Today’s health care delivery systems are based on the principles established in the modern clinical governance (CG) framework, which is typically no longer perceived as an supplementary administrative effort but rather as an essential element of ensuring the safety of patients receiving care within these systems (1, 2). An organization’s CG framework is indicative of its overall commitment to ensure that patients receive safe, high-quality care, and to create an environment conducive to accountability, learning, and on-going quality improvement. A well-designed CG framework moves an organization away from simply responding to problems and into a position where continuous assurance is provided. Specifically, through formal processes within the CG framework, organizations will identify areas of potential risk or harm; develop an organization-wide standard of care based on established best practices; monitor the performance of staff against established performance standards; and use data obtained from both patient satisfaction surveys and incidents involving adverse patient outcomes to improve the overall safety of all patients receiving care within the organization (3, 4). CG framework establishes the necessary structure and systems to ensure that all of the organization’s efforts to improve care are coordinated and integrated into a comprehensive quality assurance program. For many regional, public-sector hospitals, which consistently serve as the primary hospital for large, geographically diverse communities, establishing a coordinated and integrated framework for quality improvement is becoming increasingly important (5). Health care organizations face the dual challenge of meeting complex needs while working within constrained resources. A systematic approach to quality management is pivotal to providing consistent, safe and effective care. For an archipelagic nation like the Maldives, these challenges are compounded by the logistical challenges of productivity and supply chains; patient transfers; and workforce dispersion (6). These combined factors lead to a greater expectation of process reliability and standardization. A systematic governance architecture is, therefore, a strategic necessity; not just a luxury enjoyed by larger, urban centers. Without a systematic governance architecture, there is potential for unacceptable variance in the quality of care and there is a disconnect in the organization’s ability to learn and grow through collaborative, formal and informal processes (1, 2). It is much evident that the intentional architectural method of developing a systematic governance framework is the best and most sustainable path forward for providing high levels of reliability to these health care institutions (5).

Thus, patient safety has transformed from being an emerging concept towards becoming an essential global discipline, and it calls for the intentional and systematic development of patient safety architecture, removing avoidable patient harm from healthcare providers’ routines and processes globally (1, 2). Therefore, strategic change initiatives at Kulhudhuffushi Regional Hospital (KRH) can be placed within the international patient safety movement, which seeks to address patient safety incidents like harm and error, not as uncontrollable events, but as system failures. The World Health Assembly published the “Global Patient Safety Action Plan 2021–2030,” and the statistics associated with the need for patient safety are alarming and call for strategic and radical changes at hospitals globally (3, 7). The average risk of adverse events for patients is one out of every ten patients in high-income countries, and these statistics climb astonishingly to one out of every four patients in low- and middle-income countries globally, resulting in 134 million adverse events being experienced by patients annually, leading to 2.6 million patients’ deaths worldwide and medication errors alone amounting to economic losses equivalent to US $42 billion annually (3).

This narrative review article aims to investigate how the KRH is a major organization within the public sector in the Republic of Maldives. The focus of this article will be on examining the time period from 2022 through 2025 as an important point in the development of quality & safety assurance within the public sector of the Republic of Maldives.

In general, the quality governance of the KRH before 2022 was managed by the nursing department as an adhoc arrangement on a case to case basis and later on from 2022 to 2023. Thus, the use of committees means that while the quality governance of the KRH since 2022 was through a committee, their primary task was to be a solutions-finding committee, and any solutions produced would be based on previous inspection reports. In that regard, while the particular governing body was functioning in solving the issues it had identified, the long-term viability of the governing body was not in question.

As a result of this, the evolution of a comprehensive form of CG began, starting from point zero to accommodate the unique environment of the Republic of Maldives.

Multiple basic theoretical frameworks influence this methodology based on systems. The Donabedian Model states that we can assess and improve quality in health care delivery through three dimensions of healthcare quality; Structure (the environment in which health care is provided), Process (the activity of providing health care), and Outcomes (the effect of providing health care) (4).

The World Health Organization Patient Safety Framework defines a comprehensive direction for the development of individual healthcare systems to take specific actions to eliminate all preventable sources of harm and acknowledges the importance of leadership, governance and health system-wide learning in this process (3, 8).

The Institute for Healthcare Improvement (IHI) Model for Improvement: The strategy entails undertaking a number of fast-paced iterations using the plan-do-study-act (PDSA) model in the process of testing and implementing the change to bring about improvements in terms of quality and safety (9). The transformation of the operational model of the KRH is a good illustration of how the international model has been adopted into a regional model. KRH has been methodically creating a new paradigm for CG that goes beyond the development of good practices to create a sustainable system that will ensure the safety of all patients at all times.

This narrative review explores the importance of KRH, which plays a significant role in the public sector of the Republic of Maldives. The article deals particularly with the period between 2022 and 2025, which is the most significant period in the history of KRH in relation to the concept of quality and safety. Specifically, in 2022, the quality governance part of KRH commenced in the form of a committee prior to the establishment of the nursing departments. The primary role of this quality governance structure in KRH was to specifically deal with a set of issues that had arisen in a report generated from the previous inspection report. This phenomenon, in the form of a committee, performed a specific function from a general point of view but its aftermath gave rise to the most significant period of architectural evolution in the history of quality governance, which aimed to construct a comprehensive concept of CG from scratch, suitable for the challenges of its operating environment.

This review covers only from the year 2022 until the first quarter of 2025 and provides a chronological account on the implementation of KRH’s CG system. The article is structured into five sections, which address the five foundational pillars that were developed over time. The five pillars are: (1) Strategic change to a formally established and proactive Quality Improvement Department (QID), rather than functioning only on a reactive basis as a Committee, (2) The establishment of a formal institutional Document Control System as the basis for standardization of processes, (3) The establishment of a two-tier audit and quality improvement program to provide assurance and facilitate change, (4) Development of an evidence-based Key Performance Indicators (KPI) monitoring framework for leadership oversight, and (5) The establishment of an integrated system for learning from all types of incidents including complaints and mortality. The first strategic step taken in the development of the Governance System is the establishment of the QID in order to formalize accountability.

No successful design can ever be successfully created in isolation; an effective patient safety solution must always be designed specifically with reference to the operational characteristics associated with the institution’s operation. To understand the patient’s safety logic and necessity associated with these governance reforms at the KRH, it is therefore critical to have a complete understanding of the KRH demographics, related hazards, and civic function of the KRH community. The KRH is more than just a provider of health care services; it is also a major part of the civic infrastructure that serves a region that is vulnerable to numerous types of hydrometeorological and social risks. Within the “CITY EMERGENCY OPERATIONS PLAN” of Kulhudhuffushi, the onus is on KRH to be included as a key stakeholder in the city disaster management plan, and thereby a member of the City Disaster Management Committee (CDMC). The focus on a comprehensive approach to risk management in the city also applies to what is happening outside of the hospital. Kulhudhuffushi is the first city in the Maldives to join the United Nations Office for Disaster Risk Reduction’s (UNDRR) “Making Cities Resilient (MCR)” initiative, illustrating a holistic approach towards creating a resilient city. The civic environment can thus be considered a force multiplier for the on-going changes at KRH. Moreover, the risk assessment culture, along with other concerns embedded within the civic culture of the city, represented by an emergency operation plan for the entire city, allows the development of a shared language and understanding of the issue, applicable to both civic representatives and medical staff in the hospital. In addition, the civic context can be seen as providing structures for collaboration, something especially necessary in the field of public health. This can thus be considered a very conducive environment to implementing necessary changes in order to become a high-reliability organization.

In fact, the transition from the unstructured nature of a committee to the structured form of a department is probably the single most strategically vital step that has ever occurred at KRH from the perspective of governance evolution. The evolution that has taken place within the architectural structure of the organization has led to greater centralization in accountability, authority, and provided an everlasting mechanism to drive improvements in quality and patient safety. Evidence from the patient safety and organizational change literature indicates that centralizing structures to support governance are imperative for any organization to achieve a culture of improved patient care and safety (1, 5, 10).

Formalized document control systems are one of the basic cornerstones of safe and reliable medical practice. Effective documentation systems ensure that all medical and operational practices are evidence-based on policies, guidelines, and Standard Operating Procedures (SOPs) through document repository system. All these formal processes are documented in a clear and standardized manner and made accessible to all. Hence, creating one source of all information at one place eliminated all confusion and enabled standardization of care processes. It is vital to maintain structural quality and safety attributed to proper documentation systems in quality and safety governance has already been established in various literature evidence (4, 13, 15).

Following this, KRH moved on to focus its energy on assurance and improvement through proper means. This was achieved by the creation and implementation of the two-tier auditing system for quality assurance purposes by the QID. The two-tiered system is reflective of the best practices associated with CG, which state that both assurance and improvement are necessary to ensure closing the gap between what should be done and what actually occurs (2, 4, 12, 16).

In addition to standardization and improvement processes, the capability of measuring each component is required for successful CG. In KRH, the creation and implementation of a KPI governance structure was an important part of transforming the organizational quality and safety objectives into something achievable and measurable. Performance measurement systems are recognized as a fundamental mechanism in organizational management, as they allow the overseeing body to evaluate the effectiveness of the governance structure in its delivery and standards (1, 4, 7).

One of the most important aspects within a strategic CG process is the ability to identify, analyze, and learn from harm, near miss, and patient experience feedback. For KRH, the establishment of a system which combines elements of incident reporting, patient complaints management, and mortality review within a unifying governance infrastructure was an important step towards developing an organizational approach to learn. One of the most important concepts in modern patient safety science is the ability to recognize that, even when designing systems to identify and understand errors, there is no system within which to assign blame (2, 11, 17).

It is recognized that although key structures, processes, and measurement systems constitute the overt body of clinical and organizational governance, in the end, CG also rest on organizational culture and leadership engagement. Indeed, at KRH, every effort was made to ensure that CG structures were aligned with an organizational culture that would facilitate learning and openness and foster perpetual enhancement. Patient safety literature is unanimous in arguing that CG and improvements are not just technologies and constructs but also leadership and cultural issues that hinge on engaging and holding employees at all echelons accountable (1, 2, 5).

The phase from 2024 to 2025 is marked by the continued rollout, development, and implementation of existing governance practices throughout all departments and affiliated health centers. The vital strategies are staff training, communication, and continued support mechanisms, such that control of documents, auditing, incident capture, and KPIs become ingrained. The phase is actually that of acculturation rather than innovation, where governance practices become so ingrained that they are no longer perceived as outside or innovative.

Significant level development in the clinical incident management contributes towards integration with a more harmonious safety intelligence system. Furthermore, the extension of the current reporting system to include occupational safety incidents and confidential whistleblowing schemes indicates the move to adopt an enterprise-wide model for safety management. This direction recognizes that there is a direct correlation between staff safety and psychological safety and patient safety; transparent systems of reporting are crucial in creating an environment where people trust each other (11). The internal development route would allow adaptation to local working patterns and emerging legislation.

Once the framework is standardized, the natural progression in terms of priority would be the assessment of its overall impact. The focus would shift away from determining if a system is a legitimate process of compliance and toward determining if the system is effective in enhancing patient outcomes, patient experience, and clinical effectiveness. On-going investment in training related to specific roles would, of course, remain a key factor in continuing to ensure the understanding and recognition by all groups that safety is a shared interest, and that outcomes are improved through a collaborative effort.