LABORATORIESNOVEMBER 2019

International Standard for Laboratories
The World Anti-Doping Code International Standard for Laboratories(ISL) is a mandatory International Standard developed as part of theWorld Anti-Doping Program.
The International Standard for Laboratories first came into effect inNovember 2002. Further revisions were made after that date. The
enclosed International Standard for Laboratories was approved by the
WADA Executive Committee on 15 May 2019. The effective date of ISL
version 10.0 is 01 November 2019.
The official text of the ISL shall be maintained by WADA and shall be
published in English and French. In the event of any conflict between
the English and French versions, the English version shall prevail.
Published by:World Anti-Doping Agency
Stock Exchange Tower
800 Place Victoria (Suite 1700)
PO Box 120
Montreal, Quebec
Canada H4Z 1B7
URL: www.wada-ama.org
Tel: +1 514 904 9232
Fax: +1 514 904 8650
E-mail: code@wada-ama.org

International Standard for Laboratories – Version 10.0 – November 2019

Table of Contents
PART ONE: INTRODUCTION, CODE PROVISIONS AND DEFINITIONS ............................................... 7
1.0

Introduction, Scope and References .............................................................................................. 7
1.1 The ISL and the World Anti-Doping Program ............................................................................... 7
1.2 WADA Laboratory Standards ....................................................................................................... 8
1.2.1

Technical Documents................................................................................................... 8

1.2.2

Technical Letters .......................................................................................................... 9

1.2.3

Laboratory Guidelines ................................................................................................ 10

1.2.4

Technical Notes ......................................................................................................... 10

1.3 Sample Analysis ......................................................................................................................... 10
1.4 Laboratory Accreditation Framework and Laboratory Approval for the ABP ............................. 11
2.0

Code Provisions.............................................................................................................................. 12

3.0

Terms and Definitions .................................................................................................................... 13
3.1 Code defined terms ...................................................................................................................... 13
3.2 ISL Defined Terms........................................................................................................................ 17
3.3 International Standard for Testing and Investigations (ISTI) Defined Terms ............................... 23

PART TWO: LABORATORY ACCREDITATION REQUIREMENTS AND OPERATING STANDARDS 24
4.0

Process and Requirements for WADA Laboratory Accreditation ............................................. 24
4.1 Applicant Laboratory ................................................................................................................... 24
4.1.1

Expression of Interest ................................................................................................ 24

4.1.2

Submit Initial Application Form .................................................................................. 24

4.1.3

Provision of Letters of Support ................................................................................... 24

4.1.4

Provision of Business Plan ........................................................................................ 25

4.2 Candidate Laboratory ................................................................................................................. 25
4.2.1

Description of the Candidate Laboratory ................................................................... 25

4.2.2

Payment of Initial Accreditation Fee .......................................................................... 26

4.2.3

Laboratory Independence and Impartiality ................................................................ 26

4.2.4

Compliance with the Code of Ethics (ISL Annex A) ................................................... 27

4.2.5

Pre-Probationary Test and On-Site Assessment ....................................................... 27

4.3 Probationary Laboratory ............................................................................................................. 28
4.3.1

Obtaining ISO/IEC 17025 Accreditation by the Laboratory ....................................... 28

4.3.2

Participating in the WADA EQAS Program ................................................................ 28

4.3.3

Planning and Implementing Research and Development Activities .......................... 29

4.3.4

Planning and implementing sharing of knowledge .................................................... 29

4.3.5

Professional Liability Insurance Coverage ................................................................. 29

4.4 WADA-Accredited Laboratory .................................................................................................... 29
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4.4.1

Obtaining WADA accreditation .................................................................................. 29

4.4.2

Maintaining WADA Accreditation ............................................................................... 31

4.5 Removal of Samples................................................................................................................... 35
4.5.1

Removal of Samples for Further Analysis ................................................................. 35

4.5.2

Removal of Samples for Laboratory Quality Assessment ......................................... 36

4.6 WADA Monitoring of Accreditation Status .................................................................................. 36
4.6.1

Maintenance of WADA Accreditation ......................................................................... 36

4.6.2

Re-accreditation Costs ............................................................................................... 36

4.6.3

Issuing and Publication of Accreditation Certificate ................................................... 36

4.6.4

Loss of WADA Accreditation ...................................................................................... 37

4.6.5

Consequences of Suspended or Revoked Accreditation or Analytical Testing
Restriction .................................................................................................................. 43

4.6.6

Reinstatement of Suspended Accreditation or lifting of the Analytical Testing
Restriction .................................................................................................................. 47

4.7 Accreditation Requirements for Major Events ............................................................................ 50
4.7.1

Major Event Analytical Testing in the Laboratory Facilities ....................................... 50

4.7.2

Major Event Analytical Testing in “Satellite” Laboratory Facilities ............................. 52

4.7.3

Monitoring and Assessment during a Major Event .................................................... 53

4.8 Process for approval of Laboratories for the ABP ...................................................................... 54

5.0

4.8.1

Applicant Laboratory for WADA approval for the ABP............................................... 54

4.8.2

Candidate Laboratory for WADA approval for the ABP ............................................. 55

4.8.3

Granting of WADA Approval for the ABP ................................................................... 57

4.8.4

Maintaining Status as a WADA-approved Laboratory for the ABP ............................ 57

Application of ISO/IEC 17025 to the Analysis of Samples.......................................................... 59
5.1 Introduction and Scope ............................................................................................................... 59
5.2 Structural and Resource Requirements ..................................................................................... 59
5.2.1

General ...................................................................................................................... 59

5.2.2

Laboratory Personnel ................................................................................................. 59

5.2.3

Laboratory facility and Environmental Conditions ...................................................... 61

5.3 Process Requirements ............................................................................................................... 64
5.3.1

Reception, Registration and Handling of Samples .................................................... 64

5.3.2

Storage of Samples ................................................................................................... 67

5.3.3

Use, Transfer or Disposal of Samples ....................................................................... 71

5.3.4

Sample Analysis ......................................................................................................... 72

5.3.5

Results Management ................................................................................................. 88

5.4 Management Requirements ....................................................................................................... 92
5.4.1

Organization ............................................................................................................... 92

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6.0

5.4.2

Assuring the Quality of Analytical Results ................................................................. 92

5.4.3

Management Reviews ............................................................................................... 93

5.4.4

Document Control ...................................................................................................... 93

5.4.5

Control and Storage of Technical Records ................................................................ 94

5.4.6

Control of Nonconformities in Analytical Testing ....................................................... 94

5.4.7

Reviewing of Requests, Tenders and Contracts ....................................................... 94

5.4.8

Subcontracting of Analysis ......................................................................................... 95

5.4.9

Purchasing of Services and Supplies ........................................................................ 95

5.4.10

Cooperation with Customers and with WADA ........................................................... 96

5.4.11

Complaints ................................................................................................................. 97

WADA External Quality Assessment Scheme (EQAS) ............................................................... 98
6.1 Types of EQAS ........................................................................................................................... 98
6.1.1

Blind EQAS ................................................................................................................ 98

6.1.2

Double-Blind EQAS.................................................................................................... 98

6.1.3

Educational EQAS ..................................................................................................... 98

6.2 EQAS Sample Number and Composition................................................................................... 98
6.2.1

Number of EQAS Samples ........................................................................................ 98

6.2.2

Composition of EQAS Samples ................................................................................. 99

6.3 Laboratory Analytical Testing Procedures Used in EQAS ....................................................... 101
6.4 Reporting of EQAS results........................................................................................................ 101

7.0

6.4.1

Reporting Blind EQAS Results ................................................................................ 101

6.4.2

Reporting Double-Blind EQAS Results .................................................................... 102

6.4.3

Reporting Educational EQAS Results...................................................................... 102

6.4.4

Reporting Results for EQAS Samples Containing Non-Threshold Substance ........ 102

6.4.5

Reporting Results for EQAS Samples Containing Threshold Substances .............. 102

Evaluation of Laboratory EQAS and Routine Analytical Testing Performance ..................... 103
7.1 Evaluation of EQAS Results ..................................................................................................... 103
7.1.1

EQAS Samples Containing Non-Threshold Substances ......................................... 103

7.1.2

EQAS Samples Containing Threshold Substances ................................................. 104

7.2 Evaluation of Laboratory Performance ..................................................................................... 105
7.2.1

False Adverse Analytical Finding ............................................................................. 105

7.2.2

False Negative Finding ............................................................................................ 110

7.2.3

Further Procedural Evaluations .............................................................................. 112

7.3 Overall Laboratory Evaluation .................................................................................................. 112
ISL Points Scale Table for Assessment of Laboratory and Probationary Laboratory Performance................................................................................................................................. 113

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7.4 Probationary Period and Probationary Laboratory Evaluation ................................................. 115
7.4.1

Analytical Testing Procedures Utilized by Probationary Laboratories for the Analysis of
EQAS samples ......................................................................................................... 115

7.4.2

False Adverse Analytical Finding Result.................................................................. 115

7.4.3

False Negative Finding ............................................................................................ 115

7.4.4

Threshold Substance Result .................................................................................... 116

7.4.5

Overall Probationary Laboratory Evaluation ............................................................ 116

PART THREE: ISL ANNEXES ................................................................................................................ 117
ISL ANNEX A - CODE OF ETHICS FOR LABORATORIES and WADA-APPROVED LABORATORIESFOR THE ABP ......................................................................................................................................... 117
1.0 Confidentiality ........................................................................................................................... 117
2.0 Research in Support of Doping Control .................................................................................... 117
2.1

Research on Human Subjects ................................................................................. 117

2.2

Controlled Substances ............................................................................................. 117

3.0 Analysis..................................................................................................................................... 117
3.1

Analytical Testing for Anti-Doping Organizations .................................................... 117

3.2

Clinical or Forensic Analysis .................................................................................... 118

3.3

Other Analytical Activities ........................................................................................ 118

3.4

Sharing of Knowledge .............................................................................................. 119

4.0 Duty to Preserve the Integrity of the World Anti-Doping Program and to Avoid any Detrimental
Conduct .................................................................................................................................... 119
5.0 Breach and Enforceability ......................................................................................................... 120
ISL ANNEX B – PROCEDURAL RULES FOR THE DISCIPLINARY COMMITTEE OF THE
INTERNATIONAL STANDARD FOR LABORATORIES ........................................................................ 121
Preamble .......................................................................................................................................... 121
PART I - Composition of the Committee .......................................................................................... 121
PART II - General Provisions ........................................................................................................... 122
PART III - Scope of the Committee’s Review .................................................................................. 122
PART IV - Recommendation ............................................................................................................ 123

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PART ONE: INTRODUCTION, CODE PROVISIONS AND DEFINITIONS
1.0 Introduction, Scope and References
1.1

The ISL and the World Anti-Doping Program

The World Anti-Doping Program encompasses all of the elements necessary to ensure optimalharmonization and best practice in international and national anti-doping programs. The main elements
are:•the Code (Level 1),•

International Standards (Level 2), and•Models of Best Practice and Guidelines (Level 3).

In the introduction to the World Anti-Doping Code (Code), the purpose and implementation of theInternational 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 AntiDoping 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 International Standard for Laboratories (ISL) is to ensure that Laboratories and
WADA-Approved Laboratories for the ABP 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 WADA-Approved Laboratories for the ABP.
The ISL sets out the requirements to be followed by Laboratories and WADA-Approved Laboratories for
the ABP 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 WADA-Approved
Laboratories for the ABP and a description of the accreditation and approval processes.
Compliance with the ISL (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 WADA-Approved Laboratory for the ABP to follow a requirement in
effect at the time of Analytical Testing, which has subsequently been eliminated from this ISL orapplicable Technical Document or Technical Letter at the time of a hearing shall not serve as a defense
to an anti-doping rule violation.

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1.2

WADA Laboratory Standards

WADA will publish specific technical requirements in a Technical Document or Technical Letter. In
addition, WADA may also provide Laboratories, WADA-Approved Laboratories for the ABP and otherstakeholders with specific technical guidance and advice in the form of Laboratory Guidelines orTechnical Notes.
1.2.1

Technical Documents• Technical Documents are issued to provide direction to the Laboratories, WADA-Approved
Laboratories for the ABP and other stakeholders on specific technical or procedural issues. TechnicalDocuments 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 supersedes any previous publication on a similar topic
1 and becomes an integral part of the ISL.
• Implementation of the requirements detailed in a Technical Document may occur prior to theeffective date for implementation specified in the Technical Document and shall occur no later than theeffective date 2.
• The implementation of the requirements of WADA Technical Documents into the Laboratory’s and,if relevant to the analysis of ABP blood Samples, WADA-Approved Laboratory for the ABP’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.

1

WADA will provide guidance to Laboratories, WADA-Approved Laboratories for the ABP and other WADA
stakeholders on what other standard(s) may be affected by a new Technical Document or Technical Letter in theSummary of Modifications that accompanies the publication of the revised version of the Technical Document orTechnical Letter.
2 A failure by a Laboratory or WADA-Approved Laboratory for the ABP to implement a Technical Document orTechnical Letter after the effective date may result in the imposition of an Analytical Testing Restriction against theLaboratory 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.
Laboratories and WADA-Approved Laboratories for the ABP 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 requirementsof the Technical Document have been implemented and documented in the Laboratory’s or WADA-Approved
Laboratory for the ABP’s Standard Operating Procedure(s) [SOP(s)]. If a Laboratory or WADA-Approved Laboratory
for the ABP is not able to implement a new Technical Document by its effective date, it shall inform its clients assoon as possible. The Laboratory or WADA-Approved Laboratory for the ABP shall also send a written request to
WADA for an extension beyond the applicable effective date, providing the reasons for the delayed implementationof the Technical Document, any measures taken to ensure that Samples received in the Laboratory or WADAApproved Laboratory for the ABP will be subject to Analytical Testing in compliance with the new TechnicalDocument (for example, by subcontracting analysis to another Laboratory or WADA-Approved Laboratory for the
ABP, as applicable), as well as plans for the implementation of the new Technical Document.

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• In cases when a newly approved version of a Technical Document lowers either the Decision Limit
for a Threshold Substance or the reporting limit for a Non-Threshold Substance, as applicable, therevised limits specified in the new Technical Document shall not be applied to the reporting of analyticalresults for Samples collected before the effective date of the Technical Document 3.
• The most recently approved Technical Document shall be applied to Analytical Testing of Samples
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 reporting limit 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.
1.2.2

Technical Letters• Technical Letters are issued in letter format on an ad-hoc basis in order to provide direction to the
Laboratories, WADA-Approved Laboratories for the ABP 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 4.
• Once approved, a Technical Letter supersedes any previous publication on a similar topic 1 andbecomes an integral part of the ISL.

3 If the application of a newly approved Technical Document results in an Adverse Analytical Finding for a Sample

collected before 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 (for example if
the Decision Limit for a Threshold Substance has been lowered in the newly approved Technical Document), theLaboratory shall report the finding as a Negative Finding. In addition, the Laboratory shall record the details of thefinding as a comment in the Negative Finding Test Report.
4 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.
If a Laboratory or WADA-Approved Laboratory for the ABP is not able to implement a new Technical Letter by its
effective date, the Laboratory or WADA-Approved Laboratory for the ABP shall send a written request to WADA foran extension beyond the applicable effective date, providing the reasons for the delayed implementation of theTechnical Letter, any measures taken to ensure that Samples received in the Laboratory or WADA-Approved
Laboratory for the ABP will be subject to Analytical Testing in compliance with the new Technical Letter (for example,
by subcontracting analysis to another Laboratory or WADA-Approved Laboratory for the ABP, as applicable), as
well as plans for the implementation of the new Technical Letter.

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• The implementation of the requirements of relevant Technical Letters into the Laboratory’s and, if
relevant to the analysis of ABP blood Samples, WADA-Approved Laboratory for the ABP’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.
1.2.3

Laboratory Guidelines• Laboratory Guidelines are issued in order to provide direction to the Laboratories, WADA-Approved
Laboratories for the ABP 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 WADA Laboratory Expert Group (LabEG) and are
published on WADA’s website.
• Implementation of Laboratory Guidelines is not mandatory. However, Laboratories and WADAApproved Laboratories for the ABP are encouraged to follow, to the fullest extent possible, therecommendations of best practice included in relevant Laboratory Guidelines.
1.2.4

Technical Notes• Technical Notes are issued to Laboratories to provide detailed technical guidance on theperformance of specific Analytical Methods or procedures.
• Technical Notes are approved by the WADA 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 inTechnical Notes.
1.3

Sample Analysis

Sample analysis is part of the Analytical Testing process and involves the detection, identification, andin 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 biologicalfluids or tissues.
Laboratories may undertake other forms of analysis, subject to the provisions of the Code of Ethics (seeAnnex A of the ISL), 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, Laboratory Test Reports,
Certificates of Analysis or other documentation or correspondence shall not declare or represent that any
such testing is covered under the Laboratory’s WADA accreditation status.
WADA-Approved Laboratories for the ABP may undertake 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
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from WADA-Approved Laboratories for the ABP shall not state or represent that any such testing iscovered under their WADA approval status.
1.4

Laboratory Accreditation Framework and Laboratory Approval for the ABPThe Laboratory accreditation framework consists of two main elements: Part Two of the ISL (Laboratory
accreditation 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 (Section 4). It also includes theapplication of ISO/IEC 17025 5 to the field of Doping Control (Section 5) and a description of the
WADA External Quality Assessment Scheme (EQAS) (Section 6) as well as the procedures toevaluate the Laboratory EQAS and routine Analytical Testing performance by WADA (Section 7). The
purpose of this Part of the document is to enable the consistent application of ISO/IEC 17025 andISL-specific requirements to Analytical Testing for Doping Control by Laboratories, as well as tofacilitate the assessment of Laboratory compliance by Accreditation Bodies and WADA.
Section 4 of the ISL also describes the requirements necessary to obtain and maintain WADA
approval for the ABP.
• Part Three of the ISL includes all Annexes. Annexes A (Code of Ethics) and B (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.
In order to harmonize the accreditation of Laboratories to the requirements of ISO/IEC 17025 and of
WADA-Approved Laboratories for the ABP to the requirements of ISO/IEC 17025 or ISO 15189, as wellas the WADA-specific requirements for accreditation or approval, Accreditation Bodies are required touse the ISL, including the applicable Annexes, Technical Documents, Technical Letters and Laboratory
Guidelines as reference documents in their assessment process.
Maintenance of a laboratory’s accreditation or approval by WADA is based on satisfactory performancein the WADA EQAS and routine Analytical Testing. The EQAS performance of Laboratories and WADAApproved Laboratories for the ABP is also continually monitored by WADA and reviewed as part of their
ISO/IEC 17025 or ISO 15189 Accreditation Body assessment process, as applicable. Therefore, theLaboratory or WADA-Approved Laboratory for the ABP shall not be subject to challenge or to demands
to produce EQAS data or related EQAS documentation by third parties.
…………………………………………………………………………………………………………………………………………
Terms defined in the Code, which are included in this standard, are written in Italics.
Terms, which are defined in the ISL or other International Standards, are underlined.
Other terms are used in the ISL and other WADA Laboratory standards as follows:••••“Shall” is used to indicate a mandatory obligation;“Should” is used to indicate a strong recommendation for best practice;“May” is used to indicate an optional practice or standard;“Can” is used to indicate a possibility or a capability.

5 Effective version of ISO/IEC 17025.

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2.0 Code Provisions
The following Articles in the Code are addressed in the ISL:•

Code Art. 2 ANTI-DOPING RULE VIOLATIONS•

Code Art. 3 PROOF OF DOPING•

Code Art. 4 THE PROHIBITED LIST•

Code Art. 6 ANALYSIS OF SAMPLES•

Code Art. 10 SANCTIONS ON INDIVIDUALS•

Code Art. 13 APPEALS•

Code Art. 14 CONFIDENTIALITY AND REPORTING

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3.0 Terms and Definitions
3.1 Code defined terms
ADAMS

The Anti-Doping Administration and Management System is a Webbased database management tool for data entry, storage, sharing, andreporting designed to assist stakeholders and WADA in their antidoping 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 forLaboratories and related Technical Documents, identifies in a Sample
the presence of a Prohibited Substance or its Metabolites or Markers(including elevated quantities of endogenous substances) or evidenceof the Use of a Prohibited Method.

Adverse Passport
Finding

A report identified as an Adverse Passport Finding as described in theapplicable International Standards.

Anti-Doping
Organization

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, theInternational Paralympic Committee, other Major Event Organizations
that conduct Testing at their Events, WADA, International Federations,and National Anti-Doping Organizations.

AthleteAny Person who competes in sport at the international level (as definedby each International Federation) or the national level (as defined byeach National Anti-Doping Organization). An Anti-Doping Organization
has discretion to apply anti-doping rules to an Athlete who is neither anInternational-Level Athlete nor a National-Level Athlete, and thus tobring them within the definition of “Athlete.” In relation to Athletes who
are neither International-Level nor National-Level Athletes, an AntiDoping 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 authority who competes below the international or
national level, then the Consequences set forth in the Code (except
Article 14.3.2) 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: This definition makes it clear that all International- and NationalLevel 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 antidoping rules of the International Federations and National Anti-Doping
Organizations, respectively. The definition also allows each National Anti-

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Doping Organization, if it chooses to do so, to expand its anti-doping program
beyond International- or National-Level Athletes to competitors at lower levelsof Competition or to individuals who engage in fitness activities but do notcompete at all. Thus, a National Anti-Doping Organization could, for example,
elect to test recreational-level competitors but not require advance TUEs. But
an anti-doping rule violation involving an Adverse Analytical Finding or
Tampering results in all of the Consequences provided for in the Code (withthe exception of Article 14.3.2). The decision on whether Consequences apply
to recreational-level Athletes who engage in fitness activities but nevercompete is left to the National Anti-Doping Organization. In the same manner,a Major Event Organization holding an Event only for masters-levelcompetitors could elect to test the competitors but not analyze Samples forthe full menu of Prohibited Substances. Competitors at all levels ofCompetition should receive the benefit of anti-doping information andeducation.]

Athlete Biological
Passport (ABP)The program and methods of gathering and collating data as describedin the International Standard for Testing and Investigations andInternational Standard for Laboratories.

Atypical Finding

A report from a WADA-accredited laboratory or other WADA approved
laboratory, which requires further investigation as provided by theInternational Standard for Laboratories or related TechnicalDocuments prior to the determination of an Adverse Analytical Finding.

Atypical Passport
Finding

A report described as an Atypical Passport Finding as described in theapplicable International Standards.

CAS

The Court of Arbitration for SportCode

The World Anti-Doping Code.

Competition

A single race, match, game or singular sport contest. For example, abasketball game or the finals of the Olympic 100-meter race inathletics. For stage races and other sport contests where prizes areawarded on a daily or other interim basis the distinction between a
Competition and an Event will be as provided in the rules of theapplicable International Federation.

Consequences ofAnti-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 isbarred on account of an anti-doping rule violation for a specified periodof 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 conductedunder Article 8; (d) Financial Consequences means a financial sanction
imposed for an anti-doping rule violation or to recover costs associatedwith an anti-doping rule violation; and (e) Public Disclosure or Public

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Reporting means the dissemination or distribution of information to thegeneral public or Persons beyond those Persons entitled to earlier
notification in accordance with Article 14. Teams in Team Sports may
also be subject to Consequences as provided in Article 11.
Doping Control

All steps and processes from test distribution planning through toultimate disposition of any appeal including all steps and processes in
between such as provision of whereabouts information, Sample
collection and handling, laboratory analysis, TUEs, results
management and hearings.

Event

A series of individual Competitions conducted together under one
ruling body (e.g., the Olympic Games, FINA World Championships, or
Pan American Games).

In-Competition

Unless provided otherwise in the rules of an International Federationor the ruling body of the Event in question, “In-Competition” means theperiod commencing twelve hours 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.
[Comment: An International Federation or ruling body for an Event may
establish an “In-Competition” period that is different than the Event Period.]

Ineligibility

See Consequences of Anti-Doping Rule Violations above.

International
Standard

A standard adopted by WADA in support of the Code. Compliance withan International Standard (as opposed to another alternative standard,practice or procedure) shall be sufficient to conclude that theprocedures addressed by the International Standard were performed
properly. International Standards shall include any TechnicalDocuments issued pursuant to the International Standard.

Major Event
Organizations

The continental associations of National Olympic Committees andother international multi-sport organizations that function as the rulingbody for any continental, regional or other International Event.

MarkerA compound, group of compounds or biological variable(s) thatindicates the Use of a Prohibited Substance or Prohibited Method.

Metabolite

Any substance produced by a biotransformation process.

National Anti-Doping The entity(ies) designated by each country as possessing the primary
Organization
authority and responsibility to adopt and implement anti-doping rules,
direct the collection of Samples, the management of test results, andthe conduct of hearings at the national level. If this designation has notbeen made by the competent public authority(-ies), the entity shall be
the country’s National Olympic Committee or its designee.

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National Olympic
Committee

The organization recognized by the International Olympic Committee.
The term National Olympic Committee shall also include the NationalSport 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.

PersonA 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.

Publicly Disclose or
Publicly Report

See Consequences of Anti-Doping Rule Violations in the Code. “Thedissemination or distribution of information to the general public or
Persons beyond those Persons entitled to earlier notification inaccordance with Article 14. Teams in Team Sports may also be subject
to Consequences as provided in Article 11.”

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

Altering for an improper purpose or in an improper way; bringing
improper influence to bear; interfering improperly; obstructing,misleading orengaging in any fraudulent conduct to alter results or
prevent normal procedures from occurring.

Target Testing

Selection of specific Athletes for Testing based on criteria set forth in
the International Standard for Testing and Investigations.

Testing

The parts of the Doping Control process involving test distribution
planning, Sample collection, Sample handling, and Sample transport
to the laboratory.

TUE

Therapeutic Use Exemption, as described in Article 4.4.

Use

The utilization, application, ingestion, injection or consumption by anymeans whatsoever of any Prohibited Substance or Prohibited Method.

WADA

The World Anti-Doping Agency.

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3.2 ISL Defined Terms
Adaptive Model

A mathematical model designed to identify unusual longitudinal resultsfrom Athletes. The model calculates the probability of a longitudinal
profile of Marker values, assuming that the Athlete has a normal
physiological condition.

Aliquot

A portion of the Sample of biological fluid (e.g. urine, blood) obtained
from the Athlete used in the analytical process.

AnalyteAlso 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 andlaboratory conditions. For anti-doping purposes, an Analyte may be a
Prohibited Substance, a Metabolite of a Prohibited Substance, or aMarker 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, which is used to detect, identify and/or quantify Analytes ina Sample for Doping Control purposes in accordance with the ISL andrelevant 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

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 thetimely 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.

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 and its
associated uncertainty.

Confirmation
Procedure (CP)An Analytical Testing Procedure that has the purpose of confirming thepresence
and/or,when
applicable,
confirming
theconcentration/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.

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Corrective Action
Report (CAR)

A report describing the Root Cause Analysis investigation of a detectednonconformity and the corrective actions implemented to rectify it. If
appropriate, it shall also describe the preventive actions adopted tominimize the risk of recurrence of the nonconformity.

Decision Limit (DL)The value of the result for a Threshold Substance in a Sample,
obtained using a validated measurement procedure, above which it
can be concluded that the Threshold has been exceeded with astatistical confidence of at least 95% [see Technical Document on
Decision Limits for the Confirmatory Quantification of Threshold
Substances (TD DL)].

External Quality
Assessment
Scheme (EQAS)

Program for quality assessment of Laboratory performance, which
includes the periodical distribution of urine or blood samples toLaboratories 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 WADA-Approved Laboratories for the ABP for the analysisof 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)-forPurpose

Suitable for the intended purpose and in conformity with the ISO/IEC
17025 or ISO 15189, as applicable, the ISL and relevant TechnicalDocument(s) and Technical Letter(s).

Flexible Scope of
ISO/IEC 17025
Accreditation

Status of laboratory accreditation, which allows a Laboratory or WADAApproved Laboratory for the ABP 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 ISL
Art. 4.4.2.2 for a detailed description of Flexible Scope of ISO/IEC
17025 Accreditation.

Further Analysis

Further Analysis means any additional Analytical Testing performed on
a Sample whether using the same Analytical Method(s) or any new oradditional Analytical Testing Procedure(s) (for example, new or moresensitive Analytical Methods or Analytical Methods used to identify
additional Analytes).
[Prior to reporting a test result, a Laboratory may perform Further Analysis on
a Sample with no approval required. After reporting a test result, Further
Analysis may be performed at any time by the same Laboratory that did theoriginal Analytical Testing or by a different Laboratory or other WADAapproved laboratory, at the direction of the Anti-Doping Organization that
initiated and directed Sample collection 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 Anti-Doping Organization that initiated anddirected Sample collection or WADA and shall be responsible for any followup results management. Any Sample storage or Further Analysis initiated byInternational Standard for Laboratories – Version 10.0 – November 2019

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

Identification
Capability

Analytical parameter of assay technical performance. Lowest
estimated concentration at which a Confirmation Procedure is capableof consistently identifying (i.e. confirming under the stated test
conditions) an Analyte, for which a Reference Material is available,according to the criteria established in the Technical Document on
Minimum Criteria for Chromatographic-Mass Spectrometric
Confirmation of the Identity of Analytes for Doping Control Purposes(TD IDCR). The Identification Capability of a Laboratory cannot behigher than the MRPL; however, it may be lower. The Identification
Capability is also referred to as the Limit of Identification (LOI).

Independent
Witness

A Person, invited by the Testing Authority, the Laboratory or WADA towitness parts of the Analytical Testing process. The Independent
Witness shall be independent of the Athlete and his/her
representative(s), the Laboratory, the Sample Collection Authority, theTesting Authority / Results Management Authority or WADA, asapplicable. 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) ofa 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 (sw)

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.

International
Standard forLaboratories (ISL)The International Standard applicable to Laboratories and WADAapproved Laboratories for the ABP.

Laboratory Internal
Chain of Custody

Documentation maintained within the Laboratory to record thechronological 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.
[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(-ies)(A) WADA-accredited laboratory(-ies) applying Test Methods andprocesses to provide evidentiary data for the detection and/or
identification of Prohibited Substances or Prohibited Methods on theProhibited List and, if applicable, quantification of a Threshold
Substance in Samples of urine and other biological matrices in thecontext of Doping Control activities.

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Laboratory
Guidelines

Recommendations of Laboratory best practice provided by WADA toaddress specific Laboratory operations or to provide technicalrequirements 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.
[Laboratory Guidelines are posted on WADA’s website, are not of mandatory
application and may be later incorporated, partially or in full, in TechnicalDocument(s) or in the ISL. Laboratory Guidelines are approved by the WADA
Laboratory Expert Group].

Laboratory
Documentation
Package

The material produced by the Laboratory to support an analytical resultsuch as an Adverse Analytical Finding as set forth in the WADA
Technical Document for Laboratory Documentation Packages (TDLDOC).

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
conditions.

Limit of Identification(LOI)

Identification Capability

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 conditions.

Major Event

A series of individual international Competitions conducted together
under an international multi-sport organization functioning as a rulingbody (e.g. the Olympic Games, Pan American Games) and for which
a significant increase of resources and capacity may be required to
conduct Doping Control for the Event.

Measurement
Uncertainty (MU)

Parameter associated with a measurement result that characterizes
the dispersion of quantity values attributed to the measure andprovides confidence in the validity of the measured result [seeTechnical Document on Decision Limits for the Confirmatory
Quantification of Threshold Substances (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 Substanceor Metabolite of a Prohibited Substance or Marker of a Prohibited
Substance or Prohibited Method in the routine daily operation of theLaboratory. Individual Laboratories may and are expected to achieve
better performance [see Technical Document on Minimum Required
Performance Levels for detection and identification of Non-Threshold
Substances (TD MRPL)].

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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) orMarker(s) or evidence of the Use of a Prohibited Method(s), includedin 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, incompliance with the Technical Document on the Minimum Criteria for
Chromatographic-Mass Spectrometric Confirmation of the Identity ofAnalytes for Doping Control Purposes (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 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 thesubstance 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 (sr)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 (sR)

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.

Root Cause Analysis An investigation to identify one or more fundamental cause(s) of anonconformity based on the collection of objective evidence from an(RCA)assessment of the likely factors that led to the nonconformity. The
removal of a root cause factor prevents the recurrence of thenonconformity; in contrast, removing a causal factor can improve theoutcome, but it does not prevent the recurrence of the problem withcertainty.

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Selectivity

The ability of the Analytical Testing Procedure to detect only thesubstance of interest, without interferences from the matrix or fromother substance(s) present in the Sample.

Suspension

The temporary withdrawal of a Laboratory’s WADA accreditation.

Technical Document

Technical requirements produced by WADA on specific anti-doping
topics. Technical Documents supersede any previous publication on asimilar topic, or, if applicable, the ISL.
[Implementation of the requirements described in a Technical Document is
mandatory. Technical Documents are approved by the WADA Executive
Committee and posted on WADA’s website. All Laboratories and WADAApproved Laboratory for the ABP shall have the requirements of a TechnicalDocument implemented in their procedures no later than its “effective date”].

Technical Letter

Mandatory technical requirements provided by WADA in letter format
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
WADA-Approved Laboratory for the ABP procedures.
[Technical Letters are approved by the WADA Executive Committee, andbecome effective immediately, unless otherwise specified by WADA].

Technical Note

Technical guidance provided by WADA to Laboratories on theperformance of specific Laboratory methods or procedures.
[Technical Notes are not considered part of Technical Documents andtherefore are not of mandatory application. Technical Notes are approved by
the WADA Laboratory Expert Group and become effective immediately].

Test Method

Analytical Testing Procedure, Analytical Method.

Threshold

The maximum permissible level of the concentration, ratio or score fora Threshold Substance in a Sample. The Threshold is used to establish
the Decision Limit for reporting an Adverse Analytical Finding orAtypical Finding for a Threshold Substance.

Threshold
Substance

An exogenous or endogenous Prohibited Substance, Metabolite orMarker of a Prohibited Substance for which the identification andquantitative determination (e.g. concentration, ratio, score) in excess
of a pre-determined Decision Limit, or, when applicable, theestablishment of an exogenous origin, constitutes an Adverse
Analytical Finding. Threshold Substances are identified as such in theTechnical Document on Decision Limits (TD DL).

WADA-Approved
Laboratory(-ies) for
the ABP

Laboratory(-ies), not otherwise accredited by WADA, which apply
Analytical Methods and processes in support of the hematologicalmodule of the ABP program and in accordance with the criteria for
approval of non-accredited laboratories for the ABP.

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3.3 International Standard for Testing and Investigations (ISTI) Defined Terms
Results
Management
Authority

The organization that is responsible, in accordance with Code Art. 7.1,
for the management of the results of Testing (or other evidence of apotential anti-doping rule violation) and hearings, whether (1) an AntiDoping Organization (for example, the International Olympic
Committee or other Major Event Organization, WADA, an International
Federation, or a National Anti-Doping Organization); or (2) anotherorganization acting pursuant to the authority of and in accordance withthe rules of the Anti-Doping Organization (for example, a National
Federation that is a member of an International Federation). In respectof Whereabouts Failures, the Results Management Authority shall be
as set out in Art. I.5.1.

Sample Collection
Authority

The organization that is responsible for the collection of Samples incompliance with the requirements of the International Standard for
Testing and Investigations, whether (1) the Testing Authority itself; or(2) another organization (for example, a third party contractor) to whom
the Testing Authority has delegated or subcontracted such
responsibility (provided that the Testing Authority always remains
ultimately responsible under the Code for compliance with therequirements of the International Standard for Testing andInvestigations relating to collection of Samples).

Sample Collection
SessionAll of the sequential activities that directly involve the Athlete from thepoint that initial contact is made until the Athlete leaves the Doping
Control Station after having provided his/her Sample(s).

Suitable Volume ofUrine 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 DistributionPlan

A document written by an Anti-Doping Organization that plans Testingon Athletes over whom it has Testing Authority, in accordance with therequirements of Art. 4 of the International Standard for Testing andInvestigations.

Testing Authority

The organization that has authorized a particular Sample collection,
whether (1) an Anti-Doping Organization (for example, the International
Olympic Committee or other Major Event Organization, WADA, anInternational Federation, or a National Anti-Doping Organization); or(2) another organization conducting Testing pursuant to the authorityof and in accordance with the rules of the Anti-Doping Organization (forexample, a National Federation that is a member of an International
Federation).

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PART TWO: LABORATORY ACCREDITATION REQUIREMENTS AND OPERATINGSTANDARDS
4.0 Process and Requirements for WADA Laboratory Accreditation
This section describes the specific requirements that a laboratory shall fulfill in the process of applying
for, obtaining, and maintaining WADA accreditation, including requirements for Major Events.
4.1

Applicant Laboratory

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, 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 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 the completed Application Form, provided by WADA, duly signedby 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 requestthat the applicant laboratory submit the following letters of support:• Official letter(s) of support from host entities acceptable to WADA (e.g. universities, hospitals, privateorganizations and/or public institutions) that guarantee sufficient annual financial support for a minimumof 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 Signatory, Code-compliant (as determined by WADA) Anti-Doping
Organizations such as a National Anti-Doping Organization or Regional Anti-Doping Organization

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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 theLaboratory with a minimum of 3,000 Samples 6 per year within two (2) years of obtaining WADA
accreditation;• A declaration by the supporting Anti-Doping Organization(s) that their relationship with the applicant
laboratory is compliant with ISL Art. 4.2.3.
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 andtraining needs, and shall guarantee the long-term provision of adequate financial and human resources
to the laboratory.
4.2

Candidate Laboratory

The application materials described in ISL Arts. 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 alist of relevant scientific publications by laboratory staff;• Description of the physical laboratory facilities, including a description of the security considerationsfor 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.
- Physical Security: specific measures to maintain a secure laboratory environment (e.g., CCTV
monitoring, restricted access to sample storage areas);- IT Security: implementation of firewalls and other cyber security measures consistent with bestpractice and any applicable governmental regulations (see ISL Arts. 5.2.3.4.1 and 5.2.3.4.2);- Information Technology (IT) infrastructure: implementation of a data and information management
system (e.g. LIMS), central server/intranet which allows secure data handling (see ISL Arts.
5.2.3.4.3 and 5.2.3.4.4).

6 To determine the minimum

number of Samples, each urine Sample, blood Sample and ABP blood Sample
provided to the Laboratory shall count as an individual Sample.

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• List of actual and proposed instrumental resources and equipment, including year of purchase andconditions for instrument technical support (access to 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 ofQuantification (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;• List of laboratory sponsors;• Contract or Memorandum of Understanding with a WADA-accredited Laboratory, which will provide
mentoring and training for at least the period spanning the probationary phase of accreditation;• Status of ISO/IEC 17025 accreditation;• Description of customs regulations in the host country with respect to the reception of urine andblood samples, Reference Materials and consumables from abroad and the ability to ship Samples
outside the country as needed; and• Letter of compliance with the Code of Ethics (ISL Annex A) signed by the laboratory Director.
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 nonrefundable fee to cover the costs related to the initial accreditation process. This fee shall be determinedby WADA.
4.2.3

Laboratory Independence and Impartiality

In order to avoid potential conflicts of interest, the laboratory shall be administratively and operationallyindependent from any organization, which could exert undue pressure on the laboratory and affect theimpartial execution of its tasks and operations. This applies to, but is not limited to, Anti-Doping
Organizations or any other sport or political organizations. This is necessary in order to ensure fullconfidence in the laboratory’s competence, impartiality, judgment or operational integrity, in compliancewith ISO/IEC 17025.
• Administrative independence requires that the laboratory is a separate legal entity without any
administrative links to an Anti-Doping Organization or other sport or political organizations;• Operational independence requires that the laboratory shall manage its own affairs without
hindrance, interference or direction from any Anti-Doping Organization, sport organizations or any
Person. This requires the laboratory to 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 andsymposia, etc. This does not prevent the laboratory from receiving research grants or other financial
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support from their host organization (e.g. university, hospital, public institution), Anti-Doping
Organizations, sport organizations, government, or other sponsors, and following applicable accounting
regulations in connection with the receipt and management of those funds.
4.2.4

Compliance with the Code of Ethics (ISL Annex A)

The candidate laboratory shall implement and comply with the provision(s) of the Code of Ethics. The
laboratory shall provide the Code of Ethics to all employees and ensure their understanding andcompliance with all aspects of the Code of Ethics.
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 thisassessment 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.
4.2.5.1 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 oflaboratory EQAS results are described in ISL Sections 6 and 7, respectively.
4.2.5.2 The candidate laboratory shall report the results for the PPT blind EQAS samples in ADAMS (incompliance with ISL Art. 6.4) within a period of fifteen (15) working days, unless otherwise notified by
WADA.
• 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) working
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.
4.2.5.3 After receiving the PPT EQAS results, WADA shall inform the candidate laboratory of theevaluation 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) calendar days, or asotherwise indicated by WADA.
4.2.5.4 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) calendar days, or as otherwise
indicated by WADA.
The nonconformities identified in the WADA Assessment Report shall be satisfactorily addressed andthe 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 andon-site assessment will be taken into account in the overall review of the candidate laboratory’s

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application and may affect the timeliness of the candidate laboratory’s entry into the probationary phaseof accreditation.
4.2.5.5 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 anextension of this period.
4.2.5.6 Upon satisfactory completion of the candidate laboratory requirements (as per ISL Art. 4.2), as
determined by the LabEG, a candidate laboratory enters the probationary phase of WADA accreditation
as a “WADA probationary laboratory”.
4.3

Probationary Laboratory

4.3.1

Obtaining ISO/IEC 17025 Accreditation by the Laboratory

The probationary laboratory shall obtain ISO/IEC 17025 accreditation from an Accreditation Body, withprimary reference to the interpretation and application of the ISO/IEC 17025 requirements to the analysis
of Samples (see ISL Section 5). The Accreditation Body shall be an International Laboratory Accreditation
Cooperation (ILAC) full member that is a signatory to the ILAC Mutual Recognition Arrangement (ILACMRA).
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 ISL
Section 5). 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 theprobationary laboratory prefer to send the information directly to WADA, the laboratory shall do so withina 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.
4.3.2

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 ISL Section
6 for a description of the EQAS). During this period, WADA shall provide feedback to assist theprobationary 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 ISL Art. 6.4 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 ISL Sections
6 and 7, respectively.

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4.3.3

Planning and Implementing Research and Development Activities

The probationary laboratory shall develop a plan for its research and development activities in the fieldof 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 Code-compliant
Anti-Doping Organizations.
At least two (2) research and development activities shall be initiated and implemented within theprobationary period 7. The research activities can either be conducted by the probationary laboratory
alone or in cooperation with other Laboratories or other research organizations.
As part of its laboratory monitoring activities, WADA may request documented evidence of the researchand development activities in the field of anti-doping science implemented by the probationary laboratory.
4.3.4

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 (ISL Annex A).
4.3.5

Professional Liability Insurance Coverage

Before WADA grants accreditation, probationary laboratories shall provide documentation to WADA thatprofessional liability risk insurance coverage has been obtained to cover liability of no less than two (2)million USD annually.
4.4

WADA-Accredited Laboratory

4.4.1

Obtaining WADA accreditation

4.4.1.1

WADA Accreditation Assessment

4.4.1.1.1 Once WADA has determined that the laboratory has successfully completed the requirementsof the probationary period, and upon request by the probationary laboratory stating its readiness toproceed further, a Final Accreditation Test (FAT) and on-site assessment shall be conducted by WADA.
Representative(s) of the Accreditation Body may be invited as observers to the WADA on-site
assessment.
4.4.1.1.2 As part of the FAT, the probationary laboratory shall analyze a minimum of fifteen (15) blind
EQAS samples in the presence of a WADA assessment team. The general composition and content of
the blind EQAS samples and the evaluation of laboratory EQAS results are described in ISL Sections 6
and 7, respectively.

7 The validation or implementation of established anti-doping methods with only minor adjustments, or repetition ofresearch previously published or presented by others, is not sufficient to be considered as a research anddevelopment activity.

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4.4.1.1.3 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.
4.4.1.1.4 Costs associated with the WADA on-site visit and FAT shall be at the probationary laboratory’s
expense.
4.4.1.1.5 The probationary laboratory shall successfully report the results for the blind EQAS samples
in the FAT to WADA in accordance with ISL Art. 6.4 within five (5) working 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) working
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.
4.4.1.1.6 After receiving the FAT EQAS results, WADA shall inform the probationary laboratory of theevaluation of its performance. Corrective actions, if any, shall be conducted and reported by theprobationary laboratory to WADA within thirty (30) calendar days, or as otherwise indicated by WADA.
4.4.1.1.7 WADA shall provide an Assessment Report with the outcomes of the accreditationassessment, 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) calendar days, or as otherwise indicated by WADA.
The nonconformities shall be satisfactorily addressed and the recommendations for improvement shouldbe implemented before accreditation can be granted.
4.4.1.1.8 In order for a probationary laboratory to be considered for WADA accreditation, it shall haveall mandatory Analytical Methods, as determined by WADA, validated and incorporated into its Scope of
ISO/IEC 17025 Accreditation.
4.4.1.2

WADA Recommendation for Accreditation

4.4.1.2.1 Based on the relevant documentation received from the probationary laboratory, theAssessment Report(s) from WADA and from the relevant Accreditation Body, the LabEG shall make a
final recommendation concerning the accreditation of the probationary laboratory.
Once all accreditation requirements have been satisfactorily met by the probationary laboratory, theLabEG will submit its recommendation to grant WADA accreditation of the laboratory 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 andimprove any pending nonconformity(-ies). The provision of documentation, the analysis of additional
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EQAS samples and/or an additional on-site assessment, as determined by WADA, may be required andconducted 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 ISL Art. 4.2 or to re-start the probationary phase of accreditation inaccordance with ISL Art. 4.3.
4.4.1.2.2 Once a laboratory becomes a WADA-accredited laboratory, the new Laboratory shall, for aperiod 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 inrecognition of the WADA accreditation. Such Accreditation Certificate shall specify the name of theLaboratory and the period for which the Accreditation Certificate is valid. Accreditation 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 (ISL Section 5), granted by a relevant Accreditation Body, which is an ILAC full member andsignatory to the ILAC MRA.
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 forapproval by the Accreditation Body that provides the ISO/IEC 17025 accreditation of that Laboratory 8.
The Flexible Scope of ISO/IEC 17025 Accreditation of Laboratories is not eligible for the following
scenarios:•
New Analytical Testing Procedures: Any Analytical Testing Procedure, which is new to the field ofanti-doping analysis, shall be approved as Fit-for-purpose by WADA prior to implementation by any

8 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 theapplication of new technical and scientific developments in Analytical Testing for Doping Control.

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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 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 theanalysis of Samples, even if the analytical technique involved is already incorporated in the
Laboratory’s Scope of ISO/IEC 17025 Accreditation. Therefore, these Analytical Testing Procedures
are not eligible for the analysis of Samples within a flexible Scope of ISO/IEC 17025 Accreditation.
WADA will communicate which Analytical Testing Procedures are included in this category to the
Laboratories and to the Accreditation Bodies. In such cases, the Analytical Testing Procedure shall bevalidated by the Laboratory, and the Laboratory may be required to successfully participate in an interlaboratory 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 applying the Analytical
Testing Procedure to the analysis of Samples. However, once included within the scope, limitedchanges to these Analytical Testing Procedures may be allowed under a Flexible Scope of ISO/IEC
17025 Accreditation.
4.4.2.2.1 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 datain 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. Under exceptional circumstances, aLaboratory may apply an Analytical Testing Procedure (excluding any new or WADA-specific Analytical
Testing Procedures, as defined above), 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, theLaboratory does not automatically benefit from the presumption that the Analytical Testing Procedure
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 an Analytical Testing Procedure, which is not within the Laboratory’s Scopeof ISO/IEC 17025 Accreditation, may require the Laboratory to provide Analytical Method validation
documentation or EQAS performance data in support of that Adverse Analytical Finding.
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 theperformance requirements of the EQAS as described in ISL Section 6.

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4.4.2.4

Laboratory Independence and Impartiality

The Laboratory shall strictly maintain its full administrative and operational independence and impartiality
at all times (see ISL Art. 4.2.3) 9.
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 breaches of the Code of
Ethics identified by the Laboratory, either to the Laboratory Director or directly to WADA (if there aresuspicions that the Laboratory Director may be complicit or implicated in unethical conduct). The
Laboratory Director and/or WADA, respectively, 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 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 implicatedLaboratory staff member(s), the reporting of the breach to the pertinent authorities (e.g. law enforcement)
or even 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 toactivities associated with Code-compliant Anti-Doping Organizations.
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 years) 10. The list of scientific papers shallbe made available to WADA upon request. The Laboratory may also demonstrate a research programby documenting successful or pending applications for research grants [at least one (1) application
submitted every three (3) years].
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.

9 Laboratories shall comply with the requirements of administrative and operational independence established in

ISL Art. 4.4.2.4 (with reference to ISL Art. 4.2.3) within two (2) years after the effective date of this ISL version 10.0.
10 The validation or implementation of established anti-doping methods with only minor adjustments, or repetitionof research previously published or presented by others, is not sufficient to be considered as a research anddevelopment activity.

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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 andprovide 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 (ISL Annex A).
4.4.2.8

Maintain Professional Liability Insurance CoverageLaboratories shall provide documentation to WADA that professional liability risk insurance coverage ismaintained of no less than two (2) million USD annually.
4.4.2.9

Maintain Minimum Number of Samples

In order to maintain proficiency in Analytical Testing, Laboratories are required to analyze a minimum of
3,000 Samples 11 provided annually by Signatory, Code-compliant Anti-Doping Organizations (asdetermined by WADA) or as otherwise approved by WADA.
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 ISL Art.
4.6.4.1.2.
When an Anti-Doping Organization is declared non-compliant with the Code by WADA, it is recognizedthat this may affect a Laboratory’s ability to analyze a minimum of 3,000 Samples annually. In such cases,
WADA shall require that the Laboratory implements 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 document audit and/or an
on-site assessment, at its discretion, in order to assess the status of the Laboratory’s operations.
4.4.2.10 Publication of Fee Schedule
To assist Testing Authorities in developing Test Distribution Plans in relation to the use of different
Sample Analytical Testing menus for various sports or sport disciplines, Laboratories shall report into
ADAMS an up-to-date price list for each type of Analytical Method or service that is available to the AntiDoping Organizations.

11 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.

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4.4.2.11 Participating in WADA / Accreditation Body Re-assessments and Continuous Assessments
during the Accreditation Cycle
4.4.2.11.1 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 on-site 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 preferto provide the Assessment Report summary directly to WADA, it shall do so within thirty (30) calendar
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 Scopeof ISO/IEC 17025 Accreditation as soon as it is obtained from the Accreditation Body.
4.4.2.11.2 WADA Assessment
WADA reserves the right to conduct document-based audits as well as inspect and assess the Laboratory
through on-site assessments at any time, at WADA’s expense. The notice of the assessment will bemade in writing to the Laboratory Director. In exceptional circumstances, and at WADA’s discretion, theon-site assessment may be unannounced.
As part of an announced or unannounced Laboratory on-site assessment, WADA retains the right torequest 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

4.5.1

Removal of Samples for Further Analysis

Within the context of an investigation or Laboratory performance monitoring activity (for example, during
an on-site Laboratory assessment), WADA, initially at its expense 12, may remove Sample(s) stored in a
Laboratory in order to conduct Further Analysis for the purpose described in Code Art. 6.2. In such cases,
WADA shall notify the Testing Authority and Results Management Authority, which shall retain ownershipof the Sample(s) pursuant to ISTI Art. 10.1. Notwithstanding the aforementioned, WADA shall retain theright to request Further Analysis, at its expense, as permitted by Code Art. 6.5, Para. 2.
WADA may delegate an observer to monitor the removal of the Samples, which shall be implemented inaccordance with WADA’s instructions. During the removal of Samples, WADA shall be responsible formaintaining proper Sample chain of custody documentation and the safety and integrity of the Samples
until receipt by the other Laboratory(-ies).

12 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 Further Analysis of the Samples from theLaboratory.

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WADA may also require that the Laboratory transfer the Samples. In such situations, the Laboratory shallbe responsible for maintaining proper chain of custody documentation for all transferred Samples andthe safety and integrity of the Samples until receipt by the receiving Laboratory(-ies).
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 describedin ISL Art. 5.3.3.1, for purposes of Laboratory quality assurance and education, including theimplementation of a system of transfer of Samples reported as Negative Findings between
Laboratories 13. In this regard, the number of Samples directed by WADA for re-analysis may vary but
shall be guided by the criteria established in ISL Art. 6.2.1.1.
4.6

WADA Monitoring of Accreditation Status

WADA shall regularly review the compliance of Laboratories with the requirements listed in the ISL andrelated 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 bystakeholders 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 ISL Art. 4.4.2, including satisfactory performance by
a Laboratory in the EQAS and in routine Analytical Testing (see ISL Sections 6 and 7), 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 reaccreditation 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 inrecognition 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 ismaintained on WADA’s website.

13 A transfer of Samples with Negative Findings shall apply only to Samples from Testing Authorities which are

Code-compliant Anti-Doping Organizations.

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4.6.4

Loss 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/orTechnical 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.
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.
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 ISL Points Scale Table in ISL
Art. 7.3), or that a Laboratory has reported a False Adverse Analytical Finding with Consequence(s) for
the Athlete, the LabEG will make a recommendation to the Chairman of the WADA Executive Committeethat the Laboratory be subject to an Analytical Testing Restriction or Suspension, as applicable. In suchcircumstances, the Laboratory has no right to appeal the recommendation of the LabEG to theDisciplinary Committee before the decision is rendered by the Chairman of the WADA Executive
Committee.
4.6.4.1.2 Suspension of Accreditation and Analytical Testing Restriction – Disciplinary Proceedings
The LabEG may recommend to the Chairman of the WADA Executive Committee that a Laboratory be
subject to an Analytical Testing Restriction or a Suspension of its WADA accreditation even if theLaboratory has not reported a False Adverse Analytical Finding with Consequence(s) for an Athlete or
has not attained the maximum number of penalty points detailed in the ISL Points Scale Table in ISL Art.
7.3 , but where the Laboratory’s other Analytical Testing failure(s) and/or other identified nonconformities(as described in ISL Art. 4.6.4.2) otherwise justifies that such action be taken to ensure the full reliability
and accuracy of Analytical Testing and the accurate reporting of test results 14.
In such cases, the Laboratory and the WADA LabEG shall participate in the resolution facilitation session
foreseen in ISL Art. 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 indicatedin ISL Art. 4.6.4.4, the Chairman of the WADA Executive Committee must approve any agreement

14 If WADA determines that the noncompliance(s) leading to the Suspension of the Laboratory’s WADA accreditationor that 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.

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between the Laboratory and WADA 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 the terms of the
LabEG’s Analytical Testing Restriction or Suspension following the resolution facilitation process as per
ISL Art. 4.6.4.4, the Laboratory may appeal the LabEG’s recommendation to the Disciplinary Committee
and disciplinary proceedings will be conducted in accordance with ISL Art. 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 immediately suspended on a provisional basis pending the outcome of theLaboratory’s appeal to the Disciplinary Committee. In such cases, a decision by the Chairman of
the WADA Executive Committee to provisionally suspend the Laboratory’s WADA accreditationor subject the Laboratory to a provisional Analytical Testing Restriction shall not be subject toappeal by the Laboratory.

However, should the Laboratory be immediately subject to a provisional Analytical Testing Restriction or
should its WADA accreditation be immediately suspended on a provisional basis, the Laboratory’s appeal
to the Disciplinary Committee shall be heard within thirty (30) calendar days of the date of the impositionof the provisional Analytical Testing Restriction or the Provisional Suspension of the Laboratory’s WADA
accreditation.
4.6.4.2 Noncompliances with the ISL
Noncompliances with the ISL include, but are not limited to:• Suspension, or withdrawal of ISO/IEC 17025 accreditation;• Repeated reporting of False Adverse Analytical Findings and/or False Negative Findings 15:- The reporting of two (2) or more independent 16 False Adverse Analytical Finding per EQAS round;or- The reporting of three (3) or more independent 16 False Adverse Analytical Findings, including

EQAS and routine Analytical Testing, per 12-month period; or

15 LabEG recommendations are made in consideration of the number of false analytical findings reported by the

Laboratory, irrespective of the total number of penalty points accumulated during this period (i.e. after considerationof any applicable penalty point deductions) or whether or not the Laboratory has satisfactorily corrected thenoncompliances.
16 Independent analytical findings are produced by different and unrelated root causes and based on a satisfactory

Root Cause Analysis investigation, as determined by the WADA LabEG.

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- The reporting of three (3) or more independent 16 False Negative Findings per EQAS round; or- The reporting of four (4) or more independent 16 False Negative Findings, including EQAS androutine Analytical Testing, per 12-month period; or- Any combination of four (4) or more independent 16 False Adverse Analytical Findings and False

Negative Findings, including EQAS and routine Analytical Testing, per 12-month period.
• Failure to comply with any of the requirements or standards listed in the ISL and/or TechnicalDocuments and/or Technical Letters;• Serious and repeated noncompliances with results reporting timelines (see ISL Arts. 5.3.5.2.5 and5.3.5.2.7.3);• 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 Laboratory on-site 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:- Major changes in senior Laboratory management positions (e.g. Laboratory Director, Quality

Manager) without proper and timely notification to WADA;- Failure to appoint a permanent Laboratory Director or other senior management positions (e.g.

Quality Manager) within a reasonable timeline;- Failure to guarantee the competence and/or proper training of scientific staff, including, forexample, the qualification of analysts as Certifying Scientists and Laboratory Supervisory
Personnel (see ISL Arts. 5.2.2.6 and 5.2.2.7);- 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;- Loss of sufficient Laboratory support and resources that affects, as determined by WADA, thequality and/or viability of the Laboratory;- Failure to analyze the minimum number of Samples indicated in ISL Art. 4.4.2.9; or- 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 determinesthat Revocation is necessary to ensure the full reliability and accuracy of Analytical Testing and theaccurate reporting of analytical test results.
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• Repeated reporting of False Adverse Analytical Findings or repeated failure to take appropriate

corrective action after the reporting of a False Adverse Analytical Finding;• 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 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/orTechnical 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 ISL Art. 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 on-site assessments, by documented client complaints or throughother enquiries or investigations conducted by WADA;• Repeated failure to take appropriate corrective action following unsatisfactory performance either inroutine Analytical Testing or in a blind EQAS or double-blind EQAS round(s);• Repeated failure to take appropriate corrective action following ISL and/or Technical Document

and/or Technical Letter noncompliance(s) identified from Laboratory on-site assessment(s);• Repeated failure to analyze the minimum number of Samples indicated in ISL Art. 4.4.2.9;• Continuous, serious Laboratory staff and/or management issues (e.g. continuous turnover ofqualified staff affecting Laboratory expertise and competence, inadequate training, repeated failure totrain and qualify an appropriate number of analysts as Certifying Scientists);• Failure to cooperate with WADA or any relevant Testing Authority during a period of Suspension orfollowing 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 theoperations of the Laboratory;• Repeated and/or continuous failure to cooperate in any WADA inquiry in relation to the activities of
the Laboratory;• Failure to maintain administrative and operational independence as described in ISL Art. 4.4.2.4;• Loss of support which significantly affects the quality and/or viability of the Laboratory; and• Any other cause that materially affects the ability of the Laboratory to ensure the full reliability andaccuracy of Analytical Testing and the accurate reporting of test results.
4.6.4.4 Resolution Facilitation
Prior to the commencement of Disciplinary Proceedings in accordance with ISL Arts. 4.6.4.1.2 and4.6.4.5, the WADA 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
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Technical Letter(s) and offer the Laboratory Director an opportunity to provide further clarification to the
WADA LabEG.
During this resolution facilitation session, the Laboratory and the WADA LabEG may agree to the terms
and duration of the Suspension of the Laboratory’s WADA accreditation or the terms of 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 instituted against the Laboratory.
Should the Laboratory and the WADA LabEG be unable to come to an agreement regarding the terms
and duration of the Suspension of the Laboratory’s WADA accreditation or the terms of the Laboratory’s
Analytical Testing Restriction during the resolution facilitation session, the procedure as per ISL Art.
4.6.4.5 shall be followed.
4.6.4.5 Disciplinary Proceedings
In the event that the Laboratory decides to appeal the LabEG’s recommendation to impose an Analytical
Testing Restriction or to suspend its WADA accreditation in accordance with ISL Art. 4.6.4.1.2 or shoulda Laboratory’s WADA accreditation be subject to Revocation in accordance with ISL Art. 4.6.4.3, WADA
shall constitute an impartial Disciplinary Committee (DC) in accordance with Art. 1 of the Procedural
Rules (ISL Annex B). The DC shall be responsible for conducting Disciplinary Proceedings in accordancewith the Procedural Rules.
In such circumstances, WADA shall provide the DC with a 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 Art. 3 of theProcedural Rules (ISL Annex B).
The DC shall issue a recommendation to the Chair of the WADA Executive Committee or, whereapplicable, 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 inArt. 7 of the Procedural Rules (ISL Annex B).
4.6.4.6 Notification of Decision
Upon completion of the procedures indicated in ISL Arts. 4.6.4.5 or 7.3, as applicable, and in accordancewith the timelines indicated in Art. 7 of the Procedural Rules (ISL Annex B), WADA shall provide theLaboratory with written notice of its decision regarding the status of the Laboratory’s WADA accreditation.
This notice shall state the following:1) That the Laboratory’s WADA accreditation has been maintained (including warnings, if applicable);or2) That the Laboratory’s WADA accreditation has been suspended or revoked or that an Analytical
Testing Restriction has been imposed against the Laboratory.

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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 ISL Art. 4.6.4.5, WADA shall also provide the Laboratory with acopy 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 thedecision.
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 appealof 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 Art. 13.7. The Laboratory shall havetwenty-one (21) calendar days from the date of receipt of the decision from WADA to file an appeal toCAS.
4.6.4.8 Public Notice
WADA shall announce a change in a Laboratory’s accreditation status on its website as soon as theLaboratory is notified by WADA of its decision. The public notice shall include the name and address of
any Laboratory that has had its accreditation suspended or revoked or that has been subjected to an
Analytical Testing Restriction, as well as the name of any Laboratory that has had its Suspension or
Analytical Testing Restriction lifted. 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 ISL Art 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 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.

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4.6.5Consequences 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, WADA will 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 ISL Art. 5.4.8. 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 17 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 theapplication 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 Finding;•

Samples, which have been opened and were undergoing analysis for the Initial Testing
Procedure(s) at the time of the Analytical Testing Restriction decision;• Samples for which the “A” or “B” Confirmation Procedures had been completed, but results of theanalysis had not been reported by the Analytical Testing Restriction date, or Samples which had been
undergoing “A” or “B” Confirmation Procedures at the time of the imposition of the Analytical Testing
Restriction;• Samples which have been reported as an Adverse Analytical Finding 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 17 to another Laboratory(-ies) for the “A”
Confirmation Procedure to be performed again and for the performance of the “B” Confirmation
Procedure, if applicable.

17 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) calendar days of being notified of the Analytical Testing Restriction decision. All associated costs shallbe borne by the Laboratory under Analytical Testing Restriction.

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If the Analytical Testing Restriction has been caused by the reporting of False Negative Finding(s), andfurther 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 17 to another
Laboratory(-ies) for Further Analysis, as determined by WADA. These re-analyses may be applied to theclass of Prohibited Substances and/or Prohibited Methods or to the Analytical Testing Procedure(s) thatwere 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 Testingof Samples for any Code-compliant Anti-Doping Organization. This provision does not apply when thenoncompliance(s) that led to the Suspension do not affect the blood analyses for the ABP, as determinedby WADA.
4.6.5.2.1 If the reason for the Suspension was related to a violation of the Code of Ethics (Annex A),
all Analytical Testing in the suspended Laboratory shall cease immediately and the Laboratory shalltransfer 18 all Samples (both the “A” and “B” Samples) in the Laboratory’s custody to other
Laboratory(-ies) chosen by the Testing Authority(-ies).
4.6.5.2.2 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 18 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:•

Samples, which had been previously reported as an Adverse Analytical Finding for the same classof Prohibited Substances or Prohibited Methods when applying the same Confirmation Procedure;•

Samples for which Initial Testing Procedures had been completed and produced Presumptive
Adverse Analytical Finding(s), but for which Confirmation Procedures had not yet been performed at
the time of the Suspension;• Samples, which have been opened and were undergoing analysis for the Initial Testing Procedure(s)18 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) calendar 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 caseof Code of Ethics violation(s), the suspended or revoked Laboratory shall also reimburse the Testing Authority forthe costs of re-analyses in another Laboratory. The suspended or revoked Laboratory shall inform WADA of suchactions including providing the Sample code(s) and the identity of the relevant Testing Authority(-ies) and thechosen Laboratory(-ies). Testing Authorities should consider differences in analytical capacity between thesuspended 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 implicatedand/or WADA for guidance.

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at the time of the Suspension;• Samples which have been received at the Laboratory but not 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 18 to another Laboratory(-ies)].
• Samples for which “A” or “B” Confirmation Procedures had been completed, but results of theanalysis had not been reported by the Suspension date, or Samples which had been undergoing “A”
or “B” Confirmation Procedures at the time of the Suspension;• Samples which have been reported as an Adverse Analytical Finding based on the “A” Confirmation

Procedure prior to the Suspension.
4.6.5.2.3 A Laboratory that has had its WADA accreditation suspended for reasons other than aviolation of the Code of Ethics or the reporting of false Adverse Analytical Findings(s) shall take thefollowing steps with the Samples in the Laboratory’s custody, unless otherwise instructed by WADA:• Samples which have 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 had 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 andappropriate storage conditions. The Laboratory shall inform WADA of such actions including theprovision of the Sample codes and the identity of the relevant Testing Authority(-ies).
If the Suspension has been caused by the reporting of False Negative Finding(s), and further
investigation reveals that other Negative Finding(s) had been reported by the Laboratory, theLaboratory shall inform the Testing Authority and WADA. In such cases, both the “A” and “B” containersof the relevant Samples shall be transferred 18 to 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 associatedwith the Negative Finding(s), as determined by WADA.
•

Samples for which Initial Testing Procedures had been completed, but results had not beenreported at the time of the Suspension:
If the Initial Testing Procedure(s) have produced Presumptive Adverse Analytical Finding(s), both the“A” and “B” Samples shall be transferred 18 to another Laboratory(-ies) for the performance of the “A”
and, if needed, the “B” Confirmation Procedures.
In addition, if the Suspension has been caused by the reporting of False Negative Finding(s) and theInitial Testing Procedure(s) have produced negative results, both the “A” and “B” Samples shall also betransferred 18 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 theProhibited 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.

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If the reason for the Suspension was not related to the reporting of False Negative Findings and theInitial Testing Procedures have 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 therelevant Testing Authority(-ies).
• Samples which have 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), theLaboratory shall continue to analyze the relevant Samples until all Initial Testing Procedures arecompleted. If the Initial Testing Procedures produce Negative Findings, the Laboratory shall reportthese 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 therelevant Testing Authority(-ies).
However, if the Initial Testing Procedure has produced a Presumptive Adverse Analytical Finding, boththe “A” and “B” Samples shall be transferred 18 to another Laboratory(-ies) for the performance of the“A” and, if needed, the “B” Confirmation Procedures.
If the Suspension has been 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 18 to another
Laboratory(-ies) for the performance of the “A” and, if needed, the “B” Confirmation Procedures.
• Samples which have been received at the Laboratory but not opened yet at the time of theSuspension:
These Samples shall be kept sealed in the Laboratory under proper Laboratory Chain of Custody andappropriate storage conditions until transfer 18 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 had been undergoing “A” or “B”
Confirmation Procedures at the time of the Suspension:
Both the “A” and “B” Samples shall be transferred 18 to another Laboratory(-ies) for the repetition of the“A” and, if applicable, the “B” Confirmation Procedures.
• Samples which have 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 andappropriate storage conditions. Should a “B” Confirmation Procedure be requested during theSuspension, both “A” and “B” Samples shall be transferred 18 to another Laboratory(-ies) for the “A”
Confirmation Procedure to be performed again and for the performance of the “B” Confirmation
Procedure, if applicable.

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4.6.5.2.4 If the Suspension concerns the analysis of blood Samples for the ABP, Samples collectedprior to the Suspension date may be analyzed by the Laboratory 19. 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 / APMU can take this information into account during the results
management process.
4.6.5.2.5 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 an on-site 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 has been revoked is ineligible to perform Analytical Testing of
Samples for any Testing Authority. The Laboratory Internal Chain of Custody maintained by a revokedlaboratory for stored Samples is valid until such time that arrangements can be made, in consultation
with WADA, for the transfer 18 of relevant Samples to a Laboratory(-ies).
A laboratory whose WADA accreditation has been revoked shall arrange the transfer 18 of Samples in
the laboratory’s custody to a Laboratory(-ies) chosen by the Testing Authority or WADA, respectively,
within thirty (30) calendar days of being notified of the decision revoking its WADA accreditation. In suchcircumstances, the Samples to be transferred shall be selected by the Testing Authority or WADA 20. The
laboratory transferring the Samples shall inform WADA and provide the relevant Sample codes and theidentity of the relevant Testing Authority(-ies) and the chosen Laboratory(-ies). In addition, the revokedlaboratory 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.
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, thatappropriate 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 thatproper measures have been implemented to satisfactorily address the condition(s) specified, if any, forreinstatement of WADA accreditation.

19 Due to the negative impact of time on the integrity of blood Samples for the ABP analysis, it is not normallyfeasible to send the ABP blood Samples to other Laboratory(-ies) for timely analysis.
20 The 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 ISL Arts. 5.3.2.1. or 5.3.2.2, or other Samples for which it is the ownerpursuant to Art. 10.1 of the ISTI and that have been analyzed and are 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 betransferred to another Laboratory(-ies).

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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/orTechnical 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 an on-site 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.
The Suspension or Analytical Testing Restriction period may be extended up to a maximum of anadditional six (6) months, based on justifiable delays in submitting 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, unlessotherwise determined by WADA.
If applicable, a delay in the delivery of the ISO/IEC 17025 accreditation to the Laboratory by the relevant
Accrediting 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 theAnalytical Testing Restriction shall be rendered by the Chair of the WADA Executive Committee on thebasis 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 toextend the period of the Analytical Testing Restriction in accordance with ISL Art. 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 theextended Suspension or extended Analytical Testing Restriction period, the Laboratory’s accreditation
shall be revoked. The decision to revoke a Laboratory’s WADA accreditation shall be rendered by the
WADA Executive Committee. WADA will notify the Laboratory of the decision of the WADA Executive
Committee to revoke the Laboratory’s WADA accreditation in accordance with ISL Art. 4.6.4.6.
The Laboratory may appeal WADA’s decision to revoke its WADA accreditation in accordance with ISL
Art. 4.6.4.7.

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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 ISL Art. 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 thelaboratory 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 ISL
Arts. 4.1 to 4.3 to expedite the entry of the laboratory into, and/or shortening the duration of, theprobationary 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.
4.6.7 Voluntary Cessation of Laboratory Operations
A Laboratory may decide to voluntarily cease its anti-doping Analytical Testing operations on either atemporary 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 ISL Arts. 4.6.5.2 (temporary closure) or 4.6.5.3 (permanent closure). In addition, if theLaboratory 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) thathave been selected to receive the Samples.

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4.7

Accreditation Requirements for Major Events

Major Event Organizations should give preference to use existing facilities of a Laboratory for the analysis
of Samples.
In some cases, the reporting time requirements for a Major Event may require that the Laboratory facility
be located in proximity to the Major Event such that Samples can be delivered by Doping Control staff.
This may require the establishment by an existing Laboratory of a temporary “satellite facility”, which shallstart sufficiently in advance to validate operations at the “satellite facility” and perform the Analytical
Testing for the Major Event.
In addition, the Laboratory operations necessary for a Major Event may be such that the existing
Laboratory facilities 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 thata proper Management System, performance, security and safety are maintained.
There shall be agreement sufficiently ahead of the Major Event between the Major Event Organizationand 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. The Laboratory shall be required
to report on staffing and equipment issues as required by WADA.
4.7.1

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 needs to be issued. However, the Laboratory shall meet the requirements
listed below in this ISL Arts. 4.7.1.1 to 4.7.1.3.
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 theaccess to Sample storage room(s) (e.g. through the use of CCTV cameras).
4.7.1.1

Participation in WADA Assessment(s)WADA may perform one or more on-site assessment(s) to the Laboratory facility as soon as it is available
to determine whether the facility is Fit-for-Purpose. Expenses related to such a visit shall be at theLaboratory’s expense. Particular emphasis will be placed on the adequacy of security considerations, thephysical layout of the space to ensure that adequate separation of various parts of the Laboratory are
maintained, to provide a preliminary review of other key support elements and to assess compliance with
the ISL and Technical Documents and Technical Letters.
The Laboratory shall address and satisfactorily correct all noncompliances identified during the on-site
assessment(s) 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 Testingfor the Major Event.

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4.7.1.2

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 corrective action(s) for failure to
successfully complete 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 process should include any additional personnel added to the staff for the Major Event. The
EQAS samples shall be analyzed using the same Analytical Testing Procedures that will be used for the
analysis of Samples for the Major Event.
4.7.1.3

Completing a Pre-Event Report on Facilities and Staff

4.7.1.3.1 The Laboratory shall inform WADA of all senior personnel temporarily working in the
Laboratory for the Major Event.
4.7.1.3.2 The Laboratory Director shall ensure that these personnel are adequately trained in themethods, policies, and procedures of the Laboratory. Particular emphasis should be given to the Codeof Ethics and the confidentiality of the results management process. Adequate documentation of trainingof these temporary employees shall be maintained by the Laboratory.
4.7.1.3.3 At least two (2) months prior to start of Analytical Testing for the Major Event, the Laboratory
shall provide a report to WADA 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 ofurine and blood Samples and requests for specific analyses (e.g. agents affecting erythropoiesis);•

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 training plan with timelines for new staff, including temporary staff and invited scientists;•

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•List of Analytical Testing Procedures within the Laboratory’s Scope of ISO/IEC 17025 Accreditationand other method details as requested by WADA.
Any changes to the elements included in the Laboratory report should be immediately reported to WADA.
4.7.1.3.4 Additional Professional Liability Insurance CoverageLaboratories 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.

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4.7.2Major Event Analytical Testing in “Satellite” Laboratory Facilities

In addition to the accreditation requirements for Major Events listed in ISL Art. 4.7.1 above, if theLaboratory is required to move or extend its operations temporarily to a new physical location (“satellite
facility”), it shall also meet the following requirements:
4.7.2.1

Participating in an initial WADA / Accreditation Body Assessments

WADA may perform an initial on-site assessment to the Laboratory “satellite facility” as soon as it isavailable to determine whether the facility is adequate. The Laboratory shall be responsible for expenses
related to such on-site assessment(s). It is a WADA requirement that an ISL trained assessor shallparticipate in the Accreditation Body assessment of the “satellite facility”. Particular emphasis will beplaced 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.
4.7.2.2 The Laboratory shall be responsible for providing WADA with regular and timely written updates
on the progress of the testing facilities and capabilities.
4.7.2.3 All methods or equipment unique to the “satellite facility” shall be validated or qualified at leastone (1) month prior to the “satellite facility’s” final accreditation assessment by WADA. Any changes to
Test Methods, equipment or other procedures in the Quality Manual shall also be validated prior to theassessment.
4.7.2.4

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, theLaboratory must provide documentation that the relevant Accreditation Body has approved the continued
accreditation or accepted the suitability of the “satellite facility”.
4.7.2.5

Participating in WADA Accreditation Assessment(s)WADA shall perform on-site assessment(s) or document audit(s) of the “satellite facility”. Expenses
related to such visit(s) shall be at the Laboratory’s expense. These assessment(s) may include analysis
of a set of EQAS samples. Particular emphasis will be placed on involvement of new staff members toassess their competence.
4.7.2.6

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 beenobtained to cover liability associated with the analysis of Samples during the Major Event.
4.7.2.7

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.
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
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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 incompliance with ISL requirements during the Major Event.
4.7.3

Monitoring and Assessment during a Major Event

4.7.3.1 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 theobserver(s).
4.7.3.2 WADA, in conjunction with the Major Event Organization or relevant International Federation,
may submit double-blind EQAS samples to the Laboratory.
4.7.3.3 In the event of a False Adverse Analytical Finding, the Laboratory shall immediately cease
Analytical Testing for that class of Prohibited Substances or Prohibited Methods. The Laboratory shallapply 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 anAdverse Analytical Finding for the class of Prohibited Substances or Prohibited Methods for which thenoncompliance occurred shall be re-analyzed. The results of the investigation and analysis shall bepresented to WADA within twenty-four (24) hours unless otherwise agreed in writing.
4.7.3.4 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 unlessotherwise agreed in writing.

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4.8

Process for approval of Laboratories for the ABPThe network of WADA-accredited laboratories may be geographically limited to fully serve the practicaldevelopment of the ABP. Therefore, non-WADA-accredited laboratories, which have the capacity toanalyze 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 aLaboratory. This section describes the specific requirements that a laboratory shall fulfill in the processof applying for, obtaining, and maintaining WADA approval for the ABP.
4.8.1

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 (orlack thereof) for anti-doping Analytical Testing for the ABP on a regional or national scale, or for any otherreason(s).
4.8.1.1

Expression of Interest

The applicant laboratory shall officially contact WADA in writing to express its interest in becoming a
WADA-Approved Laboratory for the ABP.
4.8.1.2

Submit Initial Application Form

The applicant laboratory shall submit a completed initial application form, provided by WADA, withsupporting 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.
4.8.1.3

Provision of Letter(s) of Support

Upon receipt of an application and verification of the conditions mentioned above, WADA shall requestthat the applicant laboratory submit letter(s) of support from one or more Code-compliant Anti-Doping
Organization(s). The letter(s) of support shall indicate the estimated number of ABP blood Samples thatwill be provided per year to the applicant laboratory, as well as the reason(s) why an existing Laboratory
or WADA-Approved Laboratory for the ABP is not a viable option for the Anti-Doping Organization’s ABP
program.

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4.8.2

Candidate Laboratory for WADA approval for the ABPThe application materials described in ISL Arts. 4.8.1.1 to 4.8.1.3 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.
4.8.2.1

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:• 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 considerationsfor Samples and records (see ISL Art. 5.2.3.4);- Physical Security: specific measures to maintain a secure laboratory environment (e.g., CCTV
monitoring, restricted access to sample storage areas);- IT Security: implementation of firewalls and other current cyber security measures consistent withbest practice and any applicable governmental regulations;- 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 ofpurchase and conditions for instrument technical support (access to manufacturer maintenanceservices);• Status of the ABP method development and validation. Method validation report (if completed);• Status of ISO/IEC 17025 or ISO 15189 accreditation;• 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;and• Letter of compliance with the Code of Ethics (ISL Annex A) signed by the laboratory Director.
WADA may require an update of this documentation during the process of accreditation.
4.8.2.2

Laboratory Independence and Impartiality

In order to avoid potential conflicts of interest, the laboratory shall be administratively and operationallyindependent from any organization, which could exert undue pressure on the laboratory and affect theimpartial execution of its tasks and operations. This applies to, but is not limited to, Anti-Doping
Organizations or any other sport or political organizations.
• Administrative independence requires that the laboratory is a separate legal entity without any
administrative links to an Anti-Doping Organization or other sport or political organizations;• Operational independence requires that the laboratory shall manage its own affairs without
hindrance, interference or direction from any Anti-Doping Organization, sport organizations or any
Person.
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4.8.2.3

Compliance with the Code of Ethics (ISL Annex A)

The candidate laboratory shall implement and comply with the provision(s) of the Code of Ethics. The
laboratory shall provide the Code of Ethics to all employees responsible for the ABP analyses and ensure
their understanding and compliance with all aspects of the Code of Ethics.
4.8.2.4

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.
The laboratory shall correct and document any identified nonconformities with the ISO/IEC 17025 or
ISO 15189 requirements within defined timelines. The Accreditation Body should send a summary of theAssessment Report and any corrective/preventive action documentation addressing identified
nonconformities, in English or French, to WADA. Should the applicant laboratory prefer to send theinformation 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.
4.8.2.5

WADA On-Site Assessment for the ABP Approval

Prior to approval, WADA shall conduct an on-site assessment of the candidate laboratory at thelaboratory’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 (TechnicalDocument on “Blood Analytical Requirements for the Athlete Biological Passport”) requirements for the
ABP and to clarify any issues with regard to the approval process.
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 thecandidate laboratory to WADA within thirty (30) calendar days, or as otherwise indicated by WADA.
The nonconformities identified in the WADA Assessment Report shall be satisfactorily addressed andthe recommendations for improvement should be implemented before the laboratory can be accepted asa WADA-Approved Laboratory for the ABP. 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.
4.8.2.6

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 thisperiod, WADA may provide feedback to assist the laboratory to improve the quality of its Analytical
Testing process.

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4.8.2.7

Professional Liability Insurance Coverage

Before WADA grants approval, candidate laboratories shall provide documentation to WADA thatprofessional liability risk insurance coverage has been obtained to cover liability of no less than two (2)million USD annually.
4.8.3

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 anextension of this period.
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 thelaboratory the status of WADA-Approved Laboratory for the ABP.
4.8.3.1

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. The WADA Approval Certificate shall specify the name of the
WADA-Approved Laboratory for the ABP 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 WADA-Approved
Laboratories for the ABP shall be maintained on WADA’s website and in ADAMS for stakeholder
reference.
4.8.4

Maintaining Status as a WADA-approved Laboratory for the ABP

The laboratory shall meet the following requirements to maintain its WADA approval status for the ABP:

• Analysis of ABP blood Samples from Testing Authorities, which are Code-compliant Anti-Doping
Organizations, as determined by WADA;• 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 thehematological 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 ISL Section 5
relevant to the analysis of blood Samples;• Documented compliance with the Code of Ethics (ISL Annex A);• Maintenance of Professional Liability Insurance Coverage;

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• Implementation of Laboratory Internal Chain of Custody procedures, which are compliant with theTechnical Document on Laboratory Documentation Packages (TD LDOC);• Production of Blood ABP Laboratory Documentation Packages or Blood ABP Laboratory
Certificates of Analysis in compliance with the TD LDOC;• Cooperation in support of the administrative and legal processes instigated when anti-doping ruleviolations are issued and managed by Anti-Doping Organizations.
4.8.4.1 A laboratory’s WADA approval for the ABP may be suspended or revoked whenever the WADAApproved Laboratory for the ABP 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 statusis otherwise required in order to protect the integrity of the ABP blood Samples, the Analytical Testingprocess 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 shall be
conducted in accordance with the procedures described in ISL Art. 4.6.4.5, and any references madetherein, and the Procedural Rules found in Annex B of the ISL, all of which shall apply mutatis mutandis.

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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 thisdocument or in the relevant Technical Documents, Technical Letters or Laboratory Guidelines shall begoverned by ISO/IEC 17025. 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 WADA-accredited laboratory (i.e.
a Laboratory) or WADA-Approved Laboratory for the ABP and are therefore significant in the evaluation
and accreditation process.
This section introduces the specific performance standards for a Laboratory or WADA-Approved
Laboratory for the ABP, as applicable. The conduct of Laboratory Analytical Testing is considered aprocess within the definitions of ISO 17000. Performance standards are defined according to a processmodel where the Laboratory practice is structured into three (3) main categories of processes:
•
•
•
5.2
5.2.1

Structural and Resource Requirements;
Process Requirements;
Management Requirements.
Structural and Resource Requirements
GeneralGeneral structure and resource requirements shall be provided in accordance with the requirements of
ISO/IEC 17025.
5.2.2

Laboratory Personnel

5.2.2.1 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.
5.2.2.2 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 Chainof Custody protocols, and the Standard Operating Procedures (SOPs) for any Analytical Testing
Procedure that they perform.
5.2.2.3 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.
5.2.2.4

Laboratory Director

The Laboratory shall have a qualified Person as the Laboratory Director to assume professional,organizational, educational, operational and administrative responsibilities. 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.

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The Laboratory Director 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. In theabsence of a Doctoral degree, at least a Master’s degree 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 ofsubstances and methods used in doping;• Knowledge of drug metabolism and pharmacokinetics;• Proficiency in English to an extent that allows adequate performance of functions as part of theinternational 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 suchappointment and either approve it or reject it in accordance with the above qualifications.
5.2.2.5 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 theManagement 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 Bachelor’s 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.

5.2.2.6 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’s 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 theabsence of a bachelor’s degree, documented experience of five (5) years or more in a Laboratory as

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senior scientist (e.g. supervisor, section head) may be considered equivalent to a Bachelor’s degree
for this position;• Appropriate training and experience of three (3) years or more, as well as theoretical knowledge andtechnical 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 WADA Technical Documents, Technical Letters, Laboratory Guidelines andother technical standards;• Experience in the use of relevant analytical techniques such as chromatography, immunoassays,

electrophoresis or mass spectrometry;• Adequate training in the Laboratory’s Management System and thorough understanding of its

application into Laboratory processes.
5.2.2.7 Laboratory Supervisory Personnel
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’s 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’s
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 facility and Environmental Conditions

5.2.3.1

Environmental Control

5.2.3.1.1

Maintaining Appropriate Electrical Services• The Laboratory shall ensure that adequate electrical service is available for scientific instrumentationby provision of an alternative power supply (e.g. UPS system and/or power generators).
• All Laboratory instrumentation and equipment critical to Laboratory operations should be supported

in such a way that service is not likely to be interrupted.
• The Laboratory shall have policies in place to ensure the integrity of refrigerated and/or frozen stored

Samples in the event of an electrical failure.
5.2.3.1.2 The Laboratory shall have a written safety policy and compliance with Laboratory safety
policies shall be enforced.
5.2.3.1.3 The storage and handling of controlled substances shall comply with applicable national
legislation.
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5.2.3.2

Security of the Facility, Equipment and Systems

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.
5.2.3.2.1 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.
5.2.3.2.2 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).
5.2.3.2.3 Two (2) main levels of access shall be defined in the Management System and evaluated in
the threat assessment plan:• 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 identification badge while in the Laboratory facilities.
• 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 byvisitors shall be maintained.
Access to the Laboratory Controlled Zones shall be monitored and restricted to Laboratory staff andtemporarily approved/authorized personnel (e.g. maintenance engineers, auditing teams). All othervisitors 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.
5.2.3.2.4 The Laboratory should have a dedicated area within the Controlled Zone for Sample receipt
and Aliquot preparation.
5.2.3.2.5

The Laboratory should have a dedicated area within the Controlled Zone for Sample storage.

5.2.3.2.6 Access to stored Samples 21 shall be restricted to authorized personnel, based on a risk
assessment by the Laboratory.
5.2.3.2.7 The Laboratory may implement additional security measures, which should be assessed ona case-by-case basis.
5.2.3.3

Confidentiality of data, information and operations•

The Laboratory should implement a clean desk policy and either file securely any confidential orsensitive information or properly destroy it before disposal. Laboratory staff shall be trained on how to

21 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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comply with a clean desk policy, on how to ensure confidentiality of information and operations, as wellas on the risks of corruption attempts by third parties.
•

Laboratory staff shall be trained to protect their personal access badge during and out of working
hours.
• 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 becollected by unauthorized staff or recovered after disposal (for example, bottles should be destroyed,or trash containers should be properly sealed).
5.2.3.4

Control of Data and Computer Security

5.2.3.4.1 All reasonable measures, including a thorough risk assessment and vulnerability test, shallbe undertaken to prevent intrusion and copying of data from computer systems and to detect security
failures. Laboratories shall implement firewalls and other cyber security measures consistent with bestpractice and any applicable governmental regulations.
5.2.3.4.2 Access to computer terminals, computers, servers or other operating equipment shall be
restricted to authorized personnel (e.g. by using access passwords).
5.2.3.4.3 The Laboratory shall implement a data and information management system, a softwarebased 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 as
well as information and data exchange capabilities (e.g. with Laboratory instruments and ADAMS). The
system may also feature workflow management, data tracking support, Sample and Aliquot Laboratory
Internal Chain of Custody, control of stocks of Reference Materials, etc., which can also be addressedwith proper documentation.
5.2.3.4.4 The Laboratory shall implement a secure datafile storage system that prevents data loss (e.g.
failed hard drive), unauthorized access and destruction of data (e.g. fire, flooding). The datafile storage
system shall ensure that at least two (2) independent, regularly backed-up copies of all
analytical/LIMS/instrument software files are available. At least one (1) backup copy shall be stored in a
restricted and secure environment either in the Laboratory (e.g. fire and water-proof safe) or in a secureoff-site location (e.g. in a mirrored server located in a restricted area that guarantees the integrity of theserver and the stored data).
5.2.3.4.5 The software shall prevent the changing of results, unless there is a system to record thechange and the Person doing the editing, and that editing is limited to users with proper level of access.
5.2.3.4.6 All data entry related to the reporting of test results, recording of reporting processes and allchanges to reported data shall be recorded with an audit trail. This shall include the date and time,retention of original data, reason for the change to original data and the individual performing the task.
5.2.3.5
5.2.3.5.1

Laboratory Equipment
A list of available equipment shall be established and maintained.

5.2.3.5.2 As part of the Management System, the Laboratory shall operate a program for the
maintenance and calibration of equipment according to ISO/IEC 17025.

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5.2.3.5.3 General Laboratory equipment (fume hoods, centrifuges, evaporators, etc.) that is not used
for analytical measurements should be maintained by visual examination, safety checks, performanceverification and cleaning as necessary. Calibrations are only required where the setting can significantly
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 equipmentthat is used in Analytical Testing Procedure(s).
5.2.3.5.4 Equipment or volumetric devices used in measuring shall have periodic performance checks
and/or calibrations along with servicing, cleaning, and repair.
5.2.3.5.5

Qualified vendors may be contracted to service, maintain, and repair equipment.

5.2.3.5.6

All maintenance, service, and repair of equipment shall be recorded.

5.2.3.6

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 anticipatedeffect 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 ofcontinued accreditation and/or acceptance of suitability of the new Laboratory facility 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.

5.3

Process Requirements

The Laboratory shall maintain paper or electronic Laboratory Internal Chain of Custody in compliancewith the WADA Technical Document on Laboratory Internal Chain of Custody (TD LCOC).
5.3.1

Reception, Registration and Handling of Samples

5.3.1.1 The Laboratory may receive Samples, which have been collected, sealed and transported to
the Laboratory according to the WADA’s International Standard for Testing and Investigations (ISTI).
5.3.1.2

The transport container shall be inspected, and any irregularities recorded.

5.3.1.3 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).
5.3.1.4 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.
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5.3.1.5

Samples with irregularities

5.3.1.5.1 With the exception of the situation when a large number of Samples are received for longterm storage only (e.g. from a Major Event Organizer), as described in ISL Art. 5.3.2.3, 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 test menu, is not provided, e.g. missing or incomplete Doping Control Form (DCF);• Sample identification is questionable. For example, the number on the Sample container does notmatch the Sample identification number on the DCF;
• Athlete information is visible on the Laboratory copy of the DCF or any other document transferredto the Laboratory;• Sample identification numbers are different between the “A” and the “B” Sample containers of thesame 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 aurine 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 22.
5.3.1.5.2
following:

The Laboratory shall analyze each Sample received, unless the Sample meets any of the• Criteria described in ISL Arts. 5.3.1.7 or 5.3.1.8; or• Documented Sample rejection criteria, which have been agreed with the Testing Authority.

If justified by the irregularities observed, 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) calendar 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 ISL Art.
5.3.1.6, 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.

22 Further guidance on assessing the differences between “A” and “B” Samples is provided in a Technical Letter.

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5.3.1.5.3 Each Sample not subject to analysis shall be reported as “Not Analyzed” in ADAMS, and thereason(s) for not analyzing the Sample, as instructed by or agreed with the Testing Authority, shall be
specified (e.g. intermediate Samples of a Sample Collection Session, Samples with documented
irregularities).
5.3.1.5.4 When an analysis on a Sample with documented irregularities is performed, the Laboratory
shall record the irregularities noted in ADAMS.
5.3.1.5.5 The Results Management Authority shall determine the validity of Laboratory analyticalresults for a Sample with irregularities during the results management process.
5.3.1.6

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 and is leaking or has
been broken; the Sample’s integrity has been compromised in any way; the Sample is heavily
contaminated), the Laboratory, in consultation with the Testing Authority, should consider splitting theother Sample container (“A” or “B”, as applicable), provided that it is properly sealed. This process may
be applied repeatedly, if necessary.
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 beresealed and stored frozen for “B” Sample 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 ISL Arts. 5.3.4.5.4.8.6 and 5.3.4.5.4.8.9 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 ona specified date and time and advising the Athlete of the opportunity to observe the process in person
and/or through a representative 23. When the Athlete and/or his/her representative does not attend theopening and splitting of the Sample, the procedure shall be done in the presence of an Independent
Witness that is assigned by the Laboratory.
When the splitting procedure concerns blood Samples, which have been collected for Analytical Testingon 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. 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.
5.3.1.7
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 DCF(s), the Laboratory shall analyzeboth Samples collected, unless otherwise instructed by the Testing Authority.

23

If the Athlete chooses to witness the Sample splitting procedure, the Athlete forfeits his/her anonymity.

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The Laboratory may combine Aliquots from the two (2) Samples, if necessary, in order to have sufficientvolume to perform the required Analytical Testing Procedure(s).
5.3.1.8 In cases where the Laboratory receives three (3) or more urine Samples, which are linked to asingle Sample Collection Session from the same Athlete according to the DCF(s), the Laboratory shallprioritize the analysis of the first and the subsequent collected Sample with the highest Specific Gravity(SG), as recorded on the DCF:
• The Laboratory may conduct analyses on the additional collected Samples, if deemed necessary,with the agreement of the Testing Authority;• The Laboratory may combine Aliquots from multiple Samples, if necessary, in order to have sufficientvolume 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;• Samples not subject to analysis shall be reported as “Not Analyzed” in ADAMS, and the reason(s)for not analyzing the Sample shall be specified (e.g. additional Sample from a single Sample Collection
Session).
5.3.2

Storage of Samples 24

5.3.2.1

Storage of Urine Samples

5.3.2.1.1 In order to maintain the stability and integrity of the urine Samples, the Laboratory shall
implement Sample storage procedures that minimize time of storage at room and refrigerated
temperatures as well as Sample freeze/thaw cycles.
5.3.2.1.2 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.
5.3.2.1.3 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 otherrecords (either as hard-copy or in digital format) pertaining to those Samples.
5.3.2.1.4

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 orAtypical Finding for a minimum of three (3) months after reporting the final analytical result in ADAMS, or

24 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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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 25.
5.3.2.1.5

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 25.
5.3.2.1.6

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 AtypicalFinding for a minimum of six (6) months after reporting the final analytical result (for the “A” or the “B”
Sample, as applicable) in ADAMS 26, or for a longer period as informed to the Laboratory, in writing, by
the relevant Testing Authority, Results Management Authority or WADA 25.
5.3.2.1.7

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 ISL Arts. 5.3.2.1.4 to 5.3.2.1.6)
that the analysis of a urine Sample is challenged, disputed or under investigation, the Laboratory shallretain both the “A” and “B” Samples until further notice by the Testing Authority, the Results Management
Authority or WADA, as applicable 25.
5.3.2.2
5.3.2.2.1

Storage of Blood Samples
Samples for which Analytical Testing will be performed on blood serum/plasma fraction only
(not on cellular components):

The Laboratory shall follow the applicable Technical Document(s), Technical Letter(s) or Laboratory
Guidelines for the obtaining and storage of Sample serum or plasma fractions.
Blood Samples (“A” and “B” Samples) should be centrifuged as soon as practical after Laboratory
reception to obtain the serum or plasma fraction 27.
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 notsurpassing the maximum allowed time from Sample collection established in the applicable Technical

25 The Laboratory may charge storage costs to the Testing Authority or WADA, as applicable, for the storage ofSamples for periods longer than the stated minimum storage times.
26 If the “B” Sample Confirmation Procedure is not performed, the Laboratory may dispose of both the “A” and “B”

Samples within 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 Sample(s) for aminimum of six (6) months after reporting the “B” Sample analytical result.
27 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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Document, Technical Letter or Laboratory Guidelines) or frozen until analysis. In all circumstances, theLaboratory 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 “B” Sample collection
tube according to established protocols until analysis, if applicable 27.
All serum or plasma Samples retained for storage in the Laboratory shall be stored frozen according toestablished 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.
5.3.2.2.1.1

Serum/plasma “A” and “B” Samples without an Adverse Analytical Finding or AtypicalFinding

The Laboratory shall retain the serum/plasma “A” and “B” Samples without an Adverse Analytical Findingor 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 25.
5.3.2.2.1.2

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 25.
5.3.2.2.1.3

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 orAtypical 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 26 or for a longer period as informed to the Laboratory, inwriting, by the relevant Testing Authority, Results Management Authority or WADA 25.
5.3.2.2.1.4

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 ISL Arts. 5.3.2.2.1.1 to5.3.2.2.1.3) 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 25.
5.3.2.2.2

Samples for which Analytical Testing will be performed on cellular fractions of whole blood

Whole blood Samples shall be maintained refrigerated and shall be analyzed according to establishedprotocols. After Aliquots have been taken for analysis (if applicable), Samples shall be returned torefrigerated storage. Whole blood Samples shall not be frozen. In all circumstances, appropriate steps toensure the integrity of the Sample(s) shall be taken by the Laboratory.
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The Laboratory shall retain the whole blood Samples without an Adverse Analytical Finding or AtypicalFinding stored refrigerated in a secure location under continuous chain of custody for a minimum of one(1) month after reporting the final analytical result in ADAMS.
If, after completion of analyses on the cellular components of whole blood, the Sample is centrifuged toobtain the plasma fraction for additional analyses (e.g. Agents Affecting Erythropoiesis), then the plasma
Sample shall be stored according to ISL Art. 5.3.2.2.1.
5.3.2.3

Long-term Storage of Samples

5.3.2.3.1 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. The Laboratory
shall ensure that Samples are stored according to established protocols in a secure location undercontinuous chain of custody. The written request from the Testing Authority or WADA for long-term
storage of Samples shall be properly documented.
5.3.2.3.2 The Testing Authority shall retain the Sample collection records pertaining to all stored
Samples for the duration of Sample storage.
5.3.2.3.3 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 hardcopy 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 Substances(s) or Marker(s) of Prohibited Substances(s) or Prohibited
Method(s) (e.g. full-scan mass spectrometry data) as provided for in ISL Art. 5.3.4.5.5.9.
5.3.2.3.4 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, or to another Laboratory. If
the external sample storage facility is not covered by the Laboratory’s ISO/IEC 17025 accreditation, thenthe 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 or Laboratory
shall be recorded.
5.3.2.3.5 If Samples are transported to another Laboratory for long-term storage, the existing 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.
5.3.2.3.6 Samples transferred for long-term storage purposes are not subject to individual inspection
by the receiving Laboratory until a Sample has been selected for Further Analysis.
5.3.2.3.7 If Samples are to be stored at a location outside the secured area of the Laboratory which
first analyzed the Samples, the Laboratory shall secure the “A” Samples to be shipped either by re-sealing
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security and integrity as the original sealing system 28, or by sealing the box in which the Samples areshipped in a manner that maintains Sample integrity and chain of custody. Neither the Athlete nor his or
her representative nor an Independent Witness is required to be present for this procedure.
“B” Samples to be shipped shall be individually sealed, either in the original, sealed “B” Sample containeror, if previously opened, by re-sealing the individual “B” Sample container with a tamper-evident sealing
system, which has similar capabilities for security, and integrity as the original sealing system 28. The
resealing of the “B” Sample, if necessary, shall be witnessed by either the Athlete or his/her
representative or by an appointed Independent Witness (see ISL Art. 5.3.4.5.4.8.9 below).
5.3.2.3.8 During transport and long-term storage, Samples shall be stored at a temperatureappropriate to maintain the integrity of the Samples. In any anti-doping rule violation case, the issue ofthe 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.
5.3.2.3.9 The long-term storage facility shall maintain security requirements comparable to the security
requirements applicable to a Laboratory’s short-term storage of Samples.
5.3.3

Use, Transfer or Disposal of Samples

5.3.3.1 When the minimum applicable Sample storage period has expired, 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, the Laboratory shall do one of the following with the Sample(s):• Dispose of the Sample(s) 29;• If consent has been obtained from the Athlete, retain the Samples for research purposes. Samples

used for research purposes shall have any means of identification removed or the Sample shall betransferred into an anonymous container such that the contents cannot be traced back to a particular
Athlete. Research Samples may be transferred to other Laboratories or third parties (e.g. otherresearch groups);• If consent has not been obtained from the Athlete, retain the anonymized Samples for quality

assurance, quality improvement of existing Test Methods, development or evaluation of new 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 otherstatistical purposes, which are not considered as research. As such, these Samples may be used by
the Laboratory or transferred to other Laboratories or to third parties for these purposes.

28 For example, Samples may be resealed with resealing systems (e.g. “green” caps) produced by the manufacturerof the appropriate Sample collection equipment. The resealing system of shipped “A” Samples shall be tamperevident.
29 Disposal and long-term storage of Samples shall be conducted and recorded under the Laboratory Internal Chainof Custody.

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5.3.3.2 The Laboratory shall maintain SOP(s) pertaining to the retention, use for research or quality
assurance, transfer and disposal of Samples and Aliquots.
5.3.4

Sample Analysis

5.3.4.1

Aliquoting for Analysis

5.3.4.1.1 It is recommended that the Laboratory assigns specific staff member(s) to Sample aliquoting,and that the process of aliquoting is performed in a specifically designated area (see ISL Art. 5.2.3.2.4).
5.3.4.1.2 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.
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 orall 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.
For blood Samples, the Laboratory shall obtain Aliquot(s) from the blood Sample container by using
disposable pipettes or pipettes with disposable, non-re-usable tips.
5.3.4.1.3 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 Endogenous Anabolic Androgenic Steroids
Measuring and Reporting, TD EAAS).
5.3.4.2

Selection of Analytical Testing ProceduresStandard 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 ofrepresentative target Analytes of Prohibited Substances and Prohibited Methods.
5.3.4.3

Measurement Traceability

5.3.4.3.1

Reference Materials

When available, Reference Materials of substances traceable to a national standard or certified by a bodyof recognized status (e.g. USP, BP, Ph.Eur. WHO) or a Reference Material producer accredited to ISO
Guide 34: 2009 * or ISO 17034 should be used.
When a Reference Material is not certified, the Laboratory shall verify its identity and check its purity bycomparison with published data and/or by chemical characterization.

* until 30 November 2019.

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5.3.4.3.2

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 “invitro” 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 theanalytical data shall be sufficient to establish the identity of the Analyte.
5.3.4.4

Validation of Analytical Testing Procedures 30, 31

This Article applies only to the validation of Analytical Testing Procedures, and not to the review of theanalytical results for any Athlete Sample(s).
5.3.4.4.1

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.
5.3.4.4.1.1

Validation of Initial Testing Procedures for Non-Threshold Substances• The Laboratory shall validate the Selectivity, reproducibility of detection at the MRPL and Limit ofDetection (LOD) for the Initial Testing Procedure from the analysis of an adequate number ofrepresentative samples prepared in the appropriate matrix of analysis. For chromatography-mass
spectrometry based 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);• 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.

30 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-for-Purpose and shall be approved at least by the Laboratory Director and the Laboratory
Quality Manager.
31 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).

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5.3.4.4.1.2

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 only the substance ofinterest, 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 ofrepresentative samples prepared in the matrix of Sample analysis, in compliance with the TechnicalDocument on Minimum Criteria for Chromatographic-Mass Spectrometric Confirmation of the Identityof Analytes for Doping Control Purposes (TD IDCR) or other applicable Technical Document, Technical
Letter or Laboratory Guidelines. The Confirmation Procedure shall be able to discriminate between
compounds 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 consistently identified (in compliance with the TD IDCR
or other applicable Technical Document, Technical Letter or Laboratory Guidelines). The LOI shall not
exceed the applicable MRPL 32.
• Robustness: The Confirmation Procedure shall be demonstrated to produce similar results withrespect to minor variations in analytical conditions, which may affect the results of the analysis. Thoseconditions 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 33.

32 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 andConfirmation 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 LODof the Initial Testing Procedure. Furthermore, since LOD values are estimations based on Analytical Method
validation with a limited number of representative samples, a Laboratory may be able to effectively confirm thepresence 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 cleaner Sample with less matrix interferences).
A Confirmation Procedure for a Non-Threshold Substance shall allow the unequivocal identification of the NonThreshold Substance (or its representative Metabolite or characteristic Marker) in compliance with the TD IDCR. If
successfully identified, a Non-Threshold Substance can be reported at a concentration below the estimated LODof the Initial Testing Procedure or the LOI of the Confirmation Procedure.
33 Elimination of ‘injection memory’ effect is demonstrated by injecting a negative control sample for the Analyte inquestion, prepared in the same matrix as the Sample, immediately prior to the Sample of interest.

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5.3.4.4.2

Validation of Analytical Testing Procedures for Threshold Substances

As part of the validation process for chromatography-mass spectrometric Analytical Methods applied tothe 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
Isoform Differential Immunoassays for Doping Control Analyses, TD GH) or Laboratory Guidelines.
5.3.4.4.2.1

Validation of Initial Testing Procedures for Threshold Substances• The Laboratory shall validate Initial Testing Procedures that are Fit-for-Purpose, in accordance with
relevant WADA Technical Document(s), Technical Letter(s) or Laboratory Guidelines;• For chromatography-mass spectrometry based Initial Testing Procedures, the Laboratory shallvalidate the Selectivity, LOD and linear range from the analysis of an adequate number ofrepresentative samples prepared in the appropriate matrix of analysis 34;• The Laboratory should determine the cut-off levels, based on the estimated concentrations ofThreshold Substances, which will require quantitative Confirmation Procedure(s) 35. The Laboratory
shall validate the reproducibility of determinations at the cut-off level;• The estimation of Measurement Uncertainty (MU) is not required during the validation of Initial
Testing Procedures 34.
5.3.4.4.2.2

Validation of Confirmation Procedures for Threshold Substances

Factors to be investigated in the method validation procedure 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 ISL Art. 5.3.4.4.1.2).

• 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/Linear Range: The range of the quantitative Confirmation Procedure shall be documented
from at least 50% to 200% of the Threshold value.
• Repeatability (sr): 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 the

34 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.
35

In order to account for a possible underestimation of concentrations of Threshold Substances during nonquantitative Initial Testing Procedures, the Laboratory shall establish, and document in the method’s SOP, criteria(e.g. concentration cut-offs), determined during the Initial Testing Procedure method validation, to evaluate initial
results as a Presumptive Adverse Analytical Finding and ensure that all potentially positive Samples are subjected
to quantitative Confirmation Procedures.

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Threshold shall be determined.
• Intermediate Precision (sw): 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 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 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 for the Confirmatory Quantification of Threshold Substances (TD DL) or other applicable
Technical Document, Technical Letter or Laboratory Guidelines. At least, MU at levels close to theThreshold shall be determined.
5.3.4.4.2.3

Estimation of Measurement Uncertainty for Quantitative Analyses• MU of quantitative results, particularly at or close to the Threshold, shall be addressed during thevalidation of the quantitative Confirmation Procedure;• MU is further addressed in the TD DL and other relevant Technical Document(s) (e.g. TD GH) andLaboratory Guidelines;• 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.
5.3.4.5

Application of Analytical Testing Procedures

5.3.4.5.1 At minimum, all Laboratories are required to implement all mandatory Analytical Testing
Procedures 36, as determined by WADA in specific Technical Document(s), Technical Letter(s) orLaboratory Guidelines. Laboratories may implement additional methods for the analysis of particular

36 Mandatory Analytical Testing Procedures are those Analytical Methods for which all Laboratories shall haveavailable analytical capacity, in compliance with relevant Technical Document(s), Technical Letter(s) or Laboratory
Guidelines, and therefore shall 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 Prohibited Substances or Prohibited
Methods, Testing Authorities may decide to request Analytical Testing for specific Samples 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. The Laboratory shall report its Analytical Testing menu in ADAMS to inform the Anti-Doping
Organizations about its available Analytical Testing Procedures.

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Prohibited Substances or Prohibited Methods.
Analytical Testing Procedure(s) included in the Laboratory’s Scope of ISO/IEC 17025 Accreditation shallbe considered as Fit-for-Purpose and therefore the Laboratory shall not be required to provide Analytical
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 andthe 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 Analytical Method
validation documentation or EQAS performance data in support of an Adverse Analytical Finding (seeISL Art. 4.4.2.2).
5.3.4.5.2 Laboratories may 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), if the additional work is conducted at theLaboratory’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 as any other test result 37.
5.3.4.5.3

Application of Initial Testing Procedures

5.3.4.5.3.1
The Initial Testing Procedure(s) applied shall be recorded, as part of the Sample (orSample batch) record, each time it is conducted.
5.3.4.5.3.2
The Initial Testing Procedure(s) shall be performed on Aliquot(s) taken from the container
identified as the “A” Sample 38.
5.3.4.5.3.3

The Initial Testing Procedure(s) shall be Fit-for-Purpose.

5.3.4.5.3.4
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 Useof a Prohibited Substance or Prohibited Method.
5.3.4.5.3.5
Results from Initial Testing Procedure(s) can be included as part of longitudinal studies(e.g. endogenous steroid or haematological profiles), provided that the method is Fit-for-Purpose.

37 This does not apply to the analysis of Prohibited Substances, which are prohibited In-Competition only (as definedin the Prohibited List), if the Sample has been collected during the Out-of-Competition period. For Out-ofCompetition Testing, Laboratories shall analyze Samples only for those Prohibited Substances and Prohibited
Methods that are prohibited at all times (as defined in the Prohibited List), as well as for those relevant nonprohibited substances that are included in the WADA Monitoring Program or which are analyzed for resultinterpretation purposes (e.g. confounding factors of the “steroid profile”, non-prohibited substances that share
Metabolite(s) with Prohibited Substances), if applicable.
38 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 ISL Art. 5.3.1.6).

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5.3.4.5.3.6
All batches undergoing an Initial Testing Procedure shall include appropriate negative andpositive quality controls prepared in the matrix of analysis 39.
5.3.4.5.3.7
The Initial Testing Procedures for Non-Threshold Substances shall include appropriate
controls of representative substance(s) at or below the MRPL.
5.3.4.5.3.8
The Initial Testing Procedures for Threshold Substances shall include appropriate
controls close to the Threshold 39.
5.3.4.5.3.9
MU 39.

Results from Initial Testing Procedures are not required to consider the associated

5.3.4.5.3.10
The Laboratory shall establish criteria, based on its method validation and in accordancewith its SOP, to evaluate results from an Initial Testing Procedure as a Presumptive Adverse Analytical
Finding, which would trigger confirmation analyses. However, a Presumptive Adverse Analytical Finding
from an Initial Testing Procedure is not a necessary condition to perform Confirmation Procedures (e.g.
GC/C/IRMS analysis may be performed upon request from the Testing Authority or WADA).
5.3.4.5.3.11 A Confirmation Procedure for a Non-Threshold Substance with a reporting limit may also
be performed if the result estimated from the Initial Testing Procedure is lower than the applicable
reporting limit, as determined by the Laboratory in accordance with the Analytical Method’s validation
results.
5.3.4.5.3.12 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 39. 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 in accordance with themethod’s validation results (see ISL Art. 5.3.4.4.2.1) or as specifically required by the Testing Authority.
5.3.4.5.3.13 Performance of a Confirmation Procedure can always be decided by the Laboratory or
upon instruction from the Testing Authority. Irregularities in the Initial Testing Procedure(s) shall not inany event invalidate an Adverse Analytical Finding when such is adequately established by aConfirmation Procedure.
5.3.4.5.4

Application of Confirmation Procedures

5.3.4.5.4.1
The Confirmation Procedure(s) shall be recorded, as part of the Sample (or Sample batch)record, each time it is conducted.
5.3.4.5.4.2
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.
5.3.4.5.4.3
The Confirmation Procedure(s) shall be Fit-for-Purpose, including the estimation of the
MU associated with a quantitative Confirmation Procedure.
5.3.4.5.4.4
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

39 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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Confirmation Procedure should incorporate, when possible and adequate, a different Sample extraction
protocol and/or a different analytical methodology 40.
5.3.4.5.4.5
All batches undergoing a Confirmation Procedure shall include appropriate negative andpositive quality controls prepared in the matrix of analysis.
5.3.4.5.4.6

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 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 theConfirmation Procedure if Fit-for-Purpose;• 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 potentialof cross-reactivity. The Laboratory shall document, as part of the method validation, the Fitness-forPurpose of any such purification or separation method;• In 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 theaffinity-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 cellularcharacteristics. When the purpose of the test is to identify populations of blood constituents, thedetection of multiple Markers on the cells as the criteria for an Adverse Analytical Finding replaces therequirement for two (2) antibodies recognizing different antigenic epitopes.
[Comment: 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].

40

Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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5.3.4.5.4.7“A” Sample Confirmation Procedure

5.3.4.5.4.7.1 The “A” Confirmation Procedure shall be performed using new Aliquot(s) taken from thecontainer identified as the “A” Sample 41. At this point, the link between the Sample external code asshown in the Sample container and the Laboratory internal Sample code shall be verified.
5.3.4.5.4.7.2 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 theInitial 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 volume available in the “B”
Sample).
The confirmation(s) shall prioritize the identification 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 and recorded.
5.3.4.5.4.7.3 When there is a Presumptive Adverse Analytical Finding for Amfetamine, Methylphenidate,
Beta-2 Agonists, Diuretics, Glucocorticoids or Beta-blockers, or for any other Prohibited Substance or
Prohibited Method whose Use has been declared by the Athlete on the DCF, the Laboratory may contact
the Testing Authority to enquire whether an approved Therapeutic Use Exemption (TUE) exists for theProhibited Substance(s) detected 42, 43. When possible, the Laboratory should provide the concentrationof the Analyte(s) as estimated during the Initial Testing Procedure. Any such contact with the Testing
Authority shall be confirmed in writing (for further guidance, refer to the Laboratory Guidelines on TUE
enquiries).
The instruction by the Testing Authority on whether the Laboratory shall proceed or not with theconfirmation based on an approved TUE shall be provided to the Laboratory in writing. If not proceedingwith the confirmation, then the Testing Authority shall provide WADA with a copy of the approved TUE
or the associated TUE number if the TUE has been submitted into ADAMS.
No final Test Report incorporating a Presumptive Adverse Analytical Finding shall be issued 44. In cases

41 In cases when the “A” Sample cannot be used, the “A” Confirmation Procedure may be performed on an Aliquotof the split “B” Sample (see ISL Art. 5.3.1.6).
42 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 areconsidered Threshold Substances and are permitted by inhalation only up to a maximum dose (e.g. salbutamol,
formoterol and salmeterol). 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.
43 However, unless there is a prior agreement between the Testing Authority and the Laboratory, contacting theTesting Authority in such cases does not constitute an absolute requirement for the Laboratory. The Laboratory
may proceed to confirm the Presumptive Adverse Analytical Finding for Amfetamine, Methylphenidate, Beta-2Agonists, Glucocorticoids, Diuretics, Beta-blockers or a declared Prohibited Substance or Prohibited Method andreport an Adverse Analytical Finding in ADAMS according to the confirmation results obtained. In such cases, theexistence or absence of an approved TUE shall be taken into consideration during the results management process.
44 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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when the Testing Authority confirms to the Laboratory the existence of an approved TUE for theProhibited Substance, the Laboratory shall report the result as a Negative Finding as instructed by the
Testing Authority.
In cases of a resulting Adverse Analytical Finding or Atypical Finding, the existence or not of an approved
TUE (or the possibility to obtain a retroactive TUE) shall be taken into consideration during the results
management process.
5.3.4.5.4.7.4 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.
5.3.4.5.4.7.5 “A” Sample Confirmation Procedure for Non-Threshold Substances
For Non-Threshold Substances without reporting limits, Adverse Analytical Finding or Atypical Finding
decisions for the “A” Sample results shall be based on the identification of the Non-Threshold Substanceor 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 reporting limits as specified in the TD MRPL, Adverse Analytical
Finding decisions for the “A” Sample results 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 reporting limit, unless there is further evidence justifying thereporting of the finding at levels below the reporting limit (e.g. declared use of the Prohibited Substanceor if the analysis forms part of an ongoing investigation).
5.3.4.5.4.7.6 “A” Sample Confirmation Procedure for Threshold Substances
For Threshold Substances, Adverse Analytical Finding or Atypical Finding decisions for the “A” 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
and/or its Metabolite(s) or Marker(s) and their quantitative determination in the Sample at a levelexceeding 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. 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).
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 45. If there is not enough Sample volume to analyze three (3) Aliquots, the maximum number of
Aliquots that can be prepared should be analyzed.

45 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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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 forthe “A” Sample results 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) orMarker(s) (e.g. GC/C/IRMS). Atypical Findings may result from non-conclusive determinations of theorigin (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
if detected in the presence of any Prohibited Substance classified under Section 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.
5.3.4.5.4.8“B” Sample Confirmation

5.3.4.5.4.8.1 A “B” Confirmation Procedure shall be performed using Aliquot(s) taken from the container
defined as the “B” Sample 46.
5.3.4.5.4.8.2 The “B” Sample confirmation shall be performed in the same Laboratory as the “A” Sample
confirmation, unless there are exceptional circumstances, as determined by WADA and with WADA’s
prior written approval, which prevent the “B” Sample confirmation from being performed in the same
Laboratory.
5.3.4.5.4.8.3 It is the responsibility of the Testing Authority and/or Results Management Authority, as
applicable, to inform the Laboratory, in writing, whether the Athlete has waived his/her right to the analysisof the “B” Sample and, therefore, whether or not the “B” Confirmation Procedure will be performed. This
information shall be provided within the minimum Sample storage requirements established in ISL Arts.
5.3.2.1 and 5.3.2.2.
The Testing Authority and/or Results Management Authority, at its discretion, may decide to proceed withthe “B” Sample analysis, and inform the Laboratory accordingly, even when the Athlete waives his/herright to the “B” Sample analysis or if the Athlete does not respond to requests on his/her decision to
perform the “B” Sample analysis.
5.3.4.5.4.8.4 The Testing Authority or Results Management Authority should contact the Laboratory toprovide information and/or instructions in writing regarding the “B” Sample analysis within ten (10)working days following the notification of an “A” Sample Adverse Analytical Finding by the Laboratory.
5.3.4.5.4.8.5 The “B” Sample confirmation should be performed as soon as possible, and no later than
three (3) months, following the reporting of the “A” Sample Adverse Analytical Finding.
5.3.4.5.4.8.6 The following non-Laboratory Persons shall be authorized to attend the “B” Sample

46 In cases when the “B” Sample cannot be used for Analytical Testing the unopened, sealed “A” Sample may be

split (see ISL Article 5.3.1.6) 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.

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Confirmation Procedure:• The Athlete and/or one representative 47 of the Athlete or, in the absence of the Athlete and/or
representative, an Independent Witness 48;•

A translator (if applicable);• A representative of the Testing Authority or the Results Management Authority (if requested by the
Testing Authority or the Results Management Authority, respectively);• A representative of WADA or of WADA’s Independent Observers (IO) Team for Major Events (ifrequested by WADA or the IO team, respectively);• A representative of the National Olympic Committee and/or National Sport Federation and/orInternational Federation, as applicable, may also attend the “B” Sample opening procedure, uponrequest and with prior approval by the Laboratory Director.
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 or 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 and 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.
At a minimum, the Laboratory Director or representative and the Athlete or his/her representative and/or
the Independent Witness shall sign the Laboratory documentation attesting to the above. A refusal of theAthlete and/or his/her representative, or of the Independent Witness to sign, and the reasons of therefusal, shall be recorded.
5.3.4.5.4.8.7 The timing of the “B” Confirmation Procedure may be strictly fixed in the short term with nopostponement possible, when circumstances justify it. This can notably and without limitation be the casein the context of Testing during or immediately before or after Major Events, or when the further
postponement of the “B” Sample analysis could significantly increase the risk of Sample degradation.
5.3.4.5.4.8.8 The Laboratory Director may limit the number of individuals in Controlled Zones of theLaboratory based on safety or security considerations. Persons attending shall not interfere with the “B”

47 The Athlete and/or one (1) designated representative, and/or the Independent Witness have the fundamental

right to attend the “B” Sample opening, aliquoting and resealing procedures. These Persons may also havereasonable opportunity to observe other steps of the “B” Sample Confirmation Procedure, as long as their presencein the Laboratory does not interfere with the Laboratory’s routine operations or Laboratory safety or security
requirements. The Athlete may however be represented or assisted by a maximum of two (2) representatives during
the initial phase of the “B” Sample opening procedure.
48 An Independent Witness may also attend even if the Athlete is present and/or represented.

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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 beconstitutive of an anti-doping rule violation in accordance with Code Art. 2.5, “Tampering, or Attempted
Tampering with any part of Doping Control”.
5.3.4.5.4.8.9 The Laboratory shall ensure that, after opening and taking Aliquots for the “B”
Confirmation Procedure, the “B” Sample is properly resealed in the presence of the Athlete or his/her
representative or the Independent Witness, as applicable, who shall all sign the Laboratory
documentation attesting to the above. If present, the Athlete or the Athlete’s representative shall beoffered the opportunity to select the resealing equipment for the “B” Sample container from several
identical/sealed items. A refusal of the Athlete and/or his/her representative, or of the Independent
Witness to sign, and the reasons of the refusal, shall be recorded.
5.3.4.5.4.8.10 If more than one (1) Prohibited Substance, Metabolite(s) of a Prohibited Substance, orMarker(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 carrythe longest potential period of Ineligibility. The decision should be made in consultation with the Testing
Authority and documented.
5.3.4.5.4.8.11 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. Each repeat confirmation shall be performed using
Aliquot(s) different from the one(s) already analyzed. Each Aliquot used shall be recorded.
5.3.4.5.4.8.12 If the final “B” Sample confirmation results are negative, the Analytical Testing result shallbe considered a Negative Finding. The Laboratory shall notify the Testing Authority 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 five (5) working days 49.

49 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 Confirmation Procedures of the “A”
and the “B” Samples. This does not mean that the “B” confirmation results are negative, as long as the Analyte(s)targeted allows the unequivocal and conclusive identification of the Prohibited Substance or Prohibited Method in
the “B” Sample.

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5.3.4.5.4.8.13“B” Sample Confirmation Procedure for Non-Threshold Substances and exogenous
Threshold Substances

For Non-Threshold Substances (including those with reporting limits as specified in the TD MRPL) andexogenous Threshold Substances, the “B” Sample results shall only confirm the “A” Sample identification(in compliance with the TD IDCR) for the Adverse Analytical Finding to be valid 50. No quantification orreported estimation of concentrations of such Prohibited Substance, or its Metabolite(s) or Marker(s) is
necessary.
5.3.4.5.4.8.14“B” Sample Confirmation Procedure for endogenous Threshold Substances

For endogenous Threshold Substances, Adverse Analytical Finding or Atypical 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 levelexceeding the value of the relevant Threshold as specified in the TD DL or other applicable TechnicalDocument(s) or Laboratory Guidelines. The mean value determined in the “B” Sample does not need tobe identical to the mean value determined in the “A” Sample.
“B” Sample quantitative Confirmation Procedures for endogenous Threshold Substances shall be basedon the determination of the mean of measured analytical values (e.g. concentrations, chromatogram peakheights or areas) or the ratio/score calculated from the mean(s) of the measured analytical values ofthree (3) “B” Sample Aliquots 50. If there is not enough Sample volume to analyze three (3) Aliquots, themaximum 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 endogenously at low levels, Adverse Analytical Finding decisions forthe “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) orMarker(s) (e.g. GC/C/IRMS). Atypical Findings may result from non-conclusive determinations of theorigin (endogenous vs. exogenous) of the Prohibited Substance or its Metabolite(s) or Marker(s).
5.3.4.5.5 Further Analysis
5.3.4.5.5.1
Samples may be selected for Further Analysis at the discretion of the Testing Authority.
WADA may also direct the Further Analysis of stored Samples at its own expense. In such cases, WADA
shall notify the Testing Authority and Results Management Authority, which shall retain ownership of the
Sample(s) pursuant to ISTI Art. 10.1.
5.3.4.5.5.2
The choice of which Laboratory will conduct the Further Analysis will be made by the
Testing Authority or WADA, as applicable.
5.3.4.5.5.3
Requests to the Laboratory for Further Analysis shall be made in writing and be recorded
as part of the Sample’s documentation.
5.3.4.5.5.4

Further Analysis of Samples shall be performed under the ISL, Technical Documents,

50 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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Technical Letters and Laboratory Guidelines in effect at the time the Further Analysis is performed.
5.3.4.5.5.5
Further Analysis 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). However, Further Analysis shall not be aimed at detecting substances or methods, which are
no longer prohibited at the time of Further Analysis.
[Further Analysis may not be applied on a Sample, which is the subject of an ongoing Hearing Process, after the
responsible Anti-Doping Organization has notified the Athlete that the Sample is a basis for an asserted Code Art.
2.1 anti-doping rule violation, without the consent of the Athlete or approval from the Hearing Body.
When a Sample has been reported as a Negative Finding or Atypical Finding, there is no limitation on the Testing
Authority or WADA to conduct Further Analysis on the Sample.
When an Adverse Analytical Finding has been previously reported in relation to a Sample and a Code Art. 2.1 antidoping rule violation has been asserted against the Athlete (i.e. after results management for a Code Art. 2.1 antidoping rule violation in relation to the Sample has been completed), Further Analysis should not seek to detect theProhibited Substance(s) or Prohibited Method(s) that were the basis of the previously asserted anti-doping ruleviolation. Therefore, the Anti-Doping Organization requesting the Further Analysis should inform the Laboratory of
any previous Adverse Analytical Finding reported for the Sample(s) subject to Further Analysis. If previously
reported Prohibited Substance(s) or Prohibited Method(s) are detected during the Initial Testing Procedure of
Further Analysis, there is no need to conduct the corresponding Confirmation Procedure. However, if theConfirmation Procedure is conducted, and the previously reported Prohibited Substance(s) or Prohibited Method(s)are confirmed, there is no need to report these results again 51. If the results are nevertheless reported, this issue
shall be addressed by the Results Management Authority during the results management process].

5.3.4.5.5.6
Further Analysis includes, notably, but without limitation, the application of newly
developed or more sensitive Analytical Testing Procedures and/or the analysis of new target Analytes ofProhibited Substance(s) or Prohibited Method(s) [e.g. Metabolite(s) and/or Marker(s)], which were notknown 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 (inparticular, but without limitation, to analyses based on new or improved Analytical Testing Procedures).
5.3.4.5.5.7•

Further Analysis shall proceed as follows:

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

51 The result should have been already reported in ADAMS and should not be reported again. In the absence ofinitial instructions, the Laboratory shall seek instructions from the Testing Authority or WADA, as applicable.

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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” Sample Confirmation Procedure shall be applicable(as per ISL Art. 5.3.4.5.4.8).

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 ISL Art. 5.3.1.6. 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 toattend the Analytical Testing Procedures to be performed on the first split fraction of the “B” Sample(unless the Testing Authority requests otherwise) 52. 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, thesecond 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 ISL Art. 5.3.4.5.4.8.
5.3.4.5.5.8
Further Analysis may be performed on stored Samples that were previously reported ashaving Adverse Analytical Findings or Atypical Findings. Any new Prohibited Substance or Prohibited
Method detected shall be reported even if the Athlete was already sanctioned for a different Adverse
Analytical Finding 53.
5.3.4.5.5.9
Previously acquired Initial Testing Procedure data may also be re-evaluated for thepresence of Prohibited Substances or their Metabolites(s) or Markers(s) of Prohibited Substances or
Prohibited Methods, at the initiative of the Testing Authority, the Results Management Authority, WADAor 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.
5.3.4.5.6 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).

52 Since the first split fraction of the “B” Sample is considered as an “A” Sample, analysis of Aliquots taken from thisSample 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).
53 See ISL Article 5.3.4.5.5.5 with respect to the reporting of Prohibited Substance(s) or Prohibited

Method(s)previously reported as an Adverse Analytical Finding.

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5.3.5Results Management

5.3.5.1

Review of Results

5.3.5.1.1 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.
5.3.5.1.2 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 andapproval of the analytical run/batch shall be recorded.
5.3.5.1.3 At a minimum, the review of Adverse Analytical Findings and Atypical Findings shall include:• Documentation linking the Sample external code (as specified in the DCF) to the Laboratory internal
Sample code;•

Laboratory Internal Chain of Custody documentation;•

Initial Testing Procedure(s) and Confirmation Procedure(s) analytical data and calculations;•

Quality control data;•

Completeness of technical and analytical documentation supporting the reported findings;•

Compliance of test data with the Analytical Testing Procedure’s validation results (e.g. MU);

• Assessment of the existence of significant data or information that would cast doubt on or refutethe Laboratory findings 54;• When the Confirmation Procedure result(s) are rejected as Adverse Analytical Finding(s) or AtypicalFinding(s) based on the results review, the reason(s) for the rejection shall be recorded.
5.3.5.2

Documentation and Reporting

5.3.5.2.1 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 theTechnical Document on Laboratory Documentation Packages (TD LDOC).
5.3.5.2.2 Each step of Analytical Testing shall be traceable to the staff member who performed that step.
5.3.5.2.3 Significant deviation from a written SOP shall be recorded.
5.3.5.2.4 Where instrumental analyses are conducted, the operating parameters for each run shall be
included as part of the record.
5.3.5.2.5 Reporting of “A” Sample results should occur in ADAMS within fifteen (15) working days ofreceipt of the Sample.

54 The Laboratory should consider the prevailing scientific knowledge regarding, for example, the possibility ofSample 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.

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The reporting time required for specific occasions (e.g. Major Events) may be substantially less thanfifteen (15) working 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.
5.3.5.2.6 Test Report
5.3.5.2.6.1
The Laboratory shall record the test result for each individual Sample in ADAMS with themandatory information stipulated, in compliance with the relevant Technical Document, Technical Letteror Laboratory Guidelines, the items stipulated in ISO/IEC 17025, and the following:•

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) – see ISL Art. 5.3.5.2.6.6;•

Specific tests performed, in addition to the Laboratory routine test menu (e.g. ESA, GC/C/IRMS,
hGH, blood transfusions, DNA, genomic profiling, etc.);•

Any irregularities noted on Samples.

5.3.5.2.6.2
The Laboratory is not required to provide any additional Test Report, either in hard copy
or digital format, other than the submission in ADAMS (except as described in ISL Arts. 5.3.5.2.6.8 and5.3.5.2.6.12). All Code-compliant Testing Authorities shall be able to access the Test Reports of theirSamples in ADAMS. The Laboratory should record the ADAMS Test Report as part of the Sample’s
documentation.
5.3.5.2.6.3•

Test Report for Non-Threshold Substances“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 ofProhibited 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 55.
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 thedetected level of the Non-Threshold Substance(s), its Metabolite(s), or Marker(s) may be relevant to theresults management of an anti-doping case. In such instances, the Laboratory should indicate theestimated 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 beenvalidated for quantitative purposes.

55 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.

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•“B” Sample Test Report

For Non-Threshold Substances, the Laboratory report for the “B” Sample shall only establish thepresence (i.e. the identity) of the Prohibited Substance(s) or its Metabolite(s) or Marker(s) in accordancewith the TD IDCR or other applicable Technical Document(s) 55.
However, the Laboratory should provide estimated concentrations, when possible and for information
purposes only, if requested by the Testing Authority, Results Management Authority or WADA, if thedetected level of the Non-Threshold Substance(s), its Metabolite(s), or Marker(s) may be relevant toresults management of an anti-doping case. In such instances, the Laboratory should indicate theestimated 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 beenvalidated for quantitative purposes. Differences in the estimation of the detected levels of Non-Threshold
Substance(s), its Metabolite(s), or Marker(s) between the “A” and “B” Confirmation Procedures do notaffect the validity of the reported results.
5.3.5.2.6.4•

Test Report for Threshold Substances“A” Sample Test Report

For Threshold Substances, the Laboratory Test Report for the “A” Sample shall establish that theidentified 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 DL, 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 shallestablish the presence (i.e. the identity) of the Prohibited Substance(s) and/or its Metabolite(s) inaccordance 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 theestimated concentration of the Threshold Substance(s), indicating that the levels detected may havebeen impacted by the presence of the diuretic(s) or masking agent(s).
•“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 Prohibited Substance(s) or its Metabolite(s) or Marker(s) inaccordance with the TD IDCR.
For endogenous Threshold Substances, the Laboratory Test Report for the “B” Sample shall establishthat 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 theProhibited 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 shallestablish the presence (i.e. the identity) of the Prohibited Substance(s) and/or its Metabolite(s) inaccordance with the TD IDCR and the TD DL and report it as an Adverse Analytical Finding, in addition
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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).
5.3.5.2.6.5

The Laboratory shall qualify the result(s) of the analysis in the ADAMS Test Report as:•

Adverse Analytical Finding; or•Atypical Finding; or•Negative Finding; or•

Not-Analyzed: any Sample received at the Laboratory and not subject to Analytical Testing for avalid, documented reason such as Sample irregularities, intermediate Samples, etc. (see ISL Arts.
5.3.1.5.2 and 5.3.1.5.3).
5.3.5.2.6.6
The Laboratory shall have a policy regarding the provision of opinions and interpretationof 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.
[Comment: 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.]

5.3.5.2.6.7
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 requiredby specific WADA 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 a period of Suspension or Analytical Testing Restriction), or requested at thediscretion 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 recorded as part of the Sample’s
documentation. Any transfer of data and information necessary for the second opinion shall be madesecurely and respecting the confidentiality of the analytical data and any other information.
The responsibility for the result shall be of the Laboratory that performed the analysis and issued the final
Test Report.
5.3.5.2.6.8
Upon request by WADA, the Laboratory shall report a summary of the results of analyses
performed in a format specified by WADA.
5.3.5.2.6.9
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).
5.3.5.2.6.10 Requests for information by the Testing Authority, Results Management Authority or
WADA to a Laboratory shall be recorded in writing.
5.3.5.2.6.11
Presumptive Adverse Analytical Findings (when applicable – see ISL Art. 5.3.4.5.4.7.3),
Adverse Analytical Findings and Atypical Findings shall be reported in writing.

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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.
5.3.5.2.6.12 The Laboratory shall also provide any information requested by WADA in relation to theMonitoring Program (Code Art. 4.5).
5.3.5.2.7

Laboratory Documentation Package and Certificate of Analysis

5.3.5.2.7.1
Laboratory Documentation Packages and Certificates of Analysis shall be in compliancewith the TD LDOC.
5.3.5.2.7.2
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.
5.3.5.2.7.3
The Laboratory Documentation Package and/or Certificate 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) working days of the request, unless a different deadline is agreed with theResults Management Authority or WADA, respectively.
5.4Management Requirements

5.4.1

Organization

5.4.1.1 Within the framework of ISO/IEC 17025, the Laboratory shall be considered as a testinglaboratory.
5.4.1.2 The Laboratory Director shall have the responsibilities of the Chief Executive of the Laboratory,
unless otherwise noted.
5.4.2

Assuring the Quality of Analytical Results

5.4.2.1

The Laboratory shall participate in the WADA EQAS.

5.4.2.2 Analytical performance shall be monitored by operating quality control schemes appropriate to
the type and frequency of Analytical Testing performed by the Laboratory. The range of quality control
activities include, but are not limited to:•Appropriate positive and negative quality control samples (QCs) shall be included in every analyticalrun both for the Initial Testing Procedure(s) and Confirmation Procedure(s) 56;•

Appropriate internal standard(s) shall be used for chromatography methods;

56 Unless otherwise specified in a WADA Technical Document, Technical Letter or Laboratory Guidelines.

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•

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).
5.4.2.3

Internal Quality Assurance Scheme (iQAS)

5.4.2.3.1 The Laboratory shall establish a functional and robust iQAS program, in accordance with therequirements 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 thatprevents the submission of iQAS results into ADAMS.
5.4.2.3.2 The iQAS plan shall include the proficiency testing of 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.
5.4.2.3.3 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).
5.4.2.4

Internal Audits

Internal audits shall be completed in accordance with the requirements of ISO/IEC 17025, and shall havea dedicated SOP incorporating a detailed procedure for the planning and performance of the audits, thetraining 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 Person does not audit
his/her own area.
Internal audits shall be carried out by qualified Laboratory staff members. In addition, qualified membersof the Laboratory's host organization (e.g., university, institute, company) may also be included in theinternal auditing teams.
5.4.2.5

External Audits

Laboratories may also consider having their procedures and systems audited by other Laboratory
Directors or external auditing experts. However, this shall not replace the performance of internal audits
by the Laboratory.
5.4.2.6

All quality control procedures shall be documented by the Laboratory.

5.4.3

Management Reviews

Management reviews will be conducted to meet the requirements of ISO/IEC 17025.
5.4.4

Document Control

The control of documents that make up the Management System shall meet the requirements of ISO/IEC
17025.

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5.4.4.1 The Laboratory Director (or designee) shall approve the Management System documentation
and all other documents used by staff members involved in Analytical Testing.
5.4.4.2 The Laboratory shall implement a procedure in its Management System to ensure that thecontents of ISL, WADA Technical Documents, Technical Letters and Laboratory Guidelines areincorporated into the Laboratory’s SOPs by the applicable effective date and that implementation iscompleted, assessed, audited and recorded. 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 priorapproval by WADA, shall be considered a noncompliance and may affect the Laboratory accreditation
status.
5.4.5

Control and Storage of Technical Records

5.4.5.1 A copy of all Samples’ records, including Sample and Aliquot chain of custody, instrument
records, calculations, etc., shall be kept in a secure storage for a minimum of two (2) years. After two (2)years, and up to ten (10) years, the relevant records shall be kept in secure storage until Sample disposal.
5.4.5.2 An electronic copy of the analytical raw data and any data analysis review files shall be stored
for ten (10) years for all Samples.
5.4.6

Control of Nonconformities in Analytical Testing

5.4.6.1 The Laboratory shall have policies and procedures that shall be implemented when any aspectof its Analytical Testing does not comply with set requirements.
5.4.6.2 Any nonconformities in Analytical Testing shall be recorded and kept as part of the
documentation of the Sample(s) involved.
5.4.6.3

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 a thorough Root Cause
Analysis of the nonconformity.
5.4.6.4

Improvement

The Laboratory shall maintain, and when appropriate improve, the effectiveness of its Management
System in accordance with ISO/IEC 17025.
5.4.7

Reviewing of Requests, Tenders and Contracts

Review of legal documents or agreements related to Analytical Testing shall meet the requirements of
ISO/IEC 17025.

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5.4.8Subcontracting of Analysis

5.4.8.1 A Laboratory or WADA-Approved Laboratory for the ABP shall perform all work with qualified
personnel and equipment within its accredited or approved facility, respectively.
5.4.8.2 A Laboratory may subcontract an analysis to another Laboratory, in consultation with theTesting Authority (for example, in the case of a specific technology or Analytes that are not within the
Laboratory’s Scope of ISO/IEC 17025 Accreditation, an Analytical Testing Restriction decision, or as aresult of other justifications such as a need for higher sensitivity or specific equipment or expertise,workload or temporary 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 this 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 57. 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.
5.4.8.3 When subcontracting an analysis, Laboratories should follow the WADA Laboratory Guidelines
on “Conducting and Reporting Subcontracted Analysis and Further Analysis for Doping Control”.
5.4.9

Purchasing of Services and Supplies

5.4.9.1

Chemicals and Reagents

5.4.9.1.1 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 documents. 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.
5.4.9.1.2 In the case of rare or difficult to obtain Reference Materials, or Reference Collections for use
in qualitative Analytical Testing Procedures, the expiration date of the solution can be extended if
adequate documentation exists confirming that no significant deterioration has occurred or thatappropriate 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.
5.4.9.1.3 The Laboratory shall maintain control and proper records of use of controlled chemicals andreagents in accordance with national laws and other relevant regulations.
5.4.9.1.4

Waste disposal shall be in accordance with national laws and other relevant regulations. This

57 Or directly contracted by the Testing Authority. In this case, the Laboratory shall nevertheless be in charge ofensuring the Sample chain of custody in connection with the transfer of the Sample to the other Laboratory or expert
as the case may be.

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includes biohazard materials, chemicals, controlled substances, and radioisotopes, if used.
5.4.9.1.5 Environmental health and safety policies shall be in place to protect the staff, the public, andthe environment.
5.4.10

Cooperation with Customers and with WADA

5.4.10.1 Cooperation with customers shall be handled in accordance with ISO/IEC 17025.
5.4.10.2 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 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 (notincluding commercial or financial information) with Testing Authorities, which are Code-compliant AntiDoping Organizations, as determined by WADA, or Sample Collection Authorities working on behalf ofCode-compliant Anti-Doping Organizations] upon request to ensure conformity with the rules
established under the Code as part of the maintenance of WADA accreditation. This information shallbe treated in a confidential manner.
5.4.10.3

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 inregard to specific timing, report information, or other support needs. These interactions should occur ina timely manner and should include, but are not limited to, the following:• Communicating with the Testing Authority and/or Result Management Authority concerning any
significant question of Analytical Testing needs or any unusual circumstance in the Analytical Testingprocess (including delays in reporting);• Providing complete, timely and unbiased explanations to the Testing Authority and/or Result
Management Authority when requested or when there is a potential for misunderstanding of any aspectof 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;• Responding to any complaint submitted by a Testing Authority or Results Management Authority
concerning the Laboratory and its operation.

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5.4.10.3.1
As required by ISO/IEC 17025, the Laboratory shall actively monitor the quality of theservices 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.
5.4.11

Complaints

Complaints shall be handled in accordance with ISO/IEC 17025.

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6.0 WADA External Quality Assessment Scheme (EQAS)
WADA regularly distributes urine or blood External Quality Assessment Scheme (EQAS) samples toLaboratories and, when applicable, to probationary laboratories. The WADA EQAS is designed tocontinually monitor the capabilities of the Laboratories and probationary laboratories, to evaluate theirproficiency, and to improve test result uniformity between Laboratories. EQAS samples are used toassess 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 WADAspecific 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 ISL Art. 4.4.2.2) before thesubsequent 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 participating in the EQAS are expected to haveanalyzed the minimum total number of EQAS samples.

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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.
6.2.1.1 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 thefollowing 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) to be analyzed withspecific Analytical Testing Procedure(s), which are not part of the Laboratory’s routine Analytical
Testing menu;• As part of WADA Laboratory on-site 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). Laboratories shallanalyze these samples using their routine Initial Testing Procedures and Confirmation Procedures.
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 noncharacteristic 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).
6.2.2.3 EQAS Samples Containing Prohibited Substance(s), their Metabolite(s) or Marker(s), or theMarker(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).

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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 shallreflect as closely as possible the expected target Analyte Metabolite pattern and concentrations usuallyfound in Samples 58.
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 asingle Prohibited Substance or Markers of a Prohibited Method, which would represent the presence ofa single Prohibited Substance or the Use of a single Prohibited Method.
6.2.2.4 Blood EQAS Samples for the analysis of ABP blood Markers
These EQAS samples are distributed to Laboratories and WADA-Approved Laboratories for the ABP ona regular basis (e.g. monthly) with the purpose of evaluating their proficiency in the analysis and reportingof the blood Markers that constitute the hematological module of the ABP.
6.2.2.5 For Non-Threshold Substances, the concentration in the EQAS sample will be guided by, but notlimited to, one of the following criteria:• Concentrations of the Prohibited Substance and/or its Metabolite(s) or Marker(s) equal to or greaterthan the applicable MRPL (refer to TD MRPL);• 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 andwith no reporting limits, as per TD MRPL);• Non-Threshold Substances with reporting limits 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 reporting limit;• Concentrations of the Prohibited Substance and/or its Metabolite(s) or Marker(s) below 50% of theapplicable MRPL (for Non-Threshold Substances prohibited at all times with no reporting limits, foreducational purposes).
6.2.2.6 For Threshold Substances, the concentration in the EQAS sample will be guided by, but notlimited to, one of the following criteria:• Greater than 50% of the Threshold as established in the relevant Technical Document(s) orLaboratory Guidelines;• 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.

58 To the extent possible (in consideration, for example, of ethical constraints, availability of the pharmaceuticalgrade 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 preparedfrom controlled administration studies.

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6.2.2.7 Laboratories shall determine the Markers of the “steroid profile” in all urine EQAS samples (unlessspecifically not required in an educational EQAS sample).
6.3

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 tobe employed in the analysis of EQAS samples (i.e. using the Analytical Testing Procedures applied inroutine Analytical Testing).
6.4

Reporting of EQAS results

The purpose of the EQAS program is to ensure that all Laboratories maintain proficiency in theperformance of their Analytical Testing Procedures and report the 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 berequested for blind EQAS samples.
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 thequality 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 shallnot 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).
6.4.1 Reporting Blind EQAS Results
The Laboratory shall report the results of blind EQAS samples to WADA in ADAMS in the same manneras specified for routine Samples (see ISL Art. 5.3.5.2.6) unless otherwise notified by WADA. For someblind 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 date unless anextension is granted by WADA for valid reasons. For a failure to report results of blind EQAS samples
within the established deadline, without prior approval by WADA, the Laboratory shall receive two (2)penalty points, and an additional two (2) penalty points per week beyond the applicable deadline (referto the ISL Points System Table in Art. 7.3).

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6.4.2 Reporting Double-Blind EQAS Results
The Laboratory shall report the results of double-blind EQAS samples in ADAMS as per ISL Art. 5.3.5.2.6.
Reporting of results should occur within fifteen (15) working days of receipt of the samples, unless anextension 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.
Subject to an extension of the above deadline by agreement or otherwise, or to a request based onjustified grounds, as determined by WADA, failure to report results of double-blind EQAS samples in
ADAMS within thirty (30) calendar days of receipt of the samples, shall carry two (2) penalty points andan additional two (2) penalty points per week beyond the applicable deadline (refer to the ISL Points
System Table in Art. 7.3).
6.4.3 Reporting Educational EQAS Results
The Laboratory shall report the results of open or blind educational EQAS samples on or before thespecified 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.
6.4.4 Reporting Results for EQAS Samples Containing Non-Threshold Substance
6.4.4.1 Unless otherwise specified by WADA (for example, for 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, 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 theLaboratory report the estimated concentrations of the confirmed Analyte(s).
6.4.4.2 For open educational and blind EQAS samples, the Laboratory shall report the LODs of theidentified 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.
6.4.5 Reporting Results for EQAS Samples Containing Threshold Substances
6.4.5.1 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.
Unless otherwise specified by WADA (for example, for educational purposes), this provision does not
apply to EQAS samples containing those exogenous Threshold Substances specified in the TD DL
whose presence shall be reported, without the need for quantitative confirmation, if detected in thepresence of diuretics or masking agents.
6.4.5.2 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.

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7.0

Evaluation of Laboratory EQAS and Routine Analytical Testing Performance

The WADA system of Laboratory EQAS and routine Analytical Testing performance (see ISL Points
Scale Table in ISL Art. 7.3 below) has been developed by the WADA 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 antidoping Laboratory system to benefit clean Athletes.
7.1

Evaluation of EQAS Results

Satisfactory EQAS performance in single EQAS rounds 59 and over a consecutive 12-month period 60 isnecessary for maintaining WADA accreditation.
Unsatisfactory performance in an educational EQAS for a new or WADA-specific 61 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 ISL Art. 4.4.2.2). The Laboratory may only apply the newly WADA-approved method orprocedure 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.
7.1.1 EQAS Samples Containing Non-Threshold Substances
7.1.1.1 When a qualitative determination of a Non-Threshold Substance has been reported, theLaboratory 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.

59 An EQAS Round is a distribution of EQAS sample(s) to the Laboratories and the probationary laboratories forAnalytical Testing as defined by WADA.
60

The 12-month period to account for the total number of penalty points accumulated by a Laboratory or
probationary laboratory according to the ISL Points Scale Table is defined as the most recent consecutive 12-monthinterval starting either from the date that the Laboratory or the probationary laboratory reported the 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 Laboratoryor the probationary laboratory. Any assigned penalty points will expire after a 12-month period; however, the total
number of penalty points within any consecutive 12-month period shall not reach the maximum allowed number ofpenalty points established in the ISL Points Scale Table.
61 Some Analytical Testing Procedures are not eligible for a Flexible Scope of ISO/IEC 17025 Accreditation andrequire 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, validationby 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 ISL Article 4.4.2.2).

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7.1.1.2 The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s) atconcentrations greater than the MRPL (or exceeding 120% of the reporting limit, when applicable) shallbe evaluated in accordance with the ISL Points Scale Table.
7.1.1.3 The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s) atconcentrations between 50% of the MRPL and the MRPL (or less than 120% of the reporting limit, whenapplicable) 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.
7.1.1.4 The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s) atconcentrations 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 theanalyses are compliant with its validation data, SOPs, the ISL and the TD IDCR. Laboratories unable toreport 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
7.1.2.1 For EQAS samples containing Threshold Substances at levels greater than 50% of theThreshold, the quantitative determination will be statistically evaluated to determine the compatibility of
the reported result with the assigned value (reference, nominal or consensus value, as applicable)
through e.g. z-score, degree of equivalence analysis. Results shall be evaluated as per the ISL Points
Scale Table 62.
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, thedetection 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 beconsidered 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 isbased on the criteria indicated in the effective version of the TD DL or other relevant Technical Document,
Technical Letter or Laboratory Guidelines.

62 The main criterion applied for the evaluation of EQAS results for the quantification of Threshold Substances isthe 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 valueof the Threshold 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 two (2) significant
figures) for the Laboratory quantitative result is < 3.0 [see footnote 73].

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Unsatisfactory Quantitative Result (absolute z-score ≥ 3) 63

7.1.2.2

The Laboratory shall provide WADA with a satisfactory Corrective Action Report 64 for an unsatisfactory
quantitative result. The Corrective Action Report shall be submitted within ten (10) working days ofreceiving 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 ISL Points Scale
Table.
7.1.2.3

Questionable Quantitative Result (absolute z-score > 2 and < 3)

The Laboratory shall perform an internal investigation to determine the cause(s) of the questionable result
and implement appropriate corrective measures to resolve them.
7.2

Evaluation of Laboratory Performance

7.2.1 False Adverse Analytical Finding
7.2.1.1 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.
7.2.1.2

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.

63 The z–score is calculated according to the following formula and truncated to two (2) significant figures:𝑧𝑧 =Where:ȳ−ŷδȳ is the mean value of the Laboratory’s replicate determinations; ŷ is the assigned value (reference, nominal orconsensus value, as applicable); δ is the target standard deviation (e.g. uc_Max or robust Reproducibility sR of resultsfrom all participant Laboratories).
64 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 therisk 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 theimplemented actions described in the Corrective Action Report.

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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 activitiesor 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 five (5) working
days of informing WADA or been informed by WADA, as applicable, or, in exceptional cases, as otherwise
agreed with WADA.
The WADA LabEG shall review the Laboratory’s Corrective Action Report within five (5) working 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 theanalytical 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 five (5) working days (unless informed otherwise by WADA) 65. Depending on the natureof 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 reanalysis. The Laboratory will be required to inform all of its clients whose Analytical Testing results may
have been affected.

65 The retrospective review of

the analytical results and re-analysis of previous relevant Samples reported as
Adverse Analytical Finding(s) is done 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 discoveryof additional false Adverse Analytical Finding(s) shall lead to the implementation of corrective measures and shallbe communicated to the responsible Testing Authority/Results Management Authority and to WADA. However, theadditional False Adverse Analytical Finding(s) will not lead to the accumulation of additional penalty points if
produced by the same root cause, as determined by WADA.

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7.2.1.2.1

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 ISL
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 66.
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 theLaboratory’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 67.
7.2.1.2.2 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
ISL 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’s Corrective Action Report is considered unsatisfactory by the LabEG, the LabEG shallprovide feedback to the Laboratory and provide it with the opportunity to resubmit a revised Corrective
Action Report within five (5) working 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 shallmake a recommendation to the Chair of the WADA Executive Committee to suspend the Laboratory’s

66 WADA shall inform a Laboratory in writing about the imposition of penalty points, as decided by the LabEG andin accordance with the ISL 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) 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)].
67 During the period of Suspension, the Laboratory shall follow the instructions provided in ISL Article 4.6.5.2 inregard to Samples in Laboratory’s possession at the time of the Suspension. On the other hand, if an Analytical
Testing Restriction has been imposed, the Laboratory shall subcontract the affected analyses as provided in ISL
Arts. 4.6.5.1 and 5.4.8.
During the Suspension or Analytical Testing Restriction period, WADA will conduct an on-site assessment of theLaboratory’s activities, 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.

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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 67.
However, if the Laboratory is able to remedy the technical or methodological error through theimplementation of satisfactory corrective actions in a timely manner, as determined by the LabEG, theLaboratory will have ten (10) penalty points deducted, in accordance with the ISL Points Scale Table.
The Laboratory will be informed by WADA, in writing, of the final amount of penalty points assigned inconnection with the reporting of the False Adverse Analytical Finding 66. Provided that the point total
accumulated by the Laboratory for a 12-month 60 period does not exceed thirty (30) points, the Laboratory
will be able to resume Analytical Testing activities following written notification by WADA.
• Clerical/Administrative Error 68
If the Root Cause Analysis investigation performed by the Laboratory identifies the error as clerical oradministrative, the Laboratory will be initially assigned fifteen (15) penalty points in accordance with the
ISL 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’s Corrective Action Report is considered unsatisfactory by the LabEG, the LabEG shallprovide feedback to the Laboratory and provide it with the opportunity to resubmit a revised Corrective
Action Report within five (5) working 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 ten (10) penalty points in accordance with the ISL
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 67.
However, if the Laboratory is able to remedy the clerical or administrative error through theimplementation of satisfactory corrective actions in a timely manner, as determined by the LabEG, theLaboratory will have ten (10) additional penalty points deducted, in accordance with the ISL Points Scale
Table. The Laboratory will be informed by WADA, in writing, of the total amount penalty points assigned
in connection with the reporting of the False Adverse Analytical Finding 66. Provided that the point total
accumulated by the Laboratory for a 12-month 60 period does not exceed thirty (30) points, the Laboratory
will be able to resume Analytical Testing activities following written notification by WADA.

68

For the purposes of Laboratory performance evaluation, clerical/administrative errors are defined as thoseincidental, 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 typo 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 the Testing Authority.

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7.2.1.3

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 (blindand 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 tothe 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 ISL 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 ten (10) working
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) 65, within five (5)working 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.
The WADA LabEG shall review the Laboratory’s Corrective Action Report within ten (10) working days,
or within a timeline otherwise determined by WADA.
• 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
ISL Points Scale Table. However, if the False Adverse Analytical Finding is related to the analysis of adouble-blind EQAS sample and the Laboratory first informs (i.e. voluntarily self-reports) WADA of theirinvestigation 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’s Corrective Action Report for the technical or methodological error is consideredunsatisfactory by the LabEG, the LabEG shall provide feedback to the Laboratory and provide it with theopportunity to resubmit a revised Corrective Action Report within five (5) working 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
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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 aparticular class of Prohibited Substances or Prohibited Methods, as applicable 67.
However, if the Laboratory is able to remedy a technical/methodological error through the implementationof 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 ISL Points Scale Table. The Laboratory
will be informed by WADA, in writing, of the final amount of penalty points assigned in connection withthe reporting of the False Adverse Analytical Finding 66.
• Clerical/Administrative Error 68
If the Root Cause Analysis investigation performed by the Laboratory identifies the error as clerical oradministrative, the Laboratory will be initially imposed fifteen (15) penalty points in accordance with the
ISL Points Scale Table. However, if the False Adverse Analytical Finding is related to the analysis of adouble-blind EQAS sample and the Laboratory first informs (i.e. voluntarily self-reports) WADA of theirinvestigation 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’s Corrective Action Report is considered unsatisfactory by the LabEG, the LabEG shallprovide feedback to the Laboratory and provide it with the opportunity to resubmit a revised Corrective
Action Report within five (5) working 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 ten (10) penalty points in accordance with the ISL
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 67.
However, if the Laboratory is able to remedy the clerical or administrative error through theimplementation of satisfactory corrective action(s) in a timely manner, as determined by the LabEG, theLaboratory will have ten (10) points deducted, in accordance with the ISL 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 66.
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 on-site assessment
and the requirement that additional EQAS samples be analyzed by the Laboratory.
7.2.2 False Negative Finding
Laboratories failing to identify and/or report a Prohibited Substance and/or its Metabolite(s) or theMarker(s) of a Prohibited Substance or a Prohibited Method in a blind or double-blind EQAS sample orduring routine Analytical Testing shall be informed of the False Negative Finding as soon as possible by
WADA.

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WADA will immediately start an investigation to establish whether the False Negative Finding was theresult 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 ISL 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 ten (10) working days (unlessotherwise indicated by WADA).
The LabEG shall review the Laboratory’s Corrective Action Report within ten (10) working days, or withina timeline otherwise determined by WADA, and take the following steps, where appropriate:• 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 five (5) working days (or as otherwise agreed with WADA). If theLaboratory 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 inaccordance with the ISL 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 thatcaused the False Negative 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 Laboratory shall report correct results for the analysis of all EQAS samples. In addition, theLaboratory shall implement satisfactory corrective action(s) (as determined by WADA) which ensuresthat the cause(s) of the nonconformity is eliminated, thus avoiding repetition of the mistake in the
future. Failure by the Laboratory to report correct results for the additional EQAS sample(s) will incur
the imposition of additional penalty points in accordance with the ISL 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 67.
• However, 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 ISL 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 66.
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 on-site assessment
and the requirement that the Laboratory analyses additional EQAS samples.

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7.2.3 Further Procedural Evaluations 69
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 Laboratory on-site
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)
calendar 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 five (5)working 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 toperform as indicated in the ISL 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 ISL Points Scale Table below, shall prompt the WADA LabEG tomake a recommendation to the Chair of the WADA Executive Committee to impose an Analytical Testing
Restriction against the Laboratory or to impose a Suspension of the Laboratory’s WADA accreditation,
as applicable.
When the Laboratory’s WADA accreditation is suspended, any accrued penalty points leading up to theSuspension 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 70. However, when an Analytical Testing Restriction is imposed against a Laboratory, any
penalty points not related to the Analytical Testing Restriction, which were accumulated up to theimposition of the Analytical Testing Restriction or further accumulated during the Analytical Testing
Restriction period (within a 12-month period 60), 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.

69 ISL 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 ISL Arts. 7.2.1 and 7.2.2, respectively.
70 This provision doesn’t apply to a voluntary cessation of Laboratory operations (see ISL Art. 4.6.7).

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ISL Points Scale Table for Assessment of Laboratory and Probationary Laboratory Performance
Analytical
Testing
Conditions
RoutineAnalytical
Testing(ISL Art 7.2.1.2.1)

Nonconformity

False AAF+
Consequence for
the Athlete

RoutineAnalytical
Testing
False AAFOr+
No Consequence
for the Athlete

Or
EQAS(blind or double
blind)
round71

Actions and Sanctions

Cease Analytical Testing

Technical / Methodological error
orClerical / Administrative error

20

Technical / Methodological error

20

andSuspension / Analytical
Testing Restriction
Cease Analytical Testing• Self-reporting 71-5• Satisfactory and timely CAR- 10• Unsatisfactory CAR+5

Suspension / Analytical
Testing Restriction

15

Cease Analytical Testing

Clerical / Administrative error• Self-reporting 71-5• Satisfactory and timely CAR- 10• Unsatisfactory CAR+ 10

False Negative Finding

10• Self-reporting 71-5• Satisfactory and timely CAR-5• Unsatisfactory CAR+5Resume Analytical Testing(ISL Art 7.2.1.3)

RoutineAnalytical
Testing

Penalty
PointsResume Analytical Testing(ISL Art 7.2.1.2.2)

EQAS(blind or double
blind)round

Type of Error
OutcomeFalse Negative
Finding

Suspension / Analytical
Testing Restriction

additional EQAS samples 72(ISL Art 7.2.2)

Voluntary self-reporting is not applicable to blind EQAS samples.

72 The results of the analysis of the additional EQAS samples will be evaluated in accordance with this Points Scale

Table.

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EQAS Evaluation

ResultPenalty Points|z-score| ≥ 3.0 and CAR
Unsatisfactory CAR

2Satisfactory and timely CAR

1Unsatisfactory CAR

4Satisfactory and timely CAR

2

Unsatisfactory CAR

6Satisfactory and timely CAR

3

Unsatisfactory CAR

8Satisfactory and timely CAR

4

2.0 < |z-score| < 3.0
Internal Investigation0|z-score| ≥ 3.0 73
Unsatisfactory CAR

5|z-score| ≥ 3.0 73
Satisfactory and timely CAR

0

ISL, TD or TL Nonconformity

2

Unsatisfactory CAR

2

Late Submission of CAR(per 5 working days beyond the deadline)

1

Late reporting of blind or double-blind EQAS results(per 5 working days beyond the deadline)

2

4-7
Steroid Profile Markers|z-score| ≥ 3.0(Occurrences*)

8-12

13-18
≥ 19

GC/C/IRMS δ13C(≥ 3 Occurrences**)Threshold Substances(per occurrence)

Documentation*** or Technical Issue(per occurrence)

Evaluation

Penalty Points

Sanction

Point Total for single EQAS round (blind or double-blind****)
Point Total for double-blind EQAS**** for 12-month period

Suspension

≥ 20

Or
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

Analytical Testing
Restriction* Based on a total of 6 determinations: Androsterone (A), Etiocholanolone (Etio), Testosterone (T), Epitestosterone (E), 5αandrostane-3α,17β-diol (5αAdiol) and 5β-androstane-3α,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.
AAF – Adverse Analytical Finding; CAR - Corrective Action Report

73 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 accordancewith ISL Articles 7.2.1.3 and 7.2.2, respectively.

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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, 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 ISL Art. 6.2.2.
Successful participation in WADA probationary EQAS, based on the ISL Points Scale Table (less thantwenty (20) points accumulated within a single blind EQAS round and less than thirty (30) points for themost recent and consecutive twelve (12) month 60 period) is required before a probationary laboratory is
eligible to be considered for WADA accreditation. The LabEG may decide, based on its evaluation of theoverall performance of the probationary laboratory, to extend the probationary period ofaccreditation, even if the probationary laboratory did not reach the maximum number of penalty
points based on the ISL Points Scale Table. However, once a laboratory is granted WADA
accreditation, penalty points accumulated during the probationary period are annulled and are notcarried forward onto the accredited phase.
The blind EQAS samples shall be distributed in multiple rounds each year and will consist of a minimumof 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 automaticallysuspends 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.
WADA may decide to send a set of EQAS samples and/or audit 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 andpreventive action(s) within ten (10) working days of the date of the letter from WADA (unless informed
otherwise by WADA). The corrective action, if approved by WADA, shall be implemented in the routine
operations of the probationary laboratory as soon as possible.

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7.4.4 Threshold Substance Result
A probationary laboratory shall achieve satisfactory quantitative EQAS results reported based on themean 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 foreach noncompliance or failure to perform in accordance with the ISL 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 themost recent and consecutive twelve (12) month 60 period (e.g. at least fifteen (15) blind EQAS samples),and provided that all of other necessary conditions have been fulfilled, the laboratory will be audited byan assessment team appointed by WADA.
This assessment will take place while the probationary laboratory is processing and analyzing a minimumof a further fifteen (15) blind EQAS samples supplied by WADA as part of a Final Accreditation Test
(FAT). 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 on-site assessment and/or the analytical
performance and/or the presentation of the requested Laboratory Documentation Package(s) shall be
submitted within thirty (30) calendar days, unless otherwise specified by WADA, and shall beconsidered 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) calendar days prior to theend of the Suspension period (unless otherwise indicated by WADA). Failure to do so will preclude thelaboratory 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 thelaboratory. Laboratories re-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 ISL Art. 4.2).

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PART THREE: ISL ANNEXESISL ANNEX A - CODE OF ETHICS FOR LABORATORIES and WADA-APPROVEDLABORATORIES FOR THE ABP
1.0

Confidentiality

Directors of Laboratories and WADA-Approved Laboratories for the ABP, their delegates and all
Laboratory staff shall respect and comply with Code Art. 14.3.5.
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 74 and the program(s) have received proper ethical approval, if applicable.
The Laboratories are expected to develop a research and development program to support the scientificfoundation of Doping Control. This research may consist of the development of new methods ortechnologies, the pharmacological characterization of a new doping agent, the characterization of amasking agent or method, and other topics relevant to the field of Doping Control.
2.1

Research on Human Subjects

The Laboratories and WADA-Approved Laboratories for the ABP shall follow the Helsinki Accords andany 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.
2.2

Controlled Substances

The Laboratories are expected to comply with the relevant and applicable national laws regarding thehandling, storage and discarding of controlled (illegal) substances.
3.0

Analysis

3.1

Analytical Testing for Anti-Doping Organizations

The Laboratories and WADA-Approved Laboratories for the ABP shall accept Samples for Analytical
Testing 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 WADA-Approved
Laboratory for the ABP in accordance with the ISTI;•The collection is a part of an anti-doping program; and•The Testing Authority is a Code-compliant Anti-Doping Organization.

74 The Laboratory shall not engage in any research activity that undermines or is detrimental to the World Anti-

doping Program.

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3.2

Clinical or Forensic Analysis

3.2.1 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 sample is for medical diagnostic or therapeutic purposes.
3.2.2 Work to aid in forensic and/or legal investigations may be undertaken 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 integrityof an individual or the scientific validity of work performed in the anti-doping program
3.3

Other Analytical Activities

3.3.1 The Laboratory or WADA-Approved Laboratory for the ABP shall not engage in any analysis or
activity that undermines or is detrimental to the World Anti-doping Program 75.
3.3.2 Laboratories and WADA-Approved Laboratories for the ABP shall not accept Samples fromindividual Athletes on a private basis or from individuals or organizations acting on their behalf.
3.3.3 If the Laboratory or WADA-Approved Laboratory for the ABP accepts Samples from any entitythat is not a Code-compliant Anti-Doping Organization, it is the responsibility of the Director of theLaboratory or WADA-Approved Laboratory for the ABP to receive assurance, in writing, that any Adverse
Analytical Finding or Adverse Passport Finding will follow an appropriate results management process
and that the results cannot be used in any way by an Athlete or associated Person to avoid the detectionof doping.
3.3.4 The Laboratory or WADA-Approved Laboratory for the ABP shall not provide analytical services
in a Doping Control adjudication, unless specifically requested by the responsible Testing Authority,
WADA or a Hearing Body.
3.3.5 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 WADA as part of a
research program or results management process.
3.3.6 If a request pursuant to Art. 3.3.5 is made by an Athlete, the Laboratory may conduct the analysis
if agreed by the Anti-Doping Organization or WADA, which may also specify conditions that must be
followed prior to or during the analysis (e.g. verification of original sealed packages). The Laboratory shallnot provide results, documentation or advice that, in any way, could be used as an endorsement of
products or services.
Analytical activities performed under Arts. 3.2 and 3.3 above will not fall under the WADA accredited orapproved status of the laboratory. A Laboratory or WADA-Approved Laboratory for the ABP shall only

75

The World Anti-Doping Program comprises the anti-doping programs of WADA and all Code 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).

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refer to its WADA accreditation or approval status, respectively, for an activity that falls under Analytical
Testing for Code-compliant Anti-Doping Organizations.
3.4

Sharing of Knowledge

3.4.1 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) calendar days 76. Whenpossible, 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 Useof a new substance or method as a doping agent, WADA will inform all Laboratories.
3.4.2 The Laboratory Director or staff shall participate in developing standards for best practice andenhancing uniformity of Analytical Testing in the WADA accredited laboratory system.
4.0

Duty to Preserve the Integrity of the World Anti-Doping Program and to Avoid any
Detrimental Conduct

4.1 The personnel of Laboratories and WADA-Approved Laboratories for the ABP 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 integrityof the anti-doping program.
4.2 All employees of Laboratories and WADA-Approved Laboratories for the ABP 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.
4.3 No employee or consultant of Laboratories and WADA-Approved Laboratories for the ABP shallprovide counsel, advice or information to Athletes or others regarding techniques or methods used tomask 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.
4.4 No employee or consultant of Laboratories and WADA-Approved Laboratories for the ABP shallprovide information about a Test Method to an Athlete or Athlete Support Personnel, which could be used
to avoid the detection of doping.
4.5 No staff of Laboratories and WADA-Approved Laboratories for the ABP shall assist an Athlete in
avoiding collection of a representative Sample (e.g. advice on masking strategies or detection windows).
[Comment: Arts. 4.3 – 4.5 do 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 Substancesor Prohibited Methods.]

76 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.

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4.6 If a staff member of a Laboratory or WADA-Approved Laboratory for the ABP is requested to provide
evidence in anti-doping proceedings, they are expected to provide independent, scientifically-valid expert
testimony.
4.7 The Laboratory or WADA-Approved Laboratory for the ABP shall not issue any statements related
to the Laboratory analytical processes or findings, unless otherwise provided in Code Art. 14.3.5. 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) or WADA.
5.0

Breach and Enforceability

A failure to respect any of the provisions of this Code of Ethics may result in the Laboratory or WADAApproved Laboratory for the ABP 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
Art. 4.6.4.5.
In addition, a failure to respect any of the provisions of this Code of Ethics may result in staff of theLaboratory or WADA-Approved Laboratory for the ABP being subject to disciplinary action by the
Laboratory or WADA-Approved Laboratory for the ABP, respectively, resulting in consequences beyond
those stipulated under the ISL, including potential termination of employment or, where applicable, theimposition of criminal charges.

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ISL ANNEX B – PROCEDURAL RULES FOR THE DISCIPLINARY COMMITTEE OF THE
INTERNATIONAL STANDARD FOR LABORATORIESPreamble
These Procedural Rules for the Disciplinary Committee (DC) of the ISL (the “Procedural Rules”) outline
the process to be followed when a Laboratory appeals a recommendation of the LabEG in accordancewith ISL Art. 4.6.4.1.2, when a Laboratory is subject to Revocation proceedings in accordance with ISL
Art. 4.6.4.3 or, when and where applicable, Disciplinary Proceedings are instituted against a WADAApproved Laboratory for the ABP in accordance with ISL Art. 4.8.4.1. In such circumstances, anyreference made to a Laboratory in these Procedural Rules shall be understood as a reference to a WADAApproved Laboratory for the ABP, unless such reference is not applicable due to the circumstances,
specific nature or rules indicated in this ISL in relation to WADA-Approved Laboratories for the ABP.
These Procedural Rules shall be considered as an integral part of the ISL.
PART I - Composition of the CommitteeArt. 1For 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 decide which one
will serve as Chairperson.
The appointed members shall have a legal and/or scientific background with at least one member being
an anti-doping expert and one with legal training and education (including the Chairman). The Chairman
shall in any event have experience in the conduct of disciplinary or legal proceedings.
All members of an appointed 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 fromthe concerned Laboratory’s Suspension, Revocation or Analytical Testing Restriction, and mustotherwise be impartial in relation to WADA and the Laboratory concerned. The anti-doping laboratory
expert(s) may be member(s) of the WADA Laboratory Expert Group (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 confirm their impartiality and mention any
circumstance, which may be relevant in this respect.
Art. 2
If the impartiality of any member of the DC is challenged (for example, by the Laboratory), the mattershall be decided by the Chairperson if he 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,
WADA’s Director General shall make the decision.
The decision is not subject to an independent challenge.

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PART II - General Provisions
Art. 3
3.1 Once the DC is constituted, WADA will provide it with the complete case file, including all of theevidence it wishes to submit in support of the disciplinary action being taken against the Laboratory.
WADA may send the case file and any information to the DC electronically or by registered mail.
3.2 Simultaneously, WADA shall provide the Laboratory with the complete case file and with all of theavailable supporting evidence. WADA may send the case file and any information to the Laboratory
electronically or by registered mail.
3.3 Within five (5) business days of receiving the full case file, the Laboratory may respond in writing andprovide all of its evidence to the DC and shall also simultaneously provide copies of all its submissions
and evidence to WADA’s Legal Department. Any requests to extend this 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.
3.4 Upon receipt of the Laboratory’s submissions and evidence, WADA shall have five (5) business days
to make rebuttal submissions to the Disciplinary Committee. Any requests to extend this deadline shallbe addressed by WADA to the Chairperson of the DC, who shall have the discretion to grant or reject therequested extension.
3.5 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.
Art. 4
Unless both parties agree otherwise or the Chairperson orders otherwise on the basis of exceptional
circumstances, the parties shall not be permitted to include additional material after the submission of
the final evidence packages in accordance with the procedure described in Art. 3 above.
Art. 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
Art. 6
6.1 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.
6.2 To the extent not otherwise provided in these “Procedural Rules”, the Chairperson may issue
directions regarding procedural matters to the parties.
6.3 The DC shall have the right to appoint one or more independent expert(s) should it consider thatparticular 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.

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6.4 After consulting the parties, the DC may, if it deems itself to be sufficiently well informed, decide notto hold a hearing and it may determine its recommendation based on the parties’ written submissions
and the available documents.
6.5 The DC shall make its recommendation in accordance with the applicable regulations, including theCode, 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.
6.6 The DC’s decisions, including the content of its recommendation, shall be by majority.
PART IV - Recommendation
Art. 7
7.1 The recommendation of the DC shall be issued in writing, with reasons 77, within fourteen (14) calendar
days of the conclusion of the hearing. If no hearing is held, the DC shall issue its recommendation within
fourteen (14) calendar days of the communication to the parties that no hearing will be held.
7.2 Where the DC considers that a Laboratory’s accreditation should be suspended or subject to an
Analytical Testing Restriction, it shall recommend a period of Suspension or Analytical Testing Restrictionthat is proportionate to the seriousness of the noncompliance(s) with the ISL and/or TechnicalDocument(s) and/or Technical Letters and the need to ensure accurate and reliable Analytical Testing of
Samples.
7.3 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 TechnicalDocument 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 accreditationor the imposition of an Analytical Testing Restriction, or during a subsequent on-site 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 thereinstatement of the Laboratory’s WADA accreditation.
7.4 In cases where it considers that it is appropriate to do so, the DC may also recommend that theLaboratory receive a warning with no period of Suspension or no imposition of an Analytical Testing
Restriction.
7.5 The recommendation of the DC shall be provided to the Chair of the WADA Executive Committee
without delay.
7.6 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

77 The decision may be summarily reasoned.

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decision regarding the Suspension of the Laboratory’s WADA accreditation or the imposition of an
Analytical Testing Restriction within ten (10) calendar days of receiving the DC’s recommendation.
7.7 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 ten (10) calendar days of receiving the DC’s recommendation.
7.8 If the DC recommends that the Laboratory shall maintain its WADA accreditation, the Laboratory
shall be informed accordingly by WADA within seven (7) calendar days of receiving the DC’srecommendation.

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