National Health Amendment Bill

1. National Health Amendment Bill National Department of Health Briefing to the Portfolio Committee on Health 15 February 2012

2. a. Background

3. Outline of existing National Health Act (2003) with respect to Office of Standards Compliance • Section 36 – empowered the Director General to withdraw a Certificate of Need (CoN) on the recommendation of the Office of Standards Compliance in terms of 79 (7) (b) which specified OSC powers to shut down an establishment or part thereof, or recommend withdrawal or non-renewal of a CoN • Section 47 (3) – required Office of Standards Compliance and Inspectorates for Health Establishments to monitor and enforce compliance • Chapter 10 – entitled “Health Officers and Compliance Procedures” – specified the establishment of Inspectorate for Health Establishments by MECs; functions of Office of Standards Compliance within NDoH; including Ombudsperson; Inspections; Appointments, duties and powers in general of officers; and Offences

4. Policy process and benchmarking

5. Key aspects • Independence essential – 2009 decision to establish an “independent quality accreditation and management body” • Context: Quality of Care a component of the 10-point plan, Negotiated Service Delivery Agreement, NHI Green paper • National Core standards approved by the National Health Council (NHC) 2010 • NHC decisions re “Independent Office”: • National body • To cover health establishments in public and private sectors at all levels of care • Mandatory standards for compliance; to cover key quality issues • Certification of compliance (not licensing) • An early warning system to detect urgent problems • Complaints / Ombud retained • Extensive scoping / benchmarking done with similar bodies in SA and internationally for the proposed functions

6. International experience: Clarity re rationale and purpose of regulation • “Choices or options must be based on rationale” • SA situation: • Unacceptable quality of care – does not meet public expectations • Poor return on investments due to lack of expected compliance • Accountability weak, few consequences • Ethics and professionalism eroded • “Clear purpose of assessment and regulation” • SA - choices made: • Public accountability and credibility • Mandatory compliance • Pre-requisite for funding in long term through NHI • NOT voluntary peer review and improvement model

7. Overall approaches reviewed • Objective external assessment of quality • Regular, ad hoc or in-depth inspections against set standards • Regulation of compliance • Independence • Enforcement • Prioritisation and risk • Ombud investigation of complaints and redress

8. Specific areas covered (details available) • Enforcement and coordination • Process of setting standards and norms • Assessing whether standards are met (inspections) • Risk profiling and link to knowledge management • Complaints investigation • Ombuds • Communication and reporting • Stakeholder relations

9. Legislative process and changes

10. Legislative process • Draft Amendment Bill approved by Cabinet in November 2010 • Gazetted for public comment Jan – April 2011 • Comments analysed, incorporated, revised Bill approved by Cabinet July 2011 • Certified by State Law Advisors November 2011

11. Comments received on National Health Amendment Bill • Public comments received between January and April 2011 • Comments received from 28 organisations/ individuals • Private hospital groups (4) • Professional associations (4) • Municipal / provincial services and others regarding EHOs (12) • Medical aids and related (2) • National and Provincial Departments (2) • Other (4)

12. Broad issues raised in comments • Independence and governance of Office felt to be insufficiently protected • Norms and standards – process and expertise for development not clearly specified, location of function inappropriate • Concern that donations might enable undue influence to be exerted • Environmental health officers – confusion regarding relationship with “Office” vs municipalities; professional oversight • No clarity on what the Office should do in cases of non- compliance – no progressive sanctions or enforcement powers • Unclear extent of jurisdiction over private sector • Inspection reports – should be available to the public • Transitional arrangements – not specified • Probable challenge with capacity – need to contract • Regulatory duplication and overlap with other statutory bodies and legislative provisions • Definitions – unclear or missing

13. Summary of incorporation of comments into revised version • Tightens definitions; puts all functions together into sections - “must” and “may”; tightens language • Facilitates coordination among regulators • Funding sources excludes donations • Inspectors and Health Officers– clarifies each category ito. appointments, scope and powers • Non-compliance with norms and standards– now covered • Advisory function to the Minster on norms and standards • Security of tenure of CEO protects independence • Transitional arrangements to be covered in a proclamation • Ability to contract or appoint expertise

14. Summary of changes made by State Law Advisor • General – revision of language, clarity and logical sequence throughout • Changes to other sections of NHA: • Existing Section18 re-instated (complaints) • Some wording changes to existing sections 36 (2) and 47 (3) • Changes to Chapter 10 (see details) • Status of Office, appointment of CEO, appointment of Ombud by Minister with separate vote but with placement in Office, clarification of powers and penalties, access to patient records, Minister required to establish ad-hoc tribunal for appeals

15. B. OBJECTIVES OF the national health amendment bill

16. Purpose • The National Health Amendment Bill seeks to amend the National Health Act, 2003 (Act No. 61 of 2003) (“the principal Act”) and to empower the Minister to establish an independent entity, namely, the Office of Health Standards Compliance (“the Office”).

17. The Objectives of the Office The Office will— • advise the Minister on the development and implementation of enforceable norms and standards for quality and safety for the entire health system • ensure compliance with the prescribed norms and standards • deal with complaints relating to norms and standards against the entire health system

18. Governance of the Office • The Office will be headed by the Chief Executive Officer of the Office appointed by the Minister (new sect 79A). • The Chief Executive Officer holds office for a term of five years and may be reappointed for one additional term of five years. • An Ombudsperson appointed by the Minister will be located within the Office

19. c. Outline of amendment bill

20. Clause 1: Amendment of section 1 of the Act • Clause 1 seeks to amend section 1 of the principal Act in order to insert, substitute and delete certain definitions consequent to the establishment of the Office.

21. Clause 2: Amendment of section 36 of the Act • Clause 2 seeks to amend paragraph (a) of section 36(6) of the principal Act in order to align the wording and reference consequent to the establishment of the Office and rearrangement of sections in Chapter 10 of the Act. Removes reference to Office of Standards Compliance and replaces this with “the Office” as per definition

22. Clause 3: Amendment of section 47 of the Act • Clause 3 seeks to amend section 47(3) of the principal Act in order to delete the reference to the Office of Standards Compliance and the Inspectorate of Health Establishments which are replaced by the establishment of the Office.

23. Clause 4: Substitution of Chapter 10 of the Act Clause 4 seeks to substitute Chapter 10 of the principal Act in order to provide the following: • The establishment of Office; • Objects of the Office; • Functions of Office; • Appointment of Chief Executive Officer; • Functions of Chief Executive Officer; • Delegation of powers and assignment of duties by Chief Executive officer; • Accountability of and reporting by Chief Executive Officer; • Appointment of health officers and inspectors; • Appointment of Ombud; • Functions of Ombud; • Independence, impartiality and accountability of Ombud; • Inspections; • Non-compliance with prescribed norms and standards; • Environmental health investigations; • Entry and search of premises or health establishment with a warrant by health officer or inspector; • Identification prior to and resistance against entry by health officer or inspector; • Entry and search of premises or health establishment without warrant by health officer or inspector; • Constitutional right to privacy; • Disposal of items seized by health officer or inspector; • Miscellaneous provisions relating to health officers, inspectors and compliance procedures; • Appeals against decisions of Office and Ombud; and • Offences and penalties.

24. 77. Establishment of Office • Established as a juristic person Important to ensure accountability • Funded by parliamentary appropriation and fees Core business of Government, therefore major funding is from state Revenue from private and public sector to progressively offset costs Exclusion of donations due to fears of undue influence

25. 78. Objects of the Office • Monitoring compliance by health establishments with prescribed norms and standards • Ensuring consideration, investigation and disposal of complaints relating to non-compliance with norms and standards

26. 79. Functions of Office (1)The Office must— • advise on matters relating to norms and standards to be prescribed • inspect andcertify (or not) health establishments as compliant • investigate complaints • Monitor and report on indicators of risk as an early warning system • identify areas and recommend urgent intervention as required • recommend quality assurance and management systems Ensures expertise and insights gained can benefit policy development, regulation and management Provides for formal external measurement of acceptable level of compliance Monitors patient experience to identify system problems and enhance trust Real-time measurement and prioritisation of risk to counteract long intervals between inspections Recommendations for immediate corrective action to reassure public

27. 79. Functions of Office (cont) (2) The Office may- • issue guidelines on the implementation of norms and standards • publish any information relating to prescribed norms and standards • collect or request any information … from health establishments and users • liaise with any other  regulatory authority on matters of common interest and receive information; • negotiate agreements with any regulatory authority Communication function enhances capacity and voluntary compliance Publication of standards and levels of compliance or risk to enhance accountability and public trust Powers to collect all necessary data to indentify risk or enable monitoring Formal coordinated action with other regulators to ensure exchange of information and best application of powers

28. 79 A - Appointment of Chief Executive Officer • CEO appointed by Minister for 5-year term, renewable once • Subject to a performance agreement • Removal from office (grounds) • Arrangements for acting CEO • Pension and retirement benefits Security of tenure and protection of independence critical

29. 79 B - Functions of Chief Executive Officer • Head and Accounting officer in terms of PFMA; appoints staff • Responsibilities relating to administration and management of staff • Contracting or appointment of assistance (including for inspections) Functions of Accounting Officer Provisions to increase capacity, expertise and credibility

30. 79 C - Delegation of powers and assignment of duties by Chief Executive Officer • Provisions for delegation and assignment • In writing • Retention of responsibility by CEO

31. 79 D - Accountability of and reporting by Chief Executive Officer • Tabling of Annual Report in Parliament by Minister in terms of PFMA • Audited financial statements and Auditor-General’s report; detail on activities • Any report requested by the Minister

32. 80. Appointment of health officers and inspectors • Appointment of health officers by relevant authorities • Appointment of inspectors by CEO of Office • Certificates of appointment • Have powers of a peace officer in law Clarifies specific provisions relating to health officers vs. inspectors Clarifies general powers

33. 81. Appointment of Ombud • Appointed by the Minister for a 5-year term with specific terms and benefits • Located within the Office and using staff provided by it • Process for resignation, termination (with grounds) and acting appointments Enhances independence while ensuring risks to quality are identified and resources of Office are maximally utilised

34. 81 A - Functions of Ombud • May consider, investigate and dispose of .. a written or verbal complaint relating to norms and standards ..or on his or her own initiative … in a fair, timely and expeditious manner • Covers act or omission by manager or employee in any health establishment or where health service is provided • May use staff (inspectors) of Office plus use specified powers including subpoena but with regard for administrative and procedural fairness • May refer complaint to any other suitable body to investigate • Must provide report and recommendations to CEO to action through appropriate authority • Provides for dispute resolution through Minister Allows for widest possible ambit of action in a manner that enhances public trust and protection Does not duplicate other complaints functions (at delivery level, or relating to professionals) Provide for single coordinated channel of action while protecting independence

35. Independence, impartiality and accountability of Ombud • Earmarked funding provided by Parliament • Requirement for Ombud and staff to be fair and impartial and to be assisted in their function • Annual Report provided to the Minister and included in report of the Office Enhances requirement for and protection of impartiality and fairness

36. 82. Inspections • Health officer or inspector (with assistant) may enter to inspect, question, examine documents, take samples or photographs (within provisions of respect for property, privacy) • May issue compliance notice if not compliant which remains in force until compliance certificate issued Specifies permitted actions Compliance notice or certificate would be subject to organizational quality control and fair process

37. 82 A - Non-compliance with prescribed norms and standards • Notice of non-compliance to person in charge reflecting details of non-compliance, corrective action and time frames, eventual penalties • Remains in place until Office issues certificate of compliance or until successful appeal • Penalties to include fine not exceeding R10m or referral for prosecution • DG to be informed Enables corrective actions and progressive sanctions Institutional quality control

38. 83. Environmental health investigations • Health officer obligation to investigate pollution, nuisances and determine responsibility • Issue compliance notice requiring corrective action • Appeal to relevant executive authority • Requirement for professional registration Clarifies specific requirements for health officers

39. 84. Entry and search of premises or health establishment with a warrant by health officer or inspector • Power to enter any premise or establishment as specified in warrant • Defined activities including seizure of potential evidence; always within parameters of administrative justice and privacy • Obligations and rights of occupants • Process and grounds for issuing of warrant Provides for situations of serious breach or failure to allow entry

40. 85. Identification prior to and resistance against entry by health officer or inspector • Procedures to follow in entry with a warrant – announce and demand entry, communicate reasons, hand over or affix warrant, provide identification / credential • May overcome resistance if necessary Provides procedural guidance and powers

41. 86. Entry and search of premises or health establishment without warrant by health officer or inspector • May exercise above powers if agreed-to or if delay would be prejudicial, subject to the right to privacy provisions Provides for exceptional circumstances

42. 86 A - Constitutional right to privacy • Any entry or search conducted with strict regard to decency and good order including the right of a person to dignity; to freedom and security; privacy Emphasises the legal protection of those affected

43. 87. Disposal of items seized by health officer or inspector • May dispose of seized items in terms of the Criminal Procedure Act

44. 88. Miscellaneous provisions relating to health officers, inspectors and compliance procedures • Head of national or provincial department of health or head of a municipality regarded as being • the owner and occupier of relevant building or establishment • the employer of any persons carrying out any duty or exercising any power conferred by this Act Makes specific provision for situation in relation to the accountable person in the public sector

45. 88 A - Appeals against decisions of Office and Ombud • Any person (or his or her representative) aggrieved by decision of office or finding and recommendation of Ombud may appeal in writing to the Minister within 30 days • Minister must appoint independent ad-hoc tribunal of up to 3 persons chaired by retired judge or magistrate and with members having knowledge of healthcare industry • May confirm, vary or set aside decision and notify parties Places appeal function in independent body; protects the Minister

46. 89. Offences and penalties • Person guilty of an office if he or she • obstructs or hinders inspection or refuses to provide information or provide false information • impersonates a health officer or inspector • fails to comply with a compliance notice • discloses any financial or business information unless specifically ordered to do so hinders or obstructs the Ombud • Offender liable to fine or imprisonment or both Specifies penalties

47. Clause 5: Amendment of section 90 of the Act Clause 5 seeks to 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; and • the Minister to prescribe fees to be paid to the Office for services rendered.

48. Clause 6: Amendment of Arrangement of Sections of the Act • Clause 6 seeks to amend the arrangement of sections to the Act consequent to the substitution of Chapter 10.

49. Clause 7: Amendment of laws • Clause 7 seeks to amend the Public Finance Management Act, 1999 (Act No. 1 of 1999) (“the PFMA”) in order to insert an expression to the Office, for the PFMA to apply to the Office.

50. Clause 8: Short title and commencement • Clause 8 provides for the name or title of the Bill and for the date on which the Bill will come into operation.