Medical Law – Introduction of Quality Requirements and Standards

The National Health Amendment Act, 12 of 2013 (“the Amendment Act”) provides for the establishment of quality requirements and standards in respect of health services provided by health establishments in both the public and private health sectors.  The purpose of the quality requirements and standards is to promote and protect the health and safety of the users of health services.  These quality requirements and standards are prescribed by the Minister after consultation with the Office of Health Standards Compliance (“the Office”). 

The Office will act as the watchdog for monitoring and enforcing compliance by health establishments.  The Office may issue guidelines for the benefit of health establishments on the implementation of said standards and will, inter alia, be responsible for:

1. Inspection and certification of health establishments by making use of health officers and
    inspectors.

2. Investigating complaints relating to non-compliance with the quality requirements and
    standards through the appointed Ombud.

The Office functions under the control of a Board consisting of between 7 to 12 members.  The Board must, in consultation with the Minister, appoint a Chief Executive Officer (“CEO”) of the Office, who will be a member of the board ex officio.  The CEO is responsible for appointing and managing suitably qualified employees and developing efficient administration.  The Amendment Act enables the CEO to delegate any of his powers or duties to an employee of the Office.  The CEO is also entitled, after consultation with the Board, to appoint expert or technical committees to assist the Office in the performance of its functions, including the conducting of inspections. 

The Amendment Act makes provision for the designation of health officers and the appointment of inspectors responsible for inspecting health establishments to ensure compliance with the National Health Act, 61 of 2000 (“the Act”).  During an inspection, the health officers or inspectors may question any person who may have information relevant to the inspection, require the production of any document (including patient health records) and take samples of any substance or photographs relevant to the inspection.  Even though the Amendment Act cautions that inspections must be conducted with strict regard to, inter alia, a person’s right to privacy, it is concerning that the health officers and inspectors may obtain copies of patient health records seemingly without such patient’s consent.   This provision of the Amendment Act seems to constitute an infringement of an individual’s right to privacy of personal information. 

In the event of a health establishment not complying with any prescribed quality requirement or standard, the health officer or investigator will issue a notice of compliance describing, inter alia, the breach and the steps to be taken over a prescribed period of time to remedy the breach.  Should the health establishment fail to comply, certain prescribed penalties may be imposed, such as temporary or permanent closure of the health establishment or part thereof, a fine or referral to the National Prosecuting Authority for prosecution. 

The Amendment Act provides for the appointment of an Ombud, whose function is to consider, investigate and dispose of complaints relating to the non-compliance with the prescribed quality requirements and standards in a fair, independent, economical and expeditious manner. 

Any aggrieved party may lodge a written appeal with the Minister against a decision of the Office or a finding by the Ombud within 30 days of becoming aware thereof.  The Minister must appoint an independent ad hoc tribunal and submit the appeal to the tribunal for adjudication.  The tribunal consists of a maximum of three individuals with a retired High Court judge or a magistrate as chairperson.  The remaining two seats are filled by individuals knowledgeable of the health care industry.  The tribunal may confirm, set aside or vary the decision of the Office or the Ombud and must notify all concerned parties accordingly.

The introduction and implementation of quality requirements and standards in the public sector is most welcome.  However, the implementation thereof in the private sector may have little effect as most private healthcare facilities already subscribe to international standards, such as accreditation by the International Organization for Standardization (ISO).