What does the OHSC check on complaints and adverse events in a practice?

The OHSC checks for a signed complaints procedure, a register with twelve months of entries and proof that three resolved complainants were told the outcome. Regulation 21 adds a system to monitor and report all adverse events, with a register and reporting to a structure or responsible authority.

Complaints, as the OHSC scores them

Regulation 4 requires every health establishment to tell users about its complaints, compliments and suggestions system.¹ The general practice tool scores a complaints procedure covering how users complain, what is recorded, how complaints are investigated and how complainants obtain redress, as an essential measure.² The register and the communication of each resolution are vital measures, checked against entries from the previous twelve months, with zero reporting documented where no complaint came in.²

How to run both registers

1. Show users how to complain. A notice in the waiting area and on the website, naming the route and who handles it.
2. Log every complaint. Name and surname, a reference number, the date and a summary, in a manual or electronic register.
3. Answer in writing. A letter, email or report of the outcome, kept with the complaint, since the inspector reads three.
4. Log every adverse event. A register for all adverse events, including adverse drug reactions and staff exposures.
5. Report and learn. Report each event to the structure or responsible authority that monitors them, and record what changed.

1. Reference ______ Date ______ Complaint or adverse event ______
2. Complainant or patient ______ Summary ______
3. Investigated by ______ Finding ______
4. Outcome sent to complainant on ______ By letter, email or report ______
5. Reported to ______ On ______
6. Change made ______ Owner ______ Date ______

Copy template

Adverse events and what is proposed

Regulation 21 asks for a system to monitor and report all adverse events, a register for all of them, and reporting to a structure in the establishment or the responsible authority that monitors them.¹ The general practice tool scores a procedure for managing adverse drug reactions, and documented reports of them to the relevant regulator.² Draft 1 of the revised regulations, a consultation draft with nothing in force, proposes that establishments monitor patient safety incidents and take corrective action.⁴ The OHSC's own definition of a patient safety incident is an event that could have resulted or did result in harm, not due to an underlying condition.³ For how the grade is set, see the guide to OHSC grading.

Questions

What if we had no complaints this year?

Document zero reporting. The OHSC tool marks the register not applicable only where no complaint was received in the twelve months before the inspection, and asks for that to be recorded.

Does the register have to be on paper?

No. The OHSC tool accepts a manual or an electronic register, provided it holds the complainant's name, a reference, the date and a summary.

Who do we report an adverse event to?

Regulation 21 asks for reporting to a structure in the establishment or to the responsible authority that monitors adverse events, and adverse drug reactions go to the relevant regulator.

Sources

1. 1Office of Health Standards Compliance, 2018Norms and Standards Regulations applicable to different categories of health establishments, GNR 67, Government Gazette 41419, 2 February 2018Read source
2. 2Office of Health Standards Compliance, 2025Regulatory General Practice Inspection Tool v1.1, Administration and Practice ManagementRead source
3. 3Office of Health Standards Compliance, 2026Annual Inspection Report 2024/25Read source
4. 4Office of Health Standards Compliance, 2026FAQs, Review of the 2018 Norms and Standards Regulations, stakeholder consultation on Draft 1Read source

Written by the wai team from Health Professions Council of South Africa and Office of Health Standards Compliance guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the OHSC nor the HPCSA endorses wai or any software.