oral presentation to portfolio committee on health on the office...
TRANSCRIPT
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: [email protected]
cell: +27 (82) 8073351
Dr Kerrin Begg
Health Policy Workgroup
email: [email protected]
cell: +27 (82) 7719172