International Standard for Laboratories
The World Anti-Doping Code International Standard forLaboratories (ISL) is a mandatory International Standard
developed as part of the World Anti-Doping Program.
The International Standard for Laboratories first cameinto effect in November 2002. Further revisions weremade after that date. The enclosed International
Standard for Laboratories was approved by the WADA
Executive Committee on 11 May 2016. The effective dateof ISL version 9.0 is 02 June 2016.
The official text of the ISL shall be maintained by WADA
and shall be published in English and French. In the eventof any conflict between the English and French versions,
the English version shall prevail.

Published by:World Anti-Doping Agency
Stock Exchange Tower
800 Place Victoria (Suite 1700)
PO Box 120
Montreal, Quebec
Canada H4Z 1B7
URL: www.wada-ama.org
Tel:+1 514 904 9232
Fax:
+1 514 904 8650
E-mail: code@wada-ama.org

TABLE OF CONTENTSPART ONE: INTRODUCTION, CODE PROVISIONS AND DEFINITIONS ....................... 1
1.0

INTRODUCTION, SCOPE AND REFERENCES .................................................... 1

2.0

CODE PROVISIONS ......................................................................................... 3

3.0

TERMS AND DEFINITIONS ............................................................................ 10

3.1
3.2
3.3

Code defined terms ...................................................................................... 10
ISL and related Technical Documents defined Terms ......................................... 14International Standard for Testing and Investigations (ISTI) Defined Terms......... 16

PART TWO: LABORATORY ACCREDITATION REQUIREMENTS AND OPERATINGSTANDARDS ................................................................................................. 18
4.0

PROCESS AND REQUIREMENTS FOR WADA ACCREDITATION ....................... 18

4.1

Applying for a WADA Laboratory Accreditation ................................................. 18
4.1.1 Expression of interest ............................................................................. 18
4.1.2 Submitting initial application form ............................................................ 18
4.1.3 Providing letter(s) of support ................................................................... 18
4.1.4 Description of the candidate laboratory ..................................................... 19
4.1.5 Conducting initial visit............................................................................. 19
4.1.6 Issuing final report and recommendation .................................................. 19
4.1.7 Initial accreditation fee ........................................................................... 19
4.1.8 Laboratory independence ........................................................................ 20
4.1.9 Compliance with the Code of Ethics .......................................................... 20
4.2
Preparing for WADA Laboratory Accreditation ................................................... 20
4.2.1 Obtaining ISO/IEC 17025 accreditation by the laboratory ........................... 21
4.2.2 Participating in the WADA External Quality Assessment Scheme ................... 21
4.2.3 Planning and implementing research and development activities .................. 22
4.2.4 Planning and implementing sharing of knowledge ....................................... 22
4.2.5 Professional liability insurance coverage .................................................... 22
4.3
Obtaining WADA accreditation ........................................................................ 22
4.3.1 Participating in a WADA accreditation audit ............................................... 22
4.3.2 WADA report and recommendation ........................................................... 22
4.3.3 Issuing and publishing of accreditation certificate ....................................... 23
4.4
Maintaining WADA accreditation ..................................................................... 23
4.4.1 Maintaining ISO/IEC 17025 accreditation .................................................. 23
4.4.2 Participate in the WADA External Quality Assessment Scheme ..................... 24
4.4.3 Laboratory independence ........................................................................ 24
4.4.4 Documenting compliance with the WADA Laboratory Code of Ethics.............. 24
4.4.5 Documenting implemented research and development activities .................. 24
4.4.6 Documenting implemented sharing of knowledge ....................................... 24
4.4.7 Maintaining professional liability insurance coverage ................................... 25
4.4.8 Providing renewed letter(s) of support ...................................................... 25
4.4.9 Minimum number of Samples .................................................................. 25
4.4.10 Publication of fee schedule ...................................................................... 25
4.4.11 Participating in WADA/Accreditation Body re-assessments and surveillance
assessments .......................................................................................... 25
4.4.12 Flexible Scope of Accreditation ................................................................. 26
4.4.13 WADA monitoring of accreditation status ................................................... 26
4.4.14 Notification ............................................................................................ 31
4.4.15 Re-accreditation costs ............................................................................. 32

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4.5

5.0

4.4.16 Issuing and publication of accreditation certificate ...................................... 32
Accreditation requirements for Major Events .................................................... 32
4.5.1 Major Event testing in the Laboratory facilities ........................................... 33
4.5.2 Major Event testing in satellite Laboratory facilities..................................... 35
APPLICATION OF ISO/IEC 17025 TO THE ANALYSIS OF URINE DOPINGCONTROL SAMPLES ...................................................................................... 37

5.1
5.2

Introduction and Scope ................................................................................. 37
Analytical and Technical Processes .................................................................. 37
5.2.1 Receipt of Samples ................................................................................. 37
5.2.2 Handling and retention of Samples ........................................................... 37
5.2.3 Sampling and preparation of Aliquots for analysis....................................... 42
5.2.4 Analytical Testing ................................................................................... 42
5.2.5 Results management .............................................................................. 47
5.2.6 Documentation and reporting .................................................................. 48
5.3
Quality Management Processes ...................................................................... 51
5.3.1 Organization .......................................................................................... 51
5.3.2 Quality policy and objectives ................................................................... 51
5.3.3 Document control ................................................................................... 51
5.3.4 Reviewing of requests, tenders, and contracts ........................................... 51
5.3.5 Subcontracting of tests ........................................................................... 52
5.3.6 Purchasing of services and supplies .......................................................... 52
5.3.7 Service to the customer .......................................................................... 52
5.3.8 Complaints ............................................................................................ 54
5.3.9 Control of nonconformities in Analytical Testing ......................................... 54
5.3.10 Improvement......................................................................................... 54
5.3.11 Corrective action .................................................................................... 54
5.3.12 Preventive action ................................................................................... 54
5.3.13 Control and storage of technical records ................................................... 54
5.3.14 Internal audits ....................................................................................... 54
5.3.15 Management reviews .............................................................................. 55
5.4
Support Processes ........................................................................................ 55
5.4.1 General ................................................................................................. 55
5.4.2 Personnel .............................................................................................. 55
5.4.3 Accommodation and environmental conditions ........................................... 56
5.4.4 Test methods and method validation ........................................................ 58
5.4.5 Equipment............................................................................................. 62
5.4.6 Measurement traceability ........................................................................ 62
5.4.7 Assuring the quality of analytical results ................................................... 62
6.0

APPLICATION OF ISO/IEC 17025 TO THE ANALYSIS OF BLOOD DOPINGCONTROL SAMPLES ...................................................................................... 64

6.1
6.2

Introduction and Scope ................................................................................. 64
Analytical and Technical Processes .................................................................. 64
6.2.1 Receipt of Samples ................................................................................. 64
6.2.2 Handling and retention of Samples ........................................................... 64
6.2.3 Sampling and preparation of Aliquots for analysis....................................... 68
6.2.4 Analytical Testing ................................................................................... 68
6.2.5 Results management .............................................................................. 73
6.2.6 Documentation and reporting .................................................................. 73
6.3
Quality Management Processes ...................................................................... 76
6.4
Support Processes ........................................................................................ 76
6.4.1 Test methods and method validation ........................................................ 76
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PART THREE: ANNEXES ......................................................................................... 78
ANNEX A - WADA EXTERNAL QUALITY ASSESSMENT SCHEME (EQAS) .................... 78
1.0
1.1
1.2
1.3
2.0

WADA EXTERNAL QUALITY ASSESSMENT SCHEME ....................................... 78
Open (Educational) EQAS .............................................................................. 78
Blind EQAS .................................................................................................. 78
Double Blind EQAS ....................................................................................... 79
EXTERNAL QUALITY ASSESSMENT SCHEME SAMPLE COMPOSITION ............. 79

2.1

EQAS Samples Void of Prohibited Substances or Methods, their Metabolite(s) orMarker(s)(blank samples) .............................................................................. 79
2.2
Adulterated EQAS samples ............................................................................ 79
2.3
EQAS Samples Containing Prohibited Substances, their Metabolite(s) or Marker(s),or the Marker(s) of Prohibited Methods ........................................................... 79
2.3.1 EQAS sample composition ....................................................................... 79
2.3.2 Individual EQAS sample content of Prohibited Substance(s) or Method(s), or
Metabolite(s) or Marker(s) ....................................................................... 80
3.0

EVALUATION OF EXTERNAL QUALITY ASSESSMENT SCHEME ....................... 81

3.1
3.2
3.3

Evaluation of EQAS Samples Containing Non-Threshold Substances .................... 81
Evaluation of EQAS Samples Containing Threshold Substances........................... 81
Accreditation Maintenance and Laboratory Evaluation ....................................... 82
3.3.1 Methods utilized in EQAS ......................................................................... 82
3.3.2 False Adverse Analytical Finding result ...................................................... 82
3.3.3 False negative result............................................................................... 83
3.3.4 Threshold Substance result...................................................................... 84
3.3.5 Overall Laboratory evaluation .................................................................. 84
3.4
Probationary Period and Probationary Laboratory Evaluation .............................. 86
3.4.1 Methods utilized ..................................................................................... 86
3.4.2 False Adverse Analtyical Finding result ...................................................... 86
3.4.3 False negative result............................................................................... 86
3.4.4 Threshold Substance result...................................................................... 87
3.4.5 Overall probationary laboratory evaluation ................................................ 87
ANNEX B - LABORATORY CODE OF ETHICS ............................................................. 89
1.0

CONFIDENTIALITY ....................................................................................... 89

2.0

RESEARCH .................................................................................................... 89

3.0

RESEARCH IN SUPPORT OF DOPING CONTROL ............................................. 89

3.1
3.2
4.0
4.1
4.2
4.3
5.0

Human Subjects ........................................................................................... 89
Controlled Substances ................................................................................... 89
ANALYSIS ..................................................................................................... 89
Clinical or Forensic........................................................................................ 90
Other Analytical Activities .............................................................................. 90
Sharing of Information and Resources ............................................................. 91
CONDUCT DETRIMENTAL TO THE ANTI-DOPING PROGRAM .......................... 91

2016 ISL – Version 9.0

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 requirements in a TechnicalDocument. Implementation of the technical requirements described in the TechnicalDocuments is mandatory and shall occur by the effective date specified in theTechnical Document. Technical Documents supersede any previous publication on asimilar topic, or if applicable, this document. The document in effect shall be thatTechnical 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. Technical Documents are posted on WADA’s website whenapproved by the WADA Executive Committee and may be applied prior to theeffective date for implementation.
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 and Guidelines (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 have been and will be developed inconsultation 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 andoperational parts of anti-doping programs. Adherence to theInternational Standards is mandatory for compliance with the Code. The
International Standards may be revised from time to time by the WADA
Executive Committee after reasonable consultation with the Signatories,
governments and other relevant stakeholders. International Standards
and all revisions will be published on the WADA website and shallbecome effective on the date specified in the International Standard orrevision.”2016 ISL – Version 9.0

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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. A Laboratory’s
failure to follow a requirement in effect at the time of Sample analysis which has
subsequently been eliminated from this International Standard for Laboratories orapplicable Technical Document at the time of a hearing shall not be a defense to ananti-doping rule violation.
This document sets out the requirements for Laboratories that wish to demonstratethat they are technically competent, operate an effective quality management
system, and are able to produce forensically valid results. Doping Control analysis
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) of drugs and othersubstances in human biological fluids or tissues as identified on the List of Prohibited
Substances and Prohibited Methods (the Prohibited List). Laboratories may
undertake other forms of analysis, 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 accreditation and the procedures involved to fulfill the requirements. It also
includes the 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 accreditation 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 an integral part of the ISL. The incorporation of theprovisions 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 accreditation, national
accreditation bodies will use the ISL, including the Annexes and TechnicalDocuments, as reference documents in their assessment process.
Maintenance of a Laboratory’s accreditation by WADA is based on satisfactory
performance in the WADA EQAS and routine testing. A Laboratory’s EQAS
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ISO accreditation body assessment process. Therefore a Laboratory’s EQAS results
shall not be subject to challenge or to demands to produce Laboratory EQAS resultsor related EQAS documentation.
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

ANTI-DOPING RULE VIOLATIONS

2.1
Presence of a Prohibited Substance or its Metabolites or Markers in an
Athlete’s Sample.
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 be demonstrated inorder to establish an anti-doping rule violation under Article 2.1.
[Comment to Article 2.1.1: An anti-doping rule violation is committed under this
Article without regard to an Athlete’s Fault. This rule has been referred to in various
CAS decisions as “Strict Liability”. An Athlete’s Fault is taken into consideration in
determining the Consequences of this anti-doping rule violation under Article 10. This
principle has consistently been upheld by CAS.]
2.1.2 Sufficient proof of an anti-doping rule violation under Article 2.1
is established by any 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 notanalyzed; or, where the Athlete’s B Sample is analyzed and the analysisof the Athlete’s B Sample confirms the presence of the Prohibited
Substance or its Metabolites or Markers found in the Athlete’s A
Sample; or, where the Athlete’s B Sample is split into two bottles andthe analysis of the second bottle confirms the presence of the Prohibited
Substance or its Metabolites or Markers found in the first bottle.
[Comment to Article 2.1.2: The Anti-Doping Organization with results management
responsibility may, at its discretion, choose to have the B 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
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of a Prohibited Substance or its Metabolites or Markers in an Athlete’s
Sample shall constitute an anti-doping rule violation.
2.1.4 As an exception to the general rule of Article 2.1, the Prohibited
List or International Standards may establish special criteria for theevaluation of Prohibited Substances that can also be produced
endogenously.
2.2
Use or Attempted Use by an Athlete of a Prohibited Substance or a
Prohibited Method.
[Comment to Article 2.2: It has always been the case that Use or Attempted Use of a
Prohibited Substance or Prohibited Method may be established by any reliablemeans. As noted in the Comment to Article 3.2, unlike the proof required to establish
an anti-doping rule violation under Article 2.1, Use or Attempted Use may also beestablished by other reliable means such as admissions by the Athlete, witness
statements, documentary evidence, conclusions drawn from longitudinal profiling,including data collected as part of the Athlete Biological Passport, or other analyticalinformation which does not otherwise satisfy all the requirements to establish“Presence” of a Prohibited Substance under Article 2.1.
For example, Use may be established based upon reliable analytical data from theanalysis of an A Sample (without confirmation from an analysis of a B Sample) orfrom the analysis of a B Sample alone where the Anti-Doping Organization provides asatisfactory explanation for the lack of confirmation in the other Sample.]
2.2.1 It is each Athlete’s personal duty to ensure that no Prohibited
Substance enters his or her body and that no Prohibited Method is Used.
Accordingly, it is not necessary that intent, Fault, negligence or knowing
Use on the Athlete’s part be demonstrated in order to establish an antidoping rule violation for Use of a Prohibited Substance or a Prohibited
Method.
2.2.2 The success or failure of the Use or Attempted Use of a Prohibited
Substance or Prohibited Method is not material. It is sufficient that theProhibited Substance or Prohibited Method was Used or Attempted to be
Used for an anti-doping rule violation to be committed.
[Comment to Article 2.2.2: Demonstrating the "Attempted Use" of a Prohibited
Substance or a Prohibited Method requires proof of intent on the Athlete’s part. The
fact that intent may be required to prove this particular anti-doping rule violation
does not undermine the Strict Liability principle established for violations of Article
2.1 and violations of Article 2.2 in respect of Use of a Prohibited Substance or
Prohibited Method.
An Athlete’s Use of a Prohibited Substance constitutes an anti-doping rule violation
unless such substance is not prohibited Out-of-Competition and the Athlete’s Usetakes place Out-of-Competition. (However, the presence of a Prohibited Substance or2016 ISL – Version 9.0

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its Metabolites or Markers in a Sample collected In-Competition is a violation of
Article 2.1 regardless of when that substance might have been administered.)]
2.5

Tampering or Attempted Tampering with any part of Doping Control.

Conduct which subverts the Doping Control process but which would nototherwise be included in the definition of Prohibited Methods. Tampering shall
include, without limitation, intentionally interfering or attempting to interferewith a Doping Control official, providing fraudulent information to an AntiDoping Organization or intimidating or attempting to intimidate a potential
witness.
[Comment to Article 2.5: For example, this Article would prohibit altering
identification numbers on a Doping Control form during Testing, breaking the B
bottle at the time of B Sample analysis, or altering a Sample by the addition of aforeign substance.
Offensive conduct towards a Doping Control official or other Person involved in
Doping Control which does not otherwise constitute Tampering shall be addressed in
the disciplinary rules of sport organizations.]
Code Article 3
3.2

PROOF OF DOPING

Methods of Establishing Facts and Presumptions
3.2.1 Analytical methods or decision limits approved by WADA after
consultation within the relevant scientific community and which havebeen the subject of peer review are presumed to be scientifically valid.
Any Athlete or other Person seeking to rebut this presumption ofscientific validity shall, as a condition precedent to any such challenge,
first notify WADA of the challenge and the basis of the challenge. CAS
on its own initiative may also inform WADA of any such challenge. At
WADA’s request, the CAS panel shall appoint an appropriate scientificexpert to assist the panel in its evaluation of the challenge. Within 10
days of WADA’s receipt of such notice, and WADA’s receipt of the CAS
file, WADA shall also have the right to intervene as a party, appear
amicus curiae or otherwise provide evidence in such proceeding.
3.2.2 WADA-accredited laboratories, and other laboratories approved
by WADA, are presumed to have conducted Sample analysis andcustodial procedures in accordance with the International Standard forLaboratories. The Athlete or other Person may rebut this presumption
by establishing that a departure from the International Standard forLaboratories 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 for2016 ISL – Version 9.0

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Laboratories 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 3.2.2: The burden is on the Athlete or other Person to establish,
by a balance of probability, a departure from the International Standard forLaboratories that could reasonably have caused the Adverse Analytical Finding. If theAthlete or other Person does so, the burden shifts to the Anti-Doping Organization toprove to the comfortable satisfaction of the hearing panel that the departure did notcause the Adverse Analytical Finding.]
Code Article 6

ANALYSIS OF SAMPLES

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

Use of Accredited and Approved Laboratories

For purposes of Article 2.1, Samples shall be analyzed only in WADAaccredited laboratories or laboratories otherwise approved by WADA. The
choice of the WADA-accredited or WADA-approved laboratory used for the
Sample analysis shall be determined exclusively by the Anti-Doping
Organization responsible for results management.
[Comment to Article 6.1: For cost and geographic access reasons, WADA may
approve laboratories which are not WADA-accredited to perform particular analyses,
for example, analysis of blood which should be delivered from the collection site to
the laboratory within a set deadline. Before approving any such laboratory, WADA
will ensure it meets the high analytical and custodial standards required by WADA.
Violations of Article 2.1 may be established only by Sample analysis performed by a
WADA-accredited laboratory or another laboratory approved by WADA. Violations ofother Articles may be established using analytical results from other laboratories solong as the results are reliable.]
6.2

Purpose of 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, or to assist an Anti-Doping
Organization in profiling relevant parameters in an Athlete’s urine, blood orother matrix, including DNA or genomic profiling, or for any other legitimate
anti-doping purpose. Samples may be collected and stored for future analysis.
[Comment to Article 6.2: For example, relevant profile information could be used todirect Target Testing or to support an anti-doping rule violation proceeding under
Article 2.2, or both.]2016 ISL – Version 9.0

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6.3

Research on Samples

No Sample may be used for research without the Athlete’s written consent.
Samples used for purposes other than Article 6.2 shall have any means ofidentification removed such that they cannot be traced back to a particular
Athlete.
[Comment to Article 6.3: As is the case in most medical contexts, use of anonymized
Samples for quality assurance, quality improvement, or to establish reference
populations is not considered research.]
6.4

Standards for Sample Analysis and Reporting

Laboratories shall analyze Samples and report results in conformity with theInternational Standard for Laboratories. To ensure effective Testing, theTechnical Document referenced at Article 5.4.1 will establish risk assessmentbased Sample analysis menus appropriate for particular sports and sportdisciplines, and laboratories shall analyze Samples in conformity with thosemenus, except as follows:
6.4.1 Anti-Doping Organizations may request that laboratories
analyze their Samples using more extensive menus than thosedescribed in the Technical Document.
6.4.2 Anti-Doping Organizations may request that laboratories
analyze their Samples using less extensive menus than those describedin the Technical Document only if they have satisfied WADA that,
because of the particular circumstances of their country or sport, as set
out in their test distribution plan, less extensive analysis would beappropriate.
6.4.3 As provided in the International Standard for Laboratories,
laboratories at their own initiative and expense may analyze Samples
for Prohibited Substances or Prohibited Methods not included on the
Sample analysis menu described in the Technical Document or specified
by the Testing authority. Results from any such analysis shall bereported and have the same validity and consequence as any otheranalytical result.
[Comment to Article 6.4: The objective of this Article is to extend the principle of“intelligent Testing” to the Sample analysis menu so as to most effectively andefficiently detect doping. It is recognized that the resources available to fight doping
are limited and that increasing the Sample analysis menu may, in some sports andcountries, reduce the number of Samples which can be analyzed.]2016 ISL – Version 9.0

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6.5

Further Analysis of Samples

Any Sample may be subject to further analysis by the Anti-Doping
Organization responsible for results management at any time before both the
A and B Sample analytical results (or A Sample result where B Sample
analysis has been waived or will not be performed) have been communicatedby the Anti-Doping Organization to the Athlete as the asserted basis for an
Article 2.1 anti-doping rule violation.
Samples may be stored and subjected to further analyses for the purpose of
Article 6.2 at any time exclusively at the direction of the Anti-Doping
Organization that initiated and directed Sample collection or WADA. (AnySample storage or further analysis initiated by WADA shall be at WADA’s
expense.) Further analysis of Samples shall conform with the requirements of
the International Standard for Laboratories and the International Standard for
Testing and Investigations.
Code Article 13

APPEALS

13.7 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

CONFIDENTIALITY AND REPORTING

14.1 Information Concerning Adverse Analytical Findings, Atypical Findings,
and other Asserted Anti-Doping Rule Violations.
14.1.1 Notice of Anti-Doping Rule Violations to Athletes and other
Persons.
The form and manner of notice of an asserted anti-doping rule violation
shall be as provided in the rules of the Anti-Doping Organization withresults management responsibility.
14.1.2 Notice of Anti-Doping Rule Violations to National Anti-Doping
Organizations, International Federations, and WADA.
The Anti-Doping Organization with results management responsibility
shall also notify the Athlete’s National Anti-Doping Organization,
International Federation and WADA of the assertion of an anti-doping
rule violation simultaneously with the notice to the Athlete or other
Person.
14.1.3 Content of an Anti-Doping Rule Violation Notice.
Notification shall include: the Athlete’s name, country, sport anddiscipline within the sport, the Athlete’s competitive level, whether the2016 ISL – Version 9.0

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test was In-Competition or Out-of-Competition, the date of Sample
collection, the analytical result reported by the laboratory and otherinformation as required by the International Standard for Testing andInvestigations, or, for anti-doping rule violations other than Article 2.1,
the rule violated and the basis of the asserted violation.
14.1.4 Status Reports.
Except with respect to investigations which have not resulted in noticeof an anti-doping rule violation pursuant to Article 14.1.1, the AntiDoping Organizations referenced in Article 14.1.2 shall be regularly
updated on the status and findings of any review or proceedings
conducted pursuant to Article 7, 8 or 13 and shall be provided with aprompt written reasoned explanation or decision explaining theresolution of the matter.
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 Team Sport) until the Anti-Doping
Organization with results management responsibility has made Public
Disclosure or has failed to make Public Disclosure as required in Article
14.3.
[Comment to Article 14.1.5: Each Anti-Doping Organization shall provide, in its
own anti-doping rules, procedures for the protection of confidential informationand for investigating and disciplining improper disclosure of confidential
information by any employee or agent of the Anti-Doping Organization.]2016 ISL – Version 9.0

9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 WADA-accredited laboratory or other
WADA-approved laboratory that, consistent with the International Standard forLaboratories and related Technical Documents, identifies in a Sample the presence ofa Prohibited Substance or its Metabolites or Markers (including elevated quantities ofendogenous substances) or evidence of the Use of a Prohibited Method.
Adverse Passport Finding: A report identified as an Adverse Passport Finding as
described in the applicable International Standards.
Anti-Doping Organization: A Signatory that is responsible for adopting rules for
initiating, implementing or enforcing any part of the Doping Control process. This
includes, for example, the International Olympic Committee, the International
Paralympic Committee, other Major Event Organizations that conduct Testing at their
Events, WADA, International Federations, and National Anti-Doping Organizations.
Athlete: Any Person who competes in sport at the international level (as defined byeach International Federation) or the national level (as defined by each National
Anti-Doping Organization). An Anti-Doping Organization has discretion to apply antidoping rules to an Athlete who is neither an International-Level Athlete nor a
National-Level Athlete, and thus to bring them within the definition of “Athlete.” Inrelation to Athletes who are neither International-Level nor National-Level Athletes,
an Anti-Doping Organization may elect to: conduct limited Testing or no Testing at
all; analyze Samples for less than the full menu of Prohibited Substances; require
limited or no whereabouts information; or not require advance TUEs. However, if an
Article 2.1, 2.3 or 2.5 anti-doping rule violation is committed by any Athlete overwhom an Anti-Doping Organization has authority who competes below theinternational or national level, then the Consequences set forth in the Code (except
Article 14.3.2) must be applied. For purposes of Article 2.8 and Article 2.9 and for
purposes of anti-doping information and education, any Person who participates in
sport under the authority of any Signatory, government, or other sports organization
accepting the Code is an Athlete.
[Comment: This definition makes it clear that all International- and National-Level
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.
The definition also allows each National Anti-Doping Organization, if it chooses to doso, to expand its anti-doping program beyond International- or National-Level
Athletes to competitors at lower levels of Competition or to individuals who engage infitness activities but do not compete at all. Thus, a National Anti-Doping Organization
could, for example, elect to test recreational-level competitors but not require2016 ISL – Version 9.0

10advance TUEs. But an anti-doping rule violation involving an Adverse Analytical
Finding or Tampering results in all of the Consequences provided for in the Code(with the exception of Article 14.3.2). The decision on whether Consequences apply
to recreational-level Athletes who engage in fitness activities but never compete isleft to the National Anti-Doping Organization. In the same manner, a Major Event
Organization holding an Event only for masters-level competitors could elect to test
the competitors but not analyze Samples for the full menu of Prohibited Substances.
Competitors at all levels of Competition should receive the benefit of anti-doping
information and education.]
Athlete Biological Passport: The program and methods of gathering and collating
data as described in the International Standard for Testing and Investigations andInternational Standard for Laboratories.
Atypical Finding: A report from a WADA-accredited laboratory or other WADAapproved laboratory which requires further investigation as provided by theInternational Standard for Laboratories or related Technical Documents prior to thedetermination of an Adverse Analytical Finding.
Atypical Passport Finding: A report described as an Atypical Passport Finding as
described in the applicable International Standards.
CAS: The Court of Arbitration for Sport.
Code: The World Anti-Doping Code.
Competition: A single race, match, game or singular sport contest. For example, abasketball game or the finals of the Olympic 100-meter race in athletics. For stage
races and other sport contests where prizes are awarded on a daily or other interim
basis the distinction between a Competition and an Event will be as provided in therules 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, TUEs, results management and hearings.
Event: A series of individual Competitions conducted together under one ruling body(e.g., the Olympic Games, FINA World Championships, or Pan American Games).
In-Competition: Unless provided otherwise in the rules of an International
Federation or the ruling body of the Event in question, “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.
[Comment: An International Federation or ruling body for an Event may establish an“In-Competition” period that is different than the Event Period.]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

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International Standard.

anyTechnical

Documents

issuedpursuant

totheMajor Event Organizations: The continental associations of National Olympic
Committees and other international multi-sport organizations that function as theruling body for any continental, regional or other International Event.
Marker: A compound, group of compounds or biological variable(s) that indicates
the Use of a Prohibited Substance or Prohibited Method.
Metabolite: Any substance produced by a biotransformation process.
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 at the national level. If this designation has not been madeby the competent public authority(ies), the entity shall be the country’s National
Olympic Committee or its designee.
National Olympic Committee: The organization recognized by the International
Olympic Committee. The term National Olympic Committee shall also include the
National Sport Confederation in those countries where the National Sport
Confederation assumes typical National Olympic Committee responsibilities in theanti-doping area.
Out-of-Competition: Any period which is not In-Competition.
Person: A natural Person or an organization or other entity.
Prohibited List: The List identifying the Prohibited Substances and Prohibited
Methods.
Prohibited Method: Any method so described on the Prohibited List.
Prohibited Substance: Any substance, or class of substances, so described on theProhibited List.
Publicly Disclose or Publicly Report: See Consequences of Anti-Doping Rule
Violations in the Code. “The dissemination or distribution of information to thegeneral public or Persons beyond those Persons entitled to earlier notification inaccordance with Article 14. Teams in Team Sports may also be subject toConsequences as provided in Article 11.”
Sample or Specimen: Any biological material collected for the purposes of Doping
Control.
[Comment: It has sometimes been claimed that the collection of blood Samples
violates the tenets of certain religious or cultural groups. It has been determined that
there is no basis for any such claim.]
Signatories: Those entities signing the Code and agreeing to comply with the Code,as provided in Article 23.
Tampering: Altering for an improper purpose or in an improper way; bringing
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12engaging in any fraudulent conduct to alter results or prevent normal proceduresfrom occurring.
Target Testing: Selection of specific Athletes for Testing based on criteria set forthin the International Standard for Testing and Investigations.
Testing: The parts of the Doping Control process involving test distribution planning,
Sample collection, Sample handling, and Sample transport to the laboratory.
TUE: Therapeutic Use Exemption, as described in Article 4.4.
Use: The utilization, application, ingestion, injection or consumption by any means
whatsoever of any Prohibited Substance or Prohibited Method.
WADA: The World Anti-Doping Agency.
[Comment: Defined terms shall include their plural and possessive forms, as well as
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3.2

ISL and related Technical Documents defined Terms

Adaptive Model: A mathematical model that was designed to identify unusual
longitudinal results from Athletes. The model calculates the probability of alongitudinal profile of Marker values assuming, that the Athlete has a normal
physiological condition.
Aliquot: A portion of the Sample of biological fluid or tissue (e.g. urine, blood)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.
Athlete Passport Management Unit (APMU): A unit composed of a Person or Persons,designated by the Anti-Doping Organization, responsible for the administrative
management of the Passports advising the Anti-Doping Organization for intelligent,
Targeted Testing liaising with the Expert Panel compiling and authorizing an Athlete
Biological Passport Documentation Package and reporting Adverse Passport Findings.
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 aconcentration/ratio of the Prohibited Substance greater than the applicable Decision
Limit (as noted in the TD DL).]
Decision Limit: a concentration, accounting for the maximum permitted combined
uncertainty, above which an Adverse Analytical Finding shall be reported.
Fit(ness)-for-purpose: suitable for the intended purpose and compliant to the
ISO/IEC 17025 or 15189, ISL and applicable technical documents.
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 4.4.12 for a detailed descriptionof Flexible Scope of Accreditation.
Further Analysis: Any analysis for any substance or method except where an Athlete
has previously been notified of an asserted anti-doping rule violation based on an
Adverse Analytical Finding for that substance or method.
Initial 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.

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Intermediate Precision: Variation in results observed when one or more factors, suchas time, equipment, or 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 or Markers on the Prohibited List and, if applicable, quantification of aThreshold Substance in Samples of urine and other biological matrices in the context
of anti-doping 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., theOlympic Games, Pan American Games) and for which a significant increase ofresources and capacity, as determined by WADA, is required to conduct Doping
Control for the Event.
Measurement Uncertainty (MU): Parameter associated with a measurement resultthat characterizes the dispersion of quantity values attributed to a measurand.
[Comment: Knowledge of the MU increases the confidence in the validity of ameasurement result.]
Minimum Required Performance Level (MRPL): concentration of a Prohibited
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 theidentification, in compliance with the Technical Document on the Identification
Criteria for Qualitative Assays (TD IDCR), constitutes an Adverse Analytical Finding.
Presumptive Adverse Analytical Finding: The status of a Sample test result for which
there is a 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 thedetermination of the identity of an unknown substance. For example, a wellcharacterized sample obtained from a controlled administration study in whichscientific documentation of the identity of Metabolite(s) can be demonstrated.

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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 the same
Sample.
Revocation: The permanent withdrawal of a Laboratory’s WADA accreditation.
Suspension: The temporary withdrawal of a Laboratory’s WADA accreditation.
Threshold Substance: An exogenous or endogenous Prohibited Substance, Metabolite
or Marker of a Prohibited Substance which is analyzed quantitatively and for which
an analytical result (concentration, ratio or score) in excess of a pre-determined
Decision Limit constitutes an Adverse Analytical Finding. Threshold Substances are
identified as such in the Technical Document on Decision Limits (TD DL).
WADA-Approved Laboratory for the ABP: Laboratory(ies) not otherwise accredited by
WADA; applying test methods and processes in support of an Athlete Biological
Passport program and in accordance with the criteria for approval of non-accredited
laboratories for the Athlete Biological Passport.
3.3

International Standard for Testing and Investigations (ISTI)
Defined Terms

Results Management Authority: The organization that is responsible, in accordancewith Code Article 7.1, for the management of the results of Testing (or otherevidence of a potential anti-doping rule violation) and hearings, whether (1) an AntiDoping Organization (for example, the International Olympic Committee or other
Major Event Organization, WADA, an International Federation, or a National AntiDoping Organization); or (2) another organization acting pursuant to the authority ofand in accordance with the rules of the Anti-Doping Organization (for example, aNational Federation that is a member of an International Federation). In respect ofWhereabouts Failures, the Results Management Authority shall be as set out in
Article I.5.1.
Sample Collection Authority: The organisation that is responsible for the collection of
Samples in compliance with the requirements of the International Standard for
Testing and Investigations, whether (1) the Testing Authority itself; or (2) anotherorganization (for example, a third party contractor) to whom the Testing Authority
has delegated or sub-contracted such responsibility (provided that the Testing
Authority always remains ultimately responsible under the Code for compliance withthe requirements of the International Standard for Testing and Investigations
relating to collection of Samples).
Test Distribution Plan: A document written by an Anti-Doping Organization that plans
Testing on Athletes over whom it has Testing Authority, in accordance with therequirements of Article 4 of the International Standard for Testing andInvestigations.

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

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17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 for, 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

Submitting 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 be signedby the Laboratory Director and, if relevant, by the Director of the host organization.
At this stage, WADA will verify the existence of a National Anti-Doping Program(compliant with the Code and 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

Providing 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 Signatory Anti-Doping
Organization(s). Such letter(s) of support will guarantee that annually a minimum of3000 Samples from Code-compliant clients (as determined by WADA) will be
provided to the laboratory for a three (3) year period within two (2) years ofobtaining accreditation. The candidate laboratory shall submit a business plan whichis accompanied with letters of support from entities acceptable to WADA (e.g.
universities, hospitals, private organization and/or public authorities) that:•••

Guarantee sufficient annual financial support for a minimum of 3 years;
Guarantee the necessary analytical facilities and instrumentation;
Support for research and development activities;

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4.1.4

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 (8) weeks following the receipt of
the questionnaire. 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

Conducting 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.
4.1.6

Issuing 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, identify 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.

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4.1.8Laboratory 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. Operational independence implies that the Laboratory shall have a separate
budget permitting the Laboratory to manage its own affairs without hindrance orinterference.
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 EQAS samples inorder 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 in excess of thethreshold(s) or Minimum Required Performance Levels (MRPL), as applicable, of theProhibited Substances, Metabolite(s) of Prohibited Substances, or Marker(s) of
Prohibited Substances or Prohibited Methods within a time frame of ten 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 Procedure data. For
selected samples for which there is an Adverse Analytical Finding, the candidate
laboratory shall provide a Laboratory Documentation Package. Additional data to beprovided upon WADA’s request. The candidate laboratory’s performance in the preprobationary test shall be taken into consideration by WADA to gauge thelaboratory’s competence as well as allow WADA to provide feedback on areas in needof improvement. Corrective actions, if any, shall be conducted and reported by thelaboratory upon request. Such testing will be taken into account in the overall reviewof the candidate laboratory’s application and may affect the timeliness of thecandidate 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 under the title of a “WADA probationary laboratory”. The probationary
period shall incorporate at least 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.
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4.2.1

Obtaining ISO/IEC 17025 accreditation by the laboratory

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 procedures 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

Participating in the WADA External Quality Assessment Scheme

During the probationary period the laboratory shall successfully analyze at least (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 (20) EQAS samples in the presence of WADA
representatives. The final accreditation test shall assess both the scientificcompetence and the capability of the laboratory to manage multiple Samples. 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 calendar days of opening thesamples. 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 for which
there is an Adverse Analytical Finding, the probationary laboratory shall provide aLaboratory Documentation Package. This documentation shall be submitted within
two (2) weeks of WADA’s request. Costs associated with the WADA on-site visit shallbe at the laboratory’s expense.

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4.2.3

Planning and implementing research and development activities

The probationary laboratory shall develop a plan for its research and development
activities in the field of Doping Control within a three (3) year period including abudget. The probationary laboratory shall demonstrate in its budget an allocation toresearch and development activities in the field of Doping Control of at least 7% of
the annual budget for the initial three year period. At least two research anddevelopment activities shall be initiated and implemented within the probationary
period. The research activities can either be conducted by the laboratory alone or incooperation with other WADA-accredited Laboratories or other researchorganizations.
4.2.4

Planning and implementing 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.
4.3

Obtaining WADA accreditation

4.3.1

Participating 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
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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 the case where the recommendationis that the laboratory should not be accredited, the laboratory will have a maximumof six months to correct and improve specific parts of their operation, at which time afurther report will be made by WADA.
4.3.3

Issuing and publishing 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 accredited Laboratories will
be available on WADA’s website.
4.4

Maintaining WADA accreditation

In order for the Laboratory to maintain its accreditation status, the Anti-Doping
Organization of the country of the Laboratory (National Anti-Doping Organization
and/or National Olympic Committee as applicable) shall be Code compliant (asdetermined by WADA) and the Laboratory host country shall maintain its status of acountry having ratified the UNESCO Convention against Doping in Sport.
Should a Laboratory’s accreditation be suspended in this context, the Suspension will
be effective until the country ratifies the UNESCO Convention against Doping in Sport
and/or until the non-compliant Anti-Doping Organization of the country of theLaboratory is taken out of the non-compliant list by WADA’s Foundation Board. With
the exception of the duration of the Suspension which shall be as defined above, theother ISL provisions with subject to the Suspension of a Laboratory’s accreditation
remain applicable.
WADA may decide not to suspend the Laboratory’s accreditation in case of noncompliance of the Anti-Doping Organization of the country of the Laboratory if, in theyear before the declaration of non-compliance, at least 60% of samples analyzed bythat Laboratory were provided by Anti-Doping Organizations other than the AntiDoping Organization of the country of the Laboratory, or if it is highly likely that in
the year of the declaration of non-compliance at least 60% of samples analyzed bythat Laboratory are going to be provided by Anti-Doping Organizations other thanthe Anti-Doping Organization of the country of the Laboratory.
4.4.1

Maintaining 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
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.

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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 any Anti-Doping
Organization to ensure full confidence in its competence, impartiality, judgment oroperational integrity, in compliance with section 4.1.5d of ISO/IEC 17025.
Operational independence implies that the Laboratory shall have a separate budget
permitting the Laboratory to manage its own affairs without hindrance orinterference.
4.4.4

Documenting 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

Documenting implemented research and development 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
years). The list of scientific papers shall be made available to WADA upon request.
The Laboratory may also demonstrate a research program by documenting
successful or pending applications for research grants (at least one application
submitted every three 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

Documenting implemented sharing of knowledge

The Laboratory shall demonstrate its willingness and ability to share knowledge withother 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-accreditedLaboratories. A description of this sharing is provided in the Code of Ethics (Annex
B).

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4.4.7

Maintaining 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

Providing 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 provided to WADA every two years confirming three
years of support or unless otherwise approved by WADA.
4.4.9

Minimum number of Samples

In order to maintain proficiency, WADA accredited Laboratories are required, within
two 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 4.4.13.2.1, 4.4.13.2.2 and 4.4.14.
4.4.10 Publication of fee schedule
To assist Anti-Doping Organizations in developing Test Distribution Plans in relation
to the use of different Sample analysis menus for various sports or sport disciplines,
Laboratories shall publish, and provide to WADA, the most recent price list for eachtype of analytical method or service.
4.4.11 Participating in WADA/Accreditation Body re-assessments and surveillance
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.
4.4.11.1 WADA/Accreditation Body re-assessment
The Laboratory shall receive ISO/IEC 17025 accreditation including compliancewith the Application of ISO/IEC 17025 for the Analysis of Urine 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 bodyfor the on-site re-assessment.
Copies of the re-assessment summary report in English or French as well as
the Laboratory responses should be sent in a timely fashion to WADA by the2016 ISL – Version 9.0

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relevant accreditation body. Should the Laboratory prefer to provide the reassessment summary report directly to WADA, then it shall do so within 30
days.
The Laboratory shall provide to WADA a copy of the ISO/IEC 17025 certificate
as soon as it is obtained from the relevant accreditation body.
4.4.11.2 Accreditation Body surveillance assessment
When a surveillance ISO/IEC 17025 assessment is required, a copy of theassessment summary report and evidence of corrective actions for any noncompliance(s), in English or French, should be sent to WADA by the relevant
accreditation body. Should the Laboratory prefer to provide the assessment
summary report directly to WADA, then it shall do so within 30 days.
4.4.11.3 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 in another
Laboratory of WADA’s choice.
4.4.12 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. Any new
analytical method or procedure to Doping Control requiring expertise and technology
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 consultations 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.
Inclusion of a method or procedure within the Laboratory’s scope of ISO/IEC 17025
accreditation establishes that method or procedure as Fit-for-purpose and theLaboratory shall not be required to provide method validation documentation in
support of an Adverse Analytical Finding.
4.4.13 WADA monitoring of accreditation status
WADA shall conduct a periodic review of compliance of Laboratories against therequirements listed in the ISL. In addition, WADA shall also conduct an annual
review of EQAS results and relevant routine testing issues (see Section 5.0 and/or

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Section 6.0) reported to WADA by stakeholders to assess the overall performance ofeach Laboratory and to decide its accreditation status.
4.4.13.1 Maintenance of accreditation
In the event that the Laboratory has performed satisfactorily in the WADA
EQAS (Annex A) and routine operations, WADA will maintain the accreditationof the Laboratory.
4.4.13.2 Loss of accreditation
Loss of WADA accreditation may occur whenever WADA has justified reason tobelieve that the Suspension or Revocation of accreditation is required in orderto protect the interests of the Anti-Doping Community.
4.4.13.2.1

Suspension of accreditation

Suspension of accreditation may be based on, but not limited to, theresults of the EQAS (as per Annex A) or other evidence of serious ISL
deviation(s) arising from the routine analysis of Doping Control
Samples.
The following ISL non-compliances in the routine operations of aLaboratory may be considered and include, but are not limited to:
•
•

•
•
•
•
•
•
•

Suspension of ISO/IEC 17025 accreditation;
Failure to take appropriate corrective action after anunsatisfactory performance within routine Analytical Testing orin an blind EQAS or double blind EQAS round;
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;
Non-compliance(s) 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-compliance(s)identified
fromLaboratory
on-siteassessment(s);Loss of support jeopardizing the quality and/or viability of theLaboratory.

Non-compliance(s) in Laboratory routine performance will be assessedby WADA on a case-by-case basis considering the severity andconsequences to the Anti-Doping System. If evidence of serious or
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provisionally suspend a Laboratory’s accreditation pending a fullinvestigation. Such a decision may be taken by the Chairman of the
WADA Executive Committee.
The period and terms of Suspension shall be proportionate to theseriousness, as determined by the investigation, of the noncompliance(s) or lack of performance and the need to ensure accurate
and reliable drug testing of Athletes. A period of Suspension shall be ofa duration to be decided by WADA and up to a maximum of six months,
during which time any non-compliance must be corrected, documented
and reported to WADA. If the non-compliance(s) cannot be correctedduring the initial Suspension period, the Suspension shall either befurther extended or the Laboratory accreditation revoked. The
Suspension period may be extended up to a maximum of an additional
six months, based on justifiable delays in submitting the satisfactory
corrective actions. If the Laboratory has provided evidence determined
to be satisfactory by WADA that the non-compliance(s) are corrected,
the Laboratory’s accreditation shall be re-instated. If the Laboratory has
not provided evidence determined to be satisfactory by WADA at theend of the extended Suspension period, not to exceed 12 months, theLaboratory’s accreditation shall be revoked.
If applicable, a delay in the delivery of the ISO/IEC 17025 accreditation
to the Laboratory by the relevant accrediting body may also extend theWADA Suspension.
A Laboratory whose accreditation has been suspended is ineligible toperform testing of Doping Control Samples for any Testing Authority,
except when the non-compliance(s) is restricted to a particular analysis.
In this case, WADA may suspend the Laboratory from performing thatspecific analysis. If WADA determines that the non-compliance(s) islimited to a class of Prohibited Substances or a specific analyticalmethod, WADA may limit the Suspension to analysis for the class ofcompounds or analytical method in which the non-compliance(s)occurred.
During the Suspension of the Laboratory, WADA may require theLaboratory to successfully analyse blind EQAS samples and/or require
an on-site assessment by WADA, at the expense of the Laboratory, inorder to evaluate the Laboratory’s status.
4.4.13.2.2

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 ofAnalytical Testing and the accurate reporting of analytical test results.
Revocation of accreditation may be based on, but not limited to, the2016 ISL – Version 9.0

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following considerations in the EQAS analysis and/or routine operationof a Laboratory:
•
•
•
•
•

•

•
•

•
•
•
•
•
•

•
•

Reporting of False Adverse Analytical Findings;
Loss of ISO/IEC 17025 accreditation;
Repeated Suspensions of ISO/IEC 17025 accreditation or WADA
accreditation;
Systematic failure to comply with the ISL and/or TechnicalDocuments;
Serious Laboratory non-compliances identified (e.g. on-site
assessments, documented client complaints, other enquiries) as
determined by WADA;
Repeated failure to take appropriate corrective action following
unsatisfactory performance either in routine Analytical Testingor in a blind EQAS or double blind EQAS round(s);A serious or repeated non-compliance(s) with the ISL and/orTechnical Document(s);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;
Non-compliance with the WADA External Quality Assessment
Scheme requirements as defined in Annex A;
Failure to cooperate with WADA or the relevant Testing
Authority during the Suspension phase;
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 theLaboratory.

The reporting of a false Adverse Analytical Finding on a routine Sample
is a serious non-conformity. The following procedures are to befollowed:•2016 ISL – Version 9.0

The Laboratory shall immediately notify WADA if any result froma Sample is falsely reported as an Adverse Analytical Finding toan Anti-Doping Organization. WADA may provisionally suspend
the Laboratory pending resolution of the case.
29

•

•

•
•

The responsible Laboratory shall be immediately notified by
WADA if it is determined that a false Adverse Analytical Finding
has been reported. WADA may provisionally suspend theLaboratory pending resolution of the case.
The Laboratory is to provide WADA with a satisfactory root
cause analysis report including the reason(s) for the error
within five calendar days (unless informed otherwise by WADA).
Supporting documentation shall be provided such as all quality
control data from the batch of routine Samples that included thefalse Adverse Analtyical Finding sample (particularly if the error
is deemed to be technical/scientific);
WADA shall review the Laboratory’s explanation promptly;
The Laboratory may be required to review past test results andmay be required to re-analyze all relevant Samples reported as
Adverse Analytical Findings by the Laboratory from the time of
final resolution of the error to the previous 12 months orsatisfactory EQAS round, if applicable. Depending on the type oferror that caused the false Adverse Analytical Finding, thisretesting may be limited to one analyte, one or more
substance(s) or a class of Prohibited Substances or Prohibited
Methods. A statement signed by the Laboratory Director shalldocument this re-testing. The Laboratory will be required to
notify all clients whose results may have been affected by theerror in accordance with its quality management system.

A laboratory whose accreditation has been revoked is ineligible toperform testing of Doping Control Samples for Signatories. The chain ofcustody maintained by a revoked laboratory for stored Samples is valid
until such time that arrangements can be made, in consultation with
WADA, for the transfer of relevant Samples to other Laboratories assoon as practical.
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. The laboratory may provide to WADA evidence
which supports “exceptional circumstances” that may justify adjustment
to the requirements in section 4.1. If such justification is accepted, as
determined solely by the WADA Executive Committee, then the WADA
Executive Committee shall determine what steps shall be followed prior
to granting a new accreditation.
4.4.13.3 Evaluation of accreditation status
Upon receipt of all documentation required to investigate the issue(s) for
Suspension or Revocation, WADA shall review the submission and present a
written report, which may include recommendation(s), to the Disciplinary
Committee.

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Subsequently the Disciplinary Committee, as set up under WADA procedural
rules, shall make an independent recommendation to the Chair of the WADA
Executive Committee regarding the duration of Suspension or the Revocationof the WADA accreditation.
WADA shall lift the Suspension only once sufficient evidence, as determined by
WADA, is provided by the Laboratory that appropriate steps have been taken
to remedy the issue(s).
4.4.14 Notification
4.4.14.1 Written Notice
When a Laboratory is suspended or WADA seeks to revoke accreditation,
WADA shall serve the Laboratory with written notice of the Suspension or
proposed Revocation by facsimile, hand delivery, or registered or certified
mail, return receipt requested as soon as possible. This notice shall state thefollowing:1) The reason for Suspension or Revocation;2) The terms of the Suspension or Revocation; and
3) The period of Suspension.
4.4.14.2 Effective Date and Appeals
A Suspension is immediately effective upon notification.
A Revocation takes effect 30 days after notification. A Laboratory which hasreceived notice that its accreditation is in the process of being revoked shall be
under Suspension until the Revocation is made final or is rescinded by WADA.
If WADA decides not to uphold the Suspension or proposed Revocation, theSuspension is terminated immediately and any proposed Revocation shall nottake place.
WADA’s decision to suspend or revoke a Laboratory’s accreditation may be
appealed by the Laboratory to CAS within 21 days from the decisionnotification.
4.4.14.3 Public Notice
WADA shall immediately announce a Laboratory’s accreditation status on the
WADA website including the name and address of any Laboratory that has had
its accreditation suspended or revoked, and the name of any Laboratory thathas had its Suspension lifted.
WADA’s website shall be updated regarding a Laboratory’s accreditation
status.

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4.4.15 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.
4.4.16 Issuing 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.
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 cases where Samples will be transferred to an existing Laboratory facility, there
shall be agreement between the Major Event Organizer and the WADA accredited
laboratory in regards to testing requirements such as turn-around time. The
Laboratory shall 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”.
All methods or equipment unique to the satellite facility shall be validated or qualified
prior to the satellite facility accreditation assessment. Any changes to methods or2016 ISL – Version 9.032other procedures in the quality manual shall also be validated prior to theassessment.
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

Participating 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 Fit-for-purpose. Expenses
related to such a visit shall be at the Laboratory’s expense. Particularemphasis will be placed on the adequacy of security considerations, thephysical layout of the space to ensure that adequate separation of various
parts of the Laboratory are maintained, and to provide a preliminary review ofother key support elements and to assess compliance with the ISL.
4.5.1.2

Completing 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 that these personnel
are adequately trained in the methods, policies, and procedures of theLaboratory. Particular emphasis should be given to the Code of Ethics and theconfidentiality of the results management process. Adequate documentation oftraining of these temporary employees shall be maintained by the Laboratory.
At least two months prior to start of testing for the Event, the Laboratory shallprovide 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 Samples to be analyzed;
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 Event shouldbe immediately reported to WADA.

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Even if the testing is to be done at the Laboratory’s existing facility, the PreEvent Report shall be completed, particularly in regard to personnel changes
and any additional equipment.
4.5.1.3

Reviewing 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 as instructed and prior to start of scheduled Testing for
the Major Event.
4.5.1.4

External Quality Assessment Scheme

WADA may, at its sole discretion, submit EQAS samples to the Laboratory for
analysis. 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(s).
The EQAS process should include any additional personnel that are added tothe staff for the Major Event. The EQAS samples shall be analyzed using thesame 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 toprovide 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 Adverse Analytical Finding, the Laboratory shallimmediately cease testing for that class of Prohibited Substances andProhibited Methods. The Laboratory shall apply corrective action(s) within 12hours of notification of the false Adverse Analytical Finding. All Samples
analyzed prior to the false Adverse Analytical Finding will be re-analyzed forthe class of Prohibited Substances and Prohibited Methods for which the non-2016 ISL – Version 9.034

compliance occurred. The results of the investigation and analysis will bepresented to WADA within 24 hours unless otherwise agreed in writing.
In the event of a false negative, the Laboratory will be required to investigate
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 reanalyzed for the class of Prohibited Substances and Prohibited Methods forwhich the non-compliance occurred. The results of the investigation andanalysis will be presented to WADA within 48 hours unless otherwise agreed inwriting.
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

Participating in an initial WADA/Accreditation Body assessments

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. It is a WADA
requirement that an ISL trained assessor shall participate in the accreditationbody assessment of the satellite facility. Particular emphasis will be placed on
the adequacy of security considerations, the physical layout of the space toensure that adequate separation of various parts of the Laboratory are
maintained, and to provide a preliminary review of other key support elements
and to assess compliance to the ISL and ISO/IEC 17025.
4.5.2.2

Documenting 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 accreditationbody 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.
4.5.2.3

Participating 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 take place,
WADA expenses related to the assessment will be at the Laboratory’s expense.
This assessment may include analysis of a set of EQAS samples. Particularemphasis will be placed on involvement of new staff members to assess theircompetence.
4.5.2.4

Issuing and publishing of a temporary and limited Accreditation
certificate

Based on the documentation provided, WADA reserves the right to make adecision regarding accreditation of the Laboratory. In the event that
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accreditation is awarded, WADA shall issue an accreditation for the period of
the Major Event and an appropriate time before and after the actual durationof the Major Event.
In the event that the accreditation is not awarded, it is the responsibility of the
Testing Authority/ Major Event Organizer to activate a contingency plan inorder to ensure analysis of Samples in compliance with 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 under theconcepts of the International Standard for Testing and Investigations.
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 the Laboratory
representative receiving the Samples. This information shall be included into
the Laboratory Internal Chain of Custody record(s).

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 other external
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 theconcepts 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 the integrity of a Sample. For
example, irregularities noted by the Laboratory should include, but are notlimited to:
•
•
•
•

•
•

Sample Tampering is evident;
Sample is not sealed with tamper-resistant device or not sealed
upon receipt;
Sample is without a collection form (including Sample identificationcode) or a blank form is received with the Sample;
Sample identification is unacceptable. For example, the number on
the bottle does not match the Sample identification number on theform;
Sample volume is inadequate to perform the requested testingmenu;
Sample transport conditions are not consistent with preserving 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 arenoted. If applicable, any agreement between a Testing Authority andLaboratory 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 Sample collection session from the same Athlete
according to the Doping control form(s), the Laboratory should prioritize theanalysis of the first and last Samples collected.
••

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.

5.2.2.6 The Laboratory shall retain the “A” and “B” Sample(s) without anAdverse Analytical Finding or Atypical Finding for a minimum of three months
after the final analytical (“A” Sample) report is transmitted to the Testing
Authority. The Sample(s) shall be stored frozen.
Samples with irregularities shall be stored frozen for a minimum of threemonths following the report to the Testing Authority.
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38After the applicable storage period above, the Laboratory shall do one of thefollowing with the Sample(s):•Disposal of the Sample(s).

•If the Testing Authority has arranged for storage of the Samples fora period from three months to ten years, the Laboratory shall ensurethat the Samples are stored in a secure location under continuous
chain of custody;•

If consent has been obtained from the Athlete, the Samples may beretained by the Laboratory for research purposes. Samples used forresearch purposes shall have any means of identification removed or
the Sample shall be transferred into an anonymous container suchthat the contents cannot be traced back to a particular Athlete.
If consent has not been obtained from the Athlete, and provided that
the Samples are made anonymous, the Samples may be retained by
the Laboratory for quality assurance and quality improvement
purposes, including but not limited to:•••

Improving existing analytical methods;
Developing or evaluating new analytical methods;
Developing reference ranges or Decision Limits or otherstatistical purposes.

Disposal and long-term storage of Samples 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
an Adverse Analytical Finding or Atypical Finding, and all chain of custody andother records pertaining to those Samples, for a minimum of three months
after the final analytical report is submitted to the Testing Authority or as
determined by the relevant Testing Authority and/or Results Management
Authority.
5.2.2.8
If the Laboratory has been informed by the Testing Authority thatthe analysis of a Sample is challenged, disputed or under longitudinal
investigation, the Sample shall be stored frozen and all records pertaining to
the Testing of that Sample shall be stored until completion of any challenge orinvestigation.
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
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39study is pending, the Laboratory shall either make the Samples anonymous forresearch purposes (with proper consent from the Athlete) or dispose of the
Samples. Samples used for research purposes shall have any means ofidentification removed or be transferred into an anonymous container suchthat 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 Long-term storage of Samples
5.2.2.12.1 At the direction of the Testing Authority, any Sample may
be stored in long-term storage for up to ten years. Guidance on theprocess for long-term storage is found in the document entitled
Guidelines for Long Term Storage.
5.2.2.12.2 The Testing Authority should retain the Doping Control
official records pertaining to all stored Samples for the duration of
Sample storage.
5.2.2.12.3 The Laboratory should retain all chain of custody and otherrecords pertaining to a stored Sample for the duration of Sample
storage.
5.2.2.12.4 If Samples are to be stored at a location outside thesecured area of the Laboratory which first analyzed the Sample, theLaboratory shall secure the A Samples to be shipped either by resealing individual bottles with a tamper evident method or by sealing
the box in which the Samples are shipped in a manner which ensures
Samples integrity and chain of custody. Neither the Athlete nor his or
her representative nor an independent witness is required to be present
for this procedure.
5.2.2.12.5 Where Samples are transported to a different facility forlong-term storage, the chain of custody reflecting the transfer andreceipt at the long-term storage facility shall be documented.
Transported Samples are not subject to individual inspection by thereceiving Laboratory until a Sample has been selected for analysis.
5.2.2.12.6 During transport and long-term storage, Samples shall bemaintained at a temperature sufficient to maintain the analytical
integrity of the Sample. In any anti-doping rule violation case based on
the Further Analysis of a stored Sample, the issue of the temperature atwhich the Sample was transported or stored shall only be considered
where failure to maintain an appropriate temperature could have caused
the Adverse Analytical Finding or other result upon which the antidoping rule violation is based.

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5.2.2.12.7 The long-term storage facility shall maintain security
requirements comparable to the security requirements applicable to a
Laboratory’s short-term storage of Samples.
5.2.2.12.8 Samples held in long-term storage may be selected forFurther Analysis at the discretion of the Testing Authority. WADA may
also direct the Further Analysis of stored Samples at its own expense.
The choice of which Laboratory will perform the Further Analysis will bemade by the Testing Authority or WADA. Guidance on which Samples
should be subject to Further Analysis is found in the Guidelines forLong-Term Storage.
5.2.2.12.9 Further Analysis of Samples shall be performed under the
ISL and Technical Documents in effect at the time the Further Analysis
is performed.
5.2.2.12.10 Further
proceed as follows:

Analysisonlong-term

storedSamplesshall•

At the discretion of the Testing Authority, the “A” Sample may
not be used or it may be used for initial testing (as described in
Article 5.2.4.2) only, or for both initial testing and confirmation(as described in Article 5.2.4.3.1). Where confirmation is notcompleted in the A Sample the Laboratory, at the direction of the
Testing Authority shall appoint an independent witness to verify
the opening and splitting of the sealed “B” Sample (which shalloccur without requirement that the Athlete be notified or present)
and then proceed to analysis based on the “B” Sample which has
been split into 2 bottles.

•

At the opening of the “B” Sample, the Laboratory shall ensurethat the Sample is adequately homogenized (e.g. invert bottle
several times) before splitting the “B” Sample. The Laboratory
shall divide the volume of the “B” Sample into two bottles (using
Sample collection equipment compliant to ISTI provision 6.3.4) inthe presence of the independent witness. The splitting of the “B”
Sample shall be documented in the chain of custody. The
independent witness will be invited to seal one of the bottles
using a tamper evident method. If the analysis of the first bottle
reveals an Adverse Analytical Finding, the Testing Authority shalluse reasonable efforts to notify the Athlete as provided in Article
7.3 of the Code. A confirmation shall be undertaken, using thesecond sealed bottle, if requested by the Athlete or his/her
representative, or if the Testing Authority’s reasonable efforts to
notify the Athlete have not been successful or at the Testing
Authority’s election. If the Athlete or his/her representative is notpresent for the confirmation, then the Laboratory shall appoint an
independent witness to observe the opening of the second sealed
bottle.

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5.2.3Sampling 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 to disposal. The
procedures shall incorporate the concepts presented in the WADA TechnicalDocument 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 its integrity documented.
5.2.3.3 The Aliquot preparation procedure for any Initial Testing Procedureor Confirmation Procedure shall ensure that no risk of contamination of 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 note any unusual condition of theurine – for example: color, odor, turbidity or foam. Only unusual
conditions should be recorded and included as part of 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 ormanipulation may be performed if deemed necessary by the Laboratory.
5.2.4.2

Urine Initial Testing Procedure

The Initial Testing Procedure(s) shall be documented, as part of the Sample(or Sample batch) record, each time it is conducted. Laboratories may apply
additional accredited test methods to Samples (beyond the client’s requested
test menu) if the additional work is conducted at the Laboratory’s expense andthe relevant Samples have not been identified for long-term storage.
5.2.4.2.1
Unless otherwise approved by WADA after consultation
with a Testing Authority, the Initial Testing Procedure(s) shall becapable of detecting 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-for-purpose.
WADA may make specific exceptions to this section for specialized
techniques that are not required to be within the scope of accreditationof all Laboratories.
5.2.4.2.2
The Initial Testing Procedure shall be performed with a Fitfor-purpose method for the Prohibited Substance or Prohibited Method

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42being tested. A characteristic of the Initial Testing Procedure is to obtain
information about the potential presence of Prohibited Substance(s) or
Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method. Results from Initial Testing
Procedures can be included as part 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 the same matrix as
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 to consider the Measurement
Uncertainty.
5.2.4.2.5
Irregularities in the Initial Testing Procedure(s) shall notinvalidate an Adverse Analytical Finding when the Confirmation
Procedure adequately compensates for such irregularities.
5.2.4.3

Urine Confirmation Procedure

Confirmation Procedures shall be documented, as part of the Sample (orSample batch) record. The objective of the Confirmation Procedure is toaccumulate additional information to support the reporting of an Adverse
Analytical Finding. The Confirmation Procedure shall have equal or greater
selectivity than the Initial Testing Procedure.
5.2.4.3.1“A” Sample Confirmation

5.2.4.3.1.1 A Presumptive Adverse Analytical Finding from an
Initial Testing Procedure of a Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method shall be confirmed with an “A”
Confirmation Procedure using an additional Aliquot(s) taken fromthe original “A” Sample.
For Prohibited Substances included in sections S.3 Beta-2Agonists and S.9 Glucucorticosteroids of the Prohibited List only,
a Laboratory may contact the Testing Authority regarding a
Presumptive Adverse Analytical Finding to enquire whether anapproved Therapeutic Use Exemption (TUE) exists for theProhibited Substance(s) detected. Any such contact shall be inwriting with a simultaneous copy sent to WADA. The decision by
the Testing Authority to proceed with the confirmation, or notproceed with the confirmation based on an approved TUE, shallbe communicated by the Testing Authority to the Laboratory in
writing. By separate letter, the Testing Authority shall notify

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43WADA of its decision and provide to WADA a copy of theapproved TUE.
5.2.4.3.1.2 Mass spectrometry (MS) coupled to either gas (GC)or liquid chromatography (LC) is the analytical technique of
choice for confirmation of Prohibited Substances, Metabolite(s) of
Prohibited Substance(s), 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 for the 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 the Affinity Binding Assay
to eliminate the potential of cross-reactivity. The Laboratory shalldocument, as part of the method validation, the Fitness-forpurpose of any such purification or separation method.
In assays which include multiple affinity reagents (such as
sandwich immunoassays), only one of the affinity reagents(either applied for capture or detection of the target analyte)
used in the Affinity Binding Assays applied for the Initial Testing
Procedure(s) and Confirmation Procedure(s) must differ 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
analytical methods shall be applied.
Multiplexed Affinity Binding Assays, protein chips, and similar
simultaneous multi-analyte testing approaches may be used.
5.2.4.3.1.4 The Laboratory shall have a policy to define thosecircumstances where the Confirmation Procedure for an “A”
Sample may be repeated (e.g., batch quality control failure) andthe first test result shall be nullified. Each repeat confirmation
shall be documented and be performed on a new Aliquot of the“A” Sample and new quality control samples.
5.2.4.3.1.5 If more than one Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method is identified by the Initial Testing
Procedure(s), the Laboratory shall confirm as many of the2016 ISL – Version 9.0

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Presumptive Adverse Analytical Findings as possible. The decisionon the prioritization for the confirmation(s) shall be made to give
precedent to the substance(s) with the longest potential period of
Ineligibility and the decision should be made in cooperation with
the Testing Authority and documented. In addition, no final
written Test Report incorporating a Presumptive Adverse
Analytical Finding shall be issued unless authorized by the Testing
Authority in relation to the existence of an approved Therapeutic
Use Exemption (TUE) for the Prohibited Substance as per ISL
5.2.4.3.1.1.
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 the measured analytical values(e.g. concentrations) or ratio calculated from the means ofmeasured analytical values (e.g. concentrations, chromatogram
peak heights or areas) of three Aliquots. That value shall exceed
the value of the relevant Decision Limit as specified in theTechnical Document on Decision Limits or applicable Guidelines.
If insufficient Sample volume exists to analyze three Aliquots, themaximum number of Aliquots that can be prepared should beanalyzed. The reporting of Adverse Analytical Findings forThreshold Substances shall be in compliance with the TechnicalDocument 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 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 rightto the “B” confirmation analysis and therefore accepts thefindings of the “A” confirmation analysis.
5.2.4.3.2.2 The “B” Sample confirmation shall be performed in
the same Laboratory as the “A” Sample 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 shall only confirm the “A” Sample identification for
the Adverse Analytical Finding to be valid. No quantification ofsuch Prohibited Substance shall be performed.
5.2.4.3.2.5 For endogenous Threshold Substances, Adverse
Analytical Finding or Atypical Finding decisions for the “B” Sample

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45finding shall be based on the mean of measured analytical values(e.g. concentrations) or ratio calculated from the means ofmeasured analytical values (e.g. concentrations, chromatogram
peak heights or areas) of three Aliquots. That mean shall exceed
the value of the relevant Threshold as specified in the TechnicalDocument on Decision Limits or applicable Technical Document or
Guidelines.
If insufficient Sample volume exists to analyze three Aliquots, themaximum number of Aliquots that can be prepared should beanalyzed.
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 representative of the National Olympic
Committee, National Sport Federation, International Federation,
and a translator 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 or if the Athleteor the Athlete’s representative continuously claims not to beavailable on the date of the opening, despite reasonable attempts
by the Laboratory to accommodate their dates, the Testing
Authority or the Laboratory shall proceed regardless and appoint
an independent witness to verify that the “B” Sample containershows no signs of Tampering and that the identifying numbers
match that on the collection documentation. At a minimum, theLaboratory Director or representative and the Athlete or his/her
representative or the independent witness shall sign Laboratory
documentation attesting to the above.
The Laboratory Director may limit the number of individuals inControlled Zones of the Laboratory based on safety or security
considerations.
The Laboratory Director may remove, or have removed by proper
authority, any Athlete or representative(s) interfering with thetesting process. Any behavior resulting in removal shall bereported to the Testing Authority and may be considered an anti–
doping rule violation in accordance with Article 2.5 of the Code,“Tampering, or Attempted Tampering 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 is properly
resealed as per provision 5.2.2.12.

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5.2.4.3.2.8 If more than one Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method has been confirmed in the “A”
Confirmation Procedure, the Laboratory shall confirm as many of
the Adverse Analytical Findings as possible given the “B” Sample
volume available. The decision on the prioritization for theconfirmation(s) shall be made to give precedent to thesubstance(s) with the longest potential period of Ineligibility andthe decision should be made in cooperation with the Testing
Authority and documented.
5.2.4.3.2.9 The Laboratory shall have a policy to define thosecircumstances when a Confirmation Procedure for the “B” Sample
may be repeated (e.g. batch quality control failure) and the firsttest result shall be nullified. Each repeat confirmation shall be
documented and should be performed on a new Aliquot of the “B”
Sample and new quality control samples.
5.2.4.3.2.10 If the “B” Sample confirmation proves negative,
the Sample 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 other biologicalmaterial shall not be used to counter Adverse Analytical Findings or AtypicalFindings 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 conduct a
separate and impartial review of all Adverse Analytical Findings andAtypical 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;• Validity of the analytical initial and confirmatory data andcalculations;• Quality control data;• Completeness of documentation supporting the reported
analytical findings.
5.2.5.1.3
When an Adverse Analytical Finding or Atypical Finding is
rejected, the reason(s) shall be recorded.

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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 caseof an Adverse Analytical Finding or Atypical Finding, the record shall include
the data necessary to support the conclusions reported as set forth in andlimited by Technical Document on Laboratory Documentation Packages.
5.2.6.2 Each step of Analytical 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, theparameters for each run shall be included as part of the record.

operating

5.2.6.5 Reporting of “A” Sample results should occur within ten working
days of receipt of the Sample. The reporting time required for specificCompetitions 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 and/or ADAMS record shall be
generated to document the Adverse Analytical Finding(s) or Atypical Finding(s)of an individual Sample. The Laboratory Test Report shall include, in addition
to the items stipulated in ISO/IEC 17025, the following:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Sample code;
Laboratory identification code;
Type of test (Out of Competition/In-Competition);Sport and/or discipline;
Name of Competition and/or Customer reference code (for example:
ADAMS test mission code), if provided by the Testing Authority;
Date of Collection;
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);
The name of the Sample Collection Authority;
The name of the Testing Authority;
The name of the Results Management Authority, if provided;
Signature of authorized individual;

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Other information as specified by the Testing Authority and/or
WADA.
At a minimum, labelling and information provided by the Laboratory related tothe type of test, sport/discipline, test results (including comments/opinions)and client to whom the report is addressed shall also be provided in English on
the test report.
•[Comment: A complete analytical test report generated from ADAMS should beconsidered 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 quantify or report a concentration
for an analyte of non-threshold Prohibited Substances in urine Samples. The
Laboratory shall report the actual Prohibited Substance(s), Metabolite(s) of theProhibited Substance(s) or Prohibited Method(s), or Marker(s) detected in theurine Sample. Upon request of the Testing Authority, Results Management
Authority or WADA and where the detected level of a Prohibited Substance isrelevant to the result management of an anti-doping case, the Laboratory
should provide an approximate concentration.
For Threshold Substances in urine Samples, the Laboratory report shallestablish that the Prohibited Substance(s) or its Metabolite(s) or Marker(s) ofa Prohibited Method is present at a concentration and/or ratio of measured
analytical values greater than the Decision Limit in accordance with thereporting requirements as described in the relevant Technical Document.
5.2.6.8 The Laboratory shall qualify the result(s) of the analysis in the Test
Report as:•••

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

5.2.6.9 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 or interpretation isclearly identified as such. The basis upon which the opinion has been madeshall be documented.
[Comment: 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 theobserved results may suggest the need for additional Testing and whether anobserved result is consistent with a set of reported conditions.]
5.2.6.10 The Laboratory shall report all test results as defined in ISL provision
5.2.6.8 via ADAMS and simultaneously only to the relevant Testing Authority

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49and/or the responsible International Federation and/or to the Major Event
Organizations (in the case of Major International Events) not using ADAMS.
The information provided in ADAMS shall be in compliance to ISL provision
5.2.6.6. 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 should report Adverse Analytical Findings to the Testing
Authority and to WADA. All reporting shall be in accord with the confidentiality
requirements of the Code.
5.2.6.11 The Laboratory, upon request by the Testing Authority, Results
Management Authority, or WADA may be asked to review data fromlongitudinal studies. Following review of the applicable data, a report andrecommendation shall be made by the Laboratory to the Testing Authority,
Results Management Authority or WADA as to whether the data supports anAdverse Analytical Finding or not. If the Testing Authority, Results
Management Authority or WADA has concluded an Adverse Analytical Finding,the Laboratory will be informed and shall conduct the “B” confirmation analysis
according to section 5.2.4.3.2.
5.2.6.12 Upon request, the Laboratory shall report in a format specified by
WADA, a summary of the results of analyses performed. No information that
could link an Athlete’s identify with an individual result will be included. The
report will include a summary of any Samples rejected for Analytical Testing
and the reason for the rejection.
5.2.6.13 The documentation package should be provided by the Laboratory
only to the relevant Results Management Authority upon request and should
be provided within ten 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 respected by all Laboratories engaged
in Doping Control cases.
5.2.6.14.1 Testing Authority, Results Management Authority or WADA
requests for information shall be made in writing to the Laboratories.
5.2.6.14.2 Presumptive
AdverseAnalytical
Findings,
AdverseAnalytical Findings and Atypical Findings shall not be provided by
telephone.
5.2.6.14.3 Information sent by a facsimile is acceptable if the securityof the receiving facsimile machine has been verified and procedures arein 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 Atypical Findings if theAthlete can be identified or if any information regarding the identity of2016 ISL – Version 9.0

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the Athlete is included.
5.2.6.14.5
The Laboratory shall also provide any information
requested by WADA in relation to the Monitoring Program (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 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 in completing
Analytical Testing.
5.3.3.2 The Management System shall ensure that the contents of WADA
Technical Documents are incorporated into the appropriate manuals by theeffective date and that training is provided and recorded. If this is notpossible, WADA shall be contacted with a written request for an extension.
5.3.4

Reviewing 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.

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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 a specific technology that is not within the scope of accreditation of
the Laboratory, a Sample may be transferred to another Laboratory where thespecific technology is within the scope of its accreditation. In exceptional
circumstances, WADA may elect to grant specific authorization to subcontract theanalysis of a Sample using a special technique not required in Laboratories, to an
ISO-accredited laboratory, approved by WADA, that has this technique within its
scope of accreditation. In all 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 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 the analysis andbe of established purity. Reference purity documentation shall be obtained
when available and retained in the quality system documents. Chemicals,
reagents and kits labelled “Research Only” may be utilized for the purposes of
Doping Control as long as they are demonstrated to be Fit-for-purpose by the
Laboratory.
In the case of rare or difficult to obtain Reference Materials, or ReferenceCollections, particularly for use in qualitative methods, the expiration date of
the solution can be extended if adequate documentation exists confirming thatno significant deterioration that would preclude obtaining an acceptable mass
spectrum has occurred. In the case of rare or difficult to obtain reagents the
expiration date can be extended if appropriate purification has been
performed.
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.

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5.3.7.2

Ensuring responsiveness to WADA

The Laboratory Director or his/her designee shall:
•
•

•
•

5.3.7.3

Ensure adequate communication in a timely manner;
Report to WADA any unusual circumstances or information withregard to Analytical Testing, patterns of irregularities in Samples, or
potential use of new substances;
Provide complete and timely explanatory information to WADA as
appropriate and as requested;
Provide documentation to WADA (e.g. quality manual, SOPs,
contracts with Code-signatory clients or Testing Authorities (notincluding commercial or financial information)) upon request toensure conformity with the rules established under the Code as partof the maintenance of WADA accreditation. This information will betreated in a confidential manner.
Ensuring responsivenessManagement Authority

toTesting

Authority

and/orResults

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 othersupport needs. These interactions should occur in a timely manner andshould include, but are not limited to, the following:
•

•
•

•

•

Communicating with the Testing Authority and/or Result
Management Authority concerning any significant question of
Analytical Testing needs or any unusual circumstance in the
Analytical Testing process (including delays in reporting);
Acting without bias regarding the national affiliation of the
Testing Authority and/or Result Management Authority;
Providing complete and timely explanations to the Testing
Authority and/or Result Management Authority when requestedor when there is a potential for misunderstanding the Test Reportor Laboratory Documentation Package;
Providing evidence and/or expert testimony on any test result orreport produced by the Laboratory as required in administrative,
arbitration, or legal proceedings;
Responding to any 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

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incorporated
appropriate.

into

the

Laboratory

Management

Systemwhere

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 nonconformities in Analytical Testing
5.3.9.1 The Laboratory shall have policies and procedures that shall be
implemented when any aspect of its Analytical Testing or a result from its
analyses does not comply to set procedures.
5.3.9.2 Documentation of any non-compliance or departure from procedureor protocol involving analysis of a Sample shall be kept as part of the Sample
record.

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.
5.3.13 Control and storage of technical records
A copy of all records (chain of custody, instrument records, electronic analytical data,
steroid profile, calculations, etc.) supporting the analyses shall be kept in a securestorage for a minimum of two years. After two years, these records shall be kept insecure storage for as long as the relevant Samples are stored at the Laboratory or inlong-term storage (until disposal).
An electronic copy of the analytical data for all Samples shall be stored for ten years
for all Samples.
5.3.14 Internal audits
5.3.14.1 Internal audits shall be completed
requirements of ISO/IEC 17025 Section 4.14.

inaccordance

with

the

5.3.14.2 Internal Audit responsibilities may be shared amongst personnel

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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

GeneralGeneral 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 the curriculum
vitae or qualification form, a job description, and records of initial and ongoingtraining. The Laboratory shall maintain appropriate confidentiality of personal
information.
5.4.2.2 All personnel shall have a thorough knowledge of their
responsibilities including the security of the Laboratory, confidentiality of
results, Laboratory Internal Chain of Custody protocols, and the standard
operating procedures (SOPs) for any method that they perform.
5.4.2.3 The Laboratory Director is responsible for ensuring that Laboratory
personnel are adequately trained and have experience necessary to performtheir 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
Directortoassumeprofessional,organizational,
educational,
andadministrative responsibility. The Laboratory Director qualifications are:•••Ph.D. (or equivalent) in one of the natural sciences or M.D. (orequivalent) with appropriate and comparable experience and/or training
in bioanalysis, preferably in the anti-doping area. In the absence of a
PhD, extensive and appropriate anti-doping science experience andtraining (e.g. a senior Laboratory position for a minimum of ten years),
including the documented ability to develop and conduct research
projects;
Experience and competence in the analysis of biological material for
substances used in doping;
Appropriate training or experience in forensic applications of Doping
Control. It is acknowledged that the Laboratory Director plays anessential role in the anti-doping Laboratory operations and that the
WADA accreditation is delivered based upon such qualification as well as2016 ISL – Version 9.055

•

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 such appointment inaccordance with the above qualifications;
Any personnel changes to this position shall be communicated to WADA
no later than one (1) month prior to the scheduled date the Laboratory
Director vacates his/her position. A succession plan shall be forwarded
to WADA.

5.4.2.5 The Laboratory shall have qualified personnel to serve as Certifying
Scientist(s) to review all pertinent data, quality control results, and to attest to
the validity of the Laboratory’s test reports. The qualifications are:•••Bachelors Degree in Medical Technology, Chemistry, Biology, or related
natural science or equivalent. Documented experience of 8 years ormore in a Doping Control Laboratory is equivalent to a Bachelor’s
degree for this position;
Experience in the analysis of doping materials in biological fluids;
Experience in the use of relevant analytical techniques such as
chromatography, immunoassay, and mass spectrometric techniques.

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

•
•
•

5.4.3

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

Accommodation and environmental conditions
5.4.3.1

Environmental Control

5.4.3.1.1

Maintaining appropriate electrical services

5.4.3.1.1.1 The Laboratory shall ensure that adequate electricalservice is available so that there is no compromise of stored data.
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critical to Laboratory operations should be supported in such a
way that service is not likely to be interrupted.
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 theevent 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 applicable national legislation.
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 unauthorized access which may
include a threat and risk assessment by expert(s) in the 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 be monitored andrecords 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 to individuals requiring
access to the Controlled Zones such as auditing teams and individuals
performing service or repair.
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 the following
information shall be provided to WADA no later than three months prior to therelocation:2016 ISL – Version 9.0

57

•
•
•

•
•

5.4.4

Description of circumstances for moving Laboratory operations into a
new space and anticipated effect on capabilities;
Relocation date(s) including date of closing of existing facility operations
and date of opening of future facility operations;
Date(s) of ISO/IEC 17025 inspection(s) of new facilities (evidence ofcontinued accreditation required when made available by the
Accreditation Body);
New Laboratory contacts and coordinates;
Assessment of the effect of the relocation to Laboratory client
operations.

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 ofsubstances present on the Prohibited List and for associated Metabolites orMarkers or related substances. Note that for many substances, the associatedMetabolites are detected, thereby confirming the metabolism and theadministration of a Prohibited Substance. The methods shall be selected andvalidated so they are Fit-for-purpose.
5.4.4.1.1

Non-Threshold Substances

Laboratories are not required to quantify or report a concentration for
Non-Threshold Substances.
The Laboratory shall develop, as part of the method validation process,acceptable standards for identification of Prohibited Substances using
Reference Materials and in the absence of avalaible Reference Materials,
Reference Collections may be used (see the Technical Document on
Identification Criteria).
The Laboratory shall estimate the limit of detection and demonstrate
the ability to successfully detect each Non-Threshold Substance or its
representative Metabolite(s) or Marker(s) at 50% of the Minimum
Required Performance Levels (see the TD MRPL for detection andidentification of Non-Threshold Substances). A Reference Collection may
be used for identification and in such cases an estimate of the detection
capability for the method may be provided by assessing a
representative substance from the same class of Prohibited Substanceswith similar chemical structure.
5.4.4.1.2

Threshold Substances

The Laboratory shall develop quantitative methods that are Fit-forpurpose.

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58For endogenous Threshold Substances, the Athlete’s Sample will bedeemed to contain a Prohibited Substance and the Laboratory willreport an Adverse Analytical Finding if, based on any reliable analyticalmethod the Laboratory 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 in the validation procedure todemonstrate that a method is Fit-for-purpose include but are not limited
to:
•

•

•

•

•

•

•

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Specificity. The ability of the assay to detect only the substanceof interest shall be determined and documented. The assay shallbe able to discriminate between compounds of closely related
structures;
Limit of Detection (LOD) shall be determined at least to 50% of
the relevant MRPL for each Non-Threshold Substance or its
representative Metabolite(s) or Marker(s) using the relevant
Reference Material, when available (see the Technical Documenton Minimum Required Performance Levels);
Identification capability. Since the results for Non- Threshold
Substances are qualitative, not quantitative, the Laboratory
should establish criteria for the Confirmation Procedures ensuring
the identification (in compliance with the Technical Document on
Identification Criteria) of each Non-Threshold Substance or its
representative Metabolite(s) or Marker(s), for which a Reference
Material is available, at the MRPL;
Robustness. The method shall be determined to produce 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 thesubstance of interest from Sample to Sample during processing
or instrumental analysis shall be determined and implemented;
Matrix interferences. The method should avoid interference in thedetection of Prohibited Substances or their 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 ofdata or Sample from a validated Reference Collection is
acceptable. If the Laboratory can show by the analysis ofReference Material (e.g. (i) an external quality control sample, (ii)
an isolate from a urine or blood sample after an authenticatedadministration, or (iii) an “in-vitro” incubation with liver cells or59microsomes) the ability to detect a particular substance, this shallbe regarded as sufficient evidence to confirm identity.
This Article applies only to the validation of Laboratory methods, andnot to the review of the analytical results for any Athlete Sample(s).
5.4.4.2.2
Confirmation methods for Threshold Substances shall bevalidated. Factors to be investigated to demonstrate that a method is
Fit-for-purpose include but are not limited to:
•

•

•

•

•

•
•

•

Specificity. The ability of the assay to detect only the substanceof interest shall be determined and documented. The assay shallbe 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 and with different
operators performing the assay. Intermediate Precision at thethreshold shall be recorded;
Robustness. The method shall be determined to produce thesimilar results with respect to minor variations in analyticalconditions. Those conditions that are critical to reproducible
results shall be controlled;
Carryover. The conditions required to eliminate carryover of thesubstance of interest from Sample to Sample during processing
or instrumental analysis shall be determined and implemented;
Matrix interferences. The method shall limit interference in themeasurement of the amount of Prohibited Substances or their
Metabolites or Markers by components of the Sample matrix;
Standards. Reference Materials should be used for quantification,
if available;
Limit of quantification (LOQ). The Laboratory shall demonstratethat a threshold method has an established LOQ of no more than
50% of the threshold value or in accordance with the LOQ values
required in relevant Technical Document(s) or Guideline(s);Linearity shall be documented at 50% to 200% of the thresholdvalue, unless otherwise stipulated in a Technical Document or
Guideline(s).

This Article applies only to the validation of Laboratory methods, not to
the review of the analytical results for any Athlete Sample(s).
5.4.4.2.3
Analytical method validation data (including the estimationof Measurement Uncertainty as described in ISL 5.4.4.3) is assessed in
the ISO/IEC 17025 accreditation process for approval of the method for
its inclusion in the Laboratory’s ISO scope of accreditation. As such, aLaboratory shall not be required to produce validation data or otherevidence of method validation in any legal proceeding.

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5.4.4.3

Estimate of Measurement Uncertainty for quantitative analyses

5.4.4.3.1

Establishing that a substance exceeds a Threshold.

The purpose of reporting (based on the application of Decision Limits
which incorporate the maximum acceptable value of the combined
standard uncertainty (uc Max) of the Laboratory’s measurement
procedure estimated at the Threshold) 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 the Thresholdwith statistical confidence of at least 95%. The method, including
selection of standards and controls, and estimation of uncertainty shallbe Fit-for-purpose.
5.4.4.3.1.1 Uncertainty of quantitative results, particularly at
the threshold value, shall be addressed during the validation of
the assay.
5.4.4.3.1.2 Measurement Uncertainty is further addressed in theTechnical Document on Decision Limits and relevant guidelines.
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 by physical accessand by multiple levels of access controlled by passwords or othermeans 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 an updated copy shall be either 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 theediting and that editing can be limited to users with proper levelof 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, retention of original data,reason for the change to original data and the individual
performing the task.

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5.4.5Equipment
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 General
Laboratory
equipment(fume
hoods,
centrifuges,
evaporators, etc.) that is not used for making measurements should bemaintained by visual examination, safety checks and cleaning as necessary.
Calibrations are only required where the setting can significantly change thetest result. A maintenance schedule, at least to manufacturer’s
recommendations or local regulations if available, shall be established forgeneral 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, and repair.
5.4.5.5 Qualified subcontracted vendors may be used to service, maintain,
and repair measuring equipment.
5.4.5.6 All maintenance,
documented.
5.4.6

service,andrepairofequipment

shall

be

Measurement traceability
5.4.6.1

Reference Materials

When available, Reference Materials of drug or drug Metabolite(s) traceable toa national standard or certified by a body of recognized status, such as USP,
BP, Ph.Eur. or WHO, should be used. At a minimum, an analysis report must
be obtained.
When a Reference Material is not certified, the Laboratory shall verify its
identity and purity by comparison with published data or by chemical
characterization.
5.4.6.2

Reference Collections

A collection of Sample or isolates may be obtained from a biological matrix
following a verifiable administration of an authentic Prohibited Substance or
Prohibited Method, providing that the analytical data are sufficient to justify
the identity of the relevant chromatographic peak or isolate as a Prohibited
Substance or Metabolite of a Prohibited Substance or Marker of a Prohibited
Substance or Prohibited Method.
5.4.7

Assuring the quality of analytical 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

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62the submission of blind quality control samples that challenges the entire
scope of the analytical process (i.e., Sample receipt and accessioning throughresult reporting).
5.4.7.3 Analytical performance shall be monitored by operating quality
control schemes appropriate to the type and frequency of testing performedby the Laboratory. The range of quality control activities include, but are notlimited to:
•

•
•

•
•

•

Appropriate positive controls and negative controls shall be included in
the same analytical run both for the Initial Testing Procedure andConfirmation Procedure as the Presumptive Adverse Analytical Finding
Sample;Deuterated or other appropriate internal standard(s) shall be used;
Comparison of mass spectra or ion ratios from selected ion monitoring(SIM) to a Reference Material or Reference Collection Sample analyzed
in the same analytical run;
Confirmation of the “A” and “B” Samples;
For Threshold Substances, quality control charts referring to appropriate
control limits depending on the analytical method 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 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. In some circumstances, measurements ofblood parameters may be conducted according to ISO/IEC 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 and Investigations.
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 the Laboratory
representative receiving the Sample(s). This information shall be included into
the Laboratory Internal Chain of Custody record(s).

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 other external
chain of custody.

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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 forLaboratory 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 notlimited to:
•
•
•
•
•
•

Sample Tampering is evident;
Sample is not sealed with tamper-resistant device or not sealed uponreceipt;
Sample is without a collection form (including Sample identificationcode) or a blank form is received with the Sample;
Sample identification is unacceptable. For example, the number on thebottle 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 with preserving the
integrity of the Sample for anti-doping analysis.

6.2.2.4 The Laboratory shall notify and seek instructions from the Testing
Authority regarding rejection and testing of Samples for which irregularities
are noted (e.g. a Sample sent as whole blood for blood transfusion testing has
coagulated). If applicable, any agreement between a Testing Authority andLaboratory 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).
Unless otherwise specified in a specific Technical Document or Guidelines,
Samples should be centrifuged as soon as is practical after Laboratory
reception to obtain the serum or plasma fraction. When analyzed shortly after
centrifugation (within 48 hours), the serum or plasma Samples and/or Aliquots
may be stored refrigerated at approximately 4 degrees Celsius until analysis.
For longer term analyses, Samples which have been centrifuged shall befrozen according to established protocols and thawed before analysis. 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(s) for a minimum of threemonths after the Testing Authority receives the final analytical (“A” or “B”
Sample) report. The Samples shall be retained frozen under appropriate
conditions.
Samples with irregularities shall be held under appropriate conditions for aminimum of three months following the report to the Testing Authority.

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65After the applicable storage period above, the Laboratory shall do one of thefollowing with the Samples:•

Disposal of the Sample(s).

•If the Testing Authority has arranged for storage of the Samples for aperiod from three months to ten years, the Laboratory shall ensure that
the Samples are stored in a secure location under continuous chain ofcustody;•

If consent has been obtained from the Athlete, the Samples may beretained by the Laboratory for research purposes. Samples used forresearch purposes shall have any means of identification removed or
the Sample shall be transferred into an anonymous container such thatthe contents cannot be traced back to a particular Athlete.

If consent has not been obtained from the Athlete, and provided that the
Samples are made anonymous, the Samples may be retained by the
Laboratory for quality assurance and quality improvement purposes, including
but not limited to:•

Improving existing analytical methods;•

Developing or evaluating new analytical methods;•

Developing reference ranges or Decision Limits or other statistical
purposes.

Disposal and long term storage of Samples 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.
Samples shall be maintained at approximately four degrees Celsius and should
be analyzed as soon as practical but within 48 hours. As soon as practicable
after Aliquots have been taken for analysis, Samples shall be returned toapproximately four degrees Celsius storage. In all circumstances, theappropriate steps to ensure the integrity of the Sample shall be taken by the
Laboratory. The Laboratory shall retain the “A” and “B” Samples with orwithout Adverse Analytical Finding for a minimum of one month after the
Testing Authority receives the final analytical (“A” or “B” Sample) report.
Samples with irregularities shall be held under appropriate conditions for aminimum of one month following the report to the Testing Authority.
After the applicable storage period above, the Laboratory shall do one of thefollowing with the Samples:•

Disposal of the Sample(s).

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•If the Testing Authority has arranged for storage of the Samples beyond
the minimum one month period, the Laboratory shall ensure that the
Samples are stored in a secure location under continuous chain ofcustody;•

Samples used for research purposes shall have any means ofidentification removed or the Sample shall be transferred into an
anonymous container such that the contents cannot be traced back to aparticular Athlete.
If consent has been obtained from the Athlete and provided that the
Samples are made anonymous, the Samples may be retained by the
Laboratory for research purposes.
If consent has not been obtained from the Athlete, and provided that
the Samples are made anonymous, the Samples may be retained by the
Laboratory for quality assurance and quality improvement purposes,
including but not limited to:•

Improving existing analytical methods;•

Developing or evaluating new analytical methods;•

Developing reference ranges or Decision Limits or other statistical
purposes.

Disposal and long term storage of Samples 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 shall be stored
under appropriate conditions and all the records pertaining to the testing ofthat 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 the Samples available for researchor dispose of the Samples. Disposal of Samples shall be conducted andrecorded under the Laboratory Internal Chain of Custody.

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6.2.2.11 Long-term storage of Samples for Further Analysis.
The procedures for selection, transport, storage and Further Analysis set forthin Article 5.2.2.12 shall apply unless provided otherwise in an applicable
Technical Document or Guidelines.
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

The Initial Testing Procedure(s) shall be documented, as part of the Sample(or Sample batch) record, each time it is conducted. Laboratories may apply
additional accredited test methods to Samples (beyond the client’s requested
test menu) if the additional work is conducted at the Laboratory’s expense andthe relevant Samples have not been identified for long-term storage.
6.2.4.1.1
Unless otherwise approved by WADA after consulting witha Testing Authority, the Initial Testing Procedure(s) shall be capable ofdetecting 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 makespecific exceptions to this section for specialized techniques that are notrequired 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 the Initial Testing Procedure is to obtain
information about the potential presence of Prohibited Substance(s) or
Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method. Results from Initial Testing
Procedures can be included as part of longitudinal studies provided thatthe method is appropriately validated.
6.2.4.1.3
All batches undergoing the Initial Testing Procedure shall
include appropriate negative and positive controls in the same matrix as
the Samples being tested.
6.2.4.1.4
Initial Testing Procedure results are not required toconsider the Measurement Uncertainty.

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6.2.4.1.5
Irregularities in the Initial Testing Procedure(s) shall notinvalidate an Adverse Analytical Finding when the Confirmation
Procedure adequately compensates for such irregularities.
6.2.4.2

Blood Confirmation Procedure

Confirmation Procedures shall be documented, as part of the Sample (orSample batch) record. The objective of the Confirmation Procedure is toaccumulate additional information to support the reporting of an Adverse
Analytical Finding.
6.2.4.2.1“A” Sample confirmation

6.2.4.2.1.1 A Presumptive Adverse Analytical Finding from an
Initial Testing Procedure of a Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(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 the macromolecule analyzed,
unless a properly validated purification or separation method isincorporated into the confirmation method to eliminate thepotential for cross-reactivity prior to the application of “A”
confirmation Affinity Binding Assay. The Laboratory shalldocument, as part of the method validation, the Fitness-forPurpose of such purification or separation method.
In assays which include multiple affinity reagents (such as
sandwich immunoassays), only one of the affinity reagents(either applied for capture or detection of the target analyte)
used in the Affinity Binding Assays applied for the Initial Testing
Procedures and Confirmation Procedures must differ for antigenic
epitope specificity. The other affinity reagent may be used in bothassays.
For analytes that are too small to have two independent antigenic
epitopes, two different purification methods or two different
analytical methods shall be applied.
Multiplexed Affinity Binding Assays, protein chips, and similar
simultaneous multi-analyte testing approaches may be used.
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 populations of blood
constituents, the detection of multiple Markers on the cells as thecriteria for an Adverse Analytical Finding replaces the2016 ISL – Version 9.0

69requirement for two antibodies recognizing different antigenic
epitopes.
[Comment: An example is the detection of surface Markers on
red blood cells (RBCs) using flow cytometry. The flow cytometeris set up to selectively recognize RBCs. The presence on the RBCsof more than one surface Marker (as determined by antibody
labelling) as a criterion for an Adverse Analytical Finding may be
used as an alternative to multiple antibodies to the same
Marker.]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) andthe first test result shall be nullified. 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 of a Prohibited
Substance or Prohibited Method is identified by the Initial Testing
Procedures, the Laboratory shall confirm as many of the
Presumptive Adverse Analytical Findings as possible. The decisionon the prioritization for the confirmation(s) shall be made to give
precedent to non-specified substance(s) and the decision should
be made in cooperation with the Testing Authority anddocumented.
6.2.4.2.1.6 For Threshold Substances, Adverse Analytical
Finding or Atypical Finding decisions for the “A” Sample finding
shall be based on the mean of the measured analytical values(e.g.) or ratio calculated from the means of measured analyticalvalues (e.g. concentrations, chromatogram peak heights or
areas) of three Aliquots. That value shall exceed the value of therelevant Decision Limit as specified in the Technical Document on
Decision Limits or applicable Guidelines.
If insufficient Sample volume exists to analyze three Aliquots, themaximum number of Aliquots that can be prepared should beanalyzed. The reporting of Adverse Analytical Findings forThreshold Substances shall be in compliance with the TechnicalDocument on Decision Limits or the applicable TechnicalDocument or Guideline.
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 cellular components are tobe performed: In those cases where confirmation of a Prohibited2016 ISL – Version 9.0

70Substance, Metabolite(s) of a Prohibited Substance, or Marker(s)of the Use of a Prohibited Substance or Prohibited Method isrequested in the “B” Sample, the “B” Sample analysis should
occur as soon as possible and should take place no later thanseven 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 whichtests on cellular components are to be performed: Whenrequired, “B” Sample confirmation in whole blood or blood cellular
fraction should take place no later than seven working days
starting the first working day following notification of an “A”
Sample Adverse Analytical Finding by the Laboratory.
The Laboratory shall proceed as described above unless informedthat the Athlete has waived his/her right to the “B” confirmation
analysis and therefore accepts the finding(s) of the “A”
confirmation analysis.
6.2.4.2.2.2 The “B” Sample confirmation shall be performed in
the same Laboratory as the “A” Sample 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 shall only confirm the “A” Sample identification for
the Adverse Analytical Finding to be valid. No quantitation of such
Prohibited Substance shall be performed.
6.2.4.2.2.5 For endogenous Threshold Substances, Adverse
Analytical Finding decisions for the “B” Sample finding shall bebased on the mean of the measured analytical values (e.g.
concentration) or ratio calculated from the means of measured
analytical values (e.g. concentrations, chromatogram peakheights or areas) of three Aliquots. That value shall exceed thevalue of the relevant Threshold as specified in the TechnicalDocument on Decision Limits or the applicable TechnicalDocument or Guideline.
If insufficient Sample volume exists to analyze three Aliquots, themaximum number of Aliquots that can be prepared should beanalyzed.
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 representative of the National Olympic
Committee, National Sport Federation, International Federation,2016 ISL – Version 9.0

71and a translator
confirmation.

shall

be

authorizedtoattendthe“B”

If the Athlete declines to be present or the Athlete’s
representative does not respond to the invitation or if the Athleteor the Athlete’s representative continuously claim not to beavailable on the date of the opening, despite reasonable attempts
by the Laboratory to accommodate their dates, over a period not
to exceed seven working days, the Testing Authority or the
Laboratory shall proceed regardless and appoint an independent
witness to verify that the “B” Sample container shows no signs ofTampering and that the identifying numbers match that on thecollection documentation. At a minimum, the Laboratory Director
or representative and the Athlete or his/her representative or the
independent witness shall sign Laboratory documentation
attesting to the above.
The Laboratory Director may limit the number of individuals inControlled Zones of the Laboratory based on safety or security
considerations.
The Laboratory Director may remove, or have removed by proper
authority, any Athlete or representative(s) interfering with thetesting process. Any behavior resulting in removal shall bereported to the Testing Authority and may be considered an anti–
doping rule violation in accordance with Article 2.5 of the Code,“Tampering or Attempted Tampering 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 to urine section
5.2.4.3.2.7.
6.2.4.2.2.8 If more than one Prohibited Substance, Metabolite(s)of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method has been confirmed in the “A”
Confirmation Procedure, the Laboratory shall confirm as many of
the Adverse Analytical Findings as possible given the “B” sample
volume available. The decision on the prioritization for theconfirmation(s) shall be made to give precedent to thesubstance(s) with the longest potential period of Ineligibility andthe decision should be made in cooperation with the Testing
Authority and documented.
6.2.4.2.2.9 The Laboratory shall have a policy to define thosecircumstances when confirmation testing of the “B” Sample may
be repeated (e.g. batch quality control failure) and the first test
result shall be nullified. Each repeat confirmation shall be
documented and should be performed on a new Aliquot of the “B”
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Sample and new quality control samples.
6.2.4.2.2.10 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 obtained from 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 conduct a
separate and impartial review of all Adverse Analytical Findings before areport is issued. The review process shall be recorded.
6.2.5.1.2••••

At a minimum, the review shall include:

Laboratory Internal Chain of Custody documentation;
Validity of the analytical initial and confirmatory data andcalculations;
Quality control data;
Completeness of documentation supporting the reported
analytical findings.

6.2.5.1.3
When an Adverse Analytical Finding is rejected, thereason(s) shall be recorded.
6.2.6

Documentation and reporting
6.2.6.1 The Laboratory shall have documented procedures to ensure that it
maintains a coordinated record related to each Sample analyzed. In the caseof an Adverse Analytical Finding, the record shall include the data necessary tosupport the conclusions reported as set forth in and limited by the TechnicalDocument on Laboratory Document Packages.
6.2.6.2 Each step of Analytical Testing shall be traceable to the staff
member who performed that step.
6.2.6.3 Significant variance from the written procedure shall be documented
as part of the record (e.g., memorandum for the record).
6.2.6.4 Where instrumental analyses are conducted, theparameters for each run shall be included as part of the record.

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6.2.6.5 Reporting of “A” Sample results should occur within ten working
days of receipt of the Sample. The reporting time required for specificCompetitions may be substantially less than ten 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 or ADAMS record shall be generated to
document the Adverse 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:
•
•
•
•
•
•
•
•
•
•
•

•
•
•
•
•

Sample code;
Laboratory identification number;Type of test (Out of Competition/In-Competition);Sport and/or discipline;
Name of Competition and/or client reference code (for example: ADAMS
test mission code), if provided by the Testing Authority;
Date of Collection;
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 the TechnicalDocument on Decision Limits or the applicable Technical Document or
Guideline);
The name of the Sample Collection Authority;
The name of the Testing Authority;
The name of the Results Management 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 tothe type of test, sport/discipline, test results (including comments/opinions)and client to whom the report is addressed shall also be provided in English on
the test report.
[Comment: A complete analytical test report generated from ADAMS should
be considered to have fulfilled the above requirements and thereforfe should
be regarded as an official test report.]
6.2.6.7 The Laboratory is not required to quantify or report a concentration
for an analyte of non-threshold Prohibited Substances in blood Samples. The
Laboratory shall report the actual Prohibited Substance(s), Metabolite(s) of theProhibited Substance(s) or Prohibited Method(s), or Marker(s) detected in the
blood Sample. Upon request of the Testing Authority, Results Management
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relevant to the result management of an anti-doping case, the Laboratory
should provide an approximate concentration.
For Threshold Substances in blood Samples, the Laboratory report shallestablish that the Prohibited Substance(s) or its Metabolite(s) or Prohibited
Method(s) or Marker(s) of a Prohibited Method is present at a concentration
and/or ratio of measured analytical values greater than the Decision Limit inaccordance with the reporting requirements as described in the TechnicalDocument on Decision Limits or the applicable Technical Document(s) or
Guidelines.
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 Prohibited Method(s) or their Metabolite(s)or Marker(s) were detected on the test menu.

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 or interpretation isclearly identified as such. The basis upon which the opinion has been madeshall be documented.
[Comment: 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, and whether
an observed result is consistent with a set of reported conditions.]
6.2.6.10 The Laboratory shall report all test results as defined in ISL provision
6.2.6.8 via ADAMS and simultaneously only to the relevant Testing Authority
and/or the responsible International Federation and/or to the Major Event
Organization (in the case of Major International Events) not using ADAMS. The
information provided in ADAMS shall be in compliance to ISL provision 6.2.6.6.
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
requirements of the Code.
6.2.6.11 Upon request, the Laboratory shall report in a format specified by
WADA, a summary of the results of tests performed. No information that could
link an Athlete’s identity with an individual result will be included. The reportwill include a summary of any Samples rejected for Analytical Testing and thereason for the rejection.

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6.2.6.12 The documentation package should be provided by the Laboratory
only to the relevant Results Management Authority or WADA upon request andshould be provided within ten working days of the request. Laboratory
Documentation Packages shall be in compliance with the WADA TechnicalDocument on Laboratory Documentation Packages.
6.2.6.13 Athlete confidentiality shall be respected by all Laboratories engaged
in Doping Control cases.
6.2.6.13.1 Testing Authority or WADA requests for information shallbe made in writing to the Laboratories.
6.2.6.13.2 Presumptive
AdverseAnalytical
Findings,
AdverseAnalytical Findings and Atypical Findings shall not be provided by
telephone.
6.2.6.13.3 Information sent by a facsimile is acceptable if the securityof the receiving facsimile machine has been verified and procedures arein place to ensure that the facsimile has been transmitted to the correct
facsimile number.
6.2.6.13.4 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 the Athlete is included.
6.2.6.13.5 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.
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 ofsubstances present on the Prohibited List and for associated Metabolites orMarkers or related substances. Note that for many substances, the associatedMetabolites are detected; thereby confirming the metabolism and the2016 ISL – Version 9.0

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administration of a Prohibited Substance. The methods shall be selected andvalidated so they are Fit-for-purpose.
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

Uncertainty in establishing that a substance exceeds a threshold(Measurement Uncertainty) shall be addressed by the applicable TechnicalDocument or Guidelines.

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PART THREE: ANNEXESANNEX A - WADA EXTERNAL QUALITY ASSESSMENTSCHEME (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 Analytical Testing procedures.

1.0

WADA External Quality Assessment Scheme

Periodically, urine (or blood) samples are distributed by WADA to Laboratories andprobationary laboratories, to be analyzed for the presence or absence of Prohibited
Substances, Metabolites, Markers or Methods. These samples may be Blind or
Double-Blind (in such cases the content is unknown to the Laboratories) as well asOpen (also Educational) samples (in such cases the content may be indicated).
Blind and Double-Blind EQAS samples contain selected substances or methods suchas those Prohibited Substances, Metabolite(s) of Prohibited Substances, andMarker(s) of Prohibited Substances and Prohibited Methods which each Laboratory
shall examine, using their routine Initial Testing Procedures and Confirmation
Procedures to detect and identify the analyte(s) whose presence would result in thereporting of an Adverse Analytical Finding or Atypical Finding.
The Laboratory shall not communicate with other Laboratories regarding the identityof 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 or Drug Class. In general, thisapproach is used for educational purposes or for data gathering. Results fromthe Educational EQAS are not evaluated within the point scale for Laboratory
performance.
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) present 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

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78WADA. For some EQAS samples or EQAS sample sets, additional information
may be requested from the Laboratory.
1.3

Double Blind EQAS
The Laboratory receives EQAS samples which are indistinguishable fromroutine Samples. The EQAS samples may consist of blank or adulterated
samples or samples containing Prohibited Substances and Prohibited Methods
and Methods and/or their Metabolite(s) or Marker(s), the detection andidentification of which would constitute an Adverse Analytical Finding(s) orAtypical Finding(s). These samples may be used to assess turn-around time,compliance with documentation package requirements, and other nonanalytical performance criteria as well as Laboratory competence in detection
and identification of Prohibited Substances or Prohibited Methods,
Metabolite(s) of Prohibited Substances, and Marker(s) of Prohibited
Substances or Prohibited Methods.

2.0

External Quality Assessment Scheme Sample Composition

The actual composition of the EQAS samples supplied to different Laboratories in aparticular EQAS round may vary but, within any annual period, all Laboratories
participating in the EQAS are expected to have analyzed the same total number ofsamples.
2.1

EQAS Samples Void of Prohibited Substances or Methods, their Metabolite(s)or Marker(s)(blank samples)
Blank EQAS samples do not contain Prohibited Substances or their
Metabolite(s) or Marker(s) of Prohibited Substances and Prohibited 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 Samples Containing Prohibited Substances, their Metabolite(s) orMarker(s), or the Marker(s) of Prohibited Methods
2.3.1 EQAS sample composition
The concentration(s) of selected analyte(s) are those that may be expected in
the urine or blood of drug users. For some analytes, the sample composition
may consist of the parent drug and/or major Metabolite(s).
EQAS samples may be spiked with Prohibited Substances and/or their
Metabolite(s) or Marker(s) and/or may be prepared from controlled
administration studies.

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2.3.2 Individual EQAS sample content of
Method(s), or Metabolite(s) or Marker(s)Prohibited

Substance(s)orAn EQAS sample may contain more than one Prohibited Substance,
Metabolite(s), or Marker(s) of a Prohibited Substance or Prohibited 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). WADA
may also require Laboratories to report the results of EQAS samples in otherformats.
For Non-Threshold Substances, the concentration will be guided by, but notlimited to, one of the following criteria:•

The Prohibited Substance and/or its major Metabolite(s) will normally bepresent in quantities equal to or greater than the Minimum Required
Performance Level (MRPL) as applicable. The Laboratory shall report theProhibited Substance. Results will be evaluated as per section 3.3.5.

•

The Prohibited Substance and/or its major Metabolite(s) may be present
in quantities between 50% of the MPRL and the relevant MRPL asapplicable. The Laboratory shall report the Prohibited Substance and/or
its Metabolite(s) if identified at a concentration greater than 50% of the
MRPL. Between 50% of the MPRL and the relevant MRPL as applicable,
the results shall not be evaluated for the purposes of the EQAS point
system, however WADA may require an investigation and report;•

The Prohibited Substance and/or its major Metabolite(s) may be present
below 50% of the applicable MRPL for educational purposes. In thiscase, the Laboratory should report their finding(s) if the analyses arecompliant with their Standard Operating Procedures, the ISL andrelevant Technical Documents. The results shall not be evaluated for the
purposes of the EQAS point system;•

In some special cases, the Laboratory may be directed to analyze thesample for a particular Prohibited Substance as part of an educational
challenge and the results shall not be evaluated 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 by the Technical Document on
Decision Limits or relevant Guidelines;•

Between 50% of the Threshold and the relevant Decision Limit for
special purposes (e.g. estimation of maximum allowed uc)•

Threshold Substances shall evaluated as per section 3.3.5

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•

Exceptions may include the reporting of Threshold Substances below
the Decision Limit if required by the ISL or applicable TechnicalDocuments (e.g. detection of Threshold Substances at sub-thresholdlevels in the presence of diuretics or masking agents).

These concentrations and drug types may be changed periodically in response
to factors such as changes in detection technology and patterns 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.
3.1

Evaluation of EQAS Samples Containing Non-Threshold Substances
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 report the chiral species (e.g.,methamphetamine(-d) or levmetamfetamine) will be deemed 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 − xˆδWhere x is the measurement result reported by the participating laboratory.
xˆ 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;

2016 ISL – Version 9.081•

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), inclusive, isdeemed to be unsatisfactory performance.

In the EQAS, the reported concentration from the Confirmation Procedure is scored,
therefore the concentration of Threshold Substances shall be reported when themeasured mean value is greater than or equal to 50% of the Thresholdconcentration or ratio.
Concentrations of Threshold Substances (or Metabolites) determined by WADA to bepresent 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 theDecision 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 20 EQAS samples each year distributedin multiple rounds of which at least two will include Double-Blind samples. Each year
at least three samples will contain Threshold Substances. Blank samples may be
included.
The purpose of the EQAS program is to ensure that all of the Laboratories maintainproficiency of their testing methods. Contact between Laboratories regarding any
aspect of EQAS testing and EQAS results prior to reporting to WADA will beconsidered an attempt to circumvent the system. Engaging in such 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 amanner identical to that applied to routine Laboratory Samples, unlessotherwise 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.
Only validated methods or procedures described in the standard operatingprocedures and included in the Laboratory’s scope of accreditation are to be
employed in the analysis of EQAS samples (e.g. using the methods andprocedures applied in routine analysis).
3.3.2 False Adverse Analytical Finding result
A false Adverse Analytical Finding result is not acceptable in any Blind andDouble Blind EQAS sample. The following procedures are to be followed when
faced with such a situation:•

The Laboratory will be informed by WADA of a false Adverse Analytical
Finding as soon as possible;

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•

•
•

•

The Laboratory is to provide WADA with a satisfactory root cause
analysis report including the reason(s) for the error within five calendar
days (unless informed otherwise by WADA). Supporting documentation
shall be provided such as all quality control data from the batch of EQAS
or routine Samples that included the false Adverse Analytical Finding
sample (particularly if the error is deemed to be technical/scientific);
WADA shall review the Laboratory’s explanation promptly;
If the error is determined to be a technical or methodological error, theLaboratory shall receive 25 points under the scoring system described in
Section 3.3.5 and WADA shall provisionally suspend the Laboratory andsubject the Laboratory to an immediate disciplinary process. The
Laboratory may be required to re-test all Samples reported as Adverse
Analytical Findings by the Laboratory from the time of final resolution of
the error back to the time of the last relevant and satisfactory EQAS
round. Depending on the type of error that caused the false Adverse
Analytical Finding, this retesting may be limited to one analyte, a classof Prohibited Substances or Prohibited Methods, or may include any
prohibited drug and method. 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 ten points under the scoring
system described in Section 3.3.5. The Laboratory shall provide a
Corrective Action Report describing the remedial action(s) taken to
avoid the re-occurrence of the particular error in the future andevaluate the impact on routine operations and if deemed necessary the
Laboratory shall be required to review and re-analyze previously
analyzed Samples during the time required to resolve the administrative
error, the Laboratory may be provisionally suspended.

3.3.3 False negative result
Laboratories failing to identify and/or report a Prohibited Substance and/or its
Metabolite(s) or the Marker(s) of a Prohibited Substance or a Prohibited
Method in a Blind EQAS round or Double Blind EQAS sample are informed assoon as possible by WADA. The Laboratory shall receive ten points under thescoring system described in Section 3.3.5. The Laboratory must complete andreport corrective action acceptable to WADA within 30 days of the date ofwritten notification by WADA (unless informed otherwise by WADA). The
Laboratory may otherwise be advised by WADA to take corrective action(s) 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 within 30 days of thecompleting the corrective action.

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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 Documente on Decision Limits or
relevant Guideline. To report an Adverse Analytical Finding, the mean resultmust be above the corresponding Decision Limit. Laboratories shall receive
either five points for a questionable result or ten points for an unsatisfactory
result under the scoring system described in Section 3.3.5. Appropriate
corrective action shall be taken to remedy any unsatisfactory z-score and thecorrective action reported to WADA within 30 days of written notification of
unsatisfactory performance.
3.3.5 Overall Laboratory evaluation
WADA shall evaluate Laboratory EQAS performance for each round and assign
points for each non-compliance or failure to perform as summarized in thetable below. Within any EQAS round evaluation, a false Adverse AnaltyicalFinding or the accumulation of 24 or more points will result in the provisional
Suspension of accreditation until the final accreditation status (Suspension
period) is determined by WADA as described in 4.4.13. WADA will consider the
performance of Laboratories over the most recent 12 month period or themost recent and consecutive three rounds of EQAS and applicable rounds ofthe double blind EQAS. Any Laboratory that accumulates 30 or more points
during this period will have its WADA accreditation provisionally Suspended
until the final accreditation status (Suspension period or Revocation) is
determined by WADA as described in 4.4.13.
WADA is to evaluate the performance of all Laboratories based on the resultsin the WADA EQAS (Blind and Double Blind EQAS) as well as on issues brought
to WADA’s attention by stakeholders in relation to the Laboratory’s routine
testing services. The factors for consideration include, but are not limited to:
•
•
•
•
•
•
•
•
•
•
•
•

False negative(s);False Adverse Analytical Finding(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).

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84Point scale for assessment of Laboratory and probationary laboratory performance
False Adverse
Analytical Finding

25

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

Point Total for single EQAS round≥20

Suspension

Double Blind EQAS point total for 12 month
period***≥20

Suspension

Point Total per 12 month period≥30

Suspension or
Revocation of
Accreditation

Prohibited SubstancesThreshold Substances

Sample Parameters

Occurrences**

Scoring

Steroid Profile
concentrations

Evaluation|z-score|≥ 3.0

Corrective
Action Report*

Documentation includes but is not limited to Documentation Packages, Corrective Action
Reports and Test Reports.

**

Based on a total of 36 determinations (estimation of six steroid variables: Androsterone,
Etiocholanolone, Testosterone, Epitestosterone, 5α-androstane-3α,17β-diol and 5β-androstane3α,17β-diol in six EQAS samples) per EQAS round.

***

Probationary laboratories exempt from Double-Blind EQAS program

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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 WADA-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
round and 30 points for the most recent and consecutive 12 month period).
The EQAS samples shall be distributed in multiple rounds per year and willconsist of a minimum of 18 blind samples per year. At least three 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 toroutine Samples, unless otherwise specified by WADA. Methods or procedures
to be utilized in routine testing should be employed.
3.4.2 False Adverse Analtyical Finding result
Any false Adverse Analtyical Finding reported automatically suspends aprobationary 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 send a set of
EQAS samples and/or audit the laboratory prior to reinstatement to theprobationary 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) orMarker(s) of a Prohibited Substance or a Prohibited Method are informed assoon as possible by WADA. The laboratory shall take and report propercorrective action within 30 days of the date of the letter to WADA (unless
informed otherwise by WADA). Probationary laboratories may otherwise beadvised by WADA to take corrective action(s) or to change a corrective action
which has previously been reported to WADA. The corrective action reported

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86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 for quantitative
results reported based on the mean of three independent determinations. The
relative standard deviation is to be commensurate with the validation data.
The combined standard uncertainty of the procedure should not exceed that
permitted in the Technical Document on Decision Limits. To report an Adverse
Analytical Finding the mean result must be greater than the Decision Limit.
Appropriate 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 each roundand assign points for each non-compliance or failure to perform as per Point
Scale for Assessment of Probationary Laboratory Performance table in section
3.3.5 with the exception of the double blind EQAS evaluation.
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 the lossof the laboratory’s status as a candidate laboratory by WADA.
During the probationary period other elements of the EQAS scheme, which arepart of the generally applied procedures, will be considered to assess thecompetence of the laboratory. These elements include, but are not limited to:determination of the specific gravity of the samples, the initial determinationof the endogenous anabolic androgenic steroid (EAAS) profile and thepresentation of necessary documentation (test reports and the documentation
package to support an Adverse Analytical Finding).
When performance of the laboratory is considered to be satisfactory in the
EQAS over the most recent and consecutive 12 month period (e.g., at least
three EQAS rounds), and all other necessary conditions having been fulfilled,
the laboratory will be inspected by an audit team appointed by WADA.
This audit will take place while the laboratory is processing and analyzing afurther 20 EQAS samples supplied by WADA as part of a final accreditation
test. The results of the final accreditation test will be evaluated by WADA as
follows:•

No false Adverse Analtyical Finding is reported;•

The point total must be less than 20 for the 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

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87documentation packages are to be submitted within 30 days andconsidered 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
30 working days prior to the end of the Suspension (unless informed otherwise
by WADA). Failure to do so will prohibit the laboratory from re-entering theprobationary EQAS. Lifting of the Suspension occurs only when propercorrective action has been implemented and reported to WADA. WADA may
choose, at its sole discretion, to submit additional EQAS samples to thelaboratory and/or to require that the laboratory be re-audited, at the expenseof the laboratory. Laboratories re-entering the probationary EQAS shall beconsidered as a candidate laboratory and are subject to provide the applicable
fee and the required documentation to WADA.

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88ANNEX B - LABORATORY CODE OF ETHICS

1.0

Confidentiality

The Director 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

AnalysisLaboratories should exercise due diligence to ascertain that the Samples arecollected according to the World Anti-Doping Code International Standard for Testing
and Investigations or similar guidelines. These documents shall include collection of
Samples, appropriate Sample container security considerations, and formal chain ofcustody conditions. Laboratories shall ensure that Samples received are tested inaccordance with all the ISL rules.

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89The Laboratories shall accept Samples only if the following conditions are
simultaneously met:•••

That the Samples have been collected and sealed according to the World AntiDoping Code International Standard for Testing and Investigations or similar
guidelines;
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 Testing or
identification, from commercial or other sources when the conditions in the above
paragraph are not simultaneously met.
Laboratories shall not accept Samples from individual Athletes on a private basis orfrom individuals or organizations acting on their behalf.
These rules apply to all sports.
4.1

Clinical or Forensic
Occasionally the Laboratory may be requested to analyze a sample for abanned drug or endogenous substance allegedly coming from a hospitalized orill 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 and/or legal investigations may be undertaken but due
diligence should be exercised to ensure that the work is requested by anappropriate agency or body. The Laboratory should not engage in analyticalactivities or expert testimony that would intentionally question the integrity of
the individual or the scientific validity of work performed in the anti-doping
program.

4.2

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 not

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90provide 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.
4.3

Sharing of Information and Resources
4.3.1 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.
4.3.2 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 60
days. This can occur by participation in scientific meetings, publication of
results of research, sharing of specific details of methodology necessary for
detection, and working with WADA to distribute information by preparation ofa reference substance or biological excretion study or information regarding
the chromatographic 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 uniformityof 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 orare detrimental to the anti-doping program of WADA, an International Federation, a
National Anti-Doping Organization, a National Olympic Committee, a Major Event
Organizing Committee, or the International Olympic Committee. Such conduct could
include, but is not limited to, conviction for fraud, embezzlement, perjury, etc. thatwould cast doubt on the integrity of the anti-doping program.
No Laboratory employee or consultant shall provide counsel, advice or information to
Athletes or others regarding techniques or methods to mask detection of, altermetabolism of, or suppress excretion of a Prohibited Substance or Marker(s) of a
Prohibited Substance or Prohibited Method in order to avoid an Adverse Analytical
Finding. Outside the context of an arbitration hearing, no Laboratory employee or
consultant shall provide information to an Athlete or Athlete Support Personnel about
a testing method that might assist the Athlete in avoiding detection of the Use of a
Prohibited Substance or Prohibited Method. No Laboratory staff shall assist an

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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 and Prohibited
Substances or Prohibited Methods. Such provision shall remain valid for a minimumof five 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, scientificallyvalid 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 a political decisionmaking body (e.g. NADO, IF or WADA).

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