National Health Act, 2003 (Act No. 61 of 2003)

Regulations

Procedural Regulations Pertaining to the Functioning of the Office of Health Standards Compliance and Handling of Complaints by the Ombud

Chapter 3 : Inspectors and Inspections

14. Inspection process

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(1)Upon arrival at the premises of the health establishment, the inspector must clearly identify himself or herself to the person in charge by presenting—
(a)a notice of inspection, referred to in regulation 13(1), if applicable;
(b)a certificate of appointment as an inspector, issued in terms of section 80(3) of the Act; and
(c)an entry and search warrant issued in terms of section 84(5) of the Act, if applicable.

 

(2)During an inspection, the health establishment must make available the necessary staff, resources and space to allow inspectors to complete the inspection in a timely and expeditious manner.

 

(3)An inspector may question any user, occupant, health care personnel or any person on the premises of a health establishment about any information that is relevant to the inspection, or require the person in charge to produce any document, record or material for inspection.

 

(4)The person in charge may provide the inspector with any relevant information, documents, records, objects or materials for the inspector’s consideration during the inspection visit.

 

(5)Within 20 working days of the completion of the inspection, the inspector must provide his or her preliminary findings to the person in charge in writing.

 

(6)The preliminary findings must—
(a)identify the main areas of non-compliance with norms and standards;
(b)set out the consequences of non-compliance, contemplated in section 82A(2) and (4) of the Act; and
(c)set out the steps that must be undertaken to achieve compliance and timeframes for corrective action.

 

(7)The inspector must provide the person in charge not more than 20 working days to respond to the preliminary findings in writing.

 

(8)Within 20 working days of receipt of the response contemplated in sub-regulation 7, the inspector must consider such response and issue a final report to the person in charge.

 

(9)After issuing a final report contemplated in sub-regulation 8, the inspector—
(a)may recommend to the Office the issuing of a compliance certificate to the health establishment, in terms of regulation 18(2); or
(b)must issue a compliance notice to the health establishment, in terms of section 82A(1) of the Act, if any norms and standards have not been complied with.