Improving Clinical Governance And Patient Safety While Complying With Legal Standards: What Health Facilities Should Know

Introduction

Patient safety continues to be a significant concern in Nigeria¹. Recent incidents² have sparked public debate and attracted the attention of relevant stakeholders, raising questions about the state of the country's healthcare system. However, beyond public reaction, these matters present ongoing regulatory and medico-legal concerns that necessitate careful review of individual cases, internal review of processes by health facilities and necessary system-wide improvements.

While such incidents are completely unacceptable, medical errors remain a substantial challenge within healthcare systems globally. Research indicates that errors among practitioners range from 42.8% to 89.8%,³ with around one-third of patients experiencing additional harm from clinical care.⁴ Expert analysis further links one in every 24 deaths to unsafe hospital practices,⁵ while errors account for nearly 28% of facility-based fatalities.⁶ These statistics expose health facilities to considerable legal, regulatory, and reputational risks.⁷

No doubt, patient safety is recognised globally as a public health challenge and a fundamental principle of healthcare delivery.⁸ It is anchored in clinical governance, a framework designed to improve service quality, clarify professional responsibilities, and embed systems that reduce clinical errors.⁹ This framework is built on core pillars of patient safety, including incident reporting, investigation, open communication and disclosure, apology and remediation, system improvement, data tracking and evaluation, and continuous education and training.¹⁰

In Nigeria, this is reflected in multiple laws, regulations, and regulatory bodies overseeing healthcare delivery, medical ethics, and public health policy.¹¹ These laws and standards govern the quality of care, patient safety, and professional conduct in both public and private health facilities. A key example is the Medical and Dental Practitioners Act, which establishes the Medical and Dental Council of Nigeria. This body aims to ensure patient safety by regulating medical education, setting professional standards, registering and licensing practitioners, and disciplining practitioners who fall short, thereby mitigating the risks posed by unqualified practitioners.

Despite the sector being one of the most regulated in the country, there remains a public outcry for new reforms. This article will examine the concept of patient safety, review the existing legal and regulatory framework, and analyse the recently inaugurated Taskforce on Clinical Governance and Patient Safety, while proposing a practical roadmap for health facilities to enhance clinical governance and patient safety.

What is Patient Safety?

There is no single statute or judicial pronouncement that provides an explicit definition of patient safety. Instead, the concept is addressed through a combination of statutory provisions, professional regulations, and constitutional guarantees relating to the right to health and life.¹² However, the World Health Organisation (WHO) defines the term as "the absence of preventable harm to a patient and the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum."¹³ According to the WHO, patient safety encompasses organised activities that foster appropriate cultures, processes, procedures, behaviours, technologies, and environments within healthcare systems, to reduce risk, prevent avoidable harm, minimise errors, and limit their impact when they occur.

In practical terms, patient safety involves identifying, assessing, and managing patient-related risks to improve care outcomes and reduce harm. Operationally, it refers to the prevention, avoidance, and mitigation of adverse events or injuries arising from the delivery of healthcare.¹⁴ Key pillars, including clinical governance, effective communication, risk management, patient engagement, education and training, incident reporting, and continuous quality improvement, underpin patient safety.¹⁵ Central to these pillars is clinical governance, which serves as the framework through which health facilities are held accountable for continuously improving service quality and safeguarding high standards of care. It establishes robust processes, oversight mechanisms, and a culture of accountability that collectively reduce errors, protect patients, and support regulatory compliance.¹⁶ Within this framework, patient safety represents the core outcome of effective governance, linking legal obligations to everyday clinical practice.¹⁷

The Legal Standards

As one of the most regulated sectors, medical practice in Nigeria is governed by a comprehensive legal and regulatory framework that sets clear standards for quality, safety, and accountability.¹⁸ The Constitution of the Federal Republic of Nigeria 1999 provides foundational protections for patients. While not directly addressing health rights, several of the fundamental rights have significant implications for patient safety, health quality and patient rights. The right to dignity protects patients from inhuman or degrading treatment.¹⁹ The right to privacy²⁰ provides foundations for the right to informed consent, as held by the Supreme Court in the case of Medical and Dental Disciplinary Tribunal v Okonkwo.²¹ It also reinforces confidentiality obligations in clinical practice.

Notably, the National Health Act 2014 (NHA), an umbrella law for the national health system, establishes enforceable mechanisms that achieve patient safety.²² Under the Act, all public and private health establishments must obtain a Certificate of Standards before commencing operations, reinforcing minimum quality and safety thresholds.²³ It mandates providers to take steps to ensure patient safety and quality care.²⁴ Health facilities are also required to comply with quality requirements issued by the National Council on Health.²⁵ The Act prohibits refusal of emergency medical treatment²⁶ and obliges healthcare providers to give patients relevant information about their health status and proposed treatments.²⁷ Unfortunately, key parts of the Act have not been implemented. The Certificate of Standards, while a laudable idea, faces challenges because of the decentralised nature of the health system. However, if implemented strategically, it presents an opportunity to address patient safety and clinical governance in a holistic manner.

Patient rights are explicitly protected, including confidentiality²⁸, informed consent²⁹, and the right to receive information in a language they understand.³⁰ Health facilities must also secure patients' health records and prevent unauthorised access.³¹ These protections are reinforced by the Patient's Bill of Rights, which promotes dignity and safety through access to medical records, transparent billing, a clean and safe care environment, and timely intervention in urgent situations.³² The National Health Act requires that a Patient's Bill of Rights be clearly displayed in all health facilities.³³

From a professional regulatory standpoint, the Medical and Dental Practitioners Act establishes the Medical and Dental Council of Nigeria (MDCN)³⁴ and empowers it to set and periodically review the minimum standards of knowledge and skill for entry into the medical and dental professions.³⁵ This authority extends to the accreditation of training institutions, curriculum standards, and qualification thresholds.³⁶ The Act further mandates the maintenance and publication of registers of licensed practitioners, making registration the legal foundation for lawful medical practice.³⁷ The Council is also authorised to formulate, review, and enforce a Code of Conduct, embodied in the Code of Medical Ethics,³⁸ to maintain professional standards.³⁹ It has implemented these obligations partly through the establishment of the Code of Medical Ethics (2008), which sets out standards to be complied with by medical practitioners and dental surgeons.

The Code imposes obligations relating to informed consent,⁴⁰ confidentiality,⁴¹ disclosure of treatment risks and alternatives, and continuity of care. Issued pursuant to statutory authority, it constitutes delegated legislation and carries binding legal force.⁴² Breaches attract serious disciplinary sanctions, including suspension or removal from the professional register. Beyond entry and licensing, the Act provides mechanisms for addressing professional negligence, incompetence, and misconduct through the establishment of the Medical and Dental Practitioners Disciplinary Tribunal.⁴³ The Tribunal conducts preliminary investigations into allegations of misconduct, subpoenas witnesses, and is empowered to suspend practitioners where necessary to protect the public.⁴⁴

Through this framework, the MDCN operates a system of professional self-regulation anchored in law, with its disciplinary powers serving as a critical safeguard for patient safety and public confidence in healthcare delivery.

In addition, health facilities are subject to oversight by multiple regulatory bodies, including the Nursing and Midwifery Council of Nigeria, the Pharmacists Council of Nigeria, amongst others. Other regulators oversee specific cadres such as community health practitioners, medical laboratory scientists, and rehabilitation therapists.

At the state level, health facilities (not professionals) are registered and regulated by state-level health facility agencies, such as the Health Facility Monitoring and Accreditation Agency (HEFAMAA) in Lagos State, and hospital inspectorates in the State Ministries of Health in other states.⁴⁵

Collectively, these bodies reinforce the duty of care owed to patients under health law, tort law, criminal law, and regulatory standards.⁴⁶ These standards are based fundamentally on the law's requirement for health professionals to exhibit a duty of care and use reasonable care and skill in the administration of medical or surgical treatment. These standards may be understood by reference to the Code of Medical Ethics, but also to an understanding of what is generally required of health professionals as established by their peers. Examples of what may constitute challenges to patient safety and thus a breach of the duty of care are set out in the Code of Medical Ethics,⁴⁷ such as:

• Failure to keep adequate records or to safeguard existing records
• Failure to use due care in carrying out one's duties.
• Non- disclosure of material information
• Failure to keep patients' information confidential
• Lack of professional knowledge
• Failure to consult with appropriate bodies
• Failure to refer
• Incorrect Diagnosis
• Failure to Attend to Patient Promptly

Recent Developments

The Federal Government has recently inaugurated a National Taskforce on Clinical Governance and Patient Safety,⁴⁸ comprising the Minister of Health, permanent secretaries and directors of the health sector. The Taskforce is charged with strengthening coordination, establishing monitoring systems, developing guidelines, and enhancing reporting and response mechanisms for patient safety and quality performance.⁴⁹ Given the existence of an extensive legal and regulatory framework, raises legitimate questions about regulatory coherence and institutional necessity. Existing statutory bodies already regulate entry into the profession, professional conduct, patient rights, facility accreditation, and disciplinary enforcement. The core challenge within the sector has consistently been weak implementation and enforcement, rather than the absence of laws, standards, or oversight mechanisms. A good example is the failure to implement the Certificate of Standards. Furthermore, recognising that medical errors will occur in the best of systems is critical. The lack of effective learning and compensatory regimes that allow for acknowledgement of the impacts of adverse events while promoting learning from mistakes remains a critical gap.⁵⁰

The establishment of the Taskforce should be interpreted as a policy signal of heightened governmental concern over patient safety and clinical governance. For health facilities, it underscores rising expectations, increased scrutiny, and the need to move beyond nominal compliance towards a more structured, documented, and defensible approach to clinical governance, with patient safety firmly positioned as a central compliance and risk management priority. However, it is hoped that its recommendations take into account the complex regulatory environment and the continuing gaps which potentially jeopardise patient safety. As an ad hoc creation, its best value will be in making recommendations to implement and strengthen existing structures without creating undue regulatory burdens.

Practical Steps: A Compliance Roadmap for Health Facilities

To ensure compliance with medical-legal obligations and strengthen patient safety, health facilities must adopt a structured and proactive approach to clinical governance. This requires robust systems, clear processes, and a culture that prioritises quality care, transparency, and accountability.⁵¹ The following practical steps provide a roadmap for achieving these objectives:

1. Institutionalise Clinical Governance Structures: Establish multidisciplinary committees with clear mandates to oversee quality assurance, risk management, and patient safety outcomes. Committees must be integrated into executive decision-making rather than operating symbolically.
2. Standardise Clinical Processes: Develop and regularly update standard operating procedures aligned with national guidelines and professional standards. Clear protocols reduce variability in care delivery and provide defensible benchmarks during regulatory or legal reviews.
3. Strengthen Documentation Practices: Maintain accurate, contemporaneous, and comprehensive medical records, which are central to patient safety and legal defence. Poor documentation can undermine otherwise sound clinical decisions.
4. Embed Accountability and Continuous Performance Review: Establish clear lines of individual and team accountability through regular clinical audits, peer review, appraisal systems, and outcome monitoring. Performance metrics should integrate patient safety indicators, ethical compliance, and professional standards, with remedial support where gaps are identified. This ensures that professionalism, competence, and ethical conduct are continuously assessed and reinforced, rather than assumed.
5. Ensure Infrastructure and Supply Chain Reliability: Maintain critical equipment, ensure consistent availability of essential medicines, and comply with building and safety codes, as inadequate infrastructure often contributes to avoidable harm.
6. Implement Non-Punitive Incident Reporting: Encourage reporting of adverse events and near misses to identify systemic weaknesses early. Learn from previous mistakes. Structured root cause analysis and learning demonstrate organisational responsibility and align with global patient safety norms.
7. Expand Staff Training: Train clinicians and administrators not only in clinical competence but also in legal and regulatory literacy, including informed consent, patient autonomy, confidentiality, and institutional policies. Regular training fosters compliance and a culture of accountability.
8. Enhance Patient Engagement and Complaints Management: Ensure transparent communication, timely resolution of concerns, and respect for patient rights to reduce escalation of disputes into litigation or regulatory complaints.
9. Engage Specialist Health Law Firm: Health facilities should engage a law firm with demonstrable expertise in health law and medical ethics, either on a retainer or advisory basis, to oversee regulatory compliance, proactively manage legal and clinical risk, and provide strategic guidance on patient safety and clinical governance obligations. Such counsel should support staff training, advise on informed clinical and operational decision-making, ensure timely updates on evolving statutory, regulatory, and professional requirements and support when adverse events occur.

Conclusion

Patient safety is no longer a peripheral concern but a core compliance and governance priority for health facilities. The existing legal and regulatory framework already imposes clear duties on providers to deliver safe, ethical, and accountable care, with clinical governance serving as the primary vehicle for meeting these obligations. Health facilities that proactively strengthen clinical governance structures, embed patient safety into operational decision-making, and align practice with legal standards will be better positioned to manage risk, protect patients, and maintain public trust. Some suggestions laid out in this article may support health facilities as they undertake patient safety and clinical governance improvements. Ultimately, effective patient safety is not achieved through new regulations alone, but through consistent implementation, leadership accountability, and a culture that treats safety as a legal, ethical, and strategic imperative.

Footnotes

1. Onyemelukwe, Cheluchi. "Patient Safety in Nigeria." Global Patient Safety, Routledge, Aug. 2018, pp. 205–222. https://doi.org/10.4324/9781315167596-14

2. Recent cases include allegations involving Aishatu Umar, a mother of five in Kano, and Nkanu Nnamdi, the 21-month-old son of the renowned author Chimamanda Ngozi Adichie in Lagos. https://www.mondaq.com/nigeria/healthcare/1733324/medical-negligence-and-patient-safety-in-nigeria-what-the-law-says-in-2026

3. Gabriel, Akinwande Opeyemi, and Alenbesunu Faith. "Documentation of Medical Errors in Nigeria: A Review." Preprint, 5 Mar. 2024, https://doi.org/10.21203/rs.3.rs-4002952/v1

4. Ofuebe, Justina Ifeoma, et al. "Factors Contributing to Medical Errors in Healthcare Facilities in Nigeria: A Survey of Healthcare Stakeholder's Perspectives." Journal of Engineering and Applied Sciences, vol. 13, no. 12, 21 Sept. 2022, pp. 4314–4319, https://doi.org/10.36478/jeasci.2018.4314.4319

5. Momoh, Adewale. "Unsafe Hospital Care Kills One in 24 Patients in Nigeria – Expert." The Guardian Nigeria, 31 July 2025, https://guardian.ng/features/health/unsafe-hospital-care-kills-one-in-24-patients-in-nigeria-expert/, Accessed 22 Jan. 2026

6. NOIPolls Limited. "Nigerians Prioritize Patient Safety but Gaps Remain: Patient Safety Poll." NOIPolls, 17 Sept. 2025, https://www.noi-polls.com/post/patient-safety-poll

7. Ibid

8. World Health Organization. Patient Safety, 2026, https://www.who.int/health-topics/patient-safety#tab=tab_1, Accessed 27 Jan. 2026

9. Macfarlane, A J R. "What is clinical governance?." BJA education vol. 19,6 (2019): 174-175. doi:10.1016/j.bjae.2019.02.003

10. Lambert, Bruce L et al. "The "Seven Pillars" Response to Patient Safety Incidents: Effects on Medical Liability Processes and Outcomes." Health services research vol. 51 Suppl 3,Suppl 3 (2016): 2491-2515. doi:10.1111/1475-6773.12548

11. Odumu, Esther. Legal Frameworks for Healthcare Infrastructure Development in Nigerian Communities: A Comparative Analysis. SSRN, 11 May 2024, https://papers.ssrn.com/sol3/Delivery.cfm/4957749.pdf?abstractid=4957749

12. Ukpo, Queen Charles. "Observance of the Patient Safety Measures in the National Health Act: The Panacea for Medical Negligence in Nigeria." Mondaq, 26 Mar. 2024, https://www.mondaq.com/nigeria/healthcare/1444234/observance-of-the-patient-safety-measures-in-the-national-health-act-the-panacea-for-medical-negligence-in-nigeria, Accessed 27 Jan. 2026

13. World Health Organisation. Patient Safety. 11 Sept. 2023, https://www.who.int/news-room/fact-sheets/detail/patient-safety, Accessed 27 Jan. 2026

14. Ibid

15. Ibid

16. Danesi, Mustapha A. "Clinical Governance: Quality Health-Care System for 21st Century." Nigerian Journal of General Practice, vol. 17, no. 1, 17 Jan. 2019, pp. 1–7

17. Ibid

18. Odumu, Esther. Legal Frameworks for Healthcare Infrastructure Development in Nigerian Communities: A Comparative Analysis. SSRN, 11 May 2024, https://papers.ssrn.com/sol3/Delivery.cfm/4957749.pdf?abstractid=4957749

19. Section 34, 1999 Constitution of the Federal Republic of Nigeria

20. Section 37, 1999 Constitution of the Federal Republic of Nigeria

21. (2001) LPELR-1856(SC)

22. Ibid

23. Section 13, National Health Act 2014

24. Section 21(2), National Health Act 2014

25. Section 19, National Health Act 2014

26. Section 20, National Health Act 2014

27. Section 23, National Health Act 2014

28. Section 26, National Health Act 2014

29. Section 23(d), National Health Act 2014

30. Section 23(2), National Health Act 2014

31. Section 29, National Health Act 2014

32. Health Facilities Monitoring and Accreditation Agency (HEFAMAA). "Patient Bill of Rights." Lagos State Government – HEFAMAA, 17 July 2023, https://hefamaa.lagosstate.gov.ng/patient-bill-of-rights/

33. Section 24, National Health Act 2014

34. Section 1, Medical and Dental Practitioners Act

35. Ibid

36. Section 9, Medical and Dental Practitioners Act

37. Section 6, Medical and Dental Practitioners Act

38. Medical and Dental Council of Nigeria. Rules of Professional Conduct for Medical & Dental Practitioners: Code of Medical Ethics in Nigeria. Medical and Dental Council of Nigeria, https://www.mdcnigeria.org/downloads/code-of-conducts.pdf

39. Section 1(2)C, Medical and Dental Practitioners Act

40. Rule 19, Code of Medical Ethics

41. Rule 44, Code of Medical Ethics

42. Ibid

43. Section 15, Medical and Dental Practitioners Act

44. Section 15(3), Medical and Dental Practitioners Act

45. Mora, A. T., Ibrahim A., and A. I. Jatau. "Role of Selected Healthcare Regulatory Agencies in Nigeria." West African Journal of Pharmacy, vol. 29, no. 1, 2018, pp. 92–100, https://www.researchgate.net/publication/324216798_Role_of_selected_healthcare_regulatory_agencies_in_Nigeria

46. Ibid

47. Rule 28, Code of Medical Ethics

48. [48] Ileyemi, Mariam. "Nigeria Establishes Task Force to Tackle Medical Errors, Improve Patient Safety." Premium Times, 16 Jan. 2026, https://www.premiumtimesng.com/health/health-news/849932-nigeria-establishes-task-force-to-tackle-medical-errors-improve-patient-safety.html, Accessed 23 Jan. 2026

49. Pate, Muhammad (@muhammadpate). "Establishment of the National Taskforce on Clinical Governance and Patient Safety" X, Day Month 2025, https://x.com/muhammadpate/status/2011924609952886803

50. Onyemelukwe-Onuobia, Cheluchi, The Law as Compass, Lever or Stumbling Block? Harnessing the Power of Law to Reify and Realise the Right to Health. Inaugural Lecture, Babcock University, 6 Mar. 2025, Babcock University. https://babcock.edu.ng/lecture/the-law-as-compass-lever-or-stumbling-block-harnessing-the-power-of-law-to-reify-and-realise-the-right-to-health

51. Bello, Sandra. "The Legal Perspective of Patient Rights and Healthcare Delivery in Nigeria." SSRN, 15 Dec. 2023, https://papers.ssrn.com/sol3/Delivery.cfm/5386392.pdf?abstractid=5386392

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