The importance for the world anti-doping system of having access to a network of high-quality laboratories cannot be overestimated. In order for athletes and the general public to continue to have confidence in this system, samples taken in and out of competition, and then sent to anti-doping laboratories, must be processed following rigorous protocols. A laboratory that wishes to perform this kind of work must obtain and maintain - which is no small task - one of the following certifications:
- WADA accreditation to perform doping control sample analysis; Where
- WADA's approval to perform blood tests as part of the hematology module of the Athlete's biological passport.
ACCREDITED AND APPROVED LABORATORIES
A laboratory that wishes to perform analyzes of doping control samples under the World Anti-Doping Code (the Code) is subject to a dual accreditation system.
First, the laboratory must obtain and maintain accreditation according to the 17025 standard of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), which relates to analytical laboratories. This accreditation is granted by a competent and independent national body which is a full member of the International Cooperation for Laboratory Accreditation (ILAC) and a signatory of the ILAC Mutual Recognition Agreement. In the case of laboratories approved for the Athlete Biological Passport, certification according to ISO 15189 is also accepted.
Second, the laboratory must obtain and maintain WADA accreditation (or WADA approval for the Athlete Biological Passport). the International Standard for Laboratories (SIL) of the AMA establishes the criteria to be fulfilled for both, as well as the other requirements of the Agency (technical documents et technical letters) that laboratories must follow to produce valid analytical results and data.
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"Monitoring the ability of laboratories to meet the most stringent performance criteria at all times is essential for the entire anti-doping system," explains Thierry Boghosian, senior laboratory accreditation officer at WADA. The accreditation and approval of anti-doping laboratories is the responsibility of WADA. We must therefore ensure that these meet the highest quality standards. We carry out this oversight role in conjunction with ISO / IEC 17025 assessments conducted by independent national accreditation bodies. "
“WADA's dual accreditation process aims to ensure that the global network of approximately 30 Athlete Biological Passport accredited or approved laboratories are working to the highest standards, allowing us to quickly identify everything. potential problem and to solve it effectively. "
The International Standard for Laboratories stipulates the requirements that must be met by accredited laboratories and WADA approved laboratories for the Athlete's biological passport. These include technical skills, but also an effective management system and the assurance of delivering valid forensic results. The International Standard for Laboratories also details the modalities for monitoring performance through WADA's External Quality Assessment System (EQAS), as well as the Code of Ethics to be followed by laboratories.
QUALITY ASSESSMENT PROGRAM
“The effectiveness of the anti-doping system depends on the capacity of laboratories to detect and sometimes to quantify, in a reliable manner, the substances in the List of prohibitions and their metabolites or markers, observes Dr Oquel Barroso, Senior Associate Director, Laboratories and Head of the WADA Laboratories team. This is why WADA continuously monitors the performance of the anti-doping laboratory network through its external quality assessment program, which must be followed by all accredited and approved laboratories, as well as laboratories in the probationary phase of accreditation by WADA. "
This program is used to assess, by means of samples, the routine analytical capacity and performance of laboratories, as well as delivery times, overall compliance with WADA requirements (International Standard for Laboratories, technical documents, letters techniques and guidelines for laboratories), and performance criteria other than analytical.
The external quality assessment program provides for the regular distribution of urine or blood samples prepared by WADA, the content of which is only known to WADA, to accredited laboratories and in the probationary phase, which must analyze them to establish the presence or absence of prohibited substances or methods. Blood samples are also sent to approved Athlete Biological Passport laboratories for analysis of Passport blood markers.
In addition to these measurements, the external quality assessment program offers anti-doping laboratories the opportunity to compare their test results in order to promote harmonization. WADA's laboratories and those in the probationary phase also have access to continuous training, which serves, among other things, to ensure a constant improvement in the efficiency of doping analysis procedures.
The external quality assessment program uses three types of reviews:
1. Single blind samples: The laboratory knows that this is a sample of the external quality assessment program since it is delivered by the AMA supplier as part of the program, but does not know its content. .
2. Double blind samples: The laboratory does not know that this is an external quality assessment program sample since it is delivered by a doping control authority (anti-doping organization) and cannot be distinguished from a normal sample .
3. Educational modules: It can be a sample of known content or a single or double blind sample. This approach is used for training purposes or to collect data.
In addition, WADA may occasionally provide targeted laboratories during educational evaluations with new reference materials, reference collections or quality control samples to enable rapid implementation of testing procedures. analysis, whether new or existing.
The number and composition of External Quality Assessment Program samples sent to WADA accredited laboratories vary. However, all laboratories participating in the program must analyze a minimum of twenty samples from this program in a calendar year.
For the Dr Anne Danion, Head of Laboratories at WADA, “WADA's double-blind external quality assessment program, which has been in operation for over ten years, is a proven and reliable means of evaluating laboratory practices. accredited and approved and those who are in the probationary phase. "
“As part of this program, laboratories analyze samples that they cannot distinguish from normal anti-doping samples. It is a complex program based on building a reliable group of anti-doping organizations that integrate these samples into their testing program and subject each laboratory to double-blind testing, while meeting rigorous standards. chain of custody of samples and deadlines. "
“This cutting-edge program is considered a benchmark, which provides a portrait of the quality, competence and compliance of laboratories with the International Standard that concerns them. "
LABORATORY EXPERT ADVISORY GROUP
The overall management of the accreditation and approval of anti-doping laboratories around the world is ensured by the WADA Laboratory Expert Advisory Group. It is also responsible for keeping the International Standard for laboratories and the elements that come under it up to date (technical documents, technical letters and guidelines for laboratories).
This group is made up of specialists with expertise in laboratories, analytical and research methods, as well as laboratory accreditation and auditing. It includes representatives from accredited laboratories, ISO accreditation organizations, national anti-doping organizations and horse doping control laboratories, forensic laboratories and clinical laboratories.
LABORATORY AUDITORS
The collaboration between WADA and International Cooperation for Laboratory Accreditation (ILAC) enables joint assessments of compliance with the International Standard for Laboratories and ISO / IEC 17025. Working together, WADA and the ILAC can harmonize the laboratory quality control process to ensure that rigorous standards are maintained. To facilitate this process, a joint working group meets at least once a year to ensure the coordination and harmonization of tasks related to the accreditation of anti-doping laboratories.
In addition, the Agency regularly organizes, for the benefit of auditors, training on the International Standard for Laboratories and other WADA regulatory requirements and documents for laboratories.
For more information on anti-doping laboratories and WADA's external quality assessment program, please visit agency website.
