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- “A” Confirmation Procedure for Non-Threshold Substances For Non-Threshold Substances without Minimum Reporting Level s, Adverse Analytical Finding or Atypical Finding decisions for the “A” Sample shall be based on the identification of the Non-Threshold Substance or its characteristic Metabolite (s) or Marker (s), as applicable, in compliance with the TD IDCR and/or other relevant Technical Document (e.g.
TD MRPL), Technical Letter or Laboratory Guidelines .
For Non-Threshold Substances with Minimum Reporting Level s as specified in the TD MRPL, Adverse Analytical F inding decisions for the “A” Sample should be based on the identification of the Non-Threshold Substance or its characteristic Metabolite (s) or Marker (s), in compliance with the TD IDCR, at an estimated concentration greater than the Minimum Reporting Level , unless there is ISL – January 2021 Page 92 of 160 justification for reporting the finding at levels below the Minimum Reporting Level (e.g.
if the analysis forms part of an ongoing investigation).
- “A” Confirmation Procedure for Threshold Substances For Threshold Substances , Adverse Analytical Finding or Atypical Finding decisions for the “A” Sample shall be based on the confirmed identification (in accordance with the TD IDCR, applicable to Confirmation Procedures based on chromatography -mass spectrometry) of the Threshold Substance and/or its Metabolite(s) or Marker(s) and their quantitative determ ination in the Sample at a level exceeding the value of the relevant Decision Limit , which is specified in the TD DL or other applicable Technical Document (s) (e.g.
TD GH) or Laboratory Guidelines .
Quantitative Confirmation Procedures for Threshold Substances shall be based on the determination of the mean of measured analytical values ( e.g.
concentrations, chromatogram peak heights or areas) or the ratio/score calculated from the mean(s) of the measured analytical values of three (3) “A” Sample Aliquots 15.
If there is not enough Sample volume to analyze three (3) Aliquots , the maximum number of Aliquots that can be prepared should be analyzed.
By determining that the test result exceeds the Decision Limit , the quantitative Confirmation Procedure establishes that the Threshold Substance or its Metabolite(s) or Marker(s) is present in the Sampl e at a level greater than the Threshold , with a statistical confidence of at least 95% (for more information, refer to the TD DL).
For endogenous Threshold Substances , Markers of the “steroid profile”, or any other Prohibited Substance that may be produced endogenously at low levels, Adverse Analytical Finding decisions for the “A” Sample may also be based on the applic ation of any Fit-for-Purpose Confirmation Procedure that establishes the exogenous origin of the Prohibited Substance or its Metabolite (s) or Marker (s) (e.g.
GC/C/IRMS).
Atypical Findings may result from non -conclusive determinations of the origin (endogenous vs. exogenous) of the Prohibited Substance or its Metabolite (s) or Marker (s).
For some exogenous Threshold Substances , which are identified as such in the Prohibited List and the TD DL, Adverse Analytical Finding decisions for the “A” Sample do not require a quantification procedure 15 Unless otherwise specified in a Technical Document , Technical Letter or Laboratory Guidelines .
ISL – January 2021 Page 93 of 160 if detected in the presence of any Prohibited Substance classified under S5.
“Diuretics and Masking Agents” of the Prohibited List .
In such cases, the ide ntification (in accordance to the TD IDCR) of the Threshold Substance and/or its Metabolite (s) in the Sample is sufficient to conclude an Adverse Analytical Finding .
5.3.6.2.3 “B” Confirmation Procedure - Testing Laboratory The “B” Confirmation Procedure shall be performed in the same Laboratory as the “A” Confirmation Procedure , unless there are exceptional circumstances, as determined by WADA and with WADA ’s prior written approval, which prevent the “B” Confirmation Procedure from being perform ed in the same Laboratory .
- Notification and Timing of “B” Confirmation Procedure The “B” Confirmation Procedure shall only be performed by the Laboratory upon request by either the Athlete or the Testing Authority or Results Management Authority (if different) .
The Testin g Authority or Results Management Authority , as applicable, should inform the Laboratory , in writing, w ithin fifteen (15) days following the reporting of an “A” Sample Adverse Analytical Finding by the Laboratory , whether the “B” Confirmation Procedure shall be conducted .
This includes situations when the Athlete does not request the “B” Sample analysis or expressly or implicitly waives his/her right to the analysis of the “B” Sample , but the Testing Authority or Results Management Authority decides that the “B” Confirmation Procedure shall still be performed.
If the “B” Confirmation Procedure is to be performed, either upon the request of the Athlete or the Testing Authority or Results Management Authority , it should be performed as soon as possible after the Testing Authority or Results Management Authority , as applicable, has provided such notice to the Laboratory .
The timing of the “B” Confirmation Procedure may be strictly fixed within a very short period of time and without any possible postponement , if circumstances so justify it.
This can notably and without limitation be the case when a postponement of the “B” Sample analysis could significantly increase the risk of Sample degradation and/or inadequately delay the decision -making ISL – January 2021 Page 94 of 160 process in the given circumstances ( e.g.
and without limitation , during or in view of a Major Event requiring rapid completion of the Sample analysis) .
If the Athlete declines to be present in person and/or through a representative, or does not indicate whether he or she requests the “B” Sample analysis, or if the Athlete will not attend (in person and/or through a representative) once a date and time for the analysis has been proposed or if the Athlete or the Athlete’s representative claims not to be available on the date or at the time of the opening of the “B” Sample , despite reasonable attempts to find an alternative date and time convenient both to the Athlete and to the Laboratory , the Testing Authority or Results Management Authority or WADA , as applicable, shall instruct the Laboratory to proceed regardless.
The Laboratory , in consultation with the Testing Authority , the Results Management Authority or WADA , as applicable, shall appoint an Independent Witness to verify that the “B” Sample container shows no signs of Tampering and that the identifying numbers match that on the Sample collection documentation.
An Independent Witness may be appointed even if the Athlete has indicated that he/she will be present and/or represented .
- Authorization of non -Laboratory Persons to attend the “B” Confirmation Procedure The following non -Laboratory Persons shall be authorized to attend the “B” Confirmation Procedure : o The Athlete and/or representative (s) of the Athlete or, in the absence of the Athlete and/or representative (s), an Independent Witness : • The Athlete and a maximum of two (2) representatives , and/or the Independent Witness , have the right to attend the “B” Sample opening, aliquoting and resealing procedures ; • The Athlete and/or one (1) representative may also have reasonable opportunity to observe other steps of the “B” Confirm ation Procedure , as long as their presence in the Laboratory does not interfere with the Laboratory ’s routine operations or Laboratory safety or security requirements .
[Comment: An Independent Witness may also attend even if the Athlete is present and/or represented.]
o A translator (if applicable); ISL – January 2021 Page 95 of 160 o A representative of the Testing Authority or the Results Management Authority (if requested by the Testing Authority or the Results Management Authority , respectively); o A representative of the National Olympic Committee and/or National Sport Federation and/or International Federation , as applicable, may also attend the “B” Sample opening procedure, upon request and with prior approval of the Laboratory Director.
The Laboratory Director may limit the number of individuals in Controlled Zones of the Laboratory based on safety or security considerations.
Persons attending shall not interfere with the “B” Sample opening or the “B” Confirmation Procedure process in any way at any time and shall strictly follow the instructions of the Laboratory .
The Laboratory may have any Person removed, including the Athlete or Athlete’s representative, if they are not following the instructions, disturbing or interfering with the “B” Sample opening or the Analytical Testing process.
Any behavior resulting in removal shall be reported to the Testing Authority and/or Results Management Authority , as applicable.
Interference may fu rther be constitutive of an anti -doping rule violation in accordance with Code Article 2.5, “ Tampering , or Attempted Tampering with any part of Doping Control by an Athlete or other Person ”.
- Opening , Aliquoting and Resealing of “B” Sample The “B” Confirmation Procedure shall be performed using Aliquot (s) taken from the container defined as the “B” Sample .
[Comment: In cases when the “B” Sample cannot be used for Analytical Testing , the unopened, sealed “A” Sample may be split (see Article 5.3.3.2) and the “B” Confirmation Procedure (s), if needed, may be performed on an Aliquot taken from the split, resealed “A” Sample fraction designated as the “B” Sample. ]
The Athlete and/or his/her representative (s) or the Independent Witness shall verify that the “B” Sample container is properly sealed and shows no signs of Tampering , and that the identifying numbers match that on the Sample collection documentation .
At a minimum, the Laboratory Director or representative and the Athlete or their representative(s) and/or the Independent Witness shall sign the Laboratory docum entation attesting that the “B” Sample container was properly sealed and showed no signs of Tampering , and that the identifying numbers matched those on the Sample collection documentation.
ISL – January 2021 Page 96 of 160 If the Athlete , and/or their representative(s), or the Independent Witness refuse to sign the Laboratory documentation because they consider that the “B” Sample container was not properly sealed and/or showed signs of Tampering , or if the identifying numbers did not match those on the Sample collection documentation, the Laboratory shall not proceed with the “B” Confirmation Procedure and will inform the Testing Authority or Results Management Authority (if different) immediately to obtain instructions.
In such cases, the “B” Confirmation Procedure may have to be re -scheduled.
If, on the other hand, the Athlete and/or their representative(s), or the Independent Witness refuse to sign the Laboratory docum entation for any other reason, the Laboratory shall proceed with the “B” Confirmation Procedure .
At the same time, the Laboratory shall inform the Testing Authority or Results Management Authority (if different) immediately.
The reasons for the refusal sha ll be documented and included as a comment in the Test Report in ADAMS .
The Laboratory shall then ensure that the “B” Sample container is opened and Aliquots for the “B” Confirmation Procedure are taken in the presence of the Athlete or his/her representative (s) or the Independent Witness .
The Laboratory shall also ensure that, after opening and taking Aliquots for the “B” Confirmation Procedure , the “B” Sample is properly resealed in the presence of the Athlete and/or his/her representative (s) or the Independent Witness , who should be offered the opportunity to select the resealing equipment for the “B” Sample container from several identical/sealed items , if available .
At a minimum, the Laboratory Director or representative and the Athlete and/or their representative(s) and/or the Independent Witness shall sign another part of the Laboratory documentation attesting that they have witnessed the “B” Sample opening and aliquoting procedures and that the “B” Sample was properly resealed.
If the Athlete and/or their representative or the Independent Witness refuse to sign this part of the Laboratory documentation, the reasons for the refusal shall be documented and included as a comment in the Test Report in ADAMS .
In either case, the Laboratory shall continue with the “B” Confirmation Pro cedure .
ISL – January 2021 Page 97 of 160 - Target Analyte (s) If more than one (1) Prohibited Substance , Metabolite (s) of a Prohibited Substance , or Marker (s) of the Use of a Prohibited Substance or Prohibited Method has been confirmed in the “A” Confirmation Procedure , the Laboratory shall confirm as many of the Adverse Analytical Findings as possible given the “B” Sample volume available.
The decision on the prioritization for the confirmation(s) shall be made to prioritize the analysis of the Prohibited Substance (s) or Prohibited Method (s) that carry the longest potential period of Ineligibility .
The decision should be made in consultation with the Testing Authority (or Results Management Authority , if different) and documented.
- Repetition of the “B” Confirmation Procedure The Laboratory may repeat the Confirmation Procedure for a “B” Sample , if appropriate , (e.g.
quality control failure, chromatographic peak interferences, inconclusive “B” confirmation results).
In that case, the previous test result shall be nullified.
The Laboratory may repeat the “B” Confirmation Procedure using the remain ing volume of the same Aliquot initially taken from the “B” Sample container .
However, if there is not enough volume left of the initial Aliquo t, then the Laboratory shall use a new Aliquot (s) taken from the re -sealed B” Sample container.
In such cases, the re -opening, aliquoting and re -sealing of the B” Sample container shall be performed in the presence of the Athlete and/or Athlete ’s representative(s) and/or Independent Witness , as per the procedure described above .
Each Aliquot used shall be documented .
- “B” Confirmation with Negative Results If the final “B” confirmation results are negative, the Analytical Testing result shall be considered a Negative Finding .
The Laboratory shall notify the Testing Authority (or Results Management Authority , if different) and WADA immediately.
The Laboratory shall conduct an internal investigation of the causes of the discrepancy between the “A” and “B” Sample results and should report its outcomes to the Results Ma nagement Authority and WADA within seven (7) days .
[Comment: Target Analytes [e.g.
parent compound, Metabolite(s), Maker(s)] used to conclude the presence of a given Prohibited Substance or Use of a Prohibited Method may differ between the “A” and “B” Confirmation Procedures .
This does not mean that the “B” confirmation results ar e negative, as long as the Analyte (s) targeted ISL – January 2021 Page 98 of 160 allows the unequivocal and conclusive identification of the Prohibited Substance or Prohibited Method in the “B” Sample.]
- “B” Confirmation Procedure for Non-Threshold Substances and exogenous Threshold Substances For Non-Threshold Substances (including those with Minimum Reporting Level s as specified in the TD MRPL) and exogenous Threshold Substances , the “B” Sample results shall only confirm the presence of the Prohibited S ubstance (s) or its Metabolite(s) or Marker(s) identified in the “A” Sample (in compliance with the TD IDCR) for the Adverse Analytical Finding to be valid 16.
No quantification or estimation of concentrations of such Prohibited Substance , or its Metabolite (s) or Marker (s) is necessary.
- “B” Confirmation Procedure for endogenous Threshold Substances For endogenous Threshold Substances , Adverse Analytical Finding decisions for the “B” Sample results shall be based on the confirmed identification (in accordance with the TD IDCR, applicable to Confirmation Procedures based on chromatography -mass spectrometry) of the Threshold Substance or its Metabolite(s) or Marker(s) and their quantitative determination in the Sample at a level exceeding the value of the relevant Threshold as specified in the TD DL or other applicable Technical Document (s) or Laboratory Guidelines .
Comparison of the measured value of the “B ” Sample to the measured value of the “A ” Sample is not necessary to establish “B ” Sample confirmation.
The “B ” Sample value is only required to exceed the applicable Threshold .
Quantitative “B” Confirmation Procedures for endogenous Threshold Substances shall be based on the determination of the mean of measured analytical values ( e.g.
concentrations, chromatogram peak heights or areas) or the ratio/score calculated from the mean(s) of the measured analytical values of three (3) “B” Sample Aliquots 16.
If there is not enough Sample volume to analyze three (3) Aliquots , the maximum number of Aliquots that can be prepared should be analyzed.
For endogenous Threshold Substances , Markers of the “steroid profile”, or any other Prohibited Substance that may be produced 16 Unless otherwise specified in a Technical Document , Technical Letter or Laboratory Guidelines .
ISL – January 2021 Page 99 of 160 endogenously at low levels, Adverse Analytical Finding decisions for the “B” Sample results may also be based on the application of any Fit-for-Purpose Analytical Testing Procedure that establishes the exogenous origin of the Prohibited Substance and/or its Metabolite (s) or Marker (s) (e.g.
GC/C/IRMS).
Atypical Findings may result from non -conclusive determinations of the origin (endogenous vs. exogenous) of the Prohibited Subst ance or its Metabolite (s) or Marker (s).
5.3.6.3 Further Analysis Further Analysis of stored Samples shall, as a matter of principle, be aimed at detecting all the Prohibited Substance (s) or Metabolite (s) of Prohibited Substance (s), or Marker (s) of the Use of a Prohibited Substance or Prohibited Method included in the Prohibited List in force at the time of the collection of the Sample (s).
- Selection of Samples and Laboratories for Further Analysis Stored Samples may be selected for Further Analysis at the discretion of the Testing Authority .
WADA may also direct the Further Analysis of Samples at its own expense (see Code Article 6.6).
In cases where WADA takes physical possession of a Sample (s), it shall notify the Testing Authority (see Code Article 6.8), which shall retain ownership of the Sample (s) pursuant to the ISTI Article 10.1, unless ownership of the Sample (s) has been transferred pursuant to ISTI Article 10.2.
The choice of which Laboratory will conduct the Further Analysis will be made by the Testing Authority or WADA , as applicable.
Requests to the Laboratory for Further Analysis shall be made in writing and be recorded as part of the Sample ’s documentation.
When a Sample has been reported as a Negative Finding or Atypical Finding , there is no limitation on the Testing Authority or WADA or others authorized by either of them to conduct Further Analysis on the Sample .
Further Analysis may also be performed on stored Samples , which were previously reported as Adverse Analytical Findings where such report did not result in an anti -doping rule violation charge under Code Article 2.1.
Any Prohibited Substance or Prohibited Method detected, which was prohibited at the time of Sample collection, shall be reported .
However, pursuant to Code Article 6.5, Further Analysis may not be applied on a Sample after the responsible Anti-Doping Organization has charged the Athlete with a Code Article 2.1 anti -doping rule violation resulting from the analysis of the Sample , without the consent of the Athlete or approval from a hearing body .
ISL – January 2021 Page 100 of 160 Previously acquired Initial Testing Procedure data may also be re -evaluated for the presence of Prohibited Substances or their Metabolite (s) or Marker (s) of Prohibited Substances or Prohibited Methods , at the initiative of the Testing Authority , the Results Management Authority , WADA or the Laboratory itself.
The results of such re -evaluation, if suspicious, shall be communicated to the Testing Authority , the Results Management Authority or WADA , as applicable, and may lead to Further Analysis .
- Analyt ical Testing Procedures for Further Analysis of Stored Samples Further Analysis of stored Samples shall be performed under the ISL, Technical Documents , Technical Letters and Laboratory Guidelines in effect at the time the Further Analysis is performed.
Further Analysis of stored Samples includes, notably, but without limitation, the application of newly developed or more sensitive Analytical Testing Procedures and/or the analysis of new target Analytes of Prohibited Substance (s) or Prohibited Method (s) [e.g.
Metabolite (s) and/or Marker (s)], which were not known or not included in the initial Analytical Testing of the Sample .
Depending on the circumstances, and to ensure an effective and targeted use of the available Sample volume, p riorities may be set, and/or the scope of the Further Analysis restricted to specific analyses (in particular, but without limitation, to analyses based on new or improved Analytical Testing Procedures ).
- Further Analysis of Stored Samples Process a) Use of the “A” Sample The Testing Authority or WADA may instruct the Laboratory to use the “A” Sample for both the Initial Testing Procedure (s) and the “A” Confirmation Procedure (s), to use it only for the Initial Testing Procedure (s) or not to use the “A” Sample for Further Analysis at all.
If the Laboratory has been instructed to perform only Initial Testing Procedure (s) on the “A” Sample , any suspicious analytical result obtained from the “A” Sample shall be considered as a Presumptive Adverse Analytical Finding , irrespective of the Analytical Testing Procedure applied, and shall be confirmed using the split “B” Sample (see below) .
When a Confirmation Procedure is performed on the “A” Sample and an Adverse Analytical Finding is reported on this basis, the “B” Confirmation Procedure shall be applicable (as per Article 5.3.6.2.3).
ISL – January 2021 Page 101 of 160 b) Use of the split “B” Sample When the “A” Sample is used only for the Initial Testing Procedure (s) or is not used at all during Further Analysis , the “B” Sample shall be split and used for analysis.
The “B” Sample shall be split into two fractions, in accordance with Article 5.3.3.2.
The Athlete and/or a representative of the Athlete should be invited to witness the splitting procedure.