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Prior to c ommencing disciplinary proceedings in accordance with Article 4.6.4.5, and i f requested by the Laboratory , the LabEG shall hold a resolution facilitation session with the Laboratory as described in Article 4.6.4.4, at the conclusion of which the Laboratory may accept the LabEG ’s recommendation and t... |
As indicated in Article 4.6.4.4, the ISL – January 2021 Page 43 of 160 Chair man of the WADA Executive Committee must approve any agreement between the Laboratory and the LabEG regarding the Laboratory ’s accreditation status and the terms of its Analytical Testing Restriction or Suspension . |
However, if the Laboratory does not accept the LabEG ’s recommendation and /or terms for the Analytical Testing Restriction or Suspension following the resolution facilitation process , as per Article 4.6.4.4 , the Laboratory may challenge the LabEG ’s recommendation to the Disciplinary Committee and disciplinar... |
In such circumstances, the LabEG may, on the basis of the seriousness of the Laboratory ’s Analytical Testing failures and/or o ther identified nonconformities, recommend to the Chairman of the WADA Executive Committee that the Laboratory : - May continue its Analytical Testing activities pending the outcome of t... |
In such cases, a decision by the Chairman of the WADA Executive Committee to impose a Provisional Suspension or subject the Laboratory to a provisional Analytical Testing Restriction shall not be subject to appeal by the Laboratory . |
However, should the Laboratory be immediately subject to a provisional Analytical Testing Restriction or should its WADA accreditation be subject to a Provisional Suspension , the proceedings before the Disciplinary Committee should be conducted within forty-five (45) days of the date when the provisional Analy... |
4.6.4.2 Noncompliances with the ISL Noncompliances with the ISL that may lead to an Analytical Testing Restriction or Suspension include, but are not limited to: - Suspension , or withdrawal of ISO/IEC 17025 accreditation; - Failure to establish and/or maintain administrative and operational independence as d... |
after consideration of any applicable penalty point deductions) or whether or not the Laboratory has satisfactoril y corrected the noncompliances.] |
o The reporting of two (2) or more independent 5 False Adverse Analytical Finding s per EQAS round ; or o The reporting of three (3) or more independent 5 False Adverse Analytical Findings , including EQAS and routine Analytical Testing , per twelve ( 12)-month period ; or o The reporting of three (3) or more inde... |
- Failure to implement a Technical Document or Technical Letter by the effective date without prior approval by WADA ; - Failure to comply with any of the requirements or standards listed in the ISL and/or Technical Document s and/or Technical Letters ; - Serious and repeated noncompliances with results reporting ... |
ISL – January 2021 Page 45 of 160 o Major changes in senior Laboratory management positions ( e.g. |
Laboratory Director, Quality Manager) without proper and timely notification to WADA ; o Failure to appoint a permanent Laboratory Director or other senior management positions ( e.g. |
Quality Manager) within a reasonable timeline ; o Failure to guarantee the comp etence and/or proper training of scientific staff including, for example, the qualification of analysts as Certifying Scientists and Laboratory Supervisory Personnel (see Art icles 5.2.2. |
3 and 5.2.2. |
4); o Significant loss or lack of experienced staff ( e.g. |
Certifying Scientists) that affects, as determined by WADA , the Laboratory ’s ability to ensure the full reliability and accuracy of Analytical Testing and reporting of test results; o Loss of sufficient Laboratory support and resources that affects, as determined by WADA , the quality and/or viability of the Labor... |
4.6.4.3 Revocation of Accreditation The WADA Executive Committee shall revoke the WADA accreditation of any Laboratory if it determines that Revocation is necessary to ensure the full reliability an d accuracy of Analytical Testing and the accurate reporting of analytical test results. |
The LabEG shall recommend the Revocation of a Laboratory ’s WADA accreditation based on, but not limited to, the following noncompliance(s): - Repeated reporting of False Adverse Analytical Findings or repeated failure to take appropriate corrective action after the reporting of a False Adverse Analytical Finding ;... |
- Repeated reporting of False Negative Findings or repeated failure to take appropriate corrective action after the reporting of False Negative Finding (s); - Repeated suspensions of ISO/IEC 17025 accreditation or Suspensions of ISL – January 2021 Page 46 of 160 WADA accreditation or repeated impositions of Anal... |
continuous turnover of qualified staff affecting Laboratory expertise and competence, inadequate training, repeated failure to train and qualify an appropriate number of analysts as Certifying Scientists); - Failure to cooperate with WADA or any relevant Testing Authority or Results Management Authority during ... |
If the Laboratory does not accept the LabEG ’s recommendation for Revocation either following the resolution facilitation session (if held pursuant to Article 4.6.4.4) or otherwise , the LabEG shall recommend to the Chairman of the WADA Executive Committee that the Laboratory ’s WADA accreditation be immediatel... |
In such cases, a decision by the Chairman of the WADA Executive Committee to impose a Provisional Suspension against the Laboratory shall not be subject to appeal by the Laboratory . |
However, should the Laboratory be immediately subject to a Provisional Suspension , the proceedings before the Disciplinary Committee should be conducted within forty-five (45) days of the date when the Provisional Suspension of the Laboratory ’s WADA accreditation was imposed. |
4.6.4.4 Resolution Facilitation Prior to the commencement of Disciplinary Proceedings in accordance with Articles 4.6.4.1 .2, 4.6.4.3 and 4.6.4.5, the LabEG , upon request by the Laboratory Director, will hold a resolution facilitation session with the Laboratory Director (via teleconference or other means). |
During this session, the LabEG shall explain the Laboratory ’s noncompliances with the ISL and/or Technical Document (s) and/or Technical Letter (s) and offer the Laboratory Director an opportunity to provide further clarification to the LabEG . |
During the resolution facilitation session, the Laboratory and the LabEG may come to an agreement regarding the Laboratory ’s Revocation or the terms and duration of the Suspension of the Laboratory ’s WADA accreditation or the Laboratory ’s Analytical Testing Restriction . |
Any such agreement must be submitted to the Chair of the WADA Executive Committee for approval. |
Following such approval by the Chair of the WADA Executive Committee, disciplinary proceedings will not be conducted in accordance with Article 4.6.4.5 . |
If the Laboratory and the LabEG are unable to come to an agreement regarding the Laboratory ’s Revocation or the terms and duration of the Suspension of the Laboratory ’s WADA accreditation or the Laboratory ’s Analytical Testing Restriction during the resolution facilitation session, the procedure indicated in... |
ISL – January 2021 Page 48 of 160 In the case of a LabEG recommendation for Revocation , a resolution facilitation session shall not be available to a Laboratory which is already serving a Suspension or Analytical Testing Restriction . |
4.6.4.5 Disciplinary Proceedings In the event that the Laboratory decides to challenge the LabEG ’s recommendation to impose an Analytical Testing Restriction or to suspend its WADA accreditation in accordance with Article 4.6.4.1 .2 or should a Laboratory ’s WADA accreditation be subject to Revocation in acco... |
The DC shall be responsible for conducting Disciplinary Proceedings in accordance with the Procedural Rules. |
In such circumstances, WADA shall provide the DC with the case file, which shall include the relevant documentation and correspondence related to the Laboratory ’s Analytical Testing failures or other ISL noncompliances or, where applicable, the circumstances that have resulted in the Laboratory ’s WADA accreditat... |
The Laboratory shall be permitted to make written submissions and provide any supporting documents or evidence in accordance with Article 3 of the Procedural Rules (Annex C). |
The DC shall issue a recommendation to the Chair of the WADA Execut ive Committee or, where applicable (e.g. |
in the case of a Revocation ), to the WADA Executive Committee, regarding the action(s) to be taken with regard to the Laboratory ’s WADA accreditation in accordance with the requirements and procedure described in Article 7 of the Procedural Rules (Annex C). |
[Comment: For the avoidance of doubt, and as indicated in Article 4.6.4.1.1, disciplinary proceedings will not be conducted pursuant to Article 4.6.4.5 in situations where a Laboratory has accumulated the maximum allowed number of penalty points for the EQAS and/or Analytical Testing (as determined by the applica... |
Instead, and only in the aforementioned circumstances, the Laboratory may a ppeal any decision of the Chairman of the WADA Executive Committee to impose an Analytical Testing Restriction or to suspend the Laboratory ’s WADA accreditation directly to CAS in accordance with Article 4.6.4.7.] |
4.6.4.6 Notification of Decision Upon comp letion of the procedure s indicated in Articles 4.6.4.5 or 7.3, as applicable, and in accordance with the timelines indicated in Article 7 of the Procedural Rules (Annex C), WADA shall provide the Laboratory with written notice of its decision regarding the status of the... |
This notice shall state the following: ISL – January 2021 Page 49 of 160 1) That the Laboratory ’s WADA accreditation has been maintained (including warnings, if applicable); or 2) That the Laboratory ’s WADA accreditation has been suspended or revoked or that an Analytical Testing Restriction has been imposed... |
Such notice shall include: - The reason(s) for Suspension or Revocation or the imposition of an Analytical Testing Restriction ; - The terms of the Suspension , Revocation , or Analytical Testing Restriction ; and - The period of Suspension or of Analytical Testing Restriction , if applicable. |
For proceedings conducted pursuant to Article 4.6.4.5, WADA shall also provide the Laboratory with a copy of the DC’s recommendation regarding the Suspension or Revocation of the Laboratory ’s WADA accreditation or the imposition of an Analytical Testing Restriction against the Laboratory . |
4.6.4.7 Effective Date and Appeals A Suspension or Analytical Testing Restriction is effective immediately upon receipt of notification of the decision. |
A Revocation takes effect one (1) month after notification. |
The Laboratory shall remain under Suspension until such a time when the Revocation becomes effective or pending the outcome of any possible appeal of the Revocation decision by the Laboratory . |
A Laboratory may appeal a decision by WADA to revoke or suspend its WADA accreditation, or to impose an Analytical Testing Restriction , to CAS in accordance with Code Article 13.7. |
The Laboratory shall have twenty -one (21) days from the date of receipt of the decision f rom WADA to file an appeal to CAS. |
4.6.4.8 Public Notice WADA shall publicly announce a change in a Laboratory ’s accreditation status on its website as soon as the Laboratory is notified by WADA of its decision. |
In cases of Laboratory Revocation , the public notice shall specify that the Laboratory shall remain under Suspension until the date when the Revocation becomes effective, as determined in Article 4.6.4.7. |
WADA shall also indicate the terms and length of the Suspension or the Analytical Testing Restriction , as well as the nature of the Laboratory ’s ISL – January 2021 Page 50 of 160 noncompliance with the ISL and/or Technical Document (s) and/or Technical Letter (s). |
WADA ’s website shall be updated regarding a Laboratory ’s accreditation status when the Laboratory ’s WADA accreditation is reinstated following a Suspension or when an Analytical Testing Restriction is lifted. |
4.6.5 Consequences of Suspended or Revoked Accreditation or Analytical Testing Restriction 4.6.5.1 Analytical Testing Restriction If WADA determines that the noncompliance(s) are limited to a class of Prohibited Substances or Prohibited Methods or to a specific Analytical Testing Procedure , which are not inc... |
The Laboratory shall inform its clients of the imposed Analytical Testing Restriction and shall subcontract the affected analyses to another Laboratory (-ies) during the period of the Analytical Testing Restriction , as provided in Article 5.2.6. |
A Laboratory under an Analytical Testing Restriction shall inform WADA of the identity of the relevant Testing Authority (-ies) and the chosen Laboratory (-ies). |
If the reason for the Analytical Testing Restriction was related to the reporting of False Adverse Analytical Finding (s), all analyses employing the affected Analytical Testing Procedure (s) shall cease immediately. |
The Laboratory shall transfer 6 the following Samples (“A” and “B” Samples ) in the Laboratory ’s custody, which involve the analysis of the same class of Prohibited Substances or Prohibited Methods and/or the application of the affected Analytical Testing Procedure (s) subjected to the Analytical Testing Restrict... |
All associated costs shall be bo rne by the Laboratory under Analytical Testing Restriction . |
ISL – January 2021 Page 51 of 160 Finding (as requested by WADA ); - Samples , which had been opened and were undergoing analysis for the Initial Testing Procedure (s) at the time of the Analytical Testing Restriction decision; - Samples for which , at the time of the Analytical Testing Restriction decision, In... |
GC/C/IRMS analysis for Markers of the steroid profile); - Samples for which the “A” or “B” Confirmation Procedures had been completed, but results of the analysis had not been reported by the Analytical Testing Restriction date, or Samples which were undergoing “A” or “B” Confirmation Procedures at the time of ... |
These Samples shall be kept in the Laboratory under proper Laboratory Internal Chain of Custody and appropriate storage conditions. |
Should a “B” Confirmation Procedure be requested during the period of the Analytical Testing Restr iction , both “A” and “B” Samples shall be transferred 6 to another Laboratory (-ies) for the “A” Confirmation Procedure to be performed again and for the performance of the “B” Confirmation Procedure , if applicable. |
If the Analytical Testing Restriction was caused by the reporting of False Negative Finding (s), and further investigation reveals that other Negative Finding (s) had been reported for Samples that are still stored in the Laboratory , the Laboratory shall inform the Testing Authority and WADA . |
In such cases, both the “A” and “B” containers of the relevant Samples shall be transferred 6 to another Laboratory (-ies) for Further Analysis , as determined by WADA . |
These re -analyses may be applied to the class of Prohibited Substances and/or Prohibited Methods or to the Analytical Testing Procedure (s) that were associated with the Negative Finding (s), as determined by WADA. |
4.6.5.2 Suspension A Laboratory whose WADA accred itation has been suspended is ineligible to perform Analytical Testing of Samples for any Signatory . |
This provision does not apply when the noncompliance(s) that led to the Suspension do not affect the blood analyses for the ABP, as determined by WADA . |
- Suspension for Violation of the Code of Ethic s If the reason for the Suspension was related to a violation of the Code of ISL – January 2021 Page 52 of 160 Ethics (Annex A), all Analytical Testing in the suspended Laboratory shall cease immediately and the Laboratory shall transfer 7 all Samples (both the ... |
- Suspension for Reporting of False Adverse Analytical Finding (s) If the reason for the Suspension was related to the reporting of False Adverse Analytical Finding (s), all Analytical Testing shall cease immediately. |
In addition, the Laboratory shall transfer 7 the following Samples (“A” and “B” Samples ) in the Laboratory ’s custody to another Laboratory (-ies) for the performance of the “A” and, if needed, the “B” Confirmation Procedures , unless otherwise instructed by WADA : o Samples , which had been previously reported as a... |
GC/C/IRMS analysis for Markers of the steroid profile); o Samples , which had been opened and were undergoing analysis for the Initial Testing Procedure (s) at the time of the Suspension ; o Samples which had been received at the Laboratory but had not been opened at the time of the Suspensi on [these Samples shall... |
Any additional costs of analysis to those previously agreed or already paid to the suspended or revoked Laboratory shall be borne by the Laboratory under Suspension or Revocation . |
In case of Code of Ethics violation(s), the suspended or revoked Laboratory shall also reimburse the Testing Authority for the costs of re -analyses in another Laboratory . |
The suspended or revoked Laboratory shall inform WADA of such actions incl uding providing the Sample code(s) and the identity of the relevant Testing Authority (-ies) and the chosen Laboratory (-ies). |
Testing Authorities should consider differences in analytical capacity between the suspended or revoked Laboratory and the receiving Laboratory (-ies) ( e.g. |
LOI for Non-Threshold Substances , capacity to perform specific analyses). |
In such cases, the Testing Authority may cons ult the Laboratories implicated and/or WADA for guidance. |
ISL – January 2021 Page 53 of 160 Laboratory (-ies)]. |
o Samples for which “A” or “B” Confirmation Procedures had been completed, but results of the analysis had not been reported by the Suspension date, or Samples which were undergoing “A” or “B” Confirmation Procedures at the time of the Suspension ; o Samples which had been reported as Adverse Analytical Finding ... |
- Suspension for Other Reasons A Laboratory that has had its WADA accreditation suspended for reasons other than a violation of the Code of Ethics or the reporting of False Adverse Analytical Findings (s) shall take the following steps with the Samples in the Laboratory ’s custody, unless otherwise instructed by W... |
These Samples shall be kept in the Laboratory under proper Laboratory Chain of Custody and appropriate storage conditions. |
The Laboratory shall inform WADA of such actions incl uding the provision of the Sample codes and the identity of the relevant Testing Authority (-ies). |
If the Suspension was caused by the reporting of False Negative Finding (s), and further investigation reveals that other Negative Finding (s) had been reported by the Laboratory , the Laboratory shall inform the Testing Authority and WADA . |
In such cases, both the “A” and “B” containers of the relevant Samples shall be transferr ed 7 to another Laboratory (-ies) for Further Analysis , as determined by WADA . |
These analyses may be applied for all the Prohibited Substances and Prohibited Methods included in the requested Analytical Testing menu or be limited to the class of Prohibited Substances and/or Prohibited Methods or to the Analytical Testing Procedure (s) that were associated with the Negative Finding (s), as d... |
o Samples for which Initial Testing Procedures had been completed, but results had not been reported at the time of the Suspension : If the Initial Testing Procedure( s) produced Presumptive Adverse Analytical Finding (s) or other Confirmation Procedures were required (e.g. |
GC/C/IRMS analysis for Markers of the steroid profile) , both the “A” and “B” Samples shall be transferred 7 to another Laboratory (-ies) for the performance of the “A” and, if needed, the “B” Confirmation Procedures . |
ISL – January 2021 Page 54 of 160 In addition, if the Suspension was cause d by the reporting of False Negative Finding (s) and the Initial Testing Procedure (s) had produced negative results, both the “A” and “B” Samples shall also be transferred 7 to another Laboratory (-ies) for the repetition of the Initial Test... |
These analyses may be applied for all the Prohibited Substances and Prohibited Methods included in the requested Analytical Testing menu or be limited to the class of Prohibited Subs tances and/or Prohibited Methods or to the Analytical Testing Procedure (s) that were associated with the Negative Finding , as det... |
If the reason for the Suspension was not related to the reporting of False Negative Findings and the Initial Testing Procedures had produced negative results, the Sample (s) shall be reported in ADAMS as Negative Finding (s). |
These Samples shall be kept in the Laboratory under proper Laboratory Internal Chain of Custody and appropriate storage conditions un til further notice by WADA . |
The Laboratory shall inform WADA of such actions including the provision of the Sample codes and the identity of the relevant Testing Authority (-ies). |
o Samples which had been opened and were undergoing analysis for the Initial Testing Procedure (s) at the time of the Suspension : If the reason for Suspension was not related to the reporting of False Negative Finding( s), the Laboratory shall continue to analy ze the relevant Samples until all Initial Testing Pr... |
If the Initial Testing Procedures produce Negative Findings , the Laboratory shall report these findings into ADAMS and these Samples shall be kept in the Laboratory under proper Laboratory Chain of Custody and appropriate storage conditions until further notice by WADA . |
The Laboratory shall inform WADA of such actions including the provision of the Sample codes and the identity of the relevant Testing Authority (-ies). |
However, if the Initial Testing Procedure produced a Presumptive Adverse Analytical Finding , both the “A” and “B” Samples shall be transferred 7 to another Laboratory (-ies) for the performance of the “A” and, if needed, the “B” Confirmation Procedures . |
If the Suspens ion was caused by the reporting of False Negative Finding (s), then the Laboratory shall cease all Analytical Testing and have the “A” and “B” Samples transferred 7 to another Laboratory (-ies) for the performance of the “A” and, if needed, the “B” Confirmation Procedures . |
o Samples which ha d been received at the Laboratory but had not been ISL – January 2021 Page 55 of 160 opened yet at the time of the Suspension : These Samples shall be kept sealed in the Laboratory under proper Laboratory Chain of Custody and appropriate storage conditions until transfer 7 to another Laborator... |
- Samples for which “A” or “B” Confirmation Procedures had been completed, but results of analysis had not been reported by the Suspension date, or Samples which were undergoing “A” or “B” Confirmation Procedures at the time of the Suspension : Both the “A” and “B” Samples shall be transferred 7 to another Labora... |
- Samples which had been reported as an Adverse Analytical Finding based on the “A” Confirmation Procedure prior to the Suspension : These Samples shall be kept in the Laboratory under proper Laboratory Internal Chain of Custody and appropriate storage conditions. |
Should a “B” Confirmation Procedure be requested during the Suspension , both “A” and “B” Samples shall be transferred 7 to another Labora tory(-ies) for the “A” Confirmation Procedure to be performed again and for the performance of the “B” Confirmation Procedure , if applicable. |
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