors, 

consideration should be given to how to differentiate system from process factors, without 

focusing on individual blame. The notion has been put forth that it is a truly rare event for errors 

to be associated with irresponsibility, personal neglect, or intention,71 a notion supported by the 

IOM.4, 72 Yet efforts to categorize individual errors—such as the Taxonomy of Error Root Cause 

Analysis of Practice Responsibility (TERCAP), which focuses on “lack of attentiveness, lack of 

agency/fiduciary concern, inappropriate judgment, lack of intervention on the patient’s behalf, 

lack of prevention, missed or mistaken MD/healthcare provider’s orders, and documentation 

error”73 (p. 512)—may distract the team from investigating systems and process factors that can 

be modified through subsequent interventions. Even the majority of individual factors can be 

addressed through education, training, and installing forcing functions that make errors difficult 

to commit. 

Failure Modes and Effects Analysis 

Errors will inevitably occur, and the times when errors occur cannot be predicted. Failure 

modes and effects analysis (FMEA) is an evaluation technique used to identify and eliminate 

known and/or potential failures, problems, and errors from a system, design, process, and/or 

service before they actually occur.74–76 FMEA was developed for use by the U.S. military and 

has been used by the National Aeronautics and Space Administration (NASA) to predict and 

evaluate potential failures and unrecognized hazards (e.g., probabilistic occurrences) and to 

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proactively identify steps in a process that could reduce or eliminate future failures.77 The goal of 

FMEA is to prevent errors by attempting to identifying all the ways a process could fail, estimate 

the probability and consequences of each failure, and then take action to prevent the potential 

failures from occurring. In health care, FMEA focuses on the system of care and uses a 

multidisciplinary team to evaluate a process from a quality improvement perspective. 

This method can be used to evaluate alternative processes or procedures as well as to monitor 

change over time. To monitor change over time, well-defined measures are needed that can 

provide objective information of the effectiveness of a process. In 2001, the Joint Commission 

mandated that accredited health care providers conduct proactive risk management activities that 

identify and predict system weaknesses and adopt changes to minimize patient harm on one or 

two high-priority topics a year.78

HFMEA. Developed by the VA’s National Center for Patient Safety, the health failure 

modes and effects analysis (HFMEA) tool is used for risk assessment. There are five steps in 

HFMEA: (1) define the topic; (2) assemble the team; (3) develop a process map for the topic, 

and consecutively number each step and substep of that process; (4) conduct a hazard analysis 

(e.g., identify cause of failure modes, score each failure mode using the hazard scoring matrix, 

and work through the decision tree analysis);79 and (5) develop actions and desired outcomes. In 

conducting a hazard analysis, it is important to list all possible and potential failure modes for 

each of the processes, to determine whether the failure modes warrant further action, and to list 

all causes for each failure mode when the decision is to proceed further. After the hazard 

analysis, it is important to consider the actions needed to be taken and outcome measures to 

assess, including describing what will be eliminated or controlled and who will have 

responsibility for each new action.79

Research Evidence 

Fifty studies and quality improvement projects were included in this analysis. The findings 

were categorized by type of quality method employed, including FMEA, RCA, Six Sigma, Lean, 

and PDSA. Several common themes emerged: (1) what was needed to implement quality 

improvement strategies, (2) what was learned from evaluating the impact of change 

interventions, and (3) what is known about using quality improvement tools in health care. 

What Was Needed To Implement Quality Improvement Strategies? 

Substantial and strong leadership support,80–83 involvement,81, 84 consistent commitment to 

continuous quality improvement,85, 86 and visibility,87 both in writing and physically, 86 were 

important in making significant changes. Substantial commitment from hospital boards was also 

found to be necessary.86, 88 The inevitability of resource demands associated with changing 

process required senior leadership to (1) ensure adequate financial resources87–89 by identifying 

sources of funds for training and purchasing and testing innovative technologies90 and 

equipment;91 (2) facilitate and enable key players to have the needed time to be actively involved 

in the change processes,85, 88, 89 providing administrative support; 90 (3) support a time-consuming 

project by granting enough time for it to work;86, 92 and (4) emphasize safety as an organizational 

priority and reinforce expectations, especially when the process was delayed or results were 

periodically not realized.87 It was also asserted that senior leaders needed to understand the 

impact of high-level decisions on work processes and staff time,88 especially when efforts were 

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Quality Methods, Benchmarking

underway to change practice, and that quality improvement needed to be incorporated into 

systemwide leadership development.88 Leadership was needed to make patient safety a key 

aspect of all meetings and strategies,85, 86 to create a formal process for identifying annual patient 

safety goals for the organization, and to hold themselves accountable for patient safety 

outcomes.85

Even with strong and committed leadership, some people within the organization may be 

hesitant to participate in quality improvement efforts because previous attempts to create change 

were hindered by various system factors,93 a lack of organization-wide commitment,94 poor 

organizational relationships, and ineffective communication.89 However the impact of these 

barriers were found to be lessened if the organization embraced the need for change,95 changed 

the culture to enable change,90 and actively pursued institutionalizing a culture of safety and 

quality improvement. Yet adopting a nonpunitive culture of change took time,61, 90 even to the 

extent that the legal department in one hospital was engaged in the process to turn the focus to 

systems, not individual-specific issues.96 Also, those staff members involved in the process felt 

more at ease with improving processes, particularly when cost savings were realized and when 

no layoff policies were put in place to protect job security even when efficiencies were 

realized.84

The improvement process needed to engage97 and involve all stakeholders and gain their 

understanding that the investment of resources in quality improvement could be recouped with 

efficiency gains and fewer adverse events.86 Stakeholders were used to (1) prioritize which safe 

practices to target by developing a consensus process among stakeholders86, 98 around issues that 

were clinically important, i.e., hazards encountered in everyday practice that would make a 

substantial impact on patient safety; (2) develop solutions to the problems that required 

addressing fundamental issues of interdisciplinary communication and teamwork, which were 

recognized as crucial aspects of a culture of safety; and (3) build upon the success of other 

hospitals.86 In an initiative involving a number of rapid-cycle collaboratives, successful 

collaboratives were found to have used stakeholders to determine the choice of subject, define 

objectives, define roles and expectations, motivate teams, and use results from data analyses.86

Additionally, it was important to take into account the different perspectives of stakeholders.97

Because variation in opinion among stakeholders and team members was expected99 and 

achieving buy-in from all stakeholders could have been difficult to achieve, efforts were made to 

involve stakeholders early in the process, solicit feedback,100 and gain support for critical 

changes in the process.101

Communication and sharing information with stakeholders and staff was critical to 

specifying the purpose and strategy of the quality initiative;101 developing open channels of 

communication across all disciplines and at all levels of leadership/staff, permitting the voicing 

of concerns and observations throughout the process of creating change;88 ensuring that patients 

and families were appropriately included in the dialogue; ensuring that everyone involved felt 

that he or she was an integral part of the health care team and was responsible for patient safety; 

sharing lessons learned from root-cause analysis; and capturing attention and soliciting buy-in by 

sharing patient safety stories with staff and celebrating successes, no matter how small.85 Yet in 

trying to keep everyone informed of the process and the data behind decisions, some staff had 

difficulty accepting system changes made in response to the data.89

The successful work of these strategies was dependent upon having motivated80 and 

empowered teams. There were many advantages to basing the work of the quality improvement 

strategies on the teamwork of multidisciplinary teams that would review data and lead change.91

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These teams needed to be comprised of the right staff people,91, 92 include peers,102 engage all of 

the right stakeholders (ranging from senior managers to staff), and be supported by senior-level 

management/leadership.85, 86 Specific stakeholders (e.g., nurses and physicians) had to be 

involved81 and supported to actually make the change, and to be the champions103 and problemsolvers within departments59 for the interventions to succeed. Because implementing the quality 

initiatives required substantial changes in the clinician’s daily work,86 consideration of the 

attitude and willingness of front-line staff for making the specific improvements59, 88, 104 was 

needed. 

Other key factors to improvement success were implementing protocols that could be 

adapted to the patient’s needs93 and to each unit, based on experience, training, and culture.88 It 

was also important to define and test different approaches; different approaches can converge 

and arrive at the same point.81 Mechanisms that facilitated staff buy-in was putting the types and 

causes of errors in the forefront of providers’ minds, making errors visible,102 being involved in 

the process of assessing work and looking for waste,59 providing insight as to whether the 

improvement project would be feasible and its impact measurable,105 and presenting evidencebased changes.100 Physicians were singled out as the one group of clinicians that needed to 

lead106 or be actively involved in changes,86 especially when physician behaviors could create 

inefficiencies.84 In one project, physicians were recruited as champions to help spread the word 

to other physicians about the critical role of patient safety, to make patient safety a key aspect of 

all leadership and medical management meetings and strategies.85

Team leaders and the composition of the team were also important. Team leaders that 

emphasized efforts offline to help build and improve relationships were found to be necessary for 

team success.83, 93 These teams needed a dedicated team leader who would have a significant 

amount of time to put into the project.84 While the leader was not identified in the majority of 

reports reviewed for this paper, the team on one project was co-chaired by a physician and an 

administrator.83 Not only did the type and ability of team leaders affect outcomes, the visibility 

of the initiative throughout the organization was dependent upon having visible champions.100

Multidisciplinary teams needed to understand the numerous steps involved in quality 

improvement and that there were many opportunities for error, which essentially enabled teams 

to prioritize the critical items to improve within a complex process and took out some of the 

subjectivity from the analysis. The multidisciplinary structure of teams allowed members to 

identify each step from their own professional practice perspective, anticipate and overcome 

potential barriers, allowed the generation of diverse ideas, and allowed for good discussion and 

deliberations, which together ultimately promoted team building.100, 107 In two of the studies, 

FMEA/HFMEA was found to minimize group biases by benefiting from the diversity within 

multidisciplinary composition of the team and enabling the team to focus on a structured outline 

of the goals that needed to be accomplished.107, 108

Teams needed to be prepared and enabled to meet the demands of the quality initiatives with 

ongoing education, weekly debriefings, review of problems solved and principles applied,84 and 

ongoing monitoring and feedback opportunities.92, 95 Education and training of staff 95, 80, 95, 101, 104

and leadership 80 about the current problem, quality improvement tools, the planned change in 

practice intervention, and updates as the project progressed were key strategies.92 Training was 

an ongoing process 91 that needed to focus on skill deficits82 and needed to be revised as lessons 

were learned and data was analyzed during the implementation of the project.109 The assumption 

could not be made that senior staff or leadership would not need training.105 Furthermore, if the 

team had no experience with the quality tools or successfully creating change, an additional 

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Quality Methods, Benchmarking

resource could have been a consultant or someone to facilitate the advanced knowledge involved 

in quality improvement techniques.106 Another consideration was using a model that intervened 

at the hospital-community interface, coupled with an education program.97

The influence of teamwork processes enabled those within the team to improve relationships 

across departments.89 Particular attention needed to be given to effective team building,110

actively following the impact of using the rapid-cycle (PDSA) model, meeting frequently, and 

monitoring progress using outcome data analysis at least on a monthly basis.86 Effective 

teamwork and communication, information transfer, coordination among multiple hospital 

departments and caregivers, and changes to hospital organization culture were considered 

essential elements of team effectiveness.86 Yet the impact of team members that had difficulty in 

fully engaging in teamwork because of competing workloads (e.g., working double shifts) was 

dampened.97 Better understanding of each other’s role is an important project outcome and 

provides a basis for continuing the development of other practices to improve outcomes.97 The 

work of teams was motivated through continual sharing of progress and success and celebration 

of achievements.87

Teamwork can have many advantages, but only a few were discussed in the reports reviewed. 

Teams were seen as being able to increase the scope of knowledge, improve communication 

across disciplines, and facilitate learning about the problem.111 Teams were also found to be 

proactive, 91 integrating tools that improve both the technical processes and organizational 

relationships,83 and to work together to understand the current situation, define the problem, 

pathways, tasks, and connections, as well as to develop a multidisciplinary action plan.59 But 

teamwork was not necessarily an easy process. Group work was seen as difficult for some and 

time consuming,111 and problems arose when everyone wanted their way,97 which delayed 

convergence toward a consensus on actions. Team members needed to learn how to work with a 

group and deal with group dynamics, confronting peers, conflict resolution, and addressing 

behaviors that are detrimental.111

What Was Learned From Evaluating the Impact of 

Change Interventions? 

As suggested by Berwick,112 the leaders of the quality improvement initiatives in this review 

found that successful initiatives needed to simplify;96, 104 standardize;104 stratify to determine 

effects; improve auditory communication patterns; support communication against the authority 

gradient; 96 use defaults properly; automate cautiously; 96 use affordance and natural mapping 

(e.g., design processes and equipment so that the easiest thing to do is the right thing to do); 

respect limits of vigilance and attention; 96 and encourage reporting of near hits, errors, and 

hazardous conditions.96 Through the revision and standardization of policies and procedures, 

many of these initiatives were able to effectively realize the benefit of making the new process 

easier than the old and decrease the effect of human error associated with limited vigilance and 

attention.78, 80–82, 90–92, 94, 96, 102, 103, 113, 114

Simplification and standardization were found to be effective as a forcing function by 

decreasing reliance on individualized decisionmaking. Several initiatives standardized 

medication ordering and administration protocols,78, 87, 101, 103, 106–108, 109, 114–116 realizing 

improvements in patient outcomes, nurse efficiency, and effectiveness.103, 106, 108, 109, 114–116 One 

initiative used a standardized form for blood product ordering.94 Four initiatives improved pain 

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3

assessment and management by using standardized metrics and assessment tools.80, 93, 100, 117 In 

all of these initiatives, simplification and standardization were effective strategies. 

Related to simplification and standardization is the potential benefit of using information 

technology to implement checks, defaults, and automation to improve quality and reduce errors, 

in large part to embedding forcing functions to remove the possibility of errors.96, 106 The effects 

of human error could be mitigated by using necessary redundancy, such as double-checking for 

certain types of errors; this was seen as engaging the knowledge and abilities of two skilled 

practitioners 61, 101 and was used successfully to reduce errors associated with dosing.78

Information technology was successfully used to (1) decrease the opportunity for human error 

through automation;61 (2) standardize medication concentrations78 and dosing using computerenabled calculations,115, 116 standardized protocols,101 and order clarity;116 (3) assist caregivers in 

providing quality care using alerts and reminders; (4) improve medication safety (e.g., 

implementing bar coding and computerized provider order entry); and (5) track performance 

through database integration and indicator monitoring. Often workflow and procedures needed to 

be revised to keep pace with technology.78 Using technology implied that organizations were 

committed to investing in technology to enable improvement,85 but for two initiatives, the lack of 

adequate resources for data collection impacted analysis and evaluation of the initiative.93, 97

Data and information were needed to understand the root causes of errors and near errors,99

to understand the magnitude of adverse events,106 to track and monitor performance,84, 118 and to 

assess the impact of the initiatives.61 Reporting of near misses, errors, and hazardous conditions 

needs to be encouraged.96 In part, this is because error reporting is generally low and is 

associated with organizational culture106 and can be biased, which will taint results.102 

Organizations not prioritizing reporting or not strongly emphasizing a culture of safety may have 

the tendency to not report errors that harm patients or near misses (see Chapter 35. “Evidence 

Reporting and Disclosure”). Using and analyzing data was viewed as critical, yet some team 

members and staff may have benefited from education on how to effectively analyze and display 

findings.106 Giving staff feedback by having a transparent process39 of reporting findings82 was 

viewed as a useful trigger that brought patient safety to the forefront of the hospital.107 It follows 

then that not having data, whether because it was not reported or not collected, made statistical 

analysis of the impact of the initiative115 or assessing its cost-benefit ratio not possible.108 As 

such, multi-organizational collaboration should have a common database.98

The meaning of data can be better understood by using measures and benchmarks. Repeated 

measurements were found to be useful for monitoring progress,118 but only when there was a 

clear metric for measuring the degree of success.83 The use of measures could be used as a 

strategy to involve more clinicians and deepened their interest, especially physicians. Using 

objective, broader, and better measures was viewed as being important for marking progress, and 

provided a basis for “a call to action” and celebration.106 When measures of care processes were 

used, it was asserted that there was a need to demonstrate the relationship between specific 

changes to care processes and outcomes.61

When multiple measures were used, along with better documentation of care, it was easier to 

assess the impact of the initiative on patient outcomes.93 Investigators from one initiative put 

forth the notion that hospital administrators should encourage more evaluations of initiatives and 

that the evaluations should focus on comprehensive models that assess patient outcomes, patient 

satisfaction, and cost effectiveness.114 The assessment of outcomes can be enhanced by setting 

realistic goals, not unrealistic goals such as 100 percent change,119 and by comparing 

organizational results to recognized State, regional, and national benchmarks.61, 88

12 
Quality Methods, Benchmarking

The cost of the initiative was an viewed as important factor in the potential for improvement, 

even when the adverse effects of current processes were considered as necessitating rapid 

change.106 Because of this, it is important to implement changes that are readily feasible106 and 

can be implemented with minimal disruption of practice activities.99 It is also important to 

consider the potential of replicating the initiative in other units or at other sites.99 One strategy to 

improve the chances of replication is to standardize processes, which will most likely incur some 

cost.106 In some respects, the faster small problems were resolved, the faster improvements could 

be replicated throughout the entire system.84, 106 Recommendations that did not incur costs or had 

low costs and could be demonstrated to be effective were implemented expeditiously.93, 107 A 

couple of investigators stated that their interventions decreased costs and patients’ length of 

stay,103 but did not present any data to verify those statements. It was also purported that the 

costs associated with change will be recouped either in return on investment or in reduced patient 

risk (and thus reduced liability costs).61

Ensuring that those implementing the initiative receive education is critical. There were 

several examples of this. Two initiatives that targeted pain management found that educating 

staff on pain management guidelines and protocols for improving chronic pain assessment and 

management improved staff understanding, assessment and documentation, patient and family 

satisfaction, and pain management.80, 93 Another initiative educated all staff nurses on 

intravenous (IV) site care and assessment, as well as assessment of central lines, and realized 

improved patient satisfaction and reduced complications and costs.109

Despite the benefits afforded by the initiatives, there were many challenges that were 

identified in implementing the various initiatives: 

• Lack of time and resources made it difficult to implement the initiative well.82

• Some physicians would not accept the new protocol and thwarted implementation until 

they had confidence in the tool.103

• Clear expectations were lacking. 86

• Hospital leadership was not adequately engaged.86

• There was insufficient emphasis on importance and use of measures.86

• The number and type of collaborative staffing was insufficient.86

• The time required for nurses and other staff to implement the changes was 

underestimated.120

• The extent to which differences in patient severity accounted for results could not be 

evaluated because severity of illness was not measured.89

• Improvements associated with each individual PDSA cycle could not be evaluated.89

• The full impact on the costs of care, including fixed costs for overhead, could not be 

evaluated.89

• Failure to consider the influence of factors such as fatigue, distraction, time pressures.82

• The Hawthorne effect may have caused improvements more so than the initiative.118

• Many factors were interrelated and correlated.96

• There was a lack of generalizability because of small sample size.93, 119

• Addressing some of the problems created others (e.g., implementing computerized 

physician order entry (CPOE)).110

• Targets set (e.g., 100 percent of admissions) may have been too ambitious and were thus 

always demanding and difficult-to-achieve service improvements.119

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3

Despite the aforementioned challenges, many investigators found that it was important to 

persevere and stay focused because introducing new processes can be difficult, 84, 100 but the 

reward of quality improvement is worth the effort.84 Implementing quality improvement 

initiatives was considered time consuming, tedious, and difficult for people who are very action 

oriented; it required an extensive investment of resources (i.e., time, money, and energy);94 and it 

involved trial and error to improve the process.91 Given theses and other challenges, it was also 

important to celebrate the victories.84

Other considerations were given to the desired objective of sustaining the changes after the 

implementation phase of the initiative ended.105 Investigators asserted that improving quality 

through initiatives needed to be considered as integral in the larger, organizationwide, ongoing 

process of improvement. Influential factors attributed to the success of the initiatives were 

effecting practice changes that could be easily used at the bedside;82 using simple 

communication strategies; 88 maximizing project visibility, which could sustain the momentum 

for change;100 establishing a culture of safety; and strengthening the organizational and 

technological infrastructure.121 However, there were opposing viewpoints about the importance 

of spreading the steps involved in creating specific changes (possibly by forcing changes into the 

redesign of processes), rather than only relying on only adapting best practices.106, 121 Another 

factor was the importance of generating enthusiasm about embracing change through a 

combination of collaboration (both internally and externally)103 and healthy competition.

Collaboratives could also be a vehicle for encouraging the use of and learning from evidencebased practice and rapid-cycle improvement as well as identifying and gaining consensus on 

potentially better practices.86, 98

What Is Known About Using Quality Improvement Tools in 

Health Care? 

Quality tools used to define and assess problems with health care were seen as being helpful 

in prioritizing quality and safety problems99 and focusing on systems,98 not individuals. The 

various tools were used to address errors and growing costs88 and to change provider practices.117

Several of the initiatives used more than one of the quality improvement tools, such as beginning 

with root-cause analysis then using either Six Sigma, Toyota Production System/Lean, or PlanDo-Study-Act to implement change in processes. Almost every initiative included in this 

analysis performed some type of pretesting/pilot testing.92, 99 Investigators and leaders of several 

initiatives reported advantages of using specific types of quality tools. These are discussed as 

follows: 

Root-cause analysis was reported to be useful to assess reported errors/incidents and 

differentiate between active and latent errors, to identify need for changes to policies and 

procedures, and to serve as a basis to suggest system changes, including improving 

communication of risk.82, 96, 102, 105

Six Sigma/Toyota Production System was reported to have been successfully used to 

decrease defects/variations59, 61, 81 and operating costs81 and improve outcomes in a variety of 

health care settings and for a variety of processes.61, 88 Six Sigma was found to be a detailed 

process that clearly differentiated between the causes of variation and outcome measures of 

process.61 One of the advantages of using Six Sigma was that it made work-arounds and rework 

difficult because the root causes of the preimplementation processes were targeted.59, 88

Additionally, investigators reported that the more teams worked with this strategy, the better they 

14 
Quality Methods, Benchmarking

became at implementing it and the more effective the results.84 Yet it was noted that to use this 

strategy effectively, a substantial commitment of leadership time and resources was associated 

with improved patient safety, lowered costs, and increased job satisfaction.84 Six Sigma was also 

an important strategy for problem-solving and continuous improvement; communicating clearly 

about the problem; guiding the implementation process; and producing results in a clear, concise, 

and objective way.59

Plan-Do-Study-Act (PDSA) was used by the majority of initiatives included in this analysis 

to implement initiatives gradually, while improving them as needed. The rapid-cycle aspect of 

PDSA began with piloting a single new process, followed by examining results and responding 

to what was learned by problem-solving and making adjustments, after which the next PDSA 

cycle would be initiated. The majority of quality improvement efforts using PDSA found greater 

success using a series of small and rapid cycles to achieve the goals for the intervention, because 

implementing the initiative gradually allowed the team to make changes early in the process80

and not get distracted or sidetracked by every detail and too many unknowns.87, 119, 122 The ability 

of the team to successfully use the PDSA process was improved by providing instruction and 

training on the use of PDSA cycles, using feedback on the results of the baseline 

measurements,118 meeting regularly,120 and increasing the team’s effectiveness by collaborating 

with others, including patients and families,80 to achieve a common goal.87 Conversely, some 

teams experienced difficulty in using rapid-cycle change, collecting data, and constructing run 

charts,86 and one team reported that applying simple rules in PDSA cycles may have been more 

successful in a complex system.93

Failure modes and effects analysis (FMEA) was used to avoid events and improve or 

maintain the quality of care.123 FMEA was used prospectively to identify potential areas of 

failure94 where experimental characterization of the process at the desired speed of change could 

be assessed,115 and retrospectively to characterize the safety of a process by identifying potential 

areas of failure, learning about the process from the staff’s point of view.94 Using a flow chart of 

the process before beginning the analysis got the team to focus and work from the same 

document.94 Information learned from FMEA was used to provide data for prioritizing 

improvement strategies, serve as a benchmark for improvement efforts,116 educate and provide a 

rationale for diffusion of these practice changes to other settings,115 and increase the ability of the 

team to facilitate change across all services and departments within the hospital.124 Using FMEA 

facilitated systematic error management, which was important to good clinical care in complex 

processes and complex settings, and was dependent upon a multidisciplinary approach, 

integrated incident and error reporting, decision support, standardization of terminology, and 

education of caregivers.116

Health failure modes and effects analysis (HFMEA) was used to provide a more detailed 

analysis of smaller processes, resulting in more specific recommendations, as well as larger 

processes. HFEMA was viewed as a valid tool for proactive analysis in hospitals, facilitating a 

very thorough analysis of vulnerabilities (i.e., failure modes) before adverse events occurred.108

This tool was considered valuable in identifying the multifactoral nature of most errors108 and the 

potential risk for errors,111 but was seen as being time consuming.107 Initiatives that used 

HFMEA could minimize group biases through the multidisciplinary composition of the 

team78, 108, 115 and facilitate teamwork by providing a step-by-step process,107 but these initiatives 

required a paradigm shift for many.111

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3

Evidence-Based Practice Implications 

From the improvement strategies and projects assessed in this review, several themes 

emerged from successful initiatives that nurses can use to guide quality improvement efforts. The 

strength of the following practice implications is associated with the methodological rigor and 

generalizability of these strategies and projects: 

1. The importance of having strong leadership commitment and support cannot be 

overstated. Leadership needs to empower staff, be actively involved, and continuously 

drive quality improvement. Without the commitment and support of senior-level 

leadership, even the best intended projects are at great risk of not being successful. 

Champions of the quality initiative and quality improvement need to be throughout the 

organization, but especially in leadership positions and on the team. 

2. A culture of safety and improvement that rewards improvement and is driven to improve 

quality is important. The culture is needed to support a quality infrastructure that has the 

resources and human capital required for successfully improving quality. 

3. Quality improvement teams need to have the right stakeholders involved. 

4. Due to the complexity of health care, multidisciplinary teams and strategies are essential. 

Multidisciplinary teams from participating centers/units need to work closely together, 

taking advantage of communication strategies such as face-to-face meetings, conference 

calls, and dedicated e-mail listservs, and utilize the guidance of trained facilitators and 

expert faculty throughout the process of implementing change initiatives when possible.

5. Quality improvement teams and stakeholders need to understand the problem and root 

causes. There must be a consensus on the definition of the problem. To this end, a clearly 

defined and universally agreed upon metric is essential. This agreement is as crucial to 

the success of any improvement effort as the validity of the data itself. 

6. Use a proven, methodologically sound approach without being distracted by the jargon 

used in quality improvement. The importance given to using clear models, terms, and 

process is critical, especially because many of the quality tools are interrelated; using 

only one tool will not produce successful results. 

7. Standardizing care processes and ensuring that everyone uses those standards should 

improve processes by making them more efficient and effective—and improve 

organizational and patient outcomes. 

8. Evidence-based practice can facilitate ongoing quality improvement efforts. 

9. Implementation plans need to be flexible to adapt to needed changes as they come up 

10. Efforts to change practice and improve the quality of care can have multiple purposes, 

including redesigning care processes to maximize efficiency and effectiveness, improving 

customer satisfaction, improving patient outcomes, and improving organizational climate. 

11. Appropriate use of technology can improve team functioning, foster collaboration, reduce 

human error, and improve patient safety. 

12. Efforts need to have sufficient resources, including protected staff time. 

13. Continually collect and analyze data and communicate results on critical indicators 

across the organization. The ultimate goal of assessing and monitoring quality is to use 

findings to assess performance and define other areas needing improvement. 

14. Change takes time, so it is important to stay focused and persevere. 

16 
Quality Methods, Benchmarking

Research Implications 

Given the complexity of health care, assessing quality improvement is a dynamic and 

challenging area. The body of knowledge is slowly growing in this area, which could be due to 

the continued dilemma as to whether a quality improvement initiative is just that or whether it 

meets the definition of research and employs methodological rigor—even if it meets the 

requirements for publication. Various quality improvement methods have been used since 

Donabedian’s seminal publication in 1966,27 but only recently has health care quality 

improvement used the Six Sigma methodology and published findings; when it has, it has been 

used only on a single, somewhat isolated component of a larger system, making organizational 

learning and generalizability difficult. Because of the long standing importance of quality 

improvement, particularly driven by external sources (e.g., CMS and the Joint Commission) in 

the past few years, many quality improvement efforts within organizations have taken place and 

are currently in process, but may not have been published and therefore not captured in this 

review, and may not have necessarily warranted publication in the peer-reviewed literature. With 

this in mind, researchers, leaders and clinicians will need to define what should be considered 

generalizable and publishable in the peer-reviewed literature to move the knowledge of quality 

improvement methods and interventions forward.

While the impact of many of the quality improvement projects included in this analysis were 

mentioned in terms of clinical outcomes, functional outcomes, patient satisfaction, staff 

satisfaction, and readiness to change, cost and utilization outcomes and measurement is 

important in quality improvement efforts, especially when variation occurs. There are many 

unanswered questions. Some key areas are offered for consideration: 

• How can quality improvement efforts recognize the needs of patients, insurers, 

regulators, patients, and staff and be successful? 

• What is the best method to identify priorities for improvement and meet the competing 

needs of stakeholders? 

• What is the threshold of variation that needs to be attained to produce regular desired 

results? 

• How can a bottom-up approach to changing clinical practice be successful if senior 

leadership is not supportive or the organizational culture does not support change? 

In planning quality improvement initiatives or research, researchers should use a conceptual 

model to guide their work, which the aforementioned quality tools can facilitate. To generalize 

empirical findings from quality improvement initiatives, more consideration should be given to 

increasing sample size by collaborating with other organizations and providers. We need to have 

a better understanding of what tools work the best, either alone or in conjunction with other 

tools. It is likely that mixed methods, including nonresearch methods, will offer a better 

understanding of the complexity of quality improvement science. We also know very little about 

how tailoring implementation interventions contributes to process and patient outcomes, or what 

the most effective steps are that cross intervention strategies. Lastly, we do not know what 

strategies or combination of strategies work for whom and in what context, why they work in 

some settings or cases and not others, and what the mechanism is by which these strategies or 

combination of strategies work. 

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3

Conclusions 

Whatever the acronym of the method (e.g., TQM, CQI) or tool used (e.g., FMEA or Six 

Sigma), the important component of quality improvement is a dynamic process that often 

employs more than one quality improvement tool. Quality improvement requires five essential 

elements for success: fostering and sustaining a culture of change and safety, developing and 

clarifying an understanding of the problem, involving key stakeholders, testing change strategies, 

and continuous monitoring of performance and reporting of findings to sustain the change. 

Search Strategy 

To identify quality improvement efforts for potential inclusion in this systematic review, 

PubMed and CINAL were searched from 1997 to present. The following key words and terms 

were used: “Failure Modes and Effects Analysis/FMEA,” “Root Cause Analysis/RCA,” “Six 

Sigma,” “Toyota Production System/Lean,” and “Plan Do Study Act/PDSA.” Using these key 

words, 438 articles were retrieved. Inclusion criteria included reported processes involving 

nursing; projects/research involving methods such as FMEA, RCA, Six Sigma, Lean, or PDSA; 

qualitative and quantitative analyses; and reporting patient outcomes. Projects and research were 

excluded if they did not involve nursing on the improvement team, did not provide sufficient 

information to describe the process used and outcomes realized, nursing was not directly 

involved in the patient/study outcomes, or the setting was in a developing country. Findings from 

the projects and research included in the final analysis were grouped into common themes related 

to applied quality improvement. 

Author Affiliation 

Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for 

Healthcare Research and Quality. E-mail: Ronda.Hughes@ahrq.hhs.gov. 

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Evidence Table. Quality Methods 

Source Quality or Safety Issue Related to Clinical Practice Design Type Study Outcome Measure(s) Study Setting & Study Population Study Intervention Key Finding(s) Failure Modes and Effects Analysis (FMEA) Adachi 200578 Medication safety Quality improvement Medication errors, targeting wrong dose errors (Level 4) 422-bed hospital in California FMEA used to develop strategies – Standard order sets were revised, items from the formulary were removed, and the use of unapproved abbreviations was eliminated. – Used IV pumps with enhanced safety features. 1 year after medi

implemented, mewith IV infusion w59 to 46), and errdecreased from 422%. Errors relatconcentration we

Apkon 2004115 Medication safety Quality improvement Infusion drug errors (Level 4) 11-bed pediatric intensive care unit (ICU) in a children’s hospital None Standardization o

process, with the prolonging infusio72 hours, shifting pharmacy, and ppremanufactured fewer infusions pyear; process chaand patients. 

24
25

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Burgmeier 200294

Blood transfusion Quality 

improvement 

Errors associated with blood products administered to patients (Level 4) 

1 hospital in Ohio Following the 

FMEA, implemented the following changes: a standardized form listing choices for blood products and documenting medical necessity, form is faxed to the blood bank; used a blood-barrier system; required staff training; and changes in policies and procedures. 

Following the new blood transfusionreported within thNew process confinding more failudata are aggregaFlowcharting befoprocess itself was FMEA process wtedious, and diffic

Day 2006124 Dialysis treatment Quality 

improvement 

Risks for error in the process of administering dialysis (Level 4) 

1 hospital in Utah None Risk factors inclu

nephrology consuprocess; dialysis beyond their scoptreatments for chwithout a formal cinconsistently invnurses not reviewtreatment plan bea formal handoff 
26

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Esmail 2005107 Medication safety Quality 

improvement 

Systematic analysis for improvement in the ordering and administration of potassium chloride and potassium phosphate using HFMEA (Level 4) 

4 adult ICUs in 3 hospitals in Canada 

Implemented standardized protocol for potassium chloride and potassium phosphate. 

Using the HFMEAmade for the hoswho, where, and mixed, and identistandard labels foalike products. HFMEA helped pa complex medicordering to adminobjective. While the proceswas instrumental vials of intravenobe stored and pa

Gering 2005123 Patient transfer Pretest and 

post-test, quality improvement 

Adverse events (Level 3) 

2 VA medical centers 

A series of strategies to merge patients into one facility 

Nurses were critipatients from one After integration, in patient care, opcancellations decMRSA infections, decreased. 

Kim 2006116 Medication safety, 

CPOE 

Pretest, posttest study Medication order errors 

(Level 3) 

Pediatric oncology patients in 1 academic medical center in Maryland 

Implementation of a CPOE system 

After CPOE impledecrease in improdosing calculationdose calculationschecklists. There was no diffimproper dosing ohigher likelihood orders to treatme

Papastrat 2003111 Medication safety Changing practice 

project 

Error detection associated with medication administration (Level 4) 

First-semester baccalaureate nursing students at 1 university in Pennsylvania 

New teaching method 

Problem-based leto use findings froto develop solutioStudents applied settings. 
27

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Semple 200492 Patient monitoring Quality 

improvement 

Response time (Level 4) 

1 unit with telemetry in a hospital in Connecticut 

Procedure changes to enable nurse to respond to telemetry alarms 

Problem areas wnurses’ inability to color change, heaknow when their sounding. A series of changenable nurse resResponse to telefrom 12 minutes t

Singh 2004107 Error risk 

detection 

Pretest, posttest study Perceived type/cause of 

error (Level 3) 

1 academic rural primary care practice with 32 staff members 

Implementation of electronic medical record 

Perceived risk of physician and phbut hazards increinteraction in the as nurse-chart int

Singh 200799 Error risk 

detection 

Quality improvement 

Perceived type/cause of error (Level 4) 

2 primary care practices serving rural populations in New York 

None Nurses perceived 

stressed, or ill as resources for heltype and cause oHazard scores at higher, indicating greater frequency errors in their pra

Smith 200587 Medication safety Quality 

improvement 

Medication errors and adverse drug events (ADEs) (Level 4) 

1 hospital in Illinois 

Pharmacist staffing on patient care units to review orders and stock medications reduced errors by 45%; adult IV medications were standardized, and nonstandard doses were prepared by the pharmacy. 

There was a signFMEA score) red
28

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

van Tilburg 2006108 Medication safety, CPOE Quality improvement Errors associated with 

chemotherapy (Level 4) 

Pediatric oncology patients in a hospital in the Netherlands 

None Because changes 

could be made wnurse, a standardchanges in chemschedules was mBecause of admiprocedure was chpediatric oncologadminister vincrisaccess. 

Weir 2005101 Medication safety Quality 

improvement 

ADEs associated with patientcontrolled analgesia (PCA) (Level 4) 

1 hospital and clinics in California 

None Areas needing ch

standard IV PCA protocol; adding tmedication order orders; PCA pumincorrectly; and mPCAs. 71% of ADEs weprogramming errofactors (15%), eqand ordering erro

Plan-Do-Study-Act (PDSA) Baird 2001103 Medication safety Quality 

improvement 

Patient outcomes and reduced costs in the ICU (Level 4) 

Physicians, nurses, and clinical pharmacists in a 115 adult ICU beds in 1 large medical center in Texas 

Using a new heparin administration protocol in ICU 

Initial findings wit90% of patients rdoses (compared patients) and all rdoses (compared patients). Patients received because they recdose, reached a tdrug more quicklytherapeutic level. Nursing efficiency dose changes anMedication and ladecreased as did stay. 
29

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Bolch 200597 Care transitions Quality 

improvement 

Patients having a documented discharge plan, patients screened for risk, patients receiving followup care within 10 days of discharge (Level 4) 

Patients ages >

65, admitted to a hospital in South Australia 

Modified the nursing assessment/risk assessment tool 

Improvements in of discharge plandocumented discrisk assessment, community serviccommunication bcommunity provid

Buhr 200680 Pain management Quality 

improvement 

Improved assessment and management of chronic pain (Level 4) 

Patients and nurses (licensed practical nurses (LPNs), certified nursing assistants (CNAs), and registered nurses (RNs)) in 1 nursing home in North Carolina 

Increased knowledge of chronic pain assessment and management through education. Implemented updated policies and procedures, and used new tools for pain assessment and management. Revised standing orders for pain management. 

Pain assessment understanding imin the CNAs. Patient and family and feeling that paddressed increa

Docimo 200089 Throughput in 

emergency department (ED) 

Quality improvement 

Time in ED for minor illnesses and injuries (Level 4) 

1 ED in 1 hospital in Maryland 

Improved both the processes and relationships of hospital staff using PDSA cycles 

Nonacute patientaverage time of 1 waiting behind hiregistration. Physician assistatechnicians reporconditions and te

Dodds 2006119 Practice variation Quality 

improvement 

Length of stay, reduced variation in process of care (Level 4) 

Patients with chronic obstructive pulmonary disease (COPD) 

Redesigned service delivery by using a continuous quality improvement methodology and PDSA cycles 

Decrease in averIncrease in the nuadmitted directly unit and transferrdepartment. Improved the mainformation and cpatients. 
30

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Dunbar 2006100 Pain management Practice variation Quality improvement Frequency of painful 

procedures, managing pain associated with painful procedures (Level 4) 

11 neonatal ICUs Implemented 

evidence-based practices for pain management and sedation in neonates using PDSA cycles 

The combination quality improvemquality improvembetter patient out

Eisenberg 2002109

IV incidents Quality 

improvement 

IV care patient outcomes (Level 4) 

4 community hospitals 

Education of all staff nurses on IV site care and assessment, as well as assessment of central line, total parenteral nutrition (TPN). Revised 35 IV policies into 5, revised documentation flow sheets, and provided a resource manual. 

Reductions in comImproved patient No formal compla
31

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Erdek 200493 Pain management Prospective 

study 

Pain management and assessment (Level 4) 

2 surgical ICUs in 1 hospital in Maryland 

Implemented 4 PDSA cycles, including educating staff on pain management, modifying pain scales at patients’ bedsides, residents documenting pain scores for past 24 hours, and creating expectation that pain > 3 is a defect. 

Pain assessment 71%, and pain m59% to 97%. Documentation oimproved among 

Farbstein 2001106 Medication safety Quality improvement Types of medication 

administration errors (Level 4) 

6 improvement projects in hospitals in Massachusetts 

Implementation of best practices, using PDSA to assess impact 

The results preseimprovement protherapeutic anticoreceiving heparinalike errors; feweadverse events; scoumadin; improvtheir medication; of the morning disthe pharmacy. The investigators of medication safto measure outcofunctions built into changes sequentlow cost of changmentor team leaderrors to assess i
32

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Horbar 200398 Neonatal 

intensive care 

Quality improvement 

Improved quality and safety of neonatal intensive care (Level 4) 

34 centers Implemented, 

applying 4 key habits for improvement using rapid-cycle PDSA 

Developed 51 pothat were implemneonatal ICU teaand implementing 

Horner 2005117 Pain management Pretest and 

post-test study 

Improved pain assessment and management of residents (Level 3) 

9 nursing homes in North Carolina 

Chart audit and data feedback on quality indicators, provider education, and technical support for systems change using PDSA 

The number of reassessments incrResidents receivipain treatments in42%. Residents with daexcruciating pain of pain medicatio

Leape 200686 Medication 

reconciliation, communicating critical test results 

Quality improvement 

Implementation of safe practices (Level 4) 

58 hospitals (88%) in Massachusetts 

Institute for Healthcare Improvement model for improvement to care practices 

Participating hospthe following factothe practice, acceavailability of impProject success wengagement of sphysician engagePDSA cycles, pameetings. 

Pronovost 200083

Access to care Quality 

improvement 

Number of ambulance bypass hours (Level 4) 

1 hospital in Maryland 

PDSA to act on identified root causes, targeting bed sharing for patients needing ICU care that were managed in the ED 

Significant reductestimated $6 millrevenue. Success was achtools that improvecollaborative rela

Salvador 2003114 Medication safety Quality improvement Safety of hospital-based 

antenatal home care for high-risk women (Level 4) 

Physicians, nurses, and clinical pharmacists in 115 adult ICU beds in 1 large medical center in Texas 

Using a new heparin administration protocol in ICU 

New heparin protpatient care, imprand work satisfac$885 on averageThere were no dinewborn health o
33

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

van Tiel 2006118

Health care associated infections 

Quality improvement 

Compliance with infection control measures (Level 4) 

1 ICU and OR in a 715-bed university hospital in the Netherlands 

Instruction and training of nursing and medical staff on PDSA cycles 

Not wearing a facdecreased to 0%decreased to 33%Improved compliaincluding hand wawound care and tsurgical wound s

Warburton 2004120

Adverse outcomes in EDs 

Quality improvement 

Detect patients at risk for adverse outcomes, provide a plan of care, and target care services (Level 4) 

1 small hospital in Canada 

Implementation of the Elder Alert program using PDSA cycles 

Process evaluatiomeetings of provicollaborators wertools. Screening criteria patient population

Wojciechowski 2006122

PDSA Quality 

improvement 

Increasing access to patient education resources (Level 4) 

1 rehabilitation facility in a city in the Midwest 

Implementation of a new patient education system for medication and disease information using PDSA cycles 

Designing a new education system promoting change collaboration. 

Root-Cause Analysis (RCA) Gowdy 200390 Patient falls Quality 

improvment 

Incidence of inpatient falls (Level 4) 

1 hospital in North Carolina 

Implemented an action plan to prevent patient falls 

RCA identified risconfusion, gait ditoileting. Inpatient fall rate falls per 1,000 padecrease during t

Luther 2002104 Adverse events Quality 

improvement 

Incidence of ADEs, ventilatoracquired pneumonia, central-venouscatheter-related bloodstream infections (Level 4) 

2 hospitals in Texas 

Increased staffing levels and improved education. Conducted RCA to identify issues needing to be addressed by leadership and staff. 

Adverse events tprotocols decreasventilator-acquire47.8/1,000 ventilaand decreased cerelated bloodstre90th to the 50th pNosocomial InfecImplementation olength of stay from 
34

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Middleton 2007105

Root causes of errors 

Crosssectional study 

Adoption of recommendations detected from RCA (Level 4) 

12 physicians (86% response rate) and 17 nurses (100% response rate) in Sydney, Australia 

None Nurses were mor

view RCA recomthe causal statem“achievable,” and Physicians and nwere significantly the RCA recomm“eliminate” or “coSome recommento the causal statsignificantly less “achievable.” 

Mills 200582 Patient falls Quality 

improvement 

Incidence of falls and major injuries due to falls (Level 4) 

100 VA acute and long-term care facilities 

Aggregate RCA was used to support implementation of fall prevention strategies. 

61.4% of strategiand 20.9% were 34% of the facilitithe number of falreduction in majoThe impact of the been hampered bchanges without providing staff ed

Mutter 200395 Medication safety Quality 

improvement 

Frequency of medication administration errors (Level 4) 

1 451-bed acute care hospital in New Jersey 

After assessing causes of errors, established a nonpunitive environment to encourage error reporting and interviewed providers who reported errors. 

Improvement reqcontinual assessmRapid-cycle improdecrease medicaand to inform cha
35

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Plews-Ogan 2004102 Voluntary reporting of near 

miss/adverse events 

Crosssectional study 

Error reporting (Level 4) 

1 ambulatory site of a large teaching hospital 

System analysis and redesign using RCA. 

Two-thirds of the recommendations (i.e., involving mousually requiring and 10% level 3 (services). Using RCA increasystem issues weindividual blame. RCA identified threported errors, amade on an ongo

Rex 200096 Medication safety Quality 

improvement 

Rates of ADEs (Level 4) 

1 hospital in Texas 

Implemented policy changes to use forcing or constraining functions and better personnel support 

RCA identified enpatient acuity, chissues (e.g., new ADEs decreased Implementing blaidentification and performance impfocus on systems 
36

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Willeumier 200485 Medication safety Health care 

associated infections 

Quality improvement 

Rates of medication error reporting and ventilatorassociated pneumonia (VAP) rates (Level 4) 

8-hospital system in northern Illinois 

Improved medication availability, standardized nursing reassessment of medications, reinforced the 5 rights of medication administration, provided medication information, revised medication policies, and standardized nursing documentation of medication administration. Redesigned oral hygiene processes, used head positioning, and used collection and culture techniques for better diagnosis. 

Identified strategiassessment (a coFMEA). Medication error VAP rates decreaGreatest challengand sustaining a complexity of the underreporting of medical staff’s acpolicy. Improvement is dinvolvement of lewith staff, and the technology. 

Six Sigma Germaine 200791 Surgical site infections 

OR patient throughput 

Quality improvement 

OR turnover (Level 4) 

1 hospital in Michigan 

Implemented OR turnaround protocol 

Turnover decreasaverage of 18 miincrease by 5%. Surgical site infec2.14% to 1.07%. 
37

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Guinane 200481 Groin injury in cardiac 

catheterization patients 

Quality improvement 

Groin injury rates (Level 4) 

A team of physicians, nurses, and administrators involved in the care of cardiac catheterization patients in 1 hospital 

Implemented groin management process to decrease injury rates, reduce the cost of care, and improve customer satisfaction 

Groin injuries decthan 1% (e.g., 41defects) – sigma to 3.87. Length of stay thaupper limit decreato only 3% of the Operating costs tupper limit decreathe time. 

Johnson 2005125 Chest pain management Quality improvement Time for diagnosis and 

evidence-based treatment of patients with chest pain 

1 hospital in New York 

Implemented an algorithm, preprinted orders, and use of cardiac nurse practitioners from presentation in ED through discharge 

Increases in diagcardiac catheterizsurgery, especialpatients > 60 yea

Pexton 2004113 Surgical site infections Quality improvement Rate of colon and vascular surgical 

site infections (Level 4) 

1 medical center in West Virginia 

A preoperative order set with a checklist including recommended antibiotics and weight-based dosages, education of team members, physician report cards, and anesthetists and nurses prompting surgeons to use antibiotics. 

Surgical site infec91% (2.86 sigmapotential annual smillion. 
38

Source 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Toyota Production System (TPS)/Lean Aldarrab 2006126 Emergency care of patients with 

ST-elevation myocardial infarction (MI) 

Quality improvement 

Patients with appropriate reperfusion and adjunctive pharmacological treatment (Level 4) 

3-site tertiary/quaternary facility in Canada 

Implementation of evidencebased guidelines for ST-elevation in MI patients 

An RCA was useprocesses and to standardized. Targets were achappropriate reperthe median time othrombolytic therapercutaneous corappropriate thromtreatment use. It was noted that reinforcement of process would reperformance. 

Furman 200739 Error reporting Quality improvement Near-miss error reports 

(Level 4) 

1 medical center in Virginia 

Implemented an error reporting system, including a 24-hour hotline 

Nurses reported 4physicians 8%, mstaff 23%. Over a period of 3 error reports increa transparent discprocess. 

Jimmerson 200588 Medication safety Access to medical 

equipment 

Quality improvement 

Efficiency of testing patient’s glucose level at the bedside (Level 4) 

1 medical-surgical ICU in a hospital in Utah 

Installed glucometers in each room in the ICU 

Reduced time to to 4 minutes. Improved ability tthe protocol. No unlabeled speerroneous identifFewer RN interru

Nowinski 2006121

Medication administration 

Quality improvement 

Medication administration errors (Level 4) 

1 hospital in Pennsylvania 

Revised and streamlined medication administration process based on finding from an RCA 

Rapid, substantiaimprovements in achieved. Nursing staff reposatisfaction. 
39

Sourc

e 

Quality or Safety Issue Related to Clinical Practice 

Design Type 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention 

Key Finding(s) 

Printezis 200759 Using TPS in health care Literature review Reviewed five quality 

improvement projects to reduce medical errors in hospitals (Level 4) 

Improvement projects in hospitals 

None Simple pathways 

better operationaOrganizing princireliability and effedelivery systems. Problem-solver oconsultant, but sostakeholder. Many problems arelationships with TPS makes workdifficult to continuTPS helps staff ledaily activities. Front-line staff neabout making impClear, concise, acommunication is 

Thompson 200384

Medication administration 

Quality improvement 

Missing medications Complexity of the medication administration process (Level 4) 

Pharmacy and nursing units at 1 hospital in Pennsylvania 

Implemented: specific 

Rapid, substantiaimprovements in processes were aNursing staff reposatisfaction, assoimprovements.