Ten Quality Improvement Initiatives to Standardize Healthcare Processes

Abstract

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.

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

The variability in clinical care practice often stems from two separate issues [12]:

1. 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.

2. 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.

In this chapter, we will try to highlight the top-quality improvement initiatives that have significant roles in standardizing healthcare processes, reducing variation in clinical practice, and achieving predictable results, for patients, healthcare systems, and organizations. These initiatives include:

1. Clinical practice guidelines and pathways

2. Policies and procedures (P&Ps)

3. Data-driven performance

4. The 5S methodology

5. High 5s project

6. Clinical audit

7. Quality of thinking

8. Education and training

9. Accreditation process

10. 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?

Policies and procedures are essential components of effective quality improvement and patient safety programs for the following reasons:

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

2. Serve as a unique communication tool between the treatment team.

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

4. Improve consistency and accuracy of the clinical process.

5. Guide decision-making process.

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

7. 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

Healthcare P&Ps can be divided into five major types [23]:

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

2. 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.

3. 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.

4. 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

5. 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.

Internal sources	External sources
Occurrence reports/summaries Ongoing quality measurement Surveys, interviews, questionnaires Direct observation (clinical audit, walkarounds) Clinical records, reports/profiles (pharmacy, lab, blood bank, etc.) Infection control reports Regulatory and accreditation reports Clinical review findings Incident reporting system	National registry reports Communicable Disease Control (CDC) reports Research projects/literature (e.g., MEDLINE) Clinical protocols, guidelines, and practice parameters (medical colleges and boards) National Guideline Clearinghouse International library of measure Accreditation bodies reports

Table 1.

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

According to the Donabedian model, performance indicators are divided into three types structure, process, and outcome:

1. 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).

2. 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.

3. 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].

Common cause variation	Special cause variation
Caused by natural or ordinary causes	Caused by non-ordinary and unnatural causes
Inherent to system or process.	Non-inherent to the process design.
Predictable	Unpredictable
Affects all the outcomes of a process	Affects some but not necessarily all aspects of the process.
Result in a stable process	Result in unstable process
develop and test ideas that might result in improvements to the process and system.	Require investigation of the underlying causes of variations and take correct actions to fix it.

Table 2.

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.

Japanese	English	What is it about?
Seiri	Sort	Eliminate unnecessary items and tools from the workplace area.
Seiton	Set	Arranging items in the workplace area logically and efficiently.
Seiso	Shine	Clean the workplace area to maintain a safe environment.
Seiketsu	Standardize	Standardize the best practices in the workplace area right after implementing the first 3S.
Shitsuke	Sustain	Make the already-developed processes part of the practitioner’s daily routine (self-discipline).

Table 3.

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

The 5S methodology can be applied widely in healthcare practice. It can be used, for example, in the following areas:

1. 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.

2. 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.

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

4. 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.

5. 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

The 5S methodology can be applied in clinical areas as follows:

1. 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.

2. 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.

3. 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].

4. 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.

5. 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

The five major components of the High 5s project are:

1. Develop and implement Standardized Operating Protocols (SOPs)

2. Create an impact evaluation strategy.

3. Collect, report, and analyze validated data.

4. Develop a collaborative learning community.

5. 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

There are two unique features of the high 5s project which are [42]:

1. 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.

2. 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

There are six stages of the commonly accepted audit cycle, and each stage is detailed as follows [46]:

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

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

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

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

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

6. 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:

Clinical audit	Research
It is a continuous cycle of improvement	It is a systematic study
It aims to: Measures the effectiveness of health care against agreed and proven standards of care for high quality. Take the corrective actions to align the practice with these standards. Implement, monitor, and sustain the changes when indicated.	It aims to: Answer and analyze various questions and occurrences in the field of science. Develop hypotheses and test their validity. Enhance the quality of care by producing knowledge on what constitutes best practice to inform the guidelines
Tell us where we are doing it.	Discover what should doing

Table 4.

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.

Figure 1.

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.

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?

Developing effective training programs on quality and patient safety requirements can begin with assessing the existing training needs (gaps: current training and those required to meet the goal) and this can be done by gathering data from various sources in the hospital followed by developing the training programs based on the findings of gap analyses. The source of data includes but is not limited to:

• 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.

#	Education	Benefit
1	Data Management Process	It enables the trainer to understand the whole data management process including collection, validation, and analysis as well as tracking the process performance over time and picking up any deviations.
2	Auditing and Tracing Methodologies	It helps the trainer monitor the adherence of clinicians to the required standards, guidelines, and policies.
3	Performance Improvement Approaches	It assists the trainer in leading the improvement journey by utilizing the right quality improvement tools.
4	Risk Management Approaches	Whether is a proactive approach like Failure Mode and Effect Analysis (FMEA) or reactive ones like Root Cause Analysis (RCA), the trainer will be capable of forecasting any potential failure that could happen and any actual failures already occurred and setting the appropriate risk reduction solutions
5	Standards of Care Requirements	It provides the trainer with knowledge and skills about the required patient care standards and how to meet them through policies, procedures, and clinical practice guidelines.

Table 5.

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?

Despite the accreditation process emphasizing how healthcare organizations adhere to applicable standards, the ultimate goal is how continuously improve the healthcare system and processes. The accreditation can assist the health organizations in:

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

2. Assist in building a quality measurement database.

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

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

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

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

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

8. Improve the outcomes of healthcare services.

9. 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

Standards of patient care are those standards related to direct patient-family care. These standards can vary from one accreditor to another. Below are some examples of them:

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

2. Patient safety

3. Medication management

4. Infection control and prevention

5. Anesthesia and surgical

All standards including the care standards are developed with input and information from various sources that include [60]:

1. Health care organizations

2. Subject matter experts

3. Scientific literature and industry guidelines

4. Technical Advisory Panels

5. 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:

#	Care bundle	Where do they apply?
1	WHO Surgical Safety Checklists	Surgical theaters
2	Ventilator-Associated Pneumonia (VAP)	Intensive care units (ICU’s)
3	Catheter-Associated Urinary Tract Infection (CAU-TI)	ICUs
4	A central line bloodstream infection (CLABSI)	ICUs
5	Peripheral Vascular Catheter (PVC)	All clinical area
6	Antibiotic Care Bundle (ACB-Bundle)	ICU’s
7	Pressure Ulcer Prevention Care Bundle:	All areas of care where a patient is at risk for pressure ulcers.
8	Surgical Site Infection Prevention Bundle	ICUs, Surgical departments, isolation wards, etc.
9	Sepsis Care Bundle	ICUs, Isolation Wards, and all other areas where patients is vulnerable to sepsis.

Table 6.

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

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

2. 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.

3. 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].

4. 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].

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

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

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

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

9. 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.

Thanks

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

Acronyms and abbreviations

ACB	Antibiotic Care Bundle
A&E	accident & emergency
AI	artificial intelligence
CAU-TI	catheter associated urinary tract infection
CDC	communicable disease control
CIPP	Context, Input, Process, Product
CLABSI	Central Line-Associated Blood Stream Infection
CPGs	clinical practice guidelines
CQI	continuous quality improvement
EBM	evidence-based medicine
EI	emotional intelligence
ES	experiential style
FMEA	failure mode and effect analysis
GPSC	Global Patient Safety Collaborative
HAIs	hospital acquired infections
ICUs	intensive care units
ICPs	integrated care pathways
IHI	Institute of Healthcare Improvement
IOM	Institute of Medicine
ISQua	International Society for Quality in Healthcare
JCI	Joint Commission International
KPIs	Key Performance Indicators
NICE	National Institute for Health and Clinical Excellence
PDCA	Plan Do Check Act
PDSA	Plan Do Study Act
PPET	Patient, Provider, Environment, Task
P&Ps	policies & procedures
PVC	peripheral vascular catheter
QI	quality improvement
QMS	quality management system
RCA	Root Cause Analysis
RS	rational style
SOPs	Standardized Operating Protocols
STEEEP	Safe, Timely, Effective, Efficient, Equitable, Patient Centered
VAP	ventilated-associated pneumonia
WHO	World Health Organization
5S	Sort, Set, Shine, Standardize, Sustain