Presentation to Parliamentary Portfolio Committee on Health OHSC

1. Presentation to Parliamentary Portfolio Committee on HealthOHSC Tuesday, 13 March 2012 Tjaart Erasmus

2. 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

4. 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

5. Comments on Office of Health Standards Committee Independence Certification (Accreditation) Core Standards Issuing of Standards Conclusion

6. 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

7. 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

8. 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: -

9. - 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

10. 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

13. 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.

14. 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

15. 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.

16. 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.

17. Issuing of Standards 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. 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

18. 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

19. . 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 2012 npg@mweb.co.za 011 472 0628