Strategic plan and Annual Performance Plan of the Office of Health Standards Compliance

1. Strategic plan and Annual Performance Plan of the Office of Health Standards Compliance Presentation to the Health Portfolio Committee 20th August 2014

2. Outline Part A – Strategic overview Part B – Strategic objectives Programme estimates Programme outlines CEO Corporate services Office Ombud Complaints management Compliance inspection Health standard design, analysis and support • Mandate, Vision, Mission, Values • Legislative mandate • Policy mandate • Situational analysis • Performance • Organisational • Partnerships • Process • Strategic Outcome Oriented Goals • Objectives

3. Part A - strategic overview

4. Mandate • “To protect and promote the health and safety of users of health services by: • Monitoring and enforcing compliance by health establishments with norms and standards prescribed by the Minister in relation to the national health system; and • Ensuring consideration, investigation and disposal of complaints relating to non-compliance with prescribed norms and standards in a procedurally fair, economical and expeditious manner”

5. Vision, Mission Our vision: Safe and Quality Healthcare for all South Africans Our Mission: To act independently, impartially, fairly and fearlessly in guiding, monitoring and enforcing health care safety and quality standards in health establishments to serve the people of South Africa

6. Values • Our Values are informed by the South African Constitution and Batho Pele Principles: • “Human dignity; freedom and the achievement of equality; and that people must come first” • “To protect and promote the health and safety of health services users” implies that we • Act as the champion of the public and of users so as to restore credibility and trust in the health system • Respect healthcare users and their families as well as healthcare staff • Advocate for effectiveness in achieving health system change and social impact • Strive for excellence, innovation and efficiency in our operations • Are truthful, fair and committed to intellectual honesty • Practice transparency but respect confidentiality • Achieve the highest standards of ethical behaviour, teamwork and collaboration • Promote professionalism, compassion, diversity, and social responsibility

7. Legislative mandates The Constitution The National Health Act The National Health Amendment Act Other health-related Acts Other legislation

8. Constitutional mandate • Section 27 of the Constitution guarantees everyone the right of access to healthcare services, including reproductive health services and emergency medical treatment. • Requires state to take reasonable legislative and other measures, within its available resources, to achieve progressive realisation of this right. • Regulation of the quality of health services will enable all health establishments to comply with policy priorities and minimum standards of care; contributes directly to government’s progressive realisation of its constitutional obligations. • Section 41 requires all three spheres of government to work cooperatively • National government is responsible for developing and monitoring policies, legislation and norms and standards for the health sector , while Provincial government …remain responsible for the implementation of national policy and legislation • Section 44 gives National Government the authority to pass legislation with regard to functional areas of concurrent competence and to prescribe minimum norms and standards

9. National Health Act: provisions relating to prescribed standards • Definitions: “Health establishment” means the whole or part of a public or private institution, facility, building or place … that is operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions … or health services • S 47:All establishments must comply with the quality requirements and standards prescribed by the Minister after consultation with the Office • These may relate to human resources, health technology, equipment, hygiene, premises, the deliver of health services, business practices, safety, and the manner in which users are accommodated and treated. • The Office must monitor and enforce compliance with the quality requirements and standards …

10. Regulations: S 90 of the NHA as amended S90(1) of the principal Act is amended 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; • Minister may prescribe different types of norms and standards for different types of health establishments; after consultation with relevant regulatory authorities • Regulations to include: • fees to be paid to the Office for services rendered. • Norms and standards for national health systems • Functions of the Board and the Office • Environmental health, including nuisances and medical waste

11. The National Health Amendment Act (12 of 2013) (our mandate) S 78 • “To protect and promote the health and safety of users of health services by: • Monitoring and enforcing compliance by health establishments with norms and standards prescribed by the Minister in relation to the national health system; and • Ensuring consideration, investigation and disposal of complaints relating to non-compliance with prescribed norms and standards in a procedurally fair, economical and expeditious manner”

12. Two main reasons for opting to regulate quality and safety • Protect health and safety of users • “Protect” implies the State responsibility is to protect citizens from harm • “Health” describes what must be protected • “Safety” describes what must be protected • “Users” describes who must be protected • “Health”means “state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”…(WHO) • “Safety”means – “prevention of errors and adverse effects to patients associated with healthcare” (WHO) • Promote health and safety of users • “Promote”implies the state plays an ‘active’ role in quality and safety of health services • “Quality”refers to “extent to which health services for individuals and populations increase the likelihood of desired outcomes, are consistent with professional knowledge, and meet the expectations of healthcare users” (Donabedian, Bullet) • “Users”defined in National Health Act, covers users and caregivers/guardians in the case of vulnerable users

13. S79 (1) Functions of Office 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 and certify 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;

14. 79. (1) Functions of Office (cont) The Office must (cont)— (e) identify areas and make recommendations for intervention by a national or provincial department of health, a health department of a municipality or health establishment, 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.

15. 79. Functions of Office (cont) (2) The Office may- (a) issue guidelines on the implementation of norms and standards (b) collect or request any information related to norms and standards from health establishments and users (c) liaise with any other  regulatory authority on matters of common interest and receive information (d) negotiate agreements with any regulatory authority

16. 81A. 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 findings and recommendations to CEO who must take action through the appropriate authority On conclusion, must inform complainant or respondent, or both .., of findings and recommendations

17. Powers of inspection, investigation and enforcement Appointment of inspectors Powers of inspectors Powers of the Ombud Recommendations of the Ombud Compliance notices Compliance certificates Progressive sanctions

18. Legal context: Other legislation • Legislation relating to functioning of health establishments and their staff • Strengthen mandate of inspectors • Coordination • Legislation relating to operations of entities • Strengthen mandate of inspectors • Obligation on OHSC

19. Policy mandates • National policy on quality in Health (2001 – 2007) • Batho Pele and the Patient’s Rights Charter • “….access to basic care and to respectful, informed and dignified attention in an acceptable and hygienic environment. Patients should be empowered to make suitably informed decisions about their health, and to complain if they have not received decent care.” • National Core Standards for Health Establishments in South Africa (2011) • “Expected performance … for the delivery of safe, decent care” • 7 cross-cutting domains covering major areas of risk • sub-set of 6 top priorities • National Health Insurance (green paper) • Certificate of compliance to be a pre-requisite for future NHI funding

20. Performance delivery environment Situational analysis

21. The quality challenge • National Development Plan • Health system failing, gaps in resources and knowledge • Poor relationship with private sector • Silo-based management • Public perception of sub-standard care esp. in PHC • National Core Standards • Poor accountability and lack of consequences • Multiple standards and no objective measurement • Gaps in basic knowledge and competence

22. Strategies • Provide guidance • Single national set of standards • Set out expectations of managers • Framework and common understanding • Measurement / benchmarking • Detailed tool for assessment / audit • Objective, external inspectors • Immediate feedback • Improvement / correction • Government-led (sometimes national teams) • NGO or other support • Deal with bottlenecks in the system (root cause analysis) • Regulation (q.v.)

23. Regulatory response • Rationale and powers • Procedural regulations - • how the Board and the Office will function, requirements of Health Establishments • “Advise on norms and standards to be prescribed” • Scope (public and private) • Link to National Core Standards • Performance-based

24. Current environment building on the National Core Standards • Leadership • Very strong and ongoing political and senior management leadership • Main-streaming • NCS part of budgeting (“non-negotiables”), job descriptions and performance agreements • Roleplayers and stakeholders • Some contestation re roles, however widespread support for change • Challenge lies with the management and support systems

25. Envisaged impact • Improved outcomes • Improved reliability and availability of effective care • Improve safety and less harm • Universal healthcare coverage / NHI • Acceptability of care to patients • Improved efficiency • Through • Strengthening management accountability in HEs and changing incentives • Knowledge and guidance • Control systems and practices • Indirect impact on system functioning

26. A long journey …

27. Organisational environment Situational analysis

28. SWOT analysis (from Business case 2013)

29. Establishing the OHSC as a public entity, transition • Listed as schedule 3A public entity May 2014 • Board inaugurated end January 2014, first meeting in March, 4 further meetings held • 3 Board committees set up, 3 meetings of each committee already held • Board Constitution and code of conduct approved • CEO appointed on interim basis from 1 April with full powers • Formal MOA signed between NDOH and OHSC to facilitate and govern transition • Establishment of systems and structures

30. Service delivery model and structure • Single national entity • Not provincial, could one day be regional • Key functions / units • Inspectorate, Ombud, Certification and enforcement • Critical support • Corporate services; Communications • Information and analysis, development • Ombud • appointed by and reports to the Minister • placed within the Office and uses staff of the Office • Must facilitate access

31. Role and functioning of the Board • Accounting authority • Oversight and governance • Policies and plans • Appoint CEO; approve executive managers Significant work already done by the Board

32. OHSC approved Organisational Structure Ombud

33. Partnerships

34. Primary partners and stakeholders Mass media • Health establishments that are subject to regulation by the OHSC • Includes managers as well as staff members • “Head offices” of health establishments (e.g. provincial health departments and private hospital groups) are also stakeholders • Users of health establishments whose safety is to be protected and promoted by the OHSC, and their families

35. Other partners and organisations Mass media • That are interested in the regulation of healthcare services • Parliament • Other regulators, such as the nursing council, health professions council of SA, pharmacy council, Council for Medical Schemes, and accreditation authorities. • National Department of Health • That influence or have an interest in health service provision • Professional associations and trade unions of health workers, • Associations of hospitals, • Academic and training institutions in the health field, and • Certain types of NGOs • That influence or represent interests of healthcare consumers • Mass-based civil society structures (such as trade union federations, political parties and faith-based communities), • NGOs that focus on health rights and advocacy, and • Consumer bodies.

36. Process of development Significant inputs from Board meetings since March 2014 Largely based on Business case developed during 2012/13 by then-OSC

37. Strategic goals and objectives

38. Strategic Outcome-oriented Goals

39. Strategic objectives - Goal 1 • Health establishments comply with norms and standards to protect and promote the health and safety of users through the provision of quality, compassionate and responsive care. 1.1 Different types of norms and standards for different types of HEs are developed and/or revised for submission to the Minister for promulgation 1.2 All HEs obligated by prescribed norms and standards / regulated are registered annually for purposes of monitoring and inspections 1.3 Guidance is provided on compliance with norms and standards for regulated HEs 1.4 Compliance with quality standards in regulated health establishments is monitored and inspected at least every 4 years and relevant action is taken 1.5 Health Establishments found to be compliant with prescribed norms and standards are certified. 1.6 Enforcement action is taken with respect to persistently non-compliance health establishments

40. Strategic objectives – Goal 2 • The public is protected through ensuring that poor care and situations of concern are heard, responded to and corrected. 2.1 An accessible mechanism by which complaints can be lodged with the OHSC is in place and widely disseminated 2.2 Complaints regarding non-compliance with norms and standards are effectively managed and disposed of 2.3 Findings and recommendations relating to complaints of non-compliance with prescribed norms and standards are issued within agreed time frames 2.4 Recommendations made by the Ombud are monitored and enforced 2.5 Indicators of risk are monitored and inspections and reporting carried out 2.6 Information relating to compliance with norms and standards is published

41. Strategic objectives – Goal 3 • Collaboration with other entities enhances quality and compliance. 3.1 Memoranda of Agreement to further the mandate and objectives of the OHSC are signed with relevant regulators or other organisations 3.2 A platform for information sharing and coordination with stakeholders is established 3.3 Coordinated activities and enforcement of norms and standards with other role players are implemented

42. Strategic objectives – Goal 4 • Efficient and effective high performing organization that is responsive and publicly accountable. 4.1 A fully functional Office is set-up and suitably staffed in accordance with the mandate and goals of the OHSC 4.2 Staff training and development is implemented including inspectors’ accreditation 4.3 Financial management and PFMA requirements are complied with 4.4 A customised IT system is implemented 4.5 Public and provider awareness on the roles and powers of OHSC is created

43. Part B: strategic objectives by programme

44. MTEF allocated budget 2014-2017

45. Budget programme 1: CEO’s office Purpose: Provide the leadership, communication and regulatory functions required to carry out the mandate and functions of the OHSC as per legislative requirements Objectives: 1.5 Certification of compliant HEs following inspection 1.6 Enforcement action taken for persistent non-compliance 4.5 Public and provider awareness on roles and powers of OHSC created 3.1 MOAs to further mandate and objectives of OHSC signed with relevant regulators or other organisations 3.2 Platform for Stakeholder information sharing and coordination established 3.3 Coordinated activities and enforcement of norms and standards with other role players formalised Budget

46. Budget programme 2: Corporate services • Purpose: To provide the financial, human resources, IT and administrative support necessary for the OHSC to deliver on its mandate and comply with all relevant legislative requirements. Objectives: 4.1 A fully functional Office is set-up and suitably staffed in accordance with the mandate and goals of the OHSC 4.2 Staff training and development is implemented including inspectors accreditation  4.3 Financial management and PFMA requirements are complied with 4.4 A customised IT system is implemented Budget

47. Budget programme 3: Compliance inspectorate Purpose: To inspect health establishment in order to monitor compliance with prescribed norms and standards Objectives: 1.4 Compliance with quality standards in regulated health establishments is monitored and inspected at least every 4 years and relevant action is taken 1.5 Health Establishments found to be compliant with prescribed norms and standards are certified 1.6 Enforcement action is taken with respect to persistently non-compliant health establishments 2.5 Inspections are conducted according to Indicators of serious risks 3.3 Coordinated activities and enforcement of norms and standards with other role players is formalised 4.2 Staff training and development is implemented including inspectors’ accreditation Budget

48. Budget programme 4: Complaints management (and Ombud) Purpose: To consider, investigate and dispose of complaints relating to non-compliance with prescribed norms and standards Objectives: 2.1 Establish an accessible mechanism by which Complaints can be lodged 2.2 Complaints are effectively managed and disposed of 2.3 Provide findings and recommendations relating to complaints 3.3 Coordinated investigations are carried out with other regulators Budget

49. Budget programme 5: Health Standards design, analysis & support Purpose: To provide support to the work of the Office in relation to the development and analysis of norms and standards and their dissemination Objectives: 1.1 Norms and standards for different types of HEs are developed and/ or revised 1.2 Regulated health establishments are registered annually 1.3 Guidance provided for regulated health establishments 1.5 Indicators of risk are monitored and inspections and reporting carried out Budget

50. Concluding remarks This is the first Strategic plan of a new public entity As such, the direction in which the Board intends to take the Office of Health Standards Compliance is undergoing constant refinement This Strategic plan will serve as a guide for the first steps of this long journey