The Directorate of Radiation Control (DRC) of the Department of Health outlined its mandate to regulate and control radio active substances, as well as its role to authorise, review, inspect and enforce. For many years the DRC had been unable to perform optimally, and there were also concerns about possible overlaps, so a task team was formed with the National Nuclear Regulator (NNR) to discuss the future mandates. Joint efforts were to be made to ensure compliance with international obligations and regulation of sealed and non-sealed radioactive sources. A common national source register needed to be developed, as well as the compilation of a national dose register, a Code of Conduct on safety and security sources, sharing of information with other countries and setting up of a quality assurance trail. It was proposed that non-health products should fall under NNR, with health products to fall under the South African Health Products Regulatory Authority (SAHPRA), which was soon to be established. The numbers of licensed units were set out. Severe staff shortages had curtailed the Directorate’s local effectiveness, and although the moratorium on filling posts had been lifted there was difficulty in identifying suitable candidates. There were also challenges around “lost sources”, some of which were accounted for by clerical errors or wrong information from source, and in future the DRC would check all information on the database and monitor more closely through inspections, reporting breaches to the Directorate for Priority Crime Investigation. A number of sources had been lost over the previous five years, through hijackings, theft from premises or mines, liquidations or loss in transit, including at sea. Some sources were recovered at scrap yards. Although there were no regulatory prescripts for inspections, good practice guidelines were followed, and authority holders were required to provide evidence of adherence to quality assurance and regulations. The DRC outlined the results of its self-assessment, which included regulatory deficiencies, human resource constraints and lack of financial independence. Short and medium term solutions were proposed and outlined, while the long term plan included a review of legislation and regulatory mechanisms, and audit capacity to ensure protection of the public and appropriate structures.
Members were unanimously concerned about the potential risks posed to the public through loss of sources, and questioned these extensively. Members questioned if the DRC was ready for autonomy, and felt that much more should be done to fill vacancies, including possible head hunting or sourcing overseas. Members stressed that they did not get the sense that matters were being attended to with the necessary urgency, and felt that too bureaucratic an approach was taken. Questions were asked about the shortage of inspectors, why the situation had been allowed to deteriorate, and it was indicated that no information was given on some of the provinces and how the inspectorate functions were being met. Members noted the inaccuracies in the database and wondered if the information on the backlogs was correct, and whether the information on the lost sources was underreported. They also were very concerned about the economic and health risks, and stressed that this must be treated as a national emergency, asked for specific details on loss of particular substances that could be used for chemical warfare or making bombs, and asked how the effects of over-exposure were measured, calculated and treated, and whether there was sufficient capacity in this regard, and interaction with other agencies. The DRC was asked to supply written answers to whether lost sources degenerated, lost sources and their dosage.
Representatives from the South African Medical Association and the Junior Doctors of South Africa briefed the Committee about their dissatisfaction with the Health Professional Council of South Africa, and the motivation submitted to the Minister of Health for an independent registering council for medical doctors and dentists. The particular concerns related to the restrictive and bureaucratic structural relationship between HPCSA and the Medical and Dental Board, resulting in dilution of representation of doctors at Council, the authoritarian and autocratic tendencies of HPCSA, preclusion of the Medical and Dental Board from direct audience with the Minister of Health, the higher registration fees paid by doctors and the need to allow this Board the same type of self-regulation enjoyed by other health professionals. Junior doctors were worried about the shortage of experienced doctors to mentor, supervise and evaluate them during internship, inadequate equipment, and lack of recruitment and retention strategies, which had led to severe shortages of doctors, particularly in
Directorate of Radiation Control Unit of Department of Health: overview and challenges
Ms Precious Matsoso, Director General, National Department of Health, gave an overview of the Directorate of Radiation Control Unit (DRC), its work and the challenges that it experienced. She noted that the responsibility of the Radiation Control Unit was to regulate and control radioactive substances and materials. It had an oversight role, according to which it authorised, reviewed, inspected and enforced radiation control. She lamented that over the years the DRC had not been given specific attention, although its mandate derived from statutory regulations, which she listed, and which concerned regulation of hazardous substances, and controls for and lists of electronic products. The National Department of Health (DOH) had entered into discussions with the National Nuclear Regulator (NNR), which also had certain regulatory functions, about the mandate and possible overlaps. The DRC had not performed its regulatory functions optimally in the past.
Ms Matsoso said that the DRC had oversight in four areas, which were radio-nuclides, non-ionising radiation, ionising radiation and the inspectorate function. There was recognition of capacity challenges. It had already initiated some joint activities with the NNR, intending to target specific areas, and she noted that there were certain international obligations with which
The DRC had identified key areas of immediate action to address issues. These included the necessity for establishment of a common national source register, jointly developed by the DRC and NNR, the compilation of a national dose register, development of a Code of Conduct on safety and security sources, and the obligation to comply with International Atomic Energy Association (IAEA) standards. There was also a need to share information with other countries with similar capacities, to deal with disposal of radio active sources and to set up a quality assurance trail. Terms of reference for the task team had been put in place.
Ms Matsoso stressed the need for additional technical staff, to address the personnel shortages that had plagued the DRC for some time. She stressed that an effective regulatory system would ensure the safety of the public against harm from any radiation emission. Currently the DRC performed dual functions, where it regulated both health and non-health products. However, the current discussions with NNR were proposing that non-health products should fall under NNR, while the health products would fall under new South African Health Products Regulatory Authority (SAHPRA), which was soon to be established.
Dr Seppie Olivier, Director: Radiation Control, DRC, Department of Health, outlined the main functions of the Directorate, and the legal framework under which it operated. He also noted that this included regulations governing the provision of medical services and various codes of practice. He outlined the current activities, which included self-assessment of regulatory infrastructure with other African regulators and NNR. He also described the extent of its workload, and the obstacles that impeded its smooth operation.
Dr Olivier said that across the spectrum of medical and non-medical sectors, there were 6 581 X-Ray licence holders, which included doctors, hospitals and groups. There were 16 041 licensed units, either individual X-ray or particle producing units. There were 2 259 authority holders for radio active materials, and 16 671 sources on the premises of the authority holders. There were also 130 licensed Magnetic Resonance Imaging (MRI) units, 1 000 licensed laser units, 240 distributors of medical services and 2 519 licensed models. Dr Olivier reiterated Ms Matsoso’s point that severe capacity had curtailed the Directorate’s local effectiveness, and it had been unable to fulfil its legal obligations.
Dr Olivier then outlined the current staff of the DRC, indicating that a shortlisting of prospective candidates was under way for various positions. He noted the particular problem that three of the regional offices had not had inspectors for one and half years, and two vacancies had since been advertised.
Dr Olivier explained the background to “lost sources”, which had resulted from inaccurate information on the database. Wrong information had been entered, sometimes because applicants had supplied wrong serial numbers, which meant that when there was an inspection the records and equipment had not tallied. An internal search was done on all authority holders, which further revealed that some holders whose authorities had expired had been listed, and they were construed as lost sources. The DRC had, in order to address this anomaly, decided that in future it must check the information on the database against the information on the physical file kept for the particular authority holder, contact the authority holders telephonically, or conduct on-site inspection to confirm status, and, if the authority holders could not be located, the matter would be reported to the Directorate for Priority Crime Investigation (DPCI).
Dr Olivier then outlined the errors that had been uncovered in the Bellville office. In certain instances, files had not been closed when sources were sold or disposed, or documentation was filed but the database not updated. Some sources had been confiscated and kept in storage. Some sources that were reported previously as lost still appeared against the authority holders’ name, instead of being put to a different file and closed off, and some holders had disappeared.
Dr Olivier confirmed that many sources had been lost over the past five years. This had occurred variously through vehicle hijackings, burglaries at premises, company liquidation, and theft at mining plants. However, some of the sources had since been recovered at scrap yards. Some sources had also been lost at sea, in transit, in
Dr Olivier added that although the DRC had no regulatory prescript with regard to inspections, it nonetheless did follow good practice guidelines, and had a two-pronged approach for inspection of the X-ray and radiation equipment to be done in a period of three to five years. The DRC, recognising the inadequacy of staff numbers, had also initiated a system where it required the authority holders to provide evidence that quality assurance and regulations were adhered to properly. The DRC further required that licensing bodies be South African Medical Association (SAMA) standards accredited, and this process was 80% complete. The DRC lagged behind in inspections by 40%.
Dr Olivier noted that the results of self-assessment test revealed a wide range of regulatory deficiencies, including severe human resources (HR) problems and lack of financial independence. In order to solve staff problems, Dr Olivier proposed that the DRC should be given a semi-autonomous status, to enable it to compete with other organisations such as the NNR and attract suitable staff. He noted that the Green-Thompson Report had recommended that the DRC be moved to the South African Health Products Regulatory Authority. However, with the exception of medical devices, no provision had been made for that move.
Ms Matsoso outlined the short and medium term measures to address the challenges experienced by the DRC. The short-term measures involved the establishment of a task team that would include the DRC, NNR, customs authorities and South African Police Service (SAPS) and that would be mandated to produce a common national source register, the establishment of a national dose register, the code of conduct and security of sources. It must further ensure compliance with international obligations; the implementation of International Atomic Energy Agency (IAEA) Report recommendations, information sharing between the component agencies on the task team, proper disposal of radio active sources and quality assurance trails to be imposed on the applicants.
The long term plan for the task team would be to review current legislation and regulatory mechanisms for both NNR and DRC, and identify gaps that mitigated against effective regulation of materials. It should also identify possible areas of overlap between DRC and NNR. There should be an audit capacity to ensure the fulfilment of the mandate to protect the public, and the existing legislation must be strengthened to avoid duplication, and to establish appropriate structures for DRC to handle health related products under SAHPRA, while NNR handled non health products.
The Chairperson underscored the complexity of radiation, noting that it had both good, but also dangerous consequences that could arise if proper care was not taken. He expressed concern about the lost sources and the potential danger to the community. He expressed reservations about the issue of semi autonomy of DRC and noted that a lot still had to be done.
Mr M Waters (DA) expressed concern about lack of capacity in the Directorate and was also concerned about the potential risk posed by lost sources. He sought clarification on the non fulfilment of international obligations. He commented on the severe shortage of inspectors, especially in the regional offices such as
Mr Waters also referred to the press release by the DRC, which had indicated that radio active sources had been found at a scrap metal facility in the Cape Town harbour, after a report that a ship had been decommissioned, with three radiation sources still being on the ship, one being found at the scrap yard, but one was still missing. Another ship in
Dr Olivier responded that the original sources had been sent to
Mr Waters commented on the inaccurate database of sources due to staff shortages, and asked whether the DRC was intending to use the services of the private sector in order to implement its plan of action to find lost sources, and, if so, how this would be done. He pointed out that lost sources posed a risk to people’s lives.
Dr Olivier responded that it served little purpose for a list to be given of 230 names. 90 of the defaulters were from
The Chairperson indicated that he had received numerous calls from people in
Dr Seppie Olivier responded that sometimes issues were reported out of context. He said that several ships prospected for diamonds along the South African / Namibian coast and a number of these vessels had been taken off the Directorate’s list in 2003, subsequently being repatriated to
Mr G Lekgetho (ANC) expressed concern about the moratorium and the 16 vacancies in the DRC. He also asked about the monetary value of lost sources.
Dr Olivier indicated that the monetary values would be provided to the Committee in writing, although he could confirm that it was high.
Ms Matsoso said that she assumed her post in June 2010. The moratorium had existed since 2001. Between June 2010 and November 2010, the posts had been advertised and filled.
The Chairperson asked what was required by way of staff.
Ms Matsoso responded that even after the current vacancies were filled, there was still a need for additional technical staff, if the regulatory functions of the Directorate were to be handled optimally. She suggested that once it was established, SAHPRA should be responsible for medical devices and health-specific radiation material, whilst non-health radiation issues should fall under NNR. She said the past trends in the DoH had resulted in an uneven increase in administrative and managerial staff, as opposed to technical staff. The appointment of technical staff would be prioritised. It was regrettable that many of the applications came from inappropriate candidates, and urgent action was required to address the issue.
The Chairperson acknowledged the DRC’s plan of action, but wondered what could be done immediately to address the vacancies that had been outstanding for so long.
Mr D Maynier (DA) was deeply concerned about the issues. He noted that in July 2010, the DPCI, also known as the Hawks, had intercepted an international gang that had attempted to sell Cesium 137, which could be used to make a dirty bomb. He asked whether Cesium 137 was controlled by DRC, and if so whether it had been reported lost, and whether it was linked to the bomb in Hartzfontein.
Dr Olivier responded that the July incident was the only one in which radioactive material had been offered for sale. He did not have the exact details. It was simply assumed, from the timing of the sale in the middle of the World Cup, that it could have been intended for incorporation into a dirty bomb, and confirmed that Cesium 137 was commonly used because of its nuclear and physical properties.
Mr Maynier commented on the Namco liquidation, and 12 lost radioactive sources in four ships. He asked whether it was correct that two ships had been lost, and where they were located.
Dr Olivier responded that in the case of the Namco liquidation, the ships were no longer on DRC’s books and the assumption was that the sources on these ships had been properly disposed of in
Mr Maynier asked for specific details on the sources that had been lost in transit, as well as in
Dr Olivier noted that the source lost in transit was an instrument that was sent to the
Mr Maynier commented that, due to inaccurate data, the DRC was not sure about the exact number of sources lost. He asked what radio active isotopes had been lost, whether it was possible that any very high radio toxicity isotopes had been lost, and what risks they posed.
Dr Olivier said since radio nuclei was started in South Africa in the late 1940s, it was possible that virtually any type of device could have been lost, and he could provide the details if required to do so. He added that in the past ten to fifteen years, there had been several cases where radio active sources had been sold, and that incidents of theft and hijackings were higher. He said there had also been several cases where radio active material had exchanged hands many times. This was further linked to the red mercury scam.
Mr Maynier recalled that in 2006, a Russian member of the Federal Security Services was poisoned with a substance called Polonium 210. He asked whether there were reports of this substance being lost.
Dr Olivier responded that no polonium substances had been lost. He added that there was a spin-off from the
The Chairperson reminded Members that the main purpose of the meeting had been to discuss broad issues around the safety of the South African public, and whether the DRC had the capability to protect against and react to health threats.
Dr Olivier responded that all radio therapy departments throughout the country, radio therapists and radiologists received extensive information about the effects of radiation and whenever there was a case of over exposure they would be referred to the nearest oncologist or radiotherapist. Dr Olivier added that
The Chairperson commented that all Departments that had authority for radiation should have been invited to the meeting, as radiation affected people’s health. Such an invitation would be extended early next year.
The Chairperson asked what the dosage was of the lost sources, and at what distance an individual could be affected. He asked the monetary value of the lost sources.
Ms G Saal (ANC) felt that there were some unsatisfactory elements to this presentation. She commented on the staff shortages in the DRC, saying that she had expected the staff shortages in the whole country to be outlined, asking why the situation in provinces such as
Ms E More (DA) commented that whether the products were health or non health related, they were still dangerous to people and could cause cancers. She said that the objectives of better health for all would not be realised if the DRC was not functional. She expressed concern about disruptive staff changes, especially at Director-General level, saying that this had an adverse effect on patients. She asked whether consideration would be given to outsourcing inspection services to the X-ray manufacturers, given the shortage of staff to safeguard the health of the patients within the DRC. She also urged the DoH to provide a strategic plan of action to address the challenges faced by the DRC, as well as a detailed staff complement plan. She asked why appropriate staff were not head-hunted, if unsuitable applicants always applied for advertised posts.
The Chairperson commented on the serious nature of the lost sources, and noted that these chemicals could be used in chemical warfare if they fell in wrong hands.
Ms T Kenye (ANC) asked whether the inaccurate database was due to lack of capacity in the DRC. She asked how the SAPS Priority Crime Unit was sensitised about hazardous substances and how the DRC monitored the situation. Ms Kenye commented on the lack of capacity and asked whether this problem could not be picked up during short listing of candidates. She asked whether the DRC was able to trace holders who had disappeared. Ms Kenye asked whether, in accordance with Batho Pele principles, the DRC had done outreach programmes to clinics, and had informed pregnant women of the dangers and toxicity of radium during the early stages of pregnancy.
The Chairperson commented that this was a specialised unit that had to attract suitable professionals. He noted that the Department of Public Service offered fixed salaries, and this could be problematic, especially as the Directorate competed with other organisations for similar services.
Mr Maynier asked the Directorate to spell out the potential risk posed to people’s health, should they be exposed to the materials in the more than 200 lost sources.
Mr Waters noted that the actual numbers of backlog for X-ray machines and lost sources was not given in the presentation. He commented that, given the severity of the staff shortage, the 40% backlog on inspections was very low, and seemed in contradiction with the call for additional staff. He questioned whether in fact the Directorate knew the real figure for the backlog.
Mr Waters commented that the plan of action to find lost sources did not reflected a sense of urgency. He felt that this was a national emergency, and an immediate short term plan that involved the police, army and the private sector should have been put in place, instead of pursuing longer bureaucratic processes.
Mr E Sulliman (ANC) asked whether any staff could be recruited from overseas.
Ms Matsoso responded that she had met with the NNR to understand the regulatory system in
Ms Matsoso added that increased staffing would improve the Directorate’s effectiveness and reiterated that Customs, SAPS and Eskom should be involved. She again indicated that a joint task team had been established and terms of reference had been put in place. Ms Matsoso emphasised the urgent need for the establishment of a national register that would help in the identification of legal and illegal sources, as well as making institutions that held the sources responsible for them. A dose register was also needed, as this would indicate the extent of the problem and identify how significant it was. If the task team was also to include those who were to be regulated, there would be need for a Code of Conduct on how they would participate in this process. Ms Matsoso indicated that the self-assessment test had been imposed on the Directorate by the IAEA .Both the DRC and the NNR reported to the IAEA, and the question was whether it would not be better for functions to be integrated instead of both agencies reporting to one international organisation. She said these matters needed to be resolved urgently, to ensure effective function of the Directorate.
Mr Maynier echoed Mr Waters’ sentiments on lost sources and agreed that the plan of action lacked a sense of urgency. Based on the risk assessment, a process ought to be triggered for the immediate recovery of the lost sources.
The Chairperson asked what would happen to the lost sources, and whether they degenerated
Mr Waters asked what the national and health implications were of the lost sources.
Dr Olivier said it was difficult to ascertain the health implications of the lost source, as this depended on the nature and length of exposure that an individual may have to the source. Generally, there was the possible danger to exposure to an unaccounted-for source. A worst case scenario would be the infection and contamination of a whole community due to exposure to radiation, as had happened elsewhere in the world.
Ms Matsoso reminded the Members that the invitation to the DoH had specified that it should discuss staff shortages and the plan of action to fill the vacancies, inspection backlogs, and the plan of action in finding lost radiation sources. She reiterated that there was a task team that included SAPS, DRC and NNR, because the issue could not be handled by the DRC alone. A sustainable response was required. This would be achievable through a register that would reflect what was in the country, and what came through, as that identified the users. This information was currently not available, and there was an urgent need to establish the register. She reiterated that the plan of action was based on the self-assessment. The task team would respond to the needs for the distribution of inspectors per province, to increase critical mass. In the interim, NNR and other partners could be used to carry out inspections. SAPS and Customs officials needed to be trained to identify radio active material. She agreed that timelines would be included in both the short and long term measures to deal with lost sources, and conveyed to Members, along with the outcomes of the self-assessment and the terms of reference for the task team.
The Chairperson repeated that other agencies that dealt with radio active materials would be invited in future. In general, the task team plan was acceptable to the Members, although some had urged that matters needed to be handled urgently. He agreed that the national register was important, to show what was involved. He asked for further written responses on the lost sources, how they degenerated and their dosage.
Ms More suggested that all entities should be invited next year including the SAHPRA team. She added that although institutions should be made accountable for the sources held, there was need to have an accountable individual at each institution.
South African Medical Association (SAMA) Presentation
Dr Mark Sonderup, Vice-Chairman, South African Medical Association, apologised for those members of the Association (SAMA) who were unable to attend, including the Chairman, Dr Mabaso. He indicated that he wished to discuss four issues, two for noting, and two that were ongoing matters. He asked Members to note that a motivation for an independent registering council for medical doctors and dentists in
He then noted that the SAMA wished to raise two urgent matters. It requested accreditation for internship training in
Dr Sonderup said SAMA had taken its decisions after intense internal debates about the current HPCSA. It concluded that the multi-dimensional nature of HPCSA did not serve the medical and dental professions, and, by extension, the public. From an administrative perspective, HPCSA was in a shambles, and therefore had enormous problems. Although the medical and dental professions were part of HPCSA, the nursing and pharmacy professions had independent registration councils who could regulate their activities.
Dr Dumisani Bomela, Manager, South African Medical Association, gave a brief background of the status of the medical and dental profession within the HPCSA. It was originally envisaged that the HPCSA would be run around 13 professional specific boards, with the medical and dental professions being ascribed to one of those boards, and that it would thus attain self-regulation, together with an enabling working environment. The medical and dental professions had a functional board within the HPCSA, in which doctors were represented fully.
Dr Bomela highlighted the six points that were included in the proposal to the Minister of Health. These descried the restrictive and bureaucratic structural relationship between HPCSA and the Medical and Dental Board, noted the dilution of representation of doctors at Council level and highlighted the authoritarian and autocratic tendencies by HPCSA. It also noted the preclusion of the Medical and Dental Board from direct audience with the Minister of Health. It highlighted the higher registration fees paid by doctors as compared to other boards. Finally it noted SAMA’s support for the principle of self-regulation as a pragmatic route for the medical profession in
The Chairperson said the Committee would consider the issues raised by SAMA, but emphasised that doctors would not be considered as more important than other professionals.
Dr Mahlane Phalane, Chairman, Junior Doctors of South Africa (JUDOSA), highlighted that urgent action was needed to save the health system from total collapse. He expressed the frustration experienced by junior doctors. These included frustrations about inadequate equipment, and the issues around internship training, which was a pivotal issue in doctors’ medical careers, with and shortage of experienced doctors being a major factor that affected this process. Dr Phalane added that the situation of frozen posts affected not only the junior doctors but the patients as well, who were often at the mercy of inexperienced doctors having to take charge of critical areas. He stressed that lack of supervision and poor monitoring and evaluation of interns led to dire consequences for all involved. He said the HPCSA had ignored the calls for help from the junior doctors. He indicated that hospitals in
The Chairperson commented that some hospitals in the
The Chairperson noted that the National Health Insurance and security at public institutions had not been discussed because of time constraints. He acknowledged the incident in the
Dr Sonderup stressed that public health institutions should be places where both patients and workers felt safe, and called for support from the Portfolio Committee on safety concerns.
The Chairperson acknowledged the importance of security, which impacted directly on the services given by the health workers. He thanked SAMA for alerting the Committee about these issues, adding that this engagement underscored the importance of good communication.
The meeting was adjourned.
- PC Health: Briefing by Directorate of Rediation Control on staff shrtages, backlog in inspections Part 1
- PC Health: Briefing by Directorate of Radiation Control on staff shortages, backlog in inspections Part 1
- PC Health: Briefing by Directorate of Rediation Control on staff shrtages, backlog in inspections Part 2
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