Oral Presentation to

Portfolio Committee on Health

on the Office of Health Standards Compliance

as proposed under the National Health Act (Chapter 10)

16th March 2012

Dr Bruce Dietrich (Chairperson)

Dr Kerrin Begg (Health Policy Working Group)

Voluntary Association

Represents all spheres of laboratory medicine

Lab Groups

• NPG

• NHLS

Blood Transfusion

• SANBS

• WPBTS

Diagnostics

• SALDA

Professional Associations

• CMSA (Path)

• FSASP

• SMLTSA

• SASCC

• Biomedical Scientists

Who is LMG?

Who is LMG?Laboratory Medicine

SummaryPublic Labs Private Labs

Transfusion

LabsCombined

Tests done / annum 41,000,000 73,000,000 39,000,000 153,000,000

No. patients / annum 30,000,000

Laboratory Sites 250 225 89 564

Employees 6,000 11,000 2,200 >19,000

Costs as % healthcare

expenditure2.75% 2.55% -

Laboratory Medicine in the Clinical Value Chain

Sick Patient Clinician Lab Test Diagnosis Treatment

Monitor withLab Test

Modify Treatment

Well Patient

Laboratory Medicine in the Clinical Value Chain

Sick Patient Clinician Lab Test Diagnosis Treatment

Monitor withLab Test

Modify Treatment

Well Patient

“70% of clinical decisions are

informed by laboratory medicine”

Laboratory Medicine in the Clinical Value Chain

Sick Patient Clinician Lab Test Diagnosis Treatment

Monitor withLab Test

Modify Treatment

Well Patient

“70% of clinical decisions are

informed by laboratory medicine” For only 2.5%

of total healthcare

expenditure

Importance of Quality in Laboratory Medicine

Integrated Quality Management Systems are essential and fundamental in Laboratory services –to ensure :

Test Result is correct and reliable

Correct diagnosis

Correct treatment

Patient recovers / optimal quality of life

Cost-Effective Care

OHSC ApplicabilityNHA, No 61 of 2003:

“health establishment” means the whole or part of a public or private institution, facility, building or place, whether for profit or not, that is operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services;”

But the intent and design of OHSC + Core standards Framework appears to be focused on clinical service provision facilities such clinics and hospitals, and not necessarily Laboratories …. Not “Fit for Purpose”, BUT…

Laboratories already lead in Voluntary Accreditation

Accreditation involves assessing the implementation of internationally comparable quality standards as well as the competence of a laboratory to perform designated tests through independent authoritative audit and recognition

ISO 15189 : 2007= rigorous international Benchmark standard

Over past 10 years: 90% private labs already accredited 60% NHLS academic labs accredited; 21% Regional labs accredited

Thus: any test result performed in these laboratories is comparable to the same test performed anywhere else in the world using the same methodology

Laboratories already lead in Voluntary Accreditation

Accreditation involves assessing the implementation of internationally comparable quality standards as well as the competence of a laboratory to perform designated tests through independent authoritative audit and recognition

ISO 15189 : 2007= rigorous international Benchmark standard

Over past 10 years: 90% private labs already accredited 60% NHLS academic labs accredited; 21% Regional labs accredited

Thus: any test result performed in these laboratories is comparable to the same test performed anywhere else in the world using the same methodology

This protects Patient Safety

and ensures quality

Duplication and Conflict?Multiple regulatory bodies already engaged in Quality Standards Assessments:

• Health Professions Act & HPCSA

• Nursing Act & SANC

• Social Work Act

• Pharmacy Act

Standards governing HealthCare Professional

Conduct + Scope

• South African Health Products Regulatory Authority (in terms of Amendment to Medicines Act)

Standards governing medical devices and

IVD’s

• SA Bureau of Standards (SABS)

• National Regulator for Compulsory Specifications (NRCS)

Standards governing Equipment

OHSC Object & Function

Objectives of the OHSC [clause 78] only includes “monitoring” but …

Functions of OHSC [Clause 79(1)] include certification, complaints and enforcement

“Quality Assurance” and “Quality Management Systems” [Clause 79(1)(f)] need to be defined

OHSC established as juristic person [Clause 77], but must be a Schedule 3 PFMA entity (e.g. CMS, SETA’s) to guarantee independence and fee retention (so as to be appropriately resourced)

Definitions TQM includes all the

activities that organisations use to direct, control and coordinate quality, which include: formulating a quality policy, setting quality objectives, quality planning, quality control, quality assurance and quality improvement

QA is a set of activities intended to establish confidence that quality requirements will be met

Recommendations Avoid Duplication, esp. with limited resources

Allow exemption where “Health Establishments” can demonstrate accreditation with recognised legislated institution such as SANAS

Eliminate conflict with other legislation governing standards Clarify Clause 79(2)(e)

Clearly define the objectives and Functions of the OHSC Clauses 78 & 79

Define terms QMS and QA Clause 79 (1)(f)

Ensure independence + guarantee revenue retention Establish OHSC as Schedule 3 PFMA entity in Clause 77

Dr Bruce Dietrich

Chairman

email: bdiet@iafrica.com

cell: +27 (82) 8073351

Dr Kerrin Begg

Health Policy Workgroup

email: kerrin@begg.co.za

cell: +27 (82) 7719172