International Standard for Laboratories (ISL)

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 subsequently 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 
0  Introduction and Scope ................................................................................................ 8 
1  WADA Laboratory Standards..................................................................................... 8 
1.1  International Standard for Laboratories (ISL) ................................................ 8 
1.2  Technical Documents ................................................................................. 9 
1.3  Technical Letters ...................................................................................... 10 
1.4  Laboratory Guidelines ............................................................................... 11 
1.5  Technical Notes ........................................................................................ 11 
2  Sample Analysis ..................................................................................................... 11 
3  WADA Laboratory Accreditation Framework and Laboratory Approval for the ABP .... 12 
0  Code Provisions ......................................................................................................... 13 
0  Definitions and Interpretations .................................................................................. 13 
1  Defined  terms  from  the  2021  Code  that  are  used  in  the  International  Standard  for 
Laboratories ........................................................................................................... 13 
2  Defined Terms from the International Standard for Laboratories ................................ 17 
3  Defined Terms from the International Standard for Testing and Investigations ........... 22 
4  Defined Terms from the International Standard for Results Management .................. 23 
5  Interpretation .......................................................................................................... 23 
PART TWO: LABORATORY ACCREDITATION AND LABORATORY APPROVAL FOR THE 
ABP REQUIREMENTS AND OPERATING STANDARDS ..................................................... 24 
0  Process  and  Requirements  for  WADA  Laboratory  Accreditation  and  Laboratory 
Approval for the ABP.......................................................................................................... 24 
1  Applicant Laboratory for WADA Accreditation........................................................... 24 
1.1  Expression of Interest ............................................................................... 24 
1.2  Submit Initial Application Form .................................................................. 24 
1.3  Provision of Letters of Support .................................................................. 24 
1.4  Provision of Business Plan ........................................................................ 25 
2  Candidate Laboratory for WADA Accreditation ......................................................... 25 
2.1  Description of the Candidate Laboratory .................................................... 25 
2.2  Payment of Initial Accreditation Fee ........................................................... 27 
2.3  Compliance with the Code of Ethics (Annex A) .......................................... 27 
2.4  Laboratory Independence and Impartiality ................................................. 27 

 
 
 
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2.5  Pre-Probationary Test and On-Site Assessment ........................................ 27 
3  Probationary Laboratory for WADA Accreditation ..................................................... 29 
3.1  Participating in the WADA EQAS Program ................................................. 29 
3.2  Planning and Implementing Research and Development Activities .............. 29 
3.3  Planning and Implementing Sharing of Knowledge ..................................... 29 
3.4  Compliance with the Code of Ethics (Annex A) .......................................... 29 
3.5  Obtaining ISO/IEC 17025 Accreditation by the Laboratory .......................... 30 
3.6  Analytical Testing Procedures ................................................................... 30 
3.7  Laboratory Independence and Impartiality ................................................. 30 
3.8  Professional Liability Insurance Coverage .................................................. 30 
4  WADA-Accredited Laboratory .................................................................................. 31 
4.1  Obtaining WADA accreditation .................................................................. 31 
4.2  Maintaining WADA Accreditation ............................................................... 33 
5  Removal of Samples by WADA ............................................................................... 39 
5.1  Removal of Samples for Analysis or Further Analysis ................................. 39 
5.2  Removal of Samples for Laboratory Quality Assessment ............................ 40 
6  WADA Monitoring of Accreditation Status ................................................................ 40 
6.1  Maintenance of WADA Accreditation ......................................................... 40 
6.2  Re-accreditation Costs .............................................................................. 40 
6.3  Issuing and Publication of Accreditation Certificate ..................................... 40 
6.4  Withdrawal of WADA Accreditation ............................................................ 41 
6.5  Consequences of Suspended or Revoked Accreditation or Analytical Testing 
Restriction ................................................................................................ 50 
6.6  Reinstatement of Suspended Accreditation or Lifting of the Analytical Testing 
Restriction ................................................................................................ 56 
6.7  Voluntary Cessation of Laboratory Operations ........................................... 59 
7  Process and Requirements for WADA Laboratory Approval for the ABP.................... 60 
7.1  Applicant Laboratory for WADA Approval for the ABP ................................ 60 
7.2  Candidate Laboratory for WADA Approval for the ABP ............................... 61 
7.3  Granting of WADA Approval for the ABP.................................................... 63 
7.4  Maintaining Status as an ABP Laboratory .................................................. 64 
0  Application of ISO/IEC 17025 to the Analysis of Samples ......................................... 66 
1  Introduction and Scope ........................................................................................... 66 
2  Structural and Resource Requirements .................................................................... 66 
2.1  General .................................................................................................... 66 

 
 
 
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2.2  Laboratory Personnel ................................................................................ 66 
2.3  Laboratory Facilities and Environmental Conditions.................................... 69 
2.4  Laboratory Equipment ............................................................................... 73 
2.5  Metrological Traceability............................................................................ 73 
2.6  Subcontracting of Analysis ........................................................................ 74 
2.7  Purchasing of Services and Supplies ......................................................... 75 
3  Process Requirements ............................................................................................ 75 
3.1  Reviewing of Requests, Tenders and Contracts ......................................... 75 
3.2  Reception, Registration and Handling of Samples ...................................... 75 
3.3  Acceptance of Samples for Analysis .......................................................... 76 
3.4  Initial Storage and Sample Aliquoting for Analysis ...................................... 79 
3.5  Selection and Validation of Analytical Testing Procedures .......................... 80 
3.6  Sample Analysis ....................................................................................... 85 
3.7  Assuring the Validity of Analytical Results ................................................ 101 
3.8  Results Management .............................................................................. 103 
3.9  Control of Nonconformities in Analytical Testing ....................................... 109 
3.10  Complaints ............................................................................................. 109 
3.11  Storage of Samples  ............................................................................... 110 
3.12  Secondary Use or Disposal of Samples and Aliquots ............................... 115 
4  Management Requirements .................................................................................. 117 
4.1  Organization ........................................................................................... 117 
4.2  Management Reviews............................................................................. 117 
4.3  Document Control ................................................................................... 117 
4.4  Control and Storage of Technical Records ............................................... 117 
4.5  Cooperation with Customers and with WADA........................................... 117 
0  WADA External Quality Assessment Scheme (EQAS) ............................................ 120 
1  Types of EQAS ..................................................................................................... 120 
1.1  Blind EQAS ............................................................................................ 120 
1.2  Double-Blind EQAS ................................................................................ 120 
1.3  Educational EQAS .................................................................................. 120 
2  EQAS Sample Number and Composition ............................................................... 120 
2.1  Number of EQAS Samples ...................................................................... 120 
2.2  Composition of EQAS Samples ............................................................... 121 
2.3  Laboratory Analytical Testing Procedures Used in EQAS ......................... 123 

 
 
 
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3  Reporting of EQAS results..................................................................................... 123 
3.1  Reporting Blind EQAS Results ................................................................ 124 
3.2  Reporting Double-Blind EQAS Results .................................................... 124 
3.3  Reporting Educational EQAS Results ...................................................... 125 
3.4  Reporting Results for EQAS Samples Containing Non-Threshold Substances
 .............................................................................................................. 125 
3.5  Reporting Results for EQAS Samples Containing Threshold Substances .. 125 
 
0  Evaluation of Laboratory EQAS and Routine Analytical Testing Performance ....... 127 
1  Evaluation of EQAS Results .................................................................................. 127 
1.1  EQAS Samples Containing Non-Threshold Substances ........................... 128 
1.2  EQAS Samples Containing Threshold Substances ................................... 128 
2  Evaluation of Laboratory Performance ................................................................... 130 
2.1  False Adverse Analytical Finding ............................................................. 130 
2.2  False Negative Finding ........................................................................... 137 
2.3  Further Procedural Evaluations  .............................................................. 138 
3  Overall Laboratory Evaluation ................................................................................ 138 
Points  Scale  Table  for  Assessment  of  Laboratory  and  Probationary  Laboratory 
Performance ........................................................................................... 140 
4  Probationary Period and Probationary Laboratory Evaluation.................................. 142 
4.1  Analytical  Testing  Procedures  Utilized  by Probationary  Laboratories  for  the 
Analysis of EQAS samples ...................................................................... 142 
4.2  False Adverse Analytical Finding Result .................................................. 142 
4.3  False Negative Finding ........................................................................... 142 
4.4  Threshold Substance Result ................................................................... 143 
4.5  Overall Probationary Laboratory Evaluation ............................................. 143 
PART THREE: ISL ANNEXES ........................................................................................... 145 
ISL ANNEX A - CODE OF ETHICS FOR LABORATORIES and ABP LABORATORIES ..... 145 
0  Confidentiality ....................................................................................................... 145 
0  Research in Support of Doping Control .................................................................. 145 
1  Research on Human Subjects ................................................................. 145 
2  Controlled Substances ............................................................................ 145 
0  Analysis ................................................................................................................ 145 
1  Analytical Testing for Anti-Doping Organizations (Signatories or WADA) ... 146 
2  Analytical Testing for non-Signatories ...................................................... 146 
3  Clinical or Forensic Analysis .................................................................... 146 

 
 
 
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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 
 
 
   

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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 WADA 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 facilitate

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 Laboratory 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.

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1.1.2 Technical Documents

- Technical Documents are issued to provide direction to the Laboratories, ABP

Laboratories and other stakeholders on specific technical or procedural issues.

Technical Documents are modified and/or withdrawn by WADA as appropriate.

- Technical Documents 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

, 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 Laboratory’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 be 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 Documents requirements into the

Laboratory’s and, if relevant to the analysis of ABP blood Samples, 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

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.

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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 Document), 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 Technical

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 and/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 integral part of the ISL and

supersedes any previous publication on a similar topic

, 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 Samples, the ABP

Laboratory’s Management System is mandatory for obtaining and maintaining

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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 accreditation (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 Documents or Technical Letters. 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 their 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 correspondence from ABP

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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

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 Laboratories, 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 Documents,

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.

Effective version of ISO/IEC 17025.

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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 Confidentiality 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

legislation.

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 Metabolites 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 Organizations 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-

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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 and 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 sport 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 National 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.]

Athlete 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 participating 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 hearing 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 distribution of

information to the general public or Persons beyond those Persons entitled to earlier

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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 result 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 for 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, whereabouts, 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 Championships 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 collection 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 such 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 Committees

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 responsibility 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 shall 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 those 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 Failure), 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 Methods. 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 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.

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 Laboratory 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 result 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 Substance, 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 Action” 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 items 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 extent 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 flexible 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.]

ISL – January 2021 Page 19 of 160

Further Analysis: Further Analysis, as this term is used in the ISL, occurs when a Laboratory

conducts additional analysis on an “A” Sample or a “B” Sample after an analytical result for

that “A” Sample or that “B” Sample has been reported by the Laboratory.

[Comment: There is no limitation on a Laboratory’s authority to conduct repeat or confirmation

analysis, or to analyze a Sample with additional Analytical Methods, or to perform any other type of

additional analysis on an “A” Sample or “B” Sample prior to reporting an analytical result on that Sample.

That is not considered Further Analysis.

If a Laboratory is to conduct additional analysis on an “A” Sample or “B” Sample after an analytical

result for that Sample has been reported (for example: additional Sample analysis to detect EPO, or

GC/C/IRMS analysis, or analysis in connection with the Athlete Biological Passport or additional

analysis on a stored Sample) it may do so after receiving approval from the Testing Authority or Results

Management Authority (if different) or WADA. However, after an Athlete has been charged with a Code

Article 2.1 anti-doping rule violation based on the presence of a Prohibited Substance, Metabolite(s) of

a Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance or Prohibited Method in a

Sample, then Further Analysis on that Sample may only be performed with the consent of the Athlete

or approval from a hearing body (see Code Article 6.5).

Further Analysis may be performed by the same Laboratory that did the original Analytical Testing, or

by a different Laboratory or other WADA-approved laboratory, at the direction of the Testing Authority

or Results Management Authority (if different) or WADA. Any other Anti-Doping Organization that

wishes to conduct Further Analysis on a stored Sample may do so with the permission of the Testing

Authority or Results Management Authority (if different) or WADA and shall be responsible for any

follow-up Results Management. Any Sample storage or Further Analysis initiated by WADA or another

Anti-Doping Organization shall be at WADA’s or that Anti-Doping Organization’s expense.]

Independent Witness: A Person, invited by the Testing Authority, the Laboratory or WADA

to witness the opening and initial aliquoting of an Athlete’s “B” Sample. An Independent

Witness shall not be an employee or have a personal financial relationship with the Athlete or

his/her representative(s), the Laboratory, the Sample Collection Authority, the Testing

Authority / Delegated Third Parties / Results Management Authority or WADA, as applicable.

However, the Independent Witness may be indemnified for his/her service.

Initial Testing Procedure (ITP): An Analytical Testing Procedure whose purpose is to

identify those Samples which may contain a Prohibited Substance, Metabolite(s) of a

Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance or Prohibited Method

or an elevated quantity of a Prohibited Substance, Metabolite(s) of a Prohibited Substance,

or Marker(s) of the Use of a Prohibited Substance or Prohibited Method.

Intermediate Precision (s

): Variation in results observed when one or more factors, such

as time, equipment, or operator are varied within a Laboratory. It is also referred to as inter-

batch / inter-run precision.

Laboratory Internal Chain of Custody: Documentation maintained within the Laboratory to

record the chronological traceability of custody (by Person(s) or upon storage) and actions

performed on the Sample and any Aliquot of the Sample taken for Analytical Testing.

[Comment: Laboratory Internal Chain of Custody is generally documented by a written or electronic

record of the date, location, action taken, and the Person performing an action with a Sample or Aliquot.]

Laboratory: A WADA-accredited laboratory applying Test Methods and processes to provide

evidentiary data for the detection and/or identification of Prohibited Substances or Prohibited

Methods on the Prohibited List and, if applicable, quantification of a Threshold Substance in

Samples of urine and other biological matrices in the context of Doping Control activities.

ISL – January 2021 Page 20 of 160

Laboratory Expert Group (LabEG): Group of laboratory experts responsible for providing

advice, recommendations and guidance to WADA with respect to the overall management of

anti-doping Laboratory accreditation and ABP approval, Laboratory and ABP Laboratory

disciplinary action, re-accreditation and approval processes as well as Laboratory and ABP

Laboratory monitoring activities.

Laboratory Guidelines (LGs): Recommendations of Laboratory best practice provided by

WADA to address specific Laboratory operations or to provide technical requirements and

guidance on interpretation and reporting of results for the analysis of specific Prohibited

Substance(s) and/or Prohibited Method(s) or on the application of specific Laboratory

procedures.

[Comment: Laboratory Guidelines are posted on WADA’s website, are not of mandatory application

and may be later incorporated, partially or in full, in Technical Document(s) or in the ISL. Laboratory

Guidelines are approved by the LabEG].

Laboratory Documentation Package (LDP): The material produced by a Laboratory upon

request by the Testing Authority, Results Management Authority or WADA, as set forth in the

Technical Document on Laboratory Documentation Packages (TD LDOC), to support an

analytical result such as an Adverse Analytical Finding or an Atypical Finding.

Limit of Detection (LOD): Analytical parameter of assay technical performance. Lowest

concentration of an Analyte in a Sample that can be routinely detected, but not necessarily

identified or quantified, under the stated Test Method conditions.

Limit of Identification (LOI): Analytical parameter of technical performance for

chromatographic-mass spectrometric Confirmation Procedures. The LOI is estimated during

method validation to evaluate the rate of false negative results at a certain concentration level.

The LOI of a Test Method, at 5% false negative rate, for an Analyte (for which a Reference

Material is available) shall be less than the MRPL.

[Comment: Since the LOI is an estimation of the false negative rate, Laboratories may report findings

below the estimated LOI as Adverse Analytical Findings or Atypical Findings, as applicable, when the

Analyte is identified in the Sample according to the criteria established in the Technical Document on

chromatographic-mass spectrometric identification criteria (TD IDCR).]

Limit of Quantification (LOQ): Analytical parameter of assay technical performance. Lowest

concentration of an Analyte in a Sample that can be quantitatively determined with acceptable

precision and accuracy (i.e. acceptable Measurement Uncertainty) under the stated Test

Method conditions.

Major Event: A series of individual international Competitions conducted together under an

international multi-sport organization functioning as a ruling body (e.g. the Olympic Games,

Pan American Games).

Measurement Uncertainty (MU): Parameter associated with a measurement result that

characterizes the dispersion of quantity values attributed to the measure and provides

confidence in the validity of the measured result [see Technical Document on Decision Limits

(TD DL)].

Minimum Required Performance Level (MRPL): Minimum analytical criterion of Laboratory

technical performance established by WADA. Minimum concentration at which a Laboratory

is expected to consistently detect and confirm a Prohibited Substance or Metabolite of a

ISL – January 2021 Page 21 of 160

Prohibited Substance or Marker of a Prohibited Substance or Prohibited Method in the routine

daily operation of the Laboratory. Individual Laboratories may and are expected to achieve

better performance [see Technical Document on Minimum Required Performance Levels (TD

MRPL)].

Negative Finding: A test result from a Laboratory which, in accordance with the effective ISL

and/or relevant Technical Document(s) and/or Technical Letter(s), concludes that no

Prohibited Substance(s) or its Metabolite(s) or Marker(s) or evidence of the Use of a

Prohibited Method(s), included in the requested Analytical Testing menu, were found in a

Sample based on the applied Initial Testing Procedure(s) or Confirmation Procedure(s).

Non-Threshold Substance: A substance listed on the Prohibited List for which the

identification, in compliance with the Technical Document on chromatographic-mass

spectrometric identification criteria (TD IDCR) or other applicable Technical Document(s),

constitutes an Adverse Analytical Finding.

Presumptive Adverse Analytical Finding (PAAF): The status of a Sample test result from

the Initial Testing Procedure which represents a suspicious finding, but for which a

Confirmation Procedure to render a conclusive test result has not yet been performed.

Provisional Suspension: Temporary Suspension of a Laboratory’s WADA accreditation or

a laboratory’s ABP approval pending a final decision by WADA regarding its accreditation

status.

Reference Collection (RC): A collection of samples or isolates of known origin that may be

used in the determination of the identity of an unknown substance. For example, a well-

characterized sample obtained from a controlled administration or from in vitro studies in

which the presence of the substance of interest has been established.

Reference Material (RM): Reference Substance or Reference Standard, which is sufficiently

characterized, homogeneous and stable with respect to one or more specified properties and

that has been established to be fit for its intended use in an Analytical Testing Procedure.

Repeatability (s

): Variability of results obtained within a laboratory using the same method,

over a short time, using a single operator, item of equipment, etc. It is also referred to as intra-

batch / intra-run precision.

Reproducibility (s

): Variability of results obtained when different laboratories analyze

Aliquots of the same sample. Reproducibility is a property of the results obtained and

represents a measurable agreement of analytical results between different laboratories.

Revocation: The permanent withdrawal of a Laboratory’s WADA accreditation or a

laboratory’s ABP approval.

Root Cause Analysis (RCA): An investigation to identify one or more fundamental cause(s)

of a nonconformity based on the collection of objective evidence from an assessment of the

likely factors that led to the nonconformity. The removal of a root cause factor prevents the

recurrence of the nonconformity; in contrast, removing a causal factor can improve the

outcome, but it does not prevent the recurrence of the problem with certainty.

Selectivity: The ability of the Analytical Testing Procedure to detect or identify, as applicable,

the substance of interest in the Sample.

Suspension: The temporary withdrawal of a Laboratory’s WADA accreditation or a

laboratory’s ABP approval.

ISL – January 2021 Page 22 of 160

Technical Letter (TL): Mandatory technical requirements provided by WADA from time to

time (ad-hoc) to address particular issues on the analysis, interpretation and reporting of

specific Prohibited Substance(s) and/or Prohibited Method(s) or on the application of specific

Laboratory or ABP Laboratory procedures.

[Comment: Technical Letters are approved by the WADA Executive Committee and posted on

WADA’s website. Technical Letters become effective immediately, unless otherwise specified by

WADA].

Technical Note (TN): Technical guidance provided by WADA to Laboratories on the

performance of specific Laboratory methods or procedures.

[Comment: Technical Notes are not considered part of Technical Documents and therefore are not of

mandatory application. Technical Notes are approved by the LabEG and become effective

immediately].

Test Method: Analytical Testing Procedure, Analytical Method.

Threshold: The maximum permissible level of the concentration, ratio or score for a

Threshold Substance in a Sample. The Threshold is used to establish the Decision Limit for

reporting an Adverse Analytical Finding or Atypical Finding for a Threshold Substance.

Threshold Substance: An exogenous or endogenous Prohibited Substance, Metabolite or

Marker of a Prohibited Substance for which the identification and quantitative determination

(e.g. concentration, ratio, score) in excess of a pre-determined Decision Limit, or, when

applicable, the establishment of an exogenous origin, constitutes an Adverse Analytical

Finding. Threshold Substances are identified as such in the Technical Document on Decision

Limits (TD DL).

3.3 Defined Terms from the International Standard for Testing and Investigations

Sample Collection Authority: The organization that is responsible for the collection of

Samples in compliance with the requirements of the International Standard for Testing and

Investigations, whether (1) the Testing Authority itself; or (2) a Delegated Third Party to whom

the authority to conduct Testing has been granted or sub-contracted. The Testing Authority

always remains ultimately responsible under the Code for compliance with the requirements

of the International Standard for Testing and Investigations relating to collection of Samples.

Sample Collection Session: All of the sequential activities that directly involve the Athlete

from the point that initial contact is made until the Athlete leaves the Doping Control Station

after having provided their Sample(s).

Suitable Volume of Urine for Analysis: A minimum of 90 mL, whether the Laboratory will

be analyzing the Sample for all or only some Prohibited Substances or Prohibited Methods.

Test Distribution Plan: A document written by an Anti-Doping Organization that plans

Testing on Athletes over whom it has Testing Authority, in accordance with the requirements

of Article 4 of the International Standard for Testing and Investigations.

Testing Authority: The Anti-Doping Organization that authorizes Testing on Athletes it has

authority over. It may authorize a Delegated Third Party to conduct Testing pursuant to the

authority of and in accordance with the rules of the Anti-Doping Organization. Such

ISL – January 2021 Page 23 of 160

authorization shall be documented. The Anti-Doping Organization authorizing Testing

remains the Testing Authority and ultimately responsible under the Code to ensure the

Delegated Third Party conducting the Testing does so in compliance with the requirements of

the International Standard for Testing and Investigations.

3.4 Defined Terms from the International Standard for Results Management

Passport: A collation of all relevant data unique to an individual Athlete that may include

longitudinal profiles of Markers, heterogeneous factors unique to that particular Athlete and

other relevant information that may help in the evaluation of Markers.

Passport Custodian: The Anti-Doping Organization responsible for Result Management of

the Athlete’s Passport and for sharing any relevant information associated to that Athlete’s

Passport with other Anti-Doping Organization(s).

Results Management Authority: The Anti-Doping Organization responsible for conducting

Results Management in a given case.

3.5 Interpretation

3.5.1 The official text of the International Standard for Laboratories shall be published in

English and French. In the event of any conflict between the English and French

versions, the English version shall prevail.

3.5.2 Like the Code, the International Standard for Laboratories has been drafted giving

consideration to the principles of proportionality, human rights, and other applicable

legal principles. It shall be interpreted and applied in that light.

3.5.3 The comments annotating various provisions of the International Standard for

Laboratories shall be used to guide its interpretation.

3.5.4 Unless otherwise specified, references to Sections and Articles are references to

Sections and Articles of the International Standard for Laboratories.

3.5.5 Where the term “days” is used in the International Standard for Laboratories, it shall

mean calendar days unless otherwise specified.

3.5.6 The Annexes to the International Standard for Laboratories have the same mandatory

status as the rest of the International Standard.

ISL – January 2021 Page 24 of 160

PART TWO: LABORATORY ACCREDITATION AND LABORATORY

APPROVAL FOR THE ABP REQUIREMENTS AND OPERATING STANDARDS

4.0 Process and Requirements for WADA Laboratory Accreditation and Laboratory

Approval for the ABP

This section describes the specific requirements that a laboratory shall fulfill in the process of

applying for, obtaining, and maintaining WADA accreditation or WADA approval for the ABP.

4.1 Applicant Laboratory for WADA Accreditation

In principle, any laboratory that satisfies the criteria listed below may apply to become a

candidate laboratory for WADA accreditation. However, the WADA Executive Committee, at

its sole discretion, may accept or deny a laboratory’s candidacy application based on the

identified needs (or lack thereof) for anti-doping Analytical Testing on a regional or national

scale, or for any other reason(s).

4.1.1 Expression of Interest

The applicant laboratory shall officially contact WADA in writing to express its interest

in becoming a WADA-accredited laboratory.

4.1.2 Submit Initial Application Form

The applicant laboratory shall submit a completed Application Form, provided by

WADA, duly signed by the laboratory Director and, if relevant, by the Director of the

host organization (e.g. university, hospital, public institution).

An applicant laboratory may only submit an application if its host country satisfies the

following conditions:

- The existence of a National Anti-Doping Program conducted by a National Anti-

Doping Organization and/or a Regional Anti-Doping Organization, which is

compliant with the Code and the International Standards of the World Anti-Doping

Program;

- The ratification of the UNESCO Convention against Doping in Sport; and

- The payment of the annual financial contributions to WADA.

These conditions shall be documented as part of the application.

4.1.3 Provision of Letters of Support

Upon receipt of an application and verification of the conditions mentioned above,

WADA shall request that the applicant laboratory submit the following letters of

support:

- Official letter(s) of support from host organizations acceptable to WADA (e.g.

universities, hospitals, private organizations and/or public institutions) that

ISL – January 2021 Page 25 of 160

guarantee sufficient annual financial support for a minimum of three (3) years, the

provision of adequate analytical facilities, instrumentation and human resources,

as well as support for training programs, research and development activities;

- Official letter(s) of support from Signatories, such as a National Anti-Doping

Organization or Regional Anti-Doping Organization responsible for a National Anti-

Doping Program, or an International Federation responsible for an International

Anti-Doping Program. Such letter(s) of support shall indicate a commitment to

provide the Laboratory with a minimum of 3,000 Samples per year by the end of

the second calendar year after obtaining WADA accreditation;

[Comment: To determine the minimum number of Samples, each urine Sample, blood

Sample and ABP blood Sample analyzed by the Laboratory shall count as an individual

Sample.]

- A declaration by the supporting Signatory(-ies) that their relationship with the

applicant laboratory is compliant with Article 4.4.2.4.

4.1.4 Provision of Business Plan

WADA shall request the applicant laboratory to submit a business plan, which shall

include market considerations (clients, number of Samples, maintenance costs, etc.),

facility, instrumental, staffing and training needs, and shall guarantee the long-term

provision of adequate financial and human resources to the laboratory.

4.2 Candidate Laboratory for WADA Accreditation

The application materials described in Articles 4.1.1 to 4.1.4 shall be evaluated by the WADA

Executive Committee to determine whether the applicant laboratory will be granted WADA

candidate laboratory status and thereby continue within the WADA accreditation process.

Additional supporting documentation may be requested by, and at the discretion of, the WADA

Executive Committee.

4.2.1 Description of the Candidate Laboratory

Once approved by the WADA Executive Committee, the candidate laboratory shall

complete a detailed questionnaire provided by WADA and submit it to WADA within

eight (8) weeks following receipt. The questionnaire will include, but is not limited to,

the following:

- Staff list and their qualifications, including description of any relevant anti-doping

experience and a list of relevant scientific publications by laboratory staff;

- Description of the physical laboratory facilities, including a description of the

security considerations for Samples and records. The laboratory facilities shall

include ample analytical and administrative space to allow separate, restricted and

dedicated areas for analytical and administrative operations.

o Physical Security: specific measures to maintain secure and restricted access

ISL – January 2021 Page 26 of 160

to the laboratory facility and a controlled internal laboratory environment (e.g.

dedicated and restricted Sample storage areas, CCTV monitoring);

o IT Security: implementation of firewalls and other cyber security measures

consistent with best practice and any applicable governmental regulations (see

Article 5.2.3.5);

o Information Technology (IT) infrastructure: implementation of a data and

information management system (e.g. LIMS), central server/intranet which

allows secure data handling (see Article 5.2.3.5).

- List of actual and proposed instrumental resources and equipment, including year

of purchase and conditions for technical support (e.g. contract/access to

instrument manufacturer maintenance services);

- List of validated Initial Testing Procedures and Confirmation Procedures, including

target Analytes and Limits of Detection (LODs), Limits of Identification (LOIs) and,

where applicable, Limits of Quantification (LOQs) and Measurement Uncertainties

(MU);

- Status of method development and validation, including, at minimum, all

mandatory Analytical Methods and method validation reports (if completed);

- List of available Reference Materials and Reference Collections, or plans to

acquire Reference Materials or obtain Reference Collections;

- Plans to ensure compliance with laboratory independence and impartiality

requirements before receiving WADA accreditation (see Article 4.4.2.4);

- List of laboratory sponsors;

- Contract or Memorandum of Understanding with a Laboratory, which will provide

mentoring and training for at least the period spanning the probationary phase of

accreditation;

[Comment: Candidate laboratories are encouraged to establish agreement(s) with a

Laboratory(-ies) for mentoring and training, at least, up to the end of the probationary phase of

accreditation in order to ensure successful preparation towards obtaining the WADA

accreditation.

An authorization for the candidate laboratory to receive sensitive anti-doping information (e.g.

methodological or technological information, Technical Notes) and/or to obtain access to

specific, WADA-developed anti-doping tests or materials (e.g. kits, Reference Materials) may

be approved by WADA on a case-by-case basis according to the documented roadmap,

business plan and the progress made during the accreditation process and subject to the

candidate laboratory entering into a confidentiality agreement with WADA and/or the

Laboratory(-ies) that will provide the information and/or access to the aforementioned tests and

materials.]

- Status of ISO/IEC 17025 accreditation;

- Description of customs regulations in the host country with respect to the reception

ISL – January 2021 Page 27 of 160

of urine and blood samples, Reference Materials and consumables from abroad

and the ability to ship samples outside the country as needed;

- A description of how the principles of the Code of Ethics (Annex A) are integrated

into the laboratory Management System. A letter of compliance with the Code of

Ethics (Annex A) signed by the laboratory Director shall be provided.

WADA may require an update of this documentation during the process of

accreditation.

4.2.2 Payment of Initial Accreditation Fee

Prior to entering the probationary period, the candidate laboratory shall pay WADA a

one-time non-refundable fee to cover the costs related to the initial accreditation

process. This fee shall be determined by WADA.

4.2.3 Compliance with the Code of Ethics (Annex A)

The candidate laboratory shall implement and comply with the provision(s) of the Code

of Ethics. Candidate laboratories shall not conduct any anti-doping Analytical Testing

activities for Signatories or WADA and shall not accept Samples directly from

individual Athletes or from individuals or organizations acting on their behalf.

The Director of the candidate laboratory shall provide the Code of Ethics to all

employees and ensure their understanding and compliance with all aspects of the

Code of Ethics.

4.2.4 Laboratory Independence and Impartiality

As a condition to enter the probationary period, the candidate laboratory shall provide

documentation to WADA demonstrating that, before obtaining WADA accreditation,

they will comply with the requirements of Laboratory independence and impartiality

indicated in Article 4.4.2.4.

4.2.5 Pre-Probationary Test and On-Site Assessment

Prior to entering the probationary period, WADA shall conduct a pre-probationary test

(PPT) and on-site assessment of the candidate laboratory at the candidate

laboratory’s expense. The purpose of this assessment is to obtain information about

different aspects of the laboratory’s competence and to clarify any issues with regard

to the accreditation process, which are relevant for the WADA accreditation.

As part of the PPT, the candidate laboratory shall be required to analyze at least ten

(10) blind EQAS samples. The general composition and content of the blind EQAS

samples and the evaluation of laboratory EQAS results are described in Sections 6.0

and 7.0, respectively.

The candidate laboratory shall report the results for the PPT blind EQAS samples in

ADAMS (in compliance with Article 6.3.1) within a period of twenty (20) days, unless

otherwise notified by WADA.

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- Upon request, the candidate laboratory shall provide WADA with a Laboratory

Documentation Package for selected EQAS samples for which there is an Adverse

Analytical Finding. Additional data may be required upon WADA’s request. This

documentation shall be submitted within ten (10) days of WADA’s request or as

otherwise indicated by WADA;

- For selected EQAS samples with Negative Findings, WADA may request all or a

portion of the Initial Testing Procedure data.

After receiving the PPT EQAS results, WADA shall inform the candidate laboratory of

the evaluation of its performance and provide guidance for improvement. Corrective

actions, if any, shall be conducted and reported by the candidate laboratory to WADA

within thirty (30) days, or as otherwise indicated by WADA.

In addition, WADA shall provide an Assessment Report regarding the outcomes of the

on-site assessment, including any identified nonconformity(-ies), in order to allow the

candidate laboratory to implement the necessary improvements. Corrective actions, if

requested by WADA, shall be conducted and reported by the candidate laboratory to

WADA within thirty (30) days, or as otherwise indicated by WADA.

The nonconformities identified in the WADA Assessment Report shall be satisfactorily

addressed and the recommendations for improvement should be implemented before

the candidate laboratory can be accepted as a WADA probationary laboratory. The

candidate laboratory’s performance in the PPT and on-site assessment will be taken

into account in the overall review of the candidate laboratory’s application and may

affect the timeliness of the candidate laboratory’s entry into the probationary phase of

accreditation.

The maximum length of time during which a laboratory can remain as a candidate

laboratory is three (3) years, unless WADA determines that there are exceptional

circumstances that justify an extension of this period.

Upon satisfactory completion of the candidate laboratory requirements (as per Article

4.2), as determined by the LabEG, a candidate laboratory enters the probationary

phase of WADA accreditation as a “WADA probationary laboratory”.

ISL – January 2021 Page 29 of 160

4.3 Probationary Laboratory for WADA Accreditation

4.3.1 Participating in the WADA EQAS Program

During the probationary period, the laboratory shall successfully analyze at least

fifteen (15) blind EQAS samples, distributed over multiple EQAS rounds within a period

of twelve (12) months (see Section 6.0 for a description of the EQAS). During this

period, WADA shall provide feedback to assist the probationary laboratory to improve

the quality of its Analytical Testing process.

The probationary laboratory shall successfully report the results for the blind EQAS

samples to WADA in accordance with Article 6.3.1 within a period determined by

WADA. The general composition and content of the blind EQAS samples and the

evaluation of laboratory EQAS results are described in Sections 6.0 and 7.0,

respectively.

4.3.2 Planning and Implementing Research and Development Activities

The probationary laboratory shall develop a plan for its research and development

activities in the field of anti-doping science, for the initial three (3)-year period after

obtaining WADA accreditation, allocating at least 7% of the operational annual budget

expected from activities associated with Signatories.

At least two (2) research and development activities shall be initiated and implemented

within the probationary period. The research activities can either be conducted by the

probationary laboratory alone or in cooperation with other Laboratories or other

research organizations.

[Comment: The validation or implementation of established anti-doping methods with only

minor adjustments, or repetition of research previously published or presented by others, is not

sufficient to be considered as a research and development activity.]

As part of its laboratory monitoring activities, WADA may request documented

evidence of the research and development activities in the field of anti-doping science

implemented by the probationary laboratory.

4.3.3 Planning and Implementing Sharing of Knowledge

During the probationary period, the probationary laboratory shall demonstrate its

willingness and ability to collaborate and share knowledge with other Laboratories. A

description of this sharing of knowledge is provided in the Code of Ethics (Annex A).

4.3.4 Compliance with the Code of Ethics (Annex A)

The probationary laboratory shall implement and comply with the provision(s) of the

Code of Ethics. Probationary laboratories shall not conduct any anti-doping Analytical

Testing activities for Signatories or WADA and shall not accept Samples directly from

individual Athletes or from individuals or organizations acting on their behalf.

The Director of the probationary laboratory shall provide the Code of Ethics to all

ISL – January 2021 Page 30 of 160

employees and ensure their understanding and compliance with all aspects of the

Code of Ethics.

4.3.5 Obtaining ISO/IEC 17025 Accreditation by the Laboratory

Before WADA grants accreditation, the probationary laboratory shall obtain ISO/IEC

17025 accreditation from an Accreditation Body, with primary reference to the

interpretation and application of the ISO/IEC 17025 requirements to the analysis of

Samples (see Section 5.0). The Accreditation Body shall be an International

Laboratory Accreditation Cooperation (ILAC) full member that is a signatory to the

ILAC Mutual Recognition Arrangement (ILAC MRA).

The probationary laboratory shall prepare and establish the required documentation

and Management System according to the requirements of ISO/IEC 17025 applicable

to the analysis of Samples (see Section 5.0). Based on this, the laboratory shall initiate

and prepare for the accreditation process by consulting with an Accreditation Body.

The probationary laboratory shall correct and document any identified nonconformities

with the ISO/IEC 17025 standard within the defined timelines.

The Accreditation Body should send a summary of the Assessment Report and any

corrective/preventive action documentation addressing nonconformities, in English or

French, to WADA. Should the probationary laboratory prefer to send the information

directly to WADA, the laboratory shall do so within a reasonable timeline.

The ISO/IEC 17025 accreditation shall be obtained before the end of the probationary

period. This is a critical and mandatory pre-requisite for obtaining WADA accreditation.

4.3.6 Analytical Testing Procedures

Before WADA grants accreditation, probationary laboratories shall provide

documentation to WADA demonstrating that all mandatory Test Methods (e.g.

GC/C/IRMS, hGH, GHRF and EPO methods) have been validated and included in the

Laboratory’s Scope of ISO/IEC 17025 accreditation.

4.3.7 Laboratory Independence and Impartiality

Before WADA grants accreditation, probationary laboratories shall provide

documentation to WADA demonstrating compliance with the requirements of

Laboratory independence and impartiality established in Article 4.4.2.4.

4.3.8 Professional Liability Insurance Coverage

Before WADA grants accreditation, probationary laboratories shall provide

documentation to WADA demonstrating that professional liability risk insurance

coverage has been obtained to cover liability of no less than two (2) million USD

annually.

ISL – January 2021 Page 31 of 160

4.4 WADA-Accredited Laboratory

4.4.1 Obtaining WADA accreditation

4.4.1.1 WADA Accreditation Assessment - Final Accreditation Test

Once WADA has determined that the laboratory has successfully completed

the requirements of the probationary period, and upon request by the

probationary laboratory stating its readiness to proceed further, a Final

Accreditation Test (FAT) and on-site assessment shall be conducted by

WADA. At WADA’s discretion, the FAT and on-site assessment may be

conducted separately or at the same time. Representative(s) of the

Accreditation Body may be invited as observers to the WADA on-site

assessment.

As part of the FAT, the probationary laboratory shall analyze a minimum of

fifteen (15) blind EQAS samples. The general composition and content of the

blind EQAS samples and the evaluation of laboratory EQAS results are

described in Sections 6.0 and 7.0, respectively.

Compliance with the defined requirements in the Application of ISO/IEC

17025 to the analysis of Samples, the ISL and other WADA Laboratory

standards (Technical Documents, Technical Letters, Laboratory Guidelines),

and the practice and documentation of the laboratory will be assessed. The

FAT shall assess both the scientific competence and the capability of the

probationary laboratory to manage multiple Samples.

Costs associated with the WADA on-site assessment and FAT shall be at the

probationary laboratory’s expense.

The probationary laboratory shall successfully report the results for the blind

EQAS samples in the FAT to WADA in accordance with Article 6.3.1 within

seven (7) days of opening the samples, unless otherwise determined by

WADA:

- Upon request, the probationary laboratory shall provide WADA with a

Laboratory Documentation Package for selected EQAS samples for

which there is an Adverse Analytical Finding. Additional data may be

required upon WADA’s request. This documentation shall be submitted

within ten (10) days of WADA’s request or as otherwise indicated by

WADA;

- For EQAS samples with Negative Findings, WADA may request all or a

portion of the Initial Testing Procedure data.

After receiving the FAT EQAS results, WADA shall inform the probationary

laboratory of the evaluation of its performance. Corrective actions, if any,

shall be conducted and reported by the probationary laboratory to WADA

within thirty (30) days, or as otherwise indicated by WADA.

ISL – January 2021 Page 32 of 160

WADA shall provide an Assessment Report with the outcomes of the

accreditation assessment, including any identified nonconformities in order

for the probationary laboratory to implement the necessary improvements.

Corrective actions, if any, shall be conducted and reported by the

probationary laboratory to WADA within thirty (30) days, or as otherwise

indicated by WADA. The nonconformities identified in the FAT EQAS and the

Assessment Report shall be satisfactorily addressed by the laboratory and

the recommendations for improvement should be implemented before

accreditation can be granted.

4.4.1.2 WADA Recommendation for Accreditation

Based on the relevant documentation received from the probationary

laboratory, the Assessment Report(s) from WADA and from the relevant

Accreditation Body, the LabEG shall evaluate the probationary laboratory’s

progress in meeting all the requirements outlined in Articles 4.3 and 4.4.1.1.

Once all accreditation requirements have been satisfactorily met by the

probationary laboratory, the LabEG will submit its recommendation that the

laboratory be granted WADA accreditation to the WADA Executive

Committee for approval.

However, if following the FAT and on-site assessment, and the review of any

resulting Corrective Action Reports submitted by the probationary laboratory,

the LabEG determines that the probationary laboratory should not be

accredited, the laboratory will have a maximum of six (6) additional months

to correct and improve any pending nonconformity(-ies). The provision of

documentation, the analysis of additional EQAS samples and/or an

additional assessment (on-site, remotely or as a documentary audit, as

determined by WADA), may be required and conducted at the probationary

laboratory’s expense. A probationary laboratory that fails to provide

satisfactory improvements, as determined by the LabEG, after six (6) months

may be required to renew its candidacy as described in Article 4.2 or to re-

start the probationary phase of accreditation in accordance with Article 4.3.

Once a laboratory becomes a WADA-accredited laboratory, the new

Laboratory shall, for a period of one (1) year, obtain a second opinion from

an(other) Laboratory(-ies) before reporting any Adverse Analytical Finding or

Atypical Finding. WADA may extend this requirement to obtain a second

opinion beyond one (1) year.

4.4.1.3 Issuing and Publishing of WADA Accreditation Certificate

An Accreditation Certificate signed by a duly authorized representative of

WADA shall be issued in recognition of the WADA accreditation. Such

Accreditation Certificate shall specify the name of the Laboratory and the

period for which the Accreditation Certificate is valid. Accreditation

ISL – January 2021 Page 33 of 160

Certificates may be issued after the effective date, with retroactive effect. A

list of WADA-accredited laboratories shall be published on WADA’s website.

4.4.2 Maintaining WADA Accreditation

In order to maintain WADA accreditation, a Laboratory shall comply with the following

requirements.

4.4.2.1 Maintain ISO/IEC 17025 Accreditation

The Laboratory shall maintain accreditation to ISO/IEC 17025, with primary

reference to the analysis of Samples (Section 5.0), granted by a relevant

Accreditation Body, which is an ILAC full member and signatory to the ILAC

MRA for testing activities as defined in ISO/IEC 17025.

4.4.2.2 Flexible Scope of ISO/IEC 17025 Accreditation

A Laboratory may modify or add Analytes to Analytical Testing Procedures,

which are included within its Scope of ISO/IEC 17025 Accreditation or

develop new Analytical Testing Procedure(s) that involve technology already

included within the Scope of ISO/IEC 17025 Accreditation, without the need

for approval by the Accreditation Body that provides the ISO/IEC 17025

accreditation of that Laboratory.

[Comment: The flexible system of ISO/IEC 17025 Laboratory accreditation shall be

based on the overall assessment by the Accreditation Body of the demonstrated

competence of the Laboratory in the implementation of Laboratory processes and

procedures when following a Flexible Scope of ISO/IEC 17025 Accreditation system.

The flexible system of ISO/IEC 17025 Laboratory accreditation is important to ensure

that Laboratories can adapt their Analytical Testing Procedures to the detection of

new Prohibited Substances or Prohibited Methods, as well as to the application of

new technical and scientific developments in Analytical Testing for Doping Control.]

The Laboratories are not eligible to apply a Flexible Scope of ISO/IEC 17025

Accreditation to the analysis of Samples in the following scenarios:

- New Analytical Testing Procedures: Any Analytical Testing Procedure,

which is new to the field of anti-doping analysis, shall be approved as Fit-

for-Purpose by WADA prior to implementation by any Laboratory. WADA

shall use whatever means deemed appropriate, including formal

consultations with scientific expert working groups, publication(s) in peer-

reviewed scientific journal(s), or participation in an inter-laboratory

collaborative study or WADA-organized EQAS round to evaluate whether

the test is Fit-for-Purpose prior to providing approval. Before applying

such a new Analytical Testing Procedure to the analysis of Samples, a

See ILAC-G29/06:2020 “Guidelines for harmonization of scopes of ISO/IEC 17025 accreditation of WADA anti-

doping laboratories”.

ISL – January 2021 Page 34 of 160

Laboratory shall obtain an extension of the Scope of ISO/IEC 17025

Accreditation by the relevant Accreditation Body and may be required to

successfully participate in a WADA EQAS, if available;

- WADA-specific Analytical Testing Procedures: WADA may require an

extension of the Scope of ISO/IEC 17025 Accreditation to include specific

Analytical Testing Procedures before application to the analysis of

Samples, even if the analytical technique involved is already incorporated

in the Laboratory’s Scope of ISO/IEC 17025 Accreditation. WADA will

communicate to the Laboratories and to the Accreditation Bodies which

Analytical Testing Procedures are included in this category. In such

cases, the Analytical Testing Procedure shall be validated by the

Laboratory. The Laboratory may also be required to successfully

participate in an inter-laboratory collaborative study or WADA-organized

EQAS round in order to obtain an extension to the Scope of ISO/IEC

17025 Accreditation by a relevant Accreditation Body before introducing

the Analytical Testing Procedure to the analysis of Samples. However,

once included within the scope, limited changes to these Analytical

Testing Procedures may be allowed within the boundaries of a Flexible

Scope of ISO/IEC 17025 Accreditation. Nonetheless, this flexibility does

not allow the Laboratories to introduce new Analytes within these

Analytical Testing Procedures if specific method performance and

compliance decision criteria (e.g. Decision Limits) are needed and those

criteria are not yet defined in an applicable Technical Document (e.g. new

target compound(s) for GC/C/IRMS analysis).

Inclusion of an Analytical Testing Procedure within the Laboratory’s Scope

of ISO/IEC 17025 Accreditation establishes that the Analytical Testing

Procedure is Fit-for-Purpose, and the Laboratory shall not be required to

provide Analytical Method validation documentation or EQAS performance

data in support of an analytical finding.

Laboratories are expected to include Analytical Testing Procedures within

their Scope of ISO/IEC 17025 Accreditation prior to application to the

analysis of Samples. However, under exceptional circumstances, a

Laboratory may apply a method, which has been validated in accordance

with applicable Technical Document(s), Technical Letter(s) or Laboratory

Guidelines, to the analysis of Samples before inclusion into the Laboratory’s

Scope of ISO/IEC 17025 Accreditation. However, in such cases, the

Laboratory does not automatically benefit from the presumption

that the method is Fit-for-Purpose, as would otherwise be the case if the

Analytical Testing Procedure is included within the Laboratory’s Scope

of ISO/IEC 17025 Accreditation. Consequently, any Adverse Analytical

Finding reported by applying a Test Method, which is not within the

Laboratory’s Scope of ISO/IEC 17025 Accreditation, may require the

ISL – January 2021 Page 35 of 160

Laboratory to provide method validation documentation or EQAS

performance data in support of that Adverse Analytical Finding.

[Comment: Laboratories shall not apply a WADA-specific Analytical Testing

Procedure to the analysis of Samples until such method is included in the

Laboratory’s Scope of ISO/IEC 17025 Accreditation.]

4.4.2.3 Participate in the WADA EQAS Program

Laboratories are required to participate in the WADA EQAS on a continuous

basis and meet the performance requirements of the EQAS as described in

Section 6.0.

4.4.2.4 Laboratory Independence and Impartiality

The Laboratory shall be administratively and operationally independent from

any organization that could exert undue pressure on the Laboratory and

affect the impartial execution of its tasks and operations

In order to be administratively independent, the Laboratory cannot be

administered by, connected or subject to an Anti-Doping Organization, sport

organization or government Ministry of Sport or other government body

responsible for sport performance, including their Board Members, staff,

Commission Members or officials. This is necessary to avoid potential

conflicts of interest and ensure full confidence in the Laboratory’s

competence, impartiality, judgment and operational integrity, in compliance

with ISO/IEC 17025.

In order to be operationally independent, the Laboratory shall manage its

own affairs without hindrance, interference or direction from any Person. The

Laboratory shall, without limitation, control: the allocation of its budget, the

procurement of equipment and other resources, Laboratory personnel

decisions, the research conducted by the Laboratory and all Sample

Analytical Testing and reporting of results.

The Laboratory shall have a dedicated budget allowing the implementation

of an efficient approval process for the timely procurement of necessary

Reference Materials, reagents, consumables and essential equipment, as

well as independent Laboratory management decisions concerning the

recruitment, retention and training of staff, participation in scientific meetings

and symposia, etc. This does not prevent the Laboratory from receiving

research grants or other financial support from their host organization (e.g.

Laboratories shall comply with these requirements of administrative and operational independence by

1 January 2022, unless otherwise approved by WADA.

ISL – January 2021 Page 36 of 160

university, hospital, public institution), Anti-Doping Organizations, sport

organizations, government, or other sponsors, while following applicable

accounting regulations in connection with the receipt and management of

those funds.

In accordance with ISO/IEC 17025, the Laboratory shall be a legal entity, or

a defined part of a legal entity, which is legally responsible for its activities.

4.4.2.5 Document Compliance with the WADA Laboratory Code of Ethics

The Laboratory shall annually provide to WADA a letter of compliance with

the provisions of the Code of Ethics, signed by the Laboratory Director. All

staff employed at the Laboratory, permanent or temporary, shall also read,

agree to and sign the Code of Ethics. The Laboratory may be asked to

provide documentation of compliance with the provisions of the Code of

Ethics.

The Laboratory shall establish a system requiring Laboratory staff to report

any alleged breaches of the Code of Ethics to the Laboratory Director, which

the Laboratory Director shall report to WADA. However, if Laboratory staff

suspect that the Laboratory Director may have breached the Code of Ethics,

the Laboratory staff shall report the alleged breaches of the Code of Ethics

directly to WADA. The Laboratory Director and/or the Laboratory’s host

organization and/or WADA, as applicable, shall immediately and thoroughly

investigate any alleged breach of the Code of Ethics.

If the Laboratory’s investigation determines that a breach of the Code of

Ethics occurred, the Laboratory Director and/or the Laboratory’s host

organization shall immediately inform WADA of the results of the

investigation and the disciplinary actions taken. WADA may also request

further sanctions or implement sanctions as a result of its own investigations.

Sanctions may range from a personal reprimand to the expulsion of the

implicated Laboratory staff member(s), the reporting of the breach to the

pertinent authorities (e.g. law enforcement) or the Suspension or Revocation

of the Laboratory’s WADA accreditation.

4.4.2.6 Document Implemented Research and Development Activities

The Laboratory shall maintain a plan for research and development in the

field of anti-doping science, including an annual budget in this area of at least

7% of the total annual operational budget allocated to activities associated

with Signatories.

The Laboratory should document the publication of results of the research in

relevant scientific papers in the peer-reviewed literature (at least one

publication every two (2) years). The list of scientific papers shall be made

available to WADA upon request. The Laboratory may also demonstrate a

ISL – January 2021 Page 37 of 160

research program by documenting successful or pending applications for

research grants [at least one (1) application submitted every three (3) years].

[Comment: The validation or implementation of established anti-doping methods with

only minor adjustments, or repetition of research previously published or presented

by others, is not sufficient to be considered as a research and development activity.]

The Laboratory shall supply an annual progress report to WADA

documenting research and development results in the field of anti-doping

science. The Laboratory shall also relate research and development plans

for the following year.

4.4.2.7 Document Implemented Sharing of Knowledge

The Laboratory shall demonstrate its willingness and ability to share

knowledge with other Laboratories. The Laboratory shall disseminate the

results of its research and development activities to other Laboratories. The

Laboratory should make at least one (1) annual contribution to an anti-doping

symposium or conference. Laboratories are encouraged to participate in

collaborative research projects with other Laboratories, and to exchange

experience, protocols, arrange for visits of specialists and provide training to

other Laboratories and probationary laboratories in specific areas of

Analytical Testing.

The Laboratory shall supply an annual report on sharing of knowledge with

other Laboratories to WADA. A description of sharing of knowledge is

provided in the Code of Ethics (Annex A).

4.4.2.8 Maintain Professional Liability Insurance Coverage

Laboratories shall provide documentation to WADA including evidence that

professional liability risk insurance coverage is maintained of no less than

two (2) million USD annually (for example, evidence of timely payment of

applicable fees and premiums).

4.4.2.9 Providing renewed letter(s) of support

Letter(s) of support, as described in Article 4.1.3, from Signatories shall be

provided to WADA every two (2) years confirming three (3) years of support

or unless otherwise approved by WADA.

4.4.2.10 Maintain Minimum Number of Samples

In order to maintain proficiency in Analytical Testing, Laboratories are

required to analyze a minimum of 3,000 Samples provided annually by Code-

compliant Anti-Doping Organizations (as determined by WADA) or as

otherwise approved by WADA.

ISL – January 2021 Page 38 of 160

[Comment: To determine the minimum number of Samples, each urine Sample,

blood Sample and ABP blood Sample analyzed by the Laboratory shall count as an

individual Sample.]

WADA will monitor the number of Samples tested by the Laboratory. If the

number of Samples falls below 3,000 per year, the Laboratory’s WADA

accreditation may be suspended in accordance with Article 4.6.4.1.2.

It is recognized that specific circumstances may affect a Laboratory’s ability

to analyze a minimum of 3,000 Samples annually, such as when an Anti-

Doping Organization is declared non-compliant with the Code by WADA, or

when the Laboratory is not operational for the full calendar year. In such

cases, WADA shall require that the Laboratory implement measures to

maintain proficiency in Analytical Testing, for example by strengthening its

internal Quality Assurance Scheme (iQAS) and internal audits program.

WADA may also provide additional EQAS samples and/or conduct a

documentary audit and/or an on-site or remote (on-line) assessment, at its

discretion, in order to assess the status of the Laboratory’s operations.

4.4.2.11 Publication of Laboratory Analytical Testing Procedures, services and

fees

Laboratories shall report and maintain in ADAMS an up-to-date list of

Analytical Testing Procedures and services, including standard prices, to

assist Anti-Doping Organizations in developing Test Distribution Plans. Upon

request by an Anti-Doping Organization, Laboratories should cooperate with

the Anti-Doping Organization by providing other relevant information

regarding Testing plans (e.g. Laboratory analytical capabilities).

4.4.2.12 Participating in WADA / Accreditation Body Re-assessments and

Continuous Assessments during the Accreditation Cycle

• Accreditation Body Re-assessment and/or Continuous Assessment

during the Accreditation Cycle

The assessment team shall include at least one ISL-trained assessor

selected by the Accreditation Body for the assessment/re-assessment.

The relevant Accreditation Body should send copies of a summary of the

Assessment Report, in English or French, as well as the Laboratory

responses in a timely fashion to WADA. Should the Laboratory prefer to

provide the Assessment Report summary directly to WADA, it shall do so

within thirty (30) days from receiving the Accreditation Body’s

Assessment Report.

The Laboratory shall provide WADA with an updated copy of the ISO/IEC

17025 Certificate and Scope of ISO/IEC 17025 Accreditation as soon as

it is obtained from the Accreditation Body.

ISL – January 2021 Page 39 of 160

• WADA Laboratory Assessment

WADA reserves the right to conduct documentary audits as well as

inspect and assess the Laboratory through on-site or remote (on-line)

assessments at any time, at WADA’s expense. The notice of the WADA

assessment will be made in writing to the Laboratory Director. In

exceptional circumstances, and at WADA’s discretion, the assessment

may be unannounced.

As part of an announced or unannounced Laboratory assessment,

WADA retains the right to request copies of Laboratory documentation

and/or request Further Analysis of selected “A” and/or “B” Samples either

on-site or in a Laboratory(-ies) chosen by WADA.

4.5 Removal of Samples by WADA

4.5.1 Removal of Samples for Analysis or Further Analysis

Within the context of an investigation or Laboratory performance monitoring activity

(for example, during an on-site WADA Laboratory assessment), WADA, initially at its

expense, may remove Sample(s) from a Laboratory in order to conduct Further

Analysis, or analysis of the Sample if the analytical results for that Sample have not

yet been reported, for the purpose described in Code Article 6.2. In such cases, WADA

shall notify the Testing Authority, which shall retain ownership of the Sample(s)

pursuant to the Article 10.1 of the International Standard for Testing and Investigations

(ISTI). Notwithstanding the aforementioned, WADA shall retain the right to request

analysis or Further Analysis, at its expense, as permitted by Code Article 6.6.

[Comment: If Laboratory nonconformities are revealed with respect to the Analytical Testing of

any Sample, WADA retains the right to recover the expenses incurred in connection with the

analysis or Further Analysis of the Samples from the Laboratory.]

WADA may delegate an observer to monitor the removal of the Samples, which shall

be implemented in accordance with WADA’s instructions. During the removal of

Samples, WADA shall be responsible for maintaining proper Sample chain of custody

documentation and the safety and integrity of the Samples until receipt by the other

Laboratory(-ies).

WADA may also require that the Laboratory transfer the Samples. In such situations,

the Laboratory shall be responsible for maintaining proper chain of custody

documentation for all transferred Samples and the safety and integrity of the Samples

until receipt by the receiving Laboratory(-ies).

In connection with its monitoring of Laboratory performance, WADA may direct Further

Analysis of a Sample which has resulted in a Code Article 2.1 anti-doping rule violation

charge without consent of the Athlete or approval from a hearing body as provided in

Code Article 6.5, provided that the analytical result from that Further Analysis cannot

be used against the Athlete (for example, re-analysis of Samples which a Laboratory

ISL – January 2021 Page 40 of 160

has reported as Adverse Analytical Findings when the Laboratory has been

determined to have reported False Adverse Analytical Findings using the same

Analytical Method).

4.5.2 Removal of Samples for Laboratory Quality Assessment

WADA may also direct the re-analysis of anonymized Samples, which have met the

conditions described in Article 5.3.12, for purposes of Laboratory quality assurance

and education, including the implementation of a system of transfer of Samples

reported as Negative Findings between Laboratories. In this regard, the number of

Samples directed by WADA for re-analysis may vary.

[Comment: A transfer of Samples with Negative Findings shall apply only to Samples collected

by Signatories.]

4.6 WADA Monitoring of Accreditation Status

WADA shall regularly review the compliance of Laboratories with the requirements listed in

the ISL and related Technical Documents and Technical Letters. In addition, WADA shall also

conduct an annual review of EQAS results and of relevant routine Analytical Testing issues

reported to WADA by stakeholders to assess the overall performance of each Laboratory and

to decide its accreditation status.

4.6.1 Maintenance of WADA Accreditation

Compliance with all the requirements established in Article 4.4.2, including satisfactory

performance by a Laboratory in the EQAS and in routine Analytical Testing (see

Sections 6.0 and 7.0), as determined by WADA, is a critical requirement for the

maintenance of the Laboratory’s WADA accreditation.

4.6.2 Re-accreditation Costs

On an annual basis, WADA will invoice the Laboratory for a portion of the costs

associated with the WADA re-accreditation process.

4.6.3 Issuing and Publication of Accreditation Certificate

On an annual basis, when maintenance of accreditation is approved, the Laboratory

shall receive a WADA Accreditation Certificate, signed by a duly authorized

representative of WADA, which is issued in recognition of such accreditation. The

Accreditation Certificate shall specify the name of the Laboratory and the time period

for which the Accreditation Certificate is valid. WADA Accreditation Certificates may

be issued after the effective date, with retroactive effect. The list of WADA-accredited

Laboratories is maintained on WADA’s website.

ISL – January 2021 Page 41 of 160

4.6.4 Withdrawal of WADA Accreditation

A Laboratory’s WADA accreditation may be suspended or revoked, or subject to an

Analytical Testing Restriction, whenever the Laboratory fails to comply with the ISL

and/or Technical Documents and/or Technical Letters, or where the Suspension,

Revocation or Analytical Testing Restriction is otherwise required in order to protect

the integrity of the Samples, the Analytical Testing process or the interests of the Anti-

Doping Community.

The imposition of an Analytical Testing Restriction or the Suspension of a Laboratory’s

WADA accreditation should not imply the automatic withdrawal of its ISO/IEC 17025

accreditation. The status of the Laboratory’s ISO/IEC 17025 accreditation is to be

independently assessed by the relevant Accreditation Body.

4.6.4.1 Suspension of Accreditation and Analytical Testing Restriction

The Chairman of the WADA Executive Committee may suspend a

Laboratory’s WADA accreditation or impose an Analytical Testing Restriction

against a Laboratory if WADA identifies a noncompliance with the ISL and/or

Technical Documents and/or Technical Letters based on the Laboratory’s

performance during the EQAS or during routine Analytical Testing.

The Laboratory’s WADA accreditation shall be subject to a Suspension and

not to an Analytical Testing Restriction, as determined by the LabEG, when

the sanction imposed to the Laboratory impacts Analytical Methods or target

Analytes that are included in the Laboratory’s standard In-Competition or

Out-of-Competition Analytical Testing menus, because it would affect the

analysis of all respective urine and/or blood Samples received by the

Laboratory.

[Comment: If WADA determines that the noncompliance(s) leading to the

Suspension of the Laboratory’s WADA accreditation or to the imposition of an

Analytical Testing Restriction against the Laboratory does not affect the Laboratory’s

ability to analyze blood Samples for the ABP or to operate as an APMU, then the

Laboratory may, at WADA’s discretion, continue operating in such a capacity. In such

cases, WADA will inform the Laboratory accordingly.]

4.6.4.1.1 Suspension of Accreditation and Analytical Testing Restriction – No

Disciplinary Proceedings

In the event that a Laboratory has accumulated the maximum allowed

number of penalty points for the EQAS and/or Analytical Testing (as

determined by the application of the Points Scale Table in Article 7.3),

or if a Laboratory has reported a False Adverse Analytical Finding with

Consequences for an Athlete, the LabEG shall make a

recommendation to the Chairman of the WADA Executive Committee

that the Laboratory be subject to an Analytical Testing Restriction,

ISL – January 2021 Page 42 of 160

Suspension or Revocation, as applicable and as determined by the

LabEG.

If the LabEG recommends to the Chairman of the WADA Executive

Committee that the Laboratory be subject to an Analytical Testing

Restriction or Suspension when the specific above-mentioned

nonconformities are present, the Laboratory may not challenge the

recommendation of the LabEG before the Disciplinary Committee

pursuant to Article 4.6.4.5 at any time. However, in the event that the

Chairman of the WADA Executive Committee imposes an Analytical

Testing Restriction or a Suspension against the Laboratory pursuant to

this Article 4.6.4.1.1, the Laboratory may appeal the decision of the

Chairman of the WADA Executive Committee to CAS in accordance

with Article 4.6.4.7.

Notwithstanding the above, if the LabEG recommends the Revocation

of a Laboratory’s WADA accreditation in situations where the

Laboratory has accumulated the maximum allowed number of penalty

points for the EQAS and/or Analytical Testing (as determined by the

application of the Points Scale Table in Article 7.3) or where the

Laboratory reports a False Adverse Analytical Finding that results in

Consequences for an Athlete, the Laboratory may challenge the

LabEG’s recommendation before the Disciplinary Committee in

accordance with Article 4.6.4.5.

4.6.4.1.2 Analytical Testing Restriction and Suspension or Revocation of

Accreditation – Disciplinary Proceedings.

The LabEG may also recommend to the Chairman of the WADA

Executive Committee that a Laboratory be subject to an Analytical

Testing Restriction or a Suspension or Revocation of its WADA

accreditation even if the Laboratory has not reported a False Adverse

Analytical Finding with Consequences for an Athlete or has not attained

the maximum number of penalty points detailed in the Points Scale

Table in Article 7.3, but where the Laboratory’s other Analytical Testing

failure(s) and/or other identified nonconformities (as described in

Articles 4.6.4.2 and 4.6.4.3, as applicable) otherwise justifies that such

action be taken to ensure the full reliability and accuracy of Analytical

Testing and the accurate reporting of test results.

Prior to commencing disciplinary proceedings in accordance with

Article 4.6.4.5, and if requested by the Laboratory, the LabEG shall hold

a resolution facilitation session with the Laboratory as described in

Article 4.6.4.4, at the conclusion of which the Laboratory may accept

the LabEG’s recommendation and the terms of the LabEG’s Analytical

Testing Restriction or Suspension. As indicated in Article 4.6.4.4, the

ISL – January 2021 Page 43 of 160

Chairman of the WADA Executive Committee must approve any

agreement between the Laboratory and the LabEG regarding the

Laboratory’s accreditation status and the terms of its Analytical Testing

Restriction or Suspension.

However, if the Laboratory does not accept the LabEG’s

recommendation and/or terms for the Analytical Testing Restriction or

Suspension following the resolution facilitation process, as per Article

4.6.4.4, the Laboratory may challenge the LabEG’s recommendation to

the Disciplinary Committee and disciplinary proceedings will be

conducted in accordance with Article 4.6.4.5.

In such circumstances, the LabEG may, on the basis of the seriousness

of the Laboratory’s Analytical Testing failures and/or other identified

nonconformities, recommend to the Chairman of the WADA Executive

Committee that the Laboratory:

- May continue its Analytical Testing activities pending the outcome of

the Laboratory’s appeal to the Disciplinary Committee; or

- Be immediately subject to a provisional Analytical Testing Restriction

or that its WADA accreditation be subject to an immediate

Provisional Suspension pending the outcome of the disciplinary

proceedings. In such cases, a decision by the Chairman of the

WADA Executive Committee to impose a Provisional Suspension or

subject the Laboratory to a provisional Analytical Testing Restriction

shall not be subject to appeal by the Laboratory.

However, should the Laboratory be immediately subject to a provisional

Analytical Testing Restriction or should its WADA accreditation be

subject to a Provisional Suspension, the proceedings before the

Disciplinary Committee should be conducted within forty-five (45) days

of the date when the provisional Analytical Testing Restriction or the

Provisional Suspension of the Laboratory’s WADA accreditation was

imposed.

4.6.4.2 Noncompliances with the ISL

Noncompliances with the ISL that may lead to an Analytical Testing Restriction

or Suspension include, but are not limited to:

- Suspension, or withdrawal of ISO/IEC 17025 accreditation;

- Failure to establish and/or maintain administrative and operational

independence as described in Article 4.4.2.4;

- Repeated reporting of False Adverse Analytical Findings and/or False

Negative Findings:

[Comment: LabEG recommendations are made in consideration of the number of

ISL – January 2021 Page 44 of 160

false analytical findings reported by the Laboratory, irrespective of the total number

of penalty points accumulated during this period (i.e. after consideration of any

applicable penalty point deductions) or whether or not the Laboratory has

satisfactorily corrected the noncompliances.]

o The reporting of two (2) or more independent

False Adverse Analytical

Findings per EQAS round; or

o The reporting of three (3) or more independent

False Adverse

Analytical Findings, including EQAS and routine Analytical Testing, per

twelve (12)-month period; or

o The reporting of three (3) or more independent

False Negative

Findings per EQAS round; or

o The reporting of four (4) or more independent

False Negative

Findings, including EQAS and routine Analytical Testing, per twelve

(12)-month period; or

o Any combination of four (4) or more independent

False Adverse

Analytical Findings and False Negative Findings, including EQAS and

routine Analytical Testing, per twelve (12)-month period.

- Failure to implement a Technical Document or Technical Letter by the

effective date without prior approval by WADA;

- Failure to comply with any of the requirements or standards listed in the

ISL and/or Technical Documents and/or Technical Letters;

- Serious and repeated noncompliances with results reporting timelines (see

Article 5.3.8.4);

- Failure to take appropriate corrective action after an unsatisfactory

performance during routine Analytical Testing or in a blind EQAS or double-

blind EQAS round;

- Failure to take appropriate corrective action for ISL and/or Technical

Document and/or Technical Letter noncompliance(s) identified from WADA

Laboratory assessment(s);

- Failure to cooperate with WADA or the relevant Testing Authority or Results

Management Authority in providing documentation;

- Noncompliance(s) with the Code of Ethics;

- Laboratory staff and/or management issues, including but not limited to:

Independent analytical findings are produced by different and unrelated root causes and based on a satisfactory

Root Cause Analysis investigation, as determined by the LabEG.

ISL – January 2021 Page 45 of 160

o Major changes in senior Laboratory management positions (e.g.

Laboratory Director, Quality Manager) without proper and timely

notification to WADA;

o Failure to appoint a permanent Laboratory Director or other senior

management positions (e.g. Quality Manager) within a reasonable

timeline;

o Failure to guarantee the competence and/or proper training of scientific

staff including, for example, the qualification of analysts as Certifying

Scientists and Laboratory Supervisory Personnel (see Articles 5.2.2.3

and 5.2.2.4);

o Significant loss or lack of experienced staff (e.g. Certifying Scientists)

that affects, as determined by WADA, the Laboratory’s ability to ensure

the full reliability and accuracy of Analytical Testing and reporting of test

results;

o Loss of sufficient Laboratory support and resources that affects, as

determined by WADA, the quality and/or viability of the Laboratory;

o Failure to analyze the minimum number of Samples indicated in Article

4.4.2.10; or

o Failure to cooperate in any WADA enquiry in relation to the activities of

the Laboratory.

4.6.4.3 Revocation of Accreditation

The WADA Executive Committee shall revoke the WADA accreditation of any

Laboratory if it determines that Revocation is necessary to ensure the full

reliability and accuracy of Analytical Testing and the accurate reporting of

analytical test results.

The LabEG shall recommend the Revocation of a Laboratory’s WADA

accreditation based on, but not limited to, the following noncompliance(s):

- Repeated reporting of False Adverse Analytical Findings or repeated failure

to take appropriate corrective action after the reporting of a False Adverse

Analytical Finding;

[Comment: The repeated reporting of False Adverse Analytical Findings with

Consequences for an Athlete(s) shall lead to the Revocation of the Laboratory’s

WADA accreditation, irrespective of whether or not those findings were

independent as described in Article 4.6.4.2.]

- Repeated reporting of False Negative Findings or repeated failure to take

appropriate corrective action after the reporting of False Negative

Finding(s);

- Repeated suspensions of ISO/IEC 17025 accreditation or Suspensions of

ISL – January 2021 Page 46 of 160

WADA accreditation or repeated impositions of Analytical Testing

Restrictions against the Laboratory;

- Failure to correct a noncompliance with any of the requirements or

standards listed in the ISL and/or Technical Documents and/or Technical

Letters by the end of the Suspension period or at the end of an extension

of the Suspension period in accordance with Article 4.6.6.1;

- Repeated failure to comply with the ISL and/or Technical Documents

and/or Technical Letters;

- Serious Laboratory noncompliance(s) with the ISL and/or Technical

Documents and/or Technical Letters identified, for example, during WADA

Laboratory assessments, by documented client complaints or through

other enquiries or investigations conducted by WADA;

- Repeated failure to take appropriate corrective action following

unsatisfactory performance either in routine Analytical Testing or in a blind

EQAS or double-blind EQAS round;

- Repeated failure to take appropriate corrective action following ISL and/or

Technical Document and/or Technical Letter noncompliance(s) identified

from WADA Laboratory assessment(s);

- Repeated failure to analyze the minimum number of Samples indicated in

Article 4.4.2.10;

- Continuous, serious Laboratory staff and/or management issues (e.g.

continuous turnover of qualified staff affecting Laboratory expertise and

competence, inadequate training, repeated failure to train and qualify an

appropriate number of analysts as Certifying Scientists);

- Failure to cooperate with WADA or any relevant Testing Authority or

Results Management Authority during a period of Suspension or following

the imposition of an Analytical Testing Restriction;

- Analysis of Samples from Signatories in violation of a Suspension or

Analytical Testing Restriction decision;

- A serious or repeated violation(s) of the Code of Ethics;

- Conviction of any key personnel for any criminal offence that is determined

by WADA to impact the operations of the Laboratory;

- Repeated and/or continuous failure to cooperate in any WADA inquiry in

relation to the activities of the Laboratory;

- Failure to establish and/or maintain administrative and operational

independence, as described in Article 4.4.2.4, during the Suspension

period;

- Loss of support which significantly affects the quality and/or viability of the

ISL – January 2021 Page 47 of 160

Laboratory; and

- Any other cause that materially affects the ability of the Laboratory to

ensure the full reliability and accuracy of Analytical Testing and the

accurate reporting of test results.

If the Laboratory does not accept the LabEG’s recommendation for Revocation

either following the resolution facilitation session (if held pursuant to Article

4.6.4.4) or otherwise, the LabEG shall recommend to the Chairman of the

WADA Executive Committee that the Laboratory’s WADA accreditation be

immediately subject to a Provisional Suspension pending the outcome of the

disciplinary proceedings conducted pursuant to Article 4.6.4.5.

In such cases, a decision by the Chairman of the WADA Executive Committee

to impose a Provisional Suspension against the Laboratory shall not be subject

to appeal by the Laboratory. However, should the Laboratory be immediately

subject to a Provisional Suspension, the proceedings before the Disciplinary

Committee should be conducted within forty-five (45) days of the date when

the Provisional Suspension of the Laboratory’s WADA accreditation was

imposed.

4.6.4.4 Resolution Facilitation

Prior to the commencement of Disciplinary Proceedings in accordance with

Articles 4.6.4.1.2, 4.6.4.3 and 4.6.4.5, the LabEG, upon request by the

Laboratory Director, will hold a resolution facilitation session with the

Laboratory Director (via teleconference or other means). During this session,

the LabEG shall explain the Laboratory’s noncompliances with the ISL and/or

Technical Document(s) and/or Technical Letter(s) and offer the Laboratory

Director an opportunity to provide further clarification to the LabEG.

During the resolution facilitation session, the Laboratory and the LabEG may

come to an agreement regarding the Laboratory’s Revocation or the terms and

duration of the Suspension of the Laboratory’s WADA accreditation or the

Laboratory’s Analytical Testing Restriction. Any such agreement must be

submitted to the Chair of the WADA Executive Committee for approval.

Following such approval by the Chair of the WADA Executive Committee,

disciplinary proceedings will not be conducted in accordance with Article

4.6.4.5.

If the Laboratory and the LabEG are unable to come to an agreement regarding

the Laboratory’s Revocation or the terms and duration of the Suspension of

the Laboratory’s WADA accreditation or the Laboratory’s Analytical Testing

Restriction during the resolution facilitation session, the procedure indicated in

Article 4.6.4.5 shall be followed.

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In the case of a LabEG recommendation for Revocation, a resolution

facilitation session shall not be available to a Laboratory which is already

serving a Suspension or Analytical Testing Restriction.

4.6.4.5 Disciplinary Proceedings

In the event that the Laboratory decides to challenge the LabEG’s

recommendation to impose an Analytical Testing Restriction or to suspend its

WADA accreditation in accordance with Article 4.6.4.1.2 or should a

Laboratory’s WADA accreditation be subject to Revocation in accordance with

Article 4.6.4.3, WADA shall constitute an impartial Disciplinary Committee (DC)

in accordance with Article 1 of the Procedural Rules (Annex C). The DC shall

be responsible for conducting Disciplinary Proceedings in accordance with the

Procedural Rules.

In such circumstances, WADA shall provide the DC with the case file, which

shall include the relevant documentation and correspondence related to the

Laboratory’s Analytical Testing failures or other ISL noncompliances or, where

applicable, the circumstances that have resulted in the Laboratory’s WADA

accreditation being subject to Revocation proceedings. The Laboratory shall

be permitted to make written submissions and provide any supporting

documents or evidence in accordance with Article 3 of the Procedural Rules

(Annex C).

The DC shall issue a recommendation to the Chair of the WADA Executive

Committee or, where applicable (e.g. in the case of a Revocation), to the

WADA Executive Committee, regarding the action(s) to be taken with regard

to the Laboratory’s WADA accreditation in accordance with the requirements

and procedure described in Article 7 of the Procedural Rules (Annex C).

[Comment: For the avoidance of doubt, and as indicated in Article 4.6.4.1.1,

disciplinary proceedings will not be conducted pursuant to Article 4.6.4.5 in situations

where a Laboratory has accumulated the maximum allowed number of penalty points

for the EQAS and/or Analytical Testing (as determined by the application of the Points

Scale Table in Article 7.3), or if a Laboratory has reported a False Adverse Analytical

Finding with Consequence(s) for an Athlete. Instead, and only in the aforementioned

circumstances, the Laboratory may appeal any decision of the Chairman of the WADA

Executive Committee to impose an Analytical Testing Restriction or to suspend the

Laboratory’s WADA accreditation directly to CAS in accordance with Article 4.6.4.7.]

4.6.4.6 Notification of Decision

Upon completion of the procedures indicated in Articles 4.6.4.5 or 7.3, as

applicable, and in accordance with the timelines indicated in Article 7 of the

Procedural Rules (Annex C), WADA shall provide the Laboratory with written

notice of its decision regarding the status of the Laboratory’s WADA

accreditation. This notice shall state the following:

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1) That the Laboratory’s WADA accreditation has been maintained (including

warnings, if applicable); or

2) That the Laboratory’s WADA accreditation has been suspended or revoked

or that an Analytical Testing Restriction has been imposed against the

Laboratory.

Such notice shall include:

- The reason(s) for Suspension or Revocation or the imposition of an

Analytical Testing Restriction;

- The terms of the Suspension, Revocation, or Analytical Testing

Restriction; and

- The period of Suspension or of Analytical Testing Restriction, if

applicable.

For proceedings conducted pursuant to Article 4.6.4.5, WADA shall also

provide the Laboratory with a copy of the DC’s recommendation regarding the

Suspension or Revocation of the Laboratory’s WADA accreditation or the

imposition of an Analytical Testing Restriction against the Laboratory.

4.6.4.7 Effective Date and Appeals

A Suspension or Analytical Testing Restriction is effective immediately upon

receipt of notification of the decision.

A Revocation takes effect one (1) month after notification. The Laboratory shall

remain under Suspension until such a time when the Revocation becomes

effective or pending the outcome of any possible appeal of the Revocation

decision by the Laboratory.

A Laboratory may appeal a decision by WADA to revoke or suspend its WADA

accreditation, or to impose an Analytical Testing Restriction, to CAS in

accordance with Code Article 13.7. The Laboratory shall have twenty-one (21)

days from the date of receipt of the decision from WADA to file an appeal to

CAS.

4.6.4.8 Public Notice

WADA shall publicly announce a change in a Laboratory’s accreditation status

on its website as soon as the Laboratory is notified by WADA of its decision. In

cases of Laboratory Revocation, the public notice shall specify that the

Laboratory shall remain under Suspension until the date when the Revocation

becomes effective, as determined in Article 4.6.4.7.

WADA shall also indicate the terms and length of the Suspension or the

Analytical Testing Restriction, as well as the nature of the Laboratory’s

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noncompliance with the ISL and/or Technical Document(s) and/or Technical

Letter(s).

WADA’s website shall be updated regarding a Laboratory’s accreditation

status when the Laboratory’s WADA accreditation is reinstated following a

Suspension or when an Analytical Testing Restriction is lifted.

4.6.5 Consequences of Suspended or Revoked Accreditation or Analytical Testing

Restriction

4.6.5.1 Analytical Testing Restriction

If WADA determines that the noncompliance(s) are limited to a class of

Prohibited Substances or Prohibited Methods or to a specific Analytical Testing

Procedure, which are not included in the standard Analytical Testing menu for

In-Competition or Out-of-Competition Samples received by the Laboratory,

WADA may impose an Analytical Testing Restriction for that class of

Prohibited Substance(s) or Prohibited Method(s) or for the specific Analytical

Testing Procedure in which the noncompliance(s) occurred.

The Laboratory shall inform its clients of the imposed Analytical Testing

Restriction and shall subcontract the affected analyses to another Laboratory(-

ies) during the period of the Analytical Testing Restriction, as provided in Article

5.2.6. A Laboratory under an Analytical Testing Restriction shall inform WADA

of the identity of the relevant Testing Authority(-ies) and the chosen

Laboratory(-ies).

If the reason for the Analytical Testing Restriction was related to the reporting

of False Adverse Analytical Finding(s), all analyses employing the affected

Analytical Testing Procedure(s) shall cease immediately.

The Laboratory shall transfer

the following Samples (“A” and “B” Samples) in

the Laboratory’s custody, which involve the analysis of the same class of

Prohibited Substances or Prohibited Methods and/or the application of the

affected Analytical Testing Procedure(s) subjected to the Analytical Testing

Restriction, to another Laboratory(-ies) for the performance of the “A” and, if

needed, the “B” Confirmation Procedures (unless otherwise instructed by

WADA):

- Samples, which had been previously reported as an Adverse Analytical

The Laboratory under Analytical Testing Restriction shall contact the relevant Testing Authority(-ies) to arrange

for the transfer of the relevant Samples to subcontracted Laboratory(-ies), chosen by the Testing Authority, within

thirty (30) days of being notified of the Analytical Testing Restriction decision. All associated costs shall be borne

by the Laboratory under Analytical Testing Restriction.

ISL – January 2021 Page 51 of 160

Finding (as requested by WADA);

- Samples, which had been opened and were undergoing analysis for the

Initial Testing Procedure(s) at the time of the Analytical Testing Restriction

decision;

- Samples for which, at the time of the Analytical Testing Restriction

decision, Initial Testing Procedure(s) had been completed and had

produced Presumptive Adverse Analytical Findings requiring Confirmation

Procedures, or Samples that are the subject of other Confirmation

Procedures (e.g. GC/C/IRMS analysis for Markers of the steroid profile);

- Samples for which the “A” or “B” Confirmation Procedures had been

completed, but results of the analysis had not been reported by the

Analytical Testing Restriction date, or Samples which were undergoing “A”

or “B” Confirmation Procedures at the time of the imposition of the

Analytical Testing Restriction;

- Samples which had been reported as Adverse Analytical Findings based

on the “A” Confirmation Procedure prior to the imposition of the Analytical

Testing Restriction. These Samples shall be kept in the Laboratory under

proper Laboratory Internal Chain of Custody and appropriate storage

conditions. Should a “B” Confirmation Procedure be requested during the

period of the Analytical Testing Restriction, both “A” and “B” Samples shall

be transferred

to another Laboratory(-ies) for the “A” Confirmation

Procedure to be performed again and for the performance of the “B”

Confirmation Procedure, if applicable.

If the Analytical Testing Restriction was caused by the reporting of False

Negative Finding(s), and further investigation reveals that other Negative

Finding(s) had been reported for Samples that are still stored in the Laboratory,

the Laboratory shall inform the Testing Authority and WADA. In such cases,

both the “A” and “B” containers of the relevant Samples shall be transferred

to another Laboratory(-ies) for Further Analysis, as determined by WADA.

These re-analyses may be applied to the class of Prohibited Substances

and/or Prohibited Methods or to the Analytical Testing Procedure(s) that were

associated with the Negative Finding(s), as determined by WADA.

4.6.5.2 Suspension

A Laboratory whose WADA accreditation has been suspended is ineligible to

perform Analytical Testing of Samples for any Signatory. This provision does

not apply when the noncompliance(s) that led to the Suspension do not affect

the blood analyses for the ABP, as determined by WADA.

- Suspension for Violation of the Code of Ethics

If the reason for the Suspension was related to a violation of the Code of

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Ethics (Annex A), all Analytical Testing in the suspended Laboratory shall

cease immediately and the Laboratory shall transfer

all Samples (both the

“A” and “B” Samples) in the Laboratory’s custody to other Laboratory(-ies)

chosen by the Testing Authority(-ies).

- Suspension for Reporting of False Adverse Analytical Finding(s)

If the reason for the Suspension was related to the reporting of False

Adverse Analytical Finding(s), all Analytical Testing shall cease

immediately. In addition, the Laboratory shall transfer

the following

Samples (“A” and “B” Samples) in the Laboratory’s custody to another

Laboratory(-ies) for the performance of the “A” and, if needed, the “B”

Confirmation Procedures, unless otherwise instructed by WADA:

o Samples, which had been previously reported as an Adverse Analytical

Finding for the same class of Prohibited Substances or Prohibited

Methods when applying the same Confirmation Procedure (as

requested by WADA);

o Samples for which, at the time of the Suspension decision, Initial

Testing Procedure(s) had been completed and had produced

Presumptive Adverse Analytical Findings requiring Confirmation

Procedures, or Samples that are the subject of other Confirmation

Procedures (e.g. GC/C/IRMS analysis for Markers of the steroid

profile);

o Samples, which had been opened and were undergoing analysis for

the Initial Testing Procedure(s) at the time of the Suspension;

o Samples which had been received at the Laboratory but had not been

opened at the time of the Suspension [these Samples shall be kept

sealed in the Laboratory under proper Laboratory Internal Chain of

Custody and appropriate storage conditions until transfer

to another

The suspended or revoked Laboratory shall contact the relevant Testing Authority(-ies) to arrange for the transfer

of Samples to Laboratory(-ies), chosen by the Testing Authority, within thirty (30) days of being notified of the

Suspension or Revocation decision. Any additional costs of analysis to those previously agreed or already paid to

the suspended or revoked Laboratory shall be borne by the Laboratory under Suspension or Revocation. In case

of Code of Ethics violation(s), the suspended or revoked Laboratory shall also reimburse the Testing Authority for

the costs of re-analyses in another Laboratory. The suspended or revoked Laboratory shall inform WADA of such

actions including providing the Sample code(s) and the identity of the relevant Testing Authority(-ies) and the

chosen Laboratory(-ies). Testing Authorities should consider differences in analytical capacity between the

suspended or revoked Laboratory and the receiving Laboratory(-ies) (e.g. LOI for Non-Threshold Substances,

capacity to perform specific analyses). In such cases, the Testing Authority may consult the Laboratories implicated

and/or WADA for guidance.

ISL – January 2021 Page 53 of 160

Laboratory(-ies)].

o Samples for which “A” or “B” Confirmation Procedures had been

completed, but results of the analysis had not been reported by the

Suspension date, or Samples which were undergoing “A” or “B”

Confirmation Procedures at the time of the Suspension;

o Samples which had been reported as Adverse Analytical Findings

based on the “A” Confirmation Procedure prior to the Suspension.

- Suspension for Other Reasons

A Laboratory that has had its WADA accreditation suspended for reasons

other than a violation of the Code of Ethics or the reporting of False Adverse

Analytical Findings(s) shall take the following steps with the Samples in the

Laboratory’s custody, unless otherwise instructed by WADA:

o Samples which had been analyzed and reported as a Negative Finding,

and which have either been stored in the Laboratory for a period of less

than three (3) months or have been placed in long-term storage upon

request by the Testing Authority or WADA.

These Samples shall be kept in the Laboratory under proper Laboratory

Chain of Custody and appropriate storage conditions. The Laboratory

shall inform WADA of such actions including the provision of the

Sample codes and the identity of the relevant Testing Authority(-ies).

If the Suspension was caused by the reporting of False Negative

Finding(s), and further investigation reveals that other Negative

Finding(s) had been reported by the Laboratory, the Laboratory shall

inform the Testing Authority and WADA. In such cases, both the “A”

and “B” containers of the relevant Samples shall be transferred

another Laboratory(-ies) for Further Analysis, as determined by WADA.

These analyses may be applied for all the Prohibited Substances and

Prohibited Methods included in the requested Analytical Testing menu

or be limited to the class of Prohibited Substances and/or Prohibited

Methods or to the Analytical Testing Procedure(s) that were associated

with the Negative Finding(s), as determined by WADA.

o Samples for which Initial Testing Procedures had been completed, but

results had not been reported at the time of the Suspension:

If the Initial Testing Procedure(s) produced Presumptive Adverse

Analytical Finding(s) or other Confirmation Procedures were required

(e.g. GC/C/IRMS analysis for Markers of the steroid profile), both the

“A” and “B” Samples shall be transferred

to another Laboratory(-ies)

for the performance of the “A” and, if needed, the “B” Confirmation

Procedures.

ISL – January 2021 Page 54 of 160

In addition, if the Suspension was caused by the reporting of False

Negative Finding(s) and the Initial Testing Procedure(s) had produced

negative results, both the “A” and “B” Samples shall also be transferred

to another Laboratory(-ies) for the repetition of the Initial Testing

Procedure(s) and, if needed, the performance of Confirmation

Procedures. These analyses may be applied for all the Prohibited

Substances and Prohibited Methods included in the requested

Analytical Testing menu or be limited to the class of Prohibited

Substances and/or Prohibited Methods or to the Analytical Testing

Procedure(s) that were associated with the Negative Finding, as

determined by WADA.

If the reason for the Suspension was not related to the reporting of

False Negative Findings and the Initial Testing Procedures had

produced negative results, the Sample(s) shall be reported in ADAMS

as Negative Finding(s). These Samples shall be kept in the Laboratory

under proper Laboratory Internal Chain of Custody and appropriate

storage conditions until further notice by WADA. The Laboratory shall

inform WADA of such actions including the provision of the Sample

codes and the identity of the relevant Testing Authority(-ies).

o Samples which had been opened and were undergoing analysis for the

Initial Testing Procedure(s) at the time of the Suspension:

If the reason for Suspension was not related to the reporting of False

Negative Finding(s), the Laboratory shall continue to analyze the

relevant Samples until all Initial Testing Procedures are completed. If

the Initial Testing Procedures produce Negative Findings, the

Laboratory shall report these findings into ADAMS and these Samples

shall be kept in the Laboratory under proper Laboratory Chain of

Custody and appropriate storage conditions until further notice by

WADA. The Laboratory shall inform WADA of such actions including

the provision of the Sample codes and the identity of the relevant

Testing Authority(-ies).

However, if the Initial Testing Procedure produced a Presumptive

Adverse Analytical Finding, both the “A” and “B” Samples shall be

transferred

to another Laboratory(-ies) for the performance of the “A”

and, if needed, the “B” Confirmation Procedures.

If the Suspension was caused by the reporting of False Negative

Finding(s), then the Laboratory shall cease all Analytical Testing and

have the “A” and “B” Samples transferred

to another Laboratory(-ies)

for the performance of the “A” and, if needed, the “B” Confirmation

Procedures.

o Samples which had been received at the Laboratory but had not been

ISL – January 2021 Page 55 of 160

opened yet at the time of the Suspension:

These Samples shall be kept sealed in the Laboratory under proper

Laboratory Chain of Custody and appropriate storage conditions until

transfer

to another Laboratory(-ies) for Analytical Testing.

- Samples for which “A” or “B” Confirmation Procedures had been

completed, but results of analysis had not been reported by the Suspension

date, or Samples which were undergoing “A” or “B” Confirmation

Procedures at the time of the Suspension:

Both the “A” and “B” Samples shall be transferred

to another Laboratory(-

ies) for the repetition of the “A” and, if applicable, the “B” Confirmation

Procedures.

- Samples which had been reported as an Adverse Analytical Finding based

on the “A” Confirmation Procedure prior to the Suspension:

These Samples shall be kept in the Laboratory under proper Laboratory

Internal Chain of Custody and appropriate storage conditions. Should a “B”

Confirmation Procedure be requested during the Suspension, both “A” and

“B” Samples shall be transferred

to another Laboratory(-ies) for the “A”

Confirmation Procedure to be performed again and for the performance of

the “B” Confirmation Procedure, if applicable.

If the Suspension concerns the analysis of blood Samples for the ABP,

Samples collected prior to the Suspension date may be analyzed by the

Laboratory. The reporting of results for the relevant Sample(s) in ADAMS shall

include a comment regarding the Suspension at the time of analysis so that

the Testing Authority (or Results Management Authority, if different) / APMU

can take this information into account during the Results Management process.

[Comment: Due to the negative impact of time on the integrity of blood Samples for the

ABP analysis, it is not normally feasible to send the ABP blood Samples to other

Laboratory(-ies) for timely analysis.]

During a Suspension or Analytical Testing Restriction period, the Laboratory

shall continue to participate in the WADA EQAS program. WADA may require

the Laboratory to analyze additional blind EQAS samples and/or perform a

Laboratory assessment, at any time and at the expense of the Laboratory, in

order to evaluate the Laboratory’s status.

4.6.5.3 Revocation

A laboratory whose WADA accreditation or approval for the ABP has been

revoked is ineligible to perform Analytical Testing of Samples for any Testing

Authority. The Laboratory Internal Chain of Custody maintained by a revoked

laboratory for stored Samples is valid until such time that arrangements can be

ISL – January 2021 Page 56 of 160

made, in consultation with WADA, for the transfer

of relevant Samples to a

Laboratory(-ies).

A laboratory whose WADA accreditation or approval for the ABP has been

revoked shall arrange the transfer

of Samples in the laboratory’s custody to

a Laboratory(-ies) chosen by the Testing Authority or WADA, respectively,

within thirty (30) days of being notified of the decision revoking its WADA

accreditation. In such circumstances, the Samples to be transferred shall be

selected by the Testing Authority or WADA. The laboratory transferring the

Samples shall inform WADA and provide the relevant Sample codes and the

identity of the relevant Testing Authority(-ies) and the chosen

Laboratory(-ies). In addition, the revoked laboratory shall assist the relevant

Testing Authority(-ies) with the transfer of the relevant Sample data and

records to the Laboratory(-ies) that have been selected to receive the Samples.

[Comment: The revoked laboratory shall transfer all Samples in its custody for which

the Analytical Testing process has not been completed at the time of the Revocation.

The Testing Authority may also choose to transfer additional Samples retained in the

laboratory in accordance with Articles 5.3.11.1. or 5.3.11.2, or other Samples for which

it is the owner pursuant to Article 10.1 of the ISTI and that had been analyzed and

were in long-term storage at the time of the Revocation of the laboratory’s WADA

accreditation. In addition, WADA may identify and request that Samples be transferred

to another Laboratory(-ies).]

4.6.6 Reinstatement of Suspended Accreditation or Lifting of the Analytical Testing

Restriction

WADA shall lift the Suspension of the Laboratory’s WADA accreditation or lift the

Analytical Testing Restriction only when the Laboratory provides satisfactory

evidence, as determined by WADA, that appropriate steps have been taken to remedy

the noncompliance(s) that resulted in the Suspension of the Laboratory’s WADA

accreditation or the imposition of the Analytical Testing Restriction, and that proper

measures have been implemented to satisfactorily address the condition(s) specified,

if any, for reinstatement of WADA accreditation.

4.6.6.1 Extension of Suspension or Analytical Testing Restriction

If a Laboratory whose WADA accreditation has been suspended or has been

the subject of an Analytical Testing Restriction has not satisfactorily corrected

the ISL and/or Technical Document(s) and/or Technical Letter(s)

noncompliance(s) that resulted in the Suspension or Analytical Testing

Restriction, or if WADA identifies any additional ISL and/or Technical

Document(s) and/or Technical Letter(s) noncompliance(s) during a WADA

Laboratory assessment conducted during the initial Suspension or Analytical

Testing Restriction period, either the Suspension of the Laboratory’s WADA

accreditation or Analytical Testing Restriction shall be further extended or the

Laboratory’s accreditation shall be revoked, as determined by WADA.

ISL – January 2021 Page 57 of 160

The Suspension or Analytical Testing Restriction period may be extended up

to an additional six (6) months, if the Laboratory provides justifiable

explanation(s) for the delay, as determined by the LabEG, in addressing the

conditions to lift the Suspension or Analytical Testing Restriction (including the

submission of satisfactory corrective actions). The Suspension of a

Laboratory’s WADA accreditation or the Analytical Testing Restriction,

including any extensions of a Suspension or Analytical Testing Restriction,

shall not exceed twelve (12) months, unless the Laboratory is subject to

Revocation proceedings in accordance with Article 4.6.5.3 or as otherwise

determined by WADA.

If applicable, a delay in the delivery of the ISO/IEC 17025 accreditation to the

Laboratory by the relevant Accreditation Body may also constitute grounds to

extend the Suspension of the Laboratory’s WADA accreditation.

The decision to extend the Suspension of a Laboratory’s WADA accreditation

or the period of the Analytical Testing Restriction shall be rendered by the Chair

of the WADA Executive Committee on the basis of a recommendation from the

LabEG. WADA will provide the Laboratory with a decision of the Chair of the

WADA Executive Committee extending the Suspension of the Laboratory’s

WADA accreditation or extending the period of the Analytical Testing

Restriction.

The Laboratory may appeal WADA’s decision to extend the Suspension of its

WADA accreditation or to extend the period of the Analytical Testing

Restriction in accordance with Article 4.6.4.7.

If, in accordance with the terms of the extension of the Suspension of the

Laboratory’s WADA accreditation or the terms of the extension of the Analytical

Testing Restriction, the Laboratory provides evidence determined to be

satisfactory by WADA that all of the identified ISL and/or Technical Document

and/or Technical Letter noncompliance(s) have been corrected, the

Laboratory’s accreditation shall be re-instated or the Analytical Testing

Restriction may be lifted by decision of the Chair of the WADA Executive

Committee.

If the Laboratory has not provided evidence determined to be satisfactory by

WADA at the end of the extended Suspension or extended Analytical Testing

Restriction period, the LabEG shall recommend the Revocation of the

Laboratory’s accreditation. The decision to revoke a Laboratory’s WADA

accreditation shall be rendered by the WADA Executive Committee.

If the Laboratory is subject to Revocation proceedings either at the end of a six

(6) month Suspension or Analytical Testing Restriction or at the end of a

Suspension or Analytical Testing Restriction that has been extended to twelve

(12) months, the Laboratory’s WADA accreditation shall remain subject to the

Suspension or Analytical Testing Restriction, as applicable, until the

ISL – January 2021 Page 58 of 160

completion of the Revocation proceedings and pending the decision of the

WADA Executive Committee regarding the Revocation of the Laboratory’s

WADA accreditation. If the WADA Executive Committee confirms the

Revocation of the Laboratory’s WADA accreditation, then the Laboratory’s

WADA accreditation shall remain subject to the Suspension or Analytical

Testing Restriction, as applicable, until the Revocation comes into effect

according to Article 4.6.4.7.

[Comment: For Revocation proceedings conducted at the end of a Suspension or

Analytical Testing Restriction period, no resolution facilitation session, as described in

Article 4.6.4.4, will be conducted.]

WADA shall not be required to take any other formal action to extend the

Laboratory’s Analytical Testing Restriction or Suspension beyond either the

initial six (6)- month Suspension or Analytical Testing Restriction or beyond the

end of the Suspension or Analytical Testing Restriction that has been extended

to twelve (12) months, apart from formally instituting Revocation proceedings

against the Laboratory. Further, if Revocation proceedings are instituted

against a Laboratory in such circumstances, the Laboratory may not appeal

the extension of its Analytical Testing Restriction or Suspension beyond the

initial six (6)- month Suspension or Analytical Testing Restriction period or

beyond the end of the Suspension or Analytical Testing Restriction that has

been extended to twelve (12) months.

WADA will notify the Laboratory of the decision of the WADA Executive

Committee to revoke the Laboratory’s WADA accreditation in accordance with

Article 4.6.4.6.

The Laboratory may appeal WADA’s decision to revoke its WADA

accreditation in accordance with Article 4.6.4.7.

4.6.6.2 Revoked Accreditation

If a laboratory whose WADA accreditation has been revoked wishes to seek

a new WADA accreditation, it must apply for WADA accreditation as a new

laboratory in accordance with Article 4.1.

When seeking a new WADA accreditation, the laboratory may request that

WADA expedite the laboratory re-accreditation procedure, which shall be

approved by the WADA Executive Committee. To do so the laboratory shall

provide WADA, as part of its application for a new accreditation, information

that it considers constitutes “exceptional circumstances” as justification for

modifying the requirements of Articles 4.1 to 4.3 to expedite the entry of the

laboratory into, and/or shortening the duration of, the probationary phase of

accreditation. At its sole discretion, WADA’s Executive Committee may

determine whether such modifications are justified, and which steps must be

followed prior to granting approval to the laboratory to enter the probationary

phase of accreditation.

ISL – January 2021 Page 59 of 160

4.6.7 Voluntary Cessation of Laboratory Operations

A Laboratory may decide to voluntarily cease its anti-doping Analytical Testing

operations on either a temporary or permanent basis despite not having been found

to have committed any analytical failures or other ISL noncompliance(s) and not

having been subject to an Analytical Testing Restriction or Suspension or Revocation

of its WADA accreditation.

In such circumstances, the Laboratory shall inform WADA and provide, in writing, the

reason(s) for the cessation of anti-doping Analytical Testing operations as soon as the

decision is taken to cease its operations and no later than three (3) months prior to the

date on which its decision shall take effect. The Laboratory shall also take all

necessary measures to notify all its clients of the decision to cease its operations and

to arrange, in consultation with its clients, to transfer Samples to another Laboratory(-

ies) in accordance with Articles 4.6.5.2 (temporary closure) or 4.6.5.3 (permanent

closure).

If a Laboratory voluntarily ceases its anti-doping Analytical Testing operations on a

temporary basis, the Laboratory shall maintain satisfactory performance in the

analysis of EQAS samples during the period of inactivity. The period of temporary

cessation of Analytical Testing activities shall not exceed six (6) months, with one

possible extension of up to six (6) months (as determined by the Chair of the WADA

Executive Committee based on a recommendation from the LabEG). If the Laboratory

is unable to resume its Analytical Testing operations within a twelve (12)- month

period, the WADA Executive Committee shall revoke the Laboratory’s accreditation,

unless otherwise approved by WADA.

If a Laboratory decides to cease its operations on a permanent basis, the Laboratory

shall assist the relevant Testing Authority(-ies) with the transfer of relevant Sample

data and records to the Laboratory(-ies) that have been selected to receive the

Samples.

ISL – January 2021 Page 60 of 160

4.7 Process and Requirements for WADA Laboratory Approval for the ABP

The network of WADA-accredited laboratories may be geographically limited to fully serve the

practical development of the ABP. Therefore, non-WADA-accredited laboratories, which have

the capacity to analyze blood Markers, may apply for WADA approval for the purposes of

conducting blood Samples analysis in support of the hematological module of the ABP in

regions that cannot be served by a Laboratory. This Article describes the specific

requirements that a laboratory shall fulfill in the process of applying for, obtaining, and

maintaining WADA approval for the ABP.

4.7.1 Applicant Laboratory for WADA Approval for the ABP

In principle, any laboratory that satisfies the criteria listed below may apply to become

a candidate laboratory for WADA approval for the ABP. However, the WADA Executive

Committee, in its sole discretion, may accept or deny a laboratory’s candidacy

application based on the identified needs (or lack thereof) for anti-doping Analytical

Testing for the ABP on a regional or national scale, or for any other reason(s).

4.7.1.1 Expression of Interest

The applicant laboratory shall officially contact WADA in writing to express its

interest in becoming an ABP Laboratory.

4.7.1.2 Submit Initial Application Form

The applicant laboratory shall submit a completed initial application form,

provided by WADA, with supporting documentation for review by the LabEG.

An applicant laboratory may only submit an application if its host country

satisfies the following conditions:

- The existence of a National Anti-Doping Program conducted by a National

Anti-Doping Organization and/or a Regional Anti-Doping Organization

which is compliant with the Code and the International Standards of the

World Anti-Doping Program;

- The ratification of the UNESCO Convention against Doping in Sport; and

- The payment of the annual financial contributions to WADA.

These conditions shall be documented as part of the application.

4.7.1.3 Provision of Letter(s) of Support

Upon receipt of an application and verification of the conditions mentioned

above, WADA shall request that the applicant laboratory submit letter(s) of

support from one or more Signatory. The letter(s) of support shall indicate the

estimated number of ABP blood Samples that will be provided per year to the

applicant laboratory, as well as the reason(s) why an existing Laboratory or

ABP Laboratory is not a viable option for the Signatory’s ABP program.

ISL – January 2021 Page 61 of 160

4.7.2 Candidate Laboratory for WADA Approval for the ABP

The application materials described in Articles 4.7.1.1 to 4.7.1.3 shall be evaluated by

the WADA Executive Committee to determine whether the applicant laboratory will be

granted WADA candidate laboratory status for the ABP and thereby continue within

the WADA approval process.

4.7.2.1 Description of the Candidate Laboratory

Once approved by the WADA Executive Committee, the candidate laboratory

shall complete a detailed questionnaire provided by WADA and submit it to

WADA within eight (8) weeks of receipt. The questionnaire will include, but is

not limited to, the following:

- List of staff that will be responsible for the ABP analyses and their

qualifications;

- Description of the physical laboratory facilities, including a description of

the security considerations for Samples and records (see Article 5.2.3);

o Physical Security: specific measures to maintain a secure laboratory

environment (e.g., CCTV monitoring, restricted access to Sample storage

areas);

o IT Security: implementation of firewalls and other current cyber security

measures consistent with best practice and any applicable governmental

regulations;

o Information Technology (IT) infrastructure: implementation of a data and

information management system (e.g. LIMS), central server/intranet

which allows for secure data handling.

- List of actual and proposed instrumental resources and equipment for the

ABP, including year of purchase and conditions for technical support (e.g.

contract/access to instrument maintenance services);

- Status of the ABP method development and validation. Method validation

report (if completed);

- Status of ISO/IEC 17025 or ISO 15189 accreditation;

- Status of Laboratory’s independence and impartiality as described in ISL

Article 4.7.2.2;

- Description of customs regulations in the host country with respect to the

reception of blood Samples and consumables from abroad and the ability

to ship blood Samples outside the country as needed.

WADA may require an update of this documentation during the process of the

ABP approval.

ISL – January 2021 Page 62 of 160

[Comment: Candidate laboratories for ABP approval are encouraged to establish

agreement(s) with a Laboratory(-ies) for mentoring and training in order to ensure

successful preparation towards obtaining the WADA approval.]

4.7.2.2 Laboratory Independence and Impartiality

In order to avoid potential conflicts of interest, the laboratory shall be

administratively and operationally independent from any organization which

could exert undue pressure on the laboratory and affect the impartial execution

of its tasks and operations.

- Administrative independence requires that the laboratory be a separate

legal entity, or a defined part of a legal entity, without any administrative

links to an Anti-Doping Organization or any other sport organization or

government Ministry of Sport or other government body responsible for

sport performance (see Article 4.4.2.4);

- Operational independence requires that the laboratory shall manage its

ABP Analytical Testing activities without hindrance, interference or

direction from any Person.

4.7.2.3 Compliance with the Code of Ethics (Annex A)

The candidate laboratory shall implement and comply with the provision(s) of

the Code of Ethics. A letter of compliance with the Code of Ethics shall be

signed by the laboratory Director and provided to WADA.

4.7.2.4 Participating in the WADA EQAS Program for the analysis of ABP blood

Markers

The candidate laboratory shall be required to participate in at least three (3)

WADA EQAS rounds for the analysis of ABP blood Markers with satisfactory

performance, as determined by the LabEG. During this period, WADA may

provide feedback to assist the laboratory to improve the quality of its Analytical

Testing process.

4.7.2.5 Obtaining ISO/IEC 17025 or ISO 15189 Accreditation

The applicant laboratory shall obtain ISO/IEC 17025 or ISO 15189

accreditation from an Accreditation Body, which is an ILAC full member and is

a signatory to the ILAC MRA for testing laboratories according to ISO/IEC

17025 or for medical laboratories according to ISO 15189.

The laboratory shall correct and document any identified nonconformities with

the ISO/IEC 17025 or ISO 15189 requirements within defined timelines. The

ABP Laboratories shall comply with these requirements of administrative and operational independence by

1 January 2022, unless otherwise approved by WADA.

ISL – January 2021 Page 63 of 160

Accreditation Body should send a summary of the Assessment Report and any

corrective/preventive action documentation addressing identified

nonconformities, in English or French, to WADA. Should the applicant

laboratory prefer to send the information directly to WADA, the laboratory shall

do so within a reasonable timeline.

A valid ISO/IEC 17025 or ISO 15189 Accreditation Certificate and Scope of

Accreditation shall be provided to WADA before the WADA-approval can be

granted.

4.7.2.6 WADA On-Site Assessment for the ABP Approval

Prior to approval, WADA shall conduct an on-site assessment of the candidate

laboratory at the laboratory’s expense. The purpose of this assessment is to

obtain information about different aspects of the laboratory’s competence and

verify compliance with the relevant ISL and TD BAR (Technical Document on

blood analytical requirements for the Athlete Biological Passport) requirements

for the ABP and to clarify any issues with regard to the approval process.

[Comment: At WADA’s discretion, the initial on-site assessment for the ABP approval

may not be necessary or may be conducted on-line or as a document-based audit, in

cases of previously accredited or WADA-approved laboratories].

WADA shall provide an Assessment Report regarding the outcomes of the on-

site assessment, including any identified nonconformity(-ies), in order to allow

the applicant laboratory to implement the necessary improvements. Corrective

actions, if requested by WADA, shall be conducted and reported by the

candidate laboratory to WADA within thirty (30) days, or as otherwise indicated

by WADA.

The nonconformities identified in the WADA Assessment Report shall be

satisfactorily addressed and the recommendations for improvement should be

implemented before the laboratory can be accepted as an ABP Laboratory.

The laboratory’s performance in the on-site assessment will be taken into

account in the overall review of the laboratory’s status and may affect the

timeliness of the WADA approval.

4.7.2.7 Professional Liability Insurance Coverage

Before WADA grants approval, candidate laboratories shall provide

documentation to WADA that professional liability risk insurance coverage has

been obtained to cover liability of no less than two (2) million USD annually.

4.7.3 Granting of WADA Approval for the ABP

The maximum length of time during which a laboratory can remain as a candidate

laboratory for the ABP is one (1) year, unless WADA determines that there are

exceptional circumstances that justify an extension of this period.

ISL – January 2021 Page 64 of 160

Upon successful fulfilment of the requirements stated in the preceding provisions by a

candidate laboratory, the LabEG will submit a recommendation to the WADA

Executive Committee to grant the laboratory the status of an ABP Laboratory.

4.7.3.1 Issuing and Publishing of WADA Approval Certificate for the ABP

Upon granting of WADA approval for the ABP, a WADA Approval Certificate

signed by a duly authorized representative of WADA (exclusive to Analytical

Testing in support of the Hematological Module of the ABP) will be issued to

the laboratory.

On an annual basis, if approval for the ABP is maintained, the ABP Laboratory

shall receive a renewed WADA Approval Certificate signed by a duly

authorized representative of WADA (exclusive to Analytical Testing in support

of the Hematological Module of the ABP), which is issued in recognition of such

approval.

The WADA Approval Certificate shall specify the name of the ABP Laboratory

and the period of validity. WADA Approval Certificates may be issued after the

effective date of the WADA approval, with retroactive effect.

A list of ABP Laboratories shall be maintained on WADA’s website and in

ADAMS for stakeholder reference.

4.7.4 Maintaining Status as an ABP Laboratory

The laboratory shall meet the following requirements to maintain its WADA approval

status for the ABP:

- Satisfactory performance, as determined by WADA, in a WADA EQAS or similar

WADA-approved quality assurance program for the analysis of ABP blood Markers

and during routine Analytical Testing of ABP blood Samples;

- Maintenance of a valid ISO accreditation (ISO/IEC 17025 or ISO 15189);

- Availability of analytical instrumentation, which is compliant with the requirements

of the hematological module of the ABP, as determined by WADA;

- Implementation of Analytical Testing Procedures for the measurement of individual

Athlete blood Markers, which are in compliance with the TD BAR;

- Compliance with relevant WADA documents, including the relevant articles of the

Section 5.0 relevant to the analysis of blood Samples;

- Documented compliance with the Code of Ethics (Annex A);

- Maintenance of Professional Liability Insurance Coverage;

- Implementation of Laboratory Internal Chain of Custody procedures, which are

compliant with the Technical Document on Laboratory Internal Chain of Custody

(TD LCOC);

ISL – January 2021 Page 65 of 160

- Production of Laboratory Documentation Packages or Certificates of Analysis for

the Blood ABP in compliance with the Technical Document on Laboratory

Documentation Packages (TD LDOC);

- Cooperation in support of the administrative and legal processes instigated when

anti-doping rule violations are issued and managed by Anti-Doping Organizations.

4.7.4.1 Suspension or Revocation of WADA approval for the ABP

A laboratory’s WADA approval for the ABP may be suspended or revoked

whenever the ABP Laboratory fails to comply with the ISL and/or applicable

Technical Document(s) and/or Technical Letter(s), or where the Suspension or

Revocation of the laboratory’s approved status is otherwise required in order

to protect the integrity of the ABP blood Samples, the Analytical Testing

process for the ABP and the interests of the Anti-Doping Community.

Disciplinary proceedings to suspend or revoke a laboratory’s WADA approval

for the ABP (including notice, publication, and right to appeal) shall be

conducted in accordance with the procedures described in Articles 4.6.4 and

4.6.5, applied and modified accordingly, and the Procedural Rules found in

Annex C of the ISL.

ISL – January 2021 Page 66 of 160

5.0 Application of ISO/IEC 17025 to the Analysis of Samples

5.1 Introduction and Scope

This section of the ISL is intended as an extension of the application of ISO/IEC 17025 to the

field of Doping Control. Any aspect of Analytical Testing or management not specifically

discussed in this document or in the relevant Technical Documents, Technical Letters or

Laboratory Guidelines shall be governed by ISO/IEC 17025 (or ISO 15189, as applicable for

ABP Laboratories). The application focuses on the specific parts of the processes that are

critical with regard to the quality of the laboratory’s performance as a Laboratory or ABP

Laboratory, and are therefore significant in the evaluation and accreditation process.

This section introduces the specific performance standards for a Laboratory or ABP

Laboratory, as applicable. The conduct of Laboratory Analytical Testing is considered a

process within the definitions of ISO 17000. Performance standards are defined according to

a process model where the Laboratory practice is structured into three (3) main categories of

processes:

- Structural and Resource Requirements,

- Process Requirements,

- Management Requirements.

5.2 Structural and Resource Requirements

5.2.1 General

General structure and resource requirements shall be provided in accordance with the

requirements of ISO/IEC 17025.

The Laboratory shall have available the personnel, facilities, equipment, systems and

support services necessary to manage and perform its Laboratory activities.

5.2.2 Laboratory Personnel

The Laboratory Director is responsible for ensuring that the Laboratory personnel are

adequately trained and have the experience and skills necessary to perform their

duties.

All personnel shall have a thorough knowledge of their responsibilities including the

security of the Laboratory, the Code of Ethics, confidentiality of Analytical Testing

results, Laboratory Internal Chain of Custody protocols, and the Standard Operating

Procedures (SOPs) for any Analytical Testing Procedure that they perform.

The Laboratory shall have access to records for every Person employed by, or under

contract with, the Laboratory including a curriculum vitae or qualification

form(s)/certificate(s), a job description, records of completed and ongoing training and

records of authorization to perform their defined duties.

ISL – January 2021 Page 67 of 160

Specific criteria shall be met by the Laboratory Director, Laboratory Quality Manager,

Laboratory Certifying Scientists, and Laboratory Supervisory Personnel, as outlined

below.

5.2.2.1 Laboratory Director

The Laboratory shall have a qualified Person as the Laboratory Director,

whose priority is to assume and focus on the professional, organizational,

educational, operational and administrative responsibilities of the Laboratory’s

operations. The Laboratory Director plays an essential role in the anti-doping

Laboratory’s operations and the WADA accreditation is delivered based upon

such qualification as well as on the Laboratory’s operational performance.

The Laboratory Director shall be a full-time appointment and his/her

qualifications shall include:

- Doctoral degree (Ph.D. or equivalent) in one of the natural sciences with

appropriate experience and/or training in chemical and/or biochemical

analysis, preferably in the anti-doping area; or

- In the absence of a Doctoral degree, a postgraduate degree (e.g. Master’s

degree) in one of the natural sciences and appropriate anti-doping science

experience and training (e.g. a senior Laboratory position for a minimum of

five (5) years), including the documented ability to develop analytical

methodology and oversee research projects; or

- In the absence of a postgraduate degree, a Bachelor degree in one of the

natural sciences and extensive and appropriate anti-doping science

experience and training (e.g. a senior Laboratory position for a minimum of

ten (10) years), including the documented ability to develop analytical

methodology and oversee research projects;

- Experience and competence in the analysis of chemical and biological

material for the classes of substances and methods used in doping;

- Demonstrated working knowledge of drug metabolism and

pharmacokinetics;

- Proficiency in English to an extent that allows adequate performance of

functions as part of the international anti-doping community and in

accordance with the Code, the ISL, Technical Documents, Technical

Letters and Laboratory Guidelines.

Any personnel changes to the position of Laboratory Director shall be

communicated to WADA no later than one (1) month prior to the scheduled

date the Laboratory Director vacates his/her position. A succession plan shall

be forwarded to WADA. WADA reserves the right to review the credentials of

such appointment and either approve it or reject it in accordance with the above

qualifications.

ISL – January 2021 Page 68 of 160

5.2.2.2 Laboratory Quality Manager

The Laboratory shall have a single staff member appointed as the Laboratory

Quality Manager. The Quality Manager shall have responsibility and authority

to implement and ensure compliance with the Management System. The

Quality Manager’s priority and functions shall be focused on quality assurance

and quality control activities. The Quality Manager should remain independent,

as much as possible, from routine Laboratory analytical activities.

The Laboratory Quality Manager qualifications shall include:

- At least a Bachelor degree (or similar) in one of the natural sciences with

appropriate experience and/or training in chemical and/or biochemical

sciences;

- Appropriate experience of two (2) years or more in laboratory analytical

procedures;

- Appropriate documented qualifications and training in laboratory quality

management, including ISO/IEC 17025;

- Ability to ensure compliance with the Management System and quality

assurance processes.

5.2.2.3 Laboratory Certifying Scientists

The Laboratory shall have qualified personnel to serve as Certifying Scientists

to review all pertinent analytical data, Analytical Method validation results,

quality control results, Laboratory Documentation Packages, and to attest to

the validity of the Laboratory’s test results.

The qualifications of Certifying Scientists shall include:

- At least a Bachelor degree (or similar) in one of the natural sciences with

appropriate experience and/or training in chemical and/or biochemical

analysis, preferably in the anti-doping area. In the absence of a Bachelor

degree, documented experience of five (5) years or more in a Laboratory

as senior scientist (e.g. supervisor, section head) may be considered

equivalent to a Bachelor degree for this position;

- Appropriate training and experience (e.g. three (3) years or more) including

theoretical knowledge and technical competence in the analysis and

interpretation of results for chemical or biological materials, including the

classes of substances and methods used in doping;

- Knowledge of relevant Technical Documents, Technical Letters,

Laboratory Guidelines and other technical standards;

- Experience in the use of relevant analytical techniques such as

chromatography, immunoassays, electrophoresis or mass spectrometry;

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- Adequate training in the Laboratory’s Management System and thorough

understanding of its application into Laboratory processes.

5.2.2.4 Laboratory Supervisory Personnel

The Laboratory shall have qualified personnel to serve as Laboratory

Supervisors. All Laboratory Supervisors shall have a thorough understanding

of the Laboratory’s Management System including the review, interpretation

and reporting of test results, the maintenance of Laboratory Internal Chain of

Custody, and proper implementation of corrective and preventive actions in

response to analytical problems.

The qualifications for a Laboratory Supervisor shall include:

- At least a Bachelor degree (or similar) in one of the natural sciences with

appropriate experience and/or training in chemical and/or biochemical

analysis, preferably in the anti-doping area. Documented experience of

two (2) years or more in a Laboratory may be considered equivalent to a

Bachelor degree for this position;

- Experience in the use of relevant analytical techniques such as

chromatography, immunoassays, electrophoresis or mass spectrometry;

- Ability to comply with the Management System and quality assurance

processes.

5.2.3 Laboratory Facilities and Environmental Conditions

5.2.3.1 Laboratory Facilities

The Laboratory shall have Fit-for-Purpose facilities including sufficient space

for dedicated administrative, Sample handling, Sample storage and analytical

areas, which comply with the security requirements outlined below:

- A Person shall be assigned as the security officer, who has overall

knowledge of the security system and/or serves as the liaison Person with

the security services of the host organization (e.g. university, hospital,

research institute);

- The Laboratory shall have a policy for the security of its facilities,

equipment and systems against unauthorized access, which may include

a threat and risk assessment performed by expert(s) in the relevant field;

- Two (2) main levels of access shall be defined in the Management System

and evaluated in the threat assessment plan:

o Reception Zone: An initial point of control beyond which unauthorized

individuals shall not be permitted;

The Laboratory shall have a system to register visitors and authorized

individuals to the Laboratory. They shall be supplied with an

ISL – January 2021 Page 70 of 160

identification badge while in the Laboratory facilities.

o Controlled Zones: Access to these areas shall be monitored (e.g.

through the use of electronic access system(s) such as biometric

and/or personal identification cards) and records of access by visitors

shall be maintained;

Access to the Laboratory Controlled Zones shall be monitored and

restricted to Laboratory staff and temporarily approved/authorized

personnel (e.g. maintenance engineers, auditing teams). All other

visitors to the Laboratory Controlled Zones shall be continuously

escorted by Laboratory staff member(s). Access to the Laboratory

Controlled Zones shall be defined in the Laboratory’s Management

System.

- The Laboratory shall have a dedicated and restricted area within the

Controlled Zone for Sample receipt and Aliquot preparation;

Access to the Laboratory’s Sample receipt and Aliquot preparation area

shall be restricted to authorized personnel, based on a risk assessment by

the Laboratory.

- The Laboratory shall have a dedicated and restricted Sample storage area;

Access to stored Samples

shall be restricted to authorized personnel, based

on a risk assessment by the Laboratory.

Samples may be transported for long-term storage to a specialized, secure

Sample storage facility, which is located outside the Laboratory’s permanent

controlled zone, to another Laboratory, or to another Fit-for-Purpose facility

under the responsibility of the Testing Authority, which has ownership of the

Sample(s) pursuant to Article 10.1 of the ISTI. Long-term storage facilities shall

maintain security requirements comparable to the security requirements

applicable to a Laboratory’s short-term storage of Samples. If the external

Sample storage facility is not covered by the Laboratory’s ISO/IEC 17025

accreditation, then the subcontracted external storage facility shall have its

own ISO accreditation or accredited certification (e.g. 17025, 20387, 9001).

The transfer of the Samples to the long-term storage facility shall be recorded.

- The Laboratory may implement additional security measures, which should

be assessed on a case-by-case basis.

This refers to “A” and “B” Samples stored in Sample collection containers (urine collection bottles, blood collection

tubes) and should not be confused with access to Aliquots, which should be accessible to analysts for the

performance of Analytical Testing Procedures.

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5.2.3.2 Relocation of Laboratory Facilities

In cases where a Laboratory is to relocate to a new physical space, on a

permanent or temporary basis, a report containing the following information

shall be provided to WADA no later than three (3) months prior to the

relocation:

- Description of the circumstances for moving Laboratory operations into a

new space and anticipated effect on capabilities;

- Relocation date(s) including date of closing of existing facility operations

and date of opening of future facility operations;

- Expected date(s) of assessment of the new facilities by the Accreditation

Body (evidence of continued accreditation and/or acceptance of suitability

of the new Laboratory facilities required when made available by the

Accreditation Body);

- New Laboratory contact information and coordinates;

- Assessment of the effect of the Laboratory relocation on client operations.

5.2.3.3 Environmental Control

The Laboratory shall have a written safety policy and compliance with

Laboratory safety policies shall be enforced.

The Laboratory’s storage and handling of controlled substances shall comply

with applicable national legislation.

The Laboratory shall:

- Ensure appropriate electrical service (for example, by provision of an

alternative power supply such as an UPS system and/or power generators)

and environmental conditions (space, temperature, humidity, as

applicable) for all Laboratory instrumentation and equipment critical to

Laboratory operations, such that service is not likely to be interrupted;

- Have policies in place to ensure the integrity of refrigerated and/or frozen

stored Samples in the event of an electrical or freezer/refrigerator

equipment failure.

5.2.3.4 Confidentiality of Data, Information and Operations

The Laboratory should implement a clean desk policy and either file securely

any confidential or sensitive information or properly destroy it before disposal.

Laboratory staff shall be trained on how to comply with a clean desk policy, on

how to ensure confidentiality of information and operations, as well as on the

risks of corruption attempts by third parties.

Laboratory staff shall be trained to protect their personal access badge during

and outside of working hours.

ISL – January 2021 Page 72 of 160

In order to minimize any attempts of fraud or counterfeit, the Laboratory should

implement a policy to ensure that discarded urine and blood Sample

containers, as well as the seals and rings, cannot be collected by unauthorized

Persons or recovered after disposal (for example, bottles should be destroyed,

or trash containers should be properly secured).

5.2.3.5 Control and Security of Electronic Data and Information

The Laboratory shall implement all reasonable measures, based on a thorough

risk and vulnerability assessments (e.g., by a competent third party), to prevent

and to detect unauthorized access and copying of Laboratory data and

information from local and/or cloud-based computerized systems. Laboratories

shall implement technical and organizational safeguards consistent with best

practice and any applicable governmental regulations.

Access to Laboratory computer terminals, computers, servers or other

operating equipment shall be restricted to authorized personnel (e.g. by using

access passwords).

The Laboratory shall implement a data and information management system,

a software-based solution that supports and maintains proper traceability of

Laboratory operations (e.g. a Laboratory Information Management System,

LIMS) with secure and restricted access to stored electronic data by authorized

personnel as well as information and data exchange capabilities including

between the Laboratory and ADAMS.

[Comment: The data and information management system may also feature workflow

management, data tracking support, Sample and Aliquot Laboratory Internal Chain of

Custody, control of stocks of Reference Materials, etc.]

The Laboratory shall utilize a secure data storage system that prevents

unauthorized access and data loss (e.g. failed hard drive, fire, flooding). The

Laboratory shall ensure that at least two (2) independent, regularly backed-up

copies of all relevant analytical/LIMS/instrument software files are available.

- If the Laboratory is utilizing a non-cloud-based system, then at least one

(1) backup copy shall be stored in a restricted and secure environment

either in the Laboratory (e.g. fire and waterproof safe) or in a secure off-

site location (e.g. in a mirrored server that guarantees the integrity of the

server and the stored data);

- If the Laboratory is using a cloud-based system, the Laboratory data shall

be, at a minimum, replicated in two different physical locations (e.g.

between two different availability zones within the same region or between

different regions) in order to minimize the possibility of data loss.

The software utilized by the Laboratory shall prevent the changing of data and

test results, unless there is a system to record the change with audit trail

capabilities which is limited to users with authorized access. The audit trail shall

ISL – January 2021 Page 73 of 160

record the Person performing the editing task, the date and time of the edit, the

reason(s) for the change to the original data and allow the retention of the

original data.

If the Laboratory utilizes third-party computerized systems or software, the

Laboratory shall ensure the provider or operator complies with all applicable

requirements of the Code and the ISL and shall implement and maintain

technical and organizational controls necessary to safeguard Laboratory data.

5.2.4 Laboratory Equipment

The Laboratory shall have access to equipment that is required for the correct

performance of Analytical Testing activities. The Laboratory shall maintain sufficient

instrumental capacity to minimize the risk of operational delays and meet the analytical

and results reporting obligations of the ISL and its related Technical Documents,

Technical Letters and Laboratory Guidelines. A list of available equipment shall be

established and maintained.

As part of its Management System, the Laboratory shall operate a program for the

maintenance and calibration of equipment according to ISO/IEC 17025. Calibrations

are only required where the setting can change the test result. A maintenance

schedule, at least in accordance with the manufacturer’s recommendations or local

regulations, if available, shall be established for general Laboratory equipment that is

used in Analytical Testing Procedure(s).

General Laboratory equipment (fume hoods, centrifuges, evaporators, etc.) that is not

used for analytical measurements should be maintained by visual examination, safety

checks, performance verification and cleaning, as necessary.

Equipment or volumetric devices used in measuring shall have periodic performance

checks and/or calibrations along with servicing, cleaning, and repair.

Qualified vendors may be contracted to service, maintain, and repair equipment. All

maintenance, service, and repair of equipment shall be recorded.

5.2.5 Metrological Traceability

5.2.5.1 Reference Materials

When available, Reference Materials of substances traceable to a national

standard or certified by a body of recognized status (e.g. USP, BP, Ph.Eur.

WHO) or a Reference Material producer accredited to ISO 17034 should be

used.

When a Reference Material is not certified, the Laboratory shall verify its

identity and check its purity by comparison with published data and/or by

chemical characterization.

ISL – January 2021 Page 74 of 160

5.2.5.2 Reference Collections

Samples or isolates may be obtained from in vitro or in vivo sources [e.g. (i) an

external quality control sample, (ii) an isolate from a urine or blood sample after

an authenticated administration, or (iii) an “in-vitro” incubation with liver cells,

microsomes or biological fluids] and be used as Reference Collections.

Reference Collections shall be traceable to a Prohibited Substance or a

Prohibited Method, and the analytical data shall be sufficient to establish the

identity of the Analyte.

5.2.6 Subcontracting of Analysis

A Laboratory or ABP Laboratory shall perform all work with qualified personnel and

equipment within its accredited or approved facility, respectively.

A Laboratory may subcontract an analysis to another Laboratory, in consultation with

the Testing Authority. The conditions that justify subcontracting include, for example:

- A specific technology or Analyte(s) that are not within the Laboratory’s Scope of

ISO/IEC 17025 Accreditation;

- An Analytical Testing Restriction decision;

- Other justifications such as a need for higher sensitivity or specific equipment or

expertise, temporary workload or technical incapacity);

- In exceptional circumstances, WADA may elect to grant specific authorization to

subcontract analyses using specific methods to an ISO/IEC 17025-accredited

laboratory approved by WADA, which has the necessary technique within its

Scope of ISO/IEC 17025 Accreditation (for example, DNA analysis or genomic

profiling);

- Other specific investigations, such as, without limitation, forensic examinations

which need to be performed in the course of the Analytical Testing process may

also be subcontracted by the Laboratory.

[Comment: Alternatively, the analysis may be contracted by the Testing Authority. In this case,

the Laboratory shall nevertheless be in charge of ensuring the Sample chain of custody in

connection with the transfer of the Sample(s) to the other Laboratory(-ies) or expert(s) as the

case may be.]

In all such cases, the Laboratory subcontracting the analysis is only responsible for

the maintenance of the appropriate chain of custody up to Sample reception by the

subcontracted Laboratory. Such arrangements shall be clearly recorded as part of the

Sample’s documentation and included in the Laboratory Documentation Package, if

applicable.

Recommendations to facilitate the implementation of subcontracted analyses and

Further Analysis are provided in the WADA Laboratory Guidelines on “Conducting and

Reporting Subcontracted Analysis and Further Analysis for Doping Control”.

ISL – January 2021 Page 75 of 160

5.2.7 Purchasing of Services and Supplies

Chemicals and reagents shall be Fit-for-Purpose and be of appropriate purity.

Documentation indicating the purity of Reference Materials/Standards shall be

obtained when available and retained in the Management System documentation.

Chemicals, reagents and kits labelled e.g. “Research Only” or “Forensic Use Only”

may be utilized for the purposes of Doping Control as long as they are demonstrated

to be Fit-for-Purpose by the Laboratory and/or WADA.

In the case of rare or difficult to obtain Reference Materials, or Reference Collections

for use in qualitative Analytical Testing Procedures, the expiration date can be

extended if adequate documentation exists confirming that no significant deterioration

has occurred or that appropriate purification or verification of Fitness-for-Purpose has

been performed. The process to extend the expiration date of a Reference Material,

Reference Collection, or solution shall be described in the Laboratory’s Management

System documentation.

The Laboratory shall maintain control and proper records of use of controlled

chemicals and reagents in accordance with national laws and other relevant

regulations.

Waste disposal shall be in accordance with national laws and other relevant

regulations. This includes biohazard materials, chemicals, controlled substances, and

radioisotopes, if used.

Environmental health and safety policies shall be in place to protect the staff, the

public, and the environment.

5.3 Process Requirements

The Laboratory shall maintain paper or electronic Laboratory Internal Chain of Custody in

compliance with the Technical Document TD LCOC.

5.3.1 Reviewing of Requests, Tenders and Contracts

Review of legal documents or agreements related to Analytical Testing shall meet the

requirements of ISO/IEC 17025.

5.3.2 Reception, Registration and Handling of Samples

The Laboratory may receive Samples, which have been collected, sealed and

transported to the Laboratory according to the ISTI.

The transfer of the Samples from the courier or other delivery Person shall be recorded

including, at a minimum, the date, the time of receipt, the initials or (electronic)

signature of the Laboratory representative receiving the Samples and the courier

company tracking number, if available. This information shall be included into the

Laboratory Internal Chain of Custody record(s) of the Sample(s).

The Sample transport container shall be inspected, and any irregularities recorded.

ISL – January 2021 Page 76 of 160

Each individual Sample shall be inspected, and any irregularities recorded (see Article

5.3.3.1). However, Samples transferred for long-term storage purposes are not

subject to an individual inspection by the receiving Laboratory until a Sample has been

selected for Further Analysis.

The Laboratory shall have a system to uniquely identify the Samples and associate

each Sample with the collection document or other external chain of custody

information.

5.3.3 Acceptance of Samples for Analysis

The Laboratory shall analyze each Sample received, unless the Sample meets any of

the following conditions:

- In cases where the Laboratory receives two (2) urine Samples, which are linked to

a single Sample Collection Session from the same Athlete according to the Doping

Control Forms (DCF), the Laboratory shall analyze both Samples collected, unless

otherwise instructed by the Testing Authority;

[Comment: The Laboratory may combine Aliquots from the two (2) Samples, if necessary,

in order to have sufficient volume to perform the required Analytical Testing Procedure(s).]

- In cases where the Laboratory receives three (3) or more urine Samples, which

are linked to a single Sample Collection Session from the same Athlete according

to the DCF(s), the Laboratory shall prioritize the analysis of the first and the

subsequent collected Sample with the highest specific gravity (SG), as recorded

on the DCF:

[Comment: The Laboratory may conduct analyses on the additional collected Samples, if

deemed necessary, with the agreement of the Testing Authority. The Laboratory may also

combine Aliquots from multiple Samples, if necessary, in order to have sufficient volume

to perform the required Analytical Testing Procedure(s).

With the agreement of the Testing Authority, the Laboratory may store the additional

collected, non-analyzed Samples for Further Analysis.]

- If the Sample(s) meet documented Sample rejection criteria, which have been

agreed with the Testing Authority.

[Comment: If justified by the Sample irregularities observed (see Article 5.3.3.1), the

Laboratory shall seek instructions from the Testing Authority on the performance of

Analytical Testing on the Sample. The Testing Authority shall inform the Laboratory in

writing within seven (7) days whether a Sample with noted irregularities should be analyzed

or not, and/or of any further measures to be taken (e.g. splitting the Sample in accordance

with Article 5.3.3.2, forensic analysis, DNA analysis), or that the Sample should be stored

for Further Analysis. The communication between the Laboratory and the Testing Authority

shall be recorded as part of the Sample’s documentation.]

- Except as provided in this Article 5.3.3, Samples shall not be accepted by a

Laboratory for the sole purpose of being put into long-term storage or for later

analysis without first being subject to an Analytical Testing Procedure.

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5.3.3.1 Samples with Irregularities

With the exception of the situation when a large number of Samples, which

have already been analyzed, are received for long-term storage only (e.g. from

a Major Event Organization), as described in Article 5.3.11.3, the Laboratory

shall observe and document conditions that exist at the time of Sample

reception or registration that may adversely impact on the integrity of a Sample

or on the performance of Analytical Testing Procedures. Only unusual

conditions shall be recorded.

Irregularities to be noted by the Laboratory may include, but are not limited to:

- Sample transport conditions (e.g. delivery time, temperature), which may

impact the integrity of the Sample for Analytical Testing, as determined by

the Laboratory;

- Sample collection information (including Sample identification code), which

is necessary to conduct the requested Analytical Testing menu, is not

provided, e.g. missing or incomplete DCF;

- Sample identification is questionable. For example, the number on the

Sample container does not match the Sample identification number on the

DCF;

- Athlete information is visible on the Laboratory copy of the DCF or any

other document transferred to the Laboratory;

- Sample identification numbers are different between the “A” and the “B”

Sample containers of the same Sample;

- Tampering or adulteration of the Sample is evident;

- Sample is not sealed with tamper-evident device or not sealed upon

receipt;

- Sample volume does not meet the Suitable Volume of Urine for Analysis or

is otherwise inadequate to perform the requested Analytical Testing menu;

- The Sample condition(s) is unusual – for example: color, odor, presence of

turbidity or foam in a urine Sample; color, haemolysis, freezing or clotting

of a blood Sample; unusual differences in Sample appearance (e.g. color

and/or turbidity) between the “A” and the “B” Samples

When an analysis on a Sample with documented irregularities is performed,

the Laboratory shall record the irregularities in the Test Report.

Further guidance on assessing the differences between “A” and “B” Samples is provided in a Technical Letter.

ISL – January 2021 Page 78 of 160

5.3.3.2 Sample Splitting Procedure

In cases when either the “A” or “B” Sample is not suitable for the performance

of the analyses (e.g. there is insufficient Sample volume; the Sample container

has not been properly sealed or has been broken; the Sample’s integrity has

been compromised in any way; the Sample is heavily contaminated, the “A” or

“B” Sample is missing), the Laboratory shall notify and seek authorization from

the Testing Authority to split the other Sample container (“A” or “B”, as

applicable), provided that it is properly sealed. The Testing Authority shall

inform the Laboratory of its decision in writing within seven (7) days of

notification by the Laboratory. If the Testing Authority decides not to proceed

with the Sample splitting procedure, then the Laboratory shall report the

Sample as Not Analyzed in ADAMS, including the noted Sample irregularities

and the documented reasons if provided by the Testing Authority.

The first fraction of the split Sample shall be considered as the “A” Sample and

shall be used for the Initial Testing Procedure(s), unless the Initial Testing

Procedure(s) have already been performed, and the “A” Confirmation

Procedure(s), if necessary. The second fraction, considered as the “B” Sample,

shall be resealed and stored frozen for “B” Confirmation Procedure(s), if

necessary.

The process of opening and splitting the Sample and resealing of the remaining

second fraction shall be conducted in accordance with Article 5.3.6.2.3 as for

a customary “B” Sample opening, including an attempt to notify the Athlete that

the opening of the Sample to be split will occur on a specified date and time

and advising the Athlete of the opportunity to observe the process in person

and/or through a representative. When the Athlete cannot be located, does not

respond or the Athlete and/or his/her representative does not attend the

opening and splitting of the Sample, the procedure shall be done in the

presence of an Independent Witness that is assigned by the Laboratory.

[Comment: If the Athlete chooses to witness the Sample splitting procedure, the Athlete

takes responsibility for forfeiting his/her anonymity.]

When the splitting procedure concerns blood Samples, which have been

collected for Analytical Testing on the blood serum/plasma fraction, the sealed,

intact (“A” or “B”) Sample shall be centrifuged as soon as practical after

Laboratory reception to obtain the serum or plasma fraction. The centrifuged

Sample shall be stored frozen in the sealed Sample collection tube according

to established protocols until the Sample opening/splitting procedure can be

conducted. The opening of the Sample for the splitting of the serum/plasma

fraction and resealing of the second fraction shall be carried out as described

immediately above.

ISL – January 2021 Page 79 of 160

5.3.4 Initial Storage and Sample Aliquoting for Analysis

It is recommended that the Laboratory assign specific staff member(s) to Sample

aliquoting, and that the process of aliquoting is performed in a specifically designated

area (see Article 5.2.3.1).

The Aliquot preparation procedure for any Initial Testing Procedure or Confirmation

Procedure shall minimize the risk of contamination of the Sample or Aliquot. The

Laboratory shall use new material(s) (e.g. new test tubes) to take Aliquots for

Confirmation Procedures.

5.3.4.1 Urine Samples

In order to maintain the stability and integrity of the urine Samples, the

Laboratory shall implement Sample storage procedures that minimize storage

time at room and refrigerated temperatures as well as Sample freeze/thaw

cycles.

For urine Samples, the Laboratory shall obtain, following proper

homogenization of the Sample, an initial Aliquot containing enough Sample

volume for all analytical procedures (all Initial Testing Procedures or all

intended Confirmation Procedures, as applicable), by decanting the Aliquot

from the urine Sample container into a secondary container (e.g. a Falcon

tube). Procedure-specific Aliquot(s) shall then be taken from the secondary

container.

The Laboratory shall measure the pH and SG of urine Samples once, using

one Aliquot, during the Initial Testing Procedure and the Confirmation

Procedure(s) (“A” and “B” Samples). Other tests that may assist in the

evaluation of adulteration or manipulation may be performed if deemed

necessary by the Laboratory (refer to the Technical Document on measuring

and reporting the steroid profile, TD EAAS).

Urine “A” Samples should be frozen after Aliquots are taken for the Initial

Testing Procedure(s) to minimize risks of Sample microbial degradation. Urine

“B” Samples shall be stored frozen after reception until analysis, if applicable.

5.3.4.2 Blood Samples

The Laboratory shall follow the applicable Technical Document(s), Technical

Letter(s) or Laboratory Guidelines for handling and storing blood Samples.

For blood Samples, the Laboratory shall obtain Aliquot(s) from the blood

Sample container by using disposable pipettes or pipettes with disposable,

non-reusable tips.

a) Samples for which Analytical Testing will be performed on blood

serum/plasma fraction only (not on cellular components).

Blood Samples (“A” and “B” Samples), for which Analytical Testing will be

ISL – January 2021 Page 80 of 160

performed on the plasma/serum fraction only should be centrifuged as

soon as practical after Laboratory reception to obtain the serum or plasma

fraction

The “A” Sample serum or plasma fraction (contained in the “A” Sample

collection tube) and/or the “A” Sample serum or plasma Aliquots may be

stored refrigerated for a maximum of 24 hours (but not surpassing the

maximum allowed time from Sample collection established in the

applicable Technical Document, Technical Letter or Laboratory Guidelines)

or frozen until analysis. In all circumstances, the Laboratory shall take the

appropriate steps to maintain the integrity of the Sample.

“A” Sample serum or plasma Aliquots used for “A” Confirmation Procedures

shall be analyzed as soon as possible after thawing.

The “B” Sample serum or plasma fractions shall be immediately stored

frozen in the collection tube according to established protocols until

analysis, if applicable

b) Samples for which Analytical Testing will be performed on the cellular

fraction of whole blood.

Whole blood Samples shall be maintained refrigerated and shall be

analyzed according to established protocols. After Aliquots have been

taken for analysis, Samples shall be returned to refrigerated storage.

Whole blood Samples shall not be frozen. In all circumstances, appropriate

steps to ensure the integrity of the Sample(s) shall be taken by the

Laboratory.

If, after completion of analyses on the cellular components of whole blood,

the Sample is centrifuged to obtain the plasma fraction for additional

analyses (e.g. EPO), then the plasma Sample shall be stored as described

above.

5.3.5 Selection and Validation of Analytical Testing Procedures

Standard methods are generally not available for Doping Control analyses. The

Laboratory shall select, validate and document Analytical Testing Procedures, which

are Fit-for-Purpose for the analysis of representative target Analytes of Prohibited

Substances and Prohibited Methods.

Validation results for Analytical Testing Procedures shall be summarized in a

Validation Report and supported by the necessary documentation and analytical data.

The Validation Report shall indicate whether the Analytical Testing Procedure is Fit-

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines.

ISL – January 2021 Page 81 of 160

for-Purpose and shall be approved at least by the Laboratory Director and the

Laboratory Quality Manager, or other qualified senior Laboratory staff, e.g. the Deputy

Scientific Director, as designated by the Laboratory Director.

The Laboratory shall define and document the conditions that would trigger the

revalidation of an Analytical Testing Procedure (e.g. change of internal standard,

modified extraction procedure or chromatographic methodology, change in detection

technique) or a partial re-assessment of the validation process (e.g. replacement or

upgrade of instrument, addition of new Analyte to the Analytical Method).

This Article applies only to the validation of Analytical Testing Procedures, and not to

the review of the analytical results for any Sample(s).

5.3.5.1 Validation of Analytical Testing Procedures for Non-Threshold

Substances

The Laboratory shall develop, as part of the method validation process,

appropriate standard solutions for detection and/or identification and

estimation of the concentration of Non-Threshold Substances using Reference

Materials. In the absence of suitable Reference Materials, Reference

Collections may be used for detection and identification.

a) Validation of Initial Testing Procedures for Non-Threshold Substances

The Laboratory shall validate the Selectivity, carryover, reliability of

detection at the MRPL and Limit of Detection (LOD) for the Initial Testing

Procedure from the analysis of an adequate number of representative

samples prepared in the appropriate matrix of analysis. For

chromatographic-mass spectrometric Analytical Methods, the Initial

Testing Procedure shall allow the detection of each Non-Threshold

Substance or its representative Metabolite(s) or Marker(s) at 50% or less

of the Minimum Required Performance Levels (MRPL) (see the Technical

Document on Minimum Required Performance Levels, TD MRPL).

For Non-Threshold Substances with Minimum Reporting Levels (MRL), the

Laboratory shall validate and document the concentration levels that will

require a Confirmation Procedure.

If there is no available Reference Material, an estimate of the detection

capability of the Initial Testing Procedure (i.e. the LOD) for the Non-

Threshold Substance or its representative Metabolite(s) or Marker(s) may

be provided by assessing a representative substance from the same class

of Prohibited Substances with a similar chemical structure.

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b) Validation of Confirmation Procedures for Non-Threshold Substances

Factors to be investigated in the method validation procedure to

demonstrate that a Confirmation Procedure for Non-Threshold Substances

is Fit-for-Purpose include, but are not limited to:

- Selectivity: The ability of the Confirmation Procedure to detect and

identify the Analyte of interest, taking into account interference(s) from

the matrix or from other substance(s) present in the Sample. Selectivity

shall be determined and documented from the analysis of an adequate

number of representative samples prepared in the matrix of Sample

analysis, in compliance with the Technical Document on

chromatographic-mass spectrometric identification criteria (TD IDCR)

or other applicable Technical Document, Technical Letter or Laboratory

Guidelines. The Confirmation Procedure shall be able to discriminate

between Analytes of closely related structures;

- Limit of Identification (LOI): When the analyses of Non-Threshold

Substances are based on chromatographic-mass spectrometric

techniques, the Laboratory shall determine the lowest concentration at

which each Non-Threshold Substance or its representative

Metabolite(s) or Marker(s), for which a Reference Material is available,

is identified at no more than 5% false negative rate (in compliance with

the TD IDCR or other applicable Technical Document, Technical Letter

or Laboratory Guidelines). The LOI shall be lower than the applicable

MRPL;

[Comment: The TD MRPL requirement that the LOD, estimated during method

validation, shall be equal to or less than (≤) 50% of the MRPL, is applicable to

the Initial Testing Procedures and not to the Confirmation Procedures. This

ensures the detection of the Non-Threshold Substance (or its representative

Metabolite or characteristic Marker, as applicable) at the MRPL at all times,

which then triggers the subsequent performance of a Confirmation Procedure.

Due to inherent differences between the procedures (e.g. Sample preparation)

and identification requirements (e.g. number of diagnostic ions or precursor-

product ion transitions) applicable to Initial Testing Procedures and

Confirmation Procedures, their detection capabilities may differ. Therefore, it

may occur that a Sample is reported as an Adverse Analytical Finding for a

Non-Threshold Substance at concentrations lower than the estimated LOD of

the Initial Testing Procedure. Furthermore, since LOD values are estimations

based on method validation with a limited number of representative samples,

a Laboratory may be able to effectively confirm the presence of a target Non-

Threshold Substance (or its representative Metabolite or characteristic

Marker) in a given Sample at levels below the validated LOD (e.g. in a Sample

with low background or less matrix interferences).

A Confirmation Procedure for a Non-Threshold Substance shall allow the

unequivocal identification of the Non-Threshold Substance (or its

ISL – January 2021 Page 83 of 160

representative Metabolite(s) or characteristic Marker(s)) in compliance with the

TD IDCR. If successfully identified, a Non-Threshold Substance can be

reported at a concentration below the estimated LOD of the Initial Testing

Procedure or the LOI of the Confirmation Procedure.]

- Robustness: The Confirmation Procedure shall be demonstrated to

produce similar results with respect to minor variations in analytical

conditions, which may affect the results of the analysis. Those

conditions that are critical to ensuring reproducible results shall be

considered;

- Carryover: The conditions required to eliminate carryover of the

substance of interest from Sample to Sample during processing or

instrumental analysis;

[Comment: Elimination of ‘injection memory’ effect is demonstrated by

injecting a blank control sample for the Analyte in question, prepared in the

Sample matrix, immediately prior to the Sample of interest.]

5.3.5.2 Validation of Analytical Testing Procedures for Threshold Substances

As part of the validation process for chromatography-mass spectrometric

Analytical Methods applied to the analysis of Threshold Substances, the

Laboratory shall develop acceptable standard solutions for identification of

Threshold Substances using Reference Materials. For Confirmation

Procedures, Certified Reference Materials should be used for quantification, if

available.

For the application of affinity-binding assays to the analysis of Threshold

Substances, the Laboratory shall follow the applicable Technical Document

(e.g. Technical Document on human Growth Hormone, TD GH) or Laboratory

Guidelines.

a) Validation of Initial Testing Procedures for Threshold Substances

The Laboratory shall validate Initial Testing Procedures that are Fit-for-

Purpose, in accordance with relevant Technical Document(s), Technical

Letter(s) or Laboratory Guidelines.

For chromatographic-mass spectrometric Initial Testing Procedures, the

Laboratory shall validate the Selectivity, LOD and dynamic range from the

analysis of an adequate number of representative samples prepared in the

appropriate matrix of analysis

The Laboratory shall validate and document the concentration levels which

will require quantitative Confirmation Procedure(s)

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines.

ISL – January 2021 Page 84 of 160

[Comment: In order to account for a possible underestimation of concentrations of

Threshold Substances during non-quantitative Initial Testing Procedures, the

Laboratory shall establish, and document in the Test Method’s SOP, criteria (e.g.

concentration levels), determined during the Initial Testing Procedure method

validation, to evaluate initial results as Presumptive Adverse Analytical Findings

and ensure that all potentially positive Samples are subjected to quantitative

Confirmation Procedures.

Unless otherwise specified in a Technical Document, Technical Letter or

Laboratory Guidelines, the Laboratory may also choose to forward all Samples

containing an exogenous Threshold Substance to confirmation analysis, in order

to ensure that all potential Presumptive Adverse Analytical Findings are subjected

to Confirmation Procedure(s).]

The estimation of Measurement Uncertainty (MU) is not required during the

validation of Initial Testing Procedures

b) Validation of Confirmation Procedures for Threshold Substances

Factors to be investigated during the method validation to demonstrate that

a quantitative Confirmation Procedure for a Threshold Substance is Fit-for-

Purpose include but are not limited to:

- Selectivity, LOI, Robustness, Carryover (see Article 5.3.5.1);

- Limit of Quantification (LOQ): The Laboratory shall demonstrate that a

quantitative Confirmation Procedure has an established LOQ of no

more than 50% of the Threshold value or in accordance with the LOQ

values required in relevant Technical Document(s) or Laboratory

Guidelines;

- Dynamic Range: The range of the quantitative Confirmation Procedure

shall be documented from at least 50% to 200% of the Threshold value;

- Repeatability (s

): The quantitative Confirmation Procedure shall allow

for the reliable repetition of the results over a short time, using a single

operator, item of equipment, etc. Repeatability at levels close to the

Threshold shall be determined;

- Intermediate Precision (s

): The quantitative Confirmation Procedure

shall allow for the reliable repetition of the results at different times and

with different operators and instruments, if applicable, performing the

assay. Intermediate Precision at levels close to the Threshold shall be

determined;

- Bias (b): The Bias of the measurement procedure shall be evaluated

either using Certified Reference Materials or traceable Reference

Materials, if available, or from comparison with a reference method or

with the consensus values obtained from an inter-Laboratory

comparison study or EQAS participation. Bias at the levels close to the

ISL – January 2021 Page 85 of 160

Threshold shall be determined;

- Measurement Uncertainty (MU): The MU associated with the results

obtained with the quantitative Confirmation Procedure shall be

estimated in accordance with the Technical Document on Decision

Limits (TD DL) or other applicable Technical Document (e.g. TD GH),

Technical Letter or Laboratory Guidelines. At least, MU at levels close

to the Threshold shall be addressed during the validation of the

quantitative Confirmation Procedure.

Confirmation Procedure method validation data (including the estimation of

MU) is evaluated during the assessment process for inclusion of the

quantitative Confirmation Procedure within the Laboratory’s Scope of

ISO/IEC 17025 Accreditation. Therefore, for those Confirmation

Procedures that are included within the Laboratory’s Scope of ISO/IEC

17025 Accreditation, the Laboratory is not required to produce method

validation data or other evidence of method validation in any legal

proceeding.

5.3.6 Sample Analysis

Laboratories shall analyze Samples collected by Anti-Doping Organizations using In-

Competition or Out-of-Competition Analytical Testing menus to detect the presence of

Prohibited Substances or Prohibited Methods only (as defined in the Prohibited List).

In addition, Laboratories may analyze Samples for the following, in which case the

results of the analysis shall not be reported as an Atypical Finding or an Adverse

Analytical Finding:

- Non-prohibited substances or methods that are included in the WADA Monitoring

Program (see Code Article 4.5);

- Non-prohibited substances for results interpretation purposes (e.g. confounding

factors of the “steroid profile”, non-prohibited substances that share Metabolite(s)

or degradation products with Prohibited Substances), if applicable;

- Non-prohibited substances or methods requested as part of a Results

Management process by the Results Management Authority, a hearing body or

WADA;

- Non-prohibited substances or methods requested by the Testing Authority as part

of its safety code, code of conduct or other regulations (see comments to Code

Articles 5.1 and 23.2.2); or

- Additional analyses for quality assurance/quality improvement/method

development or research purposes, in accordance with the requirements indicated

in Article 5.3.12.

[Comment: An Anti-Doping Organization has the discretion to apply anti-doping rules to an

Athlete who is neither an International-Level Athlete nor a National-Level Athlete and may elect

ISL – January 2021 Page 86 of 160

to request that Samples collected from these Athletes are analyzed for less than the full menu

of Prohibited Substances and Prohibited Methods. The Anti-Doping Organization is responsible

for providing the Laboratory with the appropriate written justification for a reduced Testing

menu.]

At minimum, all Laboratories are required to implement all mandatory Analytical

Testing Procedures, as determined by WADA in specific Technical Document(s),

Technical Letter(s) or Laboratory Guidelines. Laboratories may implement additional

methods for the analysis of particular Prohibited Substances or Prohibited Methods.

[Comment: Mandatory Analytical Testing Procedures are those Analytical Methods for which

all Laboratories shall have available analytical capacity, in compliance with relevant Technical

Document(s), Technical Letter(s) or Laboratory Guidelines, and therefore should have the

Analytical Method included in their Scope of ISO/IEC 17025 Accreditation. However, based on

an In-Competition or Out-of-Competition Analytical Testing menu, a mandatory Analytical

Testing Procedure is not necessarily applied to all Samples. For some Samples, Testing

Authorities may decide to request Analytical Testing for specific Prohibited Substances or

Prohibited Methods only. These requests shall be detailed in the Sample chain of custody. On

occasion, however, certain Analytical Testing Procedures (e.g. gene doping) or the analysis of

certain Prohibited Substances (e.g. some large peptides) or Prohibited Methods (e.g.

homologous blood transfusion) with a given Analytical Testing Procedure may not be

mandatory for all Laboratories. WADA will maintain the list of mandatory Analytical Methods

for reference by the Anti-Doping Organizations.]

Analytical Testing Procedure(s) included in the Laboratory’s Scope of ISO/IEC 17025

Accreditation shall be considered as Fit-for-Purpose and therefore the Laboratory shall

not be required to provide method validation documentation or EQAS performance

data in support of an Adverse Analytical Finding.

However, if the Analytical Testing Procedure has not been included yet in the

Laboratory’s Scope of ISO/IEC 17025 Accreditation, the Laboratory shall validate the

procedure in compliance with the ISL and the applicable Technical Document(s),

Technical Letter(s) or Laboratory Guidelines prior to its application to the analysis of

Samples. In such cases, the Laboratory may be required to provide method validation

documentation or EQAS performance data in support of an Adverse Analytical Finding

(see Article 4.4.2.2).

Laboratories may, on their own initiative and prior to reporting a test result, apply

additional Analytical Testing Procedures to analyze Samples for Prohibited

Substances or Prohibited Methods not included in the standard Analytical Testing

menu or in the Technical Document for sport-specific analysis (TD SSA), provided that

the additional work is conducted at the Laboratory’s expense and does not significantly

affect the possibility to submit the Sample, as identified by the Testing Authority or

WADA, to Further Analysis. Results from any such analysis shall be reported in

ADAMS and have the same validity and Consequences as any other analytical result.

ISL – January 2021 Page 87 of 160

5.3.6.1 Application of Initial Testing Procedures

The objective of the Initial Testing Procedure is to obtain information about the

potential presence of Prohibited Substance(s) or Metabolite(s) of Prohibited

Substance(s), or Marker(s) of the Use of a Prohibited Substance or Prohibited

Method. Results from Initial Testing Procedure(s) can be included as part of

longitudinal studies (e.g. endogenous steroid or hematological profiles),

provided that the method is Fit-for-Purpose.

The Initial Testing Procedure(s) shall fulfil the following requirements:

- The Initial Testing Procedure shall be Fit-for-Purpose;

- The Initial Testing Procedure shall be performed on Aliquot(s) taken from

the container identified as the “A” Sample;

[Comment: In cases when the “A” Sample cannot be used for the Initial Testing

Procedure(s), the Initial Testing Procedure may be performed on an Aliquot of the

first bottle of the split “B” Sample, which is to be used as the “A” Sample (see

Article 5.3.3.2).]

- The Initial Testing Procedure shall be recorded, as part of the Sample (or

Sample batch) record, each time it is conducted;

- All batches undergoing an Initial Testing Procedure shall include

appropriate negative and positive quality controls prepared in the matrix of

analysis

;

- The Initial Testing Procedures for Non-Threshold Substances shall include

appropriate controls of representative substance(s) at or below the MRPL;

- The Initial Testing Procedures for Threshold Substances shall include

appropriate controls close to the Threshold

;

- Results from Initial Testing Procedures are not required to consider the

associated MU

;

- The Laboratory shall establish criteria, based on its method validation and

in accordance with its SOP, to evaluate results from an Initial Testing

Procedure as a Presumptive Adverse Analytical Finding, which would

trigger confirmation analyses.

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines.

ISL – January 2021 Page 88 of 160

5.3.6.2 Application of Confirmation Procedures

The objective of the Confirmation Procedure is to obtain a result, which

supports or does not support the reporting of an Adverse Analytical Finding or

Atypical Finding.

A Confirmation Procedure for a Non-Threshold Substance with a Minimum

Reporting Level may also be performed if the result estimated from the Initial

Testing Procedure is lower than the applicable Minimum Reporting Level, as

determined by the Laboratory in accordance with the method’s validation

results.

A result obtained in the Initial Testing Procedure for a Threshold Substance

higher than the Threshold requires a Confirmation Procedure, even if this result

is below the relevant Decision Limit

. A Confirmation Procedure may also be

performed if the result obtained in the Initial Testing Procedure is lower than

the Threshold, as determined by the Laboratory or as specifically required by

the Testing Authority (or Results Management Authority, if different) or WADA.

Irregularities in the Initial Testing Procedure(s) shall not invalidate an Adverse

Analytical Finding, which is adequately established by a Confirmation

Procedure.

The Confirmation Procedure(s) shall fulfil the following requirements:

- The Confirmation Procedure(s) shall be Fit-for-Purpose, including the

estimation of the MU associated with a quantitative Confirmation

Procedure;

- The Confirmation Procedure(s) shall be recorded, as part of the Sample (or

Sample batch) record, each time it is conducted;

- The Confirmation Procedure shall have equal or greater Selectivity than

the Initial Testing Procedure and shall provide accurate quantification

results (applicable to Threshold Substances). The Confirmation Procedure

should incorporate, when possible and adequate, a different Sample

extraction protocol and/or a different analytical methodology

;

- All batches undergoing a Confirmation Procedure shall include appropriate

negative and positive quality controls prepared in the matrix of analysis.

5.3.6.2.1 Confirmation Procedure Methods

Mass spectrometry (MS) coupled to chromatographic separation (e.g.

gas or liquid chromatography) is the analytical technique of choice for

confirmation of most Prohibited Substances, Metabolite(s) of a

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines

ISL – January 2021 Page 89 of 160

Prohibited Substance, or Marker(s) of the Use of a Prohibited

Substance or Prohibited Method. These are acceptable methods for

both the Initial Testing Procedure and the Confirmation Procedure.

Affinity-binding assays (e.g. Immunoassays), electrophoretic

methods and other Analytical Methods are also routinely used for

detection of macromolecules in Samples.

[Affinity-binding assays applied for the Initial Testing Procedure(s)

and Confirmation Procedure(s) shall use affinity reagents (e.g.

antibodies) recognizing different epitopes of the macromolecule

analyzed, unless a purification (e.g. immunopurification) or

separation method (e.g. electrophoresis, chromatography) is used

prior to the application of the affinity-binding assay to eliminate the

potential of cross-reactivity. The Laboratory shall document, as part

of the method validation, that any such purification or separation

method is Fit-for-Purpose.

In affinity-binding assays which include multiple affinity reagents

(such as sandwich immunoassays), at least one (1) of the affinity

reagents (either applied for capture or detection of the target Analyte)

used in the affinity-binding assays applied for the Initial Testing

Procedure(s) and Confirmation Procedure(s) must differ. The other

affinity reagent may be used in both affinity-binding assays.

For Analytes that are too small to have two (2) independent antigenic

epitopes, two (2) different purification methods or two (2) different

Analytical Methods shall be applied. Multiplexed affinity-binding

assays, protein chips, and similar simultaneous multi-Analyte testing

approaches may be used.

Antibodies may also be used for specific labelling of cell components

and other cellular characteristics. When the purpose of the test is to

identify populations of blood constituents, the detection of multiple

Markers on the cells as the criteria for an Adverse Analytical Finding

replaces the requirement for two (2) antibodies recognizing different

antigenic epitopes. An example is the detection of surface Markers

on red blood cells (RBCs) using flow cytometry. The flow cytometer

is set up to selectively recognize RBCs. The presence on the RBCs

of more than one surface Marker (as determined by antibody

labelling) as a criterion for an Adverse Analytical Finding may be used

as an alternative to multiple antibodies to the same Marker.]

ISL – January 2021 Page 90 of 160

5.3.6.2.2 “A” Confirmation Procedure:

- Aliquots

The “A” Confirmation Procedure shall be performed using new

Aliquot(s) taken from the container identified as the “A” Sample.

At this point, the link between the Sample external code as shown

in the Sample container and the Laboratory internal Sample code

shall be verified.

[Comment: In cases when the “A” Sample cannot be used, the “A”

Confirmation Procedure may be performed on an Aliquot of the split “B”

Sample (see Article 5.3.3.2).]

- Target Analyte(s)

If the presence of more than one (1) Prohibited Substance,

Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use

of a Prohibited Substance or Prohibited Method is detected by the

Initial Testing Procedure(s), the Laboratory shall confirm as many

of the Presumptive Adverse Analytical Findings as reasonably

possible (such decision should take into account the volumes

available in the “A” and “B” Samples). The confirmation(s) shall

prioritize the identification and/or quantification of the Prohibited

Substance(s) or Prohibited Method(s) that carry the longest

potential period of Ineligibility. The decision shall be made in

consultation with the Testing Authority (or Results Management

Authority, if different) and documented.

- Existence of approved Therapeutic Use Exemption (TUE)

When there is a Presumptive Adverse Analytical Finding for hCG,

hGH (Biomarkers Test), Beta-2 Agonists, Diuretics, Amfetamine,

Methylphenidate, Glucocorticoids or Beta-blockers, the

Laboratory may contact the Testing Authority (or Results

Management Authority, if different) to enquire whether an

approved Therapeutic Use Exemption (TUE) exists for the

Prohibited Substance(s) detected.

[Comment: Unless there is a prior agreement between the Testing

Authority (or Results Management Authority, if different) and the

Laboratory, contacting the Testing Authority (or Results Management

Authority, if different) in such cases is not a requirement for the

Laboratory. The Laboratory may proceed, at its discretion, to confirm the

Presumptive Adverse Analytical Finding for hCG, hGH (Biomarkers

Test), Beta-2 Agonists, Diuretics, Amfetamine, Methylphenidate,

Glucocorticoids or Beta-blockers and report an Adverse Analytical

Finding in ADAMS according to the confirmation results obtained.]

ISL – January 2021 Page 91 of 160

[Comment: In principle, the enquiry by Laboratories regarding the

existence of an approved TUE for a Beta-2 Agonist may be applied not

only to those Beta-2 Agonists which are prohibited under any condition,

but also to those which are permitted up to a maximum dose by

inhalation only, as specified in the Prohibited List. In such cases, the

Laboratory may enquire about the existence of an approved TUE for the

Use of a prohibited route of administration or a supra-therapeutic

inhalation dose.]

When possible, the Laboratory should provide an estimated

concentration of the Analyte(s) from the Initial Testing Procedure. Any

such contact with the Testing Authority (or Results Management

Authority, if different) shall be confirmed in writing (for further

guidance, refer to the Laboratory Guidelines on TUE enquiries).

The instruction by the Testing Authority (or Results Management

Authority, if different) on whether the Laboratory shall proceed or not

with the confirmation based on an approved TUE shall be provided to

the Laboratory in writing. If not proceeding with the confirmation, then

the Testing Authority (or Results Management Authority, if different)

shall provide WADA with a copy of the approved TUE or the

associated TUE number if the TUE has been submitted into ADAMS.

- Repetition of the “A” Confirmation Procedure

The Laboratory may repeat the Confirmation Procedure for an “A”

Sample, if appropriate, (e.g. quality control failure, chromatographic

peak interferences, inconclusive “A” confirmation results). In that

case, the previous test result shall be nullified. Each repeat

confirmation shall be performed using (a) new Aliquot(s) taken from

the “A” Sample container and shall be recorded.

- “A” Confirmation Procedure for Non-Threshold Substances

For Non-Threshold Substances without Minimum Reporting Levels,

Adverse Analytical Finding or Atypical Finding decisions for the “A”

Sample shall be based on the identification of the Non-Threshold

Substance or its characteristic Metabolite(s) or Marker(s), as

applicable, in compliance with the TD IDCR and/or other relevant

Technical Document (e.g. TD MRPL), Technical Letter or Laboratory

Guidelines.

For Non-Threshold Substances with Minimum Reporting Levels as

specified in the TD MRPL, Adverse Analytical Finding decisions for

the “A” Sample should be based on the identification of the Non-

Threshold Substance or its characteristic Metabolite(s) or Marker(s),

in compliance with the TD IDCR, at an estimated concentration

greater than the Minimum Reporting Level, unless there is

ISL – January 2021 Page 92 of 160

justification for reporting the finding at levels below the Minimum

Reporting Level (e.g. if the analysis forms part of an ongoing

investigation).

- “A” Confirmation Procedure for Threshold Substances

For Threshold Substances, Adverse Analytical Finding or Atypical

Finding decisions for the “A” Sample shall be based on the confirmed

identification (in accordance with the TD IDCR, applicable to

Confirmation Procedures based on chromatography-mass

spectrometry) of the Threshold Substance and/or its Metabolite(s) or

Marker(s) and their quantitative determination in the Sample at a level

exceeding the value of the relevant Decision Limit, which is specified

in the TD DL or other applicable Technical Document(s) (e.g. TD GH)

or Laboratory Guidelines.

Quantitative Confirmation Procedures for Threshold Substances shall

be based on the determination of the mean of measured analytical

values (e.g. concentrations, chromatogram peak heights or areas) or

the ratio/score calculated from the mean(s) of the measured

analytical values of three (3) “A” Sample Aliquots

. If there is not

enough Sample volume to analyze three (3) Aliquots, the maximum

number of Aliquots that can be prepared should be analyzed.

By determining that the test result exceeds the Decision Limit, the

quantitative Confirmation Procedure establishes that the Threshold

Substance or its Metabolite(s) or Marker(s) is present in the Sample

at a level greater than the Threshold, with a statistical confidence of

at least 95% (for more information, refer to the TD DL).

For endogenous Threshold Substances, Markers of the “steroid

profile”, or any other Prohibited Substance that may be produced

endogenously at low levels, Adverse Analytical Finding decisions for

the “A” Sample may also be based on the application of any Fit-for-

Purpose Confirmation Procedure that establishes the exogenous

origin of the Prohibited Substance or its Metabolite(s) or Marker(s)

(e.g. GC/C/IRMS). Atypical Findings may result from non-conclusive

determinations of the origin (endogenous vs. exogenous) of the

Prohibited Substance or its Metabolite(s) or Marker(s).

For some exogenous Threshold Substances, which are identified as

such in the Prohibited List and the TD DL, Adverse Analytical Finding

decisions for the “A” Sample do not require a quantification procedure

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines.

ISL – January 2021 Page 93 of 160

if detected in the presence of any Prohibited Substance classified

under S5. “Diuretics and Masking Agents” of the Prohibited List. In

such cases, the identification (in accordance to the TD IDCR) of the

Threshold Substance and/or its Metabolite(s) in the Sample is

sufficient to conclude an Adverse Analytical Finding.

5.3.6.2.3 “B” Confirmation Procedure

- Testing Laboratory

The “B” Confirmation Procedure shall be performed in the same

Laboratory as the “A” Confirmation Procedure, unless there are

exceptional circumstances, as determined by WADA and with

WADA’s prior written approval, which prevent the “B”

Confirmation Procedure from being performed in the same

Laboratory.

- Notification and Timing of “B” Confirmation Procedure

The “B” Confirmation Procedure shall only be performed by the

Laboratory upon request by either the Athlete or the Testing

Authority or Results Management Authority (if different).

The Testing Authority or Results Management Authority, as

applicable, should inform the Laboratory, in writing, within fifteen

(15) days following the reporting of an “A” Sample Adverse

Analytical Finding by the Laboratory, whether the “B”

Confirmation Procedure shall be conducted. This includes

situations when the Athlete does not request the “B” Sample

analysis or expressly or implicitly waives his/her right to the

analysis of the “B” Sample, but the Testing Authority or Results

Management Authority decides that the “B” Confirmation

Procedure shall still be performed.

If the “B” Confirmation Procedure is to be performed, either upon

the request of the Athlete or the Testing Authority or Results

Management Authority, it should be performed as soon as

possible after the Testing Authority or Results Management

Authority, as applicable, has provided such notice to the

Laboratory.

The timing of the “B” Confirmation Procedure may be strictly fixed

within a very short period of time and without any possible

postponement, if circumstances so justify it. This can notably and

without limitation be the case when a postponement of the “B”

Sample analysis could significantly increase the risk of Sample

degradation and/or inadequately delay the decision-making

ISL – January 2021 Page 94 of 160

process in the given circumstances (e.g. and without limitation,

during or in view of a Major Event requiring rapid completion of

the Sample analysis).

If the Athlete declines to be present in person and/or through a

representative, or does not indicate whether he or she requests

the “B” Sample analysis, or if the Athlete will not attend (in person

and/or through a representative) once a date and time for the

analysis has been proposed or if the Athlete or the Athlete’s

representative claims not to be available on the date or at the time

of the opening of the “B” Sample, despite reasonable attempts to

find an alternative date and time convenient both to the Athlete

and to the Laboratory, the Testing Authority or Results

Management Authority or WADA, as applicable, shall instruct the

Laboratory to proceed regardless. The Laboratory, in consultation

with the Testing Authority, the Results Management Authority or

WADA, as applicable, shall appoint an Independent Witness to

verify that the “B” Sample container shows no signs of Tampering

and that the identifying numbers match that on the Sample

collection documentation. An Independent Witness may be

appointed even if the Athlete has indicated that he/she will be

present and/or represented.

- Authorization of non-Laboratory Persons to attend the “B”

Confirmation Procedure

The following non-Laboratory Persons shall be authorized to

attend the “B” Confirmation Procedure:

o The Athlete and/or representative(s) of the Athlete or, in the

absence of the Athlete and/or representative(s), an

Independent Witness:

• The Athlete and a maximum of two (2) representatives,

and/or the Independent Witness, have the right to attend

the “B” Sample opening, aliquoting and resealing

procedures;

• The Athlete and/or one (1) representative may also have

reasonable opportunity to observe other steps of the “B”

Confirmation Procedure, as long as their presence in the

Laboratory does not interfere with the Laboratory’s routine

operations or Laboratory safety or security requirements.

[Comment: An Independent Witness may also attend even if the

Athlete is present and/or represented.]

o A translator (if applicable);

ISL – January 2021 Page 95 of 160

o A representative of the Testing Authority or the Results

Management Authority (if requested by the Testing Authority

or the Results Management Authority, respectively);

o A representative of the National Olympic Committee and/or

National Sport Federation and/or International Federation, as

applicable, may also attend the “B” Sample opening

procedure, upon request and with prior approval of the

Laboratory Director.

The Laboratory Director may limit the number of individuals in

Controlled Zones of the Laboratory based on safety or security

considerations. Persons attending shall not interfere with the “B”

Sample opening or the “B” Confirmation Procedure process in any

way at any time and shall strictly follow the instructions of the

Laboratory. The Laboratory may have any Person removed,

including the Athlete or Athlete’s representative, if they are not

following the instructions, disturbing or interfering with the “B”

Sample opening or the Analytical Testing process. Any behavior

resulting in removal shall be reported to the Testing Authority

and/or Results Management Authority, as applicable.

Interference may further be constitutive of an anti-doping rule

violation in accordance with Code Article 2.5, “Tampering, or

Attempted Tampering with any part of Doping Control by an

Athlete or other Person”.

- Opening, Aliquoting and Resealing of “B” Sample

The “B” Confirmation Procedure shall be performed using

Aliquot(s) taken from the container defined as the “B” Sample.

[Comment: In cases when the “B” Sample cannot be used for Analytical

Testing, the unopened, sealed “A” Sample may be split (see Article

5.3.3.2) and the “B” Confirmation Procedure(s), if needed, may be

performed on an Aliquot taken from the split, resealed “A” Sample

fraction designated as the “B” Sample.]

The Athlete and/or his/her representative(s) or the Independent

Witness shall verify that the “B” Sample container is properly

sealed and shows no signs of Tampering, and that the identifying

numbers match that on the Sample collection documentation. At

a minimum, the Laboratory Director or representative and the

Athlete or their representative(s) and/or the Independent Witness

shall sign the Laboratory documentation attesting that the “B”

Sample container was properly sealed and showed no signs of

Tampering, and that the identifying numbers matched those on

the Sample collection documentation.

ISL – January 2021 Page 96 of 160

If the Athlete, and/or their representative(s), or the Independent

Witness refuse to sign the Laboratory documentation because

they consider that the “B” Sample container was not properly

sealed and/or showed signs of Tampering, or if the identifying

numbers did not match those on the Sample collection

documentation, the Laboratory shall not proceed with the “B”

Confirmation Procedure and will inform the Testing Authority or

Results Management Authority (if different) immediately to obtain

instructions. In such cases, the “B” Confirmation Procedure may

have to be re-scheduled.

If, on the other hand, the Athlete and/or their representative(s), or

the Independent Witness refuse to sign the Laboratory

documentation for any other reason, the Laboratory shall proceed

with the “B” Confirmation Procedure. At the same time, the

Laboratory shall inform the Testing Authority or Results

Management Authority (if different) immediately. The reasons for

the refusal shall be documented and included as a comment in

the Test Report in ADAMS.

The Laboratory shall then ensure that the “B” Sample container is

opened and Aliquots for the “B” Confirmation Procedure are taken

in the presence of the Athlete or his/her representative(s) or the

Independent Witness.

The Laboratory shall also ensure that, after opening and taking

Aliquots for the “B” Confirmation Procedure, the “B” Sample is

properly resealed in the presence of the Athlete and/or his/her

representative(s) or the Independent Witness, who should be

offered the opportunity to select the resealing equipment for the

“B” Sample container from several identical/sealed items, if

available.

At a minimum, the Laboratory Director or representative and the

Athlete and/or their representative(s) and/or the Independent

Witness shall sign another part of the Laboratory documentation

attesting that they have witnessed the “B” Sample opening and

aliquoting procedures and that the “B” Sample was properly

resealed. If the Athlete and/or their representative or the

Independent Witness refuse to sign this part of the Laboratory

documentation, the reasons for the refusal shall be documented

and included as a comment in the Test Report in ADAMS. In

either case, the Laboratory shall continue with the “B”

Confirmation Procedure.

ISL – January 2021 Page 97 of 160

- Target Analyte(s)

If more than one (1) Prohibited Substance, Metabolite(s) of a

Prohibited Substance, or Marker(s) of the Use of a Prohibited

Substance or Prohibited Method has been confirmed in the “A”

Confirmation Procedure, the Laboratory shall confirm as many of

the Adverse Analytical Findings as possible given the “B” Sample

volume available. The decision on the prioritization for the

confirmation(s) shall be made to prioritize the analysis of the

Prohibited Substance(s) or Prohibited Method(s) that carry the

longest potential period of Ineligibility. The decision should be

made in consultation with the Testing Authority (or Results

Management Authority, if different) and documented.

- Repetition of the “B” Confirmation Procedure

The Laboratory may repeat the Confirmation Procedure for a “B”

Sample, if appropriate, (e.g. quality control failure,

chromatographic peak interferences, inconclusive “B”

confirmation results). In that case, the previous test result shall be

nullified. The Laboratory may repeat the “B” Confirmation

Procedure using the remaining volume of the same Aliquot initially

taken from the “B” Sample container. However, if there is not

enough volume left of the initial Aliquot, then the Laboratory shall

use a new Aliquot(s) taken from the re-sealed B” Sample

container. In such cases, the re-opening, aliquoting and re-

sealing of the B” Sample container shall be performed in the

presence of the Athlete and/or Athlete’s representative(s) and/or

Independent Witness, as per the procedure described above.

Each Aliquot used shall be documented.

- “B” Confirmation with Negative Results

If the final “B” confirmation results are negative, the Analytical

Testing result shall be considered a Negative Finding. The

Laboratory shall notify the Testing Authority (or Results

Management Authority, if different) and WADA immediately. The

Laboratory shall conduct an internal investigation of the causes of

the discrepancy between the “A” and “B” Sample results and

should report its outcomes to the Results Management Authority

and WADA within seven (7) days.

[Comment: Target Analytes [e.g. parent compound, Metabolite(s),

Maker(s)] used to conclude the presence of a given Prohibited

Substance or Use of a Prohibited Method may differ between the “A”

and “B” Confirmation Procedures. This does not mean that the “B”

confirmation results are negative, as long as the Analyte(s) targeted

ISL – January 2021 Page 98 of 160

allows the unequivocal and conclusive identification of the Prohibited

Substance or Prohibited Method in the “B” Sample.]

- “B” Confirmation Procedure for Non-Threshold Substances and

exogenous Threshold Substances

For Non-Threshold Substances (including those with Minimum

Reporting Levels as specified in the TD MRPL) and exogenous

Threshold Substances, the “B” Sample results shall only confirm

the presence of the Prohibited Substance(s) or its Metabolite(s)

or Marker(s) identified in the “A” Sample (in compliance with the

TD IDCR) for the Adverse Analytical Finding to be valid

. No

quantification or estimation of concentrations of such Prohibited

Substance, or its Metabolite(s) or Marker(s) is necessary.

- “B” Confirmation Procedure for endogenous Threshold

Substances

For endogenous Threshold Substances, Adverse Analytical

Finding decisions for the “B” Sample results shall be based on the

confirmed identification (in accordance with the TD IDCR,

applicable to Confirmation Procedures based on

chromatography-mass spectrometry) of the Threshold Substance

or its Metabolite(s) or Marker(s) and their quantitative

determination in the Sample at a level exceeding the value of the

relevant Threshold as specified in the TD DL or other applicable

Technical Document(s) or Laboratory Guidelines. Comparison of

the measured value of the “B” Sample to the measured value of

the “A” Sample is not necessary to establish “B” Sample

confirmation. The “B” Sample value is only required to exceed the

applicable Threshold.

Quantitative “B” Confirmation Procedures for endogenous

Threshold Substances shall be based on the determination of the

mean of measured analytical values (e.g. concentrations,

chromatogram peak heights or areas) or the ratio/score

calculated from the mean(s) of the measured analytical values of

three (3) “B” Sample Aliquots

. If there is not enough Sample

volume to analyze three (3) Aliquots, the maximum number of

Aliquots that can be prepared should be analyzed.

For endogenous Threshold Substances, Markers of the “steroid

profile”, or any other Prohibited Substance that may be produced

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines.

ISL – January 2021 Page 99 of 160

endogenously at low levels, Adverse Analytical Finding decisions

for the “B” Sample results may also be based on the application

of any Fit-for-Purpose Analytical Testing Procedure that

establishes the exogenous origin of the Prohibited Substance

and/or its Metabolite(s) or Marker(s) (e.g. GC/C/IRMS). Atypical

Findings may result from non-conclusive determinations of the

origin (endogenous vs. exogenous) of the Prohibited Substance

or its Metabolite(s) or Marker(s).

5.3.6.3 Further Analysis

Further Analysis of stored Samples shall, as a matter of principle, be aimed at

detecting all the Prohibited Substance(s) or Metabolite(s) of Prohibited

Substance(s), or Marker(s) of the Use of a Prohibited Substance or Prohibited

Method included in the Prohibited List in force at the time of the collection of

the Sample(s).

- Selection of Samples and Laboratories for Further Analysis

Stored Samples may be selected for Further Analysis at the discretion of

the Testing Authority. WADA may also direct the Further Analysis of

Samples at its own expense (see Code Article 6.6). In cases where WADA

takes physical possession of a Sample(s), it shall notify the Testing

Authority (see Code Article 6.8), which shall retain ownership of the

Sample(s) pursuant to the ISTI Article 10.1, unless ownership of the

Sample(s) has been transferred pursuant to ISTI Article 10.2.

The choice of which Laboratory will conduct the Further Analysis will be

made by the Testing Authority or WADA, as applicable. Requests to the

Laboratory for Further Analysis shall be made in writing and be recorded

as part of the Sample’s documentation.

When a Sample has been reported as a Negative Finding or Atypical

Finding, there is no limitation on the Testing Authority or WADA or others

authorized by either of them to conduct Further Analysis on the Sample.

Further Analysis may also be performed on stored Samples, which were

previously reported as Adverse Analytical Findings where such report did

not result in an anti-doping rule violation charge under Code Article 2.1.

Any Prohibited Substance or Prohibited Method detected, which was

prohibited at the time of Sample collection, shall be reported.

However, pursuant to Code Article 6.5, Further Analysis may not be applied

on a Sample after the responsible Anti-Doping Organization has charged

the Athlete with a Code Article 2.1 anti-doping rule violation resulting from

the analysis of the Sample, without the consent of the Athlete or approval

from a hearing body.

ISL – January 2021 Page 100 of 160

Previously acquired Initial Testing Procedure data may also be re-

evaluated for the presence of Prohibited Substances or their Metabolite(s)

or Marker(s) of Prohibited Substances or Prohibited Methods, at the

initiative of the Testing Authority, the Results Management Authority,

WADA or the Laboratory itself. The results of such re-evaluation, if

suspicious, shall be communicated to the Testing Authority, the Results

Management Authority or WADA, as applicable, and may lead to Further

Analysis.

- Analytical Testing Procedures for Further Analysis of Stored Samples

Further Analysis of stored Samples shall be performed under the ISL,

Technical Documents, Technical Letters and Laboratory Guidelines in

effect at the time the Further Analysis is performed.

Further Analysis of stored Samples includes, notably, but without limitation,

the application of newly developed or more sensitive Analytical Testing

Procedures and/or the analysis of new target Analytes of Prohibited

Substance(s) or Prohibited Method(s) [e.g. Metabolite(s) and/or Marker(s)],

which were not known or not included in the initial Analytical Testing of the

Sample.

Depending on the circumstances, and to ensure an effective and targeted

use of the available Sample volume, priorities may be set, and/or the scope

of the Further Analysis restricted to specific analyses (in particular, but

without limitation, to analyses based on new or improved Analytical Testing

Procedures).

- Further Analysis of Stored Samples Process

a) Use of the “A” Sample

The Testing Authority or WADA may instruct the Laboratory to use the

“A” Sample for both the Initial Testing Procedure(s) and the “A”

Confirmation Procedure(s), to use it only for the Initial Testing

Procedure(s) or not to use the “A” Sample for Further Analysis at all.

If the Laboratory has been instructed to perform only Initial Testing

Procedure(s) on the “A” Sample, any suspicious analytical result

obtained from the “A” Sample shall be considered as a Presumptive

Adverse Analytical Finding, irrespective of the Analytical Testing

Procedure applied, and shall be confirmed using the split “B” Sample

(see below).

When a Confirmation Procedure is performed on the “A” Sample and

an Adverse Analytical Finding is reported on this basis, the “B”

Confirmation Procedure shall be applicable (as per Article 5.3.6.2.3).

ISL – January 2021 Page 101 of 160

b) Use of the split “B” Sample

When the “A” Sample is used only for the Initial Testing Procedure(s)

or is not used at all during Further Analysis, the “B” Sample shall be

split and used for analysis. The “B” Sample shall be split into two

fractions, in accordance with Article 5.3.3.2. The Athlete and/or a

representative of the Athlete should be invited to witness the splitting

procedure. At a minimum, the splitting process shall be conducted in

the presence of an appointed Independent Witness.

Even if present during the splitting procedure, the Athlete and/or his/her

representative has no right to attend the Analytical Testing Procedures

to be performed on the first split fraction of the “B” Sample, which shall

be deemed as the “A” Sample. In the event an Adverse Analytical

Finding is notified based on the results of a Confirmation Procedure of

the first fraction of the “B” Sample, the second split fraction of the “B”

Sample shall be deemed as the “B” Sample. If applicable, a “B”

confirmation shall be decided and performed in accordance with Article

5.3.6.2.3.

[Comment: Since the first split fraction of the “B” Sample is considered as an

“A” Sample, analysis of Aliquots taken from this Sample may include the

performance of Initial Testing Procedure(s) and “A” Confirmation Procedures

or “A” Confirmation Procedures only (if the Initial Testing Procedure(s)

was/were already performed using the “A” Sample).]

5.3.6.4 Alternative Biological Matrices

Any negative Analytical Testing results obtained from hair, nails, oral fluid or

other biological material shall not be used to counter Adverse Analytical

Findings or Atypical Findings from urine or blood (including whole blood,

plasma or serum).

5.3.7 Assuring the Validity of Analytical Results

The Laboratory shall monitor its analytical performance and the validity of test results

by operating quality control schemes, which are appropriate to the type and frequency

of Analytical Testing performed by the Laboratory. The resulting data shall be recorded

in such a way that trends are detectable and, where practicable, statistical techniques

shall be applied to review the results.

All quality control procedures shall be documented by the Laboratory. The range of

quality control activities include, but are not limited to:

- Use of appropriate quality control samples (QCs)

[Comment: Appropriate positive and negative QCs shall be included in every analytical run

ISL – January 2021 Page 102 of 160

both for the Initial Testing Procedure(s) and Confirmation Procedure(s)

Appropriate internal standard(s) shall be used for chromatographic methods.

For Threshold Substances, quality control charts (QC-charts) referring to appropriate

control limits depending on the Analytical Testing Procedure employed (e.g. +/- 2SD; +/-

3SD; +/- U95%), shall be regularly used to monitor method performance and inter-batch

variability (when applicable).]

- Implementation of an Internal Quality Assurance Scheme (iQAS)

[Comment: The Laboratory shall establish a functional and robust iQAS program, in

accordance with the requirements of ISO/IEC 17025, which challenges the entire scope of

the Analytical Testing process (i.e. from Sample accessioning through result reporting).

The Laboratory shall implement a procedure that prevents the submission of iQAS results

into ADAMS.

The iQAS plan shall include and evaluate as many Laboratory procedures as possible,

including the submission of a sufficient number of test samples on a regular basis (e.g.

monthly) and shall incorporate as many categories of Prohibited Substances and

Prohibited Methods as possible.

The Laboratory shall have a dedicated SOP for the iQAS program, which incorporates a

detailed procedure for the planning, preparation, (blind and/or double-blind) introduction of

the iQAS samples and management of the iQAS results (reviewing and follow-up of

nonconformities).]

- Mandatory participation in the WADA EQAS (see Section 6.0).

- Implementation of Internal Audits

[Comment: Internal audits shall be conducted in accordance with the requirements of

ISO/IEC 17025, and shall have a dedicated SOP incorporating a detailed procedure

for the planning and performance of the audits, the training and selection of internal

auditors, specification of their auditing activities, as well as for management of the

internal audit conclusions (reviewing and follow-up of nonconformities).

Internal audit responsibilities may be shared amongst personnel provided that any

Laboratory staff member does not audit his/her own area.

Internal audits shall be carried out by qualified Laboratory staff members. In addition,

qualified members of the Laboratory's host organization (e.g., university, institute,

company) may also be included in the internal auditing teams.]

- Implementation of External Audits

[Comment: Laboratories may also consider having their procedures and systems

audited by other Laboratory Directors or external auditors. However, this shall not

replace the performance of internal audits by the Laboratory.]

Unless otherwise specified in a Technical Document, Technical Letter or Laboratory Guidelines.

ISL – January 2021 Page 103 of 160

5.3.8 Results Management

5.3.8.1 Review of Results

The Laboratory shall conduct a minimum of two (2) independent reviews of all

Initial Testing Procedure raw data and results. The review process shall be

recorded.

A minimum of two (2) Certifying Scientists shall conduct an independent review

of all Adverse Analytical Findings and Atypical Findings before a test result is

reported. Evidence of the review and approval of the analytical run/batch shall

be recorded.

- Second Opinion

The Laboratory may request a second opinion from other Laboratory(-ies)

before reporting an Adverse Analytical Finding or Atypical Finding. Such

requests for second opinions may be required by specific Technical

Document(s), Technical Letters or Laboratory Guidelines, required by

WADA from certain Laboratory(-ies) for all or for specific Analytical Testing

Procedures under certain conditions (e.g. following the recent obtaining of

WADA accreditation or after a period of Suspension or Analytical Testing

Restriction), or requested at the discretion of the Laboratory (e.g. for firstly

detected Analytes or for difficult to interpret findings). In any case, the

request for a second opinion shall be made in writing and the second

opinion received shall be recorded as part of the Sample’s documentation.

Any transfer of data and information necessary for the second opinion shall

be made securely and respecting the confidentiality of the analytical data

and any other information.

The Laboratory that performed the analysis is responsible for the result and

for issuing the final Test Report.

- Laboratory Review of Adverse Analytical Findings and Atypical Findings

At a minimum, the review of Adverse Analytical Findings and Atypical

Findings shall include:

o Documentation linking the Sample external code (as specified in the

DCF) to the Laboratory internal Sample code;

o Laboratory Internal Chain of Custody documentation;

o Initial Testing Procedure(s) and Confirmation Procedure(s) analytical

data and calculations;

o Quality control data;

o Completeness of technical and analytical documentation supporting the

reported findings;

ISL – January 2021 Page 104 of 160

o Compliance of test data with the Analytical Testing Procedure’s

validation results (e.g. MU);

o Assessment of the existence of significant data or information that

would cast doubt on or refute the Laboratory findings;

[Comment: The Laboratory should consider the prevailing scientific knowledge

regarding, for example, the possibility of Sample or Aliquot contamination, the

presence of analytical artifacts, the possible natural occurrence of the Analyte

at low concentrations, microbial or chemical degradation, the detection of

Metabolites which may be common to non-prohibited substances or the

absence of characteristic Phase-I or Phase-II Metabolites.]

- When the Confirmation Procedure result(s) are rejected as Adverse

Analytical Finding(s) or Atypical Finding(s) based on the results review,

the reason(s) for the rejection shall be recorded.

5.3.8.2 Traceability of Results and Documentation

The Laboratory shall have documented procedures to ensure that it maintains

a record related to each Sample analyzed. In the case of an Adverse Analytical

Finding or Atypical Finding, the record shall include the data necessary to

support the conclusions reported as set forth in and limited by the TD LDOC.

- Each step of Analytical Testing shall be traceable to the staff member who

performed that step;

- Significant deviation from a written SOP shall be recorded;

- Where instrumental analyses are conducted, the operating parameters for

each run shall be included as part of the record;

- Requests for information by the Testing Authority, Results Management

Authority or WADA to a Laboratory shall be made in writing;

- Laboratory Documentation Packages and Certificates of Analysis shall be

in compliance with the TD LDOC. Laboratories are not required to produce

a Laboratory Documentation Package for a Sample in which no Prohibited

Substance or Prohibited Method or their Metabolite(s) or Marker(s) was

detected, unless requested by a hearing body or disciplinary panel as part

of a Results Management process or Laboratory disciplinary proceedings.

5.3.8.3 Confidentiality of the Analytical Data and Athlete’s Identity

Confidentiality of the analytical data and Athlete’s identity shall be observed by

all parties (e.g. Laboratory, Testing Authority, Results Management Authority,

WADA, other parties informed including, where different, International

Federations, National Olympic Committees, National Federations). The

Laboratory shall not make any attempt to identify an Athlete that has provided

a Sample.

ISL – January 2021 Page 105 of 160

Information sent by a facsimile is acceptable provided that the correct facsimile

number is verified prior to transmission and the receipt is verified after the

facsimile has been transmitted.

Encrypted emails or documents shall be used for reporting or discussion of

Adverse Analytical Findings or Atypical Findings if the Athlete can be identified

or if any information regarding the identity of the Athlete is included. Whenever

the Laboratory handles analytical data or information where an Athlete is

identified or identifiable, the Laboratory shall treat such data in accordance with

the requirements of the International Standard for the Protection of Privacy and

Personal Information (ISPPPI).

5.3.8.4 Reporting Test Results

A Laboratory shall not conduct any additional Analytical Testing on a Sample

for which the Athlete has been charged with a Code Article 2.1 anti-doping rule

violation unless consent from the Athlete or approval from a hearing body is

obtained by the Testing Authority or Results Management Authority (if

different) – see also Article 5.3.6.3.

Unless specifically requested to make a partial submission of test results by

the Testing Authority or Results Management Authority (if different), a

Laboratory shall not report analytical results for any Sample until all analyses

detailed in the Analytical Testing menu of the relevant DCF have been

completed (e.g. ongoing analysis for EPO). Therefore:

a) If a Laboratory is requested to report an Adverse Analytical Finding(s) for

a Sample(s) before all analyses on that Sample have been completed, then

the Laboratory shall advise the Testing Authority or Results Management

Authority (if different) that Sample analysis has not been completed and, in

addition, that if the Athlete is charged with a Code Article 2.1 anti-doping

rule violation before the additional analyses on the Sample have been

completed, then the additional analyses cannot be conducted until consent

from the Athlete or approval from a hearing body is obtained;

b) If the Laboratory receives a request to conduct Confirmation Procedures

for an atypical or suspicious steroid profile of a Sample, which are triggered

by ADAMS notifications after the “A” Sample has already been reported as

an Adverse Analytical Finding, then the Laboratory shall advise the Testing

Authority or Results Management Authority (if different) that if the Athlete

is charged with a Code Article 2.1 anti-doping rule violation, the additional

Confirmation Procedures cannot be performed until consent from the

Athlete or approval from a hearing body is obtained.

- Reporting Times

Reporting of “A” Sample results should occur in ADAMS within twenty (20)

ISL – January 2021 Page 106 of 160

days of receipt of the Sample. The reporting time required for specific

occasions (e.g. for Major Events, see Annex B) may be substantially less than

twenty (20) days. The reporting time may be altered by agreement between

the Laboratory and the Testing Authority. The Testing Authority should be

informed of any delay in the reporting of “A” Sample results.

The Laboratory Documentation Packages and/or Certificates of Analysis

should be provided by the Laboratory only to the relevant Results Management

Authority or WADA upon request and should be provided within fifteen (15)

days of the request, unless a different deadline is agreed upon with the Results

Management Authority or WADA, respectively.

- Reporting Requirements

The Laboratory shall record the test result for each individual Sample from

Signatories or WADA in ADAMS.

[Comment: Test results for samples from non-Signatories, except WADA, shall not be

reported in ADAMS].

When reporting test results in ADAMS, the Laboratory shall include, in addition

to the mandatory information stipulated in ADAMS, in the relevant Technical

Document(s), Technical Letter(s) or Laboratory Guidelines, and in the ISO/IEC

17025 standard, the following:

- The SG of the Sample (Initial Testing Procedure and “A” and “B”

Confirmation Procedures);

- The name of the Results Management Authority, if provided;

- Relevant comments, if necessary, for proper interpretation of the test result

or recommendations to the Testing Authority (for example, for Target

Testing of the Athlete);

[Comment: The Laboratory shall have a policy regarding the provision of opinions

and interpretation of data. An opinion or interpretation may be included in the

ADAMS Test Report provided that the opinion or interpretation is clearly identified

as such. The basis upon which the opinion has been made shall be documented.

An opinion or interpretation may include, but not be limited to, recommendations

on how to use results, information related to the pharmacology, metabolism and

pharmacokinetics of a substance, whether the observed results may suggest the

need for additional investigations regarding potential environmental contamination

causes and/or Further Analysis and whether an observed result is consistent with

a set of reported conditions.]

- Specific tests performed, in addition to the Laboratory routine Analytical

Testing menu (e.g. EPO GC/C/IRMS, hGH, blood transfusions, DNA,

genomic profiling, etc.);

- Any irregularities noted on Samples;

ISL – January 2021 Page 107 of 160

- Any refusal by the Athlete and/or his/her representative(s) or the

Independent Witness, as applicable, to sign the Laboratory documentation

for the “B” Sample opening, aliquoting or re-sealing procedures (see Article

5.3.6.2.3).

The Laboratory is not required to provide any additional Test Report, either in

hard-copy or digital format, other than the submission of test results in ADAMS.

All Anti-Doping Organizations shall access the Test Reports of their Samples

in ADAMS. Upon request by WADA, the Laboratory shall report a summary of

the results of analyses performed in a format specified by WADA. In addition,

the Laboratory shall also provide any information requested by WADA in

relation to the Monitoring Program (Code Article 4.5).

The Laboratory shall qualify the result(s) of the analysis in the ADAMS Test

Report as:

a) Adverse Analytical Finding; or

b) Atypical Finding; or

c) Negative Finding; or

[Comment: In cases when the Testing Authority confirms to the Laboratory the

existence of an approved TUE for the Prohibited Substance, which is consistent

with the Presumptive Adverse Analytical Finding results obtained in the Initial

Testing Procedure (see Art 5.3.6.2.2), the Laboratory shall report the result as a

Negative Finding as instructed by the Testing Authority.]

d) Not Analyzed

[Comment: Any Sample received at the Laboratory and not subject to Analytical

Testing for a valid, documented reason (as instructed by or agreed with the Testing

Authority) such as Sample irregularities, intermediate Samples of a Sample

Collection Session, etc. (see Article 5.3.3).]

- Test Report for Non-Threshold Substances

a) “A” Sample Test Report

The Laboratory is not required to report concentrations for Non-Threshold

Substances. The Laboratory shall report the actual Prohibited Substance(s)

and/or its Metabolite(s), or Marker(s) of the Use of Prohibited Substance(s) or

Prohibited Method(s) present (i.e. identified, as per the TD IDCR) in the Sample

and in accordance with the reporting requirements established in the TD

MRPL.

[Comment: When applicable, the Laboratory shall record in the ADAMS Test Report

the specific Metabolite(s) or Marker(s) of the Non-Threshold Substance that were

identified in the Sample.]

ISL – January 2021 Page 108 of 160

However, the Laboratory should provide estimated concentrations when

possible and for information purposes only, upon request by the Testing

Authority, Results Management Authority or WADA, if the detected level of the

Non-Threshold Substance(s), its Metabolite(s), or Marker(s) may be relevant

to the Results Management of an anti-doping case. In such instances, the

Laboratory should indicate the estimated concentration while making it clear to

the Testing Authority, Results Management Authority or WADA that the

concentration was obtained by an Analytical Testing Procedure, which has not

been validated for quantitative purposes.

b) “B” Sample Test Report

For Non-Threshold Substances, irrespective of whether or not they have a

Minimum Reporting Level, the Laboratory result for the “B” Sample shall only

establish the presence (i.e. the identity) of the Prohibited Substance(s) or its

Metabolite(s) or Marker(s) in accordance with the TD IDCR or other applicable

Technical Document(s). The Laboratory is not required to quantify or estimate

the concentration of such Prohibited Substance, or its Metabolite(s) or

Marker(s).

- Test Report for Threshold Substances

a) “A” Sample Test Report

For Threshold Substances, the Laboratory Test Report for the “A” Sample

shall establish that the identified Prohibited Substance(s) or its

Metabolite(s) or Marker(s) is present at a concentration and/or ratio and/or

score of measured analytical values greater than the Decision Limit, and/or

that the Prohibited Substance(s) or its Metabolite(s) or Marker(s) is of

exogenous origin.

In the event that the Threshold Substance(s), which are identified as such

in the Prohibited List and the TD DL, is (are) detected in the presence of

(a) diuretic(s) or masking agent(s), the Laboratory shall establish the

presence (i.e. the identity) of the Prohibited Substance(s) and/or its

Metabolite(s) in accordance with the TD IDCR and the TD DL and report it

as an Adverse Analytical Finding, in addition to the reporting of the

diuretic(s) or masking agent(s). In such cases, the Laboratory should report

the estimated concentration of the Threshold Substance(s), indicating that

the levels detected may have been impacted by the presence of the

diuretic(s) or masking agent(s).

b) “B” Sample Test Report

For exogenous Threshold Substances, the Laboratory Test Report for the

“B” Sample shall only establish the presence (i.e. the identity) of the

ISL – January 2021 Page 109 of 160

Prohibited Substance(s) or its Metabolite(s) or Marker(s) in accordance

with the TD IDCR.

For endogenous Threshold Substances, the Laboratory Test Report for the

“B” Sample shall establish that the identified Prohibited Substance(s) or its

Metabolite(s) or Marker(s) is present at a concentration and/or ratio and/or

score of measured analytical values greater than the Threshold, and/or that

the Prohibited Substance(s) or its Metabolite(s) or Marker(s) is of

exogenous origin.

In the event that the Threshold Substance(s), which are identified as such

in the Prohibited List and the TD DL, is (are) detected in the presence of

(a) diuretic(s) or masking agent(s), the Laboratory shall establish the

presence (i.e. the identity) of the Prohibited Substance(s) and/or its

Metabolite(s) in accordance with the TD IDCR and the TD DL and report it

as an Adverse Analytical Finding, in addition to the reporting of the masking

agent(s). In such cases, the Laboratory shall report the estimated

concentration of the Threshold Substance(s), indicating that the levels

detected may have been impacted by the presence of the diuretic(s) or

masking agent(s).

5.3.9 Control of Nonconformities in Analytical Testing

The Laboratory shall have policies and procedures that shall be implemented when

any aspect of its Analytical Testing does not comply with set requirements.

Any nonconformities in Analytical Testing shall be recorded and kept as part of the

documentation of the Sample(s) involved.

- Risk Minimization

Laboratories shall take corrective actions in accordance with ISO/IEC 17025 and

WADA Laboratory Guidelines for Corrective Action Investigation and Reporting.

When conducting a corrective action investigation, the Laboratory shall perform

and record a thorough Root Cause Analysis of the nonconformity.

- Improvement

The Laboratory shall maintain, and when appropriate improve, the effectiveness

of its Management System in accordance with ISO/IEC 17025.

5.3.10 Complaints

Complaints shall be handled in accordance with ISO/IEC 17025.

ISL – January 2021 Page 110 of 160

5.3.11 Storage of Samples

5.3.11.1 Storage of Urine Samples

All urine Samples retained for storage in the Laboratory shall be stored frozen

in a secure location under continuous chain of custody. The Laboratory shall

keep all chain of custody and other records (either as hard-copy or in digital

format) pertaining to those Samples.

a) Urine Sample(s) without an Adverse Analytical Finding or Atypical Finding:

The Laboratory shall retain the “A” and “B” urine Sample(s) without an

Adverse Analytical Finding or Atypical Finding for a minimum of three (3)

months after reporting the final analytical result in ADAMS, or for a

maximum of ten (10) years after the Sample collection date, if the long-

term storage of the Sample(s) has been requested, in writing, by the

relevant Testing Authority or WADA

b) Urine Samples with Irregularities: The Laboratory shall retain the “A” and

“B” urine Sample(s) with irregularities for a minimum of three (3) months

after reporting in ADAMS, or for a longer period as determined by the

Testing Authority, Results Management Authority or WADA

c) Urine Sample(s) with an Adverse Analytical Finding or Atypical Finding:

The Laboratory shall retain the “A” and “B” urine Sample(s) with an Adverse

Analytical Finding or Atypical Finding for a minimum of six (6) months after

reporting the final analytical result (for the “A” or the “B” Sample, as

applicable) in ADAMS

, or for a longer period as informed to the

This refers to “A” and “B” Samples stored in Sample collection containers (urine collection bottles, blood collection

tubes) and should not be confused with access to Aliquots, which should be accessible to analysts for the

performance of Analytical Testing Procedures. However, minimum and maximum retention times apply to any

Aliquot(s) of a Sample that remains after completion of the Analytical Testing.

The Laboratory may charge storage costs to the Testing Authority or WADA, as applicable, for the storage of

Samples for periods longer than the stated minimum storage times. However, the Laboratory may store Samples

beyond the applicable minimum storage times at their own discretion and expense. In such cases, the Laboratory

shall inform the responsible Testing Authority. Any Further Analysis on these Samples will require the approval of

the Testing Authority or WADA.

If the “B” Sample Confirmation Procedure is not performed, the Laboratory may dispose of both the “A” and “B”

Samples six (6) months after reporting the “A” Sample analytical result. However, if the “B” Sample Confirmation

Procedure is performed, then the Laboratory shall retain both the “A” and “B” urine or plasma/serum Sample(s) for

a minimum of six (6) months after reporting the “B” Sample analytical result.

Nevertheless, the Laboratory shall contact and inform the relevant Testing Authority and WADA before disposing

of any Samples with Adverse Analytical Findings for which the Testing Authority or Results Management Authority

ISL – January 2021 Page 111 of 160

Laboratory, in writing, by the relevant Testing Authority, Results

Management Authority or WADA

d) Urine Samples under challenge, dispute or investigation: If the Laboratory

has been informed by the Testing Authority, the Results Management

Authority or WADA (in writing and within the applicable storage period as

defined in this Article 5.3.11.1) that the analysis of a urine Sample is

challenged, disputed or under investigation, the Laboratory shall retain

both the “A” and “B” Samples until further notice by the Testing Authority,

the Results Management Authority or WADA, as applicable

5.3.11.2 Storage of Blood Samples

A. Samples for which Analytical Testing has been performed on blood

serum/plasma fraction only (not on cellular components):

All serum or plasma Samples retained for storage in the Laboratory

shall be stored frozen according to established protocols in a secure

location under continuous chain of custody. The Laboratory shall keep

all chain of custody and other records (either as hard-copy or in digital

format) pertaining to those Samples.

a) Serum/plasma “A” and “B” Samples without an Adverse Analytical

Finding or Atypical Finding: The Laboratory shall retain the

serum/plasma “A” and “B” Samples without an Adverse Analytical

Finding or Atypical Finding for a minimum of three (3) months after

reporting the final analytical result in ADAMS, or for a maximum of

ten (10) years after the Sample collection date, if the long-term

storage of the Sample(s) has been requested by the relevant

Testing Authority or WADA

b) Serum/plasma Samples with irregularities: The Laboratory shall

retain the serum/plasma Samples with irregularities for a minimum

of three (3) months after reporting the final analytical result in

ADAMS, or for a longer period as determined by the Testing

Authority, Results Management Authority or WADA

c) Plasma/serum “A” and “B” Sample(s) with an Adverse Analytical

Finding or Atypical Finding: The Laboratory shall retain “A” and “B”

plasma/serum Sample(s) with an Adverse Analytical Finding or

Atypical Finding for a minimum of six (6) months after reporting the

final analytical result (for the “A” or the “B” Sample, as applicable)

(if different) has not provided instructions about the performance or not of the “B” Confirmation Procedure (see

Article 5.3.6.2.3).

ISL – January 2021 Page 112 of 160

in ADAMS

20, 21

or for a longer period as informed to the Laboratory,

in writing, by the relevant Testing Authority, Results Management

Authority or WADA

d) Plasma/serum “A” and “B” Sample(s) under challenge, dispute or

investigation: If the Laboratory has been informed by the Testing

Authority, the Results Management Authority or WADA (in writing

and within the applicable storage period as defined in this Article

5.3.11.2) that the analysis of a serum/plasma Sample is challenged,

disputed or under investigation, the Laboratory shall retain both the

“A” and “B” Samples until further notice by the Testing Authority the

Results Management Authority or WADA, as applicable

B. Samples for which Analytical Testing has been performed on cellular

fractions of whole blood.

a) Whole blood “A” and “B” Samples without an Adverse Analytical

Finding or Atypical Finding: The Laboratory shall retain the whole

blood Samples without an Adverse Analytical Finding or Atypical

Finding for a minimum of one (1) month after reporting the final

analytical result in ADAMS

b) Whole blood Samples with irregularities: The Laboratory shall retain

the whole blood Samples with irregularities for a minimum of one

(1) month after reporting the final analytical result in ADAMS, or for

a longer period as determined by the Testing Authority, Results

Management Authority or WADA

c) Whole blood “A” and “B” Sample(s) with an Adverse Analytical

Finding or Atypical Finding: The Laboratory shall retain “A” and “B”

whole blood Sample(s) with an Adverse Analytical Finding or

Atypical Finding for a minimum of three (3) months after reporting

the final analytical result (for the “A” or the “B” Sample, as

applicable) in ADAMS

21,

or for a longer period as informed to the

Laboratory, in writing, by the relevant Testing Authority, Results

Management Authority or WADA

d) Whole blood “A” and “B” Sample(s) under challenge, dispute or

investigation: If the Laboratory has been informed by the Testing

If the “B” Sample Confirmation Procedure is not performed, the Laboratory may dispose of both the “A” and “B”

whole blood Samples three (3) months after reporting the “A” Sample analytical result. However, if the “B” Sample

Confirmation Procedure is performed, then the Laboratory shall retain both the “A” and “B” whole blood Sample(s)

for a minimum of three (3) months after reporting the “B” Sample analytical result.

ISL – January 2021 Page 113 of 160

Authority, the Results Management Authority or WADA (in writing

and within the applicable storage period as defined in this Article

5.3.11.2) that the analysis of a whole blood Sample is challenged,

disputed or under investigation, the Laboratory shall retain both the

“A” and “B” Samples until further notice by the Testing Authority, the

Results Management Authority or WADA, as applicable

5.3.11.3 Long-term Storage of Samples

At the direction of the Testing Authority or WADA, any urine or

serum/plasma Sample may be stored in long-term storage for up to ten (10)

years after the Sample collection date for the purpose of Further Analysis,

subject to the conditions set out in Articles 5.3.6.3, 5.3.11.1 and 5.3.11.2.

Sample(s) may be stored in long-term storage under the custody of either

a Laboratory or another Fit-for-Purpose facility under the responsibility of

the Testing Authority, which has ownership of the Sample(s) pursuant to

Article 10.1 of the ISTI. The Testing Authority shall retain the Sample

collection records pertaining to all stored Samples for the duration of

Sample storage.

- Laboratories as Sample Custodians

The Laboratory shall ensure that Samples are stored according to

established protocols in a secure location in the Laboratory’s

permanent controlled zone and under continuous chain of custody. The

written request from the Testing Authority or WADA for long-term

storage of Samples shall be properly documented.

Samples may also be transported for long-term storage to a

specialized, secure Sample storage facility, which is located outside the

Laboratory’s permanent controlled zone and is under the responsibility

of the Laboratory or may be transported to another Laboratory. If the

external Sample storage facility is not covered by the Laboratory’s

ISO/IEC 17025 accreditation, then the subcontracted external storage

facility shall be Fit-for Purpose and have its own ISO accreditation or

certification (e.g. 17025, 20387, 9001). The transfer of the Samples to

the external long-term storage facility or Laboratory shall be recorded.

If Sample(s) are to be transported for storage at a location outside the

secured area of the Laboratory that first analyzed the Sample(s), the

Laboratory shall secure the “A” Sample(s) to be shipped either by re-

sealing individual “A” Sample container(s) with a tamper-evident

sealing system, which has similar capabilities for security and integrity

as the original sealing system, or by sealing the box in which the

Sample(s) are shipped in a manner that maintains Sample integrity and

chain of custody. Neither the Athlete nor his or her representative nor

ISL – January 2021 Page 114 of 160

an Independent Witness is required to be present for this procedure.

[Comment: For example, Sample(s) may be resealed with new resealing

systems (e.g. new bottlecaps) produced by the manufacturer of an appropriate

Sample collection equipment that replicates the security and tamper-evident

functionality of the original seal. The resealing system of shipped “A”

Sample(s) shall be tamper evident.]

“B” Sample(s) to be shipped shall be individually sealed, either in the

original, sealed “B” Sample container(s) or, if previously opened, by re-

sealing the individual “B” Sample container(s) with a tamper-evident

sealing system, which has similar capabilities for security and integrity

as the original sealing system. The resealing of the “B” Sample(s), if

necessary, shall be witnessed by either the Athlete or his/her

representative or by an appointed Independent Witness.

During transport and long-term storage, Sample(s) shall be stored at a

temperature appropriate to maintain the integrity of the Sample(s). In

any anti-doping rule violation case, the issue of the Sample’s

transportation or storage temperature shall be considered where failure

to maintain an appropriate temperature could have caused the Adverse

Analytical Finding or other result upon which the anti-doping rule

violation is based.

The Laboratory shall retain all Laboratory Internal Chain of Custody and

technical records (as per ISO/IEC 17025) pertaining to a stored Sample

for the duration of Sample storage, either as hard-copy or in digital

format. In addition, the Laboratory may retain Sample analytical data

which would allow retrospective analysis of such data, for example, for

the purpose of identifying signals for novel Metabolite(s) of Prohibited

Substance(s) or Marker(s) of Prohibited Substance(s) or Prohibited

Method(s) (e.g. full-scan mass spectrometry data) as detailed in Article

5.3.6.3.

If Sample(s) are transported to another Laboratory for long-term

storage, the Sample’s external chain of custody and other non-

analytical records (e.g. DCF), available to the transferring Laboratory,

shall also be transferred, immediately or upon later request, to the

Laboratory storing the Samples or to the Testing Authority, either as

originals or copies.

- Testing Authorities as Sample Custodians

Sample(s) may also be transported for long-term storage to a Fit-for-

Purpose, secure Sample storage facility, which is under the

responsibility of the Testing Authority that has ownership over the

Samples. In such cases, the external storage facility shall have its own

ISO accreditation or certification (e.g. 17025, 20387, 9001) and shall

ISL – January 2021 Page 115 of 160

maintain security requirements comparable to those applicable to a

Laboratory. The Testing Authority shall ensure that Samples are stored

according to established protocols in a secure location under

continuous chain of custody.

The written request from the Testing Authority for the transfer of the

Sample(s) to long-term storage shall be properly documented. The

transfer of the Samples to the external long-term storage facility shall

also be recorded. The Laboratory shall secure the Sample(s) for

transportation to the long-term storage facility as described above.

The Laboratory shall retain all Laboratory Internal Chain of Custody and

technical records (as per ISO/IEC 17025) pertaining to all Samples

transferred for long-term storage for the duration of Sample storage,

either as hard-copy or in digital format. In addition, the Laboratory may

retain Sample analytical data which would allow retrospective analysis

of such data. The Laboratory shall transfer the Sample’s external chain

of custody and other non-analytical records to the Testing Authority,

either as originals or copies, immediately or upon request.

5.3.12 Secondary Use or Disposal of Samples and Aliquots

The Laboratory shall maintain SOP(s) pertaining to the secondary use of Samples or

Aliquots for research or quality assurance, as well as for the disposal of Samples and

Aliquots. The requirements of this Article 5.3.12 apply mutatis mutandis to an Anti-

Doping Organization that takes custody of Samples for long-term storage.

When the minimum applicable Sample storage period has expired (see Articles

5.3.11.1 and 5.3.11.2), and neither the Testing Authority, the Results Management

Authority nor WADA have requested the long-term storage of the Sample for the

purpose of Further Analysis or have informed the Laboratory that a challenge, dispute,

or longitudinal study is pending, or if the Laboratory has not made its own decision to

keep the Samples for long-term storage, the Laboratory shall do one of the following

with the Sample(s) and Aliquots as soon as practicable:

5.3.12.1 Disposal of the Sample(s) and Aliquots

Disposal of Samples and Aliquots shall be recorded under the Laboratory

Internal Chain of Custody.

5.3.12.2 Secondary use of Samples and Aliquots for Research and Quality

Assurance

Samples and Aliquots shall be anonymized to ensure that any subsequent

results cannot be traced back to a particular Athlete (see Code Article 6.3).

Only after anonymization, may a Sample or Aliquot be used for:

ISL – January 2021 Page 116 of 160

a) Anti-doping research, if the Athlete consented to the use of his or her

Sample for research; or

[Comment: Athlete consent for research, as declared in the DCF or as

obtained by other means, shall be recorded in the Laboratory’s documentation

for reference.]

b) Quality assurance, quality improvement of existing Test Methods,

development or evaluation of Analytical Testing Procedures for

Prohibited Substances or Prohibited Methods included in the Prohibited

List at the time of Sample collection, or to establish reference

population ranges or Thresholds or other statistical purposes. Athlete’s

consent is not required for these purposes.

The use of Samples and Aliquots for the purposes of this Article 5.3.12.2 is

subject to the following conditions:

a) The Laboratory must respect Code Article 19 and the ISL Code of

Ethics requirements related to research, types of permitted research,

and respect of ethical standards for research or quality assurance

studies involving human subjects;

b) The Laboratory must not make any attempt to re-identify an Athlete

from Samples or Aliquots used for the purposes of this Article 5.3.12.2

or data arising from any research or quality assurance analysis;

c) The Laboratory must consult the applicable national regulations,

guidance, or authorities to determine whether a study should be

considered as falling under 5.3.12.2 a) or 5.3.12.2 b);

[Comment: If the Laboratory is unsure whether a study can proceed without

Athlete consent after consulting the foregoing sources, the Laboratory shall

consult with WADA].

d) In the event the Laboratory wishes to transfer Sample(s) or Aliquots to

be used for the purposes of this Article 5.3.12.2 to another Laboratory

or a third-party research institution or group, or wishes to partner with

another Laboratory or research institution or group for the purpose of

an Article 5.3.12.2 study, the Laboratory shall subject the receiving

party to the conditions described in this Article 5.3.12.2 by way of a

written agreement and shall prohibit the receiving party from further

transferring any Sample(s) or Aliquots or related data to another party.

ISL – January 2021 Page 117 of 160

5.4 Management Requirements

5.4.1 Organization

Within the framework of ISO/IEC 17025, the Laboratory shall be considered as a

testing laboratory.

5.4.2 Management Reviews

Management reviews will be conducted to meet the requirements of ISO/IEC 17025.

5.4.3 Document Control

The control of documents that make up the Management System shall meet the

requirements of ISO/IEC 17025. The Laboratory Director (or designee) shall approve

the Management System documentation and all other documents used by Laboratory

staff members involved in Analytical Testing.

The Laboratory shall implement a procedure in its Management System to ensure that

the contents of ISL, Technical Documents, Technical Letters and Laboratory

Guidelines are incorporated into the Laboratory’s SOPs by the applicable effective

date and that implementation is completed, recorded and assessed for compliance. If

this is not possible, the Laboratory shall send a written request for an extension beyond

the applicable effective date for consideration by WADA. Any failure by the Laboratory

to implement mandatory requirements by the established effective date, without a prior

approval by WADA, shall be considered a noncompliance and may affect the

Laboratory accreditation status.

5.4.4 Control and Storage of Technical Records

The Laboratory shall keep a copy of all Sample records to the extent needed to

produce Laboratory Documentation Packages or Certificates of Analysis, in

accordance with the TD LDOC, in a secure storage until Sample disposal or

anonymization (see Article 5.3.12).

In addition, this information shall be stored for ten (10) years from collection date for

all Sample data and chain-of-custody information related to the Athlete Biological

Passport (e.g. hematological and steroid profile Markers)

5.4.5 Cooperation with Customers and with WADA

Cooperation with customers shall be handled in accordance with ISO/IEC 17025.

- Ensuring Responsiveness to WADA

The Laboratory Director or his/her designee shall:

- Ensure adequate communication with WADA in a timely manner;

- Provide complete, appropriate and timely explanatory information as requested

ISL – January 2021 Page 118 of 160

by WADA;

- Report to WADA any unusual circumstances or information with regard to

Analytical Testing, patterns of irregularities in Samples, or potential Use of new

substances;

- Provide documentation to WADA [e.g. Management System documentation,

SOPs, contracts (not including commercial or financial information) with

Signatories, or with Sample Collection Authorities or Delegated Third Parties

working on behalf of Signatories] upon request to ensure conformity with the

rules established under the Code as part of the maintenance of WADA

accreditation. This information shall be treated in a confidential manner.

- Ensuring Responsiveness to Testing Authority and/or Results Management

Authority

The Laboratory Director shall be familiar with the Testing Authority rules and the

Prohibited List.

The Laboratory Director shall interact with the Testing Authority and/or Results

Management Authority in regard to specific timing, report information, or other

support needs. These interactions should occur in a timely manner and should

include, but are not limited to, the following:

- Communicating with the Testing Authority and/or Results Management

Authority concerning any significant question of Analytical Testing needs or

any unusual circumstance in the Analytical Testing process (including delays

in reporting);

- Providing complete, timely and unbiased explanations to the Testing Authority

and/or Results Management Authority when requested or when there is a

potential for misunderstanding of any aspect of the Analytical Testing process,

Laboratory Test Report, Certificate of Analysis or Laboratory Documentation

Package;

- If requested by the Testing Authority, the Laboratory shall provide advice

and/or opinion to the Testing Authority regarding the Prohibited Substances

and Prohibited Methods included in the Analytical Testing Procedures;

- Providing evidence and/or expert testimony on any test result or report

produced by the Laboratory as required in administrative, arbitration, or legal

proceedings. The requests from such expert testimonies shall originate, in

writing, from the Testing Authority, Results Management Authority, WADA or

hearing bodies as part of the Results Management process. The Laboratory

shall not provide expert testimony to Athletes or Athletes’ representatives,

including their legal counsels;

- Responding to any complaint submitted by a Testing Authority or Results

Management Authority concerning the Laboratory and its operation.

ISL – January 2021 Page 119 of 160

As required by ISO/IEC 17025, the Laboratory shall actively monitor the quality of the

services provided to the relevant Anti-Doping Organizations, including the introduction

of an annual questionnaire to clients to assess their satisfaction (or otherwise) with the

performance of the Laboratory. There should be documentation that the Testing

Authority or Results Management Authority concerns have been incorporated into the

Laboratory’s Management System where appropriate.

ISL – January 2021 Page 120 of 160

6.0 WADA External Quality Assessment Scheme (EQAS)

WADA regularly distributes urine or blood External Quality Assessment Scheme (EQAS) samples to

Laboratories and, when applicable, to probationary laboratories. The WADA EQAS is designed to

continually monitor the capabilities of the Laboratories and probationary laboratories, to evaluate their

proficiency, and to improve test result uniformity between Laboratories. EQAS samples are used to

assess Laboratory routine analytical capacity and performance, reporting turn-around times and overall

compliance with WADA Laboratory standards (e.g. ISL, Technical Documents and Technical Letters), as

well as other, non-analytical performance criteria. At the same time, the EQAS also represents, via its

educational components, a source of continuous improvement for the effectiveness of the Analytical

Testing Procedures.

6.1 Types of EQAS

6.1.1 Blind EQAS

The Laboratory will be aware that the sample is an EQAS sample since it is delivered

by WADA’s EQAS sample provider. However, the Laboratory will not know the content

of the sample.

6.1.2 Double-Blind EQAS

The Laboratory will not be aware that the sample is an EQAS sample since it is

delivered by a Testing Authority and is indistinguishable from routine Samples.

6.1.3 Educational EQAS

Educational EQAS samples may be provided as open (in which case the content of

the EQAS sample is known), blind or double-blind samples. This approach is used for

educational purposes or for data gathering.

As part of the educational EQAS, WADA may provide Laboratories with new

Reference Materials, Reference Collections or quality control (QC) samples for a

prompt implementation of existing or new Analytical Testing Procedures.

WADA may require the successful participation of Laboratories in an educational

EQAS for WADA-specific Analytical Testing Procedures in order for Laboratories to

seek an extension of the Laboratory’s Scope of ISO/IEC 17025 Accreditation by an

Accreditation Body (see Article 4.4.2.2) before the subsequent application of the

Analytical Testing Procedure to the routine analysis of Samples.

6.2 EQAS Sample Number and Composition

6.2.1 Number of EQAS Samples

The actual composition and number of EQAS samples supplied to different

Laboratories may vary; however, within any calendar year, all Laboratories

ISL – January 2021 Page 121 of 160

participating in the EQAS are expected to have analyzed the minimum total number of

EQAS samples.

Each year, the EQAS program will consist of:

- At least fifteen (15) blind EQAS samples, distributed by WADA in multiple rounds;

- At least five (5) double-blind EQAS samples distributed by various Testing

Authorities in several rounds;

- At least three (3) of the above EQAS samples will contain Threshold Substances.

As part of WADA’s Laboratory monitoring activities, and with the main purpose of

assisting Laboratories in their continuous improvement of performance, WADA may

increase the number of annual EQAS samples (mainly for educational purposes) for

certain Laboratories, according, but not limited, to the following criteria:

- Monitoring the effectiveness of corrective action implementation after questionable

or unsatisfactory performance in WADA EQAS or in routine Analytical Testing;

- Substantiated intelligence information received by WADA indicating questionable

or unsatisfactory Laboratory performance;

- Laboratories which do not receive enough Samples (< 100 annual Samples) for a

specific Analytical Testing Procedure, which is not part of the Laboratory’s routine

Analytical Testing menu;

- As part of WADA Laboratory assessments.

6.2.2 Composition of EQAS Samples

EQAS samples may or may not contain Prohibited Substance(s) and/or Metabolite(s)

of Prohibited Substance(s) and/or Marker(s) of Prohibited Substance(s) or Prohibited

Method(s).

6.2.2.1 Blank EQAS Samples

Blank EQAS samples do not contain Prohibited Substances or their

Metabolites or Markers of Prohibited Substances or Prohibited Methods.

6.2.2.2 Adulterated EQAS Samples

Adulterated EQAS samples are those which have been deliberately

adulterated by the spiking of non-characteristic Metabolite(s) or by the addition

of extraneous substances designed to dilute or concentrate the sample,

degrade or mask the Analyte prior to or during the analytical determination.

Adulterated EQAS samples may also be obtained from the controlled

administration or the addition of non-prohibited substances, which share

common Metabolite(s) with Prohibited Substance(s).

ISL – January 2021 Page 122 of 160

6.2.2.3 EQAS Samples Containing Prohibited Substance(s), their Metabolite(s)

or Marker(s), or the Marker(s) of Prohibited Method(s)

The concentration(s) of selected Analyte(s) are those that may be encountered

in the urine or blood after Use of Prohibited Substance(s) or Prohibited

Method(s). For some Analytes, the EQAS sample may contain the parent

Prohibited Substance and/or its Metabolite(s) and/or its Marker(s).

EQAS samples may be spiked with Prohibited Substance(s) and/or their

Metabolite(s) or Marker(s) but would be preferably prepared from controlled

administration studies. The EQAS sample composition shall reflect as closely

as possible the expected target Analyte Metabolite pattern and concentrations

usually found in Samples.

An EQAS sample may contain more than one Prohibited Substance,

Metabolite(s), or Marker(s) of a Prohibited Substance or Prohibited Method. It

may also contain multiple Metabolites or Markers of a single Prohibited

Substance or Markers of a Prohibited Method, which would represent the

presence of a single Prohibited Substance or the Use of a single Prohibited

Method.

[Comment: Double-blind EQAS samples should be representative of Samples.

Therefore, to the extent possible (in consideration, for example, of technical or ethical

constraints, availability of the pharmaceutical grade substance, etc.), double-blind

EQAS samples containing Prohibited Substance(s) and/or Metabolite(s) of Prohibited

Substance(s) and/or Marker(s) of Prohibited Substance(s) or Prohibited Method(s)

should be prepared from controlled administration studies performed in human

subjects. However, if this is not possible, then the double-blind EQAS sample(s) may

be prepared by spiking expected target Analyte(s) in the Sample matrix in

consideration of the representative metabolic profile(s).]

- EQAS samples for Non-Threshold Substances

For Non-Threshold Substances, the concentration in the EQAS sample will be

guided by, but not limited to, one of the following criteria:

o Concentrations of the Prohibited Substance and/or its Metabolite(s) or

Marker(s) equal to or greater than (≥) the applicable MRPL (refer to TD

MRPL);

o Concentrations of the Prohibited Substance and/or its Metabolite(s) or

Marker(s) between 50% of the MPRL and the MRPL (applicable only to

Non-Threshold Substances prohibited at all times and with no Minimum

Reporting Levels, as per TD MRPL);

o Non-Threshold Substances with Minimum Reporting Levels as stated in

the TD MRPL (e.g. substances prohibited In-Competition only), will

normally be present in estimated concentrations greater than (>) 120% of

the applicable Minimum Reporting Level;

ISL – January 2021 Page 123 of 160

o Concentrations of the Prohibited Substance and/or its Metabolite(s) or

Marker(s) below (<) 50% of the applicable MRPL (for Non-Threshold

Substances prohibited at all times with no Minimum Reporting Levels, for

educational purposes).

- EQAS samples for Threshold Substances

For Threshold Substances, the concentration in the EQAS sample will be

guided by, but not limited to, one of the following criteria:

o Greater than (>) 50% of the Threshold as established in the relevant

Technical Document(s) or Laboratory Guidelines;

o At less than (<) 50% of the Threshold for those exogenous Threshold

Substances specified in the TD DL whose presence shall be reported if

detected in the presence of diuretics or masking agents.

Laboratories shall determine the Markers of the “steroid profile” in all urine EQAS

samples (unless specifically noted as not required in an educational EQAS

sample).

6.2.2.4 Blood EQAS Samples for the analysis of ABP blood Markers

These EQAS samples are distributed to Laboratories and ABP Laboratories on

a regular basis (e.g. monthly) with the purpose of evaluating their proficiency

in the analysis and reporting of the blood Markers that constitute the

hematological module of the ABP.

6.2.3 Laboratory Analytical Testing Procedures Used in EQAS

All procedures associated with the Analytical Testing of the EQAS samples by the

Laboratory are to be conducted in a manner similar to that applied to routine Samples,

unless otherwise specified by WADA. No effort shall be made to optimize instrument

(e.g. change multipliers or chromatographic columns) or method performance prior to

analyzing the EQAS samples unless it is a scheduled maintenance activity. Only

validated, Fit-for-Purpose Analytical Testing Procedures described in the Laboratory’s

SOPs are to be employed in the analysis of EQAS samples (i.e. using the Initial

Testing Procedures and Confirmation Procedures applied in routine Analytical

Testing).

6.3 Reporting of EQAS results

The purpose of the EQAS program is to ensure that all Laboratories maintain proficiency in

the performance of their Analytical Testing Procedures and report valid results to WADA and

the Testing Authority in a timely manner.

A Laboratory shall not communicate with other Laboratories regarding the identity or content

of substances present in or absent from blind EQAS samples prior to the submission of EQAS

results to WADA. This prohibition also applies to Laboratory requests for second opinions,

which shall not be requested for blind EQAS samples.

ISL – January 2021 Page 124 of 160

Contact between Laboratories regarding any aspect of blind EQAS analysis (including the

results obtained) prior to reporting by all Laboratories to WADA will be considered an attempt

to circumvent the quality assessment. Engaging in such discussions will subject the

Laboratories involved to disciplinary procedures, which may lead to Suspension or Revocation

of WADA accreditation.

For double-blind EQAS samples, which are indistinguishable from routine Samples,

consultation between Laboratories before reporting such EQAS results to WADA may occur.

However, such consultation shall not involve identifying the sample as a WADA double-blind

EQAS sample (in cases when, for any reason, the Laboratory identifies the EQAS nature of

the sample).

6.3.1 Reporting Blind EQAS Results

The Laboratory shall report the results of blind EQAS samples to WADA in ADAMS in

the same manner as specified for routine Samples (see Article 5.3.8.4) unless

otherwise notified by WADA. For some blind EQAS samples or sample sets, additional

information may be requested from the Laboratory (e.g. LODs, LOQs, MU estimations,

etc.).

The results of the blind EQAS shall be submitted to WADA on or before the specified

reporting date unless an extension is granted by WADA for valid reasons. For a failure

to report results of blind EQAS samples by the established deadline, without prior

approval by WADA or without justified grounds, as determined by WADA, the

Laboratory shall receive two (2) penalty points, and an additional two (2) penalty points

for reporting eight (8) to fourteen (14) days beyond the applicable deadline (refer to

the Points Scale Table in Article 7.3). Failure to report blind EQAS results within fifteen

(15) days beyond the WADA-established or WADA-approved deadline (based on valid

justification, as determined by WADA) will result in the evaluation of the corresponding

EQAS sample(s) as False Negative Finding(s) (for those findings produced by different

and unrelated root causes) and the assignment of penalty points in accordance with

the Points Scale Table in Article 7.3. In such cases, no penalty points will be

accumulated for late reporting, in addition to those assigned for the False Negative

Finding(s).

6.3.2 Reporting Double-Blind EQAS Results

The Laboratory shall report the results of double-blind EQAS samples in ADAMS as

per Article 5.3.8.4.

Reporting of double-blind EQAS results should occur within twenty (20) days of receipt

of the samples, unless an extension has been agreed with the Testing Authority after

the Laboratory has provided the Testing Authority with a valid reason for the delay in

the reporting of the results or a postponement has been established or approved by

ISL – January 2021 Page 125 of 160

WADA based on justified grounds (e.g. double-blind EQAS samples for which a

second opinion may be required before reporting an Adverse Analytical Finding).

Failure to report double-blind EQAS results within twenty (20) days of receipt of the

samples or, subject to an extension of this deadline by agreement with the Testing

Authority or approval by WADA based on justified grounds, within the agreed or

WADA-approved deadline, shall carry two (2) penalty points and an additional two (2)

penalty points for reporting eight (8) to fourteen (14) days beyond the applicable

deadline (refer to the Points Scale Table in Article 7.3). Failure to report double-blind

EQAS results within thirty-five (35) days of receipt of the samples, or otherwise within

fifteen (15) days beyond the agreed or WADA-approved deadline, will result in the

evaluation of the corresponding EQAS sample(s) as False Negative Finding(s) (for

those findings produced by different and unrelated root causes) and the assignment

of penalty points in accordance with the Points Scale Table in Article 7.3. In such

cases, no penalty points will be accumulated for late reporting, in addition to those

assigned for the False Negative Finding(s).

6.3.3 Reporting Educational EQAS Results

The Laboratory shall report the results of open or blind educational EQAS samples on

or before the specified reporting deadline and in a format specified by WADA. Results

received after the deadline will not be included in the assessment of EQAS results nor

in the subsequent educational EQAS report.

6.3.4 Reporting Results for EQAS Samples Containing Non-Threshold Substances

Unless otherwise specified by WADA (for example, for an educational EQAS), the

report of EQAS results for Non-Threshold Substances shall include all the Analytes

whose presence in the EQAS sample has been confirmed by the Laboratory in

accordance with the TD IDCR or other applicable Technical Document, including the

Prohibited Substance(s) (i.e. parent compound(s), if applicable) and all identified

Metabolite(s) and/or Marker(s) of the Prohibited Substances or Marker(s) of Prohibited

Method(s). WADA may also require that the Laboratory report the estimated

concentrations of the confirmed Analyte(s).

For open educational and blind EQAS samples, the Laboratory shall report the LODs

of the identified Non-Threshold Substance(s) and/or Metabolite(s) and/or Marker(s),

or of the identified Marker(s) of Prohibited Method(s), as estimated during method

validation of the Initial Testing Procedure.

6.3.5 Reporting Results for EQAS Samples Containing Threshold Substances

For educational and blind EQAS samples, the report of EQAS results for Threshold

Substances shall include the values measured for each Aliquot analyzed, whenever

the measured mean value of all replicates is greater than or equal to (≥) 50% of the

applicable Threshold.

ISL – January 2021 Page 126 of 160

[Comment: Unless otherwise specified by WADA (for example, for educational purposes), this

provision does not apply to EQAS samples containing exogenous Threshold Substances

whose presence shall be reported, without the need for quantitative confirmation, if detected in

the presence of diuretics or masking agents.]

For double-blind EQAS samples, the Laboratory shall report the quantitative results in

ADAMS as done for routine Samples, in accordance with the relevant Technical

Document(s), Technical Letter(s) or Laboratory Guidelines.

ISL – January 2021 Page 127 of 160

7.0 Evaluation of Laboratory EQAS and Routine Analytical Testing Performance

The WADA system of Laboratory EQAS and routine Analytical Testing performance (see Points

Scale Table in Article 7.3 below) has been developed by the LabEG with the objective of setting a

transparent and balanced procedure for evaluation of Laboratory and probationary laboratory

operations. It is based on the principle of proportionality and is focused on improving Laboratory’s

Analytical Testing capabilities and, in the case of probationary laboratories, their readiness for

obtaining WADA accreditation. It is ultimately aimed at maintaining the confidence in and

strengthening of the anti-doping Laboratory system to benefit clean Athletes.

7.1 Evaluation of EQAS Results

Satisfactory EQAS performance in single EQAS rounds and over a consecutive twelve (12)-

month period

is necessary for maintaining WADA accreditation.

[Comment: An EQAS Round is a distribution of EQAS sample(s) to the Laboratories and the

probationary laboratories for Analytical Testing as defined by WADA.]

Unsatisfactory performance in an educational EQAS for a new or WADA-specific Analytical

Testing Procedure may prevent the Laboratory from seeking an extension of the Laboratory’s

Scope of ISO/IEC 17025 Accreditation for the Analytical Testing Procedure and from its

application in routine Analytical Testing (see Article 4.4.2.2). In such circumstances, the

Laboratory may only apply the newly WADA-approved method or procedure for routine

Sample analysis when it properly corrects the deficiencies identified in the educational EQAS

(as determined by WADA) and the method is included in the Laboratory’s Scope of ISO/IEC

17025 Accreditation.

[Comment: Some Analytical Testing Procedures are not eligible for a Flexible Scope of ISO/IEC 17025

Accreditation and require specific WADA approval before the Laboratory can apply the procedure to

the analysis of Samples. WADA approval will be based on its assessment of the Fitness-for-Purpose

of the Analytical Testing Procedure, method validation by the Laboratory, and the successful Laboratory

participation in an inter-laboratory collaborative study or WADA EQAS round. WADA will communicate

which Analytical Testing Procedures fall into this category to the Laboratories and to the Accreditation

Bodies (see Article 4.4.2.2).]

The twelve (12)-month period to account for the total number of penalty points accumulated by a Laboratory or

probationary laboratory according to the Points Scale Table is defined as the most recent consecutive twelve (12)-

month interval starting either from the date that the Laboratory or the probationary laboratory reported the

nonconforming result (EQAS or routine Analytical Testing, as applicable) in ADAMS or from the date that the

Laboratory or probationary laboratory is informed, in writing, of the assigned penalty points total by WADA,

whichever is more favorable to the Laboratory or the probationary laboratory. Any assigned penalty points will expire

after a twelve (12)-month period; however, the total number of penalty points within any consecutive twelve (12)-

month period shall not reach the maximum allowed number of penalty points established in the Points Scale Table.

ISL – January 2021 Page 128 of 160

7.1.1 EQAS Samples Containing Non-Threshold Substances

When a qualitative determination of a Non-Threshold Substance has been reported,

the Laboratory result will be evaluated on the basis of the correct reporting of the

finding (e.g. Adverse Analytical Finding, Negative Finding) as intended in the

preparation of the EQAS sample.

The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s)

at concentrations greater than (>) the MRPL (or exceeding 120% of the Minimum

Reporting Level, when applicable) shall be evaluated in accordance with the Points

Scale Table.

The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s)

at concentrations between 50% of the MRPL and the MRPL (or less than 120% of the

Minimum Reporting Level, when applicable) shall not be considered for evaluation for

the purposes of the EQAS points system. However, WADA may require an internal

investigation and Corrective Action Report from the Laboratory.

The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s)

at concentrations below (<) 50% of the applicable MRPL in an EQAS sample shall not

be evaluated for the purposes of the EQAS points system. Nonetheless, the

Laboratory should report their finding(s) if the analyses are compliant with its validation

data, SOPs, the ISL and the TD IDCR. Laboratories unable to report such

substance(s) are encouraged, on receipt of the EQAS report, to consider re-

assessment of their Analytical Testing Procedure.

7.1.2 EQAS Samples Containing Threshold Substances

For EQAS samples containing Threshold Substances at levels greater than (>) 50%

of the Threshold, the quantitative determination will be statistically evaluated (e.g. z-

score, degree of equivalence analysis) to determine the compatibility of the reported

result with the assigned value (reference, nominal or consensus value, as applicable).

Results shall be evaluated as per the Points Scale Table.

[Comment: This provision does not apply to the reporting of results for certain exogenous

Threshold Substances, identified in the TD DL, if detected in the presence of diuretics or

masking agents. In such cases, the detection and identification of the exogenous Threshold

Substance shall be reported in accordance with the TD DL. The failure to report the presence

of the Threshold Substance(s), as applicable, will be considered as a False Negative Finding.]

A Laboratory is to achieve a satisfactory statistical evaluation of quantitative results

reported based on the mean of three (3) replicate determinations. The overall

evaluation of the quantitative performance is based on the criteria indicated in the

effective version of the TD DL or other relevant Technical Document, Technical Letter

or Laboratory Guidelines.

[Comment: The main criterion applied for the evaluation of EQAS results for the quantification

of Threshold Substances is the compatibility of the reported Laboratory result with the assigned

value. Therefore, the incorrect reporting of an EQAS sample as a Negative Finding or as an

Adverse Analytical Finding, as applicable, when the assigned value of the Threshold

ISL – January 2021 Page 129 of 160

Substance in the EQAS sample is close to the Decision Limit, is not considered as a False

Negative Finding or False Adverse Analytical Finding, respectively, if the absolute z-score

(truncated to one (1) decimal place) for the Laboratory's quantitative result is < 3.0 (see footnote

31).]

7.1.2.1 Unsatisfactory Quantitative Result for Threshold Substances (absolute

z-score ≥ 3.0)

The Laboratory shall provide WADA with a satisfactory Corrective Action

Report for an unsatisfactory quantitative result. The Corrective Action Report

shall be submitted within fifteen (15) days of receiving a written notification

about the unsatisfactory result from WADA. Failure to submit a satisfactory

Correction Action Report or the late submission of the Correction Action Report

without prior approval by WADA shall result in the imposition of further penalty

points in accordance with the Points Scale Table.

[Comment: A Corrective Action Report will be considered as satisfactory when it meets

all of the following criteria, as determined by the LabEG:

- Properly and concisely identifies the root cause(s) of the nonconformity, following

an appropriate investigation into all the factors that may have caused the problem

(Root Cause Analysis);

- Leads to the documented implementation of effective corrective action(s) to solve

the problem; and

- Leads to the documented implementation of appropriate preventive actions, if

applicable, to minimize the risk of recurrence of the problem.

A satisfactory Corrective Action Report shall include only the necessary supporting

documentation (e.g. raw analytical data, data review files, evidence of procurement of

Reference Materials) which demonstrates the implemented actions described in the

Corrective Action Report.]

7.1.2.2 Questionable Quantitative Result (absolute z-score > 2.0 and < 3.0)

The Laboratory shall perform an internal investigation to determine the root

cause(s) of the questionable result and implement appropriate corrective

measures to resolve them.

The z–score is calculated according to the following formula and truncated to one (1) decimal place:

𝑧 =

ȳ − ŷ



Where:

ȳ is the mean value of the Laboratory’s replicate determinations; ŷ is the assigned value (reference, nominal or

consensus value, as applicable);  is the target standard deviation (e.g. u

c_Max

or robust Reproducibility s

of results

from all participant Laboratories).

ISL – January 2021 Page 130 of 160

7.2 Evaluation of Laboratory Performance

7.2.1 False Adverse Analytical Finding

A False Adverse Analytical Finding is not acceptable for any blind or double-blind

EQAS sample or during the course of routine Analytical Testing conducted by a

Laboratory.

7.2.1.1 False Adverse Analytical Finding during routine Analytical Testing

If the Laboratory discovers that it reported a False Adverse Analytical Finding

during routine Analytical Testing, the Laboratory shall inform WADA

immediately.

When the False Adverse Analytical Finding is identified by WADA, based on

information received from a Testing Authority, a Results Management

Authority, through WADA’s own Results Management activities or through any

other means, WADA shall inform the Laboratory immediately.

In either case, the Laboratory shall cease all Analytical Testing activities

applied to the affected Analytical Testing Procedure(s) and/or Laboratory

process(es) (e.g. Sample aliquoting, reporting of results) as soon as it

becomes aware or is informed by WADA that a False Adverse Analytical

Finding has been reported.

The Laboratory shall provide WADA with a Corrective Action Report, including

a Root Cause Analysis of the incorrect results and the corrective action(s)

implemented for its rectification, within seven (7) days of informing WADA or

being informed by WADA, as applicable, or, in exceptional cases, as otherwise

agreed with WADA.

The LabEG shall review the Laboratory’s Corrective Action Report within seven

(7) days, or within a timeline otherwise determined by WADA, and establish

the source of the incorrect result as either a technical/methodological error or

a clerical/administrative error.

The Laboratory may be required by WADA to analyze additional EQAS

samples and/or to review the relevant analytical results and to re-analyze any

relevant and available Samples previously reported as Adverse Analytical

Findings

during the preceding twelve (12) months (or during a period

The Laboratory may not re-analyze Sample(s) previously reported as Adverse Analytical Findings if the

responsible Anti-Doping Organization has charged the Athlete with a Code Article 2.1 anti-doping rule violation

resulting from the analysis of the Sample, without the consent of the Athlete or approval from a hearing body.

However, in connection with its monitoring of a Laboratory, WADA may direct Further Analysis of a Sample which

has resulted in an Article 2.1 anti-doping rule violation charge without consent of the Athlete or approval from a

hearing body as provided in Code Article 6.5, provided that the analytical result from this analysis may not be used

against the Athlete [for example, re-analyzing Samples which a Laboratory has reported as Adverse Analytical

ISL – January 2021 Page 131 of 160

otherwise determined by WADA) within seven (7) days (unless informed

otherwise by WADA). Depending on the nature of the error that caused the

False Adverse Analytical Finding, this re-analysis may be limited to one

Analyte, a class of Prohibited Substances or Prohibited Methods, or may

include any Prohibited Substance or Prohibited Method. A statement signed

by the Laboratory Director shall record this re-analysis. The Laboratory will be

required to inform all of its clients whose Analytical Testing results may have

been affected.

[Comment: The retrospective review of the analytical results and re-analysis of

previous relevant Samples reported as Adverse Analytical Finding(s) shall be

performed with the objective of determining whether any other related [i.e. produced

by the same root cause(s)] False Adverse Analytical Finding(s) have been reported by

the Laboratory. The discovery of additional false Adverse Analytical Finding(s) shall

lead to the implementation of corrective measures and shall be communicated to the

responsible Testing Authority/Results Management Authority and to WADA. However,

the additional False Adverse Analytical Finding(s) will not lead to the accumulation of

additional penalty points if produced by the same root cause(s), as determined by

WADA.]

a) False Adverse Analytical Finding with Consequences being imposed on an

Athlete

If the reporting of the False Adverse Analytical Finding has resulted in

Consequences being imposed against an Athlete, the Laboratory shall receive

twenty (20) penalty points in accordance with the Points Scale Table,

irrespective of the nature of the error (technical/methodological or

clerical/administrative) that led to the reporting of the False Adverse Analytical

Finding.

[Comment: WADA shall inform a Laboratory in writing about the imposition of penalty

points, as decided by the LabEG and in accordance with the Points Scale Table. If the

final decision regarding the number of penalty points to be imposed is conditional on

the evaluation of corrective actions or other follow-up measures (e.g. analysis of further

EQAS samples) that have been requested by the LabEG, WADA will only inform the

Laboratory about the final number of penalty points imposed at the end of the

evaluation process [e.g. 5 penalty points at the end of the evaluation process of a False

Negative Finding resolved through the timely implementation of satisfactory corrective

action(s).]

The LabEG, considering the nature of the error that caused the False Adverse

Analytical Finding result, shall make a recommendation to the Chair of the

WADA Executive Committee to suspend the Laboratory’s WADA accreditation

Findings when other Sample(s) analyzed by the Laboratory using the same Analytical Method have been

discovered to be False Adverse Analytical Finding(s)].

ISL – January 2021 Page 132 of 160

or to impose an Analytical Testing Restriction against the Laboratory for a

particular Analytical Testing Procedure or for the analysis of a particular class

of Prohibited Substances or Prohibited Methods, as applicable.

[Comment: During the period of Suspension, the Laboratory shall follow the

instructions provided in Article 4.6.5.2 in regard to Samples in the Laboratory’s

possession at the time of Suspension. Alternatively, if an Analytical Testing Restriction

has been imposed, the Laboratory shall subcontract the affected analyses as provided

in Articles 4.6.5.1 and 5.2.6.

During the Suspension or Analytical Testing Restriction period, WADA will conduct an

assessment (preferably on-site) of the Laboratory, including the analysis of further

EQAS samples.

The Suspension or Analytical Testing Restriction of the Laboratory shall be lifted only

when the aforementioned conditions are satisfactorily completed, and the Laboratory

provides sufficient evidence, as determined by WADA, that appropriate steps have

been taken to remedy the issue(s) that resulted in the Suspension or Analytical Testing

Restriction.]

b) False Adverse Analytical Finding with No Consequences being imposed

on an Athlete

- Technical or methodological error

If the Root Cause Analysis investigation performed by the Laboratory

identifies the error as technical or methodological, the Laboratory will

be initially imposed twenty (20) penalty points in accordance with the

Points Scale Table. However, if the Laboratory first informs (i.e.

voluntarily self-reports) WADA of their investigation and discovery of a

False Adverse Analytical Finding, then the Laboratory will have five (5)

points deducted from the twenty (20) penalty points initially assigned.

If the Laboratory is able to remedy the technical or methodological error

through the implementation of satisfactory corrective actions in a timely

manner, as determined by the LabEG, the Laboratory will have ten (10)

penalty points deducted, in accordance with the Points Scale Table.

The Laboratory will be informed by WADA, in writing, of the final amount

of penalty points assigned in connection with the reporting of the False

Adverse Analytical Finding. The Laboratory will be able to resume

Analytical Testing activities following written notification by WADA,

provided that the point total accumulated by the Laboratory for a twelve

(12)-month

period does not exceed thirty (30) points.

However, if the Laboratory’s Corrective Action Report is considered

unsatisfactory by the LabEG, the LabEG shall provide feedback to the

Laboratory and provide it with the opportunity to resubmit a revised

Corrective Action Report within seven (7) days (or as otherwise agreed

with WADA).

ISL – January 2021 Page 133 of 160

If the Laboratory is unable to resubmit a satisfactory revised Corrective

Action Report in a timely manner, as determined by the LabEG, then

the Laboratory will be assigned an additional five (5) penalty points and

the LabEG shall make a recommendation to the Chair of the WADA

Executive Committee to suspend the Laboratory’s WADA accreditation

or to impose an Analytical Testing Restriction against the Laboratory

for a particular Analytical Testing Procedure or for the analysis of a

particular class of Prohibited Substances or Prohibited Methods, as

applicable.

- Clerical/Administrative Error

If the Root Cause Analysis investigation performed by the Laboratory

identifies the error as clerical or administrative, the Laboratory will be

initially assigned fifteen (15) penalty points in accordance with the

Points Scale Table. However, if the Laboratory first informs (i.e.

voluntarily self-reports) WADA of their investigation and discovery of a

False Adverse Analytical Finding, then the Laboratory will have five (5)

points deducted from the fifteen (15) penalty points initially assigned.

If the Laboratory is able to remedy the clerical or administrative error

through the implementation of satisfactory corrective actions in a timely

manner, as determined by the LabEG, the Laboratory will have ten (10)

additional penalty points deducted, in accordance with the Points Scale

Table. The Laboratory will be informed by WADA, in writing, of the total

amount of penalty points assigned in connection with the reporting of

the False Adverse Analytical Finding.

The Laboratory will be able to

resume Analytical Testing activities following written notification by

WADA, provided that the point total accumulated by the Laboratory for

a twelve (12)-month

period does not exceed thirty (30) points.

However, if the Laboratory’s Corrective Action Report is considered

unsatisfactory by the LabEG, the LabEG shall provide feedback to the

Laboratory and grant an opportunity to resubmit a revised Corrective

Action Report within seven (7) days (or as otherwise agreed with

WADA). If the Laboratory is unable to submit a satisfactory revised

Corrective Action Report in a timely manner, as determined by the

LabEG, the Laboratory shall receive an additional ten (10) penalty

points in accordance with the Points Scale Table. The LabEG,

For the purposes of Laboratory performance evaluation, clerical/administrative errors are defined as those

incidental, non-systematic errors of no technical or methodological origin, which have been committed by the

Laboratory during the performance of Analytical Testing (e.g. a typographical error when manually recording an

analytical result). The Laboratory shall bear no responsibility for clerical/administrative errors reflected in the

Laboratory documentation, which were made, for example, by the Sample Collection Authority or Testing Authority.

ISL – January 2021 Page 134 of 160

considering the nature of the clerical/administrative error that caused

the False Adverse Analytical Finding result, shall make a

recommendation to the Chair of the WADA Executive Committee to

suspend the Laboratory’s WADA accreditation or to impose an

Analytical Testing Restriction against the Laboratory, as applicable.

7.2.1.2 False Adverse Analytical Finding for blind or double-blind EQAS sample

In the event that a False Adverse Analytical Finding is reported during the

EQAS, WADA will immediately start an investigation to establish if the incorrect

result was caused by the EQAS sample provider (blind and double-blind

EQAS) or the Testing Authority (double-blind EQAS).

If it is established that the False Adverse Analytical Finding result was caused

by an error made by the EQAS sample provider or the Testing Authority, the

Laboratory will be informed by WADA and no further action will be required

from the Laboratory.

If the WADA investigation indicates that the False Adverse Analytical Finding

was caused by an error made by the Laboratory during the Analytical Testing

of the EQAS sample(s), the Laboratory shall be informed by WADA as soon

as possible. However, if the False Adverse Analytical Finding is related to the

analysis of a double-blind EQAS sample and the Laboratory first informs (i.e.

voluntarily self-reports) WADA of their investigation and discovery of a False

Adverse Analytical Finding, this will be taken into consideration when

evaluating the Laboratory’s performance in accordance with the Points Scale

Table (see below).

The Laboratory shall provide WADA with a Corrective Action Report, including

a Root Cause Analysis of the incorrect result(s) and corrective action(s)

implemented for its rectification, within fifteen (15) days of being informed by

WADA (unless otherwise indicated by WADA). In addition, the Laboratory may

be required by WADA to analyze additional EQAS samples and/or to review

the analytical results and to re-analyze any relevant and available Samples

previously reported as Adverse Analytical Findings

during the preceding

twelve (12) months (or during a period otherwise determined by WADA), within

seven (7) days (unless informed otherwise by WADA). Depending on the

nature of the error that caused the false Adverse Analytical Finding, this re-

analysis may be limited to one Analyte, a class of Prohibited Substances or

Prohibited Methods, or may include any Prohibited Substance or Prohibited

Method. The re-analysis shall be documented, and the results shall be reported

to WADA. The Laboratory will be required to inform all of its clients whose

Analytical Testing results may have been affected.

The LabEG shall review the Laboratory’s Corrective Action Report within

fifteen (15) days, or within a timeline otherwise determined by WADA.

ISL – January 2021 Page 135 of 160

- Technical or methodological error

If the Root Cause Analysis investigation performed by the Laboratory

identifies the error as technical or methodological, the Laboratory will

be initially imposed twenty (20) penalty points in accordance with the

Points Scale Table. However, if the False Adverse Analytical Finding is

related to the analysis of a double-blind EQAS sample and the

Laboratory first informs (i.e. voluntarily self-reports) WADA of their

investigation and discovery of a False Adverse Analytical Finding, then

the Laboratory will have five (5) points deducted from the twenty (20)

penalty points initially assigned.

If the Laboratory is able to remedy a technical/methodological error

through the implementation of satisfactory corrective action(s) in a

timely manner, as determined by the LabEG, the Laboratory will have

ten (10) penalty points deducted, in accordance with the Points Scale

Table. The Laboratory will be informed by WADA, in writing, of the final

amount of penalty points assigned in connection with the reporting of

the False Adverse Analytical Finding.

However, if the Laboratory’s Corrective Action Report for the technical

or methodological error is considered unsatisfactory by the LabEG, the

LabEG shall provide feedback to the Laboratory and provide it with the

opportunity to submit a revised Corrective Action Report within seven

(7) days (or as otherwise agreed with WADA). If the Laboratory is

unable to resubmit a satisfactory revised Corrective Action Report in a

timely manner, as determined by the LabEG, then the Laboratory will

be assigned an additional five (5) penalty points and the LabEG shall

make a recommendation to the Chair of the WADA Executive

Committee to suspend the Laboratory’s WADA accreditation or to

impose an Analytical Testing Restriction against the Laboratory for a

particular Analytical Testing Procedure or for the analysis of a particular

class of Prohibited Substances or Prohibited Methods, as applicable.

- Clerical/Administrative Error

If the Root Cause Analysis investigation performed by the Laboratory

identifies the error as clerical or administrative, the Laboratory will be

initially imposed fifteen (15) penalty points in accordance with the

Points Scale Table. However, if the False Adverse Analytical Finding is

related to the analysis of a double-blind EQAS sample and the

Laboratory first informs (i.e. voluntarily self-reports) WADA of their

investigation and discovery of a False Adverse Analytical Finding, then

the Laboratory will have five (5) points deducted from the fifteen (15)

penalty points initially assigned.

ISL – January 2021 Page 136 of 160

If the Laboratory is able to remedy the clerical or administrative error

through the implementation of satisfactory corrective action(s) in a

timely manner, as determined by the LabEG, the Laboratory will have

ten (10) points deducted, in accordance with the Points Scale Table.

Consequently, the Laboratory will be informed by WADA, in writing, of

the final amount of penalty points assigned in connection with the

reporting of the False Adverse Analytical Finding.

However, if the Laboratory’s Corrective Action Report is considered

unsatisfactory by the LabEG, the LabEG shall provide feedback to the

Laboratory and provide it with the opportunity to resubmit a revised

Corrective Action Report within seven (7) days (or as otherwise agreed

with WADA). If the Laboratory is unable to submit a satisfactory revised

Corrective Action Report in a timely manner, as determined by the

LabEG, the Laboratory shall receive an additional ten (10) penalty

points in accordance with the Points Scale Table. The LabEG,

considering the nature of the clerical/administrative error that caused

the False Adverse Analytical Finding result, shall make a

recommendation to the Chair of the WADA Executive Committee to

suspend the Laboratory’s WADA accreditation or to impose an

Analytical Testing Restriction against the Laboratory, as applicable.

The reporting of any False Adverse Analytical Finding Result,

irrespective of whether it relates to routine Analytical Testing or the

EQAS, or whether or not it results in the Suspension of a Laboratory’s

WADA accreditation or an Analytical Testing Restriction, may trigger a

WADA Laboratory assessment and the requirement that additional

EQAS samples be analyzed by the Laboratory.

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7.2.2 False Negative Finding

Laboratories failing to identify and/or report a Prohibited Substance and/or its

Metabolite(s) or the Marker(s) of a Prohibited Substance or a Prohibited Method in a

blind or double-blind EQAS sample or during routine Analytical Testing shall be

informed of the False Negative Finding as soon as possible by WADA.

WADA will immediately start an investigation to establish whether the False Negative

Finding was the result of the Laboratory’s Analytical Testing process.

If WADA’s investigation determines that the False Negative Finding occurred due to

mistake(s) related to the Laboratory’s Analytical Testing process, the Laboratory will

be initially imposed ten (10) penalty points in accordance with the Points Scale Table.

However, if the False Negative Finding is related to the analysis of a routine Sample

or a double-blind EQAS sample and the Laboratory first informs (i.e. voluntarily self-

reports) WADA of their investigation and discovery of a False Negative Finding, then

the Laboratory will have five (5) points deducted from the ten (10) penalty points

initially assigned.

The Laboratory shall provide WADA with a Corrective Action Report within fifteen (15)

days (unless otherwise indicated by WADA).

The LabEG shall review the Laboratory’s Corrective Action Report within fifteen (15)

days, or within a timeline otherwise determined by WADA.

If the Laboratory is able to remedy the issue(s) that led to the reporting of the False

Negative Finding, through the implementation of satisfactory corrective actions in a

timely manner, as determined by the LabEG, five (5) penalty points initially imposed

will be deducted, in accordance with the Points Scale Table. Consequently, the

Laboratory will be informed by WADA, in writing, of the final amount of penalty points

assigned in connection with the reporting of the False Negative Finding.

However, If the Laboratory’s Corrective Action Report is considered unsatisfactory by

the LabEG, the LabEG shall provide feedback to the Laboratory and provide it with the

opportunity to resubmit a revised Corrective Action Report within seven (7) days (or

as otherwise agreed with WADA). If the Laboratory is unable to resubmit a satisfactory

revised Corrective Action Report in a timely manner, as determined by the LabEG, the

Laboratory shall receive an additional five (5) penalty points in accordance with the

Points Scale Table. In addition, WADA will request the Laboratory to analyze additional

(blind and/or double-blind) EQAS sample(s). Depending on the nature of the error that

caused the False Negative Finding, this additional analysis may be limited to one

Analyte, a class of Prohibited Substances or Prohibited Methods, or may include any

Prohibited Substance or Prohibited Method.

The Laboratory shall report correct results for the analysis of all EQAS samples. In

addition, the Laboratory shall implement satisfactory corrective action(s) (as

determined by WADA) which ensures that the cause(s) of the nonconformity is

eliminated, thus avoiding repetition of the mistake in the future. Failure by the

ISL – January 2021 Page 138 of 160

Laboratory to report correct results for the additional EQAS sample(s) will incur the

imposition of additional penalty points in accordance with the Points Scale Table. The

LabEG, considering the nature of the error that caused the False Negative Finding,

shall make a recommendation to the Chair of the WADA Executive Committee to

suspend the Laboratory’s WADA accreditation or to impose an Analytical Testing

Restriction against the Laboratory, as applicable.

The reporting of False Negative Finding(s), irrespective of whether it relates to routine

Analytical Testing or the EQAS, or whether or not it results in the Suspension of a

Laboratory’s WADA accreditation or an Analytical Testing Restriction, may trigger a

WADA Laboratory assessment and the requirement that the Laboratory analyses

additional EQAS samples.

7.2.3 Further Procedural Evaluations

If the LabEG considers that a Corrective Action Report is unsatisfactory, and the

Laboratory is not able to provide a satisfactory revised Corrective Action Report within

a reasonable time frame after receiving feedback from the LabEG, the Laboratory will

receive two (2) penalty points.

Corrective Action Reports related, for example, to nonconformities detected during

WADA Laboratory assessments, or to procedural or reporting nonconformities with the

ISL, Technical Documents or Technical Letters, or unsatisfactory performance in the

analysis of EQAS samples (not related to a False Adverse Analytical Finding or False

Negative Finding), shall be submitted to WADA within thirty (30) days of WADA’s

notification to the Laboratory. Late submission of Corrective Action Reports, as

determined by the LabEG, will result in the imposition of one (1) additional penalty

point per seven (7) days beyond the applicable deadline, unless the Laboratory

provides valid reasons for the delay, as determined by the LabEG.

Unless otherwise agreed with WADA, the corrective and preventive action(s) reported

to and approved by WADA shall be implemented in the routine operations of the

Laboratory immediately.

7.3 Overall Laboratory Evaluation

WADA shall evaluate Laboratory EQAS performance for each EQAS round, as well as

Laboratory performance for routine Analytical Testing, and assign penalty points for

nonconformities or failures to perform as indicated in the Points Scale Table.

The accumulation of the maximum allowed number of penalty points for the EQAS and/or

routine Analytical Testing, as determined in the Points Scale Table below, shall prompt the

LabEG to make a recommendation to the Chair of the WADA Executive Committee to impose

Article 7.2.3 does not apply to the evaluation of Corrective Action Reports for False Adverse Analytical Findings

or False Negative Findings, which are covered in Arts. 7.2.1 and 7.2.2, respectively.

ISL – January 2021 Page 139 of 160

an Analytical Testing Restriction against the Laboratory or to impose a Suspension of the

Laboratory’s WADA accreditation, as applicable.

When a Laboratory’s WADA accreditation is suspended:

- If a Laboratory under Suspension accumulates the maximum allowed number of penalty

points in the EQAS, as determined in the Points Scale Table below, and the Laboratory is

not capable of correcting the issue(s) before the end of the Suspension period, then the

LabEG shall make a recommendation to the Chair of the WADA Executive Committee to

extend the Laboratory’s Suspension for up to an additional six (6) months or until such a

time when the Laboratory can satisfactorily correct all the issues identified;

- If the Laboratory under Suspension accumulates the maximum allowed number of penalty

points during an extended period of Suspension (beyond the initial six (6) months), then

the LabEG may recommend the Revocation of the Laboratory’s accreditation to the WADA

Executive Committee;

- Any accrued penalty points leading up to the Suspension or further accumulated through

the Laboratory’s participation in the blind EQAS program during the Suspension period,

are reset to zero (0) upon reinstatement of its WADA accreditation

When a Laboratory is subject to an Analytical Testing Restriction:

- Laboratories under an Analytical Testing Restriction remain operational (except for the

activity(-ies) under the Analytical Testing Restriction) and, therefore, are evaluated during

the Analytical Testing Restriction as any other, fully operational Laboratory;

- Any penalty points not related to the Analytical Testing Restriction, which were

accumulated up to the imposition of the Analytical Testing Restriction or further

accumulated during the Analytical Testing Restriction period (within a twelve (12)-month

period

), are carried over after the lifting of the Analytical Testing Restriction. Any penalty

points accrued in relation to the Analytical Testing Restriction are removed after the lifting

of the Analytical Testing Restriction.

This provision does not apply to a voluntary cessation of Laboratory operations (see Article 4.6.7).

ISL – January 2021 Page 140 of 160

Points Scale Table for Assessment of Laboratory and Probationary Laboratory Performance

Analytical

Testing

Conditions

Nonconformity

Type of Error

Outcome

Penalty

Points

Actions and Sanctions

Routine

Analytical

Testing

(Art 7.2.1.1)

False AAF

Consequence for

the Athlete

Technical / Methodological error

Clerical / Administrative error

Cease Analytical Testing

and

Suspension / Analytical

Testing Restriction

Routine

Analytical

Testing

(Art 7.2.1.1)

EQAS

(blind or double

blind)

round

(Art 7.2.1.2)

False AAF

No Consequence

for the Athlete

Technical / Methodological error

Cease Analytical Testing

• Self-reporting

- 5

Resume Analytical Testing

• Satisfactory and timely CAR

- 10

• Unsatisfactory CAR

+ 5

Suspension / Analytical

Testing Restriction

Clerical / Administrative error

Cease Analytical Testing

• Self-reporting

- 5

Resume Analytical Testing

• Satisfactory and timely CAR

- 10

• Unsatisfactory CAR

+ 10

Suspension / Analytical

Testing Restriction

Routine

Analytical

Testing

EQAS

(blind or double

blind)

round

False Negative

Finding

(Art 7.2.2)

False Negative Finding

Additional EQAS samples

• Self-reporting

- 5

• Satisfactory and timely CAR

- 5

• Unsatisfactory CAR

+ 5

Voluntary self-reporting is not applicable to blind EQAS samples.

The results of the analysis of the additional EQAS samples will be evaluated in accordance with this Points Scale

Table.

ISL – January 2021 Page 141 of 160

EQAS Evaluation

Result

Penalty Points

Steroid Profile Markers

|z-score| ≥ 3.0

(Occurrences*)

|z-score| ≥ 3.0 and CAR

4-7

Unsatisfactory CAR

Satisfactory and timely CAR

8-12

Unsatisfactory CAR

Satisfactory and timely CAR

13-18

Unsatisfactory CAR

Satisfactory and timely CAR

≥ 19

Unsatisfactory CAR

Satisfactory and timely CAR

GC/C/IRMS δ

(≥ 3 Occurrences**)

Threshold Substances

(per occurrence)

2.0 < |z-score| < 3.0

Internal Investigation

|z-score| ≥ 3.0

Unsatisfactory CAR

|z-score| ≥ 3.0

Satisfactory and timely CAR

SG determination

(per occurrence)

|z-score| ≥ 3.0

Unsatisfactory CAR

Documentation*** or Technical Issue

(per occurrence)

ISL, TD or TL Nonconformity

Unsatisfactory CAR

Late Submission of CAR

(per 7 days beyond the deadline)

Late reporting of blind or double-blind EQAS results

(late reporting 8 to 14 days beyond the deadline)

Evaluation

Penalty Points

Sanction

Point Total for single EQAS round (blind or double-blind****)

≥ 20

Suspension

Analytical Testing

Restriction

Point Total for double-blind EQAS**** for 12-month period

Point Total for routine Analytical Testing**** for 12-month period

Point Total (blind and double-blind EQAS and routine Analytical Testing)****

for 12-month period

≥ 30

* Based on a total of 6 determinations: Androsterone (A), Etiocholanolone (Etio), Testosterone (T), Epitestosterone (E), 5-

androstane-3,17β-diol (5Adiol) and 5β-androstane-3,17β-diol (5βAdiol) per EQAS sample.

** Per EQAS sample subjected to GC/C/IRMS analysis.

*** Documentation includes but is not limited to Laboratory Documentation Packages, Corrective Action Reports and Test

Reports.

**** Probationary laboratories are exempt from the double-blind EQAS program and routine Analytical Testing.

When an unsatisfactory (|z-score| ≥ 3.0) quantification result leads to the misreporting of the EQAS sample as a

False Adverse Analytical Finding or as a False Negative Finding, then penalty points will be assigned in accordance

with Arts. 7.2.1.2 and 7.2.2, respectively.

See Arts. 6.3.1 and 6.3.2.

ISL – January 2021 Page 142 of 160

7.4 Probationary Period and Probationary Laboratory Evaluation

The probationary EQAS is a part of the initial evaluation of a probationary laboratory seeking

WADA accreditation. In addition to providing blind EQAS samples, WADA may provide, upon

request and at the expense of the probationary laboratory, samples from past EQAS rounds

in order to allow the probationary laboratory an opportunity to evaluate its performance against

the recorded performance of Laboratories. Composition of the probationary EQAS samples

corresponds to the criteria described in Article 6.2.2.

Successful participation in WADA probationary EQAS, based on the Points Scale Table (less

than twenty (20) points accumulated within a single blind EQAS round and less than thirty

(30) points for the most recent and consecutive twelve (12)-month

period) is required before

a probationary laboratory is eligible to be considered for WADA accreditation. The LabEG

may decide, based on its evaluation of the overall performance of the probationary laboratory,

to extend the probationary period of accreditation, even if the probationary laboratory did not

reach the maximum number of penalty points based on the Points Scale Table. However,

once a laboratory is granted WADA accreditation, penalty points accumulated during the

probationary period are annulled and are not carried forward onto the accredited phase.

The blind EQAS samples shall be distributed in multiple rounds each year and will consist of

a minimum of fifteen (15) blind samples. At least three (3) blind EQAS samples will contain

Threshold Substances. Blank samples may also be included.

7.4.1 Analytical Testing Procedures Utilized by Probationary Laboratories for the

Analysis of EQAS samples

All procedures associated with the handling and analysis of the EQAS samples by the

probationary laboratory are to be conducted using validated procedures in a manner

identical to those expected to be applied during routine Analytical Testing, unless

otherwise specified by WADA.

7.4.2 False Adverse Analytical Finding Result

Any False Adverse Analytical Finding of a technical/methodological nature reported

automatically suspends a probationary laboratory from further consideration for WADA

accreditation. The probationary laboratory will only be eligible for re-instatement into

the accreditation process upon providing documentation to WADA that appropriate

corrective and preventive action(s) have been implemented, as determined by the

LabEG. WADA may decide to send a set of EQAS samples and/or perform an

assessment of the probationary laboratory prior to its re-instatement to the

probationary status.

7.4.3 False Negative Finding

Any probationary laboratory reporting a False Negative Finding in a blind EQAS round

shall be informed by WADA as soon as possible. The probationary laboratory shall

take and report proper corrective and preventive action(s) within ten (10) days of the

date of the letter from WADA (unless informed otherwise by WADA). The corrective

ISL – January 2021 Page 143 of 160

action, if approved by WADA, shall be implemented in the routine operations of the

probationary laboratory as soon as possible.

7.4.4 Threshold Substance Result

A probationary laboratory shall achieve satisfactory quantitative EQAS results

reported based on the mean of three (3) independent determinations.

7.4.5 Overall Probationary Laboratory Evaluation

WADA will evaluate probationary laboratory EQAS performance for each round and

assign points for each noncompliance or failure to perform in accordance with the

Points Scale Table, with the exception of the double-blind EQAS and routine analysis

evaluation.

The Suspension period of a probationary laboratory’s participation in the EQAS shall

be determined by WADA.

Serious and repeated issues in the probationary EQAS shall result in the removal of

the laboratory’s status as a probationary laboratory by WADA.

When the performance of a probationary laboratory is considered to be satisfactory in

the EQAS over the most recent and consecutive twelve (12)-month

period (e.g. at

least fifteen (15) blind EQAS samples), and provided that all of other necessary

conditions have been fulfilled, WADA will provide the probationary laboratory with a

minimum of a further fifteen (15) blind EQAS samples to be analyzed as part of a Final

Accreditation Test (FAT). In addition, the laboratory will be audited by an assessment

team appointed by WADA. At WADA’s discretion, the FAT and on-site assessment

may be conducted separately or at the same time.

The results of the FAT will be evaluated by WADA as satisfactory if:

- No False Adverse Analytical Finding is reported;

- Less than twenty (20) penalty points are assigned for the EQAS samples tested;

- Any corrective actions required as a result of the WADA assessment and/or the

analytical performance and/or the presentation of the requested Laboratory

Documentation Package(s) shall be submitted within thirty (30) days, unless

otherwise specified by WADA, and shall be considered satisfactory by WADA.

A suspended probationary laboratory wishing to re-enter the probationary EQAS is

required to provide documentation of corrective and preventive action(s) no later than

thirty (30) days prior to the end of the Suspension period (unless otherwise indicated

by WADA). Failure to do so will preclude the laboratory from participating in the

probationary EQAS.

Lifting of the Suspension occurs only when proper corrective and preventive actions

have been implemented and reported to WADA. WADA may choose, at its sole

discretion, to submit additional EQAS samples to the laboratory and/or to require that

the laboratory be re-assessed, at the expense of the laboratory. Laboratories re-

ISL – January 2021 Page 144 of 160

entering the probationary EQAS shall be considered as candidate laboratories and are

subject to provide the applicable accreditation fee and the required documentation to

WADA (see Article 4.2).

ISL – January 2021 Page 145 of 160

PART THREE: ISL ANNEXES

ISL ANNEX A - CODE OF ETHICS FOR LABORATORIES and ABP LABORATORIES

1.0 Confidentiality

Directors of Laboratories and ABP Laboratories, their delegates and all Laboratory staff shall

respect and comply with ISL Article 5.3.8.3 and Code Article 14.3.6.

2.0 Research in Support of Doping Control

Laboratories shall participate in research programs, provided that the Laboratory Director is

satisfied with their bona fide nature and the program(s) have received proper ethical approval, if

applicable. The Laboratory shall not engage in any research activity that undermines or is

detrimental to the World Anti-Doping Program.

The Laboratories are expected to develop a research and development program to support and

expand the scientific foundation of Doping Control. This research may consist of the development

of new methods or technologies, the pharmacological characterization of a new doping agent, the

characterization of a masking agent or method, and other topics relevant to the field of Doping

Control.

2.1 Research on Human Subjects

The Laboratories and ABP Laboratories shall follow the Helsinki Declaration and any

applicable national standards as they relate to the involvement of human subjects in research.

Voluntary informed consent shall also be obtained from human subjects in any drug

administration studies for the purpose of development of a Reference Collection or proficiency

testing materials.

Athletes who may undergo Doping Control Testing by Anti-Doping Organizations shall not be

the subjects of drug administration studies that include Prohibited Substances or Prohibited

Methods.

2.2 Controlled Substances

The Laboratories are expected to comply with the relevant and applicable national laws

regarding the handling, storage and discarding of controlled (illegal) substances.

3.0 Analysis

The Laboratory or ABP Laboratory shall not engage in any analysis or activity that undermines or

is detrimental to the World Anti-Doping Program.

[Comment: The World Anti-Doping Program comprises the anti-doping programs of WADA and all

Signatories, including International Federations, National Anti-Doping Organizations, Regional Anti-Doping

Organizations, Major Event Organizations, the International Olympic Committee (IOC) or the International

Paralympic Committee (IPC).]

ISL – January 2021 Page 146 of 160

3.1 Analytical Testing for Anti-Doping Organizations (Signatories or WADA)

The Laboratories and ABP Laboratories shall accept Samples for Analytical Testing from Anti-

Doping Organizations only if all of the following conditions have been met:

- The Sample matrix is of the proper type (e.g. blood, urine) for the requested analyses;

- The Samples have been collected, sealed and transported to the Laboratory or ABP

Laboratory in accordance with the ISTI; and

- The collection is a part of a legitimate anti-doping program, as determined by WADA, or

satisfies any of the conditions for Sample analysis indicated in ISL Article 5.3.6.

3.2 Analytical Testing for non-Signatories

Laboratories and ABP Laboratories shall not accept Samples directly from individual Athletes

or from individuals or organizations acting on their behalf.

Laboratories or ABP Laboratories may accept samples from non-Signatories for analysis;

however, any such analysis shall not be conducted under the Laboratory’s WADA

accreditation or under the ABP Laboratory’s WADA approval and test results shall not be

reported in ADAMS. In addition, such analyses shall not negatively affect the Analytical

Testing of Samples from Anti-Doping Organizations, concerning, in particular, the allocation

of resources (e.g. human, financial, instrumental resources) and the reporting of results in a

reliable and timely manner.

[Comment: A Laboratory or ABP Laboratory shall only refer to its WADA accreditation or approval

status, as applicable, for an activity that falls under its Analytical Testing activities for Anti-Doping

Organizations. For the avoidance of doubt, laboratory test reports or other documentation or

correspondence related to samples from non-Signatories shall not declare or represent that any such

testing is covered under the laboratory’s WADA-accredited or -approved status].

3.3 Clinical or Forensic Analysis

Occasionally the Laboratory may be requested to analyze a sample for a banned drug or

endogenous substance coming from a hospitalized or ill Person in order to assist a physician

in the diagnostic process. In such circumstances, the Laboratory Director shall agree to

analyze the sample only if the organization making the request provides a letter explaining

the medical reason for the test and explicitly certifying that the requested analysis is for

medical diagnostic or therapeutic purposes.

The Laboratory may conduct work to aid a forensic and/or legal investigation, but due

diligence should be exercised to ensure that the work is requested by an appropriate agency

or organization. The Laboratory should not engage in analytical activities or expert testimony

that would intentionally question the integrity of an individual or the scientific validity of work

performed in the anti-doping program.

3.4 Other Analytical Activities

The Laboratory or ABP Laboratory shall not provide analytical services in a Doping Control

adjudication, unless specifically requested by the responsible Testing Authority or Results

ISL – January 2021 Page 147 of 160

Management Authority (if different), WADA or a hearing body.

The Laboratory shall not engage in analyzing commercial material or preparations (e.g.

dietary or herbal supplements), unless:

- Specifically requested by an Anti-Doping Organization or a hearing body as part of a

Results Management or adjudication process; or

- If done as part of a legitimate anti-doping research program, as determined by WADA; or

- If a request is made by an Athlete, the Laboratory may conduct the analysis if agreed by

the Anti-Doping Organization, which may also specify conditions that must be followed

prior to or during the analysis (e.g. verification of original sealed packages, product batch

number).

The Laboratory shall not provide results, documentation or advice that, in any way, could be

used as an endorsement of products or services.

Analytical activities performed under Articles 3.3 and 3.4 of Annex A will not fall under the

WADA-accredited or -approved status of the laboratory and shall not negatively affect the

Analytical Testing of Samples from Anti-Doping Organizations.

[Comment: For the avoidance of doubt, laboratory test reports or other documentation or

correspondence related to these other analytical activities shall not declare or represent that any such

testing is covered under the laboratory’s WADA-accredited or -approved status.]

3.5 Sharing of Knowledge

When information on new doping substance(s), method(s), or practice(s) is known to the

Laboratory, such information shall be shared with WADA within sixty (60) days. When

possible, the Laboratories shall share information with WADA regarding the detection of

potentially new or rarely detected doping agents as soon as possible. Immediately after having

been notified of the Use of a new substance or method as a doping agent, WADA will inform

all Laboratories.

The Laboratory Director or staff shall participate in developing standards for best practice and

enhancing uniformity of Analytical Testing in the WADA-accredited laboratory system.

[Comment: Sharing of knowledge can occur in various ways, including but not limited to directly

communicating with WADA, participating in scientific meetings, publishing results of research, sharing

of specific details of Analytical Methods, working with WADA to produce and/or distribute new

Reference Material(s) or Reference Collection(s) or disseminating information regarding the

chromatographic behaviour and mass spectra of the Analytes.]

4.0 Duty to Preserve the Integrity of the World Anti-Doping Program and to Avoid any

Detrimental Conduct

The personnel of Laboratories and ABP Laboratories shall not engage in conduct or activities that

undermine or are detrimental to the World Anti-Doping Program. Such conduct could include, but

is not limited to, fraud, embezzlement, perjury, etc. that would cast doubt on the integrity of the anti-

doping program.

ISL – January 2021 Page 148 of 160

All employees of Laboratories and ABP Laboratories shall strictly respect the confidentiality of

Analytical Testing results, as well as of all other Laboratory or Testing Authority information,

including information provided by WADA under confidentiality.

No employee or consultant of Laboratories and ABP Laboratories shall provide counsel, advice or

information to Athletes or others regarding techniques or methods used to mask or avoid detection

of, alter metabolism of, or suppress excretion of a Prohibited Substance or its Metabolite(s), or

Marker(s) of a Prohibited Substance or Prohibited Method in order to avoid an Adverse Analytical

Finding.

No employee or consultant of Laboratories and ABP Laboratories shall provide information about a

Test Method to an Athlete or Athlete Support Personnel, which could be used to avoid the detection

of doping.

No staff of Laboratories and ABP Laboratories shall assist an Athlete in avoiding collection of a

representative Sample (e.g. advice on masking strategies or detection windows).

[This does not prohibit the publication and/or presentation of scientific research results, general

presentations to educate Athletes, students, or others concerning anti-doping programs and

Prohibited Substances or Prohibited Methods.]

If a staff member of a Laboratory or ABP Laboratory is requested to provide evidence in anti-doping

proceedings, they are expected to provide independent, scientifically valid expert testimony.

The Laboratory or ABP Laboratory shall not issue any statements related to its analytical processes

or findings, unless otherwise provided in Code Article 14.3.6. The responsibility for evaluation of

these findings with further action and publication, if considered necessary, shall be the sole

responsibility of the responsible Anti-Doping Organization(s).

5.0 Breach and Enforceability

A failure to respect any of the provisions of this Code of Ethics may result in the Laboratory or ABP

Laboratory being subject to Disciplinary Proceedings instituted by WADA to either suspend or

revoke its WADA accreditation or its WADA approval, as applicable, in accordance with ISL Article

4.6.4.5.

In addition, a failure to respect any of the provisions of this Code of Ethics may result in staff of the

Laboratory or ABP Laboratory being subject to disciplinary action by the Laboratory or ABP

Laboratory, respectively, resulting in consequences beyond those stipulated under the ISL,

including potential termination of employment or, where applicable, the imposition of criminal

charges.

ISL – January 2021 Page 149 of 160

ISL ANNEX B – ACCREDITATION REQUIREMENTS FOR MAJOR EVENTS

The accreditation requirements described herein apply to those Major Events which, in order to conduct

appropriate Doping Control, would require either a significant increase of the existing Laboratory’s

resources and capacity or the establishment of a temporary “satellite facility” by an existing Laboratory.

Major Event Organizations should give preference to the use of an existing Laboratory for the analysis of

Samples. However, in some cases, the reporting time requirements for a Major Event may require that a

Laboratory facility be located in proximity to the Major Event such that Samples can be delivered by

Doping Control staff. This may require the creation of a temporary “satellite facility” by an existing

Laboratory, which shall have appropriate capabilities for the Major Event and be established sufficiently

in advance to allow for the timely transfer and validation of Laboratory operations and Test Methods.

In addition, the Laboratory operations necessary for a Major Event may be such that the existing

Laboratory’s analytical and Sample handling capacity are not adequate. This may require the expansion

of existing facilities, re-location of the Laboratory to a new permanent facility, the addition of personnel,

and/or the acquisition of additional equipment. The Director of the Laboratory designated to perform the

Analytical Testing shall ensure that a proper Management System, performance, security and safety are

maintained.

There shall be an agreement, sufficiently ahead of the Major Event, between the Major Event

Organization and the Laboratory with respect to Analytical Testing requirements such as test result turn-

around time, the expected number of blood and urine Samples to be analyzed, or the number of specific

analyses (i.e. not considered as part of the routine Analytical Testing menu) required for the Major Event.

The Laboratory shall be responsible for providing WADA with regular and timely progress reports

regarding its preparations for the Major Event.

1.0 Major Event Analytical Testing in the Laboratory Facilities

When Analytical Testing services for a Major Event are provided in the existing facilities of a

Laboratory, the WADA accreditation status of the Laboratory shall apply, and no additional WADA

Accreditation Certificate for the Major Event is required. However, the Laboratory shall meet the

requirements listed below in Annex B Articles 1.1 to 1.4.

All new Test Methods for the Major Event shall be validated at least one (1) month prior to start of

Analytical Testing for the Major Event. In addition, any changes to Test Methods, equipment or

other procedures in the Management System shall also be validated prior to the start of Analytical

Testing for the Major Event.

1.1 Participation in WADA Assessment(s)

WADA may perform one or more assessment(s) (preferably on-site) of the Laboratory’s

existing facilities with the aim to evaluate the Laboratory operations and capability to provide

Analytical Testing services for the Major Event. The number and type of assessments (on-

site, remote and/or documentary audit) will be determined by WADA based on the scale of

the Major Event’s Test Distribution Plan and the Laboratory’s progress in preparing for the

ISL – January 2021 Page 150 of 160

Major Event. These assessment(s) may include analysis of a set of EQAS samples. Costs

related to the WADA assessment(s) shall be at the Laboratory’s expense.

A first WADA assessment should be conducted at least six (6) months before the scheduled

start of the Analytical Testing for the Major Event. Emphasis will be placed on the completed

and planned implementation of the following:

- The physical layout of the Laboratory space to ensure that there is adequate analytical

and Sample handling capacity (based on the expected number of Samples and reporting

deadlines), including the separation of analytical and administrative areas of the

Laboratory;

- The adequacy of the Laboratory’s external and internal security plans, including:

o Secure Laboratory entry and exit points which are restricted to authorized personnel

only;

o Secure and restricted Laboratory controlled zones (in particular, the analytical area(s),

the Sample reception/processing room and the Sample storage units);

o Adequate Laboratory space and security measures for the “B” Sample opening

procedure, including appropriate provisions to ensure the confidentiality of the

Athlete(s);

o If requested by the Major Event Organization and in accordance with applicable

national laws or workplace regulations, Laboratories providing Analytical Testing

services during a Major Event or storing Samples collected at a Major Event should,

when justified, monitor the Laboratory perimeter and the access point(s) to Sample

storage room(s) (e.g. through the use of CCTV cameras).

- The adequacy of the Laboratory’s IT security system, including restricted and secure

central server(s), data management system (e.g. LIMS), internal network and controlled

access to the internet, if applicable;

- The Laboratory’s organizational chart for the Major Event, which includes the Laboratory

staff and planned expansion of staff including external experts. Details shall include

names, qualifications, area(s) of operation and responsibilities. In addition, the

organizational chart shall identify the Certifying Scientists (internal and external experts)

per Analytical Testing Procedure;

- The recruitment and logistics plans for the external scientists, including the names,

expertise and area(s) of responsibility for the Major Event;

- The existing instrumentation and equipment including the plan and timelines to order,

install and qualify any new instruments;

- The status of the Laboratory’s Analytical Testing Procedures, including plans and

timelines for method development and validation (including responsible scientific staff) to

meet any additional Analytical Testing requirements for the Major Event;

- The Laboratory’s scope of ISO/IEC 17025 accreditation including any planned additions

to the scope of accreditation;

ISL – January 2021 Page 151 of 160

- The status of the stock of Reference Materials, including the plans to order and implement

any new Reference Materials and/or Reference Collections;

- The Laboratory’s internal EQAS program (iQAS), including plans for the conduct of “stress

tests”. One or more stress tests are recommended to be completed by the time the

Laboratory is in its final configuration for the Major Event;

- To assess compliance with the ISL and its related Technical Documents, Technical Letters

and applicable Laboratory Guidelines.

A second WADA assessment, if necessary, should be conducted at least two (2) months

before the start of Analytical Testing for the Major Event. At this stage, the Laboratory shall

be ready to begin Analytical Testing for the Major Event, including pre-Event Testing, if

applicable. The focus of the assessment is to verify that:

- All construction requirements are completed, including any specific measures to ensure

the adequacy of the physical layout and the security of the “B” Sample opening procedure;

- All measures have been implemented to ensure the adequacy of the Laboratory’s IT

security system;

- All Analytical Methods are validated and incorporated in the Laboratory’s ISO/IEC 17025

scope of accreditation;

- All equipment and supplies are received, including Reference Materials and/or Reference

Collections;

- All staff recruitment is completed, including agreements, logistics and schedules for

external experts;

- All corrective actions from the prior WADA assessment(s) have been satisfactorily

addressed;

- The Laboratory has successfully conducted “stress tests” in order to evaluate its readiness

for the Major Event;

- Any remaining issue(s) will be addressed by the Laboratory before any Major Event

related Analytical Testing is scheduled to begin.

WADA, at its sole discretion and depending on the progress of the Laboratory in preparation

for the Major Event, may conduct additional assessments of the Laboratory before the

scheduled start of the Analytical Testing for the Major Event.

An Assessment Report will be issued to the Laboratory and the LabEG for each WADA

assessment. The Assessment Reports may include requests for Corrective Action Reports,

Actions and provide guidance as applicable.

The Laboratory shall address and satisfactorily correct all noncompliances identified during

the WADA assessment(s) and/or resulting from its analysis of EQAS samples. The

documentation of the corrective actions shall be submitted to WADA as instructed and prior

to start of the scheduled Analytical Testing for the Major Event.

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1.2 Participation in the WADA EQAS

At its sole discretion, WADA may submit EQAS samples to the Laboratory for analysis.

The Laboratory shall implement, document, and provide to WADA satisfactory corrective

action(s) for any noncompliance(s) identified in the EQAS. Unsatisfactory responses and/or

required action shall result in disqualification of the Laboratory from performing the Analytical

Testing for the Major Event.

The EQAS should be conducted at a time which includes as many Major Event staff

(Laboratory staff and temporary external experts) as possible. The EQAS samples shall be

analyzed using the same Analytical Testing Procedures that will be applied in the analysis of

Samples for the Major Event.

1.3 Pre-Event Report

At least two (2) months prior to the start of Analytical Testing for the Major Event, WADA may

require that the Laboratory provide a report consisting of the following:

- A valid signed contract between the Laboratory and the responsible Testing

Authority/Major Event Organization including a Test Distribution Plan detailing the Sample

collection schedule, number of urine and blood Samples and requests for specific

analyses (e.g. EPO);

- An organizational chart including Laboratory staff and temporary scientists employed by

the Laboratory for the Major Event. Supporting information such as job titles and

responsibilities shall be included;

- A list of all senior personnel temporarily working in the Laboratory for the Major Event

(including name, qualifications and areas(s) of responsibility);

- A training plan with timelines for new staff, including temporary staff and invited external

experts. The Laboratory Director shall ensure that these personnel are adequately trained

in the methods, policies, and procedures of the Laboratory. Particular emphasis should be

given to the Code of Ethics and the confidentiality of the Results Management process.

Adequate documentation of training of these temporary employees shall be maintained

by the Laboratory;

- A list of instrumental resources and equipment including identification of ownership;

- A summary of the Results Management process including criteria for determining

analytical results (Adverse Analytical Findings, Atypical Findings, etc.); and

- A list of Analytical Testing Procedures within the Laboratory’s Scope of ISO/IEC 17025

Accreditation and other method details as requested by WADA.

Any changes to the elements included in the Laboratory report shall be immediately reported

to WADA.

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1.4 Additional Professional Liability Insurance Coverage

Laboratories performing Analytical Testing during a Major Event shall verify their professional

liability risk insurance coverage and, if appropriate, obtain complementary coverage to

adequately cover liability associated with the analysis of Samples and the hiring of additional

temporary staff during the Major Event.

1.5 “B” Confirmation

The Laboratory shall implement a SOP for conducting “B” Confirmation Procedures, which

ensures the maintenance of the Athlete’s confidentiality in consideration of the increased

media and public attention that might be expected during the Major Event. The SOP shall

address the following topics:

- An entry and exit plan for Athletes, which ensures anonymity from external attention;

- In addition to the requirements of ISL Article 5.3.6.2.3, a representative from WADA or

WADA’s Independent Observers (IO) Team for Major Events (if requested by WADA or

the IO team, respectively) shall be authorized to attend the “B” Sample Confirmation

Procedure;

- The scheduling of the “B” Sample Confirmation Procedure shall be made as soon as

possible, in consultation with the Major Event Organizer, and taking into account that

postponement could significantly increase the risk of Sample degradation and/or

inadequately delay the decision-making process in the given circumstances.

1.6 Documentation and Reporting

The reporting time required for Major Events may be substantially less than twenty (20) days

(see also ISL Article 5.3.8.4). The agreement between the Laboratory and the Major Event

Organization shall clarify the reporting timelines for Negative Findings, Adverse Analytical

Findings, Atypical Findings and the reporting of specific test results (e.g., GC/C/IRMS, EPO).

2.0 Major Event Analytical Testing in “Satellite” Laboratory Facilities

In addition to the accreditation requirements for Major Events listed in Annex B Art 1.0, a Laboratory

which is required to move or extend its operations temporarily to a new physical location (“satellite

facility”), shall also meet the following requirements:

2.1 Participating in WADA Assessment(s)

WADA shall perform assessment(s) (preferably on-site) of the “satellite facility”. The number

and type of assessments (on-site, remote and/or documentary audit) will be determined by

WADA based on the scale of the Major Event’s Test Distribution Plan and the Laboratory’s

progress in preparing for the Major Event. These assessment(s) may include analysis of a set

of EQAS samples. Expenses related to such visit(s) shall be at the Laboratory’s expense.

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2.1.1 Initial WADA Assessment

WADA may perform an initial assessment of the Laboratory “satellite facility” as soon

as it is available in order to determine whether the new facility is adequate in relation

to the expected security, analytical and Sample handling requirements for a Major

Event. Emphasis will be placed on the adequacy of security considerations, the

physical layout of the space to ensure that adequate separation of various parts of the

Laboratory are maintained, and to provide a preliminary review of other key support

elements and to assess compliance with the ISL and ISO/IEC 17025.

2.2 Documenting ISO/IEC 17025 Accreditation of the Satellite Facility

At least one (1) month prior to the start of the scheduled Analytical Testing for the Major Event,

the Laboratory must provide documentation that the relevant Accreditation Body has

approved the continued accreditation or accepted the suitability of the “satellite facility”. An

ISL trained assessor shall participate in the Accreditation Body assessment of the “satellite

facility”.

2.3 Professional Liability Insurance Coverage

Before WADA grants accreditation for Analytical Testing during the Major Event, “satellite”

laboratories shall provide documentation to WADA that professional liability risk insurance

coverage has been obtained to cover liability associated with the analysis of Samples during

the Major Event.

2.4 Obtaining a Temporary and Limited WADA Accreditation Certificate

The Laboratory’s “satellite facility” shall obtain a Temporary and Limited WADA Accreditation

Certificate for the Major Event.

All Test Methods or equipment unique to the “satellite facility” shall be validated or qualified

at least one (1) month prior to the “satellite facility’s” final assessment for WADA accreditation.

Any changes to Test Methods, equipment or other procedures in the Management System

shall also be validated prior to the assessment.

Based on the documentation provided, WADA reserves the right to make a decision regarding

accreditation of the Laboratory “satellite facility”. In the event that the accreditation is awarded,

WADA shall issue a Temporary and Limited WADA Accreditation Certificate for the period of

the Major Event, which includes an appropriate time before and after the duration of the Major

Event.

In the event that the accreditation is not awarded, it is the responsibility of the Testing

Authority/Major Event Organization to activate a contingency plan in order to ensure Analytical

Testing of Samples in compliance with ISL requirements during the Major Event.

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3.0 Monitoring and Assessment during a Major Event

WADA may choose, at its sole discretion, to have one (1) or more observer(s) in the Laboratory

during the Major Event. The Laboratory Director and staff shall provide full cooperation and access

to the observer(s).

WADA, in conjunction with the Major Event Organization or relevant International Federation, may

submit double-blind EQAS samples to the Laboratory.

3.1 Reporting of False Analytical Findings during a Major Event

In the event of a False Adverse Analytical Finding, the Laboratory shall immediately cease

Analytical Testing for the relevant class of Prohibited Substances or Prohibited Methods. The

Laboratory shall apply corrective action(s) within twelve (12) hours of notification of the False

Adverse Analytical Finding. All Samples analyzed prior to the reporting of the False Adverse

Analytical Finding and reported with an Adverse Analytical Finding for the class of Prohibited

Substances or Prohibited Methods for which the noncompliance occurred shall be re-

analyzed. The results of the investigation and analysis shall be presented to WADA within

twenty-four (24) hours unless otherwise agreed in writing.

In the event of a False Negative Finding, the Laboratory will be required to investigate the root

cause and apply corrective actions within twenty-four (24) hours of notification of the False

Negative Finding. An appropriate number of Samples reported as a Negative Finding for the

class of Prohibited Substances and Prohibited Methods for which the noncompliance occurred

shall be re-analyzed. The results of the investigation and analysis shall be presented to WADA

within forty-eight (48) hours unless otherwise agreed in writing.

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ISL ANNEX C – PROCEDURAL RULES FOR THE DISCIPLINARY COMMITTEE

OF THE INTERNATIONAL STANDARD FOR LABORATORIES

Preamble

These Procedural Rules for the Disciplinary Committee (DC) of the ISL (the “Procedural Rules”) outline

the process to be followed when a Laboratory challenges a recommendation of the LabEG in accordance

with ISL Articles 4.6.4.1.2 or 4.6.4.5, when a Laboratory is subject to Revocation proceedings in

accordance with ISL Article 4.6.4.3 or, when and where applicable, Disciplinary Proceedings are

instituted against an ABP Laboratory in accordance with ISL Article 4.7.4.1. In such circumstances, any

reference made to a Laboratory in these Procedural Rules shall also be understood as a reference to an

ABP Laboratory, unless such reference is not applicable due to the circumstances, specific nature or

rules indicated in this ISL in relation to ABP Laboratories.

These Procedural Rules shall be considered as an integral part of the ISL.

PART I - Composition of the Committee

Article 1

For each individual case, a DC shall be constituted. It shall be composed of three (3) members including

a Chairperson.

WADA’s Director General shall appoint the three (3)-member DC for each case and select one member

to serve as Chairperson.

The appointed members shall have a legal and/or scientific background with at least one member being

an anti-doping laboratory expert and one with legal training and education (including the Chairman). The

Chairman shall have experience in the conduct of disciplinary or legal proceedings.

All appointed members of a DC shall be free of any conflict of interest with WADA, the Laboratory

concerned, or any other Laboratory, entity, organization or individual that could potentially benefit from

the concerned Laboratory’s Suspension, Revocation or Analytical Testing Restriction, and must

otherwise be impartial in relation to WADA and the Laboratory concerned. The anti-doping laboratory

expert(s) may be member(s) of the LabEG, unless the case has been the subject of previous discussion

or recommendation by the LabEG.

All DC members shall sign a declaration in which they agree to maintain the confidentiality of the

disciplinary process and any information related thereto, confirm their impartiality and mention any

circumstance that may be relevant in this respect.

Article 2

If the impartiality of any member of the DC is challenged (for example, by the Laboratory), the matter

shall be decided by the Chairperson if he/she is not the concerned DC member or by the two other DC

members if the challenge concerns the Chairperson. In the event the two DC members cannot agree,

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WADA’s Director General shall make the final decision. The decision is not subject to an independent

challenge.

PART II - General Provisions

Article 3

Once the DC is constituted, WADA will provide it with the case file which includes the evidence it wishes

to submit in support of the disciplinary action being taken against the Laboratory. WADA may send the

case file and any relevant information to the DC electronically or by registered mail.

Simultaneously, WADA shall provide the Laboratory with the case file and with all of the available

supporting evidence. WADA may send the case file and any information to the Laboratory electronically

or by registered mail.

Within seven (7) days of receiving the case file, the Laboratory may respond in writing and provide its

evidence to the DC and simultaneously to WADA’s Legal Department. Any requests to extend the

deadline shall be addressed by the Laboratory to the Chairperson of the DC, who shall have the discretion

to grant or reject the requested extension.

Upon receipt of the Laboratory’s submissions and evidence, WADA shall have seven (7) days to make

rebuttal submissions to the Disciplinary Committee. Any requests by WADA to extend this deadline shall

be addressed to the Chairperson of the DC, who shall have the discretion to grant or reject the requested

extension.

If the Laboratory fails or chooses not to respond or provide evidence within the required time frame, the

disciplinary proceedings will continue on the basis of the evidence at the disposal of the DC.

Article 4

Unless both parties agree or the Chairperson, at his/her discretion and following consultation with the

other DC members, orders otherwise on the basis of justified grounds, the parties shall not be permitted

to include additional material after the submission of the evidence packages in accordance with the

procedure described in Annex C Article 3 above. Any determination made by the Chairperson pursuant

to this article is not subject to challenge or appeal.

Article 5

The working language of the DC shall be English. The DC may accept documents in other languages at

its discretion.

PART III - Scope of the Committee’s Review

Article 6

The DC shall have the authorization to review the evidence of the case and to make a recommendation

regarding the status of the Laboratory’s WADA accreditation.

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To the extent not otherwise provided in these “Procedural Rules”, the Chairperson may issue directions

regarding procedural matters to the parties.

The DC shall have the right to appoint one or more independent expert(s) should it consider that particular

expertise is required in order for it to make its recommendation to maintain, suspend or revoke a

Laboratory’s WADA accreditation or to impose an Analytical Testing Restriction.

After consulting the parties, the DC may, if it deems itself to be sufficiently well informed, decide not to

hold a hearing and it may determine its recommendation based on the parties’ written submissions and

the available documents.

The DC shall make its recommendation in accordance with the applicable regulations, including the

Code, the ISL and any relevant Technical Documents or Technical Letters, or any other rules or law

agreed to by WADA and the Laboratory, and by default, Swiss law.

The DC’s decisions, including the content of its recommendation, shall be by majority.

PART IV - Recommendation

Article 7

The recommendation of the DC shall be issued in writing, with reasons

, within fourteen (14) days of

the conclusion of the hearing. If no hearing is held, the DC shall issue its recommendation within fourteen

(14) days of the communication to the parties that no hearing will be held.

Where the DC considers that a Laboratory’s accreditation should be suspended or subject to an Analytical

Testing Restriction, it shall recommend to the Chair of the WADA Executive Committee a period of

Suspension or Analytical Testing Restriction that is proportionate to the seriousness of the

noncompliance(s) with the ISL and/or Technical Document(s) and/or Technical Letters and the need to

ensure accurate and reliable Analytical Testing of Samples.

The DC may recommend to the Chair of the WADA Executive Committee that a Laboratory’s WADA

accreditation be suspended or subjected to an Analytical Testing Restriction for a period of up to six (6)

months (with one possible extension of up to six (6) months). During this time, any ISL and/or Technical

Document and/or Technical Letter noncompliance(s) identified within the context of the Disciplinary

Proceedings instituted against the Laboratory and resulting in the Suspension of its WADA accreditation

or the imposition of an Analytical Testing Restriction, or during a subsequent assessment conducted by

WADA during the Laboratory’s Suspension or during the period of the Analytical Testing Restriction, shall

be corrected, documented, reported to WADA and determined to be satisfactory by WADA. The DC shall

also indicate any conditions that the Laboratory shall satisfy prior to or after reinstatement of the

Laboratory’s WADA accreditation.

In cases where it considers that it is appropriate to do so, the DC may also recommend to the Chair of

the WADA Executive Committee that the Laboratory receive a private warning without the imposition of

a period of Suspension or Analytical Testing Restriction. The Laboratory may also be requested to take

The decision may be summarily reasoned.

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specified action(s) to resolve the issues identified within a defined timeline.

The recommendation of the DC shall be provided to the Chair of the WADA Executive Committee without

delay.

If the DC recommends the Suspension of the Laboratory’s WADA accreditation or the imposition of an

Analytical Testing Restriction, the Chair of the WADA Executive Committee shall render a final decision

regarding the Suspension of the Laboratory’s WADA accreditation or the imposition of an Analytical

Testing Restriction within ten (10) days of receiving the DC’s recommendation.

If the DC recommends the Revocation of the Laboratory’s WADA accreditation, the WADA Executive

Committee shall render a decision regarding the Revocation of the Laboratory’s WADA accreditation

within fourteen (14) days of receiving the DC’s recommendation.

If the DC recommends to the Chair of the WADA Executive Committee that the Laboratory shall maintain

its WADA accreditation, and the Chair of the WADA Executive Committee accepts the DC’s

recommendation, the Laboratory shall be informed accordingly by WADA within seven (7) days of

receiving the Chair of the WADA Executive Committee’s decision.

Part V – Expedited Proceedings or Single Hearing before CAS

Article 8

Where required by the circumstances, the DC may, at the request of WADA or the Laboratory, conduct

disciplinary proceedings in an expedited manner. In such situations, the DC may issue appropriate

directions and modify the timelines indicated in these Procedural Rules as required and justified by the

circumstances, but must ensure that the principles of procedural fairness, and the requirements otherwise

stated in these Procedural Rules, are respected at all times.

The decision to conduct disciplinary proceedings in an expedited manner shall be at the sole discretion

of the DC and shall not be subject to appeal.

If required due to time constraints, the DC may issue an operative recommendation to the Chairman of

the WADA Executive Committee or the WADA Executive Committee, as applicable, with reasons to

follow.

In cases of a Suspension or an Analytical Testing Restriction, the Chairman of the WADA Executive

Committee or, in cases of Revocation, the WADA Executive Committee, shall endeavor to render a

decision regarding the status of the Laboratory’s WADA accreditation as soon as reasonably possible.

Once received, WADA shall provide the decision to the Laboratory without delay.

[Comment: The Laboratory or WADA may request that disciplinary proceedings be conducted in an expedited

manner if a decision regarding the status of the Laboratory’s WADA accreditation must be made shortly prior to the

commencement of a Major Event or Event or if otherwise justified by the circumstances.]

Article 9

The Laboratory and WADA may agree to have the assertion of a noncompliance(s) with the ISL and/or

Technical Document(s) and/or Technical Letters heard in a single hearing directly before a three (3)-

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member Panel of the CAS Anti-Doping Division in accordance with the Arbitration Rules for the CAS Anti-

Doping Division.

With the consent of WADA and the Laboratory, the proceedings may be conducted in an expedited

manner in accordance with the Arbitration Rules for the CAS Anti-Doping Division.