"category of health establishment"

means the category contemplated in section 35 of the Act;

"certificate of compliance"

means a certificate referred to in Regulation 18(2), issued to the health establishment by the Office;

"compliance notice"

means a notice referred to in regulation 21(1), issued to the health establishment by an inspector;

"early warning system"

means the surveillance systems that collect information on serious user-related incidents that prompt interventions by the health establishment, Office or relevant authority;

"head of the health establishment"

means the owner and occupier of a health establishment as contemplated in section 88(a) of the Act;

"health care service"

includes all services dealing with the diagnosis and treatment of disease, or the promotion, maintenance and restoration of health including personal and non-personal health services provided by public and private health establishments;

"inspection"

means on site visits to health establishments for the purpose of gathering information and evidence to assess compliance or investigate breaches of norms and standards;

"person"

means a legal person, except where the context indicates otherwise;

"person in charge"

means a person designated as a person in charge of a health establishment, in terms of regulation 6(1);

"relevant authority"

means a provincial department of health, district health authority, municipal authority or executive management of a private hospital or private hospital group;

"self-assessment"

means the information or data resulting from an assessment conducted by the health establishment against a tool or framework published by the Office from time to time;

"serious breach"

means a breach in safety procedures which results in the user suffering permanent loss of function or death unrelated to natural causes;

"serious risk"

means any risk that could have severe negative effects on public health or result in the death of a user or permanent loss of function;

"the Act"

means the National Health Act, 2003 (Act No. 61 of 2003); and

"working day"

means any day other than a Saturday, Sunday or public holiday.