RenaCare Dialysis Clinic Business Plan › Section 11 › Regulatory & Compliance Framework

11.1 Facility Licensing

A private dialysis clinic is a “health establishment” in terms of the
National Health Act 61 of 2003. Facility licensing is administered by
the Gauteng Department of Health under the provincial regulations. The
licensing process requires: compliance with prescribed minimum
architectural, hygiene and infection-control standards; registration of
all clinical personnel; submission of operational policies and
procedures; and a site inspection prior to issue of the initial licence.
The licensing timeline is typically 4 to 6 months from submission, which
has been reflected in the implementation Gantt chart.

11.2 Clinical Registration

All clinical personnel must be registered with the relevant statutory
body before engaging in clinical practice. The Medical Director and any
other nephrologists must be registered as specialist physicians with the
Health Professions Council of South Africa (HPCSA). Registered nurses
must be registered with the South African Nursing Council (SANC), and
those performing dialysis must hold a recognised dialysis qualification.
Clinical technologists must be registered with the HPCSA in the clinical
technology (nephrology) category.

11.3 Medical Scheme Accreditation

Each medical scheme operates its own Designated Service Provider
(DSP) accreditation process. The core requirements across schemes are
consistent: valid facility licence; compliance with clinical quality
standards; demonstration of clinical outcomes (typically a six-month
ramp period of data); electronic claims capability; and agreement to a
negotiated tariff. Renacare’s DSP accreditation timeline anticipates six
schemes accredited by end of Year 1, covering approximately 85% of the
medical-aid-insured South African population.

11.4 Prescribed Minimum Benefits

Chronic Renal Failure is listed as a Chronic Disease List (CDL)
condition under the Medical Schemes Act 131 of 1998 and its regulations.
Medical schemes are legally obliged to fund diagnosis, treatment and
ongoing care of CDL conditions in full, subject to the use of a
Designated Service Provider where one has been nominated. This statutory
protection provides a durable revenue underpinning for any accredited
dialysis provider.

11.5 Data Protection (POPIA)

Patient health information is “special personal information” under
the Protection of Personal Information Act 4 of 2013. Renacare’s
information governance framework includes: an appointed Information
Officer; POPIA-compliant consent and data-subject notice forms;
electronic data encryption at rest and in transit; role-based access
controls in the EMR; breach notification procedures; and annual POPIA
compliance audit. The Company will also comply with the Health
Professions Act rules on patient records retention (minimum 6 years
after last consultation, or 21 years in the case of minors).

11.6 Occupational Health & Safety

Compliance with the Occupational Health and Safety Act 85 of 1993 is
overseen by the Head of Nursing & Clinical Operations as designated
SHE representative. Key compliance elements include: annual machine
safety certification; hazardous chemicals register; sharps injury
management; staff immunisation (Hepatitis B); and incident reporting
through the Compensation for Occupational Injuries and Diseases Act
(COIDA) framework.

11.7 Environmental & Waste Management

Healthcare risk waste is regulated under the National Environmental
Management: Waste Act 59 of 2008 and the associated Waste Management
Regulations. Renacare will contract a licensed healthcare risk waste
contractor for disposal of all clinical waste, sharps, and cytotoxic
waste. Water discharge into the municipal sewer system will comply with
the relevant municipal by-laws; no chemical discharges requiring
separate permitting are anticipated.

11.8 B-BBEE Positioning

Broad-Based Black Economic Empowerment compliance is material for
Renacare for three reasons: public-sector tender eligibility (PPP
contracts), medical-aid scheme scorecard considerations, and alignment
with the Company’s equity-of-access mission. The Company will target a
Level 2 B-BBEE rating within 36 months of commissioning through a
combination of ownership (minimum 30% black ownership within
shareholding), management control, skills development, and enterprise
and supplier development programmes.

Confidential — this business plan is provided to prospective investors and lenders for evaluation purposes only and may not be reproduced or distributed without the written consent of RenaCare Dialysis Clinic (Pty) Ltd.