The purpose of this Guideline is to provide direction to the health sector of South Africa regarding the management of PSI reporting, including the provision of appropriate feedback to patients, families/support persons and clinicians, as well as the sharing of lessons learned to prevent patient harm. This Guideline describes a national standardised system for managing PSIs to ensure that various levels of care in the health system respond effectively to PSIs. By doing so, patient safety is improved by learning from failures of the healthcare system so that the likelihood of a reoccurrence of the same event is significantly reduced. The objectives of this Guideline are to: create a framework to guide the implementation of a PSI RLS. assist facilities to comply with the norms and standards regulations applicable to different categories of health establishments (2018). prevent and or reduce harm to patients whilst undergoing medical care. standardise the definitions for PSIs. standardise the degree of severity classification. standardise the classification for PSIs by type, contributing factors, and outcomes. standardise the methodology for reporting, investigating, and responses to PSIs. ensure that statistical data on PSIs is readily available for planning and decision making. learn from data reported on PSIs to prevent reoccurrence to ensure that patient safety, quality of care and health outcomes of patients are improved. ensure that preventative measures are put in place to reduce the incidence of PSIs and prevent their reoccurrence. continuously improve quality of care through the identification of all missed opportunities in ensuring optimal patient outcomes. ensure appropriate communication with patients who have been harmed due to a PSI, including an apology if indicated.