The norms and standards regulations applicable to different categories of health establishments published in 2018 applies to district and regional hospital.
There will be specific inspection tools developed for the different categories of health establishments, i.e., (district, regional, tertiary, and central hospitals, Community Health Centres (CHCs) and clinics).

All hospitals must have piped oxygen due to the acuity levels of admitted patients. Outpatient departments and rehabilitation service units within the hospital can have oxygen cylinders only, as patients accessing these services are not ordinarily acutely unwell

The requirements for the issuing of fire certificates are the competence of the Local Municipality Fire Departments and the OHSC cannot amend these requirements. To ensure patient safety this requirement is necessary at the health establishment level.

Policies for the public health sector are and must be developed at national or provincial level. In the private sector healthcare groups, these policies can/would be developed by the respective corporate head offices. Independent health establishments will be required to develop their own policies, aligned to national policies. To expedite the process, independent health establishments may wish to access policies from other hospital groups or local public sector hospitals to serve as a template for the development of their own policies.

The current regulations do not apply to these facilities.

Ideal clinic health facility systems are used by clinics to submit the self-assessment reports. The National Department of Health (NDoH) is in consultation with the OHSC to align the ideal hospital framework to the OHSC hospital inspection tools aligned to the norms and standards regulations. These regulated norms and standards are the foundation and basis of the OHSC’s inspections processes. Another important point to note is that the inspection and certification of health establishments by the OHSC is a quality assurance framework, whereas the ideal clinic and hospital framework is a quality improvement framework.

This should be determined by the relevant clinical managers within the hospital in consultation with the EMS personnel taking into consideration the clinical condition of the patient being transported

The mandate of the OHSC extends to all the different categories of health establishments and medical depots are likely to be considered as regulations are reviewed and updated. The provincial and district health offices, on the other hand, are not the health establishments, therefore cannot be inspected by the OHSC.

The OHSC will utilise inspection data to identify systemic weaknesses within various levels of the health system and make recommendations to the relevant authorities in accordance with Section 79.(1)(e) of the National Health Act.

Klebsiella pneumonia is a superbug, and several strains of this organism are resistant to certain antibiotics. Multi-drug resistant Klebsiella pneumoniae bloodstream infection is associated with high mortality in children. An example of how deadly this organism can be was widely reported in some hospitals in Gauteng where new-borns died because of an infection by this organism in 2018. Other hospitals acquired infections are also important but following an approach which was determined through a Delphi study, it was agreed that EWS will initially focus on the Klebsiella pneumoniae indicator when it is rolled out. The EWS indicators will be reviewed periodically as data comes in and will not remain static, although it must be emphasised that EWS must have a limited number of indicators to be effective.

The early warning system (EWS) is not meant for grading of health establishments. Health establishments are graded as part of the overall assessment following a routine inspection. As part of implementation of the EWS, the OHSC collect or monitor indicators of risk to identify serious breaches to norms and standards. The information collected through the EWS is used to provide guidance to the authorities to address challenges that may result in serious harm to users. The EWS data in conjunction with other health system data will be used to risk profile health establishments.

The early warning system will derive data from various sources in order to determine the level of risk in health establishments. Structured and unstructured data sources will be used in this regard. Structured reports consist of self-reported indicators by health establishments and unstructured reports such as media reports, complaints, whistle-blowing research reports etc. where incidences of patient safety have reportedly been compromised. The different sources of data will enable the OHSC to use a data triangulation approach to have a comprehensive assessment for each individual health establishments.

The OHSC will collect information directly from health establishments as far as the indicator reporting is concerned. In instances there are delay in reporting is because of  failure of the OHSC system, the health establishments will not be unduly penalised. In addition, ongoing support through various communication channels will be provided to health establishments to ensure that information is received timeously. EWS reporting will not be done through the District Health Information System.

The OHSC protects annual returns data and any other datasets in the organisation using robust and modern IT security systems and tools. Annual returns data is mainly used for planning of inspections by the OHSC. Moreover, the OHSC periodically analyses annual returns reports which can be published by the organisation. The OHSC make use of authentication processes to enable access and logging on to the annual returns database by authorised users across the country.

Guidance and training workshops for newly completed inspection tools will be communicated to the health establishments three weeks in advance of the proposed training. Suitable dates for follow up training visits after completion of inspections will be negotiated with the relevant organisations.

The staffing or human resources norms, in general, is the competency and responsibility of the National Department of Health. Once the norms have been set, the OHSC can assess whether there is adherence to these norms.

The process starts with engagement of the relevant stakeholders in the development of the inspection tools and in this regard, the health establishments are always aware on the requirements within the tools. In addition, training will be provided to all provinces, private health care groups and independent hospitals immediately on finalisation of the inspection tools for each level of care.  Following the inspections, the OHSC can provide training workshops to assist health establishments in understanding their deficiencies and implementing actions to address the gaps identified. The OHSC prepares recommendation reports to assist the authorities to understand the gaps and how these can be rectified.

The different sectors will have different perspectives and different issues that they will wish to address. To ensure that everyone has the opportunity to ask the questions relevant to them and to communicate their perspectives as influenced by their practises and business models, standards and inspections development activities and training activities will be conducted separately.

However, the content of the tools will be comparable. Wording of the requirements will be adjusted to reflect the relevant practices and business models; however, the requirement will be the same. For example, all health establishments must conduct patient satisfaction surveys and communicate the results to their patients. However, in the public sector, the indicators to be collected and reported are specified in accordance with the National Patient Experience of Care survey categories. As a wide variety of tools are utilised in the private sector, this level of detail, i.e., the indicators to be reported, will not be specified.

The OHSC does not license health establishments as this is the role of provincial departments of health.  The OHSC mandate is limited to certification of health establishments for compliance with the norms and standards, which is a completely different process from licensing.

The certification of the health establishments which have been found to be compliant with the norms and standards will happen within fifteen (15) days from the date of a recommendation by an OHSC Inspector.

The OHSC’s responsibility does not include assessment of health practitioners, but rather focuses on the health establishments. Health establishments will be required to develop and implement systems and processes to ensure the independent practitioners provide services in accordance with best practice.

Section 13 of the National Health Act states that subject to National Archives of South Africa Act, 1996 (Act No. 43 of 1996), and the Promotion of Access to Information Act, 2000 (Act No. 2 of 2000), the person in charge of a health establishment must ensure that a health record containing such information as may be prescribed is created and maintained at that health establishment for every user of health services. The person in charge of the health establishment will be required to comply with this legislation.

The OHSC considers seven working days as reasonable time to notify a health establishment of a planned inspection.

The OHSC understands that, due to circumstances beyond the control of the health establishments, health services had to be reconfigured and the use of space had to be re-imagined accommodating COVID-19 infection control, including the non-pharmaceutical measures put in place in terms of the disaster management regulations. Most non-critical and non-urgent healthcare services were suspended, and health workers worked in a manner required to achieve COVID-19 disease outbreak control.

Conducting routine inspections using the usual tools would have proven challenging and possibly inappropriate because the functional areas were rearranged, and medical equipment used differently at the height of the pandemic.

However, the OHSC continued to collect information about early warning system (EWS) surveillance through media alerts, complaints, and self-reporting of early warning indicators to monitor the performance of health services. The OHSC further conducted COVID-19 rapid assessments at 23 field hospitals, as well as at quarantine and isolation facilities. (More details in 2. below).

The OHSC has conducted 23 rapid inspections to ensure that newly established COVID-19 field hospitals, quarantine, and isolation facilities in all provinces except in Limpopo met the minimum standards for providing safe, and quality care.

The OHSC also received and attended to 29 complaints related to infection control breaches, nonadherence to COVID-19 protocols, denying services to patient who tested positive for COVID-19, withholding information and postponement of elective surgery due to COVID-19.

There was also an investigation carried by the Health Ombud of the case concerning deficiencies in the management of a patient infected with COVID-19 at Tembisa Hospital. The OHSC inspectors and investigators supported this process undertaken by the Health Ombud.

No inspections were conducted by the OHSC during lockdown levels 4 and 5, as well as at all other times when COVID-19 transmission rates were high. Inspectors are further provided with appropriate personal protective equipment (PPE) to decrease the risk of contracting COVID-19 while conducting inspections during lockdown levels 1 – 3.

Lastly, the OHSC arranged with the National Department of Health (NDoH) to fast track the COVID-19 vaccination of OHSC staff and allowed staff time off to go for vaccination.

The OHSC’s primary responsibility is quality assurance of healthcare services. Quality of healthcare services is only one of the components that make up the status of healthcare services. Therefore, the question of the status of healthcare services cannot be determined or answered only through the work of the OHSC, as it is a much broader question.

Access to quality healthcare for South Africans reflects the constitutional obligations contained in the Bill of Rights.  The OHSC’s vision is to contribute to safe and quality healthcare by reducing avoidable mortality, morbidity, and harm within health establishments through monitoring compliance with the norms and standards, responsiveness, and accessibility of health services for users. This is done
with regular inspection to mitigate and avoid harm to the health users.

It will be difficult to make a general statement on the status of healthcare services based on the findings of the OHSC inspections. The inspections are based on the promulgated norms and standards that have only been in effect since February 2019 and the inspections thus far have only been within public healthcare facilities. It is still worth making the point that initial indications are that there are some gaps in clinical governance and clinical care, and user rights domains within public healthcare facilities that have been inspected, e.g., lack of proper records management such as incomplete consent forms, discharge reports not kept with records etc.

Many health establishments inspected in the year under review had not achieved compliant status and were not eligible for certification. A common reason for them being regarded as non-compliant was the findings in the domains mentioned above and their failure to take the opportunity to comment on – and potentially correct – findings made by the OHSC Inspectorate in the preliminary inspection report. Most simply failed to provide evidence of compliance with specific standards when requested to do so. In other instances, establishments provided evidence that was either irrelevant or not acceptable, revealing a lack of understanding of what was expected of them.

The OHSC has a legal mandate to inspect all health establishments at least once every four years.  This is despite the human resources and financial constraints the office is experiencing. In the past, health establishments were conveniently sampled and included to ensure that the set inspection target was met and applied across all provinces, districts, and sub-districts.

A geographical clustering approach was followed per province, district, and sub-district. In maximising operational and resource efficiencies, consideration of the location of and the distance between clinics across districts and sub-districts was made to decide on health establishments to include.

However, this approach was found to limit the ability to draw comparisons between provinces and districts. As a result, and to remedy the situation, the current inspections of health establishments are selected using a more scientifically sound random sampling methodology, through which it is envisaged that comparisons between districts and between provinces may be possible.

The OHSC carried out routine inspections at 387 public health clinics, against a target of 382 during 2020/21 financial year. Furthermore, the Office carried out eight risk-based inspections at public health clinics in various provinces as part of ensuring service improvement. These risk-based inspections were prompted by reports in the media, which are monitored as part of the early warning system.

Majority of health establishments were found to be non-compliant in the clinical governance and clinical care domains where the non- negotiable risk-rated measures are located. The requirements related to user health records management such as the recording of patient care on appropriate clinical stationery was not adhered to.

Governance and related processes were generally found to be areas of non-compliance. Principles of document management such as standards operating procedures and guidelines were generally not adhered to in relation to availability, sufficiency of content and validity (approval signatures by the relevant authorities).

The OHSC did not inspect private hospitals during 2020/21 financial year.

Majority of health establishments were found to be non-compliant in the clinical governance and clinical care domains where the non- negotiable risk-rated measures are located. The requirements related to user health records management such as the recording of patient care on appropriate clinical stationery was not adhered to.

Governance and related processes were generally found to be areas of non-compliance. Principles of document management such as standards operating procedures and guidelines were generally not adhered to in relation to availability, sufficiency of content and validity (approval signatures by the relevant authorities).

The OHSC did not inspect private hospitals during 2020/21 financial year.

The conducting of inspections in the private sector requires the development of the applicable inspection tools that specify how the norms and standards regulations are to be measured in that particular healthcare settings. These tools are essential for standardisation and objectivity in carrying out inspections. The tools for private health facilities were not finalised during the course of 2020/21.  The private hospital inspection tools have been finalised and the inspections will commence in the first quarter of the 2022/23 financial year.

Re-inspections are conducted to check if areas of non- compliance have been remedied. Such inspections started from Quarter 2 of 2021/22 financial year. At times, health establishments are given shorter timeframes to remedy urgent and/or critical areas of non-compliance and to submit evidence of such remedial action to the OHSC.

Certification of health establishments depends on the production of final inspection reports. Due to backlogs in the finalisation of reports, 33 certificates of compliance were issued in 2020/21 related to inspections undertaken in 2019/20. While the programme met its target timeframe, the total process of inspection and certification was prolonged.

Although all non-compliant establishments were issued with compliance notices, enforcement 8 Frequently asked questions only occurs after the finalisation of an additional inspection report that confirms persistent noncompliance.  In 2020/21 reinspection of non-compliant facilities did not take place as a result of the
disruptive impact of the COVID-19 pandemic and this delayed enforcement processes.

To date, the OHSC has not yet implemented enforcement actions on any health establishment. The rest of non-compliant health establishments were sent compliance notices and needed, in many cases, to undergo re-inspection to establish whether compliance notices had been heeded. Although all non-compliant establishments were issued with compliance notices, enforcement only occurs after the finalisation of an additional inspection report that confirms persistent non-compliance. In 2020/21 re-inspection of non-compliant facilities did not take place as a result of the disruptive
impact by the COVID-19 pandemic.

Just 33 (5%) of health establishments inspected in 2019/20 proved immediately certifiable, while the rest were sent compliance notices and needed, in many cases, to undergo re-inspection to establish whether compliance notices had been heeded.

The OHSC provides guidance and support through conducting training workshops to interpret the standards and measurement tools to facilitate the implementation thereof to improve performance.  The Office further makes the tools readily available to health establishments for use during their pre-inspection preparation. After the routine inspection, the Office releases preliminary reports to the health establishments and are invited to make further submissions before finalisation of the reports. They are further advised to review and respond to the requests for further information by Inspectors, as well as to ensure that the identified areas on non-compliance are remedied ahead of
re-inspection.

The OHSC involves the district and provincial management structures when communicating the outcome of inspections with health establishments. This is to ensure that the districts and provinces are informed enough to be able to support health establishments towards achieving compliance with the norms and standards.

Certification of health establishments depends on the production of final inspection reports. 33 certificates of compliance were issued in 2020/21 financial year. the total process of inspection and certification is long, and the delays was also caused by the transition from using the national core standards inspection system to the regulated norms and standards

All non-compliant health establishments were issued with compliance notices outlining specific the failed norms and standards and timeframes within which the identified breaches must be remedied.

The OHSC will be taking enforcement actions against persistently non-compliant health
establishments. Those enforcement actions include, among others, imposing a fine, giving a written warning or recommend closure of the whole or part of a health establishment.

The OHSC started with conceptualising the decentralisation model which led to the development of the Business Case in collaboration with the Better Health Programme South Africa (BHPSA). The implementation of the decentralisation business case is subject to availability of funds.

All OHSC reports were ordinarily released once consultation processes with the key stakeholders is completed and when they are tabled to the Portfolio Committee. During that process, preliminary inspection reports are released to health establishments and provinces. However, the Office has started releasing final inspection reports for individual health establishments as these become finalised to avoid delays in communicating inspection outcomes while the consolidation of provincial and the national reports are underway.

With the growth of the organisation, inadequate funding for the fulfilment of its mandate remains a major challenge for the OHSC. Financial constraints impact especially on the ability of OHSC inspectors to conduct the targeted number of inspections of health establishments. The number of inspections completed is proportional to available funding.

The main source of funding is the allocation from the national fiscus, with additional revenue
generated as interest from investment of funds. Donations in kind are also received for specific projects.

Section 77(1) of the National Health Amendment Act 12 of 2013 does allow the charging of the fees on the services rendered by the OHSC but the structure of fees is yet to be promulgated.

The OHSC severity assessment guidelines assist in this process, with due consideration of the probability of complications arising from the complaint, as well as the impact of the complaint on the user, health establishment and public. Examples of low-risk complaints include early closure of health establishment and lack of action by health establishments to complaints raised by members of the public. There are three levels within the complaint’s resolution process:

Low risk – A complaint is resolved when it was signposted to the health establishment for action, an acknowledgement received from the health establishment and complainant informed OHSC of his/her satisfaction to the signposting. This is an informal process.

Assessment (Early Resolution) – Formal process of requesting evidence from the health establishment on the complaint, analysis the information and making findings and recommendations (desktop process). The assessment team may also refer the complaint for investigation if necessary.

Investigations – Formal process of analysis and on-site verification of information provided. The process includes interviews, onsite inspection and document analysis, consolidation of findings and 10 Frequently asked questions legal vetting where necessary.

The OHSC has signed MOUs with some entities and as such we refer to each other to avoid health establishments receiving similar requests from different entities. Where a complainant has addressed the complaint to various bodies attempts are made to weigh the bias of the complaint and allow the entity that has a high bias to rather deal with the complaint. In some instances, joint investigations may be undertaken (though not tested yet). It is important for assurance that there has been action taken to address the complaint.

The number of approved inspection tools, recommendations arising from other OHSC information systems such as annual returns, early warning system, and complaints management are the determinants of the number of guidance workshops. In addition, there is consideration for the number of relevant health authorities and the budget allocated to the guidance and support for conducting of training workshops.

The OHSC provides guidance and support to the relevant health authority hence the target of 24 which translate to two workshops per province per annum, which comes to 18 workshops for the public sector, and 6 for the private hospital groups. Following the training workshops for the provinces they must disseminate the information through conducting of workshops for the district and health establishments to facilitate the implementation of the applicable norms and standards regulations.

Where complaints are received, they are risk-rated and assessed or investigated. In addition, the OHSC together with the NDoH are in the process of finalising the EMS regulations which will be submitted to the Minister of Health for consideration and promulgation.

Once promulgated, the applicable inspection tools which were developed together with the EMS standards will be reviewed, finalised, and used to inspect this service.

As the OHSC we are conscious that we are part of a much larger national project to ensure universal access to healthcare of good quality. The extent to which we fulfil our mandate impacts on other organisations harnessed for the same purpose – including a whole range of health sector regulators, the NDoH, provincial departments of health, private hospital sector, and individual private healthcare providers. At the centre of this effort is the envisioning and implementation of the system of National Health Insurance (NHI).

We are keenly aware that the contracting of private and public healthcare providers by the planned NHI Fund will depend, in part, on healthcare providers attaining certification by the OHSC. In order to certify the required number of health establishments, the OHSC will – beyond any doubt – need to speed up the pace of inspection and certification significantly. This will require both increased financial and human resources and smarter use of the resources at our disposal. All health establishments achieving certification by the OHSC.

The biggest strategic challenge facing the OHSC is how to progress in terms of fulfilling its mandate, particularly the compliance inspection and certification functions – with very limited resources.  The Board and management have been actively engaged in considering options for more efficient operations and increased output. These include the possibility of decentralising its operations to reduce the time and cost incurred by inspectors in covering health institutions in all provinces.

Given the restrictions applicable under the COVID-19 National State of Disaster, it only became possible to commence compliance inspections in the third quarter of the financial year because, the team undertaking inspections was reduced to half its normal strength because many staff members were classified as high risk in terms of COVID-19 and were confined to desk work.

Public awareness campaigns are conducted to reach out and share information with the public about the work of the OHSC and Health Ombud in various communities across the country.

The OHSC is always working closely with the local municipalities, community leaders, community structures and community media to mobilise communities to attend the engagements.