In part 1, we set up the legal framework for doping testing in cycling, so let’s turn our focus to the rules governing how WADA labs perform drug testing. The applicable rules are the WADA ISL (International Standard for Laboratories), and the ISO 17025 standard. Here in part 2, we'll introduce the ISL, and in part 3, ISO 17025.
The ISL: An Introduction
The document at the heart of the WADA Rules governing lab testing is the ISL. You can find the ISL at http://www.wada-ama.org/rtecontent/document/lab_aug_04.pdf. (Note that the version of the ISL applicable to the FL case is version 4.0. The current version of the ISL, version 5.0, came into effect on January 1, 2008.) The ISL also includes all WADA technical documents (TDs), including TD2003 LCOC (governing chain of custody issues) and TD2003IDCR (governing identification of substances in chromatographic testing). You can find all of these TDs listed and available for download at http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id=372.
Let’s quickly revisit how the WADA Rules incorporate the ISL. Once a WADA lab has proved an AAF, the accused athlete has the burden of proving a “departure” by the lab from the ISL. If the athlete demonstrates such a departure, then the prosecuting ADA has the burden of proving that such departure did not cause the AAF or the factual basis for the anti-doping rule violation. (WADA Rule paragraph 3.2.2.)
From the above description, you might assume that the ISL consists of a list of rules that a lab must follow in testing an athlete’s sample. Not so. The ISL is considerably more complicated, and more difficult to interpret.
The ISL contains two kinds of rules (see ISL Rule 1.0 for this summary):
Rules Governing the Accreditation Procedure. These rules set forth the process that a lab must follow in order to receive WADA accreditation. These rules do not directly address how a lab performs its testing. For example, ISL Rule 4.1.2 requires that a lab seeking accreditation must receive a letter of support from a public authority responsible for a national anti-doping program (such as USADA). I believe that all rules under ISL Articles 4 and 6 fall under this category of accreditation procedure rules.
Some rules governing the accreditation procedure are of interest to us here at TBV. For example, ISL Rule 4.2.4 requires a WADA lab to analyze a minimum of 1500 doping samples a year, or else risk the loss or suspension of its accreditation. This gives us a picture of the minimum volume of work at a WADA lab. ISL Rule 4.2.2 allows a WADA lab to add or modify its methods without the approval of the organization that provided its accreditation, with the understanding that the method must be validated the next time the lab is audited. This lets us know that the methods used at LNDD are supposed to be reviewed by an accreditation body.
Since our primary focus here is to understand lab testing, and specifically to identify the ISL rules that can serve as the grounds for an ISL “departure” under the WADA Rules, I think we can ignore all ISL rules that govern the lab accreditation process.
Operating standards for laboratory performance. This is the place where we would look to find the kind of substantive rules that a lab must follow in order to prove an AAF. These rules are contained in ISL Article 5, as well as in the TDs. Consequently, our primary focus in this article will be on the ISL rules found in Article 5
The first rule set forth in ISL Article 5 may be the single most important rule in the ISL.
ISL Rule 5.1 states that Article 5 of the ISL is a specialty document under Annex B.4 of ISO 17025, for the field of doping control. I will argue that the key to understanding the ISL is set forth in this Rule 5.1. But to understand ISL Rule 5.1, we must first answer the questions: what is ISO 17025? And why is ISO 17025 referred to in the ISL?
(We should note that ISL Rule 5.1 refers to ISO 9001 as well as to ISO 17025. We will not have time in this article to consider ISO 9001, but we will probably want to examine ISO 9001 in a later article.)
Up to the Introduction; Back to part 1; On to part 3.