January 2012

International Standard for Laboratories
The International Standard for Laboratories was first adopted
in June 2003 and became effective on 1 January 2004. The
enclosed represents version 7.0 that incorporates revisions to
the International Standard for Laboratories that wereapproved by the World Anti-Doping Agency Executive
Committee on 19 November 2011. The revised International
Standard for Laboratories is effective as of 1 January 2012.
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: info@wada-ama.org

PREAMBLE

The World Anti-Doping Code International Standard for Laboratories is a mandatorylevel 2 International Standard developed as part of the World Anti-Doping Program.
The International Standard for Laboratories version 7.0 will come into effect onJanuary 01, 2012.
The official text of the International Standard for Laboratories 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.

International Standard for Laboratories
Version 7.0, January 2012

TABLE OF CONTENTSPART ONE: INTRODUCTION, CODE PROVISIONS AND DEFINITIONS ....................... 6
1.0
Introduction, Scope and References............................................................... 6
2.0
Code Provisions .............................................................................................. 7
3.0
Terms and definitions................................................................................... 12
3.1
Code defined Terms .................................................................................... 12
3.2
ISL Defined Terms ...................................................................................... 15
3.3International Standard for Testing (IST) Defined Terms ................................... 16
PART TWO: LABORATORY ACCREDITATION REQUIREMENTS AND OPERATINGSTANDARDS ................................................................................................. 17
4.0
Process and Requirements for WADA accreditation ..................................... 17
4.1
Applying for a WADA Laboratory Accreditation ................................................ 17
4.1.1
Expression of Interest ........................................................................... 17
4.1.2
Submit initial Application Form ............................................................... 17
4.1.3
Provide letter(s) of support .................................................................... 17
4.1.4
Description of the Candidate Laboratory .................................................. 18
4.1.5
Conduct Initial visit............................................................................... 18
4.1.6
Issue final report and recommendation.................................................... 19
4.1.7
Initial accreditation fee.......................................................................... 19
4.1.8
Laboratory Independence ...................................................................... 19
4.1.9
Compliance with the Code of Ethics ......................................................... 19
4.2
Preparing for WADA Laboratory Accreditation ................................................. 19
4.2.1
Obtain Laboratory ISO/IEC 17025 accreditation ........................................ 20
4.2.2
Participate in the WADA External Quality Assessment Scheme .................... 20
4.2.3
Plan and implement research activities .................................................... 21
4.2.4
Plan and implement sharing of knowledge................................................ 21
4.2.5
Professional liability insurance coverage .................................................. 21
4.3
Obtaining WADA Accreditation ...................................................................... 22
4.3.1
Participate in a WADA accreditation audit ................................................. 22
4.3.2
WADA report and recommendation ......................................................... 22
4.3.3
Issue and publication of Accreditation certificate ....................................... 22
4.4
Maintaining WADA Accreditation ................................................................... 22
4.4.1
Maintain ISO/IEC 17025 accreditation ..................................................... 22
4.4.2
Participate in the WADA External Quality Assessment Scheme .................... 23
4.4.3
Laboratory Independence ...................................................................... 23
4.4.4
Document Compliance with the WADA Laboratory Code of Ethics ................ 23
4.4.5
Document implemented research activities .............................................. 23
4.4.6
Document implemented sharing of knowledge .......................................... 23
4.4.7
Maintain professional liability insurance coverage ...................................... 24
4.4.8
Provide renewed letter(s) of support ....................................................... 24
4.4.9
Minimum number of Samples ................................................................. 24
4.4.10Participate in WADA/Accreditation Body re-assessments and surveillance
assessments ........................................................................................ 24
4.4.11
Flexible Scope of Accreditation ............................................................... 25
4.4.12WADA report and recommendation ......................................................... 26
4.4.13
Notification .......................................................................................... 28
4.4.14Re-accreditation Costs .......................................................................... 29
4.4.15
Issue and publication of Accreditation certificate ....................................... 29
4.5
Accreditation Requirements for Major Events .................................................. 30
4.5.1
Major Event Testing in the Laboratory Facilities ........................................ 30
4.5.2
Major Event Testing in satellite Laboratory facilities ................................... 33
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Application of ISO/IEC 17025 to the Analysis of Urine Doping Control
Samples ....................................................................................................... 34
5.1
Introduction and Scope ............................................................................... 34
5.2
Analytical and Technical Processes ................................................................ 34
5.2.1
Receipt of Samples ............................................................................... 34
5.2.2
Handling and Retention of Samples ......................................................... 34
5.2.3
Sampling and Preparation of Aliquots for Analysis ..................................... 38
5.2.4
Analytical Testing ................................................................................. 38
5.2.5
Results Management............................................................................. 43
5.2.6
Documentation and Reporting ................................................................ 44
5.3
Quality Management Processes..................................................................... 47
5.3.1
Organization ........................................................................................ 47
5.3.2
Quality Policy and Objectives ................................................................. 47
5.3.3
Document Control ................................................................................ 47
5.3.4
Review of requests, tenders, and contracts .............................................. 48
5.3.5
Subcontracting of tests ......................................................................... 48
5.3.6
Purchasing of services and supplies......................................................... 48
5.3.7
Service to the customer ........................................................................ 49
5.3.8
Complaints .......................................................................................... 50
5.3.9
Control of nonconforming testing work .................................................... 50
5.3.10
Improvement ...................................................................................... 50
5.3.11
Corrective action .................................................................................. 50
5.3.12Preventive action ................................................................................. 50
5.3.13Control of records................................................................................. 51
5.3.14
Internal Audits ..................................................................................... 51
5.3.15
Management Reviews ........................................................................... 51
5.4
Support processes ...................................................................................... 51
5.4.1
General............................................................................................... 51
5.4.2
Personnel ............................................................................................ 51
5.4.3
Accommodation and environmental conditions .......................................... 53
5.4.4
Test Methods and Method Validation ....................................................... 55
5.4.5
Equipment .......................................................................................... 59
5.4.6
Measurement Traceability ...................................................................... 59
5.4.7
Assuring the quality of test results .......................................................... 60

5.0

6.0

Application of ISO/IEC 17025 to the Analysis of Blood Doping Control
Samples ....................................................................................................... 61
6.1
Introduction and Scope ............................................................................... 61
6.2
Analytical and Technical Processes ................................................................ 61
6.2.1
Receipt of Samples ............................................................................... 61
6.2.2
Handling and Retention of Samples ......................................................... 62
6.2.3
Sampling and Preparation of Aliquots for Analysis ..................................... 65
6.2.4
Analytical Testing ................................................................................. 65
6.2.5
Results Management............................................................................. 70
6.2.6
Documentation and Reporting ................................................................ 70
6.3
Quality Management Processes..................................................................... 73
6.4
Support processes ...................................................................................... 73
6.4.1
Test Methods and Method Validation ....................................................... 74

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4

PART THREE: ANNEXES ......................................................................................... 75
ANNEX A - WADA EXTERNAL QUALITY ASSESSMENT SCHEME (EQAS) .................... 75
1.0
WADA External Quality Assessment Scheme ................................................ 75
1.1Open (Educational) EQAS ............................................................................ 75
1.2
Blind EQAS ................................................................................................ 75
1.3
Double Blind EQAS ..................................................................................... 75
2.0
External Quality Assessment Scheme Sample Composition .......................... 76
2.1
EQAS Samples Void of Prohibited Substances or Methods, their Metabolite(s) orMarker(s)(Blank) ........................................................................................ 76
2.2
Adulterated EQAS Samples .......................................................................... 76
2.3
EQAS Samples Containing Prohibited Substances, their Metabolite(s) or Marker(s),or the Marker(s) of Prohibited Methods .......................................................... 76
2.3.1
EQAS Sample Composition .................................................................... 76
2.3.2
Individual EQAS Sample Content of Prohibited Substance(s) or Method(s), or
Metabolite(s) or Marker(s) ..................................................................... 76
3.0
Evaluation of External Quality Assessment Scheme ..................................... 77
3.1
Evaluation of EQAS Samples Containing Non-Threshold Substances ................... 78
3.2
Evaluation of EQAS Samples Containing Threshold Substances.......................... 78
3.3
Accreditation Maintenance and Laboratory Evaluation ...................................... 79
3.3.1
Methods utilized in EQAS ....................................................................... 79
3.3.2
False Positive result .............................................................................. 79
3.3.3
False Negative result ............................................................................ 81
3.3.4
Threshold Substance result .................................................................... 81
3.3.5
Overall Laboratory evaluation ................................................................ 81
3.4
Probationary Period and Probationary Laboratory Evaluation ............................. 83
3.4.1
Methods Utilized ................................................................................... 84
3.4.2
False Positive result .............................................................................. 84
3.4.3
False Negative result ............................................................................ 84
3.4.4
Threshold Substance result .................................................................... 84
3.4.5
Overall Probationary Laboratory Evaluation .............................................. 85
ANNEX B - LABORATORY CODE OF ETHICS ............................................................. 87
1.0
Confidentiality .............................................................................................. 87
2.0
Research ...................................................................................................... 87
3.0
Research in Support of Doping Control......................................................... 87
3.1
Human subjects ......................................................................................... 87
3.2
Controlled substances ................................................................................. 87
4.0
Analysis........................................................................................................ 87
4.1
Competitions ............................................................................................. 87
4.2
Out-of-Competition ..................................................................................... 88
4.3
Clinical or Forensic...................................................................................... 88
4.4
Other analytical activities ............................................................................ 89
4.5
Sharing of Information and Resources ........................................................... 89
4.5.1
New Substances ................................................................................... 89
4.5.2
Sharing of Knowledge ........................................................................... 89
5.0
Conduct Detrimental to the Anti-Doping Program ........................................ 89

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5

PART ONE: INTRODUCTION, CODE PROVISIONS AND
DEFINITIONS
1.0 Introduction, Scope and References
The main purpose of the International Standard for Laboratories (ISL) is to ensurelaboratory production of valid test results and evidentiary data and to achieve
uniform and harmonized results and reporting from all Laboratories.
The ISL includes requirements for obtaining and maintaining WADA accreditation ofLaboratories, operating standards for laboratory performance and a description of
the accreditation process.
WADA will publish, from time to time, specific technical recommendations in a
Technical Document. Implementation of the technical recommendations described in
the Technical Documents is mandatory and shall occur by the effective date specified
in the Technical Document. Technical Documents supersede any previous publication
on a similar topic, or if applicable, this document. The document in effect will bethat Technical Document whose effective date most recently precedes that of Sample
receipt date. The current version of the Technical Document will be available on
WADA’s website.
The ISL, including all Annexes and Technical Documents, is mandatory for all
Signatories to the Code.
The World Anti-Doping Program encompasses all of the elements needed in order toensure optimal harmonization and best practice in international and national antidoping programs.
The main elements are: the Code (Level 1), International
Standards (Level 2), and Models of Best Practice (Level 3).
In the introduction to the World Anti-Doping Code (Code), the purpose andimplementation of the International Standards are summarized as follows:“International Standards for different technical and operational areas within the anti-doping
program will be developed in consultation with the Signatories and governments and approved by
WADA. The purpose of the International Standards is harmonization among Anti-Doping
Organizations responsible for specific technical and operational parts of the anti-doping programs.
Adherence to the International Standards is mandatory for compliance with the Code.
TheInternational Standards may be revised from time to time by the WADA Executive Committee after
reasonable consultation with the Signatories and governments. Unless provided otherwise in theCode, International Standards and all revisions shall become effective on the date specified in theInternational Standard or revision.”

Compliance with an International Standard (as opposed to another alternative
standard, practice or procedure) shall be sufficient to conclude that the procedures
covered by the International Standard were performed properly.
This document sets out the requirements for Laboratories that wish to demonstratethat they are technically competent, operate an effective quality management
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system, and are able to produce forensically valid results. Doping Control testing
involves the detection, identification, and in some cases demonstration of thepresence greater than a threshold concentration or ratio of measured analyticalvalues (e.g. concentrations, chromatogram peak height or area, etc.) of drugs andother substances in human biological fluids or tissues as identified on the List ofProhibited Substances and Prohibited Methods (The Prohibited List). Laboratories
may undertake other forms of testing, within the limits of the Code of Ethics, which
are not under the scope of WADA Accreditation (e.g. Equine testing, Forensic
testing). Any such testing shall not be covered by WADA Accreditation.
The Laboratory accreditation framework consists of two main elements: Part Two of
the ISL: the Laboratory accreditation requirements and operating standards; andPart Three: the Annexes. Part Two describes the requirements necessary to obtain
WADA recognition and the procedures involved to fulfill the requirements. It also
contains an application of ISO/IEC 170251 to the field of Doping Control. The
purpose of this section of the document is to facilitate consistent application andassessment of ISO/IEC 17025 and the specific WADA requirements for Doping
Control by accreditation bodies that operate in accordance with ISO/IEC 17011. The
International Standard also sets forth the requirements for Laboratories when
adjudication results as a consequence of an Adverse Analytical Finding.
Part Three of the ISL includes all Annexes. Annex A describes the WADA External
Quality Assessment Scheme (EQAS), including performance criteria necessary tomaintain WADA accreditation. Annex B describes the ethical standards required forcontinued WADA recognition of the Laboratory. Technical Documents are issued,
modified, and deleted by WADA from time to time and provide direction to the
Laboratories and other stakeholders on specific technical issues. Once promulgated,
Technical Documents become part of the ISL. The incorporation of the provisions of
the approved WADA Technical Documents into the Laboratory’s quality management
system is mandatory for WADA accreditation.
In order to harmonize the accreditation of Laboratories to the requirements of
ISO/IEC 17025 and the WADA-specific requirements for recognition, it is expectedthat national accreditation bodies will use the ISL, including the Annexes andTechnical Documents, as reference documents in their assessment process.
Terms defined in the Code, which are included in this standard, are written in italics.
Terms, which are defined in the ISL, are underlined.
1

Current version of ISO/IEC 17025

2.0 Code Provisions
The following articles in the Code directly address the ISL:
Code Article 2
2.1

ANTI-DOPING RULE VIOLATIONS

Presence of a Prohibited Substance or its Metabolites or Markers in an
Athlete’s Sample

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2.1.1 It is each Athlete’s personal duty to ensure that no Prohibited
Substance enters his or her body. Athletes are responsible for
any Prohibited Substance or its Metabolites or Markers found to
be present in their Samples. Accordingly, it is not necessary that
intent, fault, negligence or knowing Use on the Athlete’s part bedemonstrated in order to establish an anti-doping violation under
Article 2.1.
[Comment to Article 2.1.1: For purposes of anti-doping rule violations
involving the presence of a Prohibited Substance (or its Metabolites orMarkers), the Code adopts the rule of strict liability which was found in
the Olympic Movement Anti-Doping Code (“OMADC”) and the vast
majority of pre-Code anti-doping rules.
Under the strict liability
principle, an Athlete is responsible, and an anti-doping rule violation
occurs, whenever a Prohibited Substance is found in an Athlete’s
Sample. The violation occurs whether or not the Athlete intentionally orunintentionally Used a Prohibited Substance or was negligent orotherwise at fault. If the positive Sample came from an In-Competition
test, then the results of that Competition are automatically invalidated(Article 9 (Automatic Disqualification of Individual Results)). However,the Athlete then has the possibility to avoid or reduce sanctions if theAthlete can demonstrate that he or she was not at fault or significant
fault (Article 10.5 (Elimination or Reduction of Period of Ineligibility
Based on Exceptional Circumstances)) or in certain circumstances did
not intend to enhance his or her sport performance (Article 10.4
(Elimination or Reduction of the Period of Ineligibility for Specified
Substances under Specific Circumstances)).
The strict liability rule for the finding of a Prohibited Substance in an
Athlete's Sample, with a possibility that sanctions may be modified
based on specified criteria, provides a reasonable balance between
effective anti-doping enforcement for the benefit of all "clean" Athletes
and fairness in the exceptional circumstance where a Prohibited
Substance entered an Athlete’s system through No Fault or Negligenceor No Significant Fault or Negligence on the Athlete’s part. It is
important to emphasize that while the determination of whether theanti-doping rule violation has occurred is based on strict liability, theimposition of a fixed period of Ineligibility is not automatic. The strict
liability principle set forth in the Code has been consistently upheld in
the decisions of CAS.]
2.1.2 Sufficient proof of an anti-doping rule violation under Article 2.1
is established by either of the following: presence of a Prohibited
Substance or its Metabolites or Markers in the Athlete’s A Sample
where the Athlete waives analysis of the B Sample and the B
Sample is not analyzed; or, where the Athlete’s B Sample isanalyzed and the analysis of the Athlete’s B Sample confirms thepresence of the Prohibited Substance or its Metabolites orMarkers found in the Athlete’s A Sample.
[Comment to Article 2.1.2: The Anti-Doping Organization with results
management responsibility may in its discretion choose to have the B

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Sample analyzed even if the Athlete does not request the analysis of the
B Sample.]
2.1.3 Excepting those substances for which a quantitative threshold isspecifically identified in the Prohibited List, the presence of any
quantity of a Prohibited Substance or its Metabolites or Markers
in an Athlete’s Sample shall constitute an anti-doping ruleviolation.
2.1.4 As an exception to the general rule of Article 2.1, the Prohibited
List or International Standards may establish special criteria forthe evaluation of Prohibited Substances that can also be
produced endogenously.
Code Article 3
3.2

PROOF OF DOPING

Methods of Establishing Facts and Presumptions
3.2.1 WADA-accredited laboratories are presumed to have conducted Sample
analysis and custodial procedures in accordance with the International
Standard for Laboratories. The Athlete or other Person may rebut thispresumption by establishing that a departure from the International
Standard for Laboratories occurred which could reasonably have caused
the Adverse Analytical Finding.
If the Athlete or other Person rebuts the preceding presumption by
showing that a departure from the International Standard forLaboratories occurred which could reasonably have caused the Adverse
Analytical Finding, then the Anti-Doping Organization shall have theburden to establish that such departure did not cause the Adverse
Analytical Finding.
[Comment to Article 3.2.1: The burden is on the Athlete or other Person toestablish, by a balance of probability, a departure from the International
Standard for Laboratories that could reasonably have caused the Adverse
Analytical Finding. If the Athlete or other Person does so, the burden shifts to
the Anti-Doping Organization to prove to the comfortable satisfaction of thehearing panel that the departure did not cause the Adverse Analytical Finding.]

Code Article 6

ANALYSIS OF SAMPLES

Doping Control Samples shall be analyzed in accordance with the following principles:
6.1

Use of Approved Laboratories
For purposes of Article 2.1 (Presence of a Prohibited Substance or its
Metabolites or Markers), Samples shall be analyzed only in WADA-accredited
laboratories or as otherwise approved by WADA. The choice of the WADAaccredited laboratory (or other laboratory or method approved by WADA) used
for the Sample analysis shall be determined exclusively by the Anti-Doping
Organization responsible for results management.

[Comment to Article 6.1: Violations of Article 2.1 (Presence of a Prohibited Substanceor its Metabolites or Markers) may be established only by Sample analysis performed
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by a WADA-approved laboratory or another laboratory specifically authorized by
WADA. Violations of other Articles may be established using analytical results fromother laboratories so long as the results are reliable.]
6.2

Purpose of Collection and Analysis of Samples
Samples shall be analyzed to detect Prohibited Substances and Prohibited
Methods identified on the Prohibited List and other substances as may bedirected by WADA pursuant to Article 4.5 (Monitoring Program), or to assist an
Anti-Doping Organization in profiling relevant parameters in an Athlete’s urine,
blood or other matrix, including DNA or genomic profiling, for anti-doping
purposes.
[Comment to Article 6.2: For example, relevant profile information could be
used to direct Target Testing or to support an anti-doping rule violation
proceeding under Article 2.2 (Use or Attempted Use of a Prohibited Substance),or both.]6.3

Research on Samples
No Sample may be used for any purpose other than as described in Article 6.2
without the Athlete's written consent. Samples used for purposes other than
Article 6.2 shall have any means of identification removed such that theycannot be traced back to a particular Athlete.

6.4

Standards for Sample Analysis and Reporting
Laboratories shall analyze Doping Control Samples and report results inconformity with the International Standard for Laboratories.

6.5

Retesting Samples
A Sample may be reanalyzed for the purpose of Article 6.2 at any time
exclusively at the direction of the Anti-Doping Organization that collected the
Sample or WADA. The circumstances and conditions for retesting Samples
shall conform with the requirements of the International Standard forLaboratories.

[Comment to Article 6.5: Although this Article is new, Anti-Doping Organizations havealways had the authority to reanalyze Samples. The International Standard forLaboratories or a new technical document which is made a part of the International
Standard will harmonize the protocol for such retesting.]
Code Article 13

APPEALS

13.6 Appeals
Accreditation.

fromDecisionsSuspendingor

Revoking

Laboratory

Decisions by WADA to suspend or revoke a laboratory's WADA accreditation
may be appealed only by that laboratory with the appeal being exclusively to
CAS.
Code Article 14

CONFIDENTIALTIY AND REPORTING

14.1 Information Concerning Adverse Analytical Findings, Atypical Findings,
and Other Potential Anti-Doping Rule Violations.
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14.1.1

Notice to Athletes and Other Persons
An Athlete whose Sample is brought forward as an Adverse
Analytical Finding after the initial review under Articles 7.1 or
7.3, or an Athlete or other Person who is asserted to havecommitted an anti-doping rule violation after the initial
review under Article 7.4, shall be notified by the Anti-Doping
Organization with results management responsibility as
provided in Article 7 (Results Management).

14.1.2

Notice to National Anti-Doping Organizations, International
Federations and WADA
The same Anti-Doping Organization shall also notify the
Athlete’s National Anti-Doping Organization, International
Federation and WADA not later than the completion of theprocess described in Articles 7.1 through 7.4.

14.1.3

Content of Notification
Notification shall include: the Athlete's name, country, sportand discipline within the sport, the Athlete’s competitive
level, whether the test was In-Competition or Out-ofCompetition, the date of Sample collection and the analyticalresult reported by the laboratory.

14.1.4

Status Reports
The same Persons and Anti-Doping Organizations shall be
regularly updated on the status and findings of any review orproceedings conducted pursuant to Articles 7 (Results
Management), 8 (Right to a Fair Hearing) or 13 (Appeals)
and shall be provided with a prompt written reasoned
explanation or decision explaining the resolution of thematter.

14.1.5

Confidentiality
The recipient organizations shall not disclose this information
beyond those Persons with a need to know (which would
include the appropriate personnel at the applicable National
Olympic Committee, National Federation, and team in a TeamSport) until the Anti-Doping Organization with results
management responsibility has made public disclosure or has
failed to make public disclosure as required in Article 14.2
below.

[Comment to Article 14.1.5:
Each Anti-Doping Organization shallprovide, in its own anti-doping rules, procedures for the protection ofconfidential information and for investigating and disciplining improper
disclosure of confidential information by any employee or agent of theAnti-Doping Organization.]International Standard for Laboratories
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3.0 Terms and definitions
3.1 Code defined Terms
ADAMS: The Anti-Doping Administration and Management System is a Web-based
database management tool for data entry, storage, sharing, and reporting designed
to assist stakeholders and WADA in their anti-doping operations in conjunction withdata protection legislation.
Adverse Analytical Finding: A report from a laboratory or other WADA-approved
entity that, consistent with the International Standard for Laboratories and related
Technical Documents, identifies in a Sample the presence of a Prohibited Substanceor its Metabolites or Markers (including elevated quantities of endogenous
substances) or evidence of the Use of a Prohibited Method.
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, the International
Paralympic Committee, Major Event Organizations that conduct Testing at their
Events, WADA, International Federations, and National Anti-Doping Organizations.
Athlete: Any Person who participates in sport at the international level (as definedby each International Federation), the national level (as defined by each National
Anti-Doping Organization, including but not limited to those Persons in its Registered
Testing Pool), and any other competitor in sport who is otherwise subject to thejurisdiction of any Signatory or other sports organization accepting the Code. Allprovisions of the Code, including, for example, Testing and therapeutic use
exemptions, must be applied to international- and national-level competitors. Some
National Anti-Doping Organizations may elect to test and apply anti-doping rules torecreational-level or masters competitors who are not current or potential national
caliber competitors. National Anti-Doping Organizations are not required, however,to apply all aspects of the Code to such Persons. Specific national rules may beestablished for Doping Control for non-international-level or non-national-levelcompetitors without being in conflict with the Code. Thus, a country could elect totest recreational-level competitors but not require therapeutic use exemptions or
whereabouts information. In the same manner, a Major Event Organization holding
an Event only for masters-level competitors could elect to test the competitors but
not require advance therapeutic use exemptions or whereabouts information. For
purposes of Article 2.8 (Administration or Attempted Administration) 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 national-caliber
athletes are subject to the anti-doping rules of the Code, with the precise definitionsof international- and national-level sport to be set forth in the anti-doping rules of
the International Federations and National Anti-Doping Organizations, respectively.
At the national level, anti-doping rules adopted pursuant to the Code shall apply, at aminimum, to all persons on national teams and all persons qualified to compete inany national championship in any sport. That does not mean, however, that all such
Athletes must be included in a National Anti-Doping Organization’s Registered
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12

Testing Pool. The definition also allows each National Anti-Doping Organization, if itchooses to do so, to expand its anti-doping program beyond national-caliber athletes
to competitors at lower levels of competition.
Competitors at all levels ofcompetition should receive the benefit of anti-doping information and education.]
Atypical Finding: A report from a laboratory or other WADA-approved entity which
requires further investigation as provided by the International Standard forLaboratories or related Technical Documents prior to the determination of an Adverse
Analytical Finding.
Code: The World Anti-Doping Code.
Competition: A single race, match, game or singular athletic contest. For example,
a basketball game or the finals of the Olympic 100-meter race in athletics. For stage
races and other athletic contests where prizes are awarded on a daily or otherinterim basis the distinction between a Competition and an Event will be as provided
in the rules of the applicable International Federation.
Doping Control: All steps and processes from test distribution planning through toultimate disposition of any appeal including all steps and processes in between suchas provision of whereabouts information, Sample collection and handling, laboratory
analysis, therapeutic use exemptions, results management and hearings.
Event: A series of individual Competitions conducted together under one rulingbody (e.g., the Olympic Games, FINA World Championships, or Pan American
Games).
In-Competition:
Unless provided otherwise in the rules of an International
Federation or other relevant Anti-Doping Organization, “In-Competition” means theperiod commencing twelve hours before a Competition in which the Athlete isscheduled to participate through the end of such Competition and the Sample
collection process related to such Competition.
International Standard: A standard adopted by WADA in support of the Code.
Compliance with an International Standard (as opposed to another alternative
standard, practice or procedure) shall be sufficient to conclude that the procedures
addressed by the International Standard were performed properly. International
Standards shall include any Technical Documents issued pursuant to theInternational Standard.
Marker: A compound, group of compounds or biological parameter(s) that indicates
the Use of a Prohibited Substance or Prohibited Method.
Metabolite: Any substance produced by a biotransformation process.
National Anti-Doping Organization: The entity(ies) designated by each country
as possessing the primary authority and responsibility to adopt and implement antidoping rules, direct the collection of Samples, the management of test results, andthe conduct of hearings, all at the national level. This includes an entity which may
be designated by multiple countries to serve as regional Anti-Doping Organization forsuch countries. If this designation has not been made by the competent publicauthority(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
National Sport Confederation in those countries where the National Sport
Confederation assumes typical National Olympic Committee responsibilities in theanti-doping area.
Out-of-Competition: Any Doping Control which is not In-Competition.
Person: A natural person or an organization or other entity.
Prohibited List:
Methods.

The List identifying the Prohibited Substances and Prohibited

Prohibited Method: Any method so described on the Prohibited List.
Prohibited Substance: Any substance so described on the Prohibited List.
Publicly Disclose or Publicly Report: To disseminate or distribute information to
the general public or Persons beyond those Persons entitled to earlier notification inaccordance with Article 14.
Sample/Specimen:
Control.

Any biological material collected for the purposes of Doping

Signatories: Those entities signing the Code and agreeing to comply with theCode, including the International Olympic Committee, International Federations,International Paralympic Committee, National Olympic Committees, National
Paralympic Committees, Major Event Organizations, National Anti-Doping
Organizations, and WADA.
Tampering: Altering for an improper purpose or in an improper way; bringing
improper influence to bear; interfering improperly; obstructing, misleading or
engaging in any fraudulent conduct to alter results or prevent normal proceduresfrom occurring; or providing fraudulent information to an Anti-Doping Organization.
Testing:
The parts of the Doping Control process involving test distribution
planning, Sample collection, Sample handling, and Sample transport to the
Laboratory.
Use: The utilization, application, ingestion, injection or consumption by any means
whatsoever of any Prohibited Substance or Prohibited Method.
WADA: The World Anti-Doping Agency.

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3.2 ISL Defined Terms
Aliquot: A portion of the Sample of biological fluid or tissue (e.g., urine, blood, etc.)
obtained from the Athlete used in the analytical process.
Analytical Testing: The parts of the Doping Control process involving Sample
handling, analysis and reporting following receipt in the Laboratory.
Certified Reference Material: Reference Material, characterized by a metrologicallyvalid procedure for one or more specified properties, accompanied by a certificatethat provides the value of the specified property, its associated uncertainty and astatement of metrological traceability.
Confirmation Procedure: An analytical test procedure whose purpose is to identify
the presence or to measure the concentration/ratio of one or more specific Prohibited
Substances, Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a
Prohibited Substance or Method in a Sample. [Comment: A Confirmation Procedure
for a threshold substance shall also indicate a concentration/ratio of the Prohibited
Substance greater than the applicable Decision Limit (as noted in the TechnicalDocument on Decision Limits).]
Flexible Scope of Accreditation: Process for a Laboratory to make and implement
restricted modifications in the scope of the accreditation prior to the assessment by
the national accreditation body. Please see section 4.4.11 for a detailed descriptionof Flexible Scope of Accreditation.
Initial Testing Procedure (Screen Testing Procedure): An analytical test procedure
whose purpose is to identify those Samples which may contain a Prohibited
Substance, Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method or the quantity of a Prohibited Substance,
Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method in excess of a defined threshold.
Intermediate Precision: Variation in results observed when one or more factors,
such as time, equipment, and operator are varied within a Laboratory.
International Standard for Laboratories (ISL): The International Standard applicableto Laboratories as set forth herein.
Laboratory Internal Chain of Custody: Documentation of the sequence of Persons incustody of the Sample and any Aliquot of the Sample taken for Analytical Testing.
[Comment: Laboratory Internal Chain of Custody is generally documented by awritten record of the date, location, action taken, and the individual performing anaction with a Sample or Aliquot.]
Laboratory(ies): (A) WADA-accredited laboratory(ies) applying test methods andprocesses to provide evidentiary data for the detection of Prohibited Substances,
Methods and Markers on the Prohibited List, and if applicable, quantification of aThreshold Substance, in urine and other biological Samples in the context of antidoping activities.
Laboratory Documentation Packages: The material produced by the Laboratory tosupport an analytical result such as an Adverse Analytical Finding as set forth in the
WADA Technical Document for Laboratory Documentation Packages.
Major Event: A series of individual international Competitions conducted together
under an international multi-sport organization functioning as a ruling body (e.g., theInternational Standard for Laboratories
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Olympic Games, Pan American Games) and for which a significant increase ofresources and capacity is required to conduct Doping Control for the Event as
determined by WADA.
concentration of a Prohibited
Minimum Required Performance Level (MRPL):
Substance or Metabolite of a Prohibited Substance or Marker of a Prohibited
Substance or Method that a doping Laboratory is expected to reliably detect andconfirm in the routine daily operation of the Laboratory. See Technical Document
Minimum Required Performance Levels for Detection of Prohibited Substances.
Non-Threshold Substance: A substance listed on the Prohibited List for which the
documentable detection of any amount is considered an Adverse Analytical Finding.
Presumptive Analytical Finding: The status of a Sample test result for which there isa suspicious result in the Initial Testing Procedure, but for which a confirmation test
has not yet been performed.
Reference Collection: A collection of samples of known origin that may be used in
the determination of the identity of an unknown substance. For example, a wellcharacterized sample obtained from a verified administration study in which scientificdocumentation of the identity of Metabolite(s) can be demonstrated.
Reference Material: Material, sufficiently homogeneous and stable with respect toone or more specified properties, which has been established to be fit for its intended
use in a measurement process.
Repeatability, sr: Variability observed within a laboratory, over a short time, using asingle operator, item of equipment, etc.
Reproducibility, sR: Variability obtained when different Laboratories analyze thesame Sample.
Revocation: The permanent withdrawal of a Laboratory’s WADA accreditation.
Suspension: The temporary withdrawal of a Laboratory’s WADA accreditation.
Testing Authority(ies):
The Anti-Doping Organization that has authorized aparticular test. For example, the International Olympic Committee, World AntiDoping Agency, International Federation, National Sport Organization, National AntiDoping Organization, National Olympic Committee, Major Event Organization, orother authority defined by the Code responsible for authorizing Sample Testing either
In-Competition or Out-of-Competition.
Threshold Substance: A substance listed on the TD DL for which the detection andquantification of an amount in excess of a stated threshold is considered an Adverse
Analytical Finding.

3.3 International Standard for Testing (IST) Defined Terms
Sample Collection Authority: The Anti-Doping Organization or independent agency
or subcontractor with responsibility for all processes related to Sample Collection, as
specified in Clauses 5.0, 6.0, 7.0, 8.0 and 9.0.

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

4.1 Applying for a WADA Laboratory Accreditation
4.1.1 Expression of Interest
The candidate laboratory shall officially contact WADA in writing to express its
interest in the WADA accreditation process.
4.1.2 Submit initial Application Form
The candidate laboratory shall complete the necessary information in the Application
Form as provided by WADA and deliver this to WADA. The Application shall besigned by the Laboratory Director and, if relevant, by the Director of the hostorganization.
At this stage, WADA will verify the existence of a National Anti-Doping Program(compliant with the Anti-Doping International Standards) in the country where thecandidate laboratory is located, the ratification of the UNESCO Convention against
Doping in Sport by the host country of the candidate laboratory, as well as thepayment of the nation’s financial contributions to WADA.
4.1.3 Provide letter(s) of support
Upon successful completion of the above, the candidate laboratory shall be requested
by WADA to provide an official letter of support from the responsible National AntiDoping Organization or, if not established, the National Olympic Committee. The
letter of support shall contain as a minimum: Guarantee of sufficient annual financial support for a minimum of 3
years;
 Guarantee that, within two (2) years of obtaining accreditation, aminimum of 3000 Samples from Code-compliant clients (asdetermined by WADA) will be provided annually to the laboratory for
3 years;
 Guaranteethat
thenecessary
analyticalfacilities
andinstrumentation will be provided.
Any additional information regarding the above shall be given due consideration by
WADA. The authority providing the three year letter of support is not restricted toprovide exclusive support for only one laboratory.
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Letters of support from international sport organizations such as International
Federations may also be provided in addition to the above-mentioned letters.
If the candidate laboratory, as an organization, is linked to host organizations (e.g.
universities, hospitals, private organization…) and/or supported by a public authority,
an official letter of support from such authority shall be provided. In addition to theabove-mentioned letter from the NADO or NOC, the following information should be
provided: Documentation of the administrative support for the laboratory;
 Financial support for the laboratory, if relevant; Support for the research and development activities;
 Guarantee of provision of necessary analytical
instrumentation.

facilities

and4.1.4 Description of the Candidate Laboratory
The candidate laboratory shall then complete a detailed questionnaire provided by
WADA and submit it to WADA no later than eight weeks following the receipt of thequestionnaire. The questionnaire will include, but is not limited to, the following:

Staff list and their qualifications; Description of physical facilities, including a description of the
security considerations for Samples and records;
 List of proposed and actual instrumental resources and equipment;
 Method validation data; List of available Reference Materials and/or standards, or plans toacquire Reference Materials and/or standards, including properly
validated biological Sample Reference Collections; Business plan for the laboratory demonstrating commitment toanalyse 3000 Samples from Code-compliant Testing Authorities (asdetermined by WADA) annually, within two (2) years of receiving
accreditation;
 List of sponsors of the laboratory.
WADA may require an update of this documentation during the process ofaccreditation.
4.1.5 Conduct Initial visit
WADA usually conducts an initial visit (2-3 days) to the candidate laboratory at thecandidate laboratory’s expense. The purpose of this visit is to clarify issues withregard to the accreditation process and the defined requirements in the ISL and toobtain information about different aspects of the laboratory relevant for theaccreditation. Such a visit could be conducted prior to or during the accreditation
process.
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4.1.6 Issue final report and recommendation
Within approximately twelve (12) weeks after the initial visit or the receipt of thequestionnaire, WADA will complete and submit a report to the candidate laboratory.
In the report WADA will make the necessary recommendations with respect togranting the candidate laboratory the status of WADA probationary laboratory or if
this is not the case, identifying needed improvements in order to be considered a
WADA probationary laboratory.
4.1.7 Initial accreditation fee
Prior to entering the probationary period, the candidate laboratory shall pay to WADA
a one time non-refundable fee to cover the costs related to the laboratory initialaccreditation process. This fee shall be determined by WADA.
4.1.8 Laboratory Independence
The Laboratory shall be established and remain operationally independent from AntiDoping Organizations to ensure full confidence in its competence, impartiality,
judgment or operational integrity, in compliance with section 4.1.5d of ISO/IEC
17025.
4.1.9 Compliance with the Code of Ethics
The candidate laboratory shall implement and comply with the provision(s) in the
Code of Ethics (Annex B) which are relevant for a laboratory in the probationary
period. The laboratory shall communicate the Code of Ethics to all employees andensure understanding of and commitment to the different aspects of the Code of
Ethics. The candidate laboratory shall provide to WADA a letter of compliance with
the Code of Ethics, signed by the laboratory Director.

4.2 Preparing for WADA Laboratory Accreditation
Prior to entering the probationary period, the candidate laboratory may be required
to participate in a pre-probationary test, consisting of at least ten (10) EQAS
samples in order to assess its competence at that time. The pre-probationary test
may be conducted in conjunction with an initial site visit as described in 4.1.5. The
candidate laboratory shall successfully identify and document concentrations inexcess of the threshold(s) or Minimum Required Performance Levels (MRPL), as
applicable, of the Prohibited Substances, Metabolite(s) of Prohibited Substances, orMarker(s) of Prohibited Substances or Prohibited Methods within a time frame of 10
to 15 working days as determined by WADA. The candidate laboratory shall provide
a test report for each of the samples in the pre-probationary test. For negative
samples, WADA may request all or a portion of the negative Initial Testing Proceduredata. For selected samples for which there is an Adverse Analytical Finding, thecandidate laboratory shall provide a Laboratory Documentation Package. Additional
data to be provided upon WADA’s request. The candidate laboratory’s performance inthe pre-probationary test shall be taken into consideration by WADA to gauge thelaboratory’s competence as well as allow WADA to provide feedback on areas in needInternational Standard for Laboratories
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of improvement. Corrective actions, if any, shall be conducted and reported uponrequest. Such testing will be taken into account in the overall review of the candidate
laboratory’s application and may affect the timeliness of the candidate laboratory’s
entry into the probationary phase of accreditation.
Upon successful completion of the provisions of section 4.1 and following official
notification by WADA, a candidate laboratory enters the probationary phase of WADA
accreditation as a WADA probationary laboratory. The probationary period shallincorporate at least twenty (20) EQAS samples, typically distributed over multiple
EQAS rounds, in order to prepare the probationary laboratory for the initialaccreditation. During this period, WADA shall provide appropriate feedback to assist
the laboratory in improving the quality of its testing process. In this period thelaboratory shall successfully complete provisions 4.2.1 to 4.2.5.
4.2.1 Obtain Laboratory ISO/IEC 17025 accreditation
The laboratory shall be accredited by a relevant accreditation body to ISO/IEC 17025
with primary reference to the interpretations and applications of the ISO/IEC 17025
requirements as described in the Application of ISO/IEC 17025 to the Analysis ofUrine Doping Control Samples (Section 5.0) and the Application of ISO/IEC 17025 to
the Analysis of Blood Doping Control Samples (Section 6.0). The relevant
accreditation body shall be an International Laboratory Accreditation Cooperation(ILAC) full member that is a signatory to the ILAC Mutual Recognition Arrangement(ILAC MRA). The laboratory shall prepare and establish the required documentationand system according to the requirements in Application of ISO/IEC 17025 to theAnalysis of Urine Doping Control Samples (Section 5.0) and the Application of
ISO/IEC 17025 to the Analysis of Blood Doping Control Samples (Section 6.0), as
applicable.
Based on this, the laboratory shall initiate and prepare for theaccreditation process by consulting with a relevant accreditation body. An
assessment by the representative(s) of a relevant accreditation body, including an
ISL-trained assessor, shall be conducted. The laboratory shall correct any identified
non-conformities within defined time-frames and document this accordingly.
Summaries of the Assessment Report and any documentation of correction of nonconformities, in English or French, should be sent to WADA by the relevant
accreditation body. Should the laboratory prefer to send the information directly to
WADA, the laboratory shall do so within a reasonable time frame.
The ISO/IEC 17025 accreditation shall be obtained before the end of theprobationary period.
4.2.2 Participate in the WADA External Quality Assessment Scheme
During the probationary period the laboratory shall successfully analyze at least
eighteen (18) EQAS samples in multiple rounds (See Annex A for a description of the
EQAS).
After successful completion of the probationary period, as a final proficiency test, thelaboratory shall analyze a minimum of twenty (20) EQAS samples in the presence ofInternational Standard for Laboratories
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WADA representatives. The final accreditation test shall assess both the scientificcompetence and the capability of the laboratory to manage multiple Samples. Costs
associated with the WADA on-site visit shall be at the laboratory’s expense. The
probationary laboratory shall successfully identify and/or document a concentrationin excess of the threshold or Minimum Required Performance Level (MRPL) of theProhibited Substances, Metabolite(s) of Prohibited Substances, or Marker(s) of
Prohibited Substances or Prohibited Methods within five (5) calendar days of opening
the samples. The probationary laboratory shall provide a Test Report for each of thesamples in the proficiency test. For negative samples, WADA may request all or a
portion of the negative Initial Testing Procedure data. For selected samples forwhich there is an Adverse Analytical Finding, the probationary laboratory shallThis documentation shall be
provide a Laboratory Documentation Package.
submitted within two (2) weeks of WADA’s request.
It is understood that some laboratories already perform routine anti-doping activities
under national legislation not yet in line with the UNESCO convention. Suchlaboratories entering WADA probationary phase shall report Adverse Analytical
Findings and provide annual statistics to WADA as per provisions 4.5.1.5, 5.2.6.10,
and 5.2.6.11.
4.2.3 Plan and implement research activities
The probationary laboratory shall develop a plan for its research and development
activities in the field of Doping Control within a 3 year period including a budget.
The probationary laboratory shall demonstrate in its budget an allocation to researchand development activities in the field of Doping Control of at least 7% of the annual
budget for the initial 3-year period. At least two research and development activities
shall be initiated and implemented within the probationary period. The research
activities can either be conducted by the laboratory or in cooperation with other
WADA accredited Laboratories or other research organizations.
4.2.4 Plan and implement sharing of knowledge
The probationary laboratory shall demonstrate during the probationary period its
willingness and ability to share knowledge with other WADA accredited Laboratories.
The probationary laboratory shall prepare and convey information and knowledge on
at least two specific issues to the other WADA accredited Laboratories within theprobationary period. A description of this sharing is provided in the Code of Ethics(Annex B).
4.2.5 Professional liability insurance coverage
Probationary laboratories shall provide documentation to WADA that professional
liability risk insurance coverage has been obtained to cover liability to an amount of
no less than 2 million USD annually.

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4.3 Obtaining WADA Accreditation
4.3.1 Participate in a WADA accreditation audit
In the last phase of the probationary period WADA will prepare in cooperation withthe laboratory a final WADA accreditation assessment. Compliance with the definedrequirements in the Application of ISO/IEC 17025 to the Analysis of Urine Doping
Control Samples (Section 5.0) and if necessary, the Application of ISO/IEC 17025 to
the Analysis of Blood Doping Control Samples (Section 6.0) and the practice anddocumentation of the laboratory will be assessed. If WADA has participated in theinitial ISO/IEC 17025 assessment, the final WADA assessment may only consist of adocument audit. Otherwise, the audit can be conducted together with the relevant
accreditation body or separately if more practical. Should an on-site audit take place
by WADA, the associated cost shall be at the laboratory’s expense. Based on theaudit, WADA will issue an Audit Report and submit this to the laboratory. If
applicable, the laboratory shall correct identified non-compliances within definedtime-frames and report these to WADA.
4.3.2 WADA report and recommendation
Based on the relevant documentation from the laboratory, the Audit Report(s) from
WADA representative(s) and the Audit Report(s) from the relevant accreditation
body, WADA will make a final report including a recommendation concerning theaccreditation of the laboratory. The report and recommendation will be submitted to
the WADA Executive Committee for approval. In case that the recommendation isthat the laboratory should not be accredited, the laboratory will have a maximum ofsix (6) months to correct and improve specific parts of their operation, at which timea further report will be made by WADA.
4.3.3 Issue and publication of Accreditation certificate
A certificate signed by a duly authorized representative of WADA shall be issued inrecognition of an accreditation. Such certificate shall specify the name of theLaboratory and the period for which the certificate is valid. Certificates may be
issued after the effective date, with retroactive effect.
A list of accreditedLaboratories will be available on WADA’s website.

4.4 Maintaining WADA Accreditation
In order for the Laboratory to maintain its accreditation status, the National AntiDoping Organization and/or NOC shall be declared Code-compliant (as determined by
WADA) and the Laboratory host country shall have ratified the UNESCO Convention
against Doping in Sport.
4.4.1 Maintain ISO/IEC 17025 accreditation
The Laboratory shall hold an accreditation from the relevant accreditation body, ILAC
full member, signatory to ILAC MRA, according to ISO/IEC 17025 with primaryreference to the interpretations and applications of the ISO/IEC 17025 requirements
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as described in the Application of ISO/IEC 17025 to the Analysis of Urine Doping
Control Samples (Section 5.0) and the Application of ISO/IEC 17025 to the Analysis
of Blood Doping Control Samples (Section 6.0), as applicable.
4.4.2 Participate in the WADA External Quality Assessment Scheme
The WADA accredited Laboratories are required to successfully participate in the
WADA EQAS which is described in more detail in Annex A.
4.4.3 Laboratory Independence
The Laboratory shall be operationally independent from Anti-Doping Organizations toensure full confidence in its competence, impartiality, judgment or operational
integrity, in compliance with section 4.1.5d of ISO/IEC 17025.
4.4.4 Document Compliance with the WADA Laboratory Code of Ethics
The Laboratory shall annually provide to WADA a letter of compliance with theprovisions of the Code of Ethics (Annex B), signed by the Laboratory Director. The
Laboratory may be asked to provide documentation of compliance with theprovisions of the Code of Ethics (Annex B).
4.4.5 Document implemented research activities
The Laboratory shall maintain a plan for research and development in the field of
Doping Control, including an annual budget in this area of at least 7% of the total
annual budget.
The Laboratory should document the publication of results of the research in relevantscientific papers in the peer-reviewed literature (at least one publication every two(2) years). The list of scientific papers shall be made available to WADA uponrequest. The Laboratory may also demonstrate a research program by documenting
successful or pending applications for research grants (at least one 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 Doping Control and dissemination of
the results. The Laboratory should also relate research and development plans forthe next year.
4.4.6 Document implemented sharing of knowledge
The Laboratory shall demonstrate their willingness and ability to share knowledge
with other WADA accredited Laboratories. The Laboratory should make at least one
annual contribution to an anti-doping symposium or conference. The Laboratory
shall supply an annual report on sharing of knowledge with all other WADA
accredited Laboratories. A description of this sharing is provided in the Code of Ethics(Annex B).

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4.4.7 Maintain professional liability insurance coverageLaboratories shall provide documentation to WADA that professional liability risk
insurance coverage is maintained to an amount no less than 2 million USD annually.
4.4.8 Provide renewed letter(s) of support
Letter(s) of support, as described in Section 4.1.3, from a National Anti-Doping
Organization or National Olympic Committee responsible for a national Doping
Control program or an International Federation responsible for an international
Doping Control program shall be required in years in which there is an ISO/IEC
17025 re-assessment. For any commitment of less than three years, the National
Anti-Doping Organization or National Olympic Committee responsible for a national
Doping Control program or an International Federation responsible for aninternational Doping Control program shall be required to provide letter(s) of support
for the Laboratory every year.
A letter of support from the host organization renewing its three (3) year
commitment to the Laboratory shall also be required in conjunction with each
ISO/IEC 17025 re-assessment or be generated and sent to WADA at least every two(2) years.
4.4.9

Minimum number of Samples

In order to maintain proficiency, WADA accredited Laboratories are required, within
two (2) years of the effective date of the current version of the ISL, to analyze aminimum of 3000 Doping Control Samples provided annually by Code-compliant
Testing Authorities (as determined by WADA) or as otherwise approved by WADA.
WADA will monitor the number of Samples tested by the Laboratory. If the numberof Samples falls below 3000 per year, WADA Laboratory accreditation may besuspended or revoked in accordance with sections 4.4.12.2, 4.4.12.3 and 4.4.13.
4.4.10 Participate in WADA/Accreditation Body re-assessments andsurveillance assessments
WADA reserves the right to inspect and assess the Laboratory at any time. The
notice of the assessment/inspection will be made in writing to the Laboratory
Director. In exceptional circumstances, the assessment/inspection may beunannounced.
4.4.10.1 WADA/Accreditation Body re-assessment
The Laboratory must receive ISO/IEC 17025 accreditation including
compliance with the Application of ISO/IEC 17025 for the Analysis ofUrine Doping Control Samples (Section 5.0) and Application of ISO/IEC
17025 for the Analysis of Blood Doping Control Samples (Section 6.0),
as applicable.
The assessment team shall include an ISL-trained
assessor selected by the accreditation body for the on-site reassessment.
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Copies of the re-assessment summary report in English or French aswell as the Laboratory responses should be sent in a timely fashion to
WADA by the relevant accreditation body. Should the Laboratory prefersending this information directly to WADA, the Laboratory shall do so
within a reasonable time frame.
The Laboratory shall provide a copy of the ISO/IEC 17025 certificate assoon as it is obtained from the relevant accreditation body.
4.4.10.2 Accreditation Body surveillance assessment
When a surveillance ISO/IEC 17025 assessment is required, a copy of
the assessment summary report and evidence of corrective actions forany non-compliance(s), in English or French, should be sent to WADA
by the relevant accreditation body. Should the Laboratory prefersending this information directly to WADA, the Laboratory shall do so
within a reasonable time frame.
4.4.10.3 WADA assessment
As part of an announced or unannounced assessment/inspection, WADA
retains the right to request copies of Laboratory documentation and/or
request re-analysis of selected A and/or B Samples either on-site or inanother Laboratory of WADA’s choice.
4.4.11 Flexible Scope of Accreditation
WADA accredited Laboratories may modify or add analytes to existing scientificmethods to expand their scope or develop new methods that involve technology
already within the scope of accreditation without the need for approval by the bodythat completed the ISO/IEC 17025 accreditation of that Laboratory. To have a
Flexible Scope of Accreditation, the laboratory must have within its quality
management
documentation
processes
formethodvalidation/acceptance,competence of key personnel, record keeping and reporting.
Any new analytical method or procedure to Doping control requiring expertise andtechnology outside the Laboratory scope of accreditation shall be properly validated
by the Laboratory and be determined as Fit-for-purpose by WADA prior to first
implementation by any Laboratory into the field of anti-doping analysis. WADA shalluse whatever means deemed appropriate, including formal consultation with
scientific expert working groups, and/or publication(s) in peer-reviewed scientificjournal(s) to evaluate whether the test is Fit-for-purpose prior to providing approval.
Before applying such a new method or procedure to the analysis of Doping Control
Samples, but after the approval by WADA, the Laboratory shall obtain an extensionof the scope of accreditation by a relevant accreditation body.

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4.4.12 WADA report and recommendation
WADA will annually review Laboratory compliance with the requirements listed in the
ISL. With the exception of re-accreditation and other required on-site assessments,
the annual review may consist of a documentation assessment. WADA may require
documentation from the Laboratory. Failure of the Laboratory to provide timely
information requested in evaluating performance by the specified date shall beconsidered a refusal to cooperate and may result in Suspension or Revocation ofaccreditation.
WADA will consider the overall, EQAS and routine performance of the Laboratory inmaking decisions regarding continued accreditation. The Laboratory’s performanceon aspects of the standards described in Section 5.0 and/or Section 6.0 (such as
turn-around times, Documentation Package contents, and feedback from customer
organizations) may be considered in formulating such recommendation.
4.4.12.1 Maintenance of accreditation
In the event that the Laboratory has maintained satisfactory
performance, WADA will maintain the accreditation of the Laboratory.
4.4.12.2 Suspension of accreditation
Whenever WADA has reason to believe that Suspension may berequired and that immediate action is necessary in order to protect theinterests of the Anti-Doping Community, WADA may immediately
suspend a Laboratory’s accreditation. Such a decision may be taken by
the Chairman of the WADA Executive Committee.
Suspension of accreditation may be based on, but not limited to, thefollowing considerations:










Suspension of ISO/IEC 17025 accreditation;
Failure to take appropriate corrective action after anunsatisfactory performance either in routine Analytical
Testing or in an EQAS test;
Failure to comply with any of the requirements or standards
listed in WADA ISL and/or Technical Documents;
Failure to cooperate with WADA or the relevant Testing
Authority in providing documentation;
Lack of compliance with the WADA Laboratory Code of
Ethics;Major changes in key staff without proper and timely
notification to WADA;
Failure to cooperate in any WADA enquiry in relation to theactivities of the Laboratory;
Non-compliances
identified
fromlaboratory
on-siteassessments;

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

Loss of support jeopardizing the quality and/or viability of
the Laboratory.

WADA may decide upon a Suspension of accreditation at any time basedon the results of the EQAS or other evidence of serious deviation(s) of
the ISL arising from the routine analysis of Doping Control Samples.
Violations of Laboratory routine performance will be assessed by WADA
on a case-by-case basis considering severity and consequences to theAnti-Doping System. In the event of serious violations, WADA also, in
addition to suspension, reserves the right to organize unannounced
audits which may include national accreditation body- and ISL-trained
assessors and/or WADA experts.
The period and terms of Suspension shall be proportionate to theseriousness of the non-compliance(s) or lack of performance and theneed to ensure accurate and reliable drug testing of Athletes. A periodof Suspension shall be up to 6 months, during which time any noncompliance must be corrected, documented and reported to WADA atleast six (6) weeks before the end of the Suspension period. Delay insubmitting the proper corrective actions may lead to an extension of theSuspension period. If the non-compliance is not corrected during theSuspension period, the Laboratory accreditation will be revoked, unless
an extension not to exceed two (2) months is granted by WADA.
In the case of a non-compliance, WADA may suspend the Laboratoryfrom performing analyses for any Prohibited Substances. If WADA
determines that the non-compliance is limited to a class of Prohibited
Substances, WADA may limit the Suspension to analysis for the class ofcompounds in which the non-compliance occurred.
4.4.12.3 Revocation of accreditation
The WADA Executive Committee shall revoke the accreditation of any
Laboratory accredited under these provisions if it determines that
Revocation is necessary to ensure the full reliability and accuracy of
drug tests and the accurate reporting of test results. Revocation ofaccreditation may be based on, but not limited to, the following
considerations:

Loss of ISO/IEC 17025 accreditation or repeatedSuspensions of ISO/IEC 17025 accreditation;
Systematic failure to comply with the ISL and/or TechnicalDocuments;
Serious Laboratory non-compliances identified (e.g. on-site
assessments,
documentedclientcomplaints,
otherenquiries);

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














Repeated failure to take appropriate corrective action
following unsatisfactory performance either in routine
Analytical Testing or in an EQAS test;
A serious or repeated violation of the ISL;
Failure to correct a lack of compliance with any of therequirements or standards listed in the WADA ISL (including
Annex A External Quality Assessment Scheme) during a
Suspension period;
Failure to cooperate with WADA or the relevant Testing
Authority during the Suspension phase;
Recurrent non-compliances with the ISL and/or TechnicalDocuments and lack of cooperation with WADA;
Failure to inform clients of Suspension of accreditation;
A serious or repeated violation of the Code of Ethics;
Conviction of any key personnel for any criminal offence
committed that is related to the operation of the Laboratory;
Any other cause that materially affects the ability of theLaboratory to ensure the full reliability and accuracy of drug
tests and the accurate reporting of results;
Repeated and/or continuous failure to cooperate in any
WADA inquiry in relation to the activities of the Laboratory;
Loss of support jeopardizing the quality and/or viability of
the Laboratory.

A Laboratory whose accreditation has been revoked is ineligible toperform testing of Doping Control Samples for any Testing Authority.
If a Laboratory, whose accreditation has been revoked, should seek a
new accreditation, it shall begin the process as a new laboratory as
described in Section 4.1; unless there are exceptional circumstances orjustifications as determined solely by the WADA Executive Committee.
In the case of exceptional circumstances, the WADA Executive
Committee shall determine what steps shall be followed prior to
granting a new accreditation.
4.4.13 Notification
4.4.13.1 Written Notice
When a Laboratory is suspended or WADA seeks to revoke
accreditation, WADA shall immediately serve the Laboratory withwritten notice of the Suspension or proposed Revocation by facsimile,
hand delivery, or registered or certified mail, return receipt requested.
This notice shall state the following:1) The reason for Suspension or proposed Revocation;2) The terms of the Suspension or proposed Revocation; andInternational Standard for Laboratories
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3) The period of Suspension.
4.4.13.2 Effective Date
A proposed Revocation is
A Suspension is immediately effective.
effective thirty (30) calendar days after the date on the written noticeor, if review is requested, upon WADA’s decision to uphold the proposed
Revocation. A Laboratory who has received notice that its accreditation
is in the process of being revoked shall be suspended until the
Revocation is made final or is rescinded by WADA. If WADA decides not
to uphold the Suspension or proposed Revocation, the Suspension is
terminated immediately and any proposed Revocation shall not takeplace.
4.4.13.3 Public Notice
WADA will immediately notify all relevant national public authorities,
National Accreditation Bodies, National Anti-Doping Organizations,
National Olympic Committees, International Federations, and theInternational Olympic Committee of the name and address of any
Laboratory that has had its accreditation suspended or revoked, and thename of any Laboratory that has had its Suspension lifted.
WADA will provide to any Testing Authority, upon written request,
WADA’s written decision which upholds or denies the Suspension or
proposed Revocation.
WADA’s website will be updated regarding a Laboratory’s accreditation
status.
4.4.14 Re-accreditation Costs
On an annual basis, WADA will invoice the Laboratory for a portion of the costs
associated with the re-accreditation process. The Laboratory shall assume the travel
and accommodation expenses of the WADA representative(s) in the event of on-site
assessments.
4.4.15 Issue and publication of Accreditation certificate
If maintenance of accreditation is approved, the Laboratory shall receive a certificate
signed by a duly authorized representative of WADA issued in recognition of suchaccreditation. Such a certificate shall specify the name of the Laboratory and theperiod for which the certificate shall be valid. Certificates may be issued after theeffective date, with retroactive effect.

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4.5 Accreditation Requirements for Major Events
Primarily, Major Event Organizers should consider transporting Samples to theexisting facilities of an accredited Laboratory.
In some cases, the reporting time requirements for a Major Event may require that
the Laboratory facility be located in proximity to the Competition such that Samples
can be delivered by Event Doping Control staff. This may require re-location of an
existing Laboratory for a period of time which shall start sufficiently in advance tovalidate operations at the satellite facility and perform the testing for the Event.
In addition, the Laboratory support for a Major Event may be such that the existing
accredited Laboratory facilities are not adequate. This may require re-location of theLaboratory to a new facility, the addition of personnel, and/or the acquisition of
additional equipment. The Laboratory Director of the WADA accredited Laboratory
designated to perform the testing shall be responsible to ensure that proper quality
management system, performance, security and safety are maintained.
In some circumstances, where Samples will be transferred to an existing Laboratory
facility, there must be agreement between the Major Event Organizer and the WADA
accredited Laboratory in regards whether testing requirements such as turn-aroundtime and the Athlete rights are met for in any eventuality. The Laboratory will,
however, be required to report on staffing and equipment issues as required by
WADA.
If the Laboratory is required to move or extend its operation temporarily to a newphysical location, the Laboratory shall demonstrate a valid ISO/IEC 17025
accreditation with primary compliance with the Application of ISO/IEC 17025 to theAnalysis of Urine Doping Control Samples (Section 5.0) and if necessary, theApplication of ISO/IEC 17025 to the Analysis of Blood Doping Control Samples(Section 6.0) for the new facility or satellite facility.
Any methods or equipment unique to the satellite facility shall be validated prior to
the satellite facility accreditation assessment. Any changes to methods or otherprocedures in the quality manual shall also be validated prior to the assessment.
The Laboratory shall be responsible for providing WADA with regular and timely
updates on the progress of the testing facilities.
4.5.1 Major Event Testing in the Laboratory Facilities
4.5.1.1

Participate in an initial WADA/Accreditation Body assessment

WADA may perform one or more site visit(s) to the Laboratory facility
as soon as it is available to determine whether the facility is adequate.
Expenses related to such a visit shall be at the Laboratory’s expense.
Particular emphasis will be placed on the adequacy of security
considerations, the physical layout of the space to ensure that adequate
separation of various parts of the Laboratory are maintained, and to
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provide a preliminary review of other key support elements and toassess compliance with the ISL.
4.5.1.2

Complete a Pre-Event Report on Facilities and Staff

The Laboratory shall report to WADA all senior personnel temporarily
working in the Laboratory. The Laboratory Director shall ensure thatthese personnel are adequately trained in the methods, policies, andprocedures of the Laboratory. Particular emphasis should be given to
the Code of Ethics and the confidentiality of the results management
process. Adequate documentation of training of these temporary
employees shall be maintained by the Laboratory.
At least one (1) month prior to start of testing for the Event, theLaboratory shall provide a report to WADA consisting of the following:










A valid signed contract between the Laboratory and the
responsible Testing Authority / Major Event organizer
including the schedule and number of testing to be
performed;
An organizational chart including Laboratory staff andtemporary staff scientists employed by the Laboratory for
the Event. Supporting information such as job titles andresponsibilities shall be included;
A training plan with timelines for new staff 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.);
Method(s) of reporting the test results in a secure manner tothe appropriate authorities.

Any changes that occur prior to the start of Testing for the Major Eventshould be immediately reported to WADA.
Even if the testing is to be done at the Laboratory’s existing facility, the
Pre-Event Report shall be completed, particularly in regard to personnel
changes and any additional equipment.
4.5.1.3

Review the reports and correct identified non-conformities

The Laboratory shall address and correct all identified non-compliances.
The assessment report and documentation of the corrective actions
shall be submitted to WADA prior to start of scheduled testing for the
Major Event.

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4.5.1.4

External Quality Assessment Scheme

WADA may, at its sole discretion, submit EQAS samples to the
Laboratory for analysis. The samples shall be analyzed by the same
methods used in the testing of Samples from a Major Event Organizer.
The use of these EQAS samples may be part of the ISO/IEC 17025
assessment by the relevant accreditation body.
Failure to successfully complete the EQAS will be considered by WADA
in deciding whether to accredit the Laboratory for the Major Event. In
such event, the Laboratory shall implement, document, and provide to
WADA proper corrective action.
The EQAS process should include any additional personnel that areadded to the staff for the Major Event. The samples shall be analyzed
using the same methods and procedures that will be used for the
analysis of Samples for the Major Event.
4.5.1.5

Reporting

All test result reporting shall be in accordance with the confidentiality
requirements of the Code.
4.5.1.6

Monitoring and assessment during the Major Event

WADA may choose at its sole discretion to have an observer in the
Laboratory during the Major Event. The Laboratory Director and staff
are expected to provide full cooperation to the observer.
WADA, in conjunction with the Major Event Organization or relevantInternational Federation, may submit Double Blind EQAS samples to the
Laboratory.
In the event of a false positive, the Laboratory will immediately cease
testing for that class of Prohibited Substances and Prohibited Methods.
The Laboratory shall apply corrective actions within 12 hours of
notification of the false positive. All Samples analyzed prior to the false
positive will be re-analyzed for the class of Prohibited Substances andProhibited Methods for which the non-compliance occurred. The resultsof the investigation and analysis will be presented to WADA within 24
hours unless otherwise agreed in writing.
In the event of a false negative, the Laboratory will be required toinvestigate the root cause and apply corrective actions within 24 hours
of notification of the false negative result. A representative group of
Samples in appropriate number to ensure that the risk of false
negatives is minimal will be re-analyzed for the class of Prohibited
Substances and Prohibited Methods for which the non-complianceoccurred. The results of the investigation and analysis will be presented
to WADA within 48 hours unless otherwise agreed in writing.
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4.5.2 Major Event Testing in satellite Laboratory facilities
In addition to the accreditation requirements for Major Events, satellite
laboratories shall also meet the following requirements:
4.5.2.1

Participate in an initial WADA/Accreditation Body assessment

WADA may perform one or more site visit(s) to the Laboratory facility
as soon as it is available to determine whether the facility is adequate.
Expenses related to such a visit(s) shall be at the Laboratory’s expense.
Particular emphasis will be placed on the adequacy of security
considerations, the physical layout of the space to ensure that adequate
separation of various parts of the Laboratory are maintained, and toprovide a preliminary review of other key support elements and toassess compliance to the ISL and ISO/IEC 17025.
4.5.2.2

Document ISO/IEC 17025 accreditation of the satellite facility

At least one month prior to the start of scheduled Testing for the Major
Event, the Laboratory must provide documentation that the relevant
accreditation body has accredited the satellite facility in compliance with
the Application of ISO/IEC 17025 to the Analysis of Urine Doping
Control Samples (Section 5.0) and the Application of ISO/IEC 17025 to
the Analysis of Blood Doping Control Samples (Section 6.0), as
applicable. It is a WADA requirement that an ISL trained assessor shallbe present at the accreditation body assessment of the satellite facility.
Expenses associated with such assessment will be at the Laboratory’s
expense.
4.5.2.3

Participate in WADA accreditation assessment

WADA may choose to perform an on-site assessment or a document
assessment of the satellite facility. Should an on-site assessment takeplace, WADA expenses related to the assessment will be at theLaboratory’s expense. This assessment may include analysis of a set of
EQAS samples. Particular emphasis will be placed on involvement of
new staff members to assess their competence.
4.5.2.4

Issue and publication of a temporary and limited Accreditation
certificate

Based on the documentation provided, WADA reserves the right tomake a decision regarding accreditation of the Laboratory. In the eventthat accreditation is awarded, WADA shall issue an accreditation for theperiod of the Major Event and an appropriate time before and after theactual Competition.
In the event that the accreditation is not awarded, it is the responsibilityof the Testing Authority/ Major Event Organizer to activate acontingency plan in order to ensure analysis of Samples in compliancewith ISL requirements.

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5.0 Application of ISO/IEC 17025 to the Analysis of Urine
Doping Control Samples
5.1 Introduction and Scope
This section of the document is intended as an application as described in Annex B.4(Guidelines for establishing applications for specific fields) of ISO/IEC 17025 to thefield of Doping Control. Any aspect of testing or management not specifically
discussed in this document shall be governed by ISO/IEC 17025. The application
focuses on the specific parts of the processes that are critical with regard to thequality of the laboratory’s performance as a WADA-accredited laboratory and are
therefore determined to be significant in the evaluation and accreditation process.
This section introduces the specific performance standards for a WADA-accredited
laboratory. The conduct of testing is considered a process within the definitions of
ISO 17000. Performance standards are defined according to a process model where
the Laboratory practice is structured into three main categories of processes:
 Analytical and technical processes;
 Management processes;
 Support processes.
Wherever possible, the application will follow the format of the ISO/IEC 17025
document. The concepts of the management system, continuous improvement, andcustomer satisfaction have been included.

5.2 Analytical and Technical Processes
5.2.1 Receipt of Samples
5.2.1.1

Samples may be received by any method acceptable within theconcepts of the International Standard for Testing.

5.2.1.2

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

5.2.1.3

The transfer of the Samples from the courier or other persondelivering the Samples shall be documented including at a minimum,
the date, the time of receipt, and the name and signature of theLaboratory representative receiving the Samples. This information
shall be included into the Laboratory Internal Chain of Custody
record.

5.2.2 Handling and Retention of Samples
5.2.2.1

The Laboratory shall have a system to uniquely identify the Samples
and associate each Sample with the collection document or otherexternal chain of custody.

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5.2.2.2

The Laboratory shall have Laboratory Internal Chain of Custody
procedures to maintain control of and accountability for Samples
from receipt through final disposition of the Samples.
The
procedures shall incorporate the concepts presented in the applicable
WADA Technical Document for Laboratory Internal Chain of Custody.

5.2.2.3

The Laboratory shall observe and document conditions that exist at
the time of receipt that may adversely impact on the integrity of a
Sample. For example, irregularities noted by the Laboratory should
include, but are not limited to:









Sample tampering is evident;
Sample is not sealed with tamper-resistant device or notsealed upon receipt;
Sample is without a collection form (including Sample
identification code) or a blank form is received with the
Sample;Sample identification is unacceptable. For example, thenumber on the bottle does not match the Sample
identification number on the form;
Sample volume is inadequate to perform the requested
testing menu;
Sample transport conditions are not consistent withpreserving the integrity of the Sample for anti-doping
analysis.

5.2.2.4

The Laboratory shall notify and seek instructions from the Testing
Authority regarding rejection or testing of Samples for which
irregularities are noted. If applicable, any agreement between a
Testing Authority and Laboratory that establishes Sample rejection
criteria shall be documented.

5.2.2.5

In cases where the Laboratory receives more than two Samples,
which are linked to a single Athlete according to the Doping control
form(s), the Laboratory should prioritize the analysis of the first andlast Samples collected.


5.2.2.6

The Laboratory may conduct further analyses on the intermediary
Samples collected if deemed necessary in consultation with theTesting Authority.
The Laboratory may combine Aliquots from multiple Samples,
which are linked to a single Athlete according to the Doping
Control form(s), if necessary to conduct a proper analysis.

The Laboratory shall retain the “A” and “B” Sample(s) without anAdverse Analytical Finding or Atypical Finding for a minimum of three(3) months after the final analytical (“A” Sample) report isInternational Standard for Laboratories
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transmitted to the Testing Authority. The Sample(s) shall be stored
frozen during the long term storage.
Samples with irregularities shall be stored frozen for a minimum of
three (3) months following the report to the Testing Authority.
After the applicable storage period above, the Laboratory shall do
one of the following with the Sample(s):

If the Testing Authority has arranged for storage of the
Samples for a period from three (3) months to eight (8)years, the Laboratory shall ensure that the Samples are stored
in a secure location under continuous chain of custody;

If consent has been obtained from the Athlete and provided
that the Samples are made anonymous, the Samples may beretained by the Laboratory for research purposes. Samples
used for research purposes shall have any means ofidentification removed or the Sample shall be transferred into
a container such that the contents cannot be traced back to aparticular Athlete;

Dispose of the Sample(s).

Note: The above three actions shall be conducted and recorded under the
Laboratory Internal Chain of Custody.

5.2.2.7

The Laboratory shall retain frozen the “A” and “B” Sample(s) with anAdverse Analytical Finding or Atypical Finding for a minimum of three(3) months after the final analytical report is transmitted to the
Testing Authority or as long as necessary pending the conclusion of alongitudinal study.

5.2.2.8

If the Laboratory has been informed by the Testing Authority thatthe analysis of a Sample is challenged, disputed or underlongitudinal investigation, the Sample shall be stored frozen and all
the records pertaining to the Testing of that Sample shall be stored
until completion of any challenges.

5.2.2.9

The Laboratory shall maintain a policy pertaining to retention,
release, and disposal of Samples and Aliquots.

5.2.2.10 The Laboratory shall maintain custody information on the transfer ofSamples, or portions thereof to another Laboratory.
5.2.2.11 In cases where both “A” and “B” Samples have been reported with
an Adverse Analytical Finding(s) and no challenge, dispute, or
longitudinal study is pending, the Laboratory shall either make theSamples anonymous for research purposes (with proper consent
from the Athlete) or dispose of the Samples. Samples used forInternational Standard for Laboratories
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research purposes shall have any means of identification removed or
be transferred into an anonymous container such that they cannot
be traced back to a particular Athlete. Disposal of Samples shall be
conducted and recorded under the Laboratory Internal Chain of
Custody.
5.2.2.12 Re-sealing of Samples for long-term storage and re-testing
5.2.2.12.1

In cases where a Sample has been reported negative andthe Testing Authority has arranged for storage of the
Samples for a period from three (3) months to eight (8)years, the Laboratory shall ensure that the Samples are
stored in a secure location under continuous chain ofcustody.

5.2.2.12.1.1 Cases in which sufficient urine remains in “A”
Sample for possible re-testing.
The re-testing in such cases shall follow the regular
Testing procedure.
5.2.2.12.1.2 Cases in which no urine remains of “A” Sample forpossible re-testing.

The opportunity shall be offered to the Athlete, or to

the representative of the Athlete to be present at the
opening of the sealed “B” bottle. If the Athlete
declines to be present or the Athlete’s representative
does not respond to the invitation or if the Athlete or
the Athlete’s representative continuously claim not
to be available on the date of the opening, despite
reasonable attempts by the Laboratory and Testing
Authority to accommodate their dates, theLaboratory shall appoint an independent witness toverify the opening of the sealed “B” Sample.

At the opening of the “B” Sample, the Laboratory
shall ensure that the Sample is adequately
homogenized (e.g. invert bottle several times)
before splitting the “B” Sample. The Laboratory shalldivide the volume of the “B” Sample into two bottles(using Sample collection equipment compliant to IST
provision 6.3.4) in the presence of the Athlete or the
Athlete’s representative(s) or an independent
witness. The splitting of the “B” Sample shall be
documented in the chain of custody. The Athlete or
the Athlete’s representative will be invited to seal
one of the bottles using a tamper evident method.
If the analysis of the first bottle reveals an Adverse
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Analytical
Finding,aconfirmation
shallbeundertaken, if requested by the Athlete or his/her
representative, using the second sealed bottle.
5.2.2.12.2

Sample where the “A” and the “B” bottles have been
opened and not re-sealed as per 5.2.2.12.1.2.
The Samples shall be handled as per ISL section 5.2.2.11.

5.2.3 Sampling and Preparation of Aliquots for Analysis
5.2.3.1

The Laboratory shall maintain paper or electronic Laboratory Internal
Chain of Custody procedures for control of and accountability for all
Aliquots and other subsamples and transfers from preparation
through disposal. The procedures shall incorporate the concepts
presented in the WADA Technical Document for Laboratory Internal
Chain of Custody.

5.2.3.2

Before the initial opening of a Sample bottle, the device used toensure the integrity of the Sample (e.g., security tape or a bottle
sealing system) shall be inspected and the integrity documented.

5.2.3.3

The Aliquot preparation procedure for any Initial Testing Procedureor Confirmation Procedure shall ensure that no risk of contaminationof the Sample or Aliquot exists.

5.2.4 Analytical Testing
5.2.4.1

Urine analysis for adulteration or manipulation

5.2.4.1.1

The Laboratory shall only note any unusual condition of theurine – for example: color, odor, turbidity or foam. Any
unusual conditions should be recorded and included as partof the report to the Testing Authority.

5.2.4.1.2

The Laboratory shall measure the pH and specific gravity.
Other tests that may assist in the evaluation of
adulteration or manipulation may be performed if deemednecessary.

5.2.4.2

Urine Initial Testing Procedure

5.2.4.2.1

The Initial Testing Procedure(s) shall detect the Prohibited
Substance(s) or Metabolite(s) of Prohibited Substance(s),or Marker(s) of the Use of a Prohibited Substance or
Prohibited Method for all substances covered by theProhibited List for which there is a method that is Fit-forpurpose. WADA may make specific exceptions to thissection for specialized techniques that are not required to
be within the scope of accreditation of all Laboratories.

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5.2.4.2.2

The Initial Testing Procedure shall be performed with a Fitfor-purpose method for the Prohibited Substance or
Prohibited Method being tested. A characteristic of theInitial Testing Procedure is to obtain information about thepotential
presenceofProhibited
Substance(s)orMetabolite(s) of Prohibited Substance(s), or Marker(s) of
the Use of a Prohibited Substance or Prohibited Method.
Results from Initial Testing Procedures can be included aspart of longitudinal studies (such as endogenous steroid
profiles) provided that the method is appropriately
validated.

5.2.4.2.3

All batches undergoing the Initial Testing Procedure shall
include appropriate negative and positive controls in
addition to the Samples being tested.

5.2.4.2.4

For Threshold Substances, appropriate controls near thethreshold shall be included in the Initial Testing
Procedures. Initial Testing Procedures are not required toconsider uncertainty of measurement.

5.2.4.3

Urine Confirmation Procedure
All Confirmation Procedures shall be documented. The objective of
the Confirmation Procedure is to accumulate additional information
to support an Adverse Analytical Finding. A Confirmation Procedure
shall have equal or greater selectivity/discrimination than the Initial
Testing Procedure.

5.2.4.3.1“A” Sample Confirmation

5.2.4.3.1.1 A Presumptive Analytical Finding from an Initial
Testing Procedure of a Prohibited Substance,
Metabolite(s) of a Prohibited Substance, orMarker(s) of the Use of a Prohibited Substance or
Prohibited Method shall be confirmed using an
additional Aliquot(s) taken from the original “A”
Sample.
For sections S.3 Beta-2 Agonists and S.9
Glucucorticosteroids of the Prohibited List only, andif requested by the Testing Authority, a Laboratory
may report a Presumptive Analytical Finding toenquire whether an approved Therapeutic Use
Exemption(TUE)
existsfortheProhibited
Substance(s) detected. Decision by the Testing
Authority shall be retained as part of the record.

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5.2.4.3.1.2 Mass spectrometry (MS) coupled to either gas (GC)or liquid chromatography (LC) is the analyticaltechnique of choice for confirmation of Prohibited
Substances, Metabolite(s) of a Prohibited Substance,or Marker(s) of the Use of a Prohibited Substance or
Prohibited Method. GC or High Performance Liquid
Chromatography (HPLC) coupled with MS or MS-MS
are acceptable for both Initial Testing Procedures
and Confirmation Procedures for a specific analyte.
5.2.4.3.1.3 Affinity Binding Assays (e.g. Immunoassays) arealso routinely used for detection of macromolecules
in urine samples. Affinity Binding Assays applied forthe Initial Testing Procedures and Confirmation
Procedures shall use affinity reagents (e.g.
antibodies) recognizing different epitopes of themacromolecule analyzed, unless a purification or
separation method is used prior to application of theAffinity Binding Assay to eliminate the potential ofcross-reactivity. The Laboratory shall document, aspart 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), only one of theaffinity reagents (either applied for capture ordetection of the target analyte) used in the Affinity
Binding Assays applied for the Initial Testing
Procedures and Confirmation Procedures must differ
for antigenic epitope specificity. The other affinity
reagent may be used in both immunoassays.
For analytes that are too small to have two
independent antigenic epitopes, two different
purification methods or two different analyticalmethods shall be applied.
Multiplexed Affinity Binding Assays, protein chips,
and similar simultaneous multi-analyte testing
approaches may be used.
The Initial Testing
Procedures and Confirmation Procedures may be
performed simultaneously in the same Aliquot
providing that the same preconditions describedabove for assay specificity or methods of purificationor separation are met.
5.2.4.3.1.4 The Laboratory shall have a policy to define thosecircumstances where the Confirmation Procedure forInternational Standard for Laboratories
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an “A” Sample may be repeated (e.g., batch quality
control failure) and the first test result shall benullified.
Each repeat confirmation shall be
documented and be completed on a new Aliquot of
the “A” Sample.
5.2.4.3.1.5 If more than one Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(s) of the Use ofa Prohibited Substance or Prohibited Method is
identified by the Initial Testing Procedures, theLaboratory shall confirm as many of the Presumptive
Analytical Findings as possible. The decision on theprioritization for the confirmation(s) shall be madeto give precedent to non-specified substance(s) andthe decision should be made in cooperation with theTesting Authority and documented. In addition, no
final written Test Report incorporating a Presumptive
Analytical Finding shall be issued unless authorized
by the Testing Authority in relation to the existenceof an approved Therapeutic Exemption (TUE) for theProhibited Substance.
5.2.4.3.1.6 For Threshold Substances, Adverse Analytical
Finding or Atypical Finding decisions for the “A”
Sample finding shall be based on the mean of themeasured analytical values (e.g. concentrations) or
ratiosofmeasured
analyticalvalues(e.g.
concentrations, chromatogram peak heights or
areas, etc.) of three Aliquots which shall exceed thevalue of the relevant Decision Limit.
If insufficient Sample volume exists to analyze three
Aliquots, the maximum number of Aliquots that canbe prepared should be analyzed. The reporting ofAdverse Analytical Findings for Threshold Substances
shall be in compliance with the Technical Document
on Decision Limits.
5.2.4.3.2“B” Sample Confirmation

5.2.4.3.2.1 The “B” Sample analysis should occur as soon as
possible and should take place no later than seven(7) working days starting the first working day
following notification of an “A” Sample Adverse
Analytical Finding by the Laboratory, unless theLaboratory is informed that the Athlete has waived
his/her right to the “B” confirmation analysis andaccepts the findings of the “A” confirmation analysis.

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5.2.4.3.2.2 The “B” Sample confirmation shall be performed in
the“A” Sample
thesameLaboratory as
confirmation.
5.2.4.3.2.3 If the “B” Sample confirmation proves negative, theentire test shall be considered negative.
5.2.4.3.2.4 For exogenous Threshold Substances, the “B”
Sample results need only confirm the “A” Sample
identification for the Adverse Analytical Finding to bevalid.
5.2.4.3.2.5 For endogenous Threshold Substances, Adverse
Analytical Finding or Atypical Finding decisions forthe “B” Sample finding shall be based on the meanof measured analytical values (e.g. concentrations)or ratios of measured analytical values (e.g.
concentrations, chromatogram peak heights or
areas, etc.) of three Aliquots, which shall exceed thevalue of the relevant Threshold as specified in theTechnical Document on Decision Limits.
If insufficient Sample volume exists to analyze three
Aliquots, the maximum number of Aliquots that canbe prepared should be analyzed.
5.2.4.3.2.6 The Athlete and/or his/her representative, a
representative of the entity responsible for Sample
collection or results management, a representativeof the National Olympic Committee, National Sport
Federation,
International
Federation,andatranslator shall be authorized to attend the “B”
confirmation.
If the Athlete declines to be present or the Athlete’s
representative does not respond to the invitation orif the Athlete or the Athlete’s representative
continuously claim not to be available on the date of
the opening, despite reasonable attempts by the
Laboratory to accommodate their dates, the Testing
Authority or the Laboratory shall proceed regardlessand appoint an independent witness to verify thatthe “B” Sample container shows no signs ofTampering and that the identifying numbers matchthat on the collection documentation.
At aminimum, the Laboratory Director or representative
and the Athlete or his/her representative or the
independent
witnessshall
signLaboratory
documentation attesting to the above.
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The Laboratory Director may limit the number ofindividuals in Controlled Zones of the Laboratory
based on safety or security considerations.
The Laboratory Director may remove, or haveremoved by proper authority, any Athlete or
representative(s) interfering with the testingprocess. Any behavior resulting in removal shall bereported to the Testing Authority and may beconsidered an anti–doping rule violation inaccordance with Article 2.5 of the Code, “Tampering,or Attempting to tamper, with any part of Doping
Control”.
5.2.4.3.2.7 Aliquots taken for “B” Confirmation Procedure shallbe taken from the original “B” Sample.
The Laboratory shall ensure that the “B” Sample isproperly resealed as per provision 5.2.2.12.
5.2.4.3.2.8 The Laboratory shall have a policy to define thosecircumstances when Confirmation Procedure for the“B” Sample may be repeated (e.g. batch quality
control failure) and the first test result shall benullified.
Each repeat confirmation should be
performed on a new Aliquot of the “B” Sample andnew controls.
5.2.4.3.2.9 If the “B” Sample confirmation proves negative, theSample shall be considered negative and the Testing
Authority, WADA and the International Federation
notified of the new analytical finding.
5.2.4.4

Alternative biological matrices.
Any testing results obtained from hair, nails, oral fluid or otherbiological material shall not be used to counter Adverse Analytical
Findings or Atypical Findings from urine.

5.2.5 Results Management
5.2.5.1

Review of results

5.2.5.1.1

A minimum of two certifying scientists shall independently
review all Adverse Analytical Findings and Atypical Findings
before a report is issued. The review process shall berecorded.

5.2.5.1.2

At a minimum, the review shall include: Laboratory Internal Chain of Custody documentation;

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


5.2.5.1.3

Validity of the analytical initial and confirmatory dataand calculations;
Quality control data;
Completenessof
documentation
supportingthereported analytical findings.

When an Adverse Analytical Finding or Atypical Finding is
rejected, the reason(s) shall be recorded.

5.2.6 Documentation and Reporting
5.2.6.1

The Laboratory shall have documented procedures to ensure that it
maintains a coordinated record related to each Sample analyzed. In
the case of an Adverse Analytical Finding or Atypical Finding, therecord shall include the data necessary to support the conclusions
reported.

5.2.6.2

Each step of testing shall be traceable to the staff member who
performed that step.

5.2.6.3

Significant variance from the written procedure shall be documented
as part of the record (e.g., memorandum for the record).

5.2.6.4

Where instrumental analyses are conducted, the operating
parameters for each run shall be included as part of the record.

5.2.6.5

Reporting of “A” Sample results should occur within ten (10) working
days of receipt of the Sample. The reporting time required forspecific Competitions may be substantially less than ten days. The
reporting time may be altered by agreement between the Laboratory
and the Testing Authority.

5.2.6.6

A single, distinct Test Report shall be generated to document theAdverse Analytical Finding(s) or Atypical Finding(s) of an individual
Sample. The Laboratory Test Report shall include, in addition to theitems stipulated in ISO/IEC 17025, the following:










Customer Sample identification code;
Laboratory identification code;
Type of test (Out of Competition/In-Competition);Sport and/or discipline
Name of Competition and/or Customer reference code (forexample: ADAMS test mission code), if provided;
Date of receipt of Sample;
Date of report;
Sex of the Athlete;
Type of Sample (urine, blood, etc.);

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Test results (for Threshold Substances in compliance with
the Technical Document on Decision Limits);
 The name of the Sample Collection Authority; The name of the Testing Authority (if provided); Signature of authorized individual; Other information as specified by the Testing Authority
and/or WADA.
At a minimum, labelling and information provided by the
Laboratory related to the type of test, sport/discipline, test
results (including comments/opinions) and client to whom thereport is addressed shall also be provided in English on the test
report.
Note: A complete analytical test report generated from ADAMS should
be considered to have fulfilled the above requirements and therefore
should be regarded as an official test report.

5.2.6.7

The Laboratory is not required to measure or report a concentration
for Prohibited Substances for a non-threshold analyte in urine
Samples. The Laboratory shall report the actual Prohibited
Substance(s), Metabolite(s) of the Prohibited Substance(s) or
Prohibited Method(s), or Marker(s) detected in the urine Sample.
For relevant Threshold Substances in urine Samples, the Laboratory
report shall establish that the Prohibited Substance or its
Metabolite(s) or Marker(s) of a Prohibited Method is present at aconcentration and/or ratio of measured analytical values greaterthan the Decision Limit in compliance with the Technical Document
on Decision Limits.

5.2.6.8

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

5.2.6.9

Adverse Analytical Finding; orAtypical Finding; orIn the absence of the above results, a qualification
indicating that no Prohibited Substance(s) or Metabolite(s)or Marker(s) of a Prohibited Method(s) on the test menu
were detected.

The Laboratory shall have a policy regarding the provision of
opinions and interpretation of data. An opinion or interpretation may
be included in the Test Report provided that the opinion orinterpretation is clearly identified as such. The basis upon which theopinion has been made shall be documented.
Note: An opinion or interpretation may include, but not be limited to,recommendations on how to use results, information related to thepharmacology, metabolism and pharmacokinetics of a substance, whether

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the observed results may suggest the need for additional Testing andwhether an observed result is consistent with a set of reported conditions.

5.2.6.10 In addition to reporting to the Testing Authority, the Laboratory shallsimultaneously report all test results as defined in ISL provision
5.2.6.8 to WADA via ADAMS. The information provided in ADAMS
shall be in compliance to ISL provision 5.2.6.6. The Laboratory shallalso simultaneously report any Adverse Analytical Findings (“A” and“B” results) to the responsible International Federation (and/or tothe owner of the Event in the case of Major International Events).
Atypical Findings shall be simultaneously reported to the Testing
Authority and WADA. Documented instructions from the Testing
Authority, with regard to a Presumptive Analytical Finding, shall also
be reported to WADA. In the case where the sport or Event is not
associated with an International Federation (e.g., Professional
Leagues, University and College sports) the Laboratory shall report
Adverse Analytical Findings to the Testing Authority and to WADA.
All reporting shall be in accord with the confidentiality requirementsof the Code.
5.2.6.11 The Laboratory, upon request by Testing Authorities, may be asked
to review data from longitudinal studies which include an AtypicalFinding(s). Following review of the applicable data, a report andrecommendation shall be made by the Laboratory to the Testing
Authority as to whether the data supports an Adverse Analytical
Finding or not. If the Testing Authority has concluded an Adverse
Analytical Finding, the Laboratory will be informed and shall conduct
the “B” confirmation analysis according to 5.2.4.3.2.1.
5.2.6.12 Upon request, the Laboratory shall report in a format specified by
WADA, a summary of the results of all tests performed.
No
information that could link an Athlete with an individual result will be
included. The report will include a summary of any Samples rejected
for testing and the reason for the rejection.
5.2.6.13 The documentation package should be provided by the Laboratory
only to the relevant result management authority upon request andshould be provided within 10 working days of the request.
Laboratory Documentation Packages shall be in compliance with the
WADA Technical Document on Laboratory Documentation Packages.
5.2.6.14 Athlete confidentiality shall be a key concern for all Laboratories
engaged in Doping Control cases.
5.2.6.14.1

Testing Authority requests for information shall be made inwriting to the Laboratories.

5.2.6.14.2

Adverse Analytical Findings and Atypical Findings shall not
be provided by telephone.

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5.2.6.14.3

Information sent by a facsimile is acceptable if the securityof the receiving facsimile machine has been verified andprocedures are in place to ensure that the facsimile has
been transmitted to the correct facsimile number.

5.2.6.14.4

Unencrypted email is not authorized for any reporting or
discussion of Adverse Analytical Findings or AtypicalFindings if the Athlete can be identified or if any
information regarding the identity of the Athlete isincluded.

5.2.6.14.5

The Laboratory shall also provide any information
requested by WADA in conjunction with the Monitoring
Program, as set forth in Article 4.5 of the Code.

5.3 Quality Management Processes
5.3.1 Organization
5.3.1.1

Within the framework of ISO/IEC 17025, the Laboratory shall beconsidered as a testing Laboratory.

5.3.1.2

The administrative and operational activities of the Laboratory, as
well as the hosting facility, should be independent from the AntiDoping Organization(s) providing support (e.g. financial, Samples,facilities) to the Laboratory.

5.3.1.3

The Laboratory Director shall have the responsibilities of the Chief
Executive, unless otherwise noted.

5.3.2 Quality Policy and Objectives
5.3.2.1

The Quality Policy and implementation shall meet the requirementsof ISO/IEC 17025 Section 4.2 Management System and shall include
a quality manual that describes the quality system.

5.3.2.2

A single staff member should be appointed as the Quality Manager
and shall have responsibility and authority to implement and ensurecompliance with the quality system.

5.3.3 Document Control
The control of documents that make up the Management System shall meet therequirements of ISO/IEC 17025 Section 4.3 Document Control.
5.3.3.1

The Laboratory Director (or designee) shall approve the Quality
Manual and all other documents used by staff members incompleting testing.

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5.3.3.2

The Management System shall ensure that the contents of WADA
Technical Documents are incorporated into the appropriate manuals
by the effective date and that training is provided and recorded. If
this is not possible, WADA shall be contacted with a written request
for an extension.

5.3.4 Review of requests, tenders, and contracts
Review of legal documents or agreements related to testing shall meet therequirements of ISO/IEC 17025 Section 4.4.
The Laboratory shall ensure that the Testing Authority is informed concerning theProhibited Substances that can be detected under the scope of accreditation in
Samples submitted for analysis.
5.3.5 Subcontracting of tests
A WADA accredited Laboratory shall perform all work with qualified personnel andequipment within its accredited facility.
In the case of specific technologies that may not be available in the Laboratory, aSample may be transferred to another WADA accredited Laboratory where thespecific technology is within the scope of its accreditation.
In exceptional
circumstances, WADA may elect to grant specific authorization for subcontracting
parts of the tasks. In such cases, assurance of the maintenance of the level ofquality and the appropriate chain of custody throughout the entire process is the
responsibility of the Laboratory Director. Such arrangements shall be clearly
documented as part of the permanent Sample record and included in the Laboratory
Documentation Package, if applicable.
5.3.6 Purchasing of services and supplies
5.3.6.1

Chemicals and reagents
Chemicals and reagents shall be suitable for the purpose of theanalysis and be of established purity.
Reference purity
documentation shall be obtained when available and retained in thequality system documents. Chemicals, reagents and kits labelled“Research Only” may be utilized for the purposes of Doping Control
as long as they are validated by the Laboratory.
In the case of rare or difficult to obtain reagents, Reference
Materials, or Reference Collections, particularly for use in qualitative
methods, the expiration date of the solution can be extended if
adequate documentation exists confirming that no significant
deterioration that would preclude obtaining an acceptable mass
spectrum has occurred or that purification has been performed.

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5.3.6.2

Waste disposal shall be in accord with national laws and otherrelevant regulations. This includes biohazard materials, chemicals,
controlled substances, and radioisotopes, if used.

5.3.6.3

Environmental health and safety policies shall be in place to protect
the staff, the public, and the environment.

5.3.7 Service to the customer
5.3.7.1

Service to customers shall be handled in accord with ISO/IEC 17025
Section 4.7.

5.3.7.2

Ensuring responsiveness to WADA
The Laboratory Director or his/her designee shall:







5.3.7.3

Ensure adequate communication;
Report to WADA any unusual circumstances or information
with regard to testing programs, patterns of irregularities in
Samples, or potential use of new substances;
Provide complete and timely explanatory information to
WADA as appropriate and as requested to provide quality
accreditation.
Provide documentation to WADA (e.g. quality manual, SOPs,
contracts with Code-signatory clients or Testing Authorities(not including commercial or financial information)) uponrequest to ensure conformity with the rules establishedunder the Code as part of the maintenance of WADA
accreditation.
This information will be treated in aconfidential manner.

Ensuring responsiveness to Testing Authority

5.3.7.3.1

The Laboratory Director shall be familiar with the Testing
Authority rules and the Prohibited List.

5.3.7.3.2

The Laboratory Director shall interact with the Testing
Authority with respect to specific timing, report
information, or other support needs. These interactions
should include, but are not limited to, the following: Communicating with the Testing Authority concerning any
significant question of testing needs or any unusual
circumstance in the testing process (including delays inreporting);
 Acting without bias regarding the national affiliation of
the Testing Authority;
 Providing complete and timely explanations to the Testing
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misunderstanding the Test Report or Laboratory
Documentation Package; Providing evidence and/or expert testimony on any test
result or report produced by the Laboratory as required inadministrative, arbitration, or legal proceedings;
 Responding to any comment or complaint submitted by a
Testing Authority or Anti-Doping Organization concerning
the Laboratory and its operation.
5.3.7.3.3

The Laboratory shall actively monitor the quality of theservices provided to the relevant anti-doping authorities.
There should be documentation that the Testing Authority
concerns have been incorporated into the Laboratory
Management System where appropriate.

5.3.7.3.4

The Laboratory shall develop a system, as required by
ISO/IEC 17025 for monitoring Laboratory service.

5.3.8 Complaints
Complaints shall be handled in accordance with ISO/IEC 17025 Section 4.8.
5.3.9 Control of nonconforming testing work
5.3.9.1

The Laboratory shall have policies and procedures that shall be
implemented when any aspect of its testing or a result from its
testing does not comply to set procedures.

5.3.9.2

Documentation of any non-compliance or departure from procedureor protocol involving a Sample testing shall be kept as part of thepermanent record of that Sample.

5.3.10 Improvement
The Laboratory shall continually improve the effectiveness of its management system
in accordance with ISO/IEC 17025 Section 4.10.
5.3.11 Corrective action
Corrective action shall be taken in accordance with ISO/IEC 17025 Section 4.11.
5.3.12 Preventive action
Preventive action shall be taken in accordance with ISO/IEC 17025 Section 4.12.

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5.3.13 Control of records
5.3.13.1 Technical Records
5.3.13.1.1

Analytical records on negative Samples, including
Laboratory Internal Chain of Custody documentation andthe endogenous steroid profile, shall be retained in securestorage for at least two (2) years. Analytical records on
Samples with irregularities or on rejected Samples shall be
retained in secure storage for at least two (2) years.

5.3.13.1.2

All analytical records on Samples with an Adverse
Analytical Finding, as described in Section 5.2.5.1.2, shallbe retained in secure storage for at least eight (8) years.

5.3.13.1.3

The raw data supporting all analytical results shall be
retained in secure storage for at least eight (8) years.

5.3.14 Internal Audits
5.3.14.1 Internal audits shall be completed in accordance
requirements of ISO/IEC 17025 Section 4.14.

with

the

5.3.14.2 Internal Audit responsibilities may be shared amongst personnel
provided that any Person does not audit his/her own area.
5.3.15 Management Reviews
Management reviews will be conducted to meet the requirements of ISO/IEC 17025
Section 4.15.

5.4 Support processes
5.4.1 General
General support shall be provided in accordance with the requirements of ISO/IEC
17025 (Section 5.0).
5.4.2 Personnel
5.4.2.1

Every person employed by, or under contract to, the Laboratory shallhave an accessible personnel file which shall contain copies of thecurriculum vitae or qualification form, a job description, and records
of initial and ongoing training.
The Laboratory shall maintainappropriate confidentiality of personal information.

5.4.2.2

All personnel shall have a thorough knowledge of their
responsibilities
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protocols, and the standard operating procedures for any methodthat they perform.
5.4.2.3

The Laboratory Director is responsible for ensuring that Laboratory
personnel are adequately trained and have experience necessary to
perform their duties. The approval, as well as supporting training
records, shall be retained in the individual’s personnel file.

5.4.2.4

The Laboratory shall have a qualified Person as the Laboratory
Director to assume professional, organizational, educational, andadministrative responsibility. The Laboratory Director qualifications
are:







5.4.2.5

Ph.D. (or equivalent) in one of the natural sciences ortraining comparable to a Ph.D. in one of the natural sciencessuch as a scientific or medical degree with appropriate
experience or training;Experience and competence in the analysis of biologicalmaterial for substances used in doping;
Appropriate training or experience in forensic applications of
Doping Control. It is acknowledged that the Laboratory
Director plays an essential role in the anti-doping Laboratory
operations and that the WADA accreditation is delivered
based upon such qualification as well as the Laboratory
operational performance.
WADA shall be immediately
informed of the appointment of a new Laboratory Director.
WADA reserves the right to review the credentials of suchappointments in accordance with the above qualifications;
Any personnel changes to this position shall be
communicated to WADA no later than one month prior to thescheduled date the Laboratory Director vacates his/her
position. A succession plan shall be forwarded to WADA.

The Laboratory shall have qualified personnel to serve as Certifying
Scientist(s) to review all pertinent data, quality control results, andThe
to attest to the validity of the Laboratory’s test reports.
qualifications are:

Bachelors Degree in Medical Technology, Chemistry, Biology,
or related natural science or equivalent.
Documented
experience of 8 years or more in a Doping Control
Laboratory is equivalent to a Bachelor’s degree for thisposition;
Experience in the analysis of doping materials in biologicalfluids;Experience in the use of relevant analytical techniques suchas chromatography, immunoassay, and mass spectrometrictechniques.

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5.4.2.6

Supervisory personnel shall have a thorough understanding of thequality control procedures including, the review, interpretation andreporting of test results, maintenance of Laboratory Internal Chain of
Custody and proper remedial action to be taken in response to
analytical problems. The qualifications for supervisor are:







Bachelor’s Degree in Medical Technology, Chemistry,
Biology, or related natural science or equivalent.
Documented experience of 5 years or more in a Doping
Control Laboratory is equivalent to a Bachelor’s degree forthis position;
Experience in relevant analytical testing including theanalysis of Prohibited Substances in biological material;
Experience in the use of analytical techniques such as
chromatography, immunoassay, and mass spectrometrictechniques;
Ability to ensure compliance with quality management
systems and quality assurance processes.

5.4.3 Accommodation and environmental conditions
5.4.3.1

Environmental Control

5.4.3.1.1

Maintain appropriate electrical services

5.4.3.1.1.1 The Laboratory shall ensure that adequate electricalservice is available so that there is no compromise ofstored data.
5.4.3.1.1.2 All Laboratory instrumentation and equipment
critical to Laboratory operations should be supported
in such a way that service is not likely to beinterrupted.
5.4.3.1.1.3 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.
5.4.3.1.2

The Laboratory shall have a written safety policy andcompliance with Laboratory safety policies shall be
enforced.

5.4.3.1.3

The storage and handling of controlled substances shallfollow a risk assessment and comply with applicablenational legislation.

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5.4.3.2

Security of the facility

5.4.3.2.1

The Laboratory shall have a policy for the security of its
facilities, equipment and system against unauthorizedaccess which may include a threat and risk assessment by
expert(s) in relevant field.

5.4.3.2.2

Three levels of access shall be considered in the quality
manual or threat assessment plan:

Reception zone. An initial point of control beyond which
unauthorized individuals shall be escorted by laboratory
personnel;
Common operational zones;
Controlled zones.
Access to these areas should bemonitored and records maintained of access by visitors.

5.4.3.2.3

The Laboratory shall restrict access to Controlled Zones toonly authorized Persons.
A staff member should be
assigned as the security officer who has overall knowledge
and control of the security system.

5.4.3.2.4

Unauthorized Persons shall be escorted within Controlled
Zones.
A temporary authorization may be issued toindividuals requiring access to the Controlled Zones suchas auditing teams and individuals performing service orrepair.

5.4.3.2.5

The Laboratory should have a separate Controlled Zone for
Sample receipt and Aliquot preparation.

5.4.3.3

Relocation of Laboratory Facilities
In cases where a Laboratory is to relocate, on a permanent or semipermanent basis to a new physical space, a report containing thefollowing information shall be provided to WADA no later than threemonths prior to the relocation:








Description of circumstances for moving Laboratory
operations into a new space and anticipated effect oncapabilities;
Relocation date(s) including date of closing of existing
facility operations and date of opening of future facility
operations;
Date of ISO/IEC 17025 inspection(s) of new facilities(evidence of continued accreditation required when madeavailable by the Accreditation Body);
New Laboratory contacts;

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Assessment of the effect of the relocation to Laboratory
client operations.

5.4.4 Test Methods and Method Validation
5.4.4.1

Selection of Methods
Standard methods are generally not available for Doping Control
analyses. The Laboratory shall develop, validate and document
methods for the detection of substances present on the Prohibited
List and for associated Metabolites or Markers or related substances.
Note that for many substances, the associated Metabolites aredetected, thereby confirming the metabolism and the administrationof a Prohibited Substance. The methods shall be selected andvalidated so they are Fit-for-purpose. WADA shall supply feedback to
the Laboratories regarding the suitability of the assay principle.

5.4.4.1.1

Non-Threshold Substances
Laboratories are not required to measure or report a
concentration for Non-Threshold Substances.
The Laboratory shall develop, as part of the method
validation process, acceptable standards for identificationof Prohibited Substances. (See the Technical Document on
Identification Criteria for Qualitative Assays).
The Laboratory shall demonstrate the ability to successfully
identify 100% of the time representative substances in theclass of Prohibited Substances at the Minimum Required
Performance Levels (for example twenty urines spiked at
MRPL). The Laboratory shall establish, in routine practice,
the use of control samples containing representative
substance(s) at the MRPL if the appropriate standards areavailable.
A Reference Collection may be used for
identification and in such cases an estimate of thedetection capability for the method may be provided byassessing a representative substance.

5.4.4.1.2

Threshold Substances
The Laboratory shall develop methods that are Fit-forpurpose. The method shall be capable of determining both
the relative mean concentration or ratio of measured
analytical values and the identity of the Prohibited
Substance or Metabolite(s) or Marker(s).
For endogenous Threshold Substances, the Athlete’s
Sample will be deemed to contain a Prohibited Substanceand the Laboratory will report an Adverse Analytical

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Finding if, based on any reliable analytical method theLaboratory can show that the Prohibited Substance is ofexogenous origin.
5.4.4.2

Validation of Methods

5.4.4.2.1

Confirmation methods for Non-Threshold Substances shallbe validated. Factors to be investigated to demonstratethat a method is Fit-for-purpose include but are not limited
to:












5.4.4.2.2

Specificity. The ability of the assay to detect only thesubstance of interest shall be determined anddocumented. The assay shall be able to discriminate
between compounds of closely related structures;
Identification capability. Since the results for NonThreshold Substances are not quantitative, theLaboratory should establish criteria for ensuring that asubstance representative of the class of Prohibited
Substances can be repeatedly identified and detected aspresent in the Sample at the MRPL;
Robustness.
The method shall be determined to
produce similar results with respect to minor variationsin analytical conditions.
Those conditions that are
critical to reproducible results shall be controlled;
Carryover.
The conditions required to eliminate
carryover of the substance of interest from Sample toSample during processing or instrumental analysis shallbe determined and implemented;
Matrix interferences.
The method should avoid
interference in the detection of Prohibited Substances ortheir Metabolites or Markers by components of the
Sample matrix;
Standards. Reference Materials should be used for
identification, if available.
If there is no reference
standard available, the use of data or Sample from avalidated Reference Collection is acceptable. If theLaboratory can show by the analysis of referencematerial (e.g. (i) an external quality control sample, (ii)
an isolate from a urine or blood sample after anauthenticated administration, or (iii) an in-vitro
incubation with liver cells or microsomes) the ability todetect a particular substance, this shall be regarded as
sufficient evidence to confirm identity.

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














5.4.4.3

Specificity. The ability of the assay to detect only thesubstance of interest shall be determined anddocumented. The assay shall be able to discriminate
between compounds of closely related structures;
Intermediate Precision. The method shall allow for the
reliable repetition of the results at different times andwith different operators performing the assay.
Intermediate Precision at the threshold shall berecorded;
Robustness.
The method shall be determined to
produce the similar results with respect to minor
variations in analytical conditions. Those conditions
that are critical to reproducible results shall becontrolled;
Carryover.
The conditions required to eliminate
carryover of the substance of interest from Sample toSample during processing or instrumental analysis shallbe determined and implemented;
Matrix interferences.
The method shall limit
interference in the measurement of the amount of
Prohibited Substances or their Metabolites or Markers
by components of the Sample matrix;
Standards. Reference Materials should be used forquantification, if available;
Limit of quantitation (LOQ). The Laboratory shalldemonstrate that a threshold method has anestablished LOQ of no more than 50% of the thresholdvalue for Threshold Substances;
Linearity shall be documented at 50% to 200% of thethreshold value, unless otherwise stipulated in a
Technical Document.

Estimate of Uncertainty
In most cases an identification of a Prohibited Substance, its
Metabolite(s) or Marker(s), is sufficient to report an Adverse
Analytical Finding.

5.4.4.3.1

Uncertainty in identification
The appropriate analytical characteristics shall be
documented for a particular assay. The Laboratory shallestablish criteria for identification of a compound at leastas rigorous as stated in the relevant Technical Document.

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5.4.4.3.2

Establishing that a substance exceeds a Threshold.
The purpose of reporting (based on the application ofDecision Limits which incorporate the maximum acceptablevalue of the combined standard uncertainty (uc Max) of theLaboratory’s measurement procedure estimated at theThreshold) is to establish that the Prohibited Substance or
its Metabolite(s) or Marker(s) is present at a concentration
and/or ratio of measured analytical values greater than theThreshold with statistical confidence of at least 95%. The
method, including selection of standards and controls, andestimation of uncertainty shall be Fit-for-purpose.

5.4.4.3.2.1 Uncertainty of quantitative results, particularly at
the threshold value, shall be addressed during thevalidation of the assay.
5.4.4.3.2.2 Measurement Uncertainty is further addressed in therelevant Technical Document on Decision Limits for
the Confirmatory Quantification of Threshold
Substances.
5.4.4.4

Control of Data

5.4.4.4.1

Data and Computer Security

5.4.4.4.1.1 All reasonable measures shall be taken to prevent
intrusion and copy of data from computer systems.
5.4.4.4.1.2 Access to computer terminals, computers, servers orother operating equipment shall be controlled byphysical access and by multiple levels of access
controlled by passwords or other means of employee
recognition and identification. These include, but are
not limited to account privileges, user identification
codes, disk access, and file access control.
5.4.4.4.1.3 The operating software and all files shall be backed
up on a regular basis and a current copy shall beeither stored in a fire and water proof environment
or kept off site at a secure location.
5.4.4.4.1.4 The software shall prevent the changing of results
unless there is a system to document the Person
doing the editing and that editing can be limited tousers with proper level of access.
5.4.4.4.1.5 All data entry, recording of reporting processes andall changes to reported data shall be recorded with
an audit trail. This shall include the date and time,
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retention of original data, reason for change tooriginal data and the individual performing the task.
5.4.5 Equipment
5.4.5.1

A List of available equipment is to be established and maintained.

5.4.5.2

As part of a quality system, the Laboratory shall operate a program
for the maintenance and calibration of equipment according to
ISO/IEC 17025 Section 5.5.

5.4.5.3

equipment(fume
hoods,
centrifuges,
GeneralLaboratory
evaporators, etc) that is not used for making measurements should
be maintained by visual examination, safety checks and cleaning asnecessary. Calibrations are only required where the setting cansignificantly change the test result. A maintenance schedule, atleast to manufacturer’s recommendations or local regulations if
available, shall be established for general Laboratory equipment
which is used in the test method.

5.4.5.4

Equipment or volumetric devices used in measuring shall haveperiodic performance checks along with servicing, cleaning, andrepair.

5.4.5.5

Qualified subcontracted vendors may be used to service, maintain,
and repair measuring equipment.

5.4.5.6

All maintenance,
documented.

service,andrepairofequipment

shall

be

5.4.6 Measurement Traceability
5.4.6.1

Reference Materials
When available, reference drug or drug Metabolite(s) traceable to anational standard or certified by a body of recognized status, such as
USP, BP, Ph.Eur. or WHO, should be used. At a minimum, ananalysis report must be obtained.
When a Reference Material is not certified, the Laboratory shallverify its identity and purity by comparison with published data or bychemical characterization.

5.4.6.2

Reference Collections
A collection of Sample or isolates may be obtained from a biologicalmatrix following an authentic and verifiable administration of a
Prohibited Substance or Prohibited Method, providing that theanalytical data are sufficient to justify the identity of the relevant
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Metabolite of a Prohibited Substance or Marker of a Prohibited
Substance or Prohibited Method.
5.4.7 Assuring the quality of test results
5.4.7.1

The Laboratory shall participate in the WADA EQAS.

5.4.7.2

The Laboratory shall have in place a quality control system, including
the submission of blind quality control samples that challenges theentire scope of the analytical process (i.e., Sample receipt andaccessioning through result reporting).

5.4.7.3

Analytical performance shall be monitored by operating quality
control schemes appropriate to the type and frequency of testing
performed by the Laboratory. The range of quality control activities
should include:









Positive and negative controls analyzed in the same
analytical run as the Presumptive Analytical Finding Sample;
The use of deuterated or other internal standards or
standard addition;
Comparison of mass spectra or ion ratios from selected ion
monitoring (SIM) to a Reference Material or ReferenceCollection Sample analyzed in the same analytical run;
Confirmation of the “A” and “B” Split Samples;
For Threshold Substances, quality control charts referring toappropriate control limits depending on the analyticalmethod employed (e.g., ± 10 % of the target value; +/3SD), should be used;
The quality control procedures shall be documented by the
Laboratory.

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6.0 Application of ISO/IEC 17025 to the Analysis of Blood
Doping Control Samples
6.1 Introduction and Scope
This section of the document is intended as an application as described in Annex B.4(Guidelines for establishing applications for specific fields) of ISO/IEC 17025 for thefield of Doping Control. Any aspect of testing or management not specifically
discussed in this document shall be governed by ISO/IEC 17025. The application
focuses on the specific parts of the processes that are critical with regard to thequality of the laboratory’s performance as a WADA-accredited Laboratory and are
therefore determined to be significant in the evaluation and accreditation process.
This section introduces the specific performance standards for a WADA-accreditedLaboratory. The conduct of testing is considered a process within the definitions of
ISO 17000. Performance standards are defined according to a process model where
the Laboratory practice is structured into three main categories of processes:
 Analytical and technical processes;
 Management processes;
 Support processes.
Wherever possible, the application will follow the format of the ISO/IEC 17025
document. The concepts of the management system, continuous improvement, andcustomer satisfaction have been included. In some circumstances, measurements ofblood parameters may be conducted according to ISO 15189.

6.2 Analytical and Technical Processes
6.2.1 Receipt of Samples
6.2.1.1

Samples may be received by any method acceptable under theconcepts of the International Standard for Testing.

6.2.1.2

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

6.2.1.3

The transfer of the Samples from the courier or other persondelivering the Samples shall be documented including at a minimum,
the date, the time of receipt, and the name and signature of theLaboratory representative receiving the Sample. This information
shall be included into the Laboratory Internal Chain of Custody
record.

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6.2.2 Handling and Retention of Samples
6.2.2.1

The Laboratory shall have a system to uniquely identify the Samples
and associate each Sample with the collection document or otherexternal chain of custody.

6.2.2.2

The Laboratory shall have Laboratory Internal Chain of Custody
procedures to maintain control of and accountability for Samples
from receipt through to final disposition of the Samples.
The
procedures shall incorporate the concepts presented in the applicable
WADA Technical Document for Laboratory Internal Chain of Custody.

6.2.2.3

The Laboratory shall observe and document conditions that exist at
the time of receipt that may adversely impact on the integrity of a
Sample. For example, irregularities noted by the Laboratory should
include, but are not limited to:









Sample Tampering is evident;
Sample is not sealed with tamper-resistant device or notsealed upon receipt;
Sample is without a collection form (including Sample
identification code) or a blank form is received with the
Sample;Sample identification is unacceptable. For example, thenumber on the bottle does not match the Sample
identification number on the form;
Sample volume is inadequate to perform the requested
testing menu;
Sample transport conditions are not consistent withpreserving the integrity of the Sample for anti-doping
analysis.

6.2.2.4

The Laboratory shall notify and seek advice from the Testing
Authority regarding rejection and testing of Samples for which
irregularities are noted (e.g. a Sample sent as whole blood for bloodtransfusion testing has coagulated). If applicable, any agreement
between a Testing Authority and Laboratory that establishes Sample
rejection criteria shall be documented.

6.2.2.5

Samples for which Analytical Testing is to be performed onserum/plasma fraction only (not on cellular components).
Samples should be centrifuged immediately after Laboratory
reception to obtain the serum or plasma fraction. When analyzed
shortly after centrifugation (within 48 hours), Samples and/or
Aliquots may be stored refrigerated at approximately 4 degrees
Celsius until analysis. For longer term analyses, Samples shall befrozen according to established protocols and thawed before

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analysis. In all circumstances, the appropriate steps to ensure theintegrity of the Sample shall be taken by the Laboratory. The
Laboratory shall retain the “A” and “B” Samples with or without
Adverse Analytical Finding(s) for a minimum of three (3) months
after the Testing Authority receives the final analytical (“A” or “B”
Sample) report. The Samples shall be retained frozen underappropriate conditions.
Samples with irregularities shall be held under appropriate conditions
for a minimum of three (3) months following the report to the
Testing Authority.
After the applicable storage period above, the Laboratory shall do
one of the following with the Samples:

If the Testing Authority has arranged for storage of thesamples for a period from three (3) months to eight (8) years,
the Laboratory shall ensure that the Samples are stored in asecure location under continuous chain of custody;

If consent has been obtained from the Athlete and provided
that Samples are made anonymous, the Samples may beretained by the Laboratory for research purposes. Samples
used for research purposes shall have any means ofidentification removed or the Sample shall be transferred into
a container such that the contents cannot be traced back to aparticular Athlete;

Dispose of the Sample(s).

Note: The above three actions shall be conducted and recorded under the
Laboratory Internal Chain of Custody.

6.2.2.6

Samples that consist of whole blood or blood fractions for whichtests on cellular components are to be performed.
When analyzed shortly after reception, Samples shall be stored at
approximately 4 degrees Celsius as soon as practicable after Aliquots
have been taken for analysis. If it is necessary to delay the analysis,
Samples shall be stored at approximately 4 degrees Celsius on
reception and should be analyzed within 48 hours. As soon aspracticable after Aliquots have been taken for analysis, Samples
should be returned to approximately 4 degrees Celsius storage. In all
circumstances, the appropriate steps to ensure the integrity of the
Sample shall be taken by the Laboratory. The Laboratory shall retain
the “A” and “B” Samples with or without Adverse Analytical Finding
for a minimum of 1 month after the Testing Authority receives the
final analytical (“A” or “B” Sample) report.

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Samples with irregularities shall be held under appropriate conditions
for a minimum of one (1) month following the report to the Testing
Authority.
After the applicable storage period above, the Laboratory shall do
one of the following with the Samples:

If the Testing Authority has arranged for storage of the
Samples for a period from one (1) month to eight (8) years,
the Laboratory shall ensure that the Samples are stored in asecure location under continuous chain of custody;

If consent has been obtained from the Athlete and provided
that the Samples are made anonymous, the Samples may beretained by the Laboratory for research purposes. Samples
used for research purposes shall have any means ofidentification removed or the Sample shall be transferred into
a container such that the contents cannot be traced back to aparticular Athlete;

Dispose of the Sample(s).

Note: The above three actions shall be conducted and recorded under the
Laboratory Internal Chain of Custody.

6.2.2.7

If the Laboratory has been informed by the Testing Authority thatthe analysis of a Sample is challenged or disputed, the Sample shallbe stored under appropriate conditions and all the records pertaining
to the testing of that Sample shall be stored until completion of any
challenges.

6.2.2.8

The Laboratory shall maintain a policy pertaining to retention,
release, and disposal of Samples or Aliquots.

6.2.2.9

The Laboratory shall maintain custody information on the transfer ofSamples, or portions thereof to another Laboratory.

6.2.2.10 In cases where both “A” and “B” Samples have been reported as anAdverse Analytical Finding(s) and no challenge, dispute or
longitudinal study is pending, the Laboratory shall either make theSamples anonymous for research purposes (with proper consent
from the Athlete) or dispose of the Samples. Samples used forresearch purposes shall have any means of identification removed or
be transferred into an anonymous container such that they cannot
be traced back to a particular Athlete. Disposal of Samples shall be
conducted and recorded under the Laboratory Internal Chain of
Custody.

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6.2.2.11 Re-sealing of Samples for long-term storage and re-Testing
Re-sealing of Samples for future re-testing as listed in ISL Section
5.2.2.12 shall apply.
6.2.3 Sampling and Preparation of Aliquots for Analysis
The sampling and preparation of Aliquots for analysis listed under ISL section
5.2.3 shall apply.
6.2.4 Analytical Testing
6.2.4.1

Blood Initial Testing Procedure

6.2.4.1.1

The Initial Testing Procedure(s) shall detect the Prohibited
Substance(s) or Metabolite(s) of Prohibited Substance(s),or Marker(s) of the Use of a Prohibited Substance or
Prohibited Method for substances covered by the Prohibited
List for which there is a method that is Fit-for-Purpose.
WADA may make specific exceptions to this section for
specialized techniques that are not required to be within
the scope of accreditation of all Laboratories.

6.2.4.1.2

The Initial Testing Procedure shall be performed with a Fitfor-purpose method for the Prohibited Substance or
Prohibited Method being tested. A characteristic of theInitial Testing Procedure is to obtain information about thepotential
presenceofProhibited
Substance(s)orMetabolite(s) of Prohibited Substance(s), or Marker(s) of
the Use of a Prohibited Substance or Prohibited Method.
Results from Initial Testing Procedures can be included aspart of longitudinal studies provided that the method isappropriately validated.

6.2.4.1.3

All batches undergoing the Initial Testing Procedure shall
include appropriate negative and positive controls in
addition to the Samples being tested.

6.2.4.1.4

Initial Testing Procedure results are not required toconsider uncertainty of measurement.

6.2.4.2

Blood Confirmation Procedure
All Confirmation Procedures shall be documented. The objective of
the Confirmation Procedure is to accumulate additional information
to support an Adverse Analytical Finding.

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6.2.4.2.1“A” Sample confirmation

6.2.4.2.1.1 A Presumptive Analytical Finding from an Initial
Testing Procedure of a Prohibited Substance,
Metabolite(s) of a Prohibited Substance, orMarker(s) of the Use of a Prohibited Substance or
Prohibited Method shall be confirmed using an
additional Aliquot(s) taken from the original “A”
Sample.
6.2.4.2.1.2 Affinity Binding Assays applied for the Initial Testing
Procedures and Confirmation Procedures shall use
antibodies recognizing different epitopes of themacromolecule analyzed, unless a properly validated
purification or separation method is incorporated
into the confirmation method to eliminate thepotential for cross-reactivity prior to the applicationof “A” confirmation Affinity Binding Assay. The
Laboratory shall document, as part of the method
validation,
thefitness-for-purposeofsuchpurification or separation method.
In assays which include multiple affinity reagents(such as sandwich immunoassays), only one of theaffinity reagents (either applied for capture ordetection of the target analyte) used in the Affinity
Binding Assays applied for the Initial Testing
Procedures and Confirmation Procedures must differ
for antigenic epitope specificity. The other affinity
reagent may be used in both assays.
For peptide/protein analytes that are too small tohave two independent epitopes, two different
purification methods or two different analyticalmethods shall be applied.
Multiplexed Affinity Binding Assays, protein chips,
and similar simultaneous multi-analyte testing
approaches may be used.
The Initial Testing
Procedures and Confirmation Procedures may be
performed simultaneously in the same Aliquot,
although it is required that the test be repeated as
described in Section 6.2.4.2.1.1 and that the same
preconditions described above for assay specificity
or methods of purification or separation are met.
6.2.4.2.1.3 Antibodies may also be used for specific labelling ofcell components and other cellular characteristics.
When the purpose of the test is to identify
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populations of blood constituents, the detection ofmultiple Markers on the cells as the criteria for an
Adverse Analytical Finding replaces the requirement
for two antibodies recognizing different antigenic
epitopes.
Note: 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 RBC of more than one surface Marker (asdetermined by antibody labelling) as a criterion for an
Adverse Analytical Finding may be used as an alternative
to multiple antibodies to the same Marker.

6.2.4.2.1.4 The Laboratory shall have a policy to define thosecircumstances where the Confirmation Procedure of
an “A” Sample may be repeated (e.g., batch quality
control failure) and the first test result shall benullified. Each repeat confirmation shall be
documented and be completed on a new Aliquot of
the “A” Sample.
6.2.4.2.1.5 If more than one Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(s) of the Use ofa Prohibited Substance or Prohibited Method is
identified by the Initial Testing Procedures, theLaboratory shall confirm as many of the Presumptive
Analytical Findings as possible. The decision on theprioritization for the confirmation(s) shall be madeto give precedent to non-specified substance(s) andthe decision should be made in cooperation with theTesting Authority and documented.
6.2.4.2.1.6 For Threshold Substances, Adverse Analytical
Finding decisions for the “A” Sample finding shall bebased on the mean of the measured analyticalvalues (e.g. concentration) or ratio of measured
analyticalvalues(e.g.
concentrations,chromatogram peak height or area, etc.), of three
Aliquots which shall exceed the value of the relevant
Decision Limit.
If insufficient Sample volume exists to analyze three
Aliquots, the maximum number of Aliquots that canbe prepared should be analyzed. The reporting ofAdverse Analytical Findings for Threshold Substances
shall be in compliance with the Technical Document
on Decision Limits or the applicable TechnicalDocument or Guideline.

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6.2.4.2.2“B” Sample confirmation

6.2.4.2.2.1 Samples that consist of plasma, serum or otherblood fractions for which no tests on cellularcomponents are to be performed: In those cases
where confirmation of a Prohibited Substance,
Metabolite(s) of a Prohibited Substance, orMarker(s) of the Use of a Prohibited Substance or
Prohibited Method is requested in the “B” Sample,
the “B” Sample analysis should occur as soon as
possible and should take place no later than seven(7) working days starting the first working day
following notification of an “A” Sample Adverse
Analytical Finding by the Laboratory.
Samples that consist of whole blood or blood
fractions for which tests on cellular components areto be performed: For “B” Sample confirmation inwhole blood or blood fraction with blood cells only,
the “B” Sample analysis should take place no later
than seven (7) working days starting the firstworking day following notification of an “A” Sample
Adverse Analytical Finding by the Laboratory.
The Laboratory shall proceed as described above
unless informed that the Athlete has waived his/herright to the “B” confirmation analysis and accepts
the finding(s) of the “A” confirmation analysis.
6.2.4.2.2.2 The “B” Sample confirmation shall be performed in
the“A” Sample
thesameLaboratory as
confirmation.
6.2.4.2.2.3 If the “B” Sample confirmation proves negative, theentire test shall be considered negative.
6.2.4.2.2.4 For exogenous Threshold Substances, the “B”
Sample results need only confirm the “A” Sample
identification for the Adverse Analytical Finding to bevalid.
6.2.4.2.2.5 For endogenous Threshold Substances, Adverse
Analytical Finding decisions for the “B” Sample
finding shall be based on the mean of the measured
analytical values (e.g. concentration) or ratios ofmeasured analytical values (e.g. concentrations,chromatogram peak heights or areas, etc.) of three
Aliquots which shall exceed the value of the relevant
Threshold as specified in the Technical Document on
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Decision Limits or the applicable Technical Document
or Guideline.
If insufficient Sample volume exists to analyze three
Aliquots, the maximum number of Aliquots that canbe prepared should be analyzed.
6.2.4.2.2.6 The Athlete and/or his/her representative, a
representative of the entity responsible for Sample
collection or results management, a representativeof the National Olympic Committee, National Sport
Federation,
International
Federation,andatranslator shall be authorized to attend the “B”
confirmation.
If the Athlete declines to be present or the Athlete’s
representative does not respond to the invitation orif the Athlete or the Athlete’s representative
continuously claim not to be available on the date of
the opening, despite reasonable attempts by the
Laboratory to accommodate their dates, over a
period not to exceed 7 working days, the Testing
Authority or the Laboratory shall proceed regardlessand appoint an independent witness to verify thatthe “B” Sample container shows no signs ofTampering and that the identifying numbers matchthat on the collection documentation.
At aminimum, the Laboratory Director or representative
and the Athlete or his/her representative or the
independent
witnessshall
signLaboratory
documentation attesting to the above.
The Laboratory Director may limit the number ofindividuals in Controlled Zones of the Laboratory
based on safety or security considerations.
The Laboratory Director may remove, or haveremoved by proper authority, any Athlete or
representative(s) interfering with the testingprocess. Any behavior resulting in removal shall bereported to the Testing Authority and may beconsidered an anti–doping rule violation inaccordance with Article 2.5 of the Code, “Tampering,or Attempting to tamper, with any part of Doping
Control”.
6.2.4.2.2.7 Aliquots taken for “B” Confirmation Procedure shallbe taken from the original “B” Sample. Refer tourine section 5.2.4.3.2.7.
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6.2.4.2.2.8 The Laboratory shall have a policy to define thosecircumstances when confirmation testing of the “B”
Sample may be repeated (eg batch quality control
failure) and the first test result shall be nullified.
Each repeat confirmation should be performed on a
new Aliquot of the “B” Sample and new controls.
6.2.4.2.2.9 If the “B” Sample confirmation proves negative, theSample shall be considered negative and the Testing
Authority, WADA and the International Federation
notified of the new analytical finding.
6.2.4.3

Alternative biological matrices
Any testing results of hair, nails, oral fluid or other biologicalmaterial shall not be used to counter Adverse Analytical Findings
from blood.

6.2.5 Results Management
6.2.5.1

Review of results

6.2.5.1.1

A minimum of two certifying scientists shall independently
review all Adverse Analytical Findings before a report is issued.
The review process shall be recorded.

6.2.5.1.2

At a minimum, the review shall include:

6.2.5.1.3

Laboratory Internal Chain of Custody documentation;
Validity of the analytical Initial Testing and confirmation
data and calculations;
Quality control data;
Completeness of documentation supporting the reported
analytical findings.

When an Adverse Analytical Finding is rejected, the reason(s)shall be recorded.

6.2.6 Documentation and Reporting
6.2.6.1

The Laboratory shall have documented procedures to ensure thatit maintains a coordinated record related to each Sample
analyzed. In the case of an Adverse Analytical Finding, therecord shall include the data necessary to support the conclusions
reported (as set forth in the Technical Document, Laboratory
Documentation Packages).

6.2.6.2

Each step of testing shall be traceable to the staff member who
performed that step.

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6.2.6.3

Significant variance from the written procedure shall be
documented as part of the record (e.g., memorandum for therecord).

6.2.6.4

Where instrumental analyses are conducted, the operating
parameters for each run shall be included as part of the record.

6.2.6.5

Reporting of “A” Sample results should occur within ten (10)working days of receipt of the Sample. The reporting timerequired for specific Competitions may be substantially less thanten (10) days. The reporting time may be altered by agreement
between the Laboratory and the Testing Authority.

6.2.6.6

A single, distinct Test Report shall be generated to document theAdverse Analytical Finding(s) of an individual Sample.
The
Laboratory Test Report shall include, in addition to the items
stipulated in ISO/IEC 17025, the following:

















Customer Sample identification number;Laboratory identification number;Type of test (Out of Competition/In-Competition);Sport and/or discipline;
Name of Competition and/or client reference code (forexample: ADAMS test mission code), if provided;and sport and/or discipline;
Date of receipt of Sample;
Date of report;
Sex of the Athlete;
Type of Sample (urine, blood, etc.);
Test results (for Threshold Substances, in compliance with theTechnical Document on Decision Limits or the applicable
Technical Document or Guideline);
The name of the Sample Collection Authority;
The name of the Testing Authority (if provided);Signature of authorized individual;
Other information as specified by the Testing Authority or
WADA.

At a minimum, labelling and information provided by the
Laboratory related to the type of test, sport/discipline, test
results (including comments/opinions) and client to whom thereport is addressed shall also be provided in English on the test
report.
6.2.6.7

The Laboratory is not required to measure or report a
concentration for Prohibited Substances for a non-threshold

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analyte in blood Samples. The Laboratory shall report the actual
Prohibited Substance(s), Metabolite(s) of the Prohibited
Substance(s) or Prohibited Method(s), or Marker(s) detected in
the blood Sample.
For Threshold Substances in blood Samples, the Laboratory
report shall establish that the Prohibited Substance or its
Metabolite(s) or Marker(s) of a Prohibited Method is present at aconcentration and/or ratio of measured analytical values greaterthan the Decision Limit in compliance with the TechnicalDocument on Decision Limits or the applicable TechnicalDocument or Guideline.
6.2.6.8

The Laboratory shall qualify the result(s) of the analysis in the
Test Report as:• Adverse Analytical Finding;• Atypical Finding;• In the absence of the above results, a qualification
indicating that no Prohibited Substance(s) or Metabolite(s)or Marker(s) of a Prohibited Method(s) on the test menu
was detected.

6.2.6.9

The Laboratory shall have a policy regarding the provision of
opinions and interpretation of data. An opinion or interpretation
may be included in the Test Report provided that the opinion orinterpretation is clearly identified as such. The basis upon which
the opinion has been made shall be documented.
Note: An opinion or interpretation may include, but not be limited to,recommendations on how to use results, information related to thepharmacology, metabolism and pharmacokinetics of a substance, andwhether an observed result is consistent with a set of reported
conditions.

6.2.6.10

In addition to reporting to the Testing Authority, the Laboratory
shall simultaneously report all test results as defined in ISL
provision 6.2.6.8 to WADA via ADAMS. The information provided
in ADAMS shall be in compliance to ISL provision 6.2.6.6. The
Laboratory shall also simultaneously report any Adverse
Analytical Findings (“A” and “B” results) to the responsible
International Federation (and/or to the owner of the Event in thecase of Major International Events). In the case where the sport
or Event is not associated with an International Federation (e.g.,
professional leagues, University and college sports) the
Laboratory shall report Adverse Analytical Findings to the Testing
Authority and to WADA. All reporting shall be in accord with theconfidentiality requirements of the Code.

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6.2.6.11

Upon request, the Laboratory shall report in a format specified by
WADA, a summary of the results of all tests performed. No
information that could link an Athlete with an individual result will
be included. The report will include a summary of any Samples
rejected for testing and the reason for the rejection.

6.2.6.12

The documentation package should be provided by the
Laboratory only to the relevant result management authority
upon request and should be provided within 10 working days of
the request. Laboratory Documentation Packages shall be incompliance with the WADA Technical Document on Laboratory
Documentation Packages.

6.2.6.13

Athlete confidentiality shall be a key concern for all Laboratories
engaged in Doping Control cases.

6.2.6.13.1.1 Testing Authority requests for information shall be made inwriting to the Laboratories.
6.2.6.13.1.2 Adverse Analyticaltelephone.

Findings

shall

not

be

providedby

6.2.6.13.1.3 Information sent by a facsimile is acceptable if the security of
the receiving facsimile machine has been verified andprocedures are in place to ensure that the facsimile has beentransmitted to the correct facsimile number.
6.2.6.13.1.4 Unencrypted email is not authorized for any reporting or
discussion of Adverse Analytical Findings if the Athlete can be
identified or if any information regarding the identity of theAthlete is included.
6.2.6.13.1.5 The Laboratory shall also provide any information by WADA
in conjunction with the Monitoring Program, as set forth in
Article 4.5 of the Code.

6.3 Quality Management Processes
The Laboratory management requirements listed under ISL Section 5.3 shall apply.

6.4 Support processes
Except as modified below, the Laboratory support requirements listed under ISL
Section 5.4 shall apply. Accordingly, numbering below is not consecutive, butinstead, only those sections where changes from Section 5.4 have been made areincluded.

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6.4.1 Test Methods and Method Validation
6.4.1.1

Selection of Methods
Standard methods are generally not available for Doping Control
analyses. The Laboratory shall develop, validate and document
methods for the detection of substances present on the Prohibited
List and for associated Metabolites or Markers or related substances.
Note that for many substances, the associated Metabolites aredetected; thereby confirming the metabolism and the administrationof a Prohibited Substance. The methods shall be selected andvalidated so they are Fit-for-purpose. WADA will supply feedback to
the Laboratories regarding the Fit–for-purpose of the assay principle.
For Non-Threshold Substances refer to section 5.4.4.1.1.
For Threshold Substances refer to section 5.4.4.1.2.

6.4.1.2

Validation of Methods
For Non-Threshold Substances refer to section 5.4.4.2.1.
For Threshold Substances refer to section 5.4.4.2.2.

6.4.1.3

Estimate of Uncertainty
The Laboratory shall provide an estimation of the measurement
uncertainty where applicable.

6.4.1.3.1

Uncertainty in identification
The appropriate analytical characteristics shall be documented
for a particular assay. The Laboratory shall establish criteria
for identification of a compound.

6.4.1.3.2

Uncertainty in establishing that a substance exceeds athreshold.
The purpose of reporting (based on the application of Decision
Limits, which incorporate the maximum acceptable value ofthe combined uncertainty (uc Max) of the Laboratory’s
measurement procedure estimated at the threshold), is toestablish that the Prohibited Substance or its Metabolite(s) orMarker(s) is present at a concentration and/or ratio of
measured analytical values greater than the threshold with astatistical confidence of at least 95%. The method, including
selection of standards and controls, and estimation of
uncertainty shall be Fit-for-purpose.

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PART THREE: ANNEXESANNEX A - WADA EXTERNAL QUALITY ASSESSMENT SCHEME (EQAS)
The WADA External Quality Assessment Scheme (EQAS) is designed to continuously
monitor the capabilities of the Laboratories, to evaluate Laboratory proficiency, andto improve test result uniformity between Laboratories. At the same time the EQAS
also represents, via the educational program, a source of continuous improvement
for the effectiveness of the anti-doping testing procedures. The purpose of theindividual EQAS sample will determine its composition and form.
1.0

WADA External Quality Assessment Scheme
Periodically, urine (or blood) samples are distributed by WADA to accreditedLaboratories and probationary laboratories, to be tested for the presence orabsence of Prohibited Substances or Markers. These samples may be Blind or
Double-Blind (in such cases the content is unknown to the Laboratories) as
well as Open (also Educational) samples (in such cases the content is usuallyindicated). The Laboratory shall not communicate with other Laboratories
regarding the identity of substances present in or absent from EQAS samples
prior to the submission of EQAS results to WADA by all participating
laboratories.
1.1

Open (Educational) EQAS

The Laboratory may be directed to analyze an EQAS sample for a specific
Prohibited Substance or Prohibited Method. In general, this approach is used
for educational purposes or for data gathering.
The Laboratory shall report the results of open EQAS samples in a format
specified by WADA.
1.2

Blind EQAS

The Laboratory will be aware that the sample is an EQAS sample, but will not
be aware of the Prohibited Substances or Methods, or their Metabolite(s) orMarker(s) contained in the sample.
The Laboratory shall report the results of blind EQAS samples to WADA in thesame manner as specified for routine Samples unless otherwise notified by
WADA. For some EQAS samples or EQAS sample sets, additional information
may be requested from the Laboratory.
1.3

Double Blind EQAS

The Laboratory will receive EQAS samples which are indistinguishable fromnormal testing Samples.
The EQAS samples may consist of blank oradulterated samples or samples containing Prohibited Substances and Methods
and/or their Metabolite(s) or Marker(s), the detection and identification ofInternational Standard for Laboratories
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which would constitute an Adverse Analytical Finding(s). These samples may
be used to assess turn-around time, compliance with documentation package
requirements, and other non-analytical performance criteria as well as
Laboratory competence in detection and identification of Prohibited
Substances, Metabolite(s) of Prohibited Substances, and Marker(s) of
Prohibited Substances and Prohibited Methods.
2.0

External Quality Assessment Scheme Sample Composition
The actual composition of the EQAS samples supplied to different Laboratories
in a particular EQAS round may vary but, within any annual period, allLaboratories participating in the EQAS are expected to have analyzed thesame total number of samples.
2.1

EQAS Samples Void of Prohibited Substances or Methods, their
Metabolite(s) or Marker(s)(Blank)

Blank EQAS samples include those samples that do not contain Prohibited
Substances or their Metabolite(s) or Marker(s) of Prohibited Substances andProhibited Methods.
2.2

Adulterated EQAS Samples

Adulterated samples are those which have been deliberately adulterated by
the addition of extraneous substances designed to dilute the sample, degrade
or mask the analyte during the analytical determination.
2.3

EQAS
SamplesContaining
Prohibited
Substances,
their
Metabolite(s) or Marker(s), or the Marker(s) of Prohibited
Methods
2.3.1 EQAS Sample Composition
These EQAS samples contain target substances such as those Prohibited
Substances, Metabolite(s) of Prohibited Substances, and Marker(s) of
Prohibited Substances and Prohibited Methods which each accreditedLaboratory must examine, using their routine Initial Testing Procedures
and Confirmation Procedures to detect and identify the analytes whose
presence would result in the reporting of an Adverse Analytical Finding.
The concentrations of analytes are those that might be expected in theurine or blood of drug users.
For some analytes, the sample
composition may consist of the parent drug as well as major
Metabolites.
2.3.2 Individual
EQAS
SampleContentofProhibited
Substance(s) or Method(s), or Metabolite(s) or Marker(s)An EQAS sample may contain more than one Prohibited Substance,
Metabolite(s), or Marker(s) of a Prohibited Substance or ProhibitedInternational Standard for Laboratories
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Method. It is possible that the sample will contain multiple Metabolites
of a single substance, which would represent the presence of a single
Prohibited Substance. All Metabolites detected should be reported
according to the Laboratory’s standard operating procedures (e.g., test
report, ADAMS, etc). WADA may also require Laboratories to report theresults of EQAS samples in other formats.
EQAS samples may be spiked with Prohibited Substances and/or their
Metabolite(s) or Marker(s) and/or may be prepared from administration
studies.
For Non-Threshold Substances, the concentration will be guided by, but
not limited to, one of the following criteria:The Prohibited Substance and/or its major Metabolite(s) will
normally be present in quantities greater than the Minimum
Required Performance Level (MRPL) as applicable. The Laboratory
shall report the Prohibited Substance and/or its Metabolite(s) if
present in a concentration greater than 50% of the MRPL;The Prohibited Substance and/or its major Metabolite(s) will
normally be present in quantities consistent with those present in
humans who have used the Prohibited Substance or Method;
The Prohibited Substance and/or its major Metabolite(s) may bepresent below the applicable MRPL for special purposes. In thiscase, the Laboratory would be directed to analyze the sample fora particular Prohibited Substance as part of an educational
challenge and the results shall not be considered for evaluation
for the purposes of the EQAS point system.

For Threshold Substances, the concentration in the sample will be
guided by, but not limited to, one of the following criteria:Above the decision limit as determined using the maximum
combined standard uncertainty (uc Max);
Below the applicable threshold for special purposes (>50% of thethreshold).

These concentrations and drug types may be changed periodically inresponse to factors such as changes in detection technology andpatterns of drug use.
3.0

Evaluation of External Quality Assessment Scheme
Overall and individual round Laboratory EQAS performance will be assessed inaccordance with the point system table in section 3.3.5 of this Annex.

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3.1 Evaluation
Substances

of

EQAS

SamplesContaining

Non-Threshold

When a qualitative determination has been reported, the result will be judged
to have properly reported the presence or absence of an Adverse Analytical
Finding as intended in the preparation of the EQAS sample.






3.2

The results of any Prohibited Substance and/or its Metabolite(s)above the MRPL shall be considered for evaluation as per point
system table in section 3.3.5.
The results of any Prohibited Substance and/or its Metabolite(s)between 50% of the MRPL and the MRPL shall not be considered
for evaluation for the purposes of the EQAS point system;
For those substances for which the chirality of a substance may
affect the sanction given to an athlete, failure to correctly reportthechiralspecies(e.g.,
methamphetamine(-d)
orLevmetamfetamine) will be graded as a false negative.

Evaluation of EQAS Samples Containing Threshold Substances

When a quantitative determination has been reported, the results can bescored (z-score) based on the nominal or consensus value of the sample
analyzed and a target standard deviation which may be set either by thegroup results or according to the expected precision of the measurement. The
z-score is calculated using the equation:z x  xˆWhere x is the measurement result reported by the participating laboratoryxˆ is the assigned value
δ is the target value for standard deviation
The target relative standard deviation will be set in such a way that: An absolute z-score between zero (0) and two (2.0), inclusive, isdeemed satisfactory performance; An absolute z-score between greater than two (2.0) to less than three(3.0) is deemed to be questionable performance; An absolute z-score equal to or greater than three (3.0) is deemed to
be unsatisfactory performance.
Because the reported concentration from a confirmation test is what is scored,
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measured concentration is greater than or equal to 50% of the Thresholdconcentration.
Concentrations of Threshold Prohibited Substances (or Metabolites)
determined by WADA to be present below the Decision Limit in the EQAS
samples shall not be considered for the purposes of the EQAS evaluation
unless the reporting of the substance below the Decision Limit is required by
the ISL or applicable Technical Documents (e.g. detection of a Threshold
Substance in the presence of a diuretic or masking agent).
3.3

Accreditation Maintenance and Laboratory Evaluation

Laboratories shall be challenged with at least twenty (20) EQAS samples eachyear distributed in multiple rounds of which at least two (2) will include
double-blind samples. Each year at least three (3) samples will contain
Threshold Substances. Blank samples may be included.
The purpose of the EQAS program is to ensure that all of the Laboratories
maintain proficiency of their testing methods. Contact between Laboratories
regarding any aspect of EQAS testing and EQAS results prior to reporting to
WADA will be considered an attempt to circumvent the system. Engaging insuch discussions may subject the Laboratories involved to disciplinary action.
3.3.1 Methods utilized in EQAS
All procedures associated with the handling and testing of the EQAS
samples by the Laboratory are, to the greatest extent possible, to be
carried out in a manner identical to that applied to routine Laboratory
Samples, unless otherwise specified. No effort should 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. Methods or procedures
described in the standard operating procedures are to be employed in
the initial analysis of these samples. Should a sample be suspected ofcontaining a Prohibited Substance or their Metabolite(s) or Marker(s) of
Prohibited Substances and Prohibited Methods, a confirmatory analysis
shall be performed using the methods and procedures applied in routine
Testing.
3.3.2 False Positive result
A false positive result is not acceptable as part of the Blind or the
Double Blind EQAS. The following procedures are to be followed when
faced with such a situation:
The Laboratory will be informed by WADA of a false positive finding
as soon as possible;
The Laboratory is to provide WADA with a written explanation of thereasons for the error within five (5) calendar days (unless informed

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79








otherwise by WADA). This explanation is to include the submissionof all quality control data from the batch of samples that included
the false positive sample if the error is deemed to betechnical/scientific;
WADA shall review the Laboratory’s explanation promptly and decide
what further action, if any, to take;If the error is determined to be a technical or methodological error,
the Laboratory shall receive 25 points under the scoring systemdescribed in Section 3.3.5 and WADA may immediately provisionallysuspend the Laboratory and subject the Laboratory to an immediate
disciplinary process. The Laboratory may be required to re-test all
Samples reported as Adverse Analytical Findings by the Laboratoryfrom the time of final resolution of the error back to the time of thelast satisfactory EQAS round. Depending on the type of error thatcaused the false positive, this retesting may be limited to one
analyte, a class of Prohibited Substances or Prohibited Methods, or
may include any prohibited drug. A statement signed by the
Laboratory Director shall document this re-testing. The Laboratory
will be required to notify all clients whose results may have been
affected by the error as part of its quality management system;
If the error is determined to be an administrative error (clerical,
sample mix-up, etc), the Laboratory shall receive 10 points under
the scoring system described in Section 3.3.5. The Laboratory shalltake corrective action to avoid the re-occurrence of the particularerror in the future and if deemed necessary the Laboratory shall be
required to review and re-analyze previously run Samples;
During the time required to resolve the technical or methodologicalerror, the Laboratory may be provisionally suspended. Upon
submission of all documentation required by WADA to investigate theFalse Positive result, WADA shall review the file within 30 calendar
days and make a written recommendation to the Disciplinary
Committee as to whether the Laboratory should have theiraccreditation Suspended or Revoked. Subsequently the Disciplinary
Committee, as setup under WADA procedural rules, shall make an
independent recommendation to the WADA Executive Committee
regarding Revocation or the length of Suspension of WADA
accreditation.

The reporting of a false Adverse Analytical Finding on a routine Sample
is a serious non-conformance that causes concern about the quality ofthe entire anti-doping system. In such a situation, the Laboratory shallimmediately notify WADA if any result from a Sample is falsely reported
as an Adverse Analytical Finding to an Anti-Doping Organization. WADA
may immediately provisionally suspend the Laboratory pending
resolution of the case. WADA shall review the facts of the case andmake a written recommendation to the Disciplinary Committee.
Subsequently, the Disciplinary Committee shall review the case andmake an independent recommendation to the WADA Executive
International Standard for Laboratories
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Committee regarding Revocation or the length of Suspension of WADA
accreditation.
3.3.3 False Negative result
Laboratories failing to identify and/or report a Substance and/or its
Metabolite(s) or the Marker(s) of a Prohibited Substance or a Prohibited
Method in a Blind EQAS round or Double Blind EQAS sample areinformed as soon as possible by WADA. The Laboratory shall receive 10
points under the scoring system described in Section 3.3.5.
Laboratories must complete and report corrective action acceptable to
WADA within thirty (30) calendar days of the date of written notification
by WADA (unless informed otherwise by WADA). Laboratories mayotherwise be advised by WADA to take corrective action for a given
reason or to change a corrective action which has previously beenreported to WADA. The corrective action reported to and approved by
WADA shall be implemented in the routine operation of the Laboratory
within thirty (30) days of the completing the corrective action.
3.3.4 Threshold Substance result
A Laboratory is to achieve satisfactory z-scores for quantitative results
reported based on the mean of three independent determinations. The
relative standard deviation is to be commensurate with the validation
data and the combined standard uncertainty of the procedure should
not exceed the maximum permitted in the Technical Document on
Decision Limits (TD DL). To report an Adverse Analytical Finding, themean result must be above the corresponding decision limit.
Laboratories shall receive either 5 or 10 points (depending on theirperformance) under the scoring system described in Section 3.3.5.
Appropriate corrective action shall be taken to remedy any
unsatisfactory z-score and the corrective action reported to WADA
within thirty (30) calendar days of written notification of unsatisfactory
performance.
3.3.5 Overall Laboratory evaluation
WADA will evaluate Laboratory EQAS performance for each round andassign points for each non-compliance or failure to perform assummarized in the table below. Within any EQAS round evaluation, afalse positive or the accumulation of 24 or more points will result in
Suspension of accreditation. WADA will consider the performance of theLaboratory over the most recent twelve (12) month period or the mostrecent and consecutive three (3) rounds of EQAS and two (2) rounds ofthe double blind EQAS. Any Laboratory that accumulates 30 or morepoints during this period will have its WADA-accreditation Suspended or
Revoked.

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Point Scale for Assessment of Laboratory Performance
False positive25

Immediate
Suspension

False negative

10

Corrective
Action Report|z-score| ≥ 3.0

10

Corrective
Action Report

2.0 < |z-score| < 3.0

5Internal
investigation

SG |z-score| ≥ 3.0

1

Internal
investigation

4-7

2Internal
investigation

8 – 12

4

13-18

7

≥19

10

Documentation*

ISL Non-conformity

2

Corrective
Action Report

Technical Issue

ISL Non-conformity

2

Corrective
Action Report≥ 24

Suspension≥ 30

Suspension or
Revocation ofaccreditation

Prohibited SubstancesThreshold Substances

Sample Parameters

Occurrences**

Scoring

Steroid Profile
concentrations|z-score|≥ 3.0

Point Total for single EQAS round
Evaluation
Point Total per 12 month period

Corrective
Action Report* Documentation includes but is not limited to Documentation Packages, Corrective Action Reports andTest Report.
** Based on a total of 36 determinations (estimation of six (6) steroid variables: Androsterone,
Etiocholanolone, Testosterone, Epitestosterone, 5-androstane-3,17β-diol and 5β-androstane3,17β-diol in six (6) EQAS samples) per EQAS round.

WADA is to evaluate the performance of all Laboratories based on the
results in the WADA EQAS (Blind and Double Blind EQAS) as well as on
issues brought to WADA’s attention by stakeholders in relation to theInternational Standard for Laboratories
Version 7.0, January 201282

Laboratory’s routine testing services. The factors for consideration
include, but are not limited to:













False negative(s);False Positive(s)Questionable results for prohibited Threshold Substance(s);Unsatisfactory results for prohibited Threshold Substance(s);Endogenous anabolic androgenic steroid (EAAS) profiles;
Questionable EAAS results;
Unsatisfactory EAAS results;
Improper implementation of corrective action;
Responsiveness to stakeholders (WADA, NADOs, RADOs, IFs);
Specific gravity;
Test Report(s);Documentation package(s).

Failure by a Laboratory to take appropriate action to remedy
procedures, to comply with the requirements of Technical Documents,
and recommendations made or requested by WADA will result in awarning such that if documented evidence of effective corrective action
is not received within thirty (30) calendar days, then Suspension
immediately follows.
The documentation, describing the corrective
action and preventive action taken will be assessed for acceptability by
WADA. If considered to be unsatisfactory then Suspension will result.
The Laboratory is required to provide documentation of corrective action
no later than thirty (30) calendar days prior to the end of theSuspension (unless informed otherwise by WADA). Failure to do so will
result in immediate Revocation of the accreditation. Lifting of theSuspension occurs only when proper corrective action has been taken
and reported to WADA. WADA may choose, at its sole discretion, to
submit additional EQAS samples to the Laboratory or to require that theLaboratory be re-audited, at the expense of the Laboratory after having
furnished satisfactory results for another EQAS round.
3.4

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 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 accredited Laboratories.
Successful participation in WADA probationary EQAS is required before aprobationary laboratory is eligible to be considered for accreditation based on
point scale table below (less than 20 points accumulated within a single EQAS
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round and the most recent and consecutive 12 month period). The EQAS
samples shall be distributed in multiple rounds per year and will consist of aminimum of eighteen (18) samples per year. At least three (3) EQAS samples
will contain Threshold Substances. Blank samples may also be included.
3.4.1 Methods Utilized
All procedures associated with the handling and testing of the EQAS
samples by the laboratory are, to the greatest extent possible, to be
carried out using validated procedures in a manner identical to that
expected to be applied to routine Samples, unless otherwise specified
by WADA. No effort should be made to optimize instrument (See
Section 3.3.1). Methods or procedures to be utilized in routine testingshould be employed.
3.4.2 False Positive result
Any false positive reported automatically suspends a probationary
laboratory from further consideration for accreditation. The laboratory
will only be eligible for re-instatement into the accreditation process
upon providing documentation to WADA that appropriate remedial andpreventive actions have been implemented. WADA may decide to senda set of EQAS samples and/or audit the laboratory prior toreinstatement to the probationary stage.
3.4.3 False Negative result
Probationary laboratories reporting a false negative in a Blind EQAS
round, e.g. failure to identify a Prohibited Substance and/or its
Metabolite(s) or Marker(s) of a Prohibited Substance or a Prohibited
Method are informed as soon as possible by WADA. The laboratory
shall take and report proper corrective action within 30 calendar days ofthe date of the letter to WADA (unless informed otherwise by WADA).
Probationary laboratories may otherwise be advised by WADA to takecorrective action for a given reason or to change a corrective action
which has previously been reported to WADA. The corrective action
reported to and approved by WADA shall be implemented in the routine
operation of the laboratory.
3.4.4 Threshold Substance result
A probationary laboratory is to achieve satisfactory z-scores forquantitative results reported based on the mean of three independent
determinations. The relative standard deviation is to be commensuratewith the validation data and the combined standard uncertainty of theprocedure should not exceed that permitted in the Technical Document
on Decision Limits (TD DL). To report an Adverse Analytical Finding themean result must be greater than the decision limit. Appropriate

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corrective action reported to WADA is mandatory in all cases of
unsatisfactory z-scores.
3.4.5 Overall Probationary Laboratory Evaluation
WADA will evaluate probationary laboratory EQAS performance for eachround and assign points for each non-compliance or failure to performas summarized in the table below.
Point Scale for Assessment of Probationary Laboratory Performance
False positive25

Immediate
Suspension

False negative

10

Corrective
Action Report|z-score| ≥ 3.0

10

Corrective
Action Report

2.0 < |z-score| < 3.0

5Internal
investigation

Sample Parameters

SG |z-score| ≥ 3.0

1

Internal
investigation

Documentation*

ISL Non-conformity

2

Corrective
Action Report

Technical Issue

ISL Non-conformity

2

Corrective
Action Report

Point Total for single EQAS round≥ 20

Immediate
Suspension

Point Total per 12 month period≥ 20

Immediate
Suspension

Prohibited SubstancesThreshold Substances
Scoring

Evaluation* Documentation includes but is not limited to Documentation Packages, Corrective Action Reports andTest Report.

Suspension length of probationary laboratory’s participation in the EQAS
will be determined by WADA.
Serious and repeated issues in the probationary EQAS shall result in theconsideration of the laboratory’s status as a candidate laboratory by
WADA.
During the probationary period other elements of the EQAS scheme,
which are part of the generally applied procedures, will be considered toassess the competence of the laboratory. These elements include, but
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are not limited to: determination of the specific gravity of the samples,the initial determination of the endogenous anabolic androgenic steroid(EAAS) profile and the presentation of necessary documentation (testreports and the documentation package to support an Adverse
Analytical Finding).
For laboratories already in operation prior to the WADA probationary
phase, all routine laboratory services will also be factors for evaluation
purposes.
When performance of the laboratory is considered to be satisfactory in
the EQAS over the most recent and consecutive twelve (12) month
period (e.g., at least 3 EQAS rounds), and all other necessary conditions
having been fulfilled, the laboratory will be inspected by an audit teamappointed by WADA.
This audit will take place while the laboratory is processing andanalyzing a further twenty (20) EQAS samples supplied by WADA aspart of a final accreditation test. The results of the final accreditation
test will be evaluated by WADA as follows:No false positives are reported;The point total must be less than twenty (<20) for the twenty(20) samples tested;

Any corrective actions required as a result of the audit and/or the
analytical performance and/or the presentation of the requested
documentation packages are to be submitted within 30 calendar
days and considered to be satisfactory by WADA.

A suspended probationary laboratory wishing to re-enter the
probationary EQAS is required to provide documentation of corrective
action no later than thirty (30) working days prior to the end of theSuspension (unless informed otherwise by WADA). Failure to do so willprohibit the laboratory from re-entering the probationary EQAS. Liftingof the Suspension occurs only when proper corrective action has been
implemented and reported to WADA. WADA may choose, at its sole
discretion, to submit additional EQAS samples to the laboratory or torequire that the laboratory be re-audited, at the expense of thelaboratory. Laboratories re-entering the probationary EQAS shall beconsidered as a candidate laboratory and are subject to provide theapplicable fee and the required documentation to WADA.

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ANNEX B - LABORATORY CODE OF ETHICS

1.0

Confidentiality

The heads of Laboratories, their delegates and Laboratory staff shall not discuss orcomment to the media on individual results prior to the completion of any
adjudication without consent of the organization that supplied the Sample to the
Laboratory and the organization that is asserting the Adverse Analytical Finding in
adjudication.
2.0

Research

Laboratories are entitled to participate in research programs provided that theLaboratory Director is satisfied with the bona fide nature and the programs havereceived proper ethical (e.g. human subjects) approval.
3.0

Research in Support of Doping Control

The Laboratories are expected to develop a program of research and development tosupport the scientific foundation of Doping Control. This research may consist of thedevelopment of new methods or technologies, the pharmacological characterizationof a new doping agent, the characterization of a masking agent or method, and othertopics relevant to the field of Doping Control.
3.1

Human subjects

The Laboratories shall follow the Helsinki Accords and any applicable national
standards as they relate to the involvement of human subjects in research.
Voluntary informed consent shall also be obtained from human subjects in any
drug administration studies for the purpose of development of a ReferenceCollection or proficiency testing materials.
3.2

Controlled substances

The Laboratories are expected to comply with the relevant national laws
regarding the handling and storage of controlled (illegal) substances.
4.0

Analysis
4.1

Competitions

The Laboratories shall only accept and analyze Samples originating fromknown sources within the context of Doping Control programs conducted inCompetitions organized by national and international sports governing bodies.
This includes National and International Federations, National Olympic
Committees,
national
associations,
universities,
and
other
similarorganizations. This rule applies to Olympic and non-Olympic sports.
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Version 7.0, January 201287Laboratories should exercise due diligence to ascertain that the Samples arecollected according to the World Anti-Doping Code International Standard for
Testing or similar guidelines. These guidelines shall include collection of Split
Samples, appropriate Sample container security considerations, and formal
chain of custody conditions. Laboratories shall ensure that Samples received
are tested in accordance with all the ISL rules.
4.2

Out-of-Competition

The Laboratories shall accept Samples taken during training (or Out-ofCompetition) only if the following conditions are simultaneously met:That the Samples have been collected and sealed under the conditions
generally prevailing in Competitions themselves as in Section 3.1
above;
If the collection is a part of an anti-doping program; andIf appropriate result management process will follow an Adverse
Analytical Finding.

Laboratories shall not accept Samples, for the purposes of either Initial Testingor identification, from commercial or other sources when the conditions in theabove paragraph are not simultaneously met.
Laboratories shall not accept Samples from individual Athletes on a private
basis or from individuals or organizations acting on their behalf.
These rules apply to all sports.
4.3

Clinical or Forensic

Occasionally the Laboratory may be requested to analyze a sample for abanned drug or endogenous substance allegedly coming from a hospitalized or
ill Person in order to assist a physician in the diagnostic process. Under thiscircumstance, the Laboratory Director shall explain the pre-testing issue to therequester and agree subsequently to analyze the sample only if a letteraccompanies the sample and explicitly certifies that the sample is for medical
diagnostic or therapeutic purposes.
The letter shall also explain the medical reason for the test.
Work to aid in forensic investigations may be undertaken but due diligenceshould be exercised to ensure that the work is requested by an appropriate
agency or body. The Laboratory should not engage in analytical activities orexpert testimony that would intentionally question the integrity of theindividual or the scientific validity of work performed in the anti-doping
program.

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4.4

Other analytical activities

If the Laboratory accepts Samples from any entity that is not a Testing
Authority recognized by the World Anti-Doping Code, it is the responsibility of
the Laboratory Director to ensure that any Adverse Analytical Finding will beprocessed according to the Code and that the results cannot be used in any
way by an Athlete or associated Person to avoid detection.
The Laboratory shall not engage in any analysis that undermines or isdetrimental to the anti-doping program of WADA. The Laboratory should notprovide analytical services in a Doping Control adjudication, unless specificallyrequested by the responsible Testing Authority or a Hearing Body.
The Laboratory shall not engage in analyzing commercial material or
preparations (e.g. dietary supplements) unless specifically requested by an
Anti-Doping Organization as part of a doping case investigation. The
Laboratory shall not provide results, documentation or advice that, in any
way, suggests endorsement of products or services.
4.5

Sharing of Information and Resources
4.5.1 New Substances
The WADA accredited Laboratories for Doping Control shall inform
WADA immediately when they detect a new or suspicious doping agent.
When possible, the Laboratories shall share information with WADA
regarding the detection of potentially new or rarely detected doping
agents.
4.5.2 Sharing of Knowledge
When information on new substance(s), method(s), or practise(s) is
known to the Laboratory Director, such information shall be shared with
WADA within sixty (60) calendar days. This can occur by participationin scientific meetings, publication of results of research, sharing ofspecific details of methodology necessary for detection, and working
with WADA to distribute information by preparation of a reference
substance or biological excretion study or information regarding thechromatographic retention behaviour and mass spectra of the substanceor its Metabolite(s) or Marker(s). The Laboratory Director or staff shallparticipate in developing standards for best practice and enhancing
uniformity of testing in the WADA accredited Laboratory system.

5.0

Conduct Detrimental to the Anti-Doping Program
The Laboratory personnel shall not engage in conduct or activities that
undermine or are detrimental to the anti-doping program of WADA, anInternational Federation, a National Anti-Doping Organization, a National
Olympic Committee, a Major Event Organizing Committee, or the International

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Olympic Committee. Such conduct could include, but is not limited to,conviction for fraud, embezzlement, perjury, etc. that would cast doubt on the
integrity of the anti-doping program.
No Laboratory employee or consultant shall provide counsel, advice orinformation to Athletes or others regarding techniques or methods to mask
detection of, alter metabolism of, or suppress excretion of a Prohibited
Substance or Marker(s) of a Prohibited Substance or Prohibited Method inorder to avoid an Adverse Analytical Finding. Outside the context of anarbitration hearing, no Laboratory employee or consultant shall provide
information to an Athlete or Athlete Support Personnel about a testing methodthat might assist an Athlete in avoiding detection of the use of a Prohibited
Substance or Prohibited Method. No Laboratory staff shall assist an Athlete in
avoiding collection of a representative Sample (e.g., advice on masking or
detection windows).
This paragraph does not prohibit presentations to
educate Athletes, students, or others concerning anti-doping programs andProhibited Substances or Prohibited Methods. Such provision shall remain
valid for a minimum of five (5) years following termination of the contractual
link of any employee to a Laboratory.
If Laboratory staff is requested by either party or the tribunal to appear before
an arbitration or court hearing, they are expected to provide independent,
scientifically-valid expert testimony. Laboratory experts should not be an
advocate to either party.
The Laboratory shall not issue (publish) any public warning statements related
to the Laboratory findings. The responsibility for evaluation of these findings
with further action and publication, if considered necessary, shall be left to apolitical decision-making body (e.g. NADO, IF or WADA).

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