SANAS accreditation and DAFF approval for Laboratories performing

SANAS accreditation and DAFF approval for Laboratories performing tests for the diagnosis of controlled and notifiable diseases – what does that entail? DIRECTORATE – ANIMAL HEALTH SAVC INDABA: PHEASANT HILL GUEST HOUSE, PRETORIA 2018 07 03

History of the laboratory approval system • Concern about discrepancies in laboratory standards and the lack of adherence to an international standard was raised and actively discussed since 2003. • A task group (DAFF, para-statal, provincial, private and tertiary institution laboratories) investigated options. • The goal was to raise the standard of all the laboratories involved in diagnostics for controlled and notifiable diseases to an internationally accepted level. • Why is such an international laboratory standard important? o To have confidence in the results of tests in order to identify or exclude controlled and notifiable diseases o To be able to present these tests results on an international level to prove freedom of disease and support export of animals and animal products o To scientifically support decisions on disease control measures and the outcome of such measures (quarantine, culling, controlled slaughter, vaccination etc. ) 2

History of the laboratory approval system • The internationally recognised standard for competence of testing and calibration in laboratories is the ISO/IEC 17025: 2005 (amended in 2015). • An audit system has to be in place to ensure adherence to the standard and allow for accreditation • This function is performed by the South African National Accreditation System (SANAS). SANAS is recognised by the government as the sole accreditation body in South Africa. • In order to allow laboratories to improve their standards to the internationally accepted level, DAFF performed these audits free of charge from 2003 to 2014 • This interim DAFF approval programme was terminated at the end of 2014 as was agreed upon in 2003 3

Legal basis for SANAS accreditation and DAFF approval • SANAS (accreditation) o Is established in terms of Section 3(1) of the Accreditation for Conformity Assessment Calibration and good Laboratory Practice Act, 2006 (Act No. 19 of 2006) o It is directed and legally represented by a Board of Directors, whose members are appointed by the Minister of Trade and Industry • DAFF (approval) o Regulation 12 B was promulgated in 2009 in terms of the Animal Diseases Act, 1984 (Act No. 35 of 1984). o Regulation 12 B pertains to the ‘Registration for Diagnostic Testing for Controlled and Notifiable Animal Diseases’ » Registered with the Director (person or laboratory) » Register with the Director (Production and distribution of reagents) » Fulfil requirements set by the Director » Report diseases (controlled and notifiable) to the Director 4

Current approval system - SANAS • Audit of laboratories performing diagnostics for controlled and notifiable diseases has the following structure: o SANAS accreditation (required before DAFF approval) o DAFF approval • SANAS accreditation o ISO/IEC 17025: 2015 standard o The process include a document review (quality manuals with policies, procedures, specific methods, work instructions relevant to the standard) o If the documentation is in order, an audit will be performed at the facility (witnessing of all test methods and implementation of the quality management system as well as competency of the staff) o The unit cost for each phase of accreditation is reflected in the P 14 “SANAS fees” document available on the website (www. sanas. co. za) (document review, preassessment, Initial assessment, Approval of accreditation, Continued monitoring by re-assessments over a fixed accreditation cycle) 5

Current approval system - DAFF • DAFF approval o Bio-safety and bio-security status of the laboratory o Methods utilised for testing according to OIE recommendations and South African protocols o Reagents utilised (OIE and RSA) o Result reporting system 6

Current approval system - DAFF • A certificate of DAFF approval is issued to the laboratory if all requirements have been met. • A certificate is valid for two years with an expiry date indicated on the certificate. • Results for controlled and notifiable diseases from a laboratory without DAFF approval will not be accepted • If no approved laboratories are available in South Africa for a specific disease, an application may be made to the D: AH to obtain permission to perform tests for a controlled disease (Corridor disease as an example). 7

Approved laboratories • A list of approved laboratories is available on the DAFF website: http: //www. nda. agric. za/vetweb/epidemiology/Laboratories/Approved. Labs/Labs%20 audite d%202008%20 -%202016. pdf http: //www. daff. gov. za/daffweb 3/Branches/Agricultural-Production-Health-Food. Safety/Animal-Health/Epidemiology/Approved-Laboratories 8

Laboratories approved for Brucella testing per test (1) • MRT o Allerton o OVI bacteriology o Western Cape Provincial Laboratory o University of Pretoria milk lab o NW Provincial Laboratory, • RBT o o o • df Allerton, Idexx Laboratories (Woodmead) NCP Provincial Laboratory OVI bacteriology NW Provincial Laboratory, Western Cape Provincial Laboratory 9

Laboratories approved for Brucella testing per test (2) • CFT o o OVI bacteriology NW Provincial Laboratory Western Cape Provincial Laboratory NCP Provincial Laboratory • Isolation and identification o OVR bacteriology – also do typing o NW Provincial Laboratory o Western Cape Provincial Laboratory o Allerton – culture up to species level 10

Laboratories approved for Brucella testing • Allerton Provincial Laboratory – MRT, RBT, CFT and culture up to species level • Idexx Laboratories(Pty)Ltd – RBT • Northern Cape Provincial Laboratory - RBT and CFT • OVR – bacteriology –, MRT, RBT, CFT and solation, identification and typing of Brucella species • North West provincial Veterinary Laboratory – MRT, RBT, CFT and isolation and identification of Brucella. • Stellenbosch Veterinary Laboratory - Brucella species isolation and identification, MRT, RBT, CFT • University of Pretoria (Milk Laboratory ) - MRT 11

Questions? 12