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ISL – January 2021 Page 19 of 160 Further Analysis : Further Analysis , as this term is used in the ISL, occurs when a Laboratory conducts additional analysis on an “A” Sample or a “B” Sample after an analytical result for that “A” Sample or that “B” Sample has been reported by the Laboratory .
[Comment : There is no limitation on a Laboratory ’s authority to conduct repeat or confirmation analysis, or to analyze a Sample with additional Analytical Methods , or to perform any other type of additional analysis on an “A” Sample or “B” Sample prior to reporting a n analytical result on that Sample.
That is not considered Further Analysis .
If a Laboratory is to conduct additional analysis on an “A” Sample or “B” Sample after an analytical result for that Sample has been reported (for example : additional Sample an alysis to detect EPO, or GC/C/IRMS analysis, or analysis in connection with the Athlete Biological Passport or additional analysis on a stored Sample) it may do so after receiving approval from the Testing Authority or Results Management Authority (if different) or WADA.
However, after an Athlete has been charged with a Code Article 2.1 anti -doping rule violation based on the presence of a Prohibited Substance, Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a Prohibited Substa nce or Prohibited Method in a Sample, then Further Analysis on that Sample may only be performed with the consent of the Athlete or approval from a hearing body (see Code Article 6.5).
Further Analysis may be performed by the same Laboratory that did the o riginal Analytical Testing, or by a different Laboratory or other WADA -approved laboratory, at the direction of the Testing Authority or Results Management Authority (if different) or WADA.
Any other Anti -Doping Organization that wishes to conduct Further Analysis on a stored Sample may do so with the permission of the Testing Authority or Results Management Authority (if different) or WADA and shall be responsible for any follow -up Results Management.
Any Sample storage or Further Analysis initiated by WAD A or another Anti-Doping Organization shall be at WADA’s or that Anti -Doping Organization’s expense.]
Independent Witness : A Person , invited by the Testing Authority , the Laboratory or WADA to witness the opening and initial aliquoting of an Athlete’s “B” Sample .
An Independent Witness shall not be an employee or have a personal financial relationship with the Athlete or his/her representative(s), the Laboratory , the Sample Collection Author ity, the Testing Authority / Delegated Third Parties / Results Management Authority or WADA , as applicable.
However, the Independent Witness may be indemnified for his/her service.
Initial Testing Procedure (ITP): An Analytical Testing Procedure whose purpose is to identify those Samples which may contain a Prohibited Substance , Metabolite (s) of a Prohibited Substance , or Marker(s) of the Use of a Prohibited Substance or Prohibited Method or an elevated quantity of a Prohibited Substance , Metabolite (s) of a Prohibited Substance , or Marker (s) of the Use of a Prohibited Substance or Prohibited Method .
Intermediate Precisi on (sw): Variation in results observed when one or more factors, such as time, equipment, or operator are varied within a Laboratory .
It is also referred to as inter -batch / inter -run precision.
Laboratory Internal Chain of Custody : Documentation maintained within the Laboratory to record the chronological traceability of custody (by Person(s) or upon storage) and actions performed on the Sample and any Aliquot of the Sample taken for Analytical Testing .
[Comment : Laboratory Internal Chain of Custody is generally documented by a written or electronic record of the date, location, action taken, and the Person performing an action with a Sample or Aliquot .]
Laboratory : A WADA -accredited laboratory applying Test Methods and processes to provide evidentiary data for the detection and/or identification of Prohibited Substances or Prohibited Methods on the Prohibited List and, if applicable, quantification of a Threshold Substance in Samples of urine and other biological matrices in the context of Doping Control activities.
ISL – January 2021 Page 20 of 160 Laboratory Expert Group (LabEG ): Group of laboratory experts responsible for providing advice, recommendations and guidance to WADA with respect to the overall management of anti-doping Laboratory accreditation and ABP approval, Laboratory and ABP Laboratory disciplinary action, re -accreditation and approval processes as well as Laboratory and ABP Laboratory monitoring activities.
Laboratory Guidelines (LGs): Recommendations of Laboratory best practice provided by WADA to address specific Laboratory operations or to provide technical requirements and guidance on interpretation and reporting of results for the analysis of specific Prohibited Substance (s) and/or Prohibited Method (s) or on the application of specific Laboratory procedures.
[Comment : Laboratory Guidelines are posted on WADA’s website, are not of mandatory application and may be later incorporated, partially or in full, in Technical Document(s) or in the ISL.
Labora tory Guidelines are approved by the LabEG ].
Laboratory Documentation Package (LDP): The material produced by a Laboratory upon request by the Testing Authority , Results Management Authority or WADA , as set forth in the Technical Document on Laboratory Documentation Packages (TD LDOC), to support an analytical result such as an Adverse Analytical Finding or an Atypical Finding .
Limit of Detection (LOD ): Analytical parameter of assay technical performance.
Lowest concentration of an Analyte in a Sample that can be routinely detected, but not necessarily identified or quantified, under the stated Test Method conditions .
Limit of Identification (LOI): Analy tical parameter of technical performance for chromatographic -mass spectrometric Confirmation Procedures .
The LOI is estimated during method validation to evaluate the rate of false negative results at a certain concentration level.
The LOI of a Test Method , at 5% false negative rate, for an Analyte (for which a Reference Material is available) shall be less than the MRPL .
[Comment : Since the LOI is an estimation of the false negative rate, Laboratories may report findings below the estimated LOI as Adverse Analytical Findings or Atypical Findings, as applicable, when the Analyte is identified in the Sample accordi ng to the criteria established in the Technical Document on chromatographic -mass spectrometric identification criteria (TD IDCR).]
Limit of Quantification (LOQ ): Analytical parameter of assay technical performance.
Lowest concentration of an Analyte in a Sample that can be quantitatively determined with acceptable precision and accuracy ( i.e.
acceptable Measurement Uncertainty ) under the stated Test Method conditio ns.
Major Event : A series of individual international Competitions conducted together under an international multi -sport organization functioning as a ruling body ( e.g.
the Olympic Games, Pan American Games) .
Measurement Uncertainty (MU): Parameter associated with a measurement result that characterizes the dispersion o f quantity values attributed to the measure and provides confidence in the validity of the measured result [see Technical Document on Decision Limit s (TD DL)].
Minimum Required Performance Level (MRPL ): Minimum analytical criterion of Laboratory technical performance established by WADA .
Minimum concentration at which a Laboratory is expected to consistently detect and confirm a Prohibited Substance or Metabolite of a ISL – January 2021 Page 21 of 160 Prohibited Substance or Marker of a Prohibited Substance or Prohibited Method in the routine daily operation of the Laboratory .
Individual Laboratories may and are expected to achieve better performance [see Technical Document on Minimum Required Performance Levels (TD MRPL )].
Negative Finding : A test result from a Laboratory which, in accordance with the effective ISL and/or relevant Technical Document (s) and/or Technical Letter (s), concludes that no Prohibited Substance(s) or its Metabolite(s) or Marker(s) or evidence of the Use of a Prohibited Method(s) , included in the requested Analytical Testing menu, were found in a Sample based on the applied Initial Testing Procedure (s) or Confirmation Procedure (s).
Non-Threshold Substance : A substance listed on the Prohibited List for which the identification, in compliance with the Technical Document on chromatographic -mass spectrometric identification criteria (TD IDCR) or other applicable Technical Document (s), constitutes an Adverse Analytical Finding .
Presumptive Adverse Analytical Finding (PAAF ): The status of a Sample test result from the Initial Testing Procedure which represents a suspicious finding, but for which a Confirmation Procedure to render a conclusive test result has not yet been performed.
Provisional Suspension : Temporary Suspension of a Laboratory ’s WADA accreditation or a laboratory’s ABP approval pending a final decision by WADA regarding its accreditation status.
Reference Collection (RC): A collection of samples or isolates of known origin that may be used in the determination of the identity of an unknown substance.
For example, a well -characterized sample obtained from a controlled administration or from in vitro studies in which the pres ence of the substance of interest has been established.
Reference Material (RM): Reference Substance or Reference Standard, which is sufficiently characterized, homogeneous and stable with respect to one or more specified properties and that has been esta blished to be fit for its intended use in an Analytical Testing Procedure .
Repeatability (sr): Variability of results obtained within a laboratory using the same method, over a short time, using a single operator, item of equipment, etc.
It is also referred to as intra -batch / intra -run precision.
Reproducibility (sR): Variability of results obtained when different laboratories analyze Aliquots of the same sample .
Reproducibility is a property of the results obtained and represents a measurable agreement of analytical results between different laboratories .
Revocation : The permanent withdrawal of a Laboratory ’s WADA accreditation or a laboratory’s ABP approval .
Root Cause Analysis (RCA ): An investigation to identify one or more fundamental cause(s) of a nonconformity based on the collection of objective evidence from an assessment of the likely factors that led to the nonconformity.
The removal of a root cause factor preve nts the recurrence of the nonconformity; in contrast, removing a causal factor can improve the outcome, but it does not prevent the recurrence of the problem with certainty.
Selectivity : The ability of the Analytical Testing Procedure to detect or identif y, as applicable, the substance of interest in the Sample .
Suspension : The temporary withdrawal of a Laboratory ’s WADA accreditation or a laboratory’s ABP approval .
ISL – January 2021 Page 22 of 160 Technical Letter (TL): Mandatory technical requirements provided by WADA from time to time ( ad-hoc) to address particular issues on the analysis, interpretation and reporting of specific Prohibited Substance (s) and/or Prohibited Method (s) or on the application of specific Labora tory or ABP Laboratory procedures.
[Comment : Technical Letters are approved by the WADA Executive Committee and posted on WADA’s website.
Technical Letters become effective immediately, unless otherwise specified by WADA].
Technical Note (TN): Technical guidance provided by WADA to Laboratories on the performance of specific Laboratory methods or procedures.
[Comment : Technical Notes are not considered part of Technical Documents and therefore are not of mandatory application.
Technical Notes are approved by the LabEG and become effective immediately].
Test Method : Analytical Testing Procedure , Analytical Method .
Threshold : The maximum permissible level of the concentration, ratio or score for a Threshold Substance in a Sample .
The Threshold is used to establish the Decision Limit for reporting an Adverse Analytical Finding or Atypical Finding for a Threshold Substance .
Thres hold Substance : An exogenous or endogenous Prohibited Substance, Metabolite or Marker of a Prohibited Substance for which the identification and quantitative determination (e.g.
concentration, ratio, score) in excess of a pre -determined Decision Limit , or, when applicable, the establishment of an exogenous origin, constitutes an Adverse Analytical Finding .
Threshold Substances are identified as such in the Technical Document on Decision Limits (TD DL).
3.3 Defined Terms from the International Standard for Testing and Investigations Sample Collection Authority : The organization that is responsible for the collection of Samples in compliance with the requirements of the International Standard for Testing and Investigations, whether (1) the Testing Authority itself; or (2) a Delegated Third Party to whom the authority to conduct Testing has been granted or sub -contracted .
The Testing Authority always remains ultimately responsible under the Code for compliance with the requirements of the International Standard for Testing and Investigations relating to collection of Samples .
Sample Collection Session : All of the sequential activities that directly involve the Athlete from the point that initial contact is made until the Athlete leaves the Doping Control Station after having provided their Sample (s).
Suitable Volume of Urine for Analysis : A minimum of 90 mL, whether the Laboratory will be analyzing the Sample for all or only some Prohibited Substances or Prohibited Methods .
Test Distribution Plan : A document written by an Anti-Doping Organization that plans Testing on Athletes over whom it has Testing Authority , in accordance with the requirements of Art icle 4 of the International Standard for Testing and Investigations.
Testing Authority : The Anti-Doping Organization that authorizes Testing on Athletes it has authority over.
It may authorize a Delegated Third Party to conduct Testing pursuant to the authority of and in accordance with the rules of the Anti-Doping Organization.
Such ISL – January 2021 Page 23 of 160 authorization shall be documented.
The Anti-Doping Organization authorizing Testing remains the Testing Authority and ultimately responsible under the Code to ensure the Delegated Third Party conducting the Testing does so in compliance with the requirements of the International Standard for Testing and Investigations.
3.4 Defined Terms from the International Standard for Results Management Passport : A collation of all relevant data unique to an individual Athlete that may include longitudinal profiles of Markers , heterogeneous factors unique to that particular Athlete and other relevant information that may help in the evaluation of Markers .
Passport Custodian : The Anti-Doping Organization responsible for Result Management of the Athlete ’s Passport and for shari ng any relevant information associated to that Athlete ’s Passport with other Anti-Doping Organization (s).
Results Management Authority : The Anti-Doping Organization responsible for conducting Results Management in a given case.
3.5 Interpretation 3.5.1 The official text of the International Standard for Laboratories shall be published in English and French.
In the event of any conflict between the English and French versions, the English version shall prevail.
3.5.2 Like the Code , the Internatio nal Standard for Laboratories has been drafted giving consideration to the principles of proportionality, human rights, and other applicable legal principles.
It shall be interpreted and applied in that light.
3.5.3 The comments annotating various provisions of the International Standard for Laboratories shall be used to guide its interpretation.
3.5.4 Unless otherwise specified, references to Sections and Articles are references to Sections and Articles of the International Standard for Laboratories .
3.5.5 Where the term “ days” is used in the International Standard for Laboratories , it shall mean calendar days unless otherwise specified.
3.5.6 The Annexes to the International Standard for Laboratories have the same mandatory status as the rest of the International Standard .
ISL – January 2021 Page 24 of 160 PAR T TWO: LABORATORY ACCREDITATION AND LABORATORY APPROVAL FOR THE ABP REQUIREMENTS AND OPERATING STANDARDS 4.0 Process and Requirements for WADA Laboratory Accreditation and Laboratory Approval for the ABP This section describes the specific requirements that a laboratory shall fulfill in the process of applying for, obtaining, and maintaining WADA accreditation or WADA approval for the ABP.
4.1 Appl icant Laboratory for WADA Accreditation In principle, any laboratory that satisfies the criteria listed below may apply to become a candidate laboratory for WADA accreditation.
However, the WADA Executive Committee , at its sole discretion, may accept or deny a laboratory’s candidacy application based on the identified needs (or lack there of) for anti -doping Analytical Testing on a regional or national scale, or for any other reason (s).
4.1.1 Expression of Interest The applicant laboratory shall officially contact WADA in writing to express its interest in becoming a WADA -accredited laboratory.
4.1.2 Submit Initial Application Form The applicant laboratory shall submit a completed Application Form, provided by WADA , duly signed by the laboratory Director and, if relevant, by the Director of the host organization (e.g.
university, hospital, public institution).
An applicant laboratory may only submit an application if its host country satisfies the following conditions : - The existence of a National Anti -Doping Program conducted by a National Anti -Doping Organization and/or a Regional Anti -Doping Organization , which is compliant with the Code and the International Standard s of the World Anti -Doping Program; - The ratification of the UNESCO Convention against Doping in Sport; and - The payment of the annual financial contributions to WADA .
These conditions shall be documented as part of the application.
4.1.3 Provision of Letters of Support Upon receipt of an application and verification of the conditions mentioned above, WADA shall request that the applicant laboratory submit the following letters of support: - Official letter(s) of support from host organizations acceptable to WADA (e.g.
universities, hospitals, private organization s and/or public institutions) that ISL – January 2021 Page 25 of 160 guarantee sufficient annual financial support for a minimum of three (3) years, the provision of adequate analytical facilities, instrumentation and human resources, as well as support for training programs, research and development activities; - Official letter(s) of support from Signator ies, such as a National Anti-Doping Organization or Region al Anti-Doping Organization responsible for a National Anti -Doping Program , or an International Federation responsible for an International Anti-Doping Program .
Such letter(s) of support shall indicate a commitment to provide the Laboratory with a minimum of 3,000 Samples per year by the end of the second calendar year after obtaining WADA accreditation; [Comment: To determine the minimum number of Samples, each urine Sample, blood Sample and ABP blood Sample analyzed by the Laboratory shall count as an individual Sample.]
- A declaration by the supporting Signatory (-ies) that their relationship with the applicant laboratory is compliant with Art icle 4.4.2.4 .
4.1.4 Provision of Business Plan WADA shall request the applicant laboratory to submit a business plan, which shall include market considerations (clients, number of Samples , maintenance costs, etc.
), facility, instrumental, staffing and training needs, and shall guarantee the long -term provi sion of adequate financial and human resources to the laboratory.
4.2 Candidate Laboratory for WADA Accreditation The application materials described in Articles 4.1.1 to 4.1.4 shall be evaluated by the WADA Executive Committee to determine whether the applica nt laboratory will be granted WADA candidate laboratory status and thereby continue within the WADA accreditation process.