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Participan t: Any Athlete or Athlete Support Person.
Person: A natural Person or an organization or other entity.
Possession : The actual, physical Possession , or the constructive Possession (which shall be found only if the Person has exclusive control or intends to exercise control over the Prohibited Substance or Prohibited Method or the premises in which a Prohibited Substance or Prohibited Method exists); provided, however, that if the Person does not have exclusive control over the Prohibited Substance or Prohibited Method or the premises in which a Prohibited Substance or Prohibited Method exists, constructive Possession shall only be found if the Person knew about the presence of the Prohibited Substance or Prohibited Method and intended to exercise control over it.
Provided, however, there shall be no anti -doping rule vio lation based solely on Possession if, prior to receiving notification of any kind that the Person has committed an anti -doping rule violation, the Person has taken concrete action demonstrating that the Person never intended to have Possession and has renounced Possession by explicitly declaring it to an Anti -Doping Organization.
Notwithstanding anything to the contrary in this definition, the purchase (including by any electronic or other ISA 2021 Anti -Doping Rules Page 65 of 67 means) of a Prohibited Substance or Prohibited Method constitutes Possession by the Person who makes the purchase.80 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 s ubstances, so described on the Prohibited List .
Protected Person: An Athlete or other natural Person who at the time of the anti -doping rule violation: (i) has not reached the age of sixteen (16) years; (ii) has not reached the age of eighteen (18) years and is not included in any Registered Testing Pool and has never competed in any International Event in an open category; or (iii) for reasons other than age has been determined to lack legal capacity under applicable national legislation.81 Provisional H earing : For purposes of Article 7.4.3, an expedited abbreviated hearing occurring prior to a hearing under Article 8 that provides the Athlete with notice and an opportunity to be heard in either written or oral form.82 Provisional Suspension: See Conseque nces of Anti -Doping Rule Violations above.
Publicly Disclose : See Consequences of Anti -Doping Rule Violations above.
Recreational Athlete: A natural Person who is so defined by the relevant National Anti -Doping Organization; provided, however, the term shall not include any Person who, within the five (5) years prior to committing any anti -doping rule violation, has been an International -Level Athlete (as defined by each International Federation consistent with the Internati onal Standard for Testing and Investigations) or National -Level Athlete (as defined by each National Anti -Doping Organization consistent with the International Standard for Testing and Investigations), has represented any country in an International Event in an open category or has bee n included within any Registered Testing Pool or other whereabouts information pool maintained by any International Federation or National Anti -Doping Organization.83 Regional Anti -Doping Organization: A regional entity designated by member countries to c oordinate and manage delegated areas of their national anti -doping programs, which may include the adoption and implementation of anti -doping rules, the planning and collection of Samples , the management of results, the review of TUEs , the conduct of heari ngs, and the conduct of E ducational programs at a regional level.
Registered Testing Pool : The pool of highest -priority Athletes established separately at the international level by International Federations and at the national level by National Anti -Doping Organizations , who are 80 [Comment to Possession: Under this definition, anabolic steroids found in an Athlete's car would constitute a violation unless the Athlete establishes that someone else used the car ; in that event, ISA must establish that, even though the Athlete did not have exclusive control over the car, the Athlete knew about the anabolic steroids and intended to have control over them.
Simila rly, in the example of anabolic steroids found in a home medicine cabinet under the joint control of an Athlete and spouse, ISA must establish that the Athlete knew the anabolic steroids were in the cabinet and that the Athlete intended to exercise control over them.
The act of purchasing a Prohibited Substance alone constitutes Possession, even where, for example, the product does not arrive, is received by someone else, or is sent to a third party address.]
81 [Comment to Protected Person: The Code treats Protected Persons differently than other Athletes or Persons in certain circumstances based on the understanding that, below a certain age or intellectual capacity, an Athlete or other Person may not possess th e mental capacity to understand and appreciate the prohibitions against conduct contained in the C ode.
This would include, for example, a Paralympic Athlete with a documented lack of legal capacity due to an intellectual impairment.
The term “open category ” is meant to exclude competition that is limited to junior or age group categories.]
82 [Comment to Provisional Hearing: A Provisional Hearing is only a preliminary proceeding which may not involve a full review of the facts of the case.
Following a Provisional Hearing, the Athlete remains entitled to a subsequent full hearing on the merits of the c ase.
By contrast, an “expedited hearing”, as that term is used in Article 7.4.3, is a full hearing on the merits conducted on an expedited time schedule.]
83 [Comment to Recreational Athlete: The term “open category” is meant to exclude competition that i s limited to junior or age group categories.]
ISA 2021 Anti -Doping Rules Page 66 of 67 subject to focused In -Competition and Out-of-Competition Testing as part of that International Federation's or National Anti -Doping Organization's test distribution plan and therefore are required to provide whereabouts information as provided in Article 5.
5 and the International Standard for Testing and Investigations.
Results Management : The process encompassing the timeframe between notification as per Article 5 of the International Standard for Results Management , or in certai n cases (e.g., Atypical Finding , Athlete Biological Passport , whereabouts failure), such pre- notification steps expressly provided for in Article 5 of the International Sta ndard 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 .84 Signatories : Those entities accepting the Code and agreeing to implement the Code, as provided in Article 23 of the Code.
Specified Method: See Article 4.2.2.
Specified Substance: See Article 4.2.2.
Strict Liability : The rule which provides that under Article 2.1 and Article 2.2, it is not necessary that intent, Fault , Negligence, or knowing Use on the Athlete’s part be demonstrated by the Anti-Doping Organization in order to establish an anti -doping rule violation.
Substance of Abuse: See Article 4.2.3.
Substantial Assistance: For purposes of Article 10.7.
1, a Person providing Substantial Assistance must: (1) fully disclose in a signed written statement or recorded interview all information he or she possesses in relation to anti -doping rule violations or other proceeding described in Article 10.7.1.1, and (2) fully cooperate with the investigation and adjudication of any case or matter related to that information, including, for example, presenting testimony at a hearing if requested to do so by an Anti-Doping Organization or hearing panel.
Further, the inf ormation provided must be credible and must comprise an important part of any case or proceedin g which is initiated or, if no case or proceeding is initiated, must have provided a sufficient basis on which a case or proceeding could have been brought.
Tampering : Intentional conduct which subverts the Doping Control process but which would not otherwise be included in the definition of Prohibited Methods .
Tampering shall include, without limitation, offering or accepting a bribe to perform or fail to perfor m 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 .85 Target Testing : Selection of specific Athletes for Testing based on criteria set forth in the International Standard for Testing and Investigations.
Team Sport : A sport in which the substitution of players is permitted during a Competition.
84 [Comment to Sample or Specimen: It has sometimes been claimed that the collection of blood Samples violates the tenets of certain religious or cultural groups.
It has been determined that there is no basis for any such claim.]
85 [Comment to Tampering: For example, this Article would prohibit altering identification numbers on a Doping Control form during Testing, breaking the B bottle at the time of B Sample analysis, altering a Sample by the addition of a foreign substance, or intimidating or attempt ing to intimidate a potential witness or a witness who has provided testimony or information in the Doping Control process.
Tampering includes misconduct which occurs during the Results Management.
See Article 10.9.3.3.
However, actions taken as part of a Person's legitimate defense to an anti -doping rule violation charge shall not be considered Tampering.
Offensive conduct towards a Doping Control official or other Person involved in Doping Control which does not otherwise constitute Tampering shall be addressed in the disciplinary rules of sport organizations.]
ISA 2021 Anti -Doping Rules Page 67 of 67 Technical Document : A document adopted and published by WADA from time to time containing mandatory technical requirements on specific anti -doping topics as set forth 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.
Testing Pool: The tier below the Registered Testing Pool which includes Athletes from whom some whereabouts information is required in order to locate and Test the Athle te Out-of-Competition.
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.
Trafficking : Selling, giving, transporting, sending, delivering or distributing (or Possessing for any such purpose) a Prohibited Substance or Prohibited Method (either physically or by any electronic or other means) by an Athlete , Athlete Support Person or any other Person subject to the authority of an Anti-Doping Organization to any third party; provided, however, t his definition shall not include the actions of bona fide medical personnel involving a Prohibi ted Substance Used for genuine and legal therapeutic purposes or other acceptable justification, and shall not include actions involving Prohibited Substances which are not prohibited in Out -of-Competition Testing unless the circumstances as a whole demons trate such Prohibi ted Substances are not intended for genuine and legal therapeutic purposes or are intended to enhance sport performance.
UNESCO Convention: The International Convention against Doping in Sport adopted by the 33rd session of the UNESCO G eneral Conference on 19 October 2005 including any and all amendments adopted by the States Parties to the Convention and the Conference of Parties to the International Convention against Doping in Sport.
Use: The utilization, application, ingestion, injection or consumpti on by any means whatsoever of any Prohibited Substance or Prohibited Method.
WADA: The World Anti -Doping Agency.
Without Prejudice Agreement : For purposes of Articles 10.7.1.1 and 10.8.2, a written agreement between an Anti-Doping Organization and an Athlete or other Person that allows the Athlete or other Person to provide information to the Anti-Doping Organization in a defined time- limited setting with the understanding that, if an agreement for Substantial Assistance or a case resolu tion agreement is not finalized, the information provided by the Athlete or other Person in this particular setting may not be used by the Anti-Doping Organizat ion against the Athlete or other Person in any Results Management proceeding under the Code, and that the information provided by the Anti-Doping Organization in this particular setting may not be used by the Athlete or other Person against the Anti-Doping Organization in any Results Management proceeding under the Code .
Such an agreement shall not preclude the Anti-Doping Organization, Athlete or other Person from using any information or evidence gathered from any source other than during the specific tim e-limited setting described in the agreement.
ISL – January 2021 International Standard for Laboratories The World Anti -Doping Code International Standard for Laboratories is a mandatory International Standard developed as part of the World Anti -Doping Program.
It was developed in consultation with Signatories , public authorities, and other relevant stakeholders.
The International Standard for Laboratories first came into effect in November 2002.
It was subseque ntly amended multiple times, specifically in 2003, 2004, 2008, 2009, 2012, 2015, 2016, and 2019.
A revised version was approved by the WADA Executive Committee on 15 September 2020 and is effective as of 1 January 2021.
Published by: World Anti-Doping Agency Stock Exchange Tower 800 Place Victoria (Suite 1700) PO Box 120 Montreal, Quebec Canada H4Z 1B7 www.wada -ama.org Tel: +1 514 904 9232 Fax: +1 514 904 8650 E-mail: code@wada -ama.org ISL – January 2021 Table of Contents PART ONE: INTRODUCTION, CODE PROVISIONS, INTERNATIONAL STANDARD PROVISIONS AND DEFINITIONS ................................ ................................ .......................... 8 1.0 Introduction and Scope ................................ ................................ ................................ 8 1.1 WADA Laboratory Standards ................................ ................................ ..................... 8 1.1.1 International Standard for Laboratories (ISL) ................................ ................ 8 1.1.2 Technical Documents ................................ ................................ ................. 9 1.1.3 Technical Letters ................................ ................................ ...................... 10 1.1.4 Laboratory Guidelines ................................ ................................ ............... 11 1.1.5 Technical Notes ................................ ................................ ........................ 11 1.2 Sample Analysis ................................ ................................ ................................ ..... 11 1.3 WADA Laboratory Accreditation Framework and Laboratory Approval for the ABP .... 12 2.0 Code Provisions ................................ ................................ ................................ ......... 13 3.0 Definitions and Interpretations ................................ ................................ .................. 13 3.1 Defined terms from the 2021 Code that are used in the International Standard for Laboratories ................................ ................................ ................................ ........... 13 3.2 Defined Terms from the International Standard for Laboratories ................................ 17 3.3 Defined Terms from the International Standard for Testing and Investigations ........... 22 3.4 Defined Terms from the International Standard for Results Management .................. 23 3.5 Interpretation ................................ ................................ ................................ .......... 23 PART TWO: LABORATORY ACCREDITATION AND LABORATORY APPROVAL FOR THE ABP REQUIREMENTS AND OPERATING STANDARDS ................................ ..................... 24 4.0 Process and Requirements for WADA Laboratory Accreditation and Laboratory Approval for the ABP................................ ................................ ................................ .......... 24 4.1 Applicant Laboratory for WADA Accreditation ................................ ........................... 24 4.1.1 Expression of Interest ................................ ................................ ............... 24 4.1.2 Submit Initial Application Form ................................ ................................ .. 24 4.1.3 Provision of Letters of Support ................................ ................................ .. 24 4.1.4 Provision of Business Plan ................................ ................................ ........ 25 4.2 Candidate Laboratory for WADA Accreditation ................................ ......................... 25 4.2.1 Description of the Candidate Laboratory ................................ .................... 25 4.2.2 Payment of Initial Accreditation Fee ................................ ........................... 27 4.2.3 Compliance with the Code of Ethics (Annex A) ................................ .......... 27 4.2.4 Laboratory Independence and Impartiality ................................ ................. 27 ISL – January 2021 4.2.5 Pre-Probationary Test and On -Site Assessment ................................ ........ 27 4.3 Probationary Laboratory for WADA Accreditation ................................ ..................... 29 4.3.1 Participating in the WADA EQAS Program ................................ ................. 29 4.3.2 Planning and Implementing Research and Development Activities .............. 29 4.3.3 Planning and Implementing Sharing of Knowledge ................................ ..... 29 4.3.4 Compliance with the Code of Ethics ( Annex A) ................................ .......... 29 4.3.5 Obtaining ISO/IEC 17025 Accreditation by the Laboratory .......................... 30 4.3.6 Analytical Testing Procedures ................................ ................................ ... 30 4.3.7 Laboratory Independence and Impartiality ................................ ................. 30 4.3.8 Professional Liability Insurance Coverage ................................ .................. 30 4.4 WADA -Accredited Laboratory ................................ ................................ .................. 31 4.4.1 Obtaining WADA accreditation ................................ ................................ .. 31 4.4.2 Maintaining WADA Accreditation ................................ ............................... 33 4.5 Removal of Samples by WADA ................................ ................................ ............... 39 4.5.1 Removal of Samples for Analysis or Further Analysis ................................ .
39 4.5.2 Removal of Samples for Laboratory Quality Assessment ............................ 40 4.6 WADA Monitoring of Accreditation Status ................................ ................................ 40 4.6.1 Maintenance of WADA Accreditation ................................ ......................... 40 4.6.2 Re-accreditation Costs ................................ ................................ .............. 40 4.6.3 Issuing and Publication of Accreditation Certificate ................................ ..... 40 4.6.4 Withdrawal of WADA Accreditation ................................ ............................ 41 4.6.5 Consequences of Suspended or Revoked Accreditation or Analytical Testing Restriction ................................ ................................ ................................ 50 4.6.6 Reinstatement of Suspended Accreditation or Lifting of the Analytical Testing Restriction ................................ ................................ ................................ 56 4.6.7 Voluntary Cessation of Laboratory Operations ................................ ........... 59 4.7 Process and Requirements for WADA Laboratory Approval for the ABP.................... 60 4.7.1 Applicant Laboratory for WADA Approval for the ABP ................................ 60 4.7.2 Candidate Laboratory for WADA Approval for the ABP ............................... 61 4.7.3 Granting of WADA Approval for the ABP................................ .................... 63 4.7.4 Maintaining Status as an ABP Laboratory ................................ .................. 64 5.0 Application of ISO/IEC 17025 to the Analysis of Samples ................................ ......... 66 5.1 Introduction and Scope ................................ ................................ ........................... 66 5.2 Structural and Resource Requirements ................................ ................................ .... 66 5.2.1 General ................................ ................................ ................................ .... 66 ISL – January 2021 5.2.2 Laboratory Personnel ................................ ................................ ................ 66 5.2.3 Laboratory Facilities and Environmental Conditions ................................ .... 69 5.2.4 Laboratory Equipment ................................ ................................ ............... 73 5.2.5 Metrological Traceability ................................ ................................ ............ 73 5.2.6 Subcontracting of Analysis ................................ ................................ ........ 74 5.2.7 Purchasing of Services and Supplies ................................ ......................... 75 5.3 Process Requirements ................................ ................................ ............................ 75 5.3.1 Reviewing of Requests, Tenders and Contracts ................................ ......... 75 5.3.2 Reception, Registration and Handling of Samples ................................ ...... 75 5.3.3 Acceptance of Samples for Analysis ................................ .......................... 76 5.3.4 Initial Storage and Sample Aliquoting for Analysis ................................ ...... 79 5.3.5 Selection and Validation of Analytical Testing Procedures .......................... 80 5.3.6 Sample Analysis ................................ ................................ ....................... 85 5.3.7 Assuring the Validity of Analytical Results ................................ ................ 101 5.3.8 Results Management ................................ ................................ .............. 103 5.3.9 Control of Nonconformities in Analytical Testing ................................ ....... 109 5.3.10 Complaints ................................ ................................ ............................. 109 5.3.11 Storage of Samples ................................ ................................ ............... 110 5.3.12 Secondary Use or Disposal of Samples and Aliquots ............................... 115 5.4 Management Requirements ................................ ................................ .................. 117 5.4.1 Organization ................................ ................................ ........................... 117 5.4.2 Management Reviews ................................ ................................ ............. 117 5.4.3 Document Control ................................ ................................ ................... 117 5.4.4 Control and Storage of Technical Records ................................ ............... 117 5.4.5 Cooperation with Customers and with WADA ................................ ........... 117 6.0 WADA External Quality Assessment Scheme (EQAS) ................................ ............ 120 6.1 Types of EQAS ................................ ................................ ................................ ..... 120 6.1.1 Blind EQAS ................................ ................................ ............................ 120 6.1.2 Double -Blind EQAS ................................ ................................ ................ 120 6.1.3 Educational EQAS ................................ ................................ .................. 120 6.2 EQAS Sample Number and Composition ................................ ............................... 120 6.2.1 Number of EQAS Samples ................................ ................................ ...... 120 6.2.2 Composition of EQAS Samples ................................ ............................... 121 6.2.3 Laboratory Analytical Testing Procedures Used in EQAS ......................... 123 ISL – January 2021 6.3 Reporting of EQAS results ................................ ................................ ..................... 123 6.3.1 Reporting Blind EQAS Results ................................ ................................ 124 6.3.2 Reporting Double -Blind EQAS Results ................................ .................... 124 6.3.3 Reporting Educational EQAS Results ................................ ...................... 125 6.3.4 Reporting Results for EQAS Samples Containing Non -Threshold Substances ................................ ................................ ................................ .............. 125 6.3.5 Reporting Results for EQAS Samples Containing Threshold Substances .. 125 7.0 Evaluation of Laboratory EQAS and Routine Analytical Testing Performance ....... 127 7.1 Evaluation of EQAS Results ................................ ................................ .................. 127 7.1.1 EQAS Samples Containing Non -Threshold Substances ........................... 128 7.1.2 EQAS Samples Containing Threshold Substances ................................ ... 128 7.2 Evaluation of Laboratory Performance ................................ ................................ ... 130 7.2.1 False Adverse Analytical Finding ................................ ............................. 130 7.2.2 False Negative Finding ................................ ................................ ........... 137 7.2.3 Further Procedural Evaluations ................................ .............................. 138 7.3 Overall Laboratory Evaluation ................................ ................................ ................ 138 Points Scale Table for Assessment of Laboratory and Probationary Laboratory Performance ................................ ................................ ........................... 140 7.4 Probationary Period and Probationary Laboratory Evaluation ................................ .. 142 7.4.1 Analytical Testing Procedures Utilized by Probationary Laboratories for the Analysis of EQAS samples ................................ ................................ ...... 142 7.4.2 False Adverse Analytical Finding Result ................................ .................. 142 7.4.3 False Negative Finding ................................ ................................ ........... 142 7.4.4 Threshold Substance Result ................................ ................................ ... 143 7.4.5 Overall Probationary Laboratory Evaluation ................................ ............. 143 PART THREE: ISL ANNEXES ................................ ................................ ........................... 145 ISL ANNEX A - CODE OF ETHICS FOR LABORATORIES and ABP LABORATORIES ..... 145 1.0 Confidentiality ................................ ................................ ................................ ....... 145 2.0 Research in Support of Doping Control ................................ ................................ .. 145 2.1 Research on Human Subjects ................................ ................................ .
145 2.2 Controlled Substances ................................ ................................ ............ 145 3.0 Analysis ................................ ................................ ................................ ................ 145 3.1 Analytical Testing for Anti-Doping Organizations (Signatories or WADA ) ... 146 3.2 Analytical Testing for non -Signatories ................................ ...................... 146 3.3 Clinical or Forensic Analysis ................................ ................................ .... 146 ISL – January 2021 3.4 Other Analytical Activities ................................ ................................ ........ 146 3.5 Sharing of Knowledge ................................ ................................ ............. 147 4.0 Duty to Preserve the Integrity of the World Anti -Doping Program and to Avoid any Detrimental Conduct ................................ ................................ ............................. 147 5.0 Breach and Enforceability ................................ ................................ ...................... 148 ISL ANNEX B – ACCREDITATION REQUIREMENTS FOR MAJOR EVENTS .................... 149 1.0 Major Event Analytical Testing in the Laboratory Facilities ................................ ...... 149 1.1 Participation in WADA Assessment(s) ................................ ..................... 149 1.2 Participation in the WADA EQAS ................................ ............................. 152 1.3 Pre-Event Report ................................ ................................ .................... 152 1.4 Additional Professional Liability Insurance Coverage ................................ 153 1.5 “B” Confirmation ................................ ................................ ..................... 153 1.6 Documentation and Reporting ................................ ................................ .
153 2.0 Major Event Analytical Testing in “Satellite” Laboratory Facilities ............................ 153 2.1 Participating in WADA Assessment(s) ................................ ..................... 153 2.2 Documenting ISO/IEC 17025 Accreditation of the Satellite Facility ............ 154 2.3 Professional Liability Insurance Coverage ................................ ................ 154 2.4 Obtaining a Temporary and Limited WADA Accreditation Certificate ......... 154 3.0 Monitoring and Assessment during a Major Event ................................ .................. 155 3.1 Reporting of False Analytical Findings during a Major Event ..................... 155 ISL ANNEX C – PROCEDURAL RULES FOR THE DISCIPLINARY COMMITTEE OF THE INTERNATIONAL STANDARD FOR LABORATORIES ................................ ...................... 156 Preamble ................................ ................................ ................................ .................... 156 PART I - Composition of the Committee ................................ ................................ ....... 156 PART II - General Provisions ................................ ................................ ....................... 157 PART III - Scope of the Committee’s Review ................................ ................................ 157 PART IV - Recommendation ................................ ................................ ........................ 158 Part V – Expedited Proceedings or Single Hearing before CAS ................................ ..... 159 ISL – January 2021 Page 8 of 160 PART ONE : INTRODUCTION, CODE PROVISIONS , INTERNATIONAL STANDARD PROVISIONS AND DEFINITIONS 1.0 Introduction and Scope 1.1 WADA Laboratory Standards 1.1.1 International Standard for Laboratories (ISL) In the introduction to the World Anti -Doping Code ( Code ), the purpose and implementation of the International Standards are summarized as follows: “International Standards for different technical and operational areas within the anti-doping program have been and will be developed in consultation with the Signatories and governments and approved by WADA .
The purpose of the International Standards is harmonization among Anti-Doping Organizations responsible for specific technical and operational parts of anti -doping programs.
Adherence to the International Standards is mandatory for compliance with the Code .
The International Standards may be revised from time to time by the WADA Executive Committee after reasonable consultation with the Signatories , governments and other relevant stakeholders.
International Standards and all revisions will be published on the WAD A website and shall become effective on the date specified in the International Standard or revision.” The main purpose of the ISL is to ensure that Laboratories and ABP Laboratories report valid test results based on reliable evidentiary data, and to faci litate harmonization in Analytical Testing of Samples by Laboratories and in the analysis of ABP blood Samples by Laboratories and ABP Laboratories .
The ISL sets out the requirements to be followed by Laboratories and ABP Laboratories that wish to demonstrate that they are technically competent, operate within an effective Management System, and are able to produce forensically valid results.
The ISL includes, inter alia , requirements for obtaining and maintaining WADA Laboratory accreditation and WADA laboratory approval for the ABP, operating standards for the performance of Laboratories and ABP Laboratories and a description of the accreditation and approval processes.
The ISL also sets out requirements and guidance for Anti-Doping Organizations in relation to Sample custody and storage, Analytical Testing and some aspects of Results Management .
Compliance with the ISL in effect at the time of Sample analysis (as opposed to another alternative standard, practice or procedure) shall be sufficient to conclude that the procedures covered by this International Standard were performed properly .
A failure by a Laborator y or ABP Laboratory to follow a requirement in effect at the time of Analytical Testing , which has subsequently been eliminated from this ISL or applicable Technical Document (s) or Technical Letter (s) at the time of a hearing , shall not serve as a defense to an anti -doping rule violation .
ISL – January 2021 Page 9 of 160 1.1.2 Technical Document s - Technical Document s are issued to provide direction to the Laboratories , ABP Laboratories and other stakeholders on specific technical or procedural issues.
Technical Document s are modified and/or withdrawn by WADA as appropriate .
- Technical Document s are approved by the WADA Executive Committee and published on WADA ’s website.
Once approved, a Technical Document becomes an integral part of the ISL and supersedes any previous publication on a similar topic 1, including Technical Letter (s) and/or the ISL .
- Implementation of the requirements detailed in a Technical Document may occur prior to the effective date for implementation specified in the Technical Document and shall occur no later than the effective date.
A failure by a Laboratory or ABP Laboratory to implement a Technical Document or Technical Letter by the effective date may result in the imposition of an Analytical Testing Restriction against the Laboratory for that particular Analytical Testing Procedure or a Suspension of the Laboratory ’s WADA accreditation, or a Suspension of the approval for the ABP, respectively, as determined by WADA ; [Comment: Laboratories and ABP Laboratories may implement a Technical Document as soon as it is approved by the WADA Executive Committee and published on WADA’s website, provided that the requirements of the Technical Document have been implemented and documented in the Laboratory ’s or ABP Laborato ry’s Standard Operating Procedure(s) [SOP(s)].
If a Laboratory or ABP Laboratory is not able to implement a new Technical Document by its effective date, it shall inform its clients and WADA as soon as possible.
The Laboratory or ABP Laboratory shall send a written request to WADA for an extension beyond the applicable effective date, providing the reason(s) for the delayed implementation of the Technical Document, any measures taken to ensure that Samples received in the Laboratory or ABP Laboratory will b e subject to Analytical Testing in compliance with the new Technical Document (for example, by subcontracting the analysis to another Laboratory or ABP Laboratory , as applicable ), as well as plans for the implementation of the new Technical Document.]
- The implementation of the Technical Document s requirements into the Laboratory ’s and, if relevant to the analysis of ABP blood Sample s, the ABP Laboratory ’s Management System is mandatory for obtaining and maintaining WADA accreditation or approval, respectively, and for the application of the relevant Analytical Testing Procedure (s) to the analysis of Samples ; - In cases when a newly approved version of a Technical Document lowers either a Decision Limit for a Threshold Substance or a Minimum Reporting Level for a Non-Threshold Substance , as applicable, the revised limits specified in the new 1 WADA will provide guidance to Laboratories , ABP Laboratories and other WADA stakeholders on the standard(s) that may be affected by a new Technical Document or Technical Letter in the Summary of Modifications that accompanies the publication of the revised version of the Technical Document or Technical Letter .
ISL – January 2021 Page 10 of 160 Technical Document shall not be applied to the reporting of analytical results for Samples collected before the effective date of the Technical Document .
[Comment: For example, if the application of a newly approved Technical Document results in an Adverse Analytical Finding for a Sample with a collection date prior to the effective date of that new Technical Document, which would not have resulted in an Adverse Analytical Finding with the application of the currently effective version of the Technical Document in effect at the time of Sample collection (for example if the Decision Limit for a Threshold Substance has been lowered in the newly approved Technical Docume nt), the Laboratory shall report the finding as a Negative Finding .
In addition, the Laboratory shall record the details of the finding as a comment in the Negative Finding Test Report. ]
- The most recently approved Technical Document shall be applied to the Analytical Testing of Samples prior to the effective date if it would lead to a result that benefits the Athlete (e.g.
increase of the Decision Limit for a Threshold Substance or of the Minimum Reporting Level for a Non-Threshold Substance , establishment of more stringent identification criteria for chromatographic -mass spectrometric or electrophoretic Confirmation Procedures ).
Therefore, in the case where an analytical finding does not meet the reporting criteria defined in the new Technic al Document , it shall be reported as a Negative Finding ; - Subject to the above, the analysis of Samples or the review of analytical data may occur immediately once a Technical Document has been approved.
1.1.3 Technical Letters - Technical Letters are issued in letter format on an ad-hoc basis in order to provide direction to the Laboratories , ABP Laboratories and other stakeholders on particular issues on the analysis, interpretation and reporting of results for specific Prohibited Substance (s) and/or Prohibited Method (s) or on the application of specific Laboratory procedures.
Technical Letters are modified a nd/or withdrawn by WADA as appropriate ; - Technical Letters are approved by the WADA Executive Committee and published on WADA ’s website.
Technical Letters become effective immediately, unless otherwise specified by WADA ; [Comment: Technical Letters may require actions [(e.g.
validation of new Analytes or modifications to Analytical Testing Procedures , the procurement of Reference Material (s) or Reference Collection (s)], which may justify that its application cannot be immediate.
In such cases, WADA shall make a time provision for implementation and specify an effective date for the Technical Letter .]
- Once approved, a Technical Letter becomes an i ntegral part of the ISL and supersedes any previous publication on a similar topic1, including Technical Document (s) and/or the ISL ; - The implementation of the requirements of relevant Technical Letters into the Laboratory ’s and, if relevant to the analysis of ABP blood Sample s, the ABP Laboratory ’s Management System is mandatory for obtaining and maintaining ISL – January 2021 Page 11 of 160 WADA accreditation or approval, respectively, and for the application of the relevant Analytical Testing Procedure (s) to the analysis of Samples.
1.1.4 Laboratory Guidelines - Laboratory Guidelines are issued in order to provide direction to the Laboratories , ABP Laboratories and other WADA stakeholders on new Analytical Methods or procedures approved by WADA .
Laboratory Guidelines are modified and/or deleted by WADA , as appropriate ; - Laboratory Guidelines are approved by the Laboratory Expert Group (LabEG ) and are published on WADA ’s website ; - Implementation of Laboratory Guidelines is not mandatory.
However, Laboratories and ABP Laboratories are encouraged to follow, to the fullest extent possible, the recommendations of best practice included in relevant Laboratory Guidelines .
1.1.5 Technical Notes - Technical Notes are issued to Laboratories to provide detailed technical guidance on the performance of specific Analytical Methods or procedures ; - Technical Notes are approved by the LabEG .
Technical Notes are provided to Laboratories only and are not published on WADA ’s website ; - Implementation of the recommendations detailed in Technical Notes is not mandatory.
However, Laboratories are encouraged to follow, to the fullest extent possible, the technical guidance included in Technical Notes .
1.2 Sample Analysis Sample analysis is part of the Analytical Testing process and involves the detection, identification, and in some cases demonstration of the presence above a Threshold of Prohibited Substance (s) and/or their Metabolite (s), or Marker (s) of Use of Prohibited Substances or Prohibited Methods in human biological fluids or tissues.
Laboratories may accept samples for other forms of analysis, subject to the provisions of the ISL Code of Ethics (see Annex A), which are not under the scope of WADA accred itation ( e.g.
animal sports testing, forensic testing, clinical testing, drugs of abuse testing).
Any such testing shall not be covered by the Laboratory ’s WADA accreditation and, therefore, shall not be subject to the requirements of the ISL, Technical Do cument s or Technical Letters .