National Health Amendment Bill [B24-2011]: public hearings with Minister in attendance

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Health

12 March 2012
Chairperson: Mr B Goqwana (ANC)
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Meeting Summary

The National Health Amendment Bill sought to empower the Minister to establish an independent entity, the Office of Health Standards Compliance, to perform independent oversight on healthcare. Submissions were heard from the Pure Health Consulting, South African Laboratory Diagnostic Association (SALDA), The National Pathology Group and Mr Siwaphiwe Mbara. All the submissions endorsed the Bill but with certain concerns.

Pure Health Consulting in its submission favoured a progressive approach to enforcement of compliance to norms and standards and suggested that the Bill included negotiating a grace period. The submission highlighted that governance structures of the Office should be representative and should include public participation to promote public confidence. It recommended that standard setting and the developmental role should be located within the National Department of Health. Misconduct by practitioners should be reported and progressive fines imposed for continued non-compliance.

The South African Laboratory Diagnostics Association (SALDA) in its submission raised concern that the Bill failed to clearly define quality assurance and quality management systems and would likely lead to duplication, and possibly conflicting standards and assessments being made. SALDA’s submission proposed that the Bill clearly defined the objectives of the Office and that quality standards were harmonized. The submission further recommended that conflict and duplication be eliminated and that the independence of the Office of Health Standards Compliance be enhanced. It also proposed that conflict between multiple pieces of legislation should be avoided.

Members believed the matter of the independence of the Office should be debated further.


The National Pathology Group in its submission broadly supported the establishment of a body to regulate standards in the delivery of quality healthcare services provided that pathology remained the cornerstone to medical care. It raised concern that the Bill failed to clearly define quality assurance and quality management and proposed that the Bill consider the adoption of international best practice standards. The submission recommended that the Bill should guarantee the independence of the Office of the Ombud and clarify the process of accreditation.

Members noted that the matter of duplication and independence was highlighted as a concern in all submissions presented.


Mr Siwaphiwe Mbara in his submission raised concern that the Office of the Ombud would not be accessible to the public. Further, the Bill failed to clearly define the independent nature of the Office that would free it of political interference and deployments. He advocated that the Bill elaborate how it aimed to establish the Office in a way that fostered public engagement. In addition he proposed that the Office of the Ombud was staffed with adequately trained and skilled personnel and that it was sufficiently resourced.

Meeting report

The Chairperson welcomed the Minister of Health, Dr Aaron Motsoaledi and requested all members and guest presenters introduce themselves.

Pure Health Consulting presentation
Dr Kim Faure, Director of Pure Health Consulting, noted that the submission highlighted particular sections of the Bill that caused concern and recommendations would form the basis of the submission.

She summarised the mandate of the Office of Health Standards Compliance and noted that the Bill was not clear on the role of the Office. Dr Faure recommended that standard setting and the developmental role should be located within the National Department of Health. The Office should be consulted on standards and norms with legal repercussions on their work. She also recommended that the Office should participate in the review of standards and norms. Functions of quality improvement she explained should remain with health establishments and reports on compliance should provide guidance.

Dr Faure proposed that inspection compliance to standard and norms should be clearly defined in the Bill. Regulations needed to address rules for inspections, risk profiling based inspections and set guidelines for self assessment. The Bill should clearly outline that self assessment tools will be made public.

She stated that her submission favoured a progressive approach to enforcement of compliance to norms and standards and suggested that the Bill included negotiating a grace period. Misconduct by practitioners should be reported and progressive fines imposed for continued non-compliance. She reported that enforcement should include the suspension of the Chief Executive Officer (CEO), management or a Head of Department and recommended closure of non-compliant wards. 

Dr Faure pointed out that the Bill was not clear on the reactive surveillance power of the Ombud and suggested that the Office be accorded power of adjudication (settle matters judicially) versus the powers of a commission (no powers except to provide recommendations). It should also provide for concurrent jurisdiction with the National Consumer Commission.

She highlighted that the governance structures of the Office should be representative and should include public participation to promote public confidence.


Discussion
The Chairperson thanked Dr Faure for her submission and noted that a democratic government was one that allows the voice of the people to be heard.

Ms D Robinson (DA) welcomed the submission and that it highlighted that power would not be centralised.

The Chairperson asked what was meant when the risk was graded.

Dr Kim Faure explained that risk referred to the inspection methodology and the resources should be directed towards high risk facilities.

The Chairperson asked which reports were being referred to when the submission expressed a need for quality public reporting.

Dr Faure replied that a patient who received poor quality of care should report the matter to the Consumer Commission or the Ombud, who should prepare a summary of the report.

Mr D Kganare (COPE) stated that he could find no error in the wording of Section 81B since the issues seemed clear and requested further clarity.

Ms Dr Faure explained that Section 81 B was not in question. It was the wording of Sections 81A(9) and (10) that speaks to the independence of the Office of the Ombud and the manner in which reporting was structured. She cited Section 81A(9) of the Bill and reported that “after each investigation, the Ombud must submit a report together with his or her recommendations on appropriate action to the Chief Executive Officer (CEO).” Dr Faure further noted that Section 81A(10) of the Bill stated that “the Chief Executive Officer may, subject to subsection (9), request the intervention of the Minister.....”. It was the nature of reporting that was questioned since it created the risk that independence would be compromised.

Mr Kganare disagreed and requested clarity around how independence was defined. He explained that he understood that the CEO would not have powers to reverse a decision by the Ombud.

The Chairperson noted the importance of the submission. He requested all members to read and understand every clause of the Bill.

Dr Faure expressed concern that Sections 81A(9) and (10) implied recommendations of the report should be submitted by the Ombud to the CEO and the CEO may or may not request the Minister’s intervention. The implication would be a lack of independence of the Office of the Ombud.


South African Laboratory Diagnostics Association (SALDA) submission
Dr Greg Northfield, SALDA Chairperson, raised concern that the Bill failed to clearly define quality assurance and quality management systems and would likely lead to duplication, and possibly conflicting standards and assessments being made.

Dr Northfield summarised that SALDA submission proposed that the Bill clearly defined the objectives of the Office and that quality standards was harmonized. The submission further recommended that conflict and
duplication be eliminated and that the independence of the Office of Health Standards Compliance be enhanced. It also proposed that conflict between multiple pieces of legislation should be avoided.

Discussion
The Chairperson re-iterated that the hearing process aimed at ensuring public participation and that the meeting attempted to seek clarity around public opinion.

Ms T Kenye (ANC) asked what was meant when the submission suggested that the Bill “may lead to duplication and conflict”.

Dr Deepa Maharaj, the South African Laboratory Diagnostic Association Head of Regional Affairs, replied that the health sector was made up of facilities, manufacturers, importers and distributors and it was governed by the Medicines Control Council which set minimum standards criteria. The concern raised was that this might lead to duplication. The Bill should delineate what the Office of the Ombud would be regulating in terms of quality management and assurance. She explained that the Bill failed to elucidate what was meant by quality assurance and would not avoid deviation.

Mr Kganare stated that the Office of the Ombud in terms of Section 77 would be established as a juristic person and therefore meant that it was capable to sue and be sued and asked if this did not answer the question of the independence of the Office. The Bill also protected the Minister from litigation.

Dr Maharaj stated that the submission lauded the establishment of the Office of the Ombud and agreed with the Member’s understanding of juristic person but explained that the Bill was not clear on the mandate of the Office. A schedule 3 regulatory body was proposed which would guarantee independence.

Mr Kganare suggested that Section 78(b) of the Bill prescribed that the Office of the Ombud protected and promoted the health and safety of users of health services by ensuring the investigation and disposal of complaints and asked if this did not answer the question raised.

Dr Maharaj responded that the Office of the Ombud in terms of the Bill had powers to make recommendations and not a ruling. The recommendations may or may not be taken up by the Minister or CEO. The submission proposed that an independent body be possessed with the capacity to make a ruling and cited a case of a life threatening illness as an example when ministerial intervention should not be required.

The Chairperson noted that the issue of independence required further investigation.

A member asked how the submission established that the penalty fee structure was steep.

Dr Maharaj replied that the penalty fee should be structured and appropriate in line with offences. She recommended that non-compliance be sanctioned by corrective measures where deemed appropriate.

Mr Kganare understood the penalty amount referred to the maximum penalty amount that could be imposed.

Dr Maharaj agreed but stated that the Bill was vague and did not explain who would be fined. Was it the CEO of the health establishment?

A Member stated that the submission seemed to propose the establishment of a Chapter 9 institution that would account to Parliament.

Dr Maharaj agreed and offered no further comment.

The Chairperson noted that health institutions had poor levels of quality and that the Bill attempted to standardise compliance but questioned if the establishment of a Chapter 9 institution would be feasible.

Dr Maharaj responded that best practice models suggested that quality assurance bodies were independent and cited the United Kingdom as an example where health regulatory bodies had powers to make rulings. She expressed concern that powers of recommendation limited corrective action as the recommendation could be overturned. A ruling could not be overturned since it was binding and final.


National Pathology Group submission
Dr Tjaart Erasmus, President of the National Pathology Group, pointed out that his submission broadly supported the establishment of a body to regulate standards in the delivery of quality healthcare services, provided that pathology remained the cornerstone to medical care. He raised concern that the Bill failed to clearly define quality assurance and quality management and proposed that the Bill considered the adoption of international best practice standards.

Dr Erasmus summarised the recommendations in the proposal and clarified that the Bill should guarantee the independence of the Office of the Ombud and clarify the process of accreditation.

Discussion
The Chairperson noted that duplication and independence of the Office were recurring in all submissions.

Ms B Ngcobo (ANC) commented that the submission had not included guidelines or suggestions of possible standards of quality assurance and compliance.

Dr Erasmus replied that the list of guidelines was extensive and was omitted from the submission since it was believed that the technical detail would overwhelm the Committee. The submission recommended that the Bill followed international best practice policies.

The Chairperson re-iterated that the process aimed at ensuring public participation and that the meeting attempted to seek clarity around public opinion. He pointed out that the National Department of Health has responded to the challenges in quality oversight management and assurance.

Dr Erasmus responded that the guidelines could be accessed on the internet.

Ms B Ngcobo (ANC) asked if the National Pathology Group worked closely with the National Health Laboratory Service.

Dr Erasmus replied that laboratories work closely together, particularly in times of crisis.

Ms P Kopane (DA) asked how the National Pathology Group viewed the power of the Ombud and questioned if the oversight body should be established as a public entity.

Dr Erasmus replied that the independence of the Office was considered critical to ensure setting a benchmark for quality assurance. He apologised for the absence of the legal expert who drafted the submission who could provide further clarity.

Ms M Segale-Diswai expressed confusion about the process of accreditation proposed and explained that regulatory bodies were already accredited and requested clarity around the proposal for certification.

Dr Erasmus responded that he would prefer certification since regulation already existed.

Ms Ngcobo asked that the presenter clarify what was meant by independence.

Dr Erasmus replied that his submission favoured the establishment of an external body that should set standards that ensure compliance.


Submission by Siwaphiwe Mbara
Mr Siwaphiwe Mbara, a student in policy development and member of the public, raised concern that the Office of the Ombud would not be accessible to the public. He also highlighted that the Bill failed to clearly define the independent nature of the Office that would free it of political interference and deployments. Mr Mbara advocated for the Bill to elaborate how it aimed to establish the Office to foster public engagement. In addition he proposed that the Office of the Ombud was staffed with adequately trained and skilled personnel and that it was sufficiently resourced. The submission endorsed the Bill and recommended that it received adequate resources.

Discussion
Ms Kopane asked the presenter what measures he proposed to resolve the escalating fees charged by the private sector.

Mr Mbara responded that he agreed the private sector was costly to the state.

Ms Kopane asked what interventions the presenter proposed to direct greater resources to rural development
.

Mr Mbara responded that he believed greater attempts should be made to appoint candidates with the appropriate skills.

The Chairperson commented that there was a huge gap between rich and poor in South Africa.

Mr Mbara replied that background checks should be done on executive management officers
 
Ms Dube (COPE) asked what how the presenter believed they could improve the recruitment and retention of skills.

Mr Mbara replied that a thorough screening process should be conducted.

The Chairperson thanked the presenters for their submissions.

The meeting was adjourned.


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