An overview of how WADA labs receive accreditationRupert Beloff
In the ongoing struggle against doping in sport, the World Anti-Doping Agency (WADA) has taken an increasingly important role since its establishment in 1999. Its World Anti-Doping Code1 has been adopted by over six hundred sports organisations worldwide and provides international harmonisation in anti-doping rules, procedures and practice. Its annual Prohibited List2 of substances and methods provides an up to date catalogue of banned drugs.
Determining what substances should be banned and setting standards for anti-doping practice is undoubtedly of paramount importance in the battle for clean sports. What is of no less importance is ensuring that the laboratories that test samples collected by doping control officers adhere to recognised practices and standards.
To achieve this aim WADA:
- provides an accreditation process,
- requires laboratories that comply with its International Standards For Laboratories,3
- monitors their performance through a mandatory External Quality Assessment Scheme (EQAS).
This article aims to provide an overview of the process by which laboratories receive accreditation and maintain it.
The Accreditation Process
The accreditation process is a lengthy one. First a laboratory must apply for accreditation, and then prepare fully for accreditation before receiving it. Once accreditation has been obtained steps must be taken to maintain it. The procedure for each of these steps is set out in the ISL. References in the following paragraphs are to specific paragraphs of the ISL.
Applying for WADA Accreditation
The candidate laboratory must start the process by contacting WADA and expressing interest in receiving accreditation (4.1.1).
WADA will then provide the laboratory with an application form to complete and will also verify that there is a National Anti-Doping program that is compliant with both the WADA Code and ISL in the country where the laboratory is based; that the country has ratified the UNESCO Convention against Doping in Sport and that the country has paid its contributions to WADA (4.1.2).
Once the application form has been completed and WADA has made its initial checks a candidate laboratory is required to provide a letter of support from an Anti-Doping Organisation that is a signatory to the WADA code (4.1.3). This letter will guarantee that a minimum of three thousand samples will be provided to the laboratory for testing for a three-year period within two years of accreditation being granted. The candidate laboratory is also required to submit a business plan accompanied by further letters of support that guarantee:
- sufficient financial support for at least three years;
- that the necessary analytical facilities and instrumentation will be available; and
- that there is sufficient support for research and development activities.
Following the receipt of the letters of support and business plan WADA then provides the candidate laboratory with a further detailed questionnaire. This must be completed within eight weeks and, as a minimum requirement, contains details of staff and their qualifications, a description of physical facilities, actual and proposed instruments and equipment, a list of available reference materials, a business plan showing a commitment to analyse three thousand samples annually and a list of sponsors (4.1.4).
Once all of the required documentation has been received WADA will usually conduct an initial visit to the laboratory. This will last two or three days and is funded by the candidate laboratory. Its purpose is to clarify any issues that may have arisen with the accreditation process (4.1.5).
Within twelve weeks of receipt of the questionnaire or initial visit WADA will issue a report on the candidate laboratory either recommending the candidate laboratory for probationary accreditation or identifying any improvements that are needed to be considered a WADA probationary laboratory (4.1.6).
Prior to entering the probationary period the candidate laboratory has to pay a one off initial accreditation fee before receiving probationary accreditation (4.1.7).
The laboratory is also required to be operationally independent from any Anti-Doping Organisation, which will usually require a separate budget (4.1.8) and must implement the Code of Ethics (Annex B of ISL) relevant to a laboratory in the probationary period (4.1.9).
Preparing for WADA Accreditation
Prior to entering any probationary period the candidate laboratory may be required to participate in a pre-probationary test. This will require the testing of at least ten EQAS samples (4.2).
During the probationary period itself the laboratory must be accredited by a relevant body to ISO/IEC 17025, the main ISO standard used by testing and calibration laboratories, (4.2.1) and must also participate in the EQAS analysing at least eighteen samples during the period and a further twenty samples as a final proficiency test (4.2.2).
It must also develop a research and development plan for Doping Control activities including a budget. The plan must implement at least two research and development activities with a minimum budget of seven per cent of the laboratory’s total budget for a three year period. These activities can either be undertaken alone or in conjunction with other WADA accredited laboratories (4.2.3).
The candidate laboratory must also show its willingness and ability to share knowledge on at least two specific issues with other WADA accredited laboratories (4.2.4).
Finally the candidate laboratory must provide evidence to WADA that it has professional indemnity insurance of at least two million USD annually (4.2.5).
Obtaining WADA Accreditation
Towards the end of the probationary period WADA will prepare a final accreditation assessment in cooperation with the laboratory. Compliance with the defined requirements in the application of ISO/IEC 17025 to the Analysis of Urine Doping Control Samples and (only if necessary) Blood Doping Control Samples will be checked and if necessary an on-site audit will be undertaken by WADA. Any non-compliant aspects that are identified must be corrected (4.3.1).
WADA will then make a final report based upon relevant documentation and the audit reports. If the recommendation is that the laboratory should not be accredited then it will have a maximum period of six months to make the necessary improvements (4.3.2). If on the other hand the recommendation is for accreditation than a certificate will be issued for a specific period (4.3.3).
Maintaining WADA Accreditation
Once a laboratory has received accreditation it must maintain those requirements it had to fulfil for accreditation in the first place (4.4) namely:
- ISO/IEC 17025 Accreditation (4.4.1)
- Participation in the WADA External Quality Assessment Scheme (4.4.2)
- Laboratory Independence (4.4.3)
- Plan for research and development activities (4.4.5)
- Willingness and ability to share knowledge (4.4.6)
- Professional indemnity insurance (4.4.7)
- Periodic renewed letters of support (4.4.8)
- Minimum number of samples analysed (4.4.9)
In addition it must publish a price list for each type of analytical method or service that it provides (4.4.10).
In order to ensure that laboratories continue to adhere to the standards set out in the ISL, WADA has the right to inspect and reassess an accredited laboratory at any time. Usually notice is given in writing, but exceptionally the inspection may be unannounced (4.4.11). As part of this assessment WADA can request documentation held by the laboratory or re-analysis of various samples and can also request re-assessment related to ISO accreditation (4.4.11).
Suspension and Revocation of Accreditation
Accreditation may be suspended or revoked if WADA has justified reason to believe that such action is required to protect the interests of the Anti-Doping Community (188.8.131.52). This is assessed on a case-by-case basis taking into account of matters, including but not limited to, evidence of non-compliance with the requirements of the ISL, loss of ISO/IEC 17025 accreditation and failure to take appropriate corrective action following unsatisfactory EQAS performance. Any suspension will be proportionate to seriousness of that non-compliance and the need to ensure accurate and reliable drug testing of athletes. The period of suspension may up to a maximum of six months initially with the option to extend the suspension for a further six months if matters have not been remedied (184.108.40.206.1).
Revocation of accreditation is reserved for more serious instances of non-compliance for example reporting of false analytical samples, systemic failure to comply with the ISL or the conviction of key personnel for criminal offences relating to the operation of the laboratory (220.127.116.11.2).
WADA will gather together all documentation required to investigate issues that might give rise to suspension or revocation of accreditation, review it and produce a written report. The report will then be presented to the Disciplinary Committee who will in turn recommend suspension or revocation to the Chair of the WADA Executive Committee (18.104.22.168).
If a laboratory has is accreditation revoked then it has to start the whole process of obtaining accreditation from scratch unless it can provide evidence of exceptional circumstances that might justify a modification of the usual procedures for applying for accreditation (22.214.171.124).
The decision to revoke a laboratory’s accreditation can be appealed to the Court of Arbitration for Sport. Arguments of ignorance of the requirements of the ISL or that any failures led to no actual harm are unlikely to be accepted as valid grounds for allowing such appeal (see for example DCC, Universiti Sains Malaysia v WADA4).
Whilst the procedure of obtaining and maintaining WADA accreditation for laboratories is onerous and lengthy, the credibility of the whole system of laboratory anti-doping testing is fundamental to the credibility of WADA and the world anti-doping regime as a whole. Given the continued prevalence of high profile doping cases it is unsurprising that WADA has implemented such comprehensive requirements for accreditation and ongoing monitoring.
In April and May this year three laboratories have had their accreditation suspended (Bloemfontein,5 Beijing6 and Lisbon7) and one has had its accreditation revoked (Moscow8), this could be considered a measure of the rigour of this regime. However the suspension of the Bloemfontein laboratory means that there are now no accredited laboratories in Africa. This coupled with the fact that currently only thirty-one9 laboratories hold WADA accreditation worldwide must give rise to a concern that too few laboratories manage to make the grade. WADA President Sir Craig Reedie has stated that measures have been put in place since the recent suspensions to ensure that there are no gaps in anti-doping sample analysis procedures worldwide.10 However, the long term maintenance of effective, fair and trusted anti-doping testing requires not only the existence of testing laboratories with high standards but also sufficient numbers of the same. The solution must be for laboratories to raise their game rather than WADA to impose less stringent standards.
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- Tags: Anti-Doping | China | Governance | International Standard for Laboratories (ISL) | Portgual | Regulation | Russia | South Africa | World Anti-Doping Agency (WADA) | World Anti-Doping Code (WADC)
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About the Author
Rupert is a tenant at 4-5 Gray’s Inn Square and Kings Chambers.
He has substantial and wide ranging experience of sports litigation and advisory work including regulatory and disciplinary proceedings, anti-doping, free movement and right to play cases and contractual and sponsorship disputes.