1. Presentation to the Health Portfolio Committee 20th August 2014
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
Mandate, Vision, Mission, Values
Legislative mandate
Policy mandate
Situational analysis
Performance
Organisational
Partnerships
Process
Strategic Outcome Oriented Goals
Objectives
Programme estimates
Programme outlines
CEO
Corporate services
Office Ombud
Complaints management
Compliance inspection
Health standard design, analysis and support

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. Safe and Quality Healthcare for all South Africans
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
“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
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”

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 Through
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 … Year Standards and Audit tools
Legislation and regulation
2008
First draft of national standards and very rough measurement tool; piloted in 27 facilities
National Health Act (2003) outlines “Office of Standards Compliance” within National DOH
2009
Refinement through a working group of stakeholders
Identification of “6 priorities” as sub-set
Initial quality improvement projects and workshops
Policy decision to establish independent “quality management and accreditation body”.
2010
2nd national pilot of revised tool and further refinement and use
Finalisation of “National Core Standards for Health Establishments in South Africa”
Bill outline approved by National Health Council: mandatory standards and norms, external certification, Ombud function
2011
Publication of NCS
Baseline audit of all facilities using sub-set of tools
Self-assessments used as basis of QI
Bill gazetted for public comment; approved by Cabinet, certified by law advisors
Inspectors appointed
2012
Baseline assessments used by national “Facility improvement teams”
3rd revision of audit tools
National inspections by OSC
Bill to National Assembly, National Council of Provinces
Inspector training
Preparation for Office
2013
Ongoing mock inspections and reporting
Multiple awareness / guidance / training activities / materials
“Non-negotiables”, performance agreements
Bill debated, approved by Portfolio Committee
Bill taken to public hearings in all provinces; approved by NCOP and the Parliament
Promulgated

27. Organisational environment
Situational analysis

28. SWOT analysis (from Business case 2013)
Strengths
Legislative authority: New health sector public entity to regulate health standards and compliance
Independent Board and Ombud reporting directly to the Minister of Health
Significant period of development of tools and procedures
Weaknesses
Limited powers to enforce compliance
Limited ability to correctly predict problems and to intervene through early warning system or enforcement
Perceived lack of independence resulting from historical link with the National Department of Health
Opportunities
Strong political support
Public expectations on quality
Favourable context and clear expectation of role within NDP
Threats
Real or perceived interference in selection of facilities or complaints, reporting of findings or certification
Resistance from establishments or authorities not willing to comply
Concurrent powers and disagreements with other regulators

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
Minister
Board
Audit, Risk and Finance Committee
Human Resources and Remuneration Committee
Certification and Enforcement Committee
ExCo
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
Minister
OHSC Board
CEO
Corporate Services
Finance and Supply Chain Management
Human Resources and Administration
Information Technology & Document Management
Health Standards Design, Analysis and Support
Health Standards Design
Systems and Data Analysis
Guidance and Support
Expert Panel
Compliance Inspectorate
Compliance Inspection - Routine
Compliance Inspection - Specialised
Complaints Management
Complaints Centre & Assessment
Complaints Investigation
Office of the CEO
Governance and Strategy
Stakeholder Relations and Communications
Certification and Enforcement
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
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.
Mass media

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
Indicators
1. Public Health establishments comply with norms and standards for health and safety of users and provision of quality, compassionate and responsive care.
% HEs complying with quality standards
2. The public is protected through ensuring that poor care and situations of concern are heard, responded to and corrected
% submission rate for monitoring indicators
% response rate; within specified time frames
3. Written agreements exist for collaboration and information sharing relating to implementation of the mandate of the OHSC
% signed agreements
4. An efficient and effective high performing organization that is responsive and publicly accountable
Functional office, staffing and systems
Public awareness initiatives

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
Programme Estimates
2014/15
2015/16
2016/17
Budget programme / business unit
1. Office of the CEO
7,201,633
11,467,031
12,287,933
2. Corporate Services
29,825,558
27,198,686
30,049,071
3. Compliance Inspection
28,785,656
34,508,795
36,367,283
4. Complaints Management
3,888,450
6,405,006
6,704,841
4a. Office of the Ombud
991,043
3,022,390
3,187,653
5. Health Standards Design, Analysis & Support
6,260,660
7,933,092
8,093,219
Total
76,953,000
90,535,000
96,690,000
Economic classification
Compensation of employees
31,174,291
53,427,462
56,365,972
Goods and services
36,572,376
34,087,414
37,151,510
Payments for capital assets
9,206,333
3,020,123
3,172,519
Total and MTEF allocation

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
Classification
Amount
2014/15
2015/16
2016/17
COE
2,596,679
6,574,795
6,936,408
G&S
4,604,954
4,892,236
5,351,525
Capital -
Total
7,201,633
11,467,031
12,287,933

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.
Budget
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
Classification
Amount
2014/15
2015/16
2016/17
COE
3,612,759
9,147,686
9,650,808
G&S
17,006,466
15,030,876
17,225,754
Capital
9,206,333
3,020,123
3,172,519
Total
29,825,558
27,198,686
30,049,071

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
Classi-fication
Amount 2014/14
2015/16
2016/17
COE
18,916,906
24,435,071
25,779,001
G&S
9,868,750
10,073,724
10,588,282
Capital -
Total
28,785,656
34,505,795
36,367,283

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
Classification
Amount
2014/15
2015/16
2016/17
COE
3, 852,006
8,320,069
8,77,672
G&S
1,027,486
1,175,485
1,114,822
Capital -
Total
4,879,492
9,495,554
9,892,494

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
Classification
Amount
2014/15
2015/16
2016/17
COE
2,195,940
4,949,842
5,222,082
G&S
4,064,720
2,983,250
2,871,136
Capital -
Total
6,260,660
7, 933,092
8 093,219
Classification
Amount
COE xx
G&S
Capital
Total

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