Progress Report on Quality

National Consultative Health Forum

28 March 2013

Outline

1. Policy and Legislative process 2. Outline of the Bill3. Preparatory work

• Inspections• Norms • Monitoring and Early Warning System• Complaints investigation• Information and Training• Business case development• Drafting of regulations and prescribed standards

POLICY AND LEGISLATIVE PROCESS

1

Key aspects of policy

• Decision taken in 2009 to establish an “independent quality management body”

• Quality of Care a component of (a) the 10-point plan, and (b) Negotiated Service Delivery Agreement (NSDA) – Output 4

• National Core Standards (NCS) approved by the National Health Council (NHC) in 2010

• NHC decisions re “Independent Office” were: – All health establishments (Public and Private, all levels of care) will

be monitored by the Office– 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/contracting to provide specified services by NHI fund

Legislative process • Draft Amendment Bill approved by Cabinet: 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• 1st reading of Bill to Portfolio Committee: February 2012• Public hearings (20+ organisations): March 2012; strong in-principle

support • In-committee review and approval: 18th June 2012 • “B” Bill approved by National Assembly on 14th August 2012• 2nd reading of Bill in NCOP August 2012; provincial hearings

September and October in all provinces with • “D” version of Bill approved by NCOP December 2012 • Awaiting final approval in National Assembly prior to promulgation

Summary of public inputs that strengthened the Bill

Need to strengthen independence and transparency: •need for a Board •community input •Appointment and dismissal of CEO and Ombud•Reports, recommendations (incl. Ombud) must be made 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 a “health establishment”• Scope of regulated standards (not NCS)

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

Clarity needed on Licensing and Certificate of Need

Public expression of urgent need to deal with their complaints and challenges in accessing quality care , explanation of what went wrong

NATIONAL HEALTH AMENDMENT BILL

2

Objects of the Office(Section 78 of Amendment Bill)

• The Office will be an independent public entity funded by Parliament

• 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

Functions of Office (Section 79 of Amendment Bill)

(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;

Functions of Office (cont)

(1) The Office must –(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.

Functions of Office (cont)

(2) The Office may-

(a) issue guidelines on the implementation of norms and standards

(b) collect or request any information relating to prescribed norms and standards from health establishments and users

(c) liaise with any other regulatory authority or request and receive from them information in respect of: (i) matters of common interest, or (ii) a specific complaint or investigation

(d) negotiate cooperative agreements with any regulatory authority

Functions of Ombud (Section 81A of Amendment Bill)

• The Ombud may, on receipt of a written or verbal complaint relating to norms and standards, or on the Ombud’s own initiative, consider and investigate the complaint 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

• When investigating a complaint, the Ombud may use staff (inspectors) of OHSC as well as his/her 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 in turn must take action through the appropriate authority

• On conclusion, the Ombud must inform the complainant or respondent, or both, of findings and recommendations

Non-compliance with prescribed norms and standards

(Section 82A of Amendment Bill)

• 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

(Section 82A of Amendment Bill - continue)

• If person in charge fails to comply with notice, OHSC 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 to be determined;  or

– Refer the matter to the National Prosecuting Authority for prosecution.

PREPARATORY WORK

Inspections and audit tool, complaints and training

Preparatory work:Audit tool and “mock” Inspections

• Audit tool for both hospitals and PHC complete– Access data base, comprising specified evidence of compliance in 526

risk-rated (q.v.) “measures” • Sub-set covers only those relevant to the 6 priorities• Uses multiple methodologies to collect evidence

– Data base included as module into DHIS – On-site feedback and reports

• Audit tool used for self-assessments and baseline audits; closing gaps a major focus of Health Facility Improvement Teams (HFIT)

• Inspection plans/ schedules linked to provincial training / guidance; based on (i) provincial request, (ii) HFIT or NHI districts, (iii) suspected risk (e.g. pattern of complaints)

• Testing various aspects of the procedures to be used to decide on certification

Preparatory work:“Mock” Inspections

• Inspection plans developed based on – Provincial request– Facility Improvement or NHI districts– Suspected risk (e.g. pattern of complaints)– Current Inspectorate capacity (being expanded)

• Facilities selected within a referral system in a district / sub-district

• Linked to provincial feedback and guidance• Testing and training on various aspects of the procedure

– Revised / improved tools and reports– Tasks and roles before, during and after inspections – Validation

Mock (training) audits to date

NHI PILOT DISTRICTS TO BE COVERED BY END MARCH 2013

Distict

Total Number

of Facilities

Total Covered

Percentage Covered to

date

To be covered by end March

2013Percentage by

end March 2013

Dr Kenneth Kaunda 48 5 10.41% 5 20.83%Gert Sibande 89 15 16.85% 11 29.21%Pixley Ka Seme 43 8 18.60% 4 27.91%Vhembe 129 10 7.75% 5 11.63%Umzinyathi 52 5 9.61% 5 19.23%Umgungundlovu 70 0 0% 12 17.14%Amajuba 27 0 0% 12 44.44%Tshwane 92 14 15.21% 6 21.74%OR Tambo 167 2 1.19% 25 16.17%Thabo Mofitsnyana 86 11 12.79% 5 18.60%

Preparatory work: Norms

• Level of supply for key inputs essential to ensure quality care or outputs achieved

• To be set based on national policy development, international best-practice and costing / affordability

• Initial work underway to monitor• Package of care delivered (per type of establishment) • Basic human resources related to workload • Critical infrastructure and equipment• Key outputs / outcomes

• To be collected / updated annually largely using existing information • To be verified on-site at the time of inspections as part of

determining compliance for purposes of certification • Areas of significant reported deviation from norms could form part

of early warning system (q.v.)

Preparatory work: Monitoring and Early Warning System

• Bill specifies certification valid for up to 4 years; however certain establishments may require more frequent or ad-hoc inspections and possible change to certification status

• Early warning system specified in Bill • Will monitor indicators for ongoing quality measurement (i.e. in

addition to on-site audit reports) to determine level of risk to quality

• To be used to identify where there are problems in order to alert for urgent action, prioritise inspections, review certification status

• Information to be obtained from – Routine reporting (but expanded to measure outcomes) – Surveillance system (to be developed) – will report on serious

breaches of norms and standards at time of occurrence – Community based monitoring – Complaints

Preparatory work: Complaints investigation

• System to review, refer, investigate complaints currently received by Minister, DG, NDOH being used to develop procedures for future Office and Ombud

• Referred to appropriate body where needed (esp. Provinces; professional bodies)

• Monthly customised reports produced, including for HODs• Identification of serious system failures / breaches:

– referred to inspection teams, panel of clinicians set up to assist • Intended focus on

– Responding to actual patient concerns and problems – Improving the complaints management system – Preventing recurrence and harm through identifying failures on

the system

ROAD SHOWS & TRAINING TO DATE

Preparatory Work: Business case development

• Business case required to list Office as public entity– Assistance being provided through Technical Assistance Unit

(TAU) of the Treasury – Extensive international benchmarking work done – Options paper produced October 2012 – Final Business case by end March 2013 to cover structure,

functions, budget and implementation plans – Stakeholders contacted to review / strengthen draft proposals

• Submission to be sent to the relevant Ministers for required approvals

Preparatory work:Drafting of regulations and prescribed

standards

• Process of drafting initiated, to cover

– Regulatory processes

– Schedules (e.g. Indicators / reporting)

– Standards and norms to be prescribed

• Will follow all consultation process and expert input required of any process of developing regulations

• To take account of coordination / agreements with other regulators

Thank youThank you

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