The World Anti-Doping Agency (WADA) announces publication of the 2021 International Standard for Laboratories (ISL) (version 11.0), which was approved by WADA’s Executive Committee (ExCo) during its 14-15 September 2020 meeting and takes effect 1 January 2021. The French version will be made available in the coming weeks.
The main purpose of the ISL is to set out the requirements for anti-doping Laboratories 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 WADA accreditation process.
Similar to the 2021 World Anti-Doping Code (Code) and other International Standards that enter into force at the same time, the ISL underwent extensive stakeholder consultation. While the Code and the majority of the other Standards were approved by WADA’s Foundation Board and ExCo, respectively, during the Agency’s World Conference on Doping in Sport held in November 2019, the ISL followed a different path.
As communicated in November 2019, a revised version 10.0 of the ISL -- which was reviewed in order to reflect and incorporate relevant changes and update the document in line with new technical, scientific and regulatory developments -- was approved by WADA’s ExCo in May 2019 and became effective on 1 November 2019. Subsequently, a revised version 11.0 of the ISL was drafted to ensure consistency with the 2021 Code and the other Standards. The amended draft 11.0 was circulated for stakeholder consultation from 10 December 2019 to 4 March 2020 and, further to stakeholder feedback, was finalized by the ISL working group and approved by the ExCo. It reflects the aim of WADA and its stakeholders to further improve and harmonize Laboratory-related anti-doping rules and activities.
The modifications within version 11.0, as compared to the current 2019 ISL v. 10.0, include:
- Removal of footnotes and their incorporation into the main text as comments;
- Reorganization of some articles in order to make the reading easier to follow and in line with the new ISO/IEC 17025 standard structure and Laboratory sample flow (e.g. storage of samples at the end of the analytical testing process);
- Revision of the terms and definitions section to include new 2021 Code, new ISL and International Standard for Results Management (ISRM) definitions;
- Important modifications and updates to Section 4 (Laboratory Accreditation Requirements) in regards, for example to: candidate and probationary laboratories; flexible scope of accreditation; Laboratory independence; Laboratory disciplinary process and consequences of a Laboratory analytical testing restriction; suspension or revocation of the WADA accreditation; as well as, process for approval of a Laboratory by WADA for blood Athlete Biological Passport analysis.
- Updates to Section 5 (Analysis of Samples), including the translocation of some articles, which has been done in line with the new ISO/IEC 17025 structure and Laboratory sample flow. This section includes important changes and clarifications on requirements for Laboratory security, including control and security of electronic data and information; “A” and “B” sample confirmation procedures; additional analyses that Laboratories may perform on doping control samples in addition to routine anti-doping testing; long-term sample storage and further analysis; reporting of results and secondary use (research, quality assurance) and disposal of samples.
- Updates to Section 6 (External Quality Assessment Scheme Program) and Section 7 (Laboratory Performance Evaluation), regarding the source of double-blind EQAS samples, reporting of blind and double-blind samples in a timely manner and evaluation of Laboratories under suspension;
- Further clarifications in some provisions of Annex A: Code of Ethics; and
- A new Annex B: Accreditation for Major Events, whereas the former Annex B becomes Annex C: Procedural Rules.
WADA thanks all contributors for their valuable feedback regarding this new version of the ISL.