OHSC Compliance Summary

This summary provides a comprehensive overview of the regulatory requirements for general practices in South Africa, based on the OHSC (Office of Health Standards Compliance) inspection framework. It highlights essential compliance areas, from administration and clinical care to infection control and waste management — no overwhelming paperwork, just clear guidance to help your practice meet OHSC inspection standards.

Regulatory General Practice Compliance Summary (v1.1)

Based on:

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Administration and Practice Management
Regulatory General Practice Inspectioin Tool v1.1

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Clinical Care and Support
Regulatory General Practice Inspection Tool v1.1

1. Administration & Practice Management Compliance Overview

1.1 User Rights

Your practice must:

  • Provide clear information on available healthcare services and access procedures.
  • Have a Complaints, Compliments, and Suggestions SOP, including:
    • How users can submit complaints.
    • What information is collected.
    • The investigation and redress process.
    • Logging and communicating resolutions within 12 months.
  • Maintain a complaints register with full details (name, reference, date, summary).
  • Inform users of the complaints resolution outcome (e.g., email or letter).

1.2 Access to Care

  • Have a triage or prioritisation system to identify and manage urgent cases (life-threatening, frail, infants, acutely unwell).
  • SOP must include prioritisation procedure and communication method (e.g., waiting-room notice).

1.3 Clinical Governance & Clinical Care

  • Health Records SOP: must address filing, confidentiality, retention, access, release, archiving, and disposal — aligned with the HPCSA Booklet 9, National Health Act, and POPIA.
  • Staff Training: all personnel handling records must receive training or orientation annually.
  • Archiving & Disposal: maintain registers and certificates in line with HPCSA retention guidelines.
  • Informed Consent SOP: outline procedure, required information, legal standing, and emergency consent processes (HPCSA Booklet 4).
  • Safe Injection & Surgical SOPs: must detail aseptic technique, sterilisation, sharps management, documentation, and infection control.
  • Research SOPs: if applicable, ensure ethical approval, consent forms, and insurance disclosure.

1.4 Infection Prevention & Control

  • Maintain sufficient linen and ensure clean/dirty segregation.
  • Train staff on infection control (standard precautions, transmission-based precautions).
  • Have SOPs for decontamination, testing of sterilisation equipment, pest control, and remedial actions for breaches.
  • Maintain valid service level agreements (SLAs) for outsourced decontamination or pest control.

1.5 Waste Management

  • Have a Waste Management SOP including segregation, handling, storage, collection, and disposal.
  • Keep a valid SLA for waste removal, monitor compliance, and record corrective actions.

1.6 Adverse Events

  • Have a system and SOP for reporting adverse drug reactions and other adverse events.
  • Reports must be submitted to appropriate authorities and documented internally.

2. Clinical Care & Support Compliance Overview

2.1 User Information & Access

  • Display visible information on:
    • Services provided.
    • Operating hours.
    • Complaints procedure.
    • Indicative pricing.
    • Results of user experience surveys.
  • Maintain visible emergency contact details (GP, after-hours, EMS).
  • Keep copies of referral letters for all external referrals, including reason, summary, and receiving provider details.

2.2 Health Record Management

  • All user records must include:
    • Name, ID or DOB, contact details, next of kin, and unique patient number.
    • Date/time of visit, allergies, assessments, management plan, prescribed meds, investigations, referrals, and follow-up plan.
    • Doctor's signature and permanent ink (no correction fluid).
  • POPIA notice must be displayed.
  • Secure all paper and digital records (passwords, lockable cabinets).
  • Diagnostic results must be available, reviewed, communicated to the patient, and acted upon.

2.3 Informed Consent

  • Every surgical or invasive procedure must have a correctly completed, signed consent form including:
    • Patient details, nature of procedure, date, signatures of both patient and provider.

2.4 Clinical Management & Emergency Preparedness

  • Clinical guidelines (HIV, TB, NCDs, Maternity, Child Health) must be available in consulting rooms.
  • Emergency trolley/bag must contain required equipment, drugs, and consumables — all functional and in date.
  • Emergency equipment checks must be documented monthly.
  • Practice must display resuscitation protocols and maintain cleanliness and infection control standards.

2.5 Infection Prevention & Control

  • Each service area must have:
    • Working handwash basins, soap dispensers, paper towels, general waste bins.
    • Alcohol-based hand rub and laminated hand-hygiene posters.
    • Designated clean and dirty linen storage.
  • Staff must be familiar with prophylactic immunisations for high-risk exposure and decontamination procedures.

3. Self-Assessment Compliance Checklist

Use this checklist to evaluate your own general practice readiness before inspection:

Domain Requirement
User Rights SOP for complaints management (includes reporting, investigation, redress)
Complaints register maintained and up-to-date
Patients informed of complaint resolutions
Services, hours, pricing, and complaints info visibly displayed
Access to Care Triage procedure in place and displayed
Emergency contacts displayed
Health Records Records SOP includes filing, retention, confidentiality
Staff trained on records management
POPIA notice displayed
Secure storage for physical and electronic records
Informed Consent Consent SOP includes information, legal standing, review
Signed consent forms on file for all surgical procedures
Clinical Management Current national clinical guidelines accessible
Emergency trolley/bag checked monthly
Stock of emergency drugs and equipment (valid, unexpired)
Infection Control Handwashing stations functional in all areas
Hand hygiene posters displayed
Clean and dirty linen storage areas identified
Infection prevention training records available
Decontamination SOP and records of staff training
Pest control and waste management SLAs valid
Waste Management Waste segregation and disposal SOP implemented
Compliance monitoring and remedial actions documented
Adverse Events SOP for adverse drug reaction reporting
Evidence of reporting and review

Elle Health Pty (Ltd) Regulatory Compliance Statement

Elle Health complies with all applicable clauses of the Regulatory General Practice Inspection Tools v1.1 that relate to data confidentiality, record management, and administrative integrity.

Our platform adheres to the Protection of Personal Information Act (POPIA), HPCSA ethical standards for record confidentiality, and maintains documented SOPs for complaints management, data retention, and information security.

Clinical, environmental, and infection control standards under the regulatory tools are not applicable to our operations as a non-clinical, digital service provider.