Licensing of Private Health Care Facilities

 


The Department of Health is the custodian of health care delivery in South Africa. This includes care delivered at public as well as private facilities. The responsibility is devolved to the provincial departments.

Quality of care and safety of patients and users is best achieved if the structure of the health care facilities facilitates optimal delivery. The minimum requirements for such facilities are laid down in Regulation R158 of 1980, as amended in 1996. Private facilities will only be licensed if they show a high level of compliance with Regulation R158 and the Norms and Standards Regulations

Public Notice (22/11/2022) | Non-payment of annual re-licensing fees | List of licensed facilities

KZN Province - licensing unit OHSC guidance and support workshop on acute private hospital inspection tools: 13 April 2023 (passcode: $Suu!@3m)

 

License Application : new facility or an extension to an existing facility

If you have difficulty with downloading the above documents, a hard copy can be requested from Ms N Ndlovu

Applications will only be processed after receipt of the application fee of R10 000. (Payment arrangements - account and reference number) can be made through Mr Siphamandla Mtolo, KZN DOH Banking Services, 033-395 3041.

The applicable completed and signed form together with:

  • a motivation letter
  • proof of payment of the application fee
  • proof of available site
  • proof of site specific advert in the local and provincial newspapers for the intention to develop / extend a healthcare facility - please attach the email address of  Nonhlanhla.Ndlovu2@kznhealth.gov.za   for receipt of objections in your advert. (with 30 days as a notice period)
  • proof of community endorsement of the project
  • a letter from the Local Authority/Municipality approving the development of a private health care facility in the proposed area
  • Municipality zoning letter (if the site is rented, a pro forma lease agreement together with appropriate certificates indicating suitability of the site for human occupation and safety)
  • a feasibility study/business plan
  • proof of available or intention to fund to be included in the application
  • certified Identity Document copies of the applicant/s

These must to be submitted to the Head of KZN Department of Health through Deputy Director: Private & State-Aided Institutions, Block 2, Town Hill Office Park, or hand delivered at Department of Health Office Park, Block 2,  35 Hyslop Road, Town Hill, Pietermaritzburg, 3201. Telephone 033-940-2488 / 033-940-2483 .

NB. Incomplete applications will not be considered.

Application can also be made online at: https://private-licensing-nhi.kznhealth.gov.za/login where you are expected to first REGISTER as a USER and once this is approved, you can fill the forms and upload all documents.

 

Approvals are site restricted.

Receipt of applications will be acknowledged within 7 days. The decision-making process may take 6 months.

Inspections for Pre-or Commissioning of a new facility or an extension to an existing facility.

After approval of an application for a new facility or extension to an existing facility, the applicant or a representative or a Hospital Manager (which ever case may be) needs to submit a request for inspection  and make necessary payment to the Private Licensing Office for administration and scheduling.

It is the facility's license holder responsibility to obtain municipal and other approvals prior to commissioning. Operational activities should not resume before an approvals has been formally communicated by the department.

Progress reports have to be submitted detailing progress or, where there are delays, these need to be explained or motivated

When building activities have been completed, a commissioning inspection must requested and a Private Licensing inspection team will performs the inspection after receiving a filled request form and proof of payment for an inspection. If there are still shortcomings, the developer/owner is provided with a report and allowed time to correct these.

If the new building is found compliant with all conditions stipulated in R158, a commissioning inspection report is issued by the Private Licensing team together and a formal letter by the HOD of the commissioning of the facility is sent, together with a license.

Only when such an approval letter has been received by the license holder and other necessary approvals from other bodies, such as the Board of Healthcare Funders will such a facility allowed to open to the public.

Choice of Termination of Pregnancy (CToP) and Birthing Clinics

The Department is starting a process to license all free standing CToP and birthing clinics in the province. A CToP clinics means a standalone healthcare facility does not include a hospital that is licensed as a hospital, an ambulatory surgery center that is licensed as an ambulatory surgery center, or a physician's office as long as the surgical procedures performed at the physician's office are not primarily surgical abortion procedures and abortion inducing drugs are not the primarily dispensed or prescribed drug at the physician's offices.

A birthing clinic means a healthcare facility for childbirth where care is provided in the midwifery and wellness model. The birth clinics is freestanding and not a hospital. Birth clinics are an integrated part of the healthcare system and are guided by principles of prevention, sensitivity, safety, appropriate medical intervention and cost-effectiveness.

Birth clinics are for low risk birth. Birth clinics can serve as a community-based location for prenatal & postpartum care & wrap-around services for a mixed risk population. The licensure of these facilities seeks to;

  • assure the public can be assured the facility meets quality of care standards
  • bestow recognition for the purposes of payment, population health planning, and health system integration, and
  • support clinics to meet evidence-based standards and engage in continuous quality improvement
Women's health and Maternity care is an integral component of primary health care and a health service for women. The clinics are licensed for one year. The Department of Health inspectors will visit clinics at least once every year, or if a need arises, and conduct an inspection of the facility for compliance quality standards.

 

Renal and Oncology Units

Detailed floor plans for dialysis units, chemotherapy units and oncology bunkers must be submitted to the department for approval prior to commencement of construction.

 

Relicensing

A programme of relicensing inspections will be planned for each calendar year in accordance with the prescripts as set out in the R158. However, we encourage license holders or Hospital Managers to submit an inspection request form and make the required payment so that an inspection can be planned.

A license is valid for a period of 12 months from the date of issuing, but not exceeding the 31 December of that year. A relicensing fee as per the new fee structure is applicable and is payable in advance.

 

Following each inspection, the outcomes will be discussed with the management team and time, depending on the severity, for improvement is granted. Following this, the inspection visit will take place during which the inspection team inspects all parts of the facility.

An inspection report is compiled and sent to the facility with a new license and an instruction letter summarizing the issues that need to be attended to. In exceptional circumstances where circumstances are found to be a threat to safety of patients and/or staff, the facility can be instructed to close part of the facility till these matters have been attended to.

Appeal Process

Applicants and license holders can appeal against decisions regarding the application for new licenses and renewal of licenses respectively. This needs to be done within 2 weeks from the date of the decision letter. Appeals are addressed to the MEC for Health through the HODs office. The MEC will refer the matter to the Licensing Appeals Committee which is chaired by the MEC.
 

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This page last edited on 07 June, 2023

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