Presentation to Parliamentary Portfolio Committee on Health

OHSC

Tuesday, 13 March 2012Tjaart Erasmus

The National Pathology Group (NPG) is the official subgroup for pathology of the South African Medical Association

Diagnostic pathologists from all disciplines are members

Virtually all privately practicing pathologists are members

The NPG fully supports the establishment of an Office of Health Standards

Pathology is the cornerstone of appropriate medical diagnosis and care.

Up to 70% of medical care is based on correct and appropriate pathology testing

It is the hidden science that saves lives

Comments on Office of Health Standards Committee

Independence

Certification (Accreditation)

Core Standards

Issuing of Standards

Conclusion

Independence

Must be explicitly guaranteed and not only be an advisory body to Minister

Must be accountable to parliament to prevent potential erosion of independence and potential risks of lack of clarity of objectives in the future

Certification (we prefer the term accreditation)

Pathology has an existing and long standing fully functional system of accreditation by SANAS (South African Accreditation System)

More than 90% of facilities of NPG members are accredited

Many of the NHLS (National Health Laboratory Services) are also accredited.

SANAS accreditation is accepted as the de facto standard and objective to achieve in pathology

South African National Accreditation System

SANAS was established in terms of Section 21 of the Companies Act, 61 of 1973, registration number 1996/00354/08. On 1 May 2007 it became a public entity with the promulgation of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act (Act 19 of 2006).

SANAS has its office on the The DTI Campus, Sunnyside, Pretoria, South Africa. It is directed and legally represented by a Board of Directors whose members are appointed by the Minister of Trade and Industry.

SANAS operates in accordance with the requirements, criteria, rules and regulations laid down in the following documents:

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- The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006)-The requirements of the international standard ISO/IEC 17011:2004, General requirements for bodies providing assessments and accreditation of conformity assessment bodies.Approval Committees make decisions concerning the granting and continuation of accreditation and GLP compliance.

www.sanas.co.za

History of the South African National Accreditation System

Accreditation in South Africa dates back to 1980 with the formation of the National Calibration Service (NCS), later the National Laboratory Accreditation Service (NLA).

The government through the Department of Trade and Industry (DTI) had recognised the need to create a single national accreditation system as long ago as 1993, and the establishment of such a system was approved by Cabinet in late 1994.

The new accreditation body was officially launched in August 1996. A Memorandum of Agreement was signed with the DTI in December 1997, through which SANAS is now recognised as the single national authority for the accreditation of test and calibration laboratories

South African Pathology laboratories started implementing SANAS accreditation from the mid 1990’s

SANAS accreditation is also the acknowledged standard in Southern Africa and elsewhere on the African Continent.

BENEFITS OF BECOMING ACCREDITED

Impartial feedback from independent examinations by experts against a defined scope of activity

Comparisons of technical ability against similar facilities

Customer has access to independent complaint mechanism

National and International recognition of competence

International benchmarking

In essence:

Use SANAS accreditation as the method of ‘certification’ for pathology

Avoid equating the CON (certificate of need) with certification / accreditation.

Very contentious in the medical fraternity.Requires much more public debate and wider consultation.

Core Standards

Do not use (or enforce) standards which could potentially conflict with those set elsewhere on clinical governance or equipment

Clinical governance refers to compliance with norms and treatment guidelines or protocols

These should be set by professionals working in the specific fields using the best scientific evidence

Clinical guidelines should be authorised under Health Professions Act to diagnose and treat specific conditions

The result will be quality care.

Amendment Bill does not provide for process in terms of which standards will be issued. To be prescribed by minister on advice of OHSC.No effective way for publication of standards.Delays due to Government Gazette constraints.

Issuing of Standards

The amendment bill should allow the OHSC to issue standards as notices(similar to HPCSA or CMS)

Must oblige the OHSC to publish all standards for public comment

.

Conclusion

Use existing accreditation structures in pathology: SANAS

Use broad professional expertise and consensus to ensure good clinical governance in line with Health Professions Act

Secure independence of the OHSC by explicit wording in bill

Make certain discretionary powers mandatory (publish draft standards)

Create certainty about relationship between the OHSC and the CON as matter of urgency

.The National Pathology Group is a well organised and representative professional organisation.

We are committed through our members to continue playing a vital quality role in patient diagnosis and care and contribute constructively to the health sector in Southern Africa.

Our members are a significant employer group and contribute extensively to training in the laboratory environment and broader medical fraternity

We are available to contribute to the further exploration of the issues outlined in our presentation

Thank you!Tjaart Erasmus 13 March

2012npg@mweb.co.za011 472 0628