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Quality improvement into practice

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• Adam Backhouse , quality improvement programme lead 1 ,
• Fatai Ogunlayi , public health specialty registrar 2
• 1 North London Partners in Health and Care, Islington CCG, London N1 1TH, UK
• 2 Institute of Applied Health Research, Public Health, University of Birmingham, B15 2TT, UK
• Correspondence to: A Backhouse adam.backhouse{at}nhs.net

What you need to know

Thinking of quality improvement (QI) as a principle-based approach to change provides greater clarity about ( a ) the contribution QI offers to staff and patients, ( b ) how to differentiate it from other approaches, ( c ) the benefits of using QI together with other change approaches

QI is not a silver bullet for all changes required in healthcare: it has great potential to be used together with other change approaches, either concurrently (using audit to inform iterative tests of change) or consecutively (using QI to adapt published research to local context)

As QI becomes established, opportunities for these collaborations will grow, to the benefit of patients.

The benefits to front line clinicians of participating in quality improvement (QI) activity are promoted in many health systems. QI can represent a valuable opportunity for individuals to be involved in leading and delivering change, from improving individual patient care to transforming services across complex health and care systems. 1

However, it is not clear that this promotion of QI has created greater understanding of QI or widespread adoption. QI largely remains an activity undertaken by experts and early adopters, often in isolation from their peers. 2 There is a danger of a widening gap between this group and the majority of healthcare professionals.

This article will make it easier for those new to QI to understand what it is, where it fits with other approaches to improving care (such as audit or research), when best to use a QI approach, making it easier to understand the relevance and usefulness of QI in delivering better outcomes for patients.

How this article was made

AB and FO are both specialist quality improvement practitioners and have developed their expertise working in QI roles for a variety of UK healthcare organisations. The analysis presented here arose from AB and FO’s observations of the challenges faced when introducing QI, with healthcare providers often unable to distinguish between QI and other change approaches, making it difficult to understand what QI can do for them.

How is quality improvement defined?

There are many definitions of QI ( box 1 ). The BMJ ’s Quality Improvement series uses the Academy of Medical Royal Colleges definition. 6 Rather than viewing QI as a single method or set of tools, it can be more helpful to think of QI as based on a set of principles common to many of these definitions: a systematic continuous approach that aims to solve problems in healthcare, improve service provision, and ultimately provide better outcomes for patients.

Definitions of quality improvement

Improvement in patient outcomes, system performance, and professional development that results from a combined, multidisciplinary approach in how change is delivered. 3

The delivery of healthcare with improved outcomes and lower cost through continuous redesigning of work processes and systems. 4

Using a systematic change method and strategies to improve patient experience and outcome. 5

To make a difference to patients by improving safety, effectiveness, and experience of care by using understanding of our complex healthcare environment, applying a systematic approach, and designing, testing, and implementing changes using real time measurement for improvement. 6

In this article we discuss QI as an approach to improving healthcare that follows the principles outlined in box 2 ; this may be a useful reference to consider how particular methods or tools could be used as part of a QI approach.

Principles of QI

Primary intent— To bring about measurable improvement to a specific aspect of healthcare delivery, often with evidence or theory of what might work but requiring local iterative testing to find the best solution. 7

Employing an iterative process of testing change ideas— Adopting a theory of change which emphasises a continuous process of planning and testing changes, studying and learning from comparing the results to a predicted outcome, and adapting hypotheses in response to results of previous tests. 8 9

Consistent use of an agreed methodology— Many different QI methodologies are available; commonly cited methodologies include the Model for Improvement, Lean, Six Sigma, and Experience-based Co-design. 4 Systematic review shows that the choice of tools or methodologies has little impact on the success of QI provided that the chosen methodology is followed consistently. 10 Though there is no formal agreement on what constitutes a QI tool, it would include activities such as process mapping that can be used within a range of QI methodological approaches. NHS Scotland’s Quality Improvement Hub has a glossary of commonly used tools in QI. 11

Empowerment of front line staff and service users— QI work should engage staff and patients by providing them with the opportunity and skills to contribute to improvement work. Recognition of this need often manifests in drives from senior leadership or management to build QI capability in healthcare organisations, but it also requires that frontline staff and service users feel able to make use of these skills and take ownership of improvement work. 12

Using data to drive improvement— To drive decision making by measuring the impact of tests of change over time and understanding variation in processes and outcomes. Measurement for improvement typically prioritises this narrative approach over concerns around exactness and completeness of data. 13 14

Scale-up and spread, with adaptation to context— As interventions tested using a QI approach are scaled up and the degree of belief in their efficacy increases, it is desirable that they spread outward and be adopted by others. Key to successful diffusion of improvement is the adaption of interventions to new environments, patient and staff groups, available resources, and even personal preferences of healthcare providers in surrounding areas, again using an iterative testing approach. 15 16

What other approaches to improving healthcare are there?

Taking considered action to change healthcare for the better is not new, but QI as a distinct approach to improving healthcare is a relatively recent development. There are many well established approaches to evaluating and making changes to healthcare services in use, and QI will only be adopted more widely if it offers a new perspective or an advantage over other approaches in certain situations.

A non-systematic literature scan identified the following other approaches for making change in healthcare: research, clinical audit, service evaluation, and clinical transformation. We also identified innovation as an important catalyst for change, but we did not consider it an approach to evaluating and changing healthcare services so much as a catch-all term for describing the development and introduction of new ideas into the system. A summary of the different approaches and their definition is shown in box 3 . Many have elements in common with QI, but there are important difference in both intent and application. To be useful to clinicians and managers, QI must find a role within healthcare that complements research, audit, service evaluation, and clinical transformation while retaining the core principles that differentiate it from these approaches.

Alternatives to QI

Research— The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. 17

Clinical audit— A way to find out if healthcare is being provided in line with standards and to let care providers and patients know where their service is doing well, and where there could be improvements. 18

Service evaluation— A process of investigating the effectiveness or efficiency of a service with the purpose of generating information for local decision making about the service. 19

Clinical transformation— An umbrella term for more radical approaches to change; a deliberate, planned process to make dramatic and irreversible changes to how care is delivered. 20

Innovation— To develop and deliver new or improved health policies, systems, products and technologies, and services and delivery methods that improve people’s health. Health innovation responds to unmet needs by employing new ways of thinking and working. 21

Why do we need to make this distinction for QI to succeed?

Improvement in healthcare is 20% technical and 80% human. 22 Essential to that 80% is clear communication, clarity of approach, and a common language. Without this shared understanding of QI as a distinct approach to change, QI work risks straying from the core principles outlined above, making it less likely to succeed. If practitioners cannot communicate clearly with their colleagues about the key principles and differences of a QI approach, there will be mismatched expectations about what QI is and how it is used, lowering the chance that QI work will be effective in improving outcomes for patients. 23

There is also a risk that the language of QI is adopted to describe change efforts regardless of their fidelity to a QI approach, either due to a lack of understanding of QI or a lack of intention to carry it out consistently. 9 Poor fidelity to the core principles of QI reduces its effectiveness and makes its desired outcome less likely, leading to wasted effort by participants and decreasing its credibility. 2 8 24 This in turn further widens the gap between advocates of QI and those inclined to scepticism, and may lead to missed opportunities to use QI more widely, consequently leading to variation in the quality of patient care.

Without articulating the differences between QI and other approaches, there is a risk of not being able to identify where a QI approach can best add value. Conversely, we might be tempted to see QI as a “silver bullet” for every healthcare challenge when a different approach may be more effective. In reality it is not clear that QI will be fit for purpose in tackling all of the wicked problems of healthcare delivery and we must be able to identify the right tool for the job in each situation. 25 Finally, while different approaches will be better suited to different types of challenge, not having a clear understanding of how approaches differ and complement each other may mean missed opportunities for multi-pronged approaches to improving care.

What is the relationship between QI and other approaches such as audit?

Academic journals, healthcare providers, and “arms-length bodies” have made various attempts to distinguish between the different approaches to improving healthcare. 19 26 27 28 However, most comparisons do not include QI or compare QI to only one or two of the other approaches. 7 29 30 31 To make it easier for people to use QI approaches effectively and appropriately, we summarise the similarities, differences, and crossover between QI and other approaches to tackling healthcare challenges ( fig 1 ).

How quality improvement interacts with other approaches to improving healthcare

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QI and research

Research aims to generate new generalisable knowledge, while QI typically involves a combination of generating new knowledge or implementing existing knowledge within a specific setting. 32 Unlike research, including pragmatic research designed to test effectiveness of interventions in real life, QI does not aim to provide generalisable knowledge. In common with QI, research requires a consistent methodology. This method is typically used, however, to prove or disprove a fixed hypothesis rather than the adaptive hypotheses developed through the iterative testing of ideas typical of QI. Both research and QI are interested in the environment where work is conducted, though with different intentions: research aims to eliminate or at least reduce the impact of many variables to create generalisable knowledge, whereas QI seeks to understand what works best in a given context. The rigour of data collection and analysis required for research is much higher; in QI a criterion of “good enough” is often applied.

Relationship with QI

Though the goal of clinical research is to develop new knowledge that will lead to changes in practice, much has been written on the lag time between publication of research evidence and system-wide adoption, leading to delays in patients benefitting from new treatments or interventions. 33 QI offers a way to iteratively test the conditions required to adapt published research findings to the local context of individual healthcare providers, generating new knowledge in the process. Areas with little existing knowledge requiring further research may be identified during improvement activities, which in turn can form research questions for further study. QI and research also intersect in the field of improvement science, the academic study of QI methods which seeks to ensure QI is carried out as effectively as possible. 34

Scenario: QI for translational research

Newly published research shows that a particular physiotherapy intervention is more clinically effective when delivered in short, twice-daily bursts rather than longer, less frequent sessions. A team of hospital physiotherapists wish to implement the change but are unclear how they will manage the shift in workload and how they should introduce this potentially disruptive change to staff and to patients.

Before continuing reading think about your own practice— How would you approach this situation, and how would you use the QI principles described in this article?

Adopting a QI approach, the team realise that, although the change they want to make is already determined, the way in which it is introduced and adapted to their wards is for them to decide. They take time to explain the benefits of the change to colleagues and their current patients, and ask patients how they would best like to receive their extra physiotherapy sessions.

The change is planned and tested for two weeks with one physiotherapist working with a small number of patients. Data are collected each day, including reasons why sessions were missed or refused. The team review the data each day and make iterative changes to the physiotherapist’s schedule, and to the times of day the sessions are offered to patients. Once an improvement is seen, this new way of working is scaled up to all of the patients on the ward.

The findings of the work are fed into a service evaluation of physiotherapy provision across the hospital, which uses the findings of the QI work to make recommendations about how physiotherapy provision should be structured in the future. People feel more positive about the change because they know colleagues who have already made it work in practice.

QI and clinical audit

Clinical audit is closely related to QI: it is often used with the intention of iteratively improving the standard of healthcare, albeit in relation to a pre-determined standard of best practice. 35 When used iteratively, interspersed with improvement action, the clinical audit cycle adheres to many of the principles of QI. However, in practice clinical audit is often used by healthcare organisations as an assurance function, making it less likely to be carried out with a focus on empowering staff and service users to make changes to practice. 36 Furthermore, academic reviews of audit programmes have shown audit to be an ineffective approach to improving quality due to a focus on data collection and analysis without a well developed approach to the action section of the audit cycle. 37 Clinical audits, such as the National Clinical Audit Programme in the UK (NCAPOP), often focus on the management of specific clinical conditions. QI can focus on any part of service delivery and can take a more cross-cutting view which may identify issues and solutions that benefit multiple patient groups and pathways. 30

Audit is often the first step in a QI process and is used to identify improvement opportunities, particularly where compliance with known standards for high quality patient care needs to be improved. Audit can be used to establish a baseline and to analyse the impact of tests of change against the baseline. Also, once an improvement project is under way, audit may form part of rapid cycle evaluation, during the iterative testing phase, to understand the impact of the idea being tested. Regular clinical audit may be a useful assurance tool to help track whether improvements have been sustained over time.

Scenario: Audit and QI

A foundation year 2 (FY2) doctor is asked to complete an audit of a pre-surgical pathway by looking retrospectively through patient documentation. She concludes that adherence to best practice is mixed and recommends: “Remind the team of the importance of being thorough in this respect and re-audit in 6 months.” The results are presented at an audit meeting, but a re-audit a year later by a new FY2 doctor shows similar results.

Before continuing reading think about your own practice— How would you approach this situation, and how would you use the QI principles described in this paper?

Contrast the above with a team-led, rapid cycle audit in which everyone contributes to collecting and reviewing data from the previous week, discussed at a regular team meeting. Though surgical patients are often transient, their experience of care and ideas for improvement are captured during discharge conversations. The team identify and test several iterative changes to care processes. They document and test these changes between audits, leading to sustainable change. Some of the surgeons involved work across multiple hospitals, and spread some of the improvements, with the audit tool, as they go.

QI and service evaluation

In practice, service evaluation is not subject to the same rigorous definition or governance as research or clinical audit, meaning that there are inconsistencies in the methodology for carrying it out. While the primary intent for QI is to make change that will drive improvement, the primary intent for evaluation is to assess the performance of current patient care. 38 Service evaluation may be carried out proactively to assess a service against its stated aims or to review the quality of patient care, or may be commissioned in response to serious patient harm or red flags about service performance. The purpose of service evaluation is to help local decision makers determine whether a service is fit for purpose and, if necessary, identify areas for improvement.

Service evaluation may be used to initiate QI activity by identifying opportunities for change that would benefit from a QI approach. It may also evaluate the impact of changes made using QI, either during the work or after completion to assess sustainability of improvements made. Though likely planned as separate activities, service evaluation and QI may overlap and inform each other as they both develop. Service evaluation may also make a judgment about a service’s readiness for change and identify any barriers to, or prerequisites for, carrying out QI.

QI and clinical transformation

Clinical transformation involves radical, dramatic, and irreversible change—the sort of change that cannot be achieved through continuous improvement alone. As with service evaluation, there is no consensus on what clinical transformation entails, and it may be best thought of as an umbrella term for the large scale reform or redesign of clinical services and the non-clinical services that support them. 20 39 While it is possible to carry out transformation activity that uses elements of QI approach, such as effective engagement of the staff and patients involved, QI which rests on iterative test of change cannot have a transformational approach—that is, one-off, irreversible change.

There is opportunity to use QI to identify and test ideas before full scale clinical transformation is implemented. This has the benefit of engaging staff and patients in the clinical transformation process and increasing the degree of belief that clinical transformation will be effective or beneficial. Transformation activity, once completed, could be followed up with QI activity to drive continuous improvement of the new process or allow adaption of new ways of working. As interventions made using QI are scaled up and spread, the line between QI and transformation may seem to blur. The shift from QI to transformation occurs when the intention of the work shifts away from continuous testing and adaptation into the wholesale implementation of an agreed solution.

Scenario: QI and clinical transformation

An NHS trust’s human resources (HR) team is struggling to manage its junior doctor placements, rotas, and on-call duties, which is causing tension and has led to concern about medical cover and patient safety out of hours. A neighbouring trust has launched a smartphone app that supports clinicians and HR colleagues to manage these processes with the great success.

This problem feels ripe for a transformation approach—to launch the app across the trust, confident that it will solve the trust’s problems.

Before continuing reading think about your own organisation— What do you think will happen, and how would you use the QI principles described in this article for this situation?

Outcome without QI

Unfortunately, the HR team haven’t taken the time to understand the underlying problems with their current system, which revolve around poor communication and clarity from the HR team, based on not knowing who to contact and being unable to answer questions. HR assume that because the app has been a success elsewhere, it will work here as well.

People get excited about the new app and the benefits it will bring, but no consideration is given to the processes and relationships that need to be in place to make it work. The app is launched with a high profile campaign and adoption is high, but the same issues continue. The HR team are confused as to why things didn’t work.

Outcome with QI

Although the app has worked elsewhere, rolling it out without adapting it to local context is a risk – one which application of QI principles can mitigate.

HR pilot the app in a volunteer specialty after spending time speaking to clinicians to better understand their needs. They carry out several tests of change, ironing out issues with the process as they go, using issues logged and clinician feedback as a source of data. When they are confident the app works for them, they expand out to a directorate, a division, and finally the transformational step of an organisation-wide rollout can be taken.

Education into practice

Next time when faced with what looks like a quality improvement (QI) opportunity, consider asking:

How do you know that QI is the best approach to this situation? What else might be appropriate?

Have you considered how to ensure you implement QI according to the principles described above?

Is there opportunity to use other approaches in tandem with QI for a more effective result?

How patients were involved in the creation of this article

This article was conceived and developed in response to conversations with clinicians and patients working together on co-produced quality improvement and research projects in a large UK hospital. The first iteration of the article was reviewed by an expert patient, and, in response to their feedback, we have sought to make clearer the link between understanding the issues raised and better patient care.

Contributors: This work was initially conceived by AB. AB and FO were responsible for the research and drafting of the article. AB is the guarantor of the article.

Competing interests: We have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

Provenance and peer review: This article is part of a series commissioned by The BMJ based on ideas generated by a joint editorial group with members from the Health Foundation and The BMJ , including a patient/carer. The BMJ retained full editorial control over external peer review, editing, and publication. Open access fees and The BMJ ’s quality improvement editor post are funded by the Health Foundation.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

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Quality Improvement Essentials Toolkit

Download these ten essential quality improvement tools to help you with your improvement projects, continuous improvement, and quality management, whether you use the Model for Improvement, Lean, or Six Sigma.

• 10 quality improvement tools: Cause and Effect Diagram, Driver Diagram, Failure Modes and Effects Analysis (FMEA) Tool, Flowchart, Histogram, Pareto Chart, PDSA Worksheet, Project Planning Form, Run Chart, Scatter Diagram
• Instructions, examples, and a template for each tool

Note: Spanish and Portuguese translations of this toolkit also available for download.

IHI’s Quality Improvement Essentials Toolkit includes the tools and templates you need to launch a successful quality improvement project and manage performance improvement. Each of the ten quality improvement (QI) tools can be used with the Model for Improvement , Lean, or Six Sigma, and includes a short description, instructions, an example, and a blank template.

The QI tools include:

• Cause and Effect Diagram: Also known as the Ishikawa or fishbone diagram, this tool helps you analyze the root causes contributing to an outcome.
• Failure Modes and Effects Analysis: Also used in Lean management and Six Sigma, FMEA is a systematic, proactive method for identifying potential risks and their impact.
• Run Charts: These charts help you monitor performance over time.
• PDSA Worksheet: Plan-Do-Study-Act rapid-cycle testing helps teams assess whether a change leads to improvement using a methodical learning process.

Download the complete toolkit with all ten tools, or download individual tools as you need them to guide your continuous improvement work.

*NOTE: Before filling out the templates, first save the PDF files to your computer. Then open and use that version of the tool. Otherwise, your changes will not be saved.

How to Cite This Document: Quality Improvement Essentials Toolkit . Boston: Institute for Healthcare Improvement; 2017. (Available at ihi.org)

IHI QI Essentials Toolkit Overview

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Home > Books > Contemporary Topics in Patient Safety - Volume 3 [Working Title]

Ten Quality Improvement Initiatives to Standardize Healthcare Processes

Submitted: 05 January 2024 Reviewed: 08 January 2024 Published: 16 February 2024

DOI: 10.5772/intechopen.1004229

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Contemporary Topics in Patient Safety - Volume 3 [Working Title]

M.D. Philip N. Salen and Dr. Stanislaw P. Stawicki

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Quality improvement is a continuous journey to standardize healthcare processes and structure to reduce variation, achieve predictable results, and improve outcomes for patients, healthcare systems, and organizations. Improving quality is about making health care safe, effective, patient-centered, timely, efficient, and equitable. It’s about giving the people closest to problems affecting care quality the time, permission, skills, and resources they need to solve them. Patient safety it’s a fundamental principle of excellent patient care. On the other hand, patient safety it’s a fundamental principle of excellent patient care. Patient safety also is one of the key components of the Institute of Medicine’s (IOM) six domains of healthcare quality (Safe, Timely, Effective, Efficient, Equitable, and Patient-centered) that is used as a metric to evaluate how safe is the practice. This work aims to highlight the main quality improvement initiatives, and tools used to standardize healthcare processes and improve patient safety.

• patient safety
• performance improvement
• quality initiatives
• standardization
• patient outcomes
• continuous quality improvement

Author Information

Mohammed m. albaadani *.

• Health Watch Wigan and Leigh, United Kingdom

Adel Omar Bataweel

• King Fahad Medical City, Riyadh, Saudi Arabia

Alaa Mahmoud Ismail

• Prince Sultan Military Medical City, Riyadh, Saudi Arabia

Jameelah Mohammed Yaqoob

• Ministry of Health and Population, Sana, Yemen

Ebrahim Sarwi Asiri

Hesham ahmed eid.

• Founder of Quality Education Club, Cairo, Egypt

Khaled M. Kasasbeh

Mohamed fathy shaban.

• King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia

Nasr Ali Mohammed

Samir mohammed bawazir, siham mohammed saleh.

• Prince Sultan Cardiac Center, Riyadh, Saudi Arabia

Yasser Sami Amer

• King Saud University Medical City, Riyadh, Saudi Arabia

*Address all correspondence to: [email protected]

1. Introduction

The healthcare system is designed to produce health, but it may do the opposite and cause harm. There are many factors influencing the likelihood of error. These factors include medical device design, the volume of tasks, the unity and clarity of guidelines and policies, the behavior of others focusing on strategies that maximize the frequency of things going right, the dependency of healthcare providers on one another, the diversity of patients, clinicians and other staff, the vulnerability of patients, variations in the physical layout of clinical environments, variability or lack of regulations, implementation of new technology, the diversity of care pathways and organizations involved [ 1 , 2 ]. These factors not only increase the vulnerability of patient harm but also make the healthcare system very complex and chaotic. Therefore, there is an urgent need for feasible solutions to cope with these challenges and standardize healthcare processes, making the health system safe, effective, and more efficient. Quality improvement initiatives play a key role in enhancing the quality of processes in hospitals and improving patient safety outcomes. By implementing evidence-based practices and clinical guidelines, healthcare organizations can ensure that patients receive appropriate and effective therapies that are tailored to their individual needs [ 3 ]. Quality improvement is defined as a systematic approach that is guided by data to improve health services and the quality of care and outcomes for patients based on iterative change, continuous testing and measurement, and empowerment of frontline teams [ 4 ]. It is also defined as the monitoring, assessing, and enhancement of quality healthcare standards as well as the implementation of a series of rigorous, systematic, organization-wide processes that result in measurable improvement in healthcare services [ 5 ]. On the other hand, continuous quality improvement (CQI) is defined as a progressive incremental improvement of processes, safety, and patient care [ 6 ]. The concept of CQI originated in Japan after World War II and was used extensively in the industrial and manufacturing sectors and has been utilized in the health sector [ 7 , 8 ]. Over several years, continuous quality improvement has evolved rapidly, and many methodologies have been developed to guide organizations toward streamlining their processes, reducing waste, and improving efficiency. There are many quality improvement tools and approaches which include clinical audit; Plan, Do, Study, Act; model for improvement; LEAN/Six Sigma; performance benchmarking, process mapping, and statistical process control [ 9 ].

2. Methodology

For this chapter, we conducted thorough research using a comprehensive literature search approach. We explored internet-based bibliographic databases such as Google™ Scholar and PubMed, as well as direct websites of reputable peer-reviewed journals, books, training courses, programs, and reference websites Joint Commission International (JCI), International Society for Quality in Healthcare (ISQua), and Institute of Healthcare Improvement (IHI) related to healthcare quality, safety, and improvement research. Our specific search terms included but were not limited to “patient safety,” “healthcare quality,” “health care quality,” “evidence-based healthcare,” “quality improvement,” “improvement research,” “implementation research,” “quality of health care,” “practice guidelines,” “clinical audit,” “accreditation,” “care bundles,” “patient care bundle” “continuous quality management,” “management, total quality,” and “education.” Initially, we found 230 results and refined our reference list to approximately 150 highly relevant to our chapter’s focus. Further screening excluded resources not aligned with the scope, resulting in a final list of 65 citations included in this chapter.

3. What is variation?

Since this chapter seeks to provide some tools to reduce variation that could affect the outcome of provided care services, it is very important to shed light on this concept. Variation means deviation from the norm. In clinical practice, variation means differences in healthcare processes or outcomes, compared to peers or a gold standard such as an evidence-based guideline recommendation [ 10 ]. Variations in healthcare are wide-ranging and can include an array of different treatment options, diagnostic procedures, and medication dosages. Variation is not necessarily bad, and it can be good as long as it occurs within certain parameters. Clinical variations can be either warranted or unwarranted. Warranted clinical variation is essentially unavoidable, as all doctors, nurses, and other practitioners have a different understanding or insight into a particular problem and utilize different protocols of problem management. On the other hand, unwarranted clinical variation is about the overuse or underuse of certain therapies, treatments, or diagnosis materials in a way that potentially hurts patient outcomes or the sustainability of the health system. The second type of variation is much more problematic in healthcare practice because it can increase the vulnerability to errors [ 11 ].

4. Sources of variation

The major sources of variation can be grouped into two major classes: common cause variation also called random variation which can happen in stable processes and special cause variation which is mainly seen in unstable processes. Both types will be explained later.

5. Contributing factors of the variability of health care

Operational variability refers to differences in care delivered directly by different involved in the patient care process. While each provider delivers care based on his/her understanding of the patient’s diagnosis and treatment plan, this can lead to significant differences in the way of delivering patient care.

Knowledge variability refers to differences in expertise among medical staff. This type of variability is often difficult to assess because it’s based on an individual provider’s educational and experience level.

Clinical practice guidelines and pathways

Policies and procedures (P&Ps)

Data-driven performance

The 5S methodology

High 5s project

Clinical audit

Quality of thinking

Education and training

Accreditation process

Care bundles

6. Clinical practice guidelines and pathways

6.1 background.

Clinical practice guidelines (CPGs) and integrated care pathways (ICPs) play a vital role in modern healthcare by providing a framework for standardizing medical practices and improving the quality and safety of patient care. These evidence-based tools offer healthcare professionals a structured approach to clinical decision-making, ensuring that patients receive the most effective and appropriate care. This article explores the significance of CPGs and ICPs in enhancing healthcare outcomes, quality improvement, and patient safety.

Clinical practice guidelines (CPGs) are systematically developed, evidence-based recommendations and statements that guide healthcare professionals in making informed decisions about the most appropriate healthcare interventions for specific clinical situations or conditions. CPGs are typically founded on a comprehensive review of the best available medical evidence, expert consensus, and the consideration of patient values and preferences. They aim to standardize and improve the quality of healthcare by providing a structured framework for clinical decision-making, diagnosis, treatment, and patient management [ 13 ].

Integrated care pathways (ICPs), also referred to as care pathways or clinical pathways, are multidisciplinary plans of care that outline the essential steps, activities, and interventions required for the effective management of patients with specific medical conditions, across the entire continuum of care. ICPs are designed to promote collaboration among healthcare professionals from various disciplines and ensure a seamless and coordinated delivery of care. They often incorporate CPGs and evidence-based practices into a structured framework that helps optimize patient outcomes, streamline healthcare processes, and enhance patient and caregiver engagement. They are also considered one of the main types of CPG implementation tools [ 14 , 15 ]. ICPs are particularly valuable for managing complex or chronic conditions by outlining the most appropriate care trajectories and facilitating communication and continuity of care among healthcare providers.

6.2 Evidence-based medicine and CPGs

Evidence-based medicine (EBM) is of paramount importance in healthcare as it ensures that clinical decisions and interventions are grounded in the best available scientific evidence. EBM promotes the rational, efficient, and patient-centered delivery of care by systematically integrating rigorous research findings with clinical expertise and patient values and preferences. It enhances the quality and safety of healthcare, reducing variations in practice and minimizing the potential for risk or harm. By adhering to EBM principles, healthcare professionals can optimize diagnostic accuracy, and treatment outcomes, reduce unnecessary interventions, and allocate resources more effectively, ultimately leading to improved patient outcomes, increased patient satisfaction, and the continuous advancement of medical knowledge and practice [ 13 ].

EBM forms the foundation of contemporary and modern healthcare. CPGs and ICPs are essential tools to apply EBM and Evidence-Based Healthcare in general, as they translate the latest research findings into practical recommendations for clinical practice and serve as a bridge between research and patient care.

One of the primary roles of CPGs and ICPs is to standardize care across healthcare settings which in turn leads to greater consistency, integration, and predictability in healthcare delivery. When healthcare professionals follow established CPGs and ICPs, patients can expect a uniform level of care, reducing variations and the potential for errors. This standardization is particularly critical in complex and high-risk areas, such as surgery and critical care.

6.3 Improving quality and safety of care

Adherence to CPGs and ICPs can significantly enhance the quality of care provided to patients [ 16 , 17 ]. By following evidence-based recommendations, healthcare providers can optimize treatment plans, reduce complications, and achieve better patient outcomes. CPGs help identify best practices, allowing healthcare institutions to measure and improve their performance continuously.

Patient safety is a paramount concern in healthcare, and CPGs and ICPs contribute significantly to minimizing risks. CPGs have a significant role in aiding the identification and mitigation of potential errors and adverse events [ 15 , 18 ]. They guide infection control, medication management, and other critical aspects of patient safety, ultimately reducing the likelihood of harm.

Moreover, by promoting efficient and effective care, these tools can lead to cost savings for healthcare systems that further highlight the economic benefits of using CPGs and ICPs. Standardized approaches reduce unnecessary procedures, hospital readmissions, and complications, resulting in better resource allocation and improved cost-effectiveness.

6.4 Challenges in guideline and pathway implementation

Implementing CPGs and their ICPs in healthcare settings faces several challenges [ 15 , 18 , 19 ]. The complexity of CPGs, varying levels of the quality of evidence, and the need for adaptation to local contexts (i.e., contextualization) can hinder effective implementation. Additionally, healthcare professionals may experience information overload, leading to difficulty in staying updated with numerous CPGs for the same health topics. Barriers to adoption include resistance to change, lack of awareness, and limited time and resources. Strategies to overcome these barriers involve engaging all relevant stakeholders in CPG development or adaptation, providing regular training, involving quality and clinical champions, regular audits and feedback, involving patients, and integrating CPGs into clinical workflows and ICPs. Successful models, such as the use of electronic health records for CPG dissemination and clinical decision support through automation or digitalization of CPGs and ICPs, have shown positive impacts on patient care by improving adherence to evidence-based practices.

6.5 Future, innovations, and the way forward

The landscape of CPGs and ICPs is evolving with advances in technology and methodology. As healthcare moves toward more dynamic, real-time decision-making, the development and dissemination of CPGs are increasingly incorporating sophisticated data analysis and digital platforms. This evolution is aimed at ensuring that guidelines are current, evidence-based, and readily accessible to healthcare professionals, especially with emerging concepts like living CPGs, living systematic reviews, and living sphere evidence [ 17 ].

Emerging technologies, such as machine learning and natural language processing, are revolutionizing the way CPGs are developed and disseminated. These technologies facilitate the analysis of large datasets to identify patterns and trends, which can inform CPG development. Additionally, digital dissemination platforms, including mobile apps and online portals, are making it easier for healthcare providers to access and apply guidelines in clinical practice.

The integration of artificial intelligence (AI) and data analytics is expected to pave the way for personalized CPG recommendations. AI algorithms can analyze patient data, consider individual health conditions and preferences, and suggest customized care plans and pathways. This approach aims to enhance the precision of treatments, improve patient outcomes, and streamline clinical decision-making processes, ushering in a new era of personalized medicine in CPG implementation.

7. Policies and Procedures (P&Ps)

7.1 background.

Policies are defined by the Joint Commission International (JCI) as rules and principles that guide and inform the organization’s procedures and processes whereas a procedure is defined as step-by-step instructions for how a task is performed [ 20 ]. Delivery of high-quality healthcare services requires up-to-date policies and procedures that reflect the latest good practice, and ensure compliance with the regulatory and legislative requirements [ 21 ]. In addition to their role in facilitating adherence to healthcare laws, accreditation requirements, licensing, and certification standards, clinical teams including doctors, nurses, pharmacists, and other care providers who are involved in patient care, P&Ps can play a vital role in communicating expectations and standards to staff, set guidelines for day-to-day operations and improvements, streamline processes and enhance patient safety [ 22 ].

7.2 Why policies and procedures are important?

Assist in carrying out daily patient care by clarifying the roles and responsibilities.

Serve as a unique communication tool between the treatment team.

Unify the practices between multidisciplinary teams and reduce the potential error rate that could happen due to variations in clinical practice.

Improve consistency and accuracy of the clinical process.

Guide decision-making process.

Protect the organization’s reputation and minimize any potential liabilities.

Improve confidence and satisfaction in teamwork.

7.3 General guidance for writing effective P&Ps

All policies and procedures should be written in simple and clear language to make them comprehensible to everyone. Minimize using abbreviations that could interrupt or confuse the reader. It is recommended to avoid using complex sentences with multiple clauses that would complicate understanding what the policy is about. They also must state clearly who does what and articulate the roles and responsibilities of individuals and departments responsible for carrying out certain duties. Finally, all P&Ps should be accessible to all teams.

7.4 Types of healthcare P&Ps

Patient care: is related to all P&Ps that guide clinicians to perform daily and routine patient care operations in the healthcare practice.

Health and safety: any kind of policy that helps staff deal with and handle any safety and health risks that could arise during patient care.

Drug handling and management: all types of policies and guidelines that assist in handling the medication management cycle transfer, storage, prescribing, preparation, administration, and so on.

Information management: all policies that support proper management of sensitive information inside healthcare facilities. They can include topics such as confidentiality, security, privacy, integrity of information, and distribution of medical records. It also includes retention time for patient medical records and other information

Administrative and human resources: it pertains to all policies that deal with recruitment, retention, development, and continuing education of staff.

7.5 Management of P&Ps

Policies and procedures must be developed through a standardized and systematic process starting by addressing the need for them that could stem from new legal requirements, and then assembling a multidisciplinary team (owners) that will be responsible for drafting, reviewing, finalizing, and approving the policy. Before implementing the P&PSs, the staff should be familiar with them and this can be achieved through focused training. Adherence of the staff should be monitored and any challenges or obstacles during implementation should be raised and fixed by the quality improvement team. Policies and procedures must be reviewed and updated periodically to ensure their relevancy and effectiveness.

8. Data-driven performance

8.1 background.

Data is a vital and valuable resource in healthcare, it is like a compass or the dashboard of the vehicle that serves to monitor its performance and alert the driver of any problem. In the healthcare field, we use Key Performance Indicators (KPIs) to track the improvement process (observe, analyze, optimize, and transform a healthcare process) and to make sure that staff are adhering to the standards of care. These metrics also can be used to compare (benchmarking) the organization’s performance to other similar healthcare facilities and identify areas for improvement [ 24 ]. Furthermore, they can help to support the effectiveness and efficiency of clinical care as well as to enhance continuous performance measurement [ 25 ]. Finally, these metrics can enable informed decision-making based on actual healthcare delivery models, for example, healthcare practitioners and leaders can use accurate, valid, reliable, timely, relevant, legible, and complete data to proactively adjust the clinical course of treatment for individual patients [ 26 , 27 ]. Performance indicators should not be seen as a quality improvement tool that will provide feasible solutions for how to fix the performance problems, they act only as diagnostic means and trigger the organization for any deviation in their process’s performance.

8.2 Sources of data

There are many sources for getting data either internal sources within the healthcare facility or external from accreditation, government, semi-government, non-profit patient advocacy, and commercial organizations in the field. The data collected from internal sources assist in regularly evaluating the performance of healthcare processes whereas the data used from external sources facilitate comparison with other organizations in the same field and have a similar scope of services as well as assist in setting performance targets. Table 1 shows the main sources of data.

Source of data.

8.3 Performance indicators

Performance monitoring is a continuous process that involves collecting data to determine if a service is meeting desired standards or targets [ 27 ]. Key Performance Indicators (KPIs) are well-defined performance measures that are used to observe, analyze, optimize, and transform a healthcare process to increase satisfaction for both patients and healthcare providers alike. These metrics are commonly used by care facilities to compare their performance to other care facilities and identify areas for improvement [ 24 ]. The performance measures are formulated either based on standards determined through evidence-based academic literature or the consensus of experts when evidence is unavailable [ 27 ].

8.4 Type of performance indicators

Structure measure : it evaluates the context in which healthcare is delivered from two aspects: the capacity of the physical settings (buildings, staff number, cost per unit, and used equipment, medicines, and systems) and the capabilities of care providers (staff qualifications, training, and competencies).

Process measure : it reflects the way health systems and processes work to deliver the desired outcome by applying specific actions that are consistent with professional standards of care and evidence-based guidelines for diagnosis.

Outcome measure: it refers to the effects or the outcome of healthcare such as reduced morbidity and mortality, reduced length of stay, reduced hospital-acquired infections, adverse incidents or harm.

8.5 Balancing measure

Balancing measure is another type of measure that aims to look at a system from different directions/dimensions. Any changes designed to improve one part of the system should not cause new problems in other parts of the system. For example, for reducing the time patients spend on a ventilator after surgery we must make sure that the reintubation rates are not increasing.

8.6 What is a benchmark?

Benchmark refers to a point of reference that is used to evaluate the performance or quality of something. It is a standard or a set of criteria against which something can be measured or compared [ 28 ]. Benchmarking can be conducted internally by comparing the performance of specific processes with similar processes in different areas of the same organization. For example, comparing ventilator-associated pneumonia (VAP) rates in different medical intensive care units (ICUs). It can be done also externally (locally, nationally, or internationally); within healthcare organizations of similar size and scope, against medical practice literature, or through participation in national or international databases. Whether internal or external benchmarking the ultimate aim is to provide clinicians with valuable information that guides them in the decision-making process.

8.7 Process variation

Variation refers to the lack of uniformity and difference in the performance of the process compared to the acceptable performance of peers. In clinical practice, clinical variation can drive poor care quality, wasted resources, and lead to excessive cost of services [ 29 ].

8.8 Types of process variations

There are two types of process variations common cause variation and special cause variation. Table 2 shows the main differences between them [ 30 ].

Types of process variations.

Source: ©2023 Institute for Healthcare Improvement. Used with permission.

9. 5S methodology

9.1 background.

The 5S methodology is identified as one of the most common lean management tools used not only to improve the workplace environment but also to improve the functional aspects of the process. 5S was developed in Japan and used by Toyota [ 31 ]. The 5S methodology is also called lean and it is composed of five Japanese words Seiri, Seiton, Seiso, Seiketsu, and Shitsuke, which means sort, set in order, shine, standardize, and sustain. 5S methodology is a set of actions that need to be conducted systematically in a sequence order one after the other with the full participation of staff responsible for the process and it should be repeated continuously [ 32 ]. The 5S methodology can benefit any organization that is genuinely committed to becoming less wasteful, more efficient, and keen on enhancing safety, establishing goals, and streamlining the workflow of the process [ 33 ]. Table 3 shows the general principles of 5S.

General principles of 5S methodology.

To facilitate the application of 5S and avoid fall back of the first 3S and consequently long-term implementation for the whole methodology, it is recommended to divide it into two phases, the initial phase focuses on the achievement of the first 3S (Sort, Set, and Shine), and the second phase focuses on the last 2S (Standardize and Sustain) [ 32 ]. In the context of healthcare quality improvement, the 5S methodology has been recognized as one of the lean-quality improvement tools and it was used to maximize added value by removing all unnecessary factors that do not generate value [ 34 ]. The method had a great impact on the promoting of healthcare services effectively, and increased staff motivation in healthcare facilities where resources are scarce and prevailing of other demotivating factors [ 35 , 36 ]. On the other hand, applying 5S can enhance patient safety by reducing the rate of errors, improving the efficiency of healthcare services, reducing waiting time, and creating a safer and more organized environment for patient care.

9.2 Scope of using 5S in healthcare practice

Error reporting systems : implementing robust systems for reporting and tracking errors, near misses, and adverse events can help identify potential risks and prevent future occurrences.

Medication reconciliation : developing thorough processes for reconciling a patient’s medication history is essential to avoid adverse drug events and ensure accurate and safe medication administration.

Fall prevention programs: implementing protocols to assess and minimize fall risks for patients, especially those with mobility issues, can prevent injuries and improve safety.

Standardized protocols : developing standardized protocols for various procedures and care processes, such as surgical checklists and hand hygiene protocols, can improve consistency and reduce errors.

Patient identification protocols : implementing strict protocols for patient identification, especially before administering medications or performing any procedures, can mitigate the risk of errors.

9.3 Example for applying the 5S in healthcare practice

Sort : this involves removing unnecessary items from the clinical and operational areas in the hospitals to eliminate clutter and improve efficiency. In healthcare settings, this can help ensure that essential patient care items are easily accessible while reducing the risk of errors caused by confusion or clutter, putting in consideration removing the extra unnecessary equipment and supplies will decrease the chance of mistakes in utilizing the wrong supplies.

Set in order : in patient care areas, this can involve organizing medical supplies and equipment in a standardized and consistent manner, making it easier for healthcare providers to find what they need quickly and reducing the potential for error.

Shine: in healthcare, this S is a crucial part of infection control programs. By maintaining a clean and safe environment, the risk of patient harm due to contaminated surfaces or equipment will be reduced. If the clinical area is carefully inspected and all old notices, posters, broken equipment, and unused machines are removed from the area, the potential hazards and risks can be identified easily [ 37 ]. Shining can be expanded to include cleaning all types of equipment that are under use like computers, keyboards, monitors, tables, etc. Cleaning should be conducted periodically with the full participation of all the staff in the area. Using a simple cleaning checklist can improve the execution of this phase as well as assist the CQI and the infection control department in the tracing process [ 32 ].

Standardize: after implementing the first three 3S’s, the next step is to standardize care processes to ensure the consistency and reliability of the care provided to patients. This S involves creating standardized protocols for handling daily clinical tasks such as medication administration process, patient handoffs, prevention of patient falls, and other critical care processes to minimize any potential for errors and harm.

Sustain: this may involve ongoing training, regular audits, and continuous improvement efforts to ensure that patient safety remains a top priority. To ensure this phase, it is recommended to link this S with a group of Key performance measures, in which any trend or special variation can be triggered quickly.

10. The high 5S project

10.1 background.

Without a doubt, patient safety has gained considerable global attention and focus from health leaders, researchers, healthcare providers, and business and management development organizations. It is a fundamental principle of high-quality patient care [ 38 ]. The safety of patients has been incorporated into many healthcare delivery models developed by various healthcare organizations, for example, is a key component of the Institute of Medicine’s (IOM) six domains of healthcare quality, which are abbreviated as STEEEP (Safe, Timely, Effective, Efficient, Equitable, and Patient-centered).

Furthermore, it is one of the key indicators and measures used to assess the safety of healthcare practices. Patient safety is defined by the World Health Organization (WHO) as the absence of preventable harm to a patient and the reduction of risk of unnecessary harm associated with health care to an acceptable minimum [ 39 ]. Within the context of a broader health system, patient safety is a framework of organized activities that creates cultures, processes, procedures, behaviors, technologies, and environments in health care that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make the error less likely and reduce the impact of harm when it does occur [ 39 ]. The WHO had declared and adopted several important patient safety initiatives, to urge and guide member states, particularly in low- and middle-income countries with fragile health systems to focus and prioritize patient safety as one of the most important components of healthcare delivery through publications, capacity building, education, campaigns, tools, and relevant conferences [ 40 ].

Clean Hand is Safer Care, Safe Surgery Saves Lives (surgical safety checklist), Patient Safety research, anti-microbial Resistance, and the multi-professional patient safety curriculum guide, Global Patient Safety Collaborative (GPSC), and Medication without Harm are among the WHO global Patient safety initiatives [ 40 ]. The 5 s project was another WHO patient safety initiative, and it will be the focus of this section.

10.2 What is the high 5s project?

The high 5s project is one of the important global patient safety initiatives that was launched by the World Health Organization (WHO) in 2006. It aims to address continuing major concerns about patient safety around the world as well as to facilitate the implementation and evaluation of standardized patient safety solutions within a global learning community to achieve measurable, significant, and sustainable reductions in challenging patient safety problems [ 41 ].

10.3 Scope of the 5s project

Develop and implement Standardized Operating Protocols (SOPs)

Create an impact evaluation strategy.

Collect, report, and analyze validated data.

Develop a collaborative learning community.

Disseminating learned lessons globally.

There are five SOPs and associated evaluation instruments were developed between 2007 and 2009 to address the following challenges: Medication Accuracy at Transitions in Care, Correct Procedure at the Correct Body Site, Use of Concentrated Injectable Medicines, Communication During Patient Care Handovers, and Health Care-Associated Infections [ 42 ].

10.4 Attributes of the high 5s project

Standardization is the process of developing, agreeing upon, and implementing technical or uniform specifications, criteria, methods, processes, designs, or practices that can increase compatibility, interoperability, safety, repeatability, and quality. Process standardization is the specification and communication of a process at a level of detail sufficient to permit consistent and verifiable implementation by different users at different times and in different settings. Standardization can reduce variation and minimize the tendency of process failure. It also enables shared learning, facilitates multi-disciplinary teamwork, and improves efficiency in interactions by establishing optimum conditions.

Evaluation: the high 5s project evaluation approach addresses the impact measurement challenge from different perspectives, including qualitative data collection regarding the SOP implementation experiences, quantitative performance measurement results, event analysis, and organization culture assessment. These methods were used to assess the feasibility and impact of implementing standardized patient safety protocols.

11. Clinical audit

11.1 background.

Audit is a Latin word that means to hear [ 43 ]. Clinical audit was defined by the National Institute for Health and Clinical Excellence (NICE) as a quality improvement process that seeks to improve patient care and outcomes through a systematic review against explicit criteria and the implementation of change [ 44 ]. It is also defined as a process that seeks to identify where improvements can be made within healthcare services by measuring them against evidence-based standards [ 45 ].

11.2 Audit vs. quality improvement

As we mentioned before in this chapter, quality improvement (QI) is a systematic approach that is used to study whole processes (clinical and non-clinical) formulating healthcare systems unlike clinical audit it is mainly clinically oriented. Although the auditing process is quite longer than some quality improvement approaches like PDSA and it can take months till completed, both tools have the same goal which is to look at the current status of healthcare standards and think how they could be improved. On the other hand, the scope of the audit is broader than QI approaches, it can be conducted on a small scale, for example, auditing a specific process in the hospital, or auditing the whole level of care (Primary Care, Home Care, and a group of Hospitals (trust) and or it can be carried out at national level (national clinical audits).

11.3 What is clinical audit

The audit is one of the key quality improvement measures as well as one of the main pillars of clinical governance and it allows healthcare organizations to continually work toward improving the quality of care and optimizing patient safety by showing them where they are falling short allowing them to implement the required improvements and repeat the cycle to assess the effectiveness of implemented change [ 46 ]. The main goal of clinical audits is to facilitate the process of quality improvement because that will be very beneficial and will lead to improved outcomes for patients. Clinical audits can look at care at a national level (national clinical audits) and local clinical audits can also be carried out locally in trusts, hospitals, or primary care practices wherever healthcare is provided.

11.4 The cycle of clinical audit

Choose the audit topic (identify problem) for example, patients waiting too long in accident and emergency (A&E).

Defining standards/criteria , for example, guidelines recommend that 95% of patients should wait <4 hours.

Collect data , for example, record over a week how long patients wait (determining that 92% wait for <4 h).

Analysis , for example, 92% versus 95% target, areas for improvement.

Implementing change , for example, an action plan to help reach the target.

Reaudit , for example, do steps 1–5 again until reaching the target then set the required measures to sustain gained change.

11.5 Audit vs. research

Clinical audit and research can overlap with each other in clinical practice and it is very important to recognize the differences between them. Table 4 explores the key differences between these two tools:

Key differences between clinical audit and research.

11.6 Barriers and enablers factors for effective audit

There are many factors that can influence for conducting a good audit, these include lack of expertise, inadequate data due to lack of documentation or record keeping, auditing being conducted subjectively and not based on proven standards, lack of leadership support, and scarcity of resources due to limited budgets. Quality of feedback also can limit the benefits of the change that would be brought from the audit. In contrast, performing an effective audit requires training, allocating the time for the staff, and having a reliable source of data like electronic health records, an information technology system that bridges the gap between routine collected data and auditing as well as the independence of the clinical auditor.

12. Quality of thinking

One of the quality definitions is doing the right thing right. However, the right thing is not determined by quality per se but on a higher level like strategic planning may be doing our tasks right and free of flaws or harm. Healthcare services can extend beyond just being safe care to be timely, effective, efficient, equitable, and patient-centered.

Therefore, safety is the number one priority as the patient should not add more negative health issues than what they already have. Additionally, they need to be treated for what they came for promptly, with an effective outcome in an efficient way with the same rights as others and in a nice way. This could be summarized also in three words devised by IHI (Institute of Healthcare Improvement): be nice to me, treat me, and do not harm me Figure 1 . For this to be achieved there are four factors at play affecting these dimensions causing less quality of care.

The IHI three principles of care.

There are four factors of system thinking Patient, Provider, Environment, and Task, and since we are using an acronym, we might call it PPET for short, Figure 2 .

Four components of quality thinking.

Much work has been put into the environmental factor (sometimes called system or facility and here it includes all the surroundings from equipment, devices, lights, flooring, policy & and procedures, pathways, and protocols) as it is believed it will fail the provider from doing their task right and this is true but proved inadequate as error rates are on the increase.

The patient factor could be out of this chapter’s scope as it needs a complete chapter on how to communicate well with patients and get the complete information enabling providers to achieve and reach a proper diagnosis for example.

Task factor is also another important factor where different tasks require different and higher demands of awareness and mindfulness as in the case of the rule-based and knowledge-based tasks compared with skill or routine-based tasks. However, the most important factor that had little attention is the provider factor. Providers could unintentionally fail to perform their tasks appropriately leading to system failure and undesirable patient outcomes. Here we want to talk about the quality of the provider’s thinking in achieving the dimension of Quality STEEEP (Safe, Timely, Effective, Efficient, Equitable, and Patient-centered).

One would agree that the same task can be done differently by different providers and even it can be done with variations by the same provider. The same task can be done incorrectly by certain providers but may be not done by others. Similarly, some providers will make errors with patients and even not follow the policy and procedure of the system.

The quality of work or performance is linked and affected by the provider’s thinking styles, personality traits, emotional intelligence (EI), and many other intangible factors like sub-clinical psychopathy when it comes to counterproductive behavior at the workplace which would compromise patient safety. Therefore, maybe we need to come up with a new terminology like human internal and external factors to be more specific so the external factors cover everything outside the provider (e.g., system, environment, policy & and procedures, patients, tasks, protocols, clinical pathways, etc.) and internal factors which are intrinsic or brain structure and makeup of individuals that process internally everything external and produce certain behavior accordingly.

Organizations should start taking this aspect seriously to understand the variations among healthcare providers and even within the same service providers to understand why they behave in certain ways that might expose them to more patient safety errors and even counterproductive work behavior. For example, the style of thinking in terms of experiential style (ES, more associated with effect and rapid response) and rational style (RS, more conscious and analytical) were found to differ between nurses and physicians. Nurses relied significantly more on ES compared to physicians and one positive aspect of this is that higher individual scores in ES would report errors compared to lower ES. However, higher scores in RS were shown to be linked to lower error rates, but it is better if the individual had higher scores in both RS and ES to have a real positive effect on lowering clinical errors [ 47 ].

Another intrinsic factor that affects the quality of work is EI which has many dimensions. For example, creative thinking was linked to the Sociability factor of the EI, the higher the score the more creative the person is. Additionally, these factors also affected the error rate in the person [ 48 ]. Another EI dimension that has a positive impact on the quality of care is self-control where higher scores had significantly safer quality of care [ 49 ].

On the negative side, lower scores in EI are associated with self-harm, and personality disorders that might be harmful to patient safety [ 49 ].

Personality traits were shown to predict which individual might be at higher risk of erring, have negative qualities in the workplace like bullying, and even how they would care for patient’s needs. Higher scores in the personality trait of Conscientiousness would lower the risk of clinical errors and in pharmacy staff this had a positive effect on how pharmacy staff would recommend treatments that are less likely to cause pain or interfere with the patient’s daily activities hence enhancing safer care and better quality of patient experience [ 50 ].

Agreeableness personality trait had also a positive impact on the quality of care if the individual had higher scores, however, it has a detrimental effect on the quality of care from an error rate point of view and provider-patient communication if the score is low and also it makes the individual at a significantly higher risk of initiation of bullying and violence. In general individuals with high scores of agreeableness were found to be friendly, cooperative, and supportive whereas individuals with low scores tended to be selfish and less caring. Additionally, high scores in neuroticism were associated with violence, more anxiety, a higher risk of burnout, and errors [ 49 ].

One of the explanations for certain personality traits and EI individuals being more at risk of lower quality of care from an error point of view, bullying, violence, less cooperation, and shorter span of attention could be because they tend to be more anxious than others [ 51 ]. Healthcare is a stressful environment of long hours, less time for proper meals, burnout, lack of sleep, and stressful demands for problem resolution and patients’ needs. With more anxiety as a normal base for these individuals then they would feel the stress of work even much more than others. Stress like this was shown to be associated with a negative effect on the hippocampus and the amygdala affecting their volume which in turn affects memory, learning, and accessing information they would be much more emotional and would be caught in a vicious circle leading them to errors and negative workplace behaviors [ 52 , 53 , 54 ].

In conclusion, quality of work depends on external and internal factors surrounding the provider which put them at more risk of errors and other negative behavior. Healthcare organizations must have a holistic approach to quality of care if they want to reduce harm to patients, staff, and the organization.

13. Education and training

13.1 background.

Training is important in health and social care, to ensure safety for everyone involved in delivering care and for those receiving it and to maintain the highest levels of care quality [ 55 ]. Quality improvement training programs were defined as any activity that explicitly aimed to teach professionals about methods that could be used to analyze and improve the quality of healthcare. In recent years, these programs have grown fast to include ongoing education like workshops, online courses, collaboratives, and ad hoc training set up to support running specific improvement projects. This growth in the quality training programs has supported the participants in improving their knowledge, skills, and attitudes and utilizing what they have learned in their clinical practice [ 56 ]. Education and training can break down barriers to providing safe care, creating an environment where all staff learn from error, patients are at the center of care, treated with openness and honesty, and where staff are trained to focus on patient needs [ 57 ]. Quality training programs can also assist practitioners in complying with local and national required standards, policies, and practice guidelines and ultimately unifying the protocols of care.

13.2 How to develop an effective training program?

Key Performance Indicators (KPIs) reports

Incident reporting system

Root Cause Analysis (RCA) recommendations

Accreditation body findings

Recommendation of quality improvement projects

Tracing and auditing reports

Patient safety walk-rounds

Failure Mode and Effect Analysis (FMEA) recommendations

Table 5 shows some examples of these training programs and their benefits for the healthcare practitioner.

Quality training programs.

13.3 Evaluation of training and education process

Training evaluation is an essential component of capacity-building initiatives. It helps to assess the effectiveness of the training program, identifies areas of improvement, and ensures that the training meets the needs of the participants and that invested resources in training are being used effectively [ 57 ].

Evaluation can be done by one of the evaluation methods such as pre-and post-training assessments, Kirkpatrick’s Four Levels of Evaluation, CIPP (Context, Input, Process, Product) model, observation, Surveys, and Questionnaires, or any other alternative method that is approved by the organization’s education training department [ 58 ].

14. Accreditation process

14.1 background.

Accreditation is about turning the noise of the complex health system into musical rhythms. According to the International Society for Quality in Healthcare, accreditation is a process “in which trained external peer reviewers evaluate a healthcare organization’s compliance with pre-established performance standards [ 59 ]. In other words, it’s an approval seal to show to what extent healthcare organizations are committed to providing safe patient care. Being accredited means the organization has met the highest and most excellent standards of care. The Joint Commission International (JCI) defines a standard as a statement that defines the performance expectations, structures, or processes that must be in place for an organization to provide safe and high-quality patient care, treatment, and services [ 20 ]. Standards also are described as the minimum level as the minimum accepted level of practice and quality. They are also developed in alignment with regulatory requirements, ensuring that healthcare facilities conform to laws and regulations related to patient safety. Examples include that healthcare facilities are required to report any medical equipment-related incidents to the National Food & Drug Authority, and healthcare providers are not allowed to practice their professions unless the relevant national regulatory entities license them. A quality management system (QMS), on the other hand, is a mechanism to ensure that procedures are being carried out in line with agreed standards and full participation by all staff members [ 59 ].

14.2 Accreditation vs. regulations

These two concepts are not identical. Accreditation as mentioned before is an approval seal to show to what extent the healthcare organizations are committed to providing safe patient care and it is granted by an independent accrediting body that the organization has met applicable standards and requirements, while regulations are group of rules that strictly followed, and they enforced by national authorities and regulators like Ministries of Health, Medical and Nursing counsels, Food Drug Authorities, etc.

14.3 What are the benefits of accreditation?

Building up the quality management system (QMS) with required policies, protocols, procedures, and checklists.

Assist in building a quality measurement database.

Provide effective comparison with self, and others as well as with best practice.

Assisting the organization in developing and disseminating a culture of continuous improvement for all staff.

Ensure a safe care environment by reducing the potential risks that could jeopardize care recipients and caregivers alike.

Establish an organizational culture of openness, and transparency, speak up, and learn from past experiences that facilitate improvement initiatives and sustain change.

Assist in Reducing the variations in the clinical practice that could put patient safety at big risk.

Improve the outcomes of healthcare services.

Provide a comprehensive framework for healthcare organizations to enhance patient safety by incorporating best evidence-based practice.

14.4 Accreditation cycle

The accreditation preparation cycle consists of five phases: the first phase is planning which is about conducting a gap analysis of the current situation to see what the required documents (what we already have and what we should have). After identifying the gaps, the next step is to assemble multiple teams to prepare the required documentation. Then the next phase is to educate and train staff about the required documents. After that, monitor the compliance of the staff with required documents by conducting unplanned periodic audits. This cycle should be repeated until reaching the optimum level of performance. Once the optimum level of performance has been achieved, the final phase is to maintain this level of practice. Continuous leadership support, in place-equipped, quality management system, staff vigilance, and commitment are the key drivers to sustain the gain change.

14.5 Standards of patient care

Patient care (access, assessment, transition, and continuity of care)

Patient safety

Medication management

Infection control and prevention

Anesthesia and surgical

Health care organizations

Subject matter experts

Scientific literature and industry guidelines

Technical Advisory Panels

Other key stakeholders

15. Care bundles

15.1 background.

The concept of care bundles has been developed in 2001 by the Institute for Healthcare Improvement (IHI). A bundle is defined as a set of evidence-based practices—generally three to five—that when performed collectively and reliably, have been proven to improve patient outcomes [ 61 , 62 ]. The Bundle of care is an ongoing process that’s repeated daily until the patient no longer requires an invasive device or his or her status has improved. All of the elements of the bundle must be performed in a sequence of series of steps by one healthcare team within the same time frame to ensure that clinical improvement occurs. The adoption of ‘care bundles’ can be seen as a fundamental shift in thinking from the acceptance of some adverse outcomes as an inevitable result of delivered care to the concept of significant reduction or even elimination of such adverse outcomes [ 62 ]. The theory of care bundles is very close to the cycle of Deming Cycle of Change Plan, Do, Check, Act (PDCA) where there is repeated practice as well as careful monitoring for staff compliance with the care bundle and also the patient outcome to assess the effectiveness. Therefore, Care Bundles are frequently introduced to clinical practices as components of quality improvement initiatives [ 62 ].

15.2 Types of bundles

Care bundles are widely used in clinical practice to manage and prevent certain health conditions. Table 6 shows the most common types of bundles and the areas where they can be applied:

Types of care bundles.

15.3 Impact of using care bundles on clinical practice

Care bundles are one of the quality improvement initiatives that enhance the reliability of the care process which resulted in clinical outcomes improvement. They have great input on standardizing patient care processes and unifying clinical practice. In the infection prevention control field, bundles participated in reducing the negative outcomes that accompany the medical management process like hospital-acquired infections (HAIs). Antibiotic Care Bundle (ACB), for example, plays a significant role in implementing the antibiotic stewardship program that not only improves the proper use of antibiotics and optimizes the course of therapy, but also goes beyond to slowing the resistance of bacteria, decreasing the length of stay of patients and ultimately reducing the expenses of health care. Furthermore, each element of the bundle can be traced to assess the effectiveness of delivered care hence it provides reliable measures that can be used to see the areas required improvement.

15.4 Key points to implement successful care bundles

To improve effectiveness, bundles of care can be implemented in several phases: development or adoption, piloting, training, education, auditing, and feedback.

Collected data is used to assess the compliance of the staff or to see how bundles are effective and should be accessed, have a reliable collection measure, validated, and analyzed in due course of time to guide the decision-making process.

Measurement should be accurate, consistent, and ongoing to authentically reflect hospital practice and, feedback should be delivered frequently (weekly or monthly if possible) to encourage improvement and sustainability [ 61 ].

To implement the bundle successfully, each element of the bundle must be implemented collectively with complete consistency to achieve the most favorable outcomes (“all or none” approach) [ 61 ].

Elements of the care bundle must be concise, simple, and prescriptive and neither static nor complex and hinder a successful adoption and implementation [ 63 ].

All of the elements of the bundle must be performed in a sequence by one healthcare team and within the same time frame.

Education, reminders audits, and feedback are the key components for the implementation of care bundles [ 64 ].

A flowchart is one of the useful quality tools that can be used to design care bundles [ 65 ].

Leadership support and staff commitment are the main success drivers of any care bundle.

16. Conclusion

Variations in healthcare are wide-ranging and can include an array of different treatment options, diagnostic procedures, and medication dosages that could jeopardize patient safety. Standardization can reduce variation and minimize the tendency of process failure. It also can enable shared learning, facilitate multi-disciplinary teamwork, and improve efficiency in interactions by establishing optimum conditions. Therefore, it is necessary to standardize healthcare processes, reducing variations in practice and minimizing the potential for risk or harm, this can be achieved by ongoing training, regular audits, and continuous improvement efforts, using care bundles, implementing standards of care, and following practice guidelines, policies, and procedures. And finally, having a dedicated quality culture to implement these initiatives, and achieve and sustain the desired improvement for the processes and system is the bedrock of this journey.

Acknowledgments

We thank Allah Almighty who gives me guidance and assistance to complete this work.

To all our families.

To everyone share their scientific insights and invaluable experiences in the healthcare improvement field.

To our colleagues whom we worked with and enriched our experiences.

And to all those who complete us…without them we are incomplete.

Conflict of interest

We hereby certify that there is not any actual or potential conflict of interest or unfair advantage at this time, in us providing the offer submission or performing the services required.

We want to express our gratitude to all Intechopen team for their tireless efforts to guide and help us accomplish this work.

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

StatPearls [Internet].

Continuous quality improvement.

Brian O'Donnell ; Vikas Gupta .

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Last Update: April 3, 2023 .

• Definition/Introduction

Continuous Quality Improvement (CQI) is a progressive incremental improvement of processes, safety, and patient care. The goal of CQI may include improvement of operations, outcomes, systems processes, improved work environment, or regulatory compliance. Process improvement may be "gradual" or "breakthrough" in nature. CQI project development commonly includes defining the problem, benchmarking, setting a goal, then iterative quality improvement projects. Through the iterative process, improvements are made, the effect of the improvements is measured, then the process is repeated until the desired outcome is achieved. Common methodologies for improvement include Lean, Six Sigma, Plan-Do-Study-Act (PDSA) cycles, and Baldrige Criteria. [1] [2] [3] [4]

As the technology for collecting care-delivery data and methods for tracking outcomes becomes more sophisticated and integrated into healthcare, CQI will become more vital to delivering quality care while maintaining profitability, healthcare provider satisfaction, and patient satisfaction. Overall, CQI is a quality initiative that repeatedly asks members of the healthcare team to determine, "How are we doing?" and, "Can we do it better?"

• Issues of Concern

Projects should be targeted at specific, quantifiable patient care or operational outcomes. Projects should be designed in line with institutional interests, values, and key stakeholders. Failure to understand these interests and institutional political dimensions can result in the failure of the project. [5]

Outcomes should be measured through definable metrics designated as primary and secondary. Primary metrics are measurements of the outcome sought. Secondary metrics ensure that the error or deficiency is not changed to a new problem through the interventions of the project. For example, if the primary metric is to have more patients seen each day in a clinic, a reasonable secondary metric would be the number of patient care errors that occur. This ensures that deficiencies are improved through the changes made and not just transitioned into a new deficiency. [3]  

Many CQI initiatives focus on improving one or more areas. Common CQI goals include: [6]  

• Cost reduction
• Decreased appointment wait time
• Reduced in-department wait time
• Higher patient volume
• Decreased cycle time
• Reducing defects
• Increased patient and/or staff safety
• Increased patient and/or staff satisfaction
• Clinical Significance

In the seminal report "To Err is Human," in 1999, the Institue of Medicine detailed the impact of medical errors within healthcare in the United States. At that time, estimates were that between 44,000 and 98,000 people died each year due to preventable medical errors. The focus of this report was not that there were bad people, but rather there were inadequate systems in place to keep patients safe while delivering high-quality medical care. It called upon the medical community to evaluate the systems and practice of healthcare delivery to improve patient safety and develop better systems to reduce errors. [7]  For example, after implementing a CQI strategy, a large healthcare consortium in Alabama serving HIV patients was able to decrease the missed-visits rate of its HIV patients by a statistically significant margin compared to a control group. [8]  A systematic review examining the application of Sig Sigma and Lean methodologies in surgery noted improvement or benefit in over 88% of studies. [9] Though the researchers noted this might be influenced by systemic bias and imprecision in the definition of improvement. Another large systematic review looked at CQI applications in radiology. Across 23 studies, all noted improvements in either 1 or more areas, including cost-saving, reduced appointment wait time, decreased in-department wait time, higher patient volume, decreased cycle time, reduced defects, or increased patient or staff safety and satisfaction. [6]  There are numerous other examples of CQI providing clinically significant results, and the modern healthcare provider should be aware of CQI's importance for improving their healthcare delivery model.

• Nursing, Allied Health, and Interprofessional Team Interventions

Specific goals for CQI projects can be developed through benchmarking, where performance is compared to similar institutions or core measures. Each goal should have metrics that are tracked to determine the outcomes of interventions. A successful CQI initiative is the result of a careful and thoughtful structured planning approach. For example, once clear goals have been established, various methodologies are possible to develop interventions. Before implementing CQI, careful planning and "groundwork" needs to be done, which may include articulating CQI goals, identifying specific clinical outcomes and administrative outcomes for the organization's future state, evaluating current processes to identify what functions and does not function in the organization's current state, understanding how healthcare information technology can help your organization meet its goals, and developing a plan to collect data going forward and compare progress to benchmarks.

After this framework is set and the organization is 'fit' for CQI, organizations can utilize CQI strategies.

Strategies for Interventions

Lean: Developed by Toyota Corporation, Lean methodology is a process of improving value to customers and employees with a focus on the reduction of waste. Kaizen is a core concept of lean and is concentrated on continual improvement. Lean defines 7 types of waste, i.e., transport, inventory, motion, waiting, overproduction, over-processing, and defects. The goal is to reduce the amount of non-value-added activities, thereby increasing the amount of time and effort spent on value-added tasks. [1] [10]

Six Sigma: Developed at Motorola by Bill Smith in (1980), Six Sigma methodologies are focused on reducing error rates. Six Sigma refers to six standard deviations from the mean. If a process reaches Six Sigma, error rates should be less than 3.7/million opportunities. The process proceeds through 5 phases: define, measure, analyze, improve, and control (DMAIC). [11]

PDSA: Plan-Do-Study-Act, also known as the Deming cycle, is a four-step process for quality improvement. During the planning stage, objectives and desired outcomes are defined. The 'do' phase allows for the implementation of the plan from the first stage. During the 'study' phase, results are then gathered and studied to determine what effect the plan has had. Finally, during the 'act' stage, if the process has achieved the goal, it is then controlled to ensure continued compliance, or if it has failed to achieve the goal, a new PDSA cycle is implemented to adjust to better meet outcomes. [12] [1]

Baldrige Award Criteria: This methodology focuses on improving the entire organization and instituting and nourishing a culture focused on CQI. It evolved from an award for organizational excellence through self-assessment into the methodology as implemented across the industry. The Baldridge Criteria focuses on enterprise-level improvement through improved communication, productivity, and effectiveness in seven categories: leadership, strategic planning, customer focus, measurement (including analysis and knowledge management), workforce focus, operations focus, and results. An important caveat to the Baldrige Criteria is that each of these seven criteria needs a champion in the organization to lead and manage improvement. This is because the Baldrige Criteria are suited for enterprise-level improvement rather than a single business or service entity. [13] [14]

It should be noted that no single CQI methodology, including Lean, Six Sigma, PDSA, and Baldrige, is thought to be superior to the other methodologies. Rather, the selection of a methodology should incorporate the organization's goals, the feasibility of the data and other resources, the skill sets of those involved, and, ultimately, the strategy that best fits the organization.

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Disclosure: Brian O'Donnell declares no relevant financial relationships with ineligible companies.

Disclosure: Vikas Gupta declares no relevant financial relationships with ineligible companies.

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