The National Health Amendment Bill sought to amend the National Health Act to empower the Minister to establish an independent entity called the Office of Health Standards Compliance aimed at addressing the low standards at health facilities.
The objects of the Office would be to protect and promote the health and safety of users of health services, firstly by monitoring and enforcing compliance by health establishments with prescribed norms and standards, and secondly by ensuring consideration, investigation and disposal of complaints relating to breaches of norms and standards. The Office’s functions were closely tied to the norms and standards. The Office would be required to advise the Minister on matters relating to the determination of norms and standards to be prescribed for the health system and the review of such norms and standards. It would inspect and certify health establishments; inform the public; investigate complaints relating to breaches of prescribed norms and standards; monitor indicators of risk as an early warning system relating to serious breaches of norms and standards; identify areas and make recommendations for intervention by a national or provincial department of health or a health department of a municipality.
Members asked how the Department intended to help health facilities prepare for inspections and meet the norms and standards; about the lines of accountability, who specific staff members reported to; the composition of the Board; what qualifications were required of the CEO, Chair and vice-Chair of the Board, the inspectors and the Ombud and how these people would be appointed. Members asked about the financial implications of the Bill; from where the funds would come and how the norms and standards had been determined. The Committee looked for assurance that wide and deep consultation had been conducted on the Bill and on the norms and standards.
Ms Malebona Precious Matsoso, Director General of the National Department of Health, said that the National Health Amendment Bill sought to amend the National Health Act (No 61 of 2003) and to empower the Minister to establish an independent entity called the Office of Health Standards Compliance. This Office was needed because the current standard of the health services was unacceptably low. Eight clauses would amend Sections 1, 21, 25, 47, and 90, Chapter 10, the arrangement of the sections of the Act, the amendment of other laws and the short title.
This sought to amend Section 1 of the Principal Act in order to insert, substitute and delete certain definitions consequent to the establishment of the Office. It was proposed that a definition of an Environmental Health Practitioner was inserted. An Environmental Health Practitioner used to be referred to as a Health Inspector, but was now being changed to align with other pieces of legislation.
This sought to amend paragraph (f) of Section 21(2) of the Act in order to assign port health services to the national sphere of government in line with the UN International Health Regulations and the International Health Regulations Act (No 28 of 1974). It was essential for South Africa to comply with International Health Regulations. An example of this was the recent incident in which a number of Nigerians were deported because they did not have the required yellow fever certificate. It was required that the entry of citizens of other countries with high-risk status be regulated. The most important of these regulations was to ensure that there was control of transmission of diseases at various points of entry, whether they were by land, air or sea. These points of entry must be manned by competent Port Health Officers. The incident was indicative of the weakness in the system, and this was one aspect that the Bill hoped to address.
It sought to amend Section 25 of the Act in order to delete the reference to “port health services” under the provincial sphere of government pursuant to the amendment sought under clause 2.
It sought to amend section 47(3) of the Act to delete the reference to the Office of Standards Compliance and the Inspectorate of Health Establishments which were replaced by the establishment of the Office. It substituted Chapter 10 of the Principal Act, which was where the most substantive changes would be made, as this was the Chapter that made provision for the establishment of the Office. It outlined its functions, which were to make recommendations to the heads of National, Provincial and Municipal Departments or health establishments, including private and public ones, as well as its establishment, objects and control. When the Bill was first introduced there was no provision for a Board, but after concerns about its independence had been raised, this was to be included. Therefore this Chapter also outlined the establishment and composition of the Board, and how its Chairperson, Vice-Chairperson and members would be appointed. It detailed the disqualification from membership of the Board and vacation of office, the meetings and committees of the Board.
Clause 4 would also outline the appointment of the Chief Executive Officer, its functions, delegation of powers and assignment of duties, and the accountability of and reporting by the Chief Executive Officer. It also provided details of the appointment of the health officer or inspector; the appointment, functions, independence, impartiality and accountability of Ombud. The Ombud would be hired for a seven-year non-renewable term, and would be responsible for informing complainants and respondents of findings and recommendations.
Clause 4 provided for inspections; non-compliance with prescribed norms and standards; environmental health investigations; entry and search of premises or health establishment with a warrant by the health officer or inspector; the constitutional right to privacy; the disposal of items seized by health officers or inspectors; miscellaneous provisions relating to health officers, inspectors and compliance procedures; appeals against decisions of Office and Ombud; and offences and penalties. The Office would issue a “Compliance Certificate” to increase public awareness, which would be valid for up to four years. Non-compliance would lead to a progressive response in accordance with the gravity of the situation.
This amend section 90(1) of the principal Act in order to provide for:
• consultation by the Minister with the Office, in addition to the National Health Council, when the Minister makes regulations in terms of the Act;
• Regulations to include:
- the Minister to prescribe fees to be paid to the Office for services rendered;
- Norms and standards to be prescribed;
- Functions of the Board and the Office;
- Environmental health, including nuisances and medical waste.
This amended the arrangement of sections consequent to the substitution of Chapter 10.
This clause amends the Public Finance Management Act in order to insert an expression to the Office, for the PFMA to apply to the Office.
This provided for the name of the Bill and for the date on which the Bill would come into operation.
Some groups had raised concerns about the scope of norms and standards to be prescribed or enforced. Some groups, for example, pathology, had asked to be excluded, as it was felt that the kind of work they conducted was extremely different to the patient-centred work that the Bill was aimed at. There were also concerns raised about the transparency and about the duplication of roles. The Department felt that these concerns had been addressed. Different types of standards were specified in the Principal Act and the Minister was to specify the scope for various types of establishments. As for any regulations, a transparent process of development had been followed, including expert input and public comment.
The Office would be established as a juristic person in terms of the Public Finance Management Act. In other words, it was to be listed as a schedule 3A public entity. It would be funded by parliamentary appropriation and from fees for services rendered. The Board would be made up of experts appointed by the Minister, and the Board would then appoint the CEO, who would be the Accounting Officer, and would advise the Minister on the appointment of the Ombud.
The objects of the Office would be to protect and promote the health and safety of users of health services, firstly by monitoring and enforcing compliance by health establishments with prescribed norms and standards, and secondly by ensuring consideration, investigation and disposal of complaints relating to breaches of norms and standards.
The Office’s functions were closely tied to the norms and standards. The Office would be required to advise the Minister on matters relating to the determination of norms and standards to be prescribed for the health system and the review of such norms and standards. It would inspect and certify health establishments as compliant or non-compliant with prescribed norms and standards, or, where appropriate and necessary, withdraw such certification. The information about certification would be made available to the public so that they could make informed choices. The Office would investigate complaints relating to breaches of prescribed norms and standards; monitor indicators of risk as an early warning system relating to serious breaches of norms and standards and report any breaches to the Minister without delay. It would identify areas and make recommendations for intervention by a national or provincial department of health or a health department of a municipality, where it is necessary, to ensure compliance with prescribed norms and standards. Information relating to prescribed norms and standards would be published through the media and, where appropriate, to specific communities. The Office would recommend quality assurance and management systems for the national health system to the Minister for approval; keep all records of its activities; and finally, advise the Minister on any matter referred to it by the Minister.
The Office would function under the control of the Board. The Board would determine the policy of the Office; do the necessary planning in connection with the functions, powers and duties of the Office; and perform such other functions as may be assigned to it by this Act. The Board would consist of no less than seven and no more than twelve members appointed by the Minister. The CEO was to be appointed by the Minister after consultation with the Board for a five-year term, renewable once. The CEO would be the head of the organisation and the accounting officer in terms of the PFMA. It would be responsible for staffing and management, contracting of expertise and capacity, delegation and assignment, accounting and records, as well as providing the Board with annual and ad hoc reports.
Health Officers would be appointed by the relevant authorities while inspectors would be appointed by the CEO. They would be given certificates of appointment and be obliged to show these during the course of their duties. They would have powers of a peace enforcer in law.
The Ombud would be appointed by the Minister after consultation with the Board on a seven-year term which would be non-renewable. The position would be located within the Office and use staff provided by it. Following a written or verbal complaint relating to norms and standards, or on its own initiative, the Ombud would investigate and consider non-compliance with norms and standards in a fair, economical and expeditious manner. A complaint may involve an act or omission by a person in charge of or employed by a health establishment or any facility or place providing a health service. The Ombud would be able to use staff of the Office, in addition to wide specified powers, including subpoena, but with regard for administrative and procedural fairness. It would refer complaints to any other suitable body to investigate and obtain a report for them; provide reports and recommendations to the CEO and recommend action through the appropriate authority; and provide for dispute resolution through the Minister. On conclusion, it would have to inform complainants or respondents or both of the findings and recommendations.
The independence, impartiality and accountability of the Ombud would be guaranteed. Earmarked funding would be provided by Parliament, when dealing with any complaint in terms of the Act, the Ombud and support staff would be independent and impartial and perform his or her functions in good faith and without hear, favour, bias or prejudice. An annual report would be provided to the Minister and included in the report of the Office.
The rest of the slides had been discussed with the Committee before, so in the interests of leaving time for discussion, Ms Matsoso ended the presentation with a brief explanation of the preparatory work that the Department had been doing. About 4000 health establishments had been audited, and the findings were written up in complete reports. Investigations on the problems had begun, so that the Department could help provinces plan ahead in advance.
The Chairperson asked if Ms Matsoso could speak to issues of medical waste disposal, which there had been problems with and which was part of environmental health. Where would that fit in? She asked what structure was dealing with quality assurance before and what its functions were. She also wished to know what authority the Board had over environmental health practitioners at district level.
Ms Matsoso responded that the audits that had been conducted were conducted by the Department for its own preparation. All facilities had been audited for six basic standards. These were cleanliness, safety, security, infection control, length of queues, and the attitude of health workers. There were another of other standards that could have been audited, such as HR, equipment, functionality, and so on, but this audit focused on the absolute basics. The findings were very disturbing, as 80% of the facilities did not comply. Health establishments should be the cleanest place that people go to, and yet facilities were failing to pass the audit on the basis of cleanliness. The Department was therefore trying to build a system where a culture of cleanliness in health facilities was created. Reports were being received as far back as 2009 of babies being put in boxes because there were not enough cots. This sort of thing was not acceptable and everyone needed to get on board to remedy it, including the provinces, hospitals, clinics and every single health worker. It was everyone’s responsibility.
During the audit it was discovered that medical waste was not being dealt with correctly. In one facility it was not being collected and so it was buried nearby. The pile-up had caused snakes and rats to be found at the facility. Another facility had had no running water for three years. Nurses were fetching water with buckets. At a third facility, the staff had put money together themselves to buy mops and soap.
The Department had therefore set up teams to prepare facilities to reform, as they did not want facilities to feel that they were being ‘pounced’ on. These facility improvement teams included national, provincial and district levels, and they had seen some significant improvements. The Department had a number of before and after stories that it would be pleased to present the Committee at another time.
Ms Rantho pointed out that portfolio committees had a constitutional right to exercise oversight. In the Bill the inspector seemed to have so much power, as if there was no Portfolio Committees for Health at national and provincial levels that was going to be exercising oversight. Oversight at that level was being undermined. Who would the health inspector reporting to?
Ms Matsoso stressed that the Department recognised the role of the Committees and respected the institutions of government. The proposed plans would not and should not replace the role of parliamentary oversight, but instead aimed to strengthen it. Parliament would need foot soldiers to assist them, as it was not possible for the Committee to inspect 4000 facilities. Inspectors would do the legwork and then hand the information over to Parliament.
Ms Rantho asked to whom the Ombud would report? Would he present to the Committee? Committees were not mentioned in this Bill. Ms Rantho had reservations about the powers being given to health inspectors.
It would be up to the Committee to decide if the Ombud should present to Parliament or not.
Ms Matsoso recognised that the powers of inspectors may have gone overboard, as the Department did not want people to have no accountability.
The Department had seen a number of examples of very committed health workers. The case of nurses using their own resources to buy brooms and mops and soap was one example. But the staff’s options were sometimes restrained. For example there had been a case of a CEO who had been required to write and ask for permission to change the light bulbs in the parking lot. Another important issue was the security services who protected the staff. There had been cases of nurses and doctors being raped or stabbed, and therefore it was essential to closely assess the security services. However, in some cases these services were outsourced, and the contracts were not managed at the hospital. The hospital CEO often did not know what the terms of the contract were, and so could not enforce them. Every single one of these aspects needed to be adequately solved. This Bill was supposed to correct those problems and strengthen the oversight role of the Committee.
Ms Mncube noted that a fine of R10 million could be implemented, she asked who would be fined. If the non-compliance was for a whole unit, why should the person be fined instead of the institution?
Ms Matsoso responded that the issue of fines was a difficult one because punitive measures were required but the Department wanted to avoid taking resources away from facilities. Fining the hospitals would reduce the level of service available to the hospital.
Ms Mncube welcomed the attention being paid to health regulations at the point of entry, noting that even during the H1N1 virus breakout, flights were not sprayed when coming into the country.
With regard to Port Health Officers, Ms Matsoso agreed that they were very important figures. South Africa had an obligation to comply with international health regulations, and therefore Port Health Officers needed better training. The Department had asked a number of other countries for assistance with this.
Ms Mncube asked what the financial implications were for the Provinces when appointing inspectors. Was the money going to come from the Treasury?
Ms Mncube also wished to know what would happen if the board was dysfunctional. Would the Minister have the power to disband it?
It was a serious omission that the Bill did not outline what should be done if the Board was dysfunctional. This would be rectified.
Finally, Ms Mncube worried that the inspectors may invade people’s privacy or that the right to privacy may create a loophole that could be exploited.
Ms Matsoso responded that the rights to privacy might indeed be used as an excuse or a loophole. The Department would request legal advice on this.
Adv Lufuno Makhoshi, the Department’s legal advisor, responded that they had made an effort to balance the extensive powers of inspectors with an individual’s right to privacy. There were provisions on how entry and seizure should be conducted. This must be done subject to Section 85 and 86. They provided clearly for the right to privacy. Thus the inspector did not have open-ended powers. Entry was limited to the premises of the health establishment and specifically excluded the private dwelling. These measures had been built in to allay fears that he or she would have too much power. The inspectors were also required to identify themselves so that if a complaint was laid it could be laid against a specific person.
Ms Majola thanked the DG for the presentation, saying that it came at a critical time as it was good to have compliance but presently there were health facilities with no compliance at all - they were in a dire situation. What was the reason for that? In the rural areas it was even worse. Ms Majola asked what the financial implications were. Provincial committees had already submitted reports of non-compliance because of factors which were out of their control, such as staff shortages and faulty equipment. On top of that, the service providers appointed to build new clinics were building them without basic requirements. How would compliance be achieved under these circumstances?
Ms Matsoso responded that the audit findings were revealing because there were facilities that were doing very well. In some provinces health workers had good attitudes, facilities were clean, and equipment was functional. They had tried to ascertain why certain facilities were this way and had found that the answer was good management, this was what the Bill tried to address.
Dr Caroll Marshall, NDHS Chief Director of Quality, spoke to the costs. There were different types of cost associated with the Bill. The first was the Office itself. The budget for this had been made available under medium term expenditure framework to appoint Officers. Over time this would need to become established, but for the first year this was estimated to cost R48.5 million. The Department was in the process of discussing next year with the Treasury. It was a costly enterprise, but the cost was very little in comparison to the total health budget.
There were also costs at the facility level to assist them to meet the standards. This was not small, which was one of the reasons why progress would have to be incremental. For many of the standards though health workers accepted that they did not require additional funds. All that was needed was to reintroduce procedures that were originally part of procedure but that had been allowed to slip or were not being encouraged enough. Culture change should not cost money. This was not an entirely resource driven process but was rather based on ensuring that support functions functioned. Some changes would require resources, and the Department was working out how much that will be.
Mr W Faber (DA, Northern Cape) asked if traditional healers and traditional doctors were being regulated by the Department.
Ms Matsoso responded that there was an Act that had established a Traditional Healers Council which provided oversight for traditional healers. That council still needed to be appointed so that they could make traditional healers comply.
Mr Faber asked if there a specific reason for the Ombud’s contract being seven years non-renewable, as opposed to five.
Ms Matsoso responded that the initial proposal was five years, but the Portfolio Committee had changed it to seven, in order to avoid a situation where individuals were removed from their post just as they reached the peak of their performance.
Mr Faber noted that the compliance certificate was issued for “no more than” four years, which implied that it could be issued for shorter time periods, up to and including four years. Was that the case?
Ms Matsoso responded that the Compliance Certificate was for four years – no more and no less. The provision would be changed to avoid ambiguity.
Mr M de Villiers (DA, Western Cape) noted that clause 78 mentioned norms and standards. Asked what the Department intended to do to inform establishments about the new norms and standards and to help them raise their standards so that they could adhere to the new law. The presentation had said that the Minister could prescribe different norms and standards. Mr de Villiers worried that this might cause inconsistencies.
Ms Matsoso responded that the time given to respond to the written warning would be specified when it was given, as there was not a standard timeframe. Normally the timeline given was relative to the nature and severity of the lack of compliance. It depended as well on the risk posed to patients. The Department wanted to maintain that flexibility.
Mr de Villiers asked what qualifications were required to be on the Board.
Mr de Villiers said that in the case of an establishment having received a written warning, how long would it have to respond?
Mr de Villiers asked about the non-compliance imposed upon a person or health establishment. When appointing a person as head of an establishment, there were certain criteria that should go into his contract. Would there be a revision of contracts?
Mr de Villiers said that he was especially worried about old age homes, which were also health facilities.
Ms Matsoso responded that the Department would publish a list of health care facilities that would have to comply, as there were some facilities, such as retirement homes or ambulances, where it was not clear whether they qualified.
Mr Plaatjies commended the intention to enforce standards. He asked if this standard of compliance applied both to private and public facilities.
Ms Matsoso responded that it applied to both public and private.
Mr Plaatjies asked what the criteria was for appointing inspectors and what qualifications they would have.
Mr Plaatjies asked if the Minister determined the norms and standards alone or if this was done through consultation.
Dr Marshall responded that the Department had developed over the last four years a provisional set of national norms and standards based on extensive consultation around country with both the public and the private sector. Standards were based on South Africa’s own existing national policies, and were not imported. They had been tested several times, including in the audit that the DG had talked about. They had gone to all the provinces and spoken to all the CEOs, and had also conducted road shows to familiarise people with the norms and standards. The aim had partly been to challenge facilities to be honest with themselves about why standards were not being upheld. All the feedback received had been built into the Bill.
Mr Faber asked if this would lead to unnecessary litigation. In the case that litigation occurred, were there plans and resources to fight the litigation?
Ms Matsoso responded that there was a need to move away from a blame culture. Health workers needed to see it as their responsibility to comply. But the law intended to remove lawyers from hospitals and doctors from courts.
Mr Faber asked if the norms and standards cover strictly health issues, or would they cover the human element as well, and how staff were treating patients.
Ms Matsoso responded that the Department was eager to present the norms and standards that had been decided on to the Committee. They were making every effort to share them with the public and with the facilities that would have to comply with them.
Mr Faber said he did not see much emphasis on public education, and informing people about what the standards were.
Ms D Rantho (ANC, Eastern Cape) asked who would comprise the ad hoc tribunal, would they have the knowledge and expertise necessary?
Mr Makhoshi responded that the Department had not wanted a fixed tribunal because the complaints would vary. If the tribunal was ad hoc, they could look at the nature of the complaint and the relevant expertise required, and then appoint the tribunal to adjudicate specifically on the problems at hand.
Ms Rantho asked why the CEO could only be renewed once.
The Department was concerned about replacing the CEO just as he or she reached his or her peak at the job, but also wanted to avoid creating fiefdoms. They were looking at allowing exemptions to the rule.
The Chairperson asked why some groups had asked for exclusion, such as pathology.
Ms Matsoso explained that the laboratory had no interaction with the patient. This law was to protect people who used the facilities, therefore different standards applied for laboratories.
The Chairperson asked how often inspections would be done.
The Chairperson asked what kind of assistance the Department would provide to those facilities that were non-compliant.
Ms Matsoso replied that the Department was committed to helping the facilities meet the norms and standards. They had set up facility improvement teams which would assess the level of readiness on an ongoing basis. They had also been running mock inspections to see if the tools and approaches were appropriate. Thus far 85 facilities had been inspected. In this way and the Department was beginning to see a change in attitudes. They hoped that health workers would grow accustomed to these inspections.
The Department recognised that it would not be possible for facilities to comply immediately, progress would be incremental. Attitudes would take time to change, and this was the important factor. People had become used to an abnormal and substandard state of affairs. This culture needed to be changed so that if something were wrong, staff would do whatever it took to get it fixed.
The Chairperson reiterated the questions about the authority of the Board over the environmental health practitioners, and the logic of appointing only health experts to the Board and not taking into consideration those people who were using the services.
Ms Matsoso responded that environment officers are not appointed under this amendment, they would remain under the Provincial authority and Municipalities, except for the Port Health Officers.
Ms Matsoso responded that the Bill specified the competencies of the members of the Board and said what expertise each member should have. One representative should be from organised labour and another from civil society or the community.
Mr Thabang Masutha, a legal advisor, noted that inspectors could enter premises but that excluded private dwellings, but Section 84 contradicted this by saying that it included private dwellings.
Mr Makhoshi responded that Section 82 excluded private dwellings, but Section 84 included it. The distinction was with regard to whether there was a warrant, which the inspector would have to apply for.
Dr Marshall added that Section 84 had specifically included private dwellings because there had been instances of illegal practice from a private dwelling.
Mr Masutha asked if health officers had powers of arrest. Legal speaking that would not be correct, unless they were making a citizen’s arrest.
Ms Mncube asked if the health inspectors would get the police to make arrests.
Mr Makhoshi responded that Officers could be accompanied by a police officer.
Mr Masutha said that the Minister alone making regulations was problematic. It was important to consult widely and to consult other regulatory bodies.
Ms Matsoso responded that Section 90 of the Act stated that the Minister would make regulations in consultation with the National Health Council and a number of other organisations.
Mr Masutha noted that the DG had raised the issue of contract management with the CEO. Would the contract management be part of the oversight? This would need a level of legal qualifications for someone to be able to interpret contracts. The team should also have legal professionals in it.
Mr de Villiers asked if the Minister appointed the Chairperson and Vice-Chairperson. He asked if the Board should not elect the Chairperson.
Ms Matsoso responded that the Department was recommending that the Minister appoint the Chairperson after consultation from the Board and a recommendation from the Board. The Minister would not do this unilaterally.
Mr Makunyane suggested that it would be helpful to add a definition of ‘health establishment’ so that it eliminated confusion.
Mr Makunyane argued that public education on the standards should be part of the functions of the Office. It should not be done on an ad hoc basis, but staff should be dedicated to it.
Ms Matsoso welcomed the addition of public education and said that it was something that should be given consideration.
Mr Plaatjies noted that the Bill specified that the CEO should be fit and proper. He asked if this meant physically fit.
Mr Makhoshi explained that the concept of ‘fit and proper’ did not relate to the physical fitness or someone going to gym regularly. This was a person who was fit and proper to perform the functions of a CEO and who had certain expertise which would allow him to perform the necessary functions.
The Chairperson thanked the DG and her team for the presentation and adjourned the meeting.
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