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For the avoidance of doubt, test reports or other documentation or correspondence from Laboratories shall not declare or represent that any such testing is covered under the ir WADA accreditation status.
ABP Laboratories may also accept samples for other forms of analyses, which are not within the scope of the WADA approval ( e.g.
forensic testing, clinical testing, drugs of abuse testing).
For the avoidance of doubt, test reports or other documentation or co rrespondence from ABP ISL – January 2021 Page 12 of 160 Laboratories shall not state or represent that any such testing is covered under their WADA approval status.
1.3 WADA Laboratory Accreditation Framework and Laboratory Approval for the ABP The WADA Laboratory accreditation and Laboratory approval for the ABP framework consists of two main elements: Part Two of the ISL ( Laboratory accreditation and Laboratory approval for the ABP requirements and operating standards) and Part Three (the Annexes).
- Part Two of the ISL describes the requirements necessary to obtain and maintain WADA accreditation and the procedures involved to fulfill these requirements, as well as the requirements necessary to obtain and maintain WADA approval for the ABP (Section 4 .0).
It also includes the application of ISO/IEC 17025 2 to the field of Doping Control (Section 5.0) and a description of the WADA External Quality Assessment Scheme (EQAS ) (Section 6 .0) as well as the procedures to evaluate Laboratory EQAS and routine Analytical Testing performance by WADA (Section 7 .0).
The purpose of Part Two of the ISL is to enable the consistent application of ISO/IEC 17025 and ISL -specific requirements to Analytical Testing for Doping Control by Laboratories and ABP Laborator ies, as well as to facilitate the assessment of Laboratory and ABP Laboratory compliance by Accreditation Bodies and WADA.
- Part Three of the ISL includes all Annexes.
Annex A (Code of Ethics) , Annex B (Accreditation and Analytical Testing Requirements for Major Events ) and Annex C (Procedural Rules) describe the ethical and legal standards required for continued WADA accreditation of the Laboratory or continued approval of the laboratory for the ABP, as well as the specific requirements to conduct Analytical Testing during Major Events .
In order to harmonize the accreditation of Laboratories to the requirements of ISO/IEC 17025 and the approval of ABP Laboratories to the requirements of ISO/IEC 17025 (or ISO 15189 ), as well as the WADA -specific requirements for accreditation or approval, Accreditation Bodies are required to use the ISL, including the applicable Annexes, Technical Document s, Technical Letters and Laboratory Guidelines as reference documents in their assessment process.
[Comment: While Laboratories are required to be accredited to the requirements of ISO/IEC 17025 (applicable to testing and calibration laboratories), ABP Laboratories may be accredited to either the ISO/IEC 17025 or ISO 15189 (applicable to medical laboratories) standards].
Maintenance of a laboratory’s WADA accreditation or approval for the ABP is based on satisfactory performance in the applicable EQAS and in routine Analytical Testing .
The EQAS performance of Laboratories and ABP Laboratories is continually monitored by WADA and reviewed as part of their Accreditation Body assessment process, as applicable.
Therefore, the Laboratory or ABP Laboratory shall not be subject to challenge or to demands to produce EQAS data or related EQAS documentation by third parties.
2 Effective version of ISO/IEC 17025.
ISL – January 2021 Page 13 of 160 Terms used in this International Standard that are defined terms from the Code are italicized.
Terms that are defined in this or another International Standard are underlined.
2.0 Code Provisions The following articles in the 2021 Code are directly relevant to the International Standard for Laboratories , they can be obtained by referring to the Code itself: • Code Article 2 Anti-doping Rule Violations • Code Article 3 Proof of Doping • Code Article 4 The Prohibited List • Code Article 6 Analysis of Samples • Code Article 10 Sanctions of Individuals • Code Article 13 Results Management: Appeals • Code Article 14 Confidential ity and Reporting 3.0 Definitions and Interpretations 3.1 Defined terms from the 2021 Code that are used in the International Standard for Laboratories ADAMS : The Anti -Doping Administration and Management System is a Web -based database management tool for data entry, storage, sharing, and reporting designed to assist stakeholders and WADA in their anti -doping operations in conjunction with data protection legisl ation.
Adverse Analytical Finding : A report from a WADA -accredited laboratory or other WADA -approved laboratory that, consistent with the International Standard for Laboratories establishes in a Sample the presence of a Prohibited Substance or its Metabol ites or Markers or evidence of the Use of a Prohibited Method .
Anti-Doping Organization : WADA or a Signatory that is responsible for adopting rules for initiating, implementing or enforcing any part of the Doping Control process.
This includes, for example, the International Olympic Committee, the International Paralympic Committee, other Major Event Organization s that conduct Testing at their Events , International Federations, and National Anti -Doping Organizations.
Athlete : Any Person who competes in sport at the international level (as defined by each International Federation) or the national level (as defined by each National Anti -Doping Organization).
An Anti-Doping Organization has discretion to apply anti -doping rules to an Athlete who is neither an International -Level Athlete nor a National -Level Athlete , and thus to bring them within the definition of “ Athlete .” In relation to Athletes who are neither International - ISL – January 2021 Page 14 of 160 Level nor National -Level Athletes , an Anti-Doping Organization may elect to : conduct limited Testing or no Testing at all; analyze Samples for less than the full menu of Prohibited Substances ; require limited or no whereabouts information; or not require advance TUEs .
However, if an Article 2.1, 2.3 or 2.5 anti -doping rule violation is committed by any Athlete over whom an Anti-Doping Organization has elected to exercise its authority to test an d who competes below the international or national level, then the Consequences set forth in the Code must be applied.
For purposes of Article 2.8 and Article 2.9 and for purposes of anti -doping information and education, any Person who participates in spo rt under the authority of any Signatory , government, or other sports organization accepting the Code is an Athlete .
[Comment : Individuals who participate in sport may fall in one of five categories : 1) International -Level Athlete, 2) National -Level Athlete, 3) individuals who are not International or National -Level Athletes but over whom the International Federation or Nation al Anti -Doping Organization has chosen to exercise authority, 4) Recreational Athlete, and 5) individuals over whom no International Federation or National Anti -Doping Organization has, or has chosen to, exercise authority.
All International and National -Level Athletes are subject to the anti -doping rules of the Code, with the precise definitions of international and national level sport to be set forth in the anti -doping rules of the International Federations and National Anti -Doping Organizations.]
Athle te Biological Passport (ABP ): The program and methods of gathering and collating data as described in the International Standard for Testing and Investigations and International Standard for Laboratories.
Atypical Finding : A report from a WADA -accredited laboratory or other WADA -approved laboratory, which requires further investigation as provided by the International Standard for Laboratories or related Technical Documents prior to the determination of an Adverse Analytical Finding .
CAS : The Court of Arbitration for Sport .
Code : The World Anti -Doping Code .
Competition : A single race, match, game or singular sport contest.
For example, a basketball game or the finals of the Olympic 100 -meter race in athletics.
For stage races and other sport contests where prizes are awarded on a daily or other interim basis the distinction between a Competition and an Event will be as provided in the rules of the applicable International Federation.
Consequences of Anti -Doping Rule Violations (“Consequences”) : An Athlete’s or other Person ’s violation of an anti -doping rule may result in one or more of the following : (a) Disqualification means the Athlete ’s results in a particular Competition or Event are invalidated, with all resulting Consequences including forfeiture of any medals, points and prizes; (b) Ineligibility means the Athlete or other Person is barred on account of an anti -doping rule violation for a specified period of time from participat ing in any Competition or other activity or funding as provided in Article 10.12.1; (c) Provisional Suspension means the Athlete or other Person is barred temporarily from participating in any Competition or activity prior to the final decision at a hearin g conducted under Article 8; (d) Financial Consequences means a financial sanction imposed for an anti -doping rule violation or to recover costs associated with an anti -doping rule violation; and (e) Public Disclosure means the dissemination or distributio n of information to the general public or Persons beyond those Persons entitled to earlier ISL – January 2021 Page 15 of 160 notification in accordance with Article 14.
Teams in Team Sports may also be subject to Consequences as provided in Article 11.
Decision Limit : The value of the res ult for a Threshold Substance in a Sample , above which an Adverse Analytical Finding shall be reported, as defined in the International Standard for Laboratories.
Delegated Third Parties : Any Person to which an Anti-Doping Organization delegates any aspect of Doping Control or anti -doping Education programs including, but not limited to, third parties or other Anti-Doping Organizations that conduct Sample collection or other Doping Control services or anti -doping Educational programs fo r the Anti-Doping Organization , or individuals serving as independent contractors who perform Doping Control services for the Anti-Doping Organization (e.g., non -employee Doping Control officers or chaperones) This definition does not include CAS.
Doping Control : All steps and processes from test distribution planning through to ultimate disposition of any appeal and the enforcement of Consequences , including all steps and processes in between, including but not limited to, Testing , investigations, wherea bouts, TUEs , Sample collection and handling, laboratory analysis, Results Management , and investigations or proceedings relating to violations of Article 10.14 (Status During Ineligibility or Provisional Suspension ).
Event : A series of individual Competitions conducted together under one ruling body (e.g., the Olympic Games, World Champi onships of an International Federation or Pan American Games).
In-Competition : The period commencing at 11 : 59 pm on the day before a Competition in which the Athlete is scheduled to participate through the end of such Competition and the Sample collecti on process related to such Competition .
Provided, however, WADA may approve, for a particular sport, an alternative definition if an International Federation provides a compelling justification that a different definition is necessary for its sport; upon s uch approval by WADA , the alternative definition shall be followed by all Major Event Organizations for that particular sport.
[Comment : Having a universally accepted definition for In -Competition provides greater harmonization among Athletes across all sport, eliminates or reduces confusion among Athletes about the relevant timeframe for In -Competition Testing, avoids inadvertent Adverse Analytical Findings in between Competitions during an Event and assists in preventing any potential performance enhancement benefits from substances prohibited Out -of-Competition being carried over to the Competition.]
Ineligibility : See Consequences of Anti-Doping Rule Violations above.
International Standard : A standard adopted by WADA in support of the Code .
Compliance with an International Standard (as opposed to another alternative standard, practice or procedure) shall be sufficient to conclude that the procedures addressed by the International Standard were performed properly.
International Standards shall include any Technical Documents issued pursuant to the International Standard.
Major Event Organizations : The continental associations of National Olympic Committee s and other international multi -sport organizations that function as the ruling body for any continental, regional or other International Event .
ISL – January 2021 Page 16 of 160 Marker : A compound, group of compounds or biological variable(s) that indicates the Use of a Prohibited Substance or Prohibited Method.
Metabolite : Any substance produced by a biotransformation process.
Minimum Reporting Level : The estimated concentration of a Prohibited Substance or its Metabolite (s) or Marker (s) in a Sample below which WADA -accredited laboratories should not report that Sample as an Adverse Analytical Finding .
National Anti -Doping Organization : The entity( -ies) designated by each country as possessing the primary authority and responsib ility to adopt and implement anti -doping rules, direct the collection of Samples , the management of test results, and the conduct of hearings at the national level.
If this designation has not been made by the competent public authority( -ies), the entity s hall be the country’s National Olympic Committee or its designee.
National Olympic Committee : The organization recognized by the International Olympic Committee.
The term National Olympic Committee shall also include the National Sport Confederation in th ose countries where the National Sport Confederation assumes typical National Olympic Committee responsibilities in the anti -doping area.
Out-of-Competition : Any period which is not In-Competition .
Person : A natural Person or an organization or other entity.
Prohibited List : The List identifying the Prohibited Substances and Prohibited Methods .
Prohibited Method : Any method so described on the Prohibited List .
Prohibited Substance : Any substance, or class of substances, so described on the Prohibited List .
Results Management : The process encompassing the timeframe between notification as per Article 5 of the International Standard for Results Management , or in certain cases ( e.g., Atypical Finding , Athlete Biological Passport , Whereabouts Fail ure), such pre -notification steps expressly provided for in Article 5 of the International Standard for Results Management , through the charge until the final resolution of the matter, including the end of the hearing process at first instance or on appeal (if an appeal was lodged).
Sample or Specimen : Any biological material collected for the purposes of Doping Control .
Signatories : Those entities signing the Code and agreeing to comply with the Code , as provided in Article 23.
Tampering : Intentional conduct which subverts the Doping Control process, but which would not otherwise be included in the definition of Prohibited Method s. Tampering shall include, without limitation, offering or accepting a bribe to perform or fail to perform an act, preventing the collection of a Sample , affecting or making impossible the analysis of a Sample , falsifying documents submitted to an Anti-Doping Organization or TUE committee or hearing panel, procuring false testimony from witnesses, committing any other fraudulent act upon the Anti-Doping Organization or hearing body to affect Results Management or the imposition of Consequences , and any other similar intentional interference or Attempted interference with any aspect of Doping Control .
Target Testing : Selection of specific Athletes for Testing based on criteria set forth in the International Standard for Testing and Investigations.
ISL – January 2021 Page 17 of 160 Technical Document : A document adopted and published by WADA from time to time containing mandatory technical requirements on specific anti -doping topics as set for th in an International Standard .
Testing : The parts of the Doping Control process involving test distribution planning, Sample collection, Sample handling, and Sample transport to the laboratory.
Therapeutic Use Exemption (TUE) : A Therapeutic Use Exemption allows an Athlete with a medical condition to Use a Prohibited Substance or Prohibited Method , but only if the conditions set out in Article 4.4 and the International Standard for Therapeutic Use Exemptions are met.
Use: The utilization, application, ingestion, injection or consumption by any means whatsoever of any Prohibited Substance or Prohibited Method.
WADA : The World Anti -Doping Agency.
3.2 Defined Terms from the International Standard for Laboratories ABP Laboratory : A laboratory not otherwise accredited by WADA, which is approved by WADA to apply Analytical Methods and processes in support of the hematological module of the ABP program and in accordance with the criteria for approval of non -accredited laboratories for the ABP.
Aliquot : A portion of the Sample of biological fluid ( e.g.
urine, blood) obtained from the Athlete used in the analytical process.
Analyte : Also known as or referred to as a substance, compound or measurand, which is analyzed and/or determined in a biological matrix using an Analytical Testing Procedure performed under controlled analytical and laboratory conditions.
For anti -doping purposes, an Analyte may be a Prohibited Substance , a Metabolite of a Prohibited Substance , or a Marker of the Use of a Prohibited Substance or Prohibited Method .
Analytical Method : Analytical Testing Procedure , Test Method .
Analytical Testing : The parts of the Doping Control process performed at the Laboratory , which include Sample handling, analysis and reporting of results.
Analytical Testing Procedure : A Fit-for-Purpose procedure, as demonstrated through method validation, and used to detect, identify and/or quantify Analytes in a Sample for Doping Control purposes in accordance with the ISL and relevant Technical Document (s), Technical Letter (s) or Labora tory Guidelines .
An Analytical Testing Procedure is also referred to or known as an Analytical Method or Test Method .
Analytical Testing Restriction (ATR) : Restriction on a Laboratory ’s application of specified Analytical Testing Procedure( s) or the analysis of a particular class(es) of Prohibited Substances or Prohibited Methods to Samples , as determined by WADA .
Athlete Passport Management Unit (APMU ): A unit composed of a Person or Persons that is responsible for the timely management of Athlete Biological Passports in ADAMS on behalf of the Passport Custodian .
Bias (b): Deviation of a measured result from the expected or reference value when using the complete measurement procedure.
ISL – January 2021 Page 18 of 160 Certificate of Analysis : The material produced by a Laboratory or ABP Laboratory upon request by an APMU , Expert Panel , or WADA as set forth in the Technical Document on Laboratory Documentation Packages (TD LDOC), to support an analytical resu lt for a Sample that is judged to confirm the baseline level of a urine or blood Marker of the Athlete Biological Passport .
Certified Reference Material (CRM ): Reference Material (RM), characterized by a metrologically valid procedure for one or more specified properties, which is accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.
Confirmation Procedure (CP): An Analytical Testing Procedure that has the purpose of confirming the presence and/or, when applicable, confirming the concentration/ratio/score and/or establishing the origin (exogenous or endogenous) of one or more specific Prohibited Substances , Metabolite (s) of a Prohibited Substan ce, or Marker (s) of the Use of a Prohibited Substance or Prohibited Method in a Sample .
Corrective Action Report (CAR ): A report describing the Root Cause Analysis investigation of a detected nonconformity and the corrective actions implemented to rectify it.
If appropriate, it shall also describe the improvements adopted to minimize the risk of recurrence of the nonconformity.
[Comment : The term “Corrective Actio n” is widespread in the ISO standards for laboratories and it is used to describe the actions that ought to be taken by a laboratory in cases of nonconformities that occur during the performance of its work.
This term is recognized as one of the minimum it ems that the laboratory Management System shall address.
Thus, corrective action reports (CARs) are used by accreditation bodies all over the world to understand and assess the treatment of nonconformities by laboratories, including an analysis of the exte nt and cause (i.e.
root cause analysis) of the nonconformities.]
External Quality Assessment Scheme (EQAS ): Program for quality assessment of Laboratory performance, which includes the periodical distribution of urine or blood samples to Laboratories and probationary laboratories by WADA , to be analyzed for the presence or absence of Prohibited Substances and/or their Metabolite (s), or Marker (s) of Use of Prohibited Substances or Prohibited Methods .
The EQAS includes also the provision of blood samples to ABP Laboratories for the analysis of the blood Markers of the Athlete Biological Passport .
EQAS samples may be open ( i.e.
educational; in such cases the content may be indicated), blind or double -blind (in such cases the content is unknown to the Laboratories ).
Fit(ness) -for-Purpose : Suitable for the intended purpose and in conformity with the ISO/IEC 17025 or ISO 15189, as applicable, the ISL and relevant Technical Document (s) and Technical Letter (s).
Flexible Scope of ISO/IEC 17025 Accreditation : Status of laboratory accreditation, which allows a Laboratory to make and implement restricted modifications in the Scope of ISO/IEC 17025 Accreditation, as applicable, prior to the assessment by the Accreditation Body.
See Article 4.4.2.2 for a detailed description of Flexible Scope of ISO/IEC 17025 Accreditation .
[Comment : The concept of f lexible scope of accreditation may also be applied, as determined by the Accreditation Body, to the analysis of ABP blood Markers when included in the scope of ISO 15189 accreditation of ABP Laboratories .]