Briefing to the Select Committee on Social Services

On the National Health Amendment Bill

Tuesday, 04 September 2012

1

Outline

1. Policy framework and Legislative process2. National Health Amendment Bill3. Current NDOH functions related to future

OHSC

2

1. Policy framework and legislative process

3

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

4

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

5

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

6

Specific areas covered in “Benchmarking of Best Practice” (qv)

Regulation of compliance: independence, coordination, enforcement, prioritisation

Process of setting standards and normsAssessing 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 redressCommunication and reporting Stakeholder relations

7

Legislative process Draft Amendment Bill approved by Cabinet in November

2010Gazetted for public comment Jan – April 2011Comments analysed, incorporated, revised Bill approved

by Cabinet July, certified by State Law Advisors November 2011

1st reading of Bill to Portfolio Committee February 2012Public 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 2012NCOP 4th Sept., then provincial hearings

8

9

Summary of public inputs on Bill Need to strengthen independence and transparency:

•need for a Board •community input •Appointment and dismissal of CEO, Ombud•Reports, recommendations (incl. Ombud) must be public•Standards must be developed in transparent manner with expert input

Powers and consequences: •progressive sanctions with clear processes •accountability •Transitional arrangements

Definitions and clarity of scope: •Definition of an “establishment”•Scope of regulated standards (not NCS)

Alignment and overlap:•Other regulators esp. in field of health NB HPCSA; Environmental Health

Clarity needed on Licensing and Certificate of need

“B” Bill: Major changes from certified versionRelating 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

10

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 recommendationsOffices issues a “Compliance Certificate” (valid for up

to 4 years) Non-compliance leads to progressive response in

accordance with gravity of situation

11

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 bodiesHowever concerns felt to be already addressed

Different types of standards specified in principal ActMinister 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

12

2. Outline of National Health Amendment Bill

13

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”).

14

Clause 1: Amendment of section 1 of Act Clause 2: Amendment of section 21 of ActClause 3: Amendment of section 25 of ActClause 4: Amendment of section 47 of ActClause 4: Substitution of Chapter 10 of ActClause 5: Amendment of Sections 90 of Act Clause 6:Amendment of Arrangement of

sections of Act Clause 7: Amendment of lawsClause 8: Short title and commencement

 15

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

16

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).

17

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.

18

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.

19

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

20

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)

21

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—

a.Monitoring and enforcing compliance by health establishments with prescribed norms and standards

b.Ensuring consideration, investigation and disposal of complaints relating to breaches of norms and standards

22

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 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;

(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.

 

23

79. Functions of Office (cont)

(2) The Office may-a)issue guidelines on the implementation of norms and

standardsb)collect or request any information … from health

establishments and usersc) liaise with any other  regulatory authority on matters

of common interest and receive informationd)negotiate agreements with any regulatory authority

(3) The Minister may prescribe different norms and standards for different types of health establishments

24

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 BoardThe Board consists of no less than 7 and no more

than 12 members appointed by the Minister (see (a) to (f) )

25

(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 removal79 F – Meetings of the Board Rules, quorum, decisions, minutes 79 G – Committees of the Board Appointment of internal and external committees

26

(cont) 79 H – Appointment of CEOCEO appointed by Minister after consultation

with the Board for 5-year term, renewable once(all after consultation with the Board) - Subject

to a performance agreementGrounds for removal from office Arrangements for acting CEOPension and retirement benefits 79 I – Functions of CEOHead and accounting officer in terms of the

PFMAResponsibilities for staffing and managementContracting of expertise and capacity

27

(cont) 79 J - Delegation of powers &

assignment of duties by CEODelegation and assignment 79 K - Accountability of and reporting

by CEOAccounting and recordsAnnual report through Board, content,

tabling by Minister, access to public Ad hoc reports from Board or CEO to

Minister

28

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

29

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

30

81 A - Functions of OmbudFollowing 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 31

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

32

82. InspectionsHealth 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

33

82 A - Non-compliance with prescribed norms and standardsInspector 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

34

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

compliancerequire from establishment a written response re continued non-

compliancerecommend to the relevant authority any appropriate and

suitable action, including disciplinary proceedingsrecommend 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

35

83 - Environmental health investigations

Health officer obligation to investigate constitutional violations, pollution, nuisances

Determine responsibilityIssue compliance notice requiring

corrective action Person affected may appeal to

relevant executive authority36

84 - Entry and search of premises or health establishment with a warrant by health officer or inspectorPower 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

37

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

38

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

39

87. Disposal of items seized by health officer or inspector

May dispose of seized items in terms of the Criminal Procedure Act

40

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

41

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

42

89. Offences and penaltiesPerson 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

43

  Clause 5: Amendment of section 90 of the ActClause 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 prescribedFunctions of the Board and the OfficeEnvironmental health, including nuisances and

medical waste

44

Clause 6: Amendment of Arrangement of Sections of the ActClause 6 seeks to amend the arrangement

of sections to the Act consequent to the substitution of Chapter 10.

45

 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.

46

Clause 8: Short title and commencementClause 8 provides for the name or title of

the Bill and for the date on which the Bill will come into operation.

47

3. Current functions within NDOH

(preparatory work; for transfer)

48

Preparatory work: National Core Standards

Requirements for establishments (not clinical /professional)

Reflect current policies in different cross-cutting areasExtract of key aspects (as screening tool) Not prescribed (guideline, approved by National Heath Council)

Prioritises major concerns from patients / publicAttitudes, 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 sectorLink to management requirements, budgets, staff development

49

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 complianceCurrently 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 procedures50

Preparatory work: Monitoring and Early Warning System Quality measurement indicator list developed

using a number of collection methods:National Indicator Data Set (NIDS) (added to

routine reporting)“Quality risk profiles”

Existing or routine information will be used to indentify where there are problems in order to prioritise inspections

Surveillance system planned, in order to alert to serious breaches of standards in real time

Surveys 51

Preparatory work: Complaints investigation

System set up to review, refer, investigate complaints made to the Minister or Director General

Referred to appropriate body where needed (esp. province)

Initial staffing in place Identification of serious system failures / breaches

needing more detailed investigationIntended focus on

Improving the system as a whole, preventing recurrence and harm

Changing attitude to patient concerns and handling of complaints

Call centre to be set up 52