The World Anti-Doping Agency (WADA) announced publication of the revised International Standard for Laboratories (ISL), which was approved by WADA’s Executive Committee (ExCo) on 15 May 2019 and will enter into force on 1 November 2019. The ISL is one of six International Standards that works in conjunction with the World Anti-Doping Code (Code) to bring harmonization among Anti-Doping Organizations across various technical areas.
The main purpose of the ISL is to set out the requirements for laboratories that wish to demonstrate that they are technically competent, operate within an effective Quality Management System and are able to produce forensically valid results. The ISL includes, inter alia, requirements for obtaining and maintaining WADA laboratory accreditation, operating standards for laboratory performance and a description of the laboratory accreditation process.
The modifications in this new version of the ISL are substantial and include:
- Important modifications and updates to Section 1 (Introduction) regarding the description of the different WADA laboratory standards;
- Revisions to the section of ISL definitions to include new metrological and method validation terms;
- Important modifications and updates to Section 4 (Process and Requirements for WADA laboratory accreditation) in regard to, for example, the different stages of the accreditation process, laboratory independence, laboratory disciplinary processes and the consequences of a laboratory suspension or revocation; as well as, the criteria for approval of a laboratory for Athlete Biological Passport (ABP) blood testing;
- A new Section 5 (Analysis of Samples), in which the previous Sections 5 (Analysis in Urine) and 6 (Analysis in Blood) have been merged. The updated structure of Section 5 follows the newly approved ISO/IEC 17025:2017 standard, and includes important updates on sample storage and further analysis, method validation requirements, etc.;
- Updates to Annex A – in which the External Quality Assessment Scheme (EQAS) has been split into two new Sections: Section 6 (EQAS Program) and Section 7 (Laboratory Performance Evaluation), and requirements have been thoroughly revised; and
- The addition of a new Annex B: Procedural Rules for the Disciplinary Committee of the ISL, whereas the revised ISL Code of Ethics remains as Annex A.
A first revised version of the ISL was circulated to WADA-accredited laboratories from 2 March to 30 April 2018. A second round of consultation with all WADA stakeholders was conducted from 14 July to 14 September 2018 and, following a request from the WADA ExCo at its November 2018 meeting in Baku, Azerbaijan, a further consultation phase was carried out with all WADA stakeholders from 10 December 2018 to 4 March 2019. The comments received during these consultations were carefully reviewed, and the relevant modifications were incorporated into the 2019 ISL version 10.0 for presentation and approval by the WADA ExCo on 15 May 2019.
The 2019 ISL version 10.0 reflects WADA’s constant efforts to further improving and harmonizing laboratory-related anti-doping rules and activities worldwide. The ISL may undergo further revision in 2020 to bring it in line with the 2021 Code. The Code and other International Standards are currently subject to a review process that will culminate with approval at WADA’s next World Conference on Doping in Sport, in November 2019, in Katowice, Poland; after which, the revised 2021 Code and Standards will take effect on 1 January 2021.