National Health Amendment Bill: Enhancing Quality of Care and Compliance

1. Briefing to the Select Committee on Social ServicesOn the National Health Amendment Bill Tuesday, 04 September 2012

2. Outline • Policy framework and Legislative process • National Health Amendment Bill • Current NDOH functions related to future OHSC

3. 1. Policy framework and legislative process

4. Provisions of 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

5. Rationale of regulatory approach • “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 • “Purpose of assessment / regulation needs to be clear” • SA choices made: • Public accountability and credibility • Mandatory compliance • Pre-requisite for funding decisions (long term through NHI) • NOT voluntary peer review and improvement model

6. Key aspects of policy • 2009 decision to establish an “independent quality management body” • Quality of Care a component of the 10-point plan, Negotiated Service Delivery Agreement • National Core Standards approved by the National Health Council (NHC) 2010 • NHC decisions re “Independent Office”: • All health establishments (Public and private, all levels of care) • Mandatory standards - to cover key quality issues • Certification of compliance (not licensing) • Complaints / Ombud retained • NHI Green paper: certification by Office a pre-requisite for accreditation to provide specified services by NHI fund

7. Specific areas covered in “Benchmarking of Best Practice” (qv) • Regulation of compliance: independence, coordination, enforcement, prioritisation • Process of setting standards and norms • Assessing whether standards are met (routine, ad hoc or in-depth inspections) • Risk profiling and link to knowledge management • Complaints management; investigation by ombud and recommendations on redress • Communication and reporting • Stakeholder relations

8. 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, certified by State Law Advisors November 2011 • 1st reading of Bill to Portfolio Committee February 2012 • Public hearings (20+ organisations) on 13th and 16th March • Uniform in-principle support • Some concerns raised • In-committee review and approval (18th June) • National Assembly 2nd reading 14th August 2012 • NCOP 4th Sept., then provincial hearings

10. “B” Bill: Major changes from certified version • Relating to the Principal Act: • Sections 21 & 25 – shift of Port Health Services from Provincial to National office • (Section 36 (Certificate of Need) - no longer mentioned) • Section 47 Office role re Norms and Standards • Regulations expanded • Definitions: • EHOs inserted

11. Changes (cont) • Functions • Recommendations to be made to heads of national, provincial, municipal departments or (private) health establishments (also in subsequent sections) • Shift “publish information” from “may” to “must” • Board established (S 79) - membership, role and functions • Ombud: 7 year non-renewable term • must inform complainant & respondent of findings and recommendations • Offices issues a “Compliance Certificate” (valid for up to 4 years) • Non-compliance leads to progressive response in accordance with gravity of situation

12. Concerns re scope of norms and standards to be prescribed / enforced • Some groups asking for exclusion (e.g Pathology) • Concerns re transparency, duplication of role of clinicians, other bodies However concerns felt to be already addressed • Different types of standards specified in principal Act • Minister to specify scope for various types of establishments • Transparent process of development: as for any regulations (expert input, public comment) • Services Level Agreements (SLAs) with other regulators / bodies

13. 2. Outline of National Health Amendment Bill

14. PURPOSE OF THE NATIONAL HEALTH AMENDMENT BILL • 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”).

15. Clause 1: Amendment of section 1 of Act • Clause 2: Amendment of section 21 of Act • Clause 3: Amendment of section 25 of Act • Clause 4: Amendment of section 47 of Act • Clause 4: Substitution of Chapter 10 of Act • Clause 5: Amendment of Sections 90 of Act • Clause 6:Amendment of Arrangement of sections of Act • Clause 7: Amendment of laws • Clause 8: Short title and commencement

16. 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. • EHP

17. Clause 2: Amendment of section 36 of the Act • Clause 2 seeks 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, 1974 (Act No. 28 of 1974).

18. Clause 3: Amendment of section 25 of the Act • Clause 3 seeks 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.

19. Clause 4: Amendment of section 47 of the Act • Clause 4 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.

20. 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: • Establishment of Office; • Objects of the Office; • Functions of Office; • Control of Office • Composition of Board • Appointment of members of Board • Chairperson and vice-chairperson of Board • Disqualification from membership of Board and vacation of office; • Meetings of Bard; • Committees of Board; • 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 officer or inspector; • 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

21. 77. Establishment of Office • Established as a juristic person in terms of the PFMA (i.e. to be listed as a schedule 3A public entity) • Funded by parliamentary appropriation and fees for services rendered • Board made up of experts appointed by the Minister • Board appoints CEO (who is the Accounting Officer) and advises the Minister on appointment of Ombud (placed within the Office)

22. 78. Objects of the Office • The objects of the Office are to protect and promote the health and safety of users of health services by— • Monitoring and enforcing compliance by health establishments with prescribed norms and standards • Ensuring consideration, investigation and disposal of complaints relating to breaches of norms and standards

23. 79. Functions of Office (1)The Office must— (a) 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; (b) inspect andcertify health establishments as compliant or non-compliant with prescribed norms and standards or, where appropriate and necessary, withdraw such certification (c) investigate complaints relating to breaches of prescribed standards and norms (d) 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; (e) 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; (f) publish information relating to prescribed norms and standards through the media and, where appropriate, to specific communities (g) recommend quality assurance and management systems for the national health system to the Minister for approval; (h) keep records of all its activities; and (i) advise the Minister on any matter referred to it by the Minister.

24. 79. Functions of Office (cont) (2) The Office may- • issue guidelines on the implementation of 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 (3) The Minister may prescribe different norms and standards for different types of health establishments

25. 79 – (Appointment of the Board &CEO) 79A – Control of Office • The Office functions under the control of the Board. • (2)   The Board must— • (a) determine the policy of the Office; • (b) do the necessary planning in connection with the functions, powers and duties of the Office; and • (c) perform such other functions as may be assigned to it by this Act. 79B - Composition of the Board • The Board consists of no less than 7 and no more than 12 members appointed by the Minister (see (a) to (f) )

26. (cont.) 79C- Appointment of members • Provisions for nomination, appointments, constitution of quorum 79D – Chairperson and vice-chairperson of the Board • Designation by Minister; acting provisions 79E - Disqualification form membership of the Board and vacation of office • Criteria for membership and for removal 79 F – Meetings of the Board • Rules, quorum, decisions, minutes 79 G – Committees of the Board • Appointment of internal and external committees

27. (cont) 79 H – Appointment of CEO • CEO appointed by Minister after consultation with the Board for 5-year term, renewable once • (all after consultation with the Board) - Subject to a performance agreement • Grounds for removal from office • Arrangements for acting CEO • Pension and retirement benefits 79 I – Functions of CEO • Head and accounting officer in terms of the PFMA • Responsibilities for staffing and management • Contracting of expertise and capacity

28. (cont) • 79 J - Delegation of powers & assignment of duties by CEO • Delegation and assignment • 79 K - Accountability of and reporting by CEO • Accounting and records • Annual report through Board, content, tabling by Minister, access to public • Ad hoc reports from Board or CEO to Minister

29. 80. Appointment of health officers and inspectors • Appointment of health officers by relevant authorities • Appointment of inspectors by CEO of Office • Certificates of appointment and obligation to show these • Have powers of a peace officer in law

30. 81. Appointment of Ombud • Appointed by the Minister after consultation with the Board; process for inviting applications • 7-year term non-renewable; with specific terms and benefits • Located within the Office and using staff provided by it • Process for resignation, termination (with grounds) and acting appointments

31. 81 A - Functions of Ombud • Following a written or verbal complaint relating to norms and standards, or on Ombud’s own initiative, may 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 • May use staff (inspectors) of Office plus use wide specified powers (….) including subpoena, but with regard for administrative and procedural fairness • May refer complaint to any other suitable body to investigate and obtain a report from them • Must provide report and recommendations to CEO; and recommend action through appropriate authority • Provides for dispute resolution through Minister • On conclusion, must inform complainant or respondent or both of findings and recommendations

32. 81 B - Independence, impartiality and accountability of Ombud • Earmarked funding to be provided by Parliament • When dealing with any complaint in terms of this Act, the Ombud and support staff must be independent and impartial; and perform his or her functions in good faith and without fear, favour, bias or prejudice • Annual Report provided to the Minister and included in report of the Office

33. 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 • Compliance certificate valid for no more than 4 years (unless revoked) to be renewed in prescribed manner

34. 82 A - Non-compliance with prescribed norms and standards • Inspector may issue notice of non-compliance to person in charge of establishment • Notice to reflect: the health establishment concerned; any prescribed norm and standard that have not been complied with; details of the nature and extent of non-compliance; any steps that are required to be taken and the period over which such steps must be taken; and the penalties that may be imposed in the event of continued non-compliance • Notice remains in place until Office issues certificate of compliance or until successful appeal

35. 82A (cont) • If person in charge fails to comply with notice, Office may as appropriate and taking into account the nature, extent, gravity and severity of the contravention: • Issue written warning with a prescribed time frame to achieve compliance • require from establishment a written response re continued non-compliance • recommend to the relevant authority any appropriate and suitable action, including disciplinary proceedings • recommend to the Minister the temporary or permanent closure of an establishment or part thereof that constitutes a serious risk to public health or to health service users; •   in respect of that non-compliance, impose upon that person or health establishment a fine not exceeding R10 million rand;  or • refer the matter to the National Prosecuting Authority for prosecution. • The Chief Executive Officer must inform the Director-General of any persistent non-compliance

36. 83 - Environmental health investigations • Health officer obligation to investigate constitutional violations, pollution, nuisances • Determine responsibility • Issue compliance notice requiring corrective action • Person affected may appeal to relevant executive authority

37. 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; may be accompanied by police officer • Defined activities including examination of any document; seizure of potential evidence, observation of any process; always within parameters of administrative justice and privacy • Obligations and rights of occupants • Process and grounds for issuing of warrant though magistrate

38. 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

39. 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 86A – Constitutional right to privacy • Any entry or search must be conducted with strict regard to decency and good order including the right of a person to dignity; to freedom and security; privacy

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

41. 88. Miscellaneous provisions relating to health officers, inspectors and compliance procedures • Head of national or provincial department of health or head of a municipality or head of a heath estblishment regarded as being owner and occupier of relevant building • The employer of any persons carrying out any duty or exercising any power conferred by this Act

42. 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

43. 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

44. 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; • 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

45. 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.

46. 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.

47. 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.

48. 3. Current functions within NDOH (preparatory work; for transfer)

49. Preparatory work: National Core Standards • Requirements for establishments (not clinical /professional) • Reflect current policies in different cross-cutting areas • Extract of key aspects (as screening tool) • Not prescribed (guideline, approved by National Heath Council) • Prioritises major concerns from patients / public • Attitudes, Cleanliness, Waiting times, Patient safety & security, Infection prevention & control, Availability of medicines & supplies • Wide consultation and dissemination • Developed as “universal” standards: public and private, all levels • Focus at present is on public sector • Link to management requirements, budgets, staff development

50. Preparatory work:Inspections • Initial teams of inspectors appointed and trained, currently conducing “mock” training audits • Inspection plans developed based on provincial request, facility improvement needs, suspected risk (e.g. pattern of complaints) • Inspectors use audit tool that measures NCS compliance • Currently a module of the District Health Information System • Provides on-site feedback and reports • (Has also been used for Self-assessments and Baseline audit; closing gaps a major focus of Facility Improvement Teams) • Teams also testing various aspects of the procedures