1. National Health Amendment Bill Comments Public Hearings Health Portfolio Committee 13 March 2012 DR KIM FAURE PURE HEALTH CONSULTING, Redefining Healthcare

2. PURE HEALTH CONSULTING Redefining Healthcare 2 PURE HEALTH CONSULTING Redefining Healthcare Comments on NHA Bill 8/17/2015  The comments represent my own views along with those of a number of individuals who have contributed their insights towards this submission.  Pure Health Consulting:  Independent healthcare consultant  Integrally involved in:  The implementation of the latest version of the National Core Standards for Health Establishments,  The strategic documents and plans for the future Office of Health Standards Compliance (OHSC);  Passionate about ensuring that this new body achieves its mandate in a way that adds integrity to the health systems 2

3. Specific Comments 8/17/2015

4. PURE HEALTH CONSULTING Redefining Healthcare 4 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 “Protect and promote the health and safety of users of health services”  Culture of patient centeredness guides the work of the staff of the Office  Positions the Office as a patient advocate The Mandate of the Office

5. PURE HEALTH CONSULTING Redefining Healthcare 5 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 “Protect and promote the health and safety of users of health services” Four strategic objectives 1. Fostering an improvement in the quality of health services; 2. Disseminating information and promoting awareness amongst users of health services; 3. Acting swiftly against poor and hazardous health services and; 4. Function with integrity and sound governance Fulfilling the Mandate of the Office of Health Standards Compliance

6. PURE HEALTH CONSULTING Redefining Healthcare 6 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 a. Establishing norms and standards b. Inspecting compliance of health establishments against standards; c. Enforcing compliance to the standards through a variety of incentives and sanctions 1. Fostering an improvement in the quality of health services;

7. PURE HEALTH CONSULTING Redefining Healthcare 7 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 a. Establishing norms and standards b. Inspecting compliance of health establishments against standards; c. Enforcing compliance to the standards through a variety of incentives and sanctions 1. Fostering an improvement in the quality of health services; i. Advising on Norms and Standards ii. Risk based inspections iii. Progressive approach to enforcement

8. PURE HEALTH CONSULTING Redefining Healthcare 8 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 1.a.i. Advising on Norms and Standards Norms & Standards development Monitor and enforce compliance (audits, accreditation, certification) Quality improvement NDOH Independent regulator (OHSC) Provincial DOH, districts, establishments

9. PURE HEALTH CONSULTING Redefining Healthcare 9 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 1.a.i. Advising on Norms and Standards  Bill not clear on advising role of the Office Recommendation:  Standards setting and development role should be within the NDOH  The Office should be consulted on standards and norms with legal repercussions on their work  The Office should participate in the review of standards and norms  Functions of quality improvement should remain with health establishments (reports on compliance should provide guidance)

10. PURE HEALTH CONSULTING Redefining Healthcare 10 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 a. Establishment of norms and standards b. Inspecting compliance of health establishments against standards; c. Enforcing compliance to the standards through a variety of incentives and sanctions and; 1. Fostering an improvement in the quality of health services; i. Advising on Norms and Standards ii. Risk based inspections iii. Progressive approach to enforcement

11. PURE HEALTH CONSULTING Redefining Healthcare 11 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 1.a.ii. Inspection compliance to standards and norms  Ideal world – the Office can assess every facility in South Africa every 3 yrs  Risk based directed inspections:  Each facility is risk classified (Early Warning Indicators and NCS self assessments)  ALL high risk establishments assessed 1- 2 yrly  Medium and low risk randomly sampled  ALL submit yearly self assessments and weekly EWI  Recommendation Regulations need to address:  Rules for inspections  Risk profiling based frequency of inspections  Set guidelines for self assessments  Declare that self assessment tools will be made public

12. PURE HEALTH CONSULTING Redefining Healthcare 12 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 a. Setting of norms and standards b. Inspecting compliance of health establishments against standards; c. Enforcing compliance to the standards through a variety of incentives and sanctions and; 1. Fostering an improvement in the quality of health services; i. Advising on Norms and Standards ii. Risk based inspections iii. Progressive approach to enforcement (HAS, CQC)

13. PURE HEALTH CONSULTING Redefining Healthcare 13 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 Recommendation: a. Negotiating a grace period b. Reporting any misconduct by practitioners (HPCSA or SANC) c. Setting progressive fines for continued gross non- compliance d. Suspending management and the Chief Executive or Head of Department as relevant e. Recommending the closure of non-compliant wards 1.c.i. Progressive approach to enforcement

14. PURE HEALTH CONSULTING Redefining Healthcare 14 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 “Protect and promote the health and safety of users of health services” Four strategic objectives 1. Fostering an improvement in the quality of health services; 2. Disseminating information and promoting awareness amongst users of health services; 3. Acting swiftly against poor and hazardous health services and; 4. Function with integrity and sound governance Fulfilling the Mandate of the Office of Health Standards Compliance

15. PURE HEALTH CONSULTING Redefining Healthcare 15 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 2. Disseminating information and promoting awareness amongst users Reporting function Education function

16. PURE HEALTH CONSULTING Redefining Healthcare 16 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 2. Disseminating information and promoting awareness amongst users  Educate users as to their rights and expectations for quality of care  User involvement through seeking their opinions on norms, standards and quality of care  Views of healthcare professionals as patient’s advocate Recommendation:  User surveys on quality driven by the Office Reporting function Education function

17. PURE HEALTH CONSULTING Redefining Healthcare 17 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015  Dissemination of information to users engenders accountability within the healthcare system  Sect 79D(5)(a) – implies the MOH has an opportunity to first sanction reports before publication  Silent on public reporting  Implications on transparency, autonomy and integrity of the Office Recommendation:  No sanction by the MOH  Reports published direct to public while informing the MOH (CQC eg) 2. Disseminating information and promoting awareness amongst users  Educate users as to their rights and expectations for quality of care  User involvement through seeking their opinions on norms, standards and quality of care  Views of healthcare professionals as patient’s advocate Recommendation:  User surveys on quality driven by the Office Reporting function Education function

18. PURE HEALTH CONSULTING Redefining Healthcare 18 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 “Protect and promote the health and safety of users of health services” Four strategic objectives 1. Fostering an improvement in the quality of health services; 2. Disseminating information and promoting awareness amongst users of health services; 3. Acting swiftly against poor and hazardous health services and; 4. Function with integrity and sound governance Fulfilling the Mandate of the Office of Health Standards Compliance

19. PURE HEALTH CONSULTING Redefining Healthcare 19 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 3. Acting swiftly against poor and hazardous health services Surveillancea. Reactive i. Reports of adverse events ii. Complaints management Ombudsman b. Proactive i. Early warning system

20. PURE HEALTH CONSULTING Redefining Healthcare 20 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015  “consideration, investigation and disposal of complaints relating to non compliance with prescribed norms and standards in a procedurally fair, economical and expeditious manner”  Adjudicative (settle matters judicially) versus commission (no powers, provides recommendations)  Investigations unit – structural concern limiting objectivity of findings (findings are against the OHSC)  Complaints Investigations unit – no powers of adjudication, make recommendations, investigate  Risk of increased litigation (free investigations)  High workloads as ALL complaints will be investigated (resources, capacity, overshadow the inspection functions)  Concurrent jurisdiction with Consumer Commission 3. Reactive Surveillance - Ombudsman

21. PURE HEALTH CONSULTING Redefining Healthcare 21 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 Recommendation:  Powers of adjudication and dispute resolution  Progressive complaints management process – only escalated complaints, high risk complaints  Remedies available to ombudsman to ensure redress  Preference given to health sector ombuds for quality related complaints 3. Reactive Surveillance - Ombudsman

22. PURE HEALTH CONSULTING Redefining Healthcare 22 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 “Protect and promote the health and safety of users of health services” Four strategic objectives 1. Fostering an improvement in the quality of health services; 2. Disseminating information and promoting awareness amongst users of health services; 3. Acting swiftly against poor and hazardous health services and; 4. Function with integrity and sound governance Fulfilling the Mandate of the Office of Health Standards Compliance

23. PURE HEALTH CONSULTING Redefining Healthcare 23 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015  Regulators are by definition agencies that safeguard the health and safety of citizens  Agencies are only effective if they are empowered with appropriate enforcement tools and governance structures  Public entity  greatest autonomy in its functions and decisions – promotes public confidence  Requires a board or council which sets the strategic agenda, approves reports and decides on enforcement measures  Chief executive officer manages day to day operations  Level of separation that may shield the Minister from extensive litigation resulting from claims of poor quality care 4. Governance structures of the Office

24. PURE HEALTH CONSULTING Redefining Healthcare 24 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 Governance of the OHSC – public entity Executive Authority (Minister of Health) Board Executive Officer Advisory unitOmbudsmanInspectorate Information and Intelligence unit Support services Subcommittee on Inspections Subcommittee on Enforcement Advisory Subcommittee on norms and standards

25. PURE HEALTH CONSULTING Redefining Healthcare 25 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015  Concurrent jurisdictions – overlapping provisions between this Bill and other legislation (Consumer protection act, Health professionals act, Pharmacy act)  Co-ordinated approach – where other government agencies have the power to take action, the Office works with them to co-ordinate their actions to avoid duplication  Reduce regulatory burden of health establishments  Memorandums of understanding between regulators and Information Sharing Protocols (HPCSA, SANC, SAPC, MCC, public protector, Human Rights Council, Auditor General) 4. Governance structures of the Office

26. PURE HEALTH CONSULTING Redefining Healthcare 26 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 “Protect and promote the health and safety of users of health services” Fulfilling the Mandate of the Office

27. Pure Health Consulting Dr Kim Faure 082 565 1388 kim.faure@mweb.co.za www.ourhealthsouthafrica.blogspot.com 8/17/2015 27

28. PURE HEALTH CONSULTING Redefining Healthcare 28 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 Informing the efficient and effective use of resources

29. PURE HEALTH CONSULTING Redefining Healthcare 29 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 Informing the efficient and effective use of resources Norms & Standards development Monitor and enforce compliance (audits, accreditation, certification) Quality improvement NDOH informs the OHSC of norms and standards within their available resources Compliance reports identify gaps for QIP OHSC informs the revision of norms and standards

30. PURE HEALTH CONSULTING Redefining Healthcare 30 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 Governance of the OHSC

31. PURE HEALTH CONSULTING Redefining Healthcare 31 PURE HEALTH CONSULTING Redefining Healthcare 8/17/2015 a. Inspecting compliance of health establishments against standards; b. Providing enabling reports for establishments to rectify any gaps; c. Enforcing compliance to the standards through a variety of incentives and sanctions and; 1. Fostering an improvement in the quality of health services; i. Detailed reports to establishments, provincial management and MOH