An analysis of medical risk inspections in the context of the Office of Health Standards Compliance (OHSC)

Abstract

Section 27 of the Constitution of the Republic of South Africa states, “everyone has a right to have access to healthcare services” and puts an obligation to the state to “take reasonable legislative measures within its available resources, to achieve the progressive realisation” of this right.

One of the steps taken by the state, for the progressive realisation of this right was the establishment of the Office of Health Standards Compliance (OHSC), as an independent entity and regulator in the healthcare sector, “to protect and promote the health and safety of users of health services.” The OHSC implements its mandate by conducting annual health establishment inspections to monitor and enforce compliance with norms and standards prescribed by the National Core Standards (NCS).

This dissertation focuses on the Patient Safety, Clinical Governance and Care domain of the NCS. This domain is interrogated from a medical risk perspective and advances a proposal that the OHSC’s mandate would be strengthened by adding operationally focused medical risk inspections when conducting their inspections. Using an integrated multi-layered approach, the proposal is built by using various legal sources, such as the Constitution, various legislations such as the National Health Act, the National Health Insurance Bill, case law, published reports and articles.

The dissertation highlights the aetiology of patient harm, the magnitude of harm and the ineffective role of medical malpractice litigation in improving patient safety. The ineffectiveness of tort law reforms has been discussed and likened to treating symptoms instead of root causes of patient harm. Blame culture of patient safety and reporting mechanisms are also discussed as areas that are also ineffective in promoting patient safety. Case law is used to provide practical examples of patient harm and motivation for an operationally-focused medical risk standard.

It concludes by submitting a proposed medical risk inspection standard to complement domain two of the NCS for use by OHSC when conducting annual health establishment inspections.