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The Laboratory may be required by WADA to analyze additional EQAS samples and/or to review the relevant analytical results and to re-analyze any relevant and available Samples previously reported as Adverse Analytical Findings 25 during the preceding twelve (12) months (or during a period 25 The Laboratory may not re -analyze Sample (s) previously reported as Adverse Analytical Findings if 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. |
However, in connection with its monitoring of a Laboratory , WADA may direct Further Analysis of a Sample which has resulted in an Article 2.1 anti -doping rule violation charge without consent of the Athlete or approval from a hearing body as provided in Code Article 6.5, provided that the analytical result from this an alysis may not be used against the Athlete [for example, re -analyzing Samples which a Laboratory has reported as Adverse Analytical ISL – January 2021 Page 131 of 160 otherwise determined by WADA ) within seven (7) days (unless informed otherwise by WADA ). |
Depending on the nature of the error that caused the False Adverse Analytical Finding , this re -analysis may be limited to one Analyte , a class of Prohibited Substances or Prohibited Methods , or may include any Prohibited Substance or Prohibited Method . |
A statement signed by the Laboratory Director shall record this re -analysis. |
The Laboratory will be required to inform all of its clients whose Analytical Testing results ma y have been affected. |
[Comment: The retrospective review of the analytical results and re -analysis of previous relevant Samples reported as Adverse Analytical Finding(s) shall be performed with the objective of determining whether any other related [i.e. |
p roduced by the same root cause(s)] False Adverse Analytical Finding(s) have been reported by the Laboratory . |
The discovery of additional false Adverse Analytical Finding(s) shall lead to the implementation of corrective measures and shall be communicated to the responsible Testing Authority /Results Management Authority and to WADA. |
However, the additional False Adverse Analytical Finding(s) will not lead to the accumulation of additional penalty points if produced by the same root cause(s), as determined by WADA.] |
a) False Adverse Analytical Finding with Consequences being imposed on an Athlete If the reporting of the False Adverse Analytical Finding has resulted in Consequences being imposed against an Athlete , the Laboratory shall receive twenty (20) penalty points in accordance with the Points Scale Table, irrespective of the nature of the error (technical/methodological or clerical/administrative) that led to the reporting of the False Adverse Analytical Finding . |
[Comment: WADA shall inform a Laboratory in writing about the imposition of penalty points, as decided by the LabEG and in accordance with the Points Scale Table. |
If the final decision regarding the number of penalty points to be imposed is conditional on the evaluation of corrective actions or other follow -up measures (e.g. |
analysis of further EQAS samples) that have been requested by the LabEG , WADA will only inform the Laboratory about the final number of penalty points imposed at the end of the evaluation process [e.g. |
5 penalty points at the end of the evaluation process of a False Negative Finding resolved through the timely implementation of satisfactory corrective action(s).] |
The LabEG , considering the nature of the error that caused the False Adverse Analytical Finding result, shall make a recommendation to the Chair of the WADA Executive Committee to suspend the Laboratory ’s WADA accreditation Findings when other Sample (s) analyzed by the Laboratory using the same Analytical Method have been discovered to be False Adverse Analytical Finding (s)]. |
ISL – January 2021 Page 132 of 160 or to impose an Analytical Testing Restriction against the Laboratory for a particular Analytical Testing Procedure or for the analysis of a particular class of Prohibited Substances or Prohibited Methods , as applicable . |
[Comment: During the period of Suspension , the Laboratory shall follow the instructions provided in Article 4.6.5.2 in regard to Samples in the Laboratory ’s possession at the time of Suspension . |
Alternatively, if an Analytical Testing Restriction has been imposed, the Laboratory shall subcontract the affected analyses as provided in Articles 4.6.5.1 and 5. |
2.6. |
During the Suspension or Analytical Testing Res triction period, WADA will conduct an assessment (preferably on -site) of the Laboratory , including the analysis of further EQAS samples. |
The Suspension or Analytical Testing Restriction of the Laboratory shall be lifted only when the aforementioned conditions are satisfactorily completed, and the Laboratory provides sufficient evidence, as determined by WADA, that appropriate steps have been taken to remedy the issue(s) that resulted in the Suspension or Analytical Testing Restriction .] |
b) False Adverse Analytical Finding with No Consequences being imposed on an Athlete - Technical or methodological error If the Root Cause Analysis investigation performed by the Laboratory identifies the error as technical or methodological, t he Laboratory will be initially imposed twenty (20) penalty points in accordance with the Points Scale Table. |
However, if the Laboratory first inform s (i.e. |
voluntarily self-report s) WADA of the ir investigation and discovery of a False Adverse Analytical Finding , then the Laboratory will have five (5) points deducted from the twenty (20) penalty points initially assigned . |
If the Laboratory is able to remedy the technical or methodological error through the implementation of satisfactory corrective actions in a timely manner, as determined by the LabEG , the Laboratory will have ten (10) penalty points deducted , in accordance with the Points Scale Table . |
The Laboratory will be informed by WADA , in writing, of the final amount of penalty points assigned in connection with the reporting of the False Adverse Analytical Finding . |
The Laboratory will be able to resume Analytical Testing activities following wr itten notification by WADA , provided that the point total accumulated by the Laboratory for a twelve (12)-month 23 period does not exceed thirty (30) points . |
However, if the Laboratory ’s Corrective Action Report is considered unsatisfactory by the LabEG , the LabEG shall provide feedback to the Laboratory and provide it with the opportunity to resubmit a revised Corrective Action Report within seven (7) days (or as otherwise agreed with WADA ). |
ISL – January 2021 Page 133 of 160 If the Laboratory is unable to resubmit a satisfactory revised Corrective Action Report in a timely manner, as determined by the LabEG , then the Laboratory will be assigned an additional five (5) penalty points and the LabEG shall make a recommendation to the Cha ir of the WADA Executive Committee to suspend the Laboratory ’s WADA accreditation or to impose an Analytical Testing Restriction against the Laboratory for a particular Analytical Testing Procedure or for the analysis of a particular class of Prohibited Substances or Prohibited Methods , as applicable . |
- Clerical /Administrative Error 26 If the Root Cause Analysis investigation performed by the Laboratory identifies the error as clerical or administrative, t he Laboratory will be initially assigned fifteen (15) penalty points in accordance with the Points Scale Table. |
However, if the Laboratory first informs ( i.e. |
voluntarily self -reports) WADA of the ir inv estigation and discovery of a False Adverse Analytical Finding , then the Laboratory will have five (5) points deducted from the fifteen (15) penalty points initially assigned. |
If the Laboratory is able to remedy the c lerical or administrative error through the implementation of satisfactory corrective actions in a timely manner, as determined by the LabEG , the Laboratory will have ten (10) additional penalty points deducted , in accordance with the Points Scale Table . |
The Labo ratory will be informed by WADA , in writing, of the total amount of penalty points assigned in connection with the reporting of the F alse Adverse Analytical Finding . |
The Laboratory will be able to resume Analytical Testing activities following written notification by WADA , provided that the point total accumulated by the Laboratory for a twelve ( 12)-month 23 period does not exceed thirty (30) points. |
However, if the Laboratory’s Corrective Action Report is considered unsatisfactory by the LabEG , the LabEG shall provide feedback to the Laboratory and grant an opportunity to resubmit a revised Corrective Action Report within seven (7) days (or as otherwise agreed with WADA ). |
If the Laboratory is unable to submit a satisfactory revised Corrective Action Report in a timely manner, as determined by the LabEG , the Laboratory shall receive an additional ten (10) penalty points in accordance with the Points Scale Table. |
The LabEG , 26 For the purposes of Laboratory performance evaluation, clerical/administrative errors are defined as those incidental, non -systematic errors of no technical or methodological origin, which have been committed by the Labora tory during the performance of Analytical Testing (e.g. |
a typographical error when manually recording an analytical result). |
The Laboratory shall bear no responsibility for clerical/administrative errors reflected in the Laboratory documentation, which were made, for example, by the Sample Collection Authority or Testing Authority . |
ISL – January 2021 Page 134 of 160 considering the na ture of the clerical/administrative error that caused the False Adverse Analytical Finding result, shall make a recommendation to the Chair of the WADA Executive Committee to suspend the Laboratory ’s WADA accreditation or to impose an Analytical Testing Restriction against the Laboratory , as applicable. |
7.2.1.2 False Adverse Analytical Finding for blind or double -blind EQAS sample In the event that a False Adverse Analytical Finding is reported during the EQAS , WADA will immediately start an investigation to establish if the incorrect result was caused by the EQAS sample provider (blind and double -blind EQAS ) or the Testing Authority (double -blind EQAS ). |
If it is established that the False Adverse Analytical Finding result was caused by an error made by the EQAS sample provider or the Testing Authority , the Laboratory will be informed by WADA and no further action will be required from the Laboratory . |
If the WADA investigation indicates that the False Adverse Analytical Finding was caused by an error made by the Laboratory during the Analytical Testing of the EQAS sample(s), the Laboratory shall be informed by WADA as soon as possible. |
However, if the False Adverse Analytical Finding is related to the analysis of a double -blind EQAS sample and the Laboratory first informs ( i.e. |
voluntarily self -reports) WADA of the ir investigation and discovery of a False Adverse Analytical Finding , this will be taken into consideration when evaluating the Laboratory ’s performance in accordance with the Points Scale Table (see below). |
The Laboratory shall provide WADA with a Corrective Action Report , including a Root Cause Analysis of the incorrect result(s) and corrective action(s) implemented for its rectification, within fifteen (15) days of being informed by WADA (unless otherwise indicated by WADA ). |
In addition, the Laboratory may be required by WADA to analyze additional EQAS samples and/or to review the analytical results and to re -analyze any relevant and available Samples previously reported as Adverse Analytical Findings 25 during the preceding twelve (12) months (or during a period otherwise determined by WADA ), within seven (7) days (unless informed otherwise by WADA ). |
Depending on the nature of the error that caused the false Adverse Analytical Finding , this re -analysis may be limited to one Analyte , a class of Prohibited Substances or Prohibited Methods , or may include any Prohibited Substance or Prohibited Method . |
The re-analysis shall be documented, and the results shall be reported to WADA . |
The Laboratory will be required to inform all of its cli ents whose Analytical Testing results may have been affected. |
The LabEG shall review the Laboratory ’s Corrective Action Report within fifteen (15) days, or within a timeline otherwise determined by WADA . |
ISL – January 2021 Page 135 of 160 - Technical or methodological error If the Root Cause Analysis investigation performed by the Laboratory identifies the error as technical or methodological, t he Laboratory will be initially imposed twenty (20) penalty points in accordance with the Points Scale Table. |
However, if the False Adverse Analytical Finding is related to the analysis of a double -blind EQAS sample and the Laboratory first informs ( i.e. |
voluntarily se lf-reports) WADA of the ir investigation and discovery of a False Adverse Analytical Finding , then the Laboratory will have five (5) points deducted from the twenty (20) penalty points initially assigned. |
If the Laboratory is able to remedy a technical/methodological error through the implementation of satisfactory corrective action(s) in a timely manner, as determined by the LabEG , the Laboratory will have ten (10) penalty points deducted , in accordance with the Points Sca le Table . |
The Laboratory will be informed by WADA , in writing, of the final amount of penalty points assigned in connection with the reporting of the False Adverse Analytical Finding . |
However, if the Laboratory ’s Corrective Action Report for the technical or methodological error is considered unsatisfactory by the LabEG , the LabEG shall provide feedback to the Laboratory and provide it with the opportunity to submit a revised Corrective Action Report within seven (7) days (or as otherwise agreed with WADA ). |
If the Laboratory is unable to resubmit a satisfactory revised Corrective Action Report in a timely manner, as determined by the LabEG , then the Laboratory will be assigned an additional five (5) penalty points and the LabEG shall make a recommendation to the Chair of the WADA Executive Committee to suspend the Laboratory ’s WADA accreditation or to impose an Analytical Testing Restriction against the Laboratory for a particular Analytical Testing Procedure or for the analysis of a particular class of Prohibited Substances or Prohibited Methods , as applicable . |
- Clerical /Administrative Error 26 If the Root Cause Analysis investigation performed by the Laboratory identifies the error as clerical or administrative, t he Laboratory will be initially imposed fifteen (15) penalty points in accordance with the Points Scale Table. |
However, if the False Adverse Analytical Finding is related to the analysis of a double -blind EQAS sample and the Laboratory first informs ( i.e. |
voluntarily self -reports) WADA of the ir investigation and discovery of a False Adverse Analytical Finding , then the Laboratory will have five (5) points deduct ed from the fifteen (15) penalty points initially assigned. |
ISL – January 2021 Page 136 of 160 If the Laboratory is able to remedy the c lerical or administrative error through the implementation of satisfactory corrective action(s) in a timely manner, as determined by the LabEG , the Laboratory will have ten (10) points deducted, in accordance with the Points Scale Table. |
Consequently, the Laboratory will be informed by WADA , in writing, of the final amount of penalty points assigned in connection with the reporting of the False Advers e Analytical Finding . |
However, if the Laboratory ’s Corrective Action Report is considered unsatisfactory by the LabEG , the LabEG shall provide feedback to the Laboratory and provide it with the opportunity to resubmit a revised Corrective Action Report within seven (7) days (or as otherwise agreed with WADA ). |
If the Laboratory is unable to submit a satisfactory revised Corrective Action Report in a timely manner, as determined by the LabEG , the Laboratory shall receive an additional ten (10) penalty points in accordance with the Points Scale Table. |
The LabEG , considering the nature of the clerical/administrative error that caused the False Adverse Analytical Finding result, shall make a recommendation to t he Chair of the WADA Executive Committee to suspend the Laboratory ’s WADA accreditation or to impose an Analytical Testing Restriction against the Laboratory , as applicable. |
The reporting of any False Adverse Analytical Finding Result, irrespective of whether it relates to routine Analytical Testing or the EQAS , or whether or not it results in the Suspension of a Laboratory ’s WADA accreditation or an Analytical Testing Restriction , may trigger a WADA Laboratory assessment and the requirement that additional EQAS samples be analyzed by the Laboratory . |
ISL – January 2021 Page 137 of 160 7.2.2 False Negative Finding 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 or double -blind EQAS sample or during routine Analytical Testing shall be informed of the False Negative Finding as soon as possible by WADA . |
WADA will immediately start an investigation to establish w hether the False Negative Finding was the result of the Laboratory ’s Analytical Testing process . |
If WADA ’s investigation determines that the False Negative Finding occurred due to mistake(s) related to the Laboratory ’s Analytical Testing process , the Laboratory will be initially imposed ten (10) penalty points in accordance with the Points Scale Table. |
However, if the False Negative Finding is related to the analysis of a routine Sample or a double -blind EQAS sample and the Laboratory first informs ( i.e. |
voluntarily self -reports) WADA of the ir investigation and discovery of a False Negative Finding , then the Laboratory will have five (5) points deducted from the ten (10) penalty points initially assigned. |
The Laboratory shall provide WADA with a Corrective Action Report within fifteen (15) days (unless otherwise indicated by WADA ). |
The LabEG shall review the Laboratory ’s Corrective Action Report within fifteen (15) days, or within a timeline otherwise determined by WADA . |
If the Laboratory is able to remedy the issue(s) that led to the reporting of the False Negative Finding , through the implementation of satisfactory corrective actions in a timely manner, as determined by the LabEG , five (5) penalty points initially imposed will be deducted, in accordance with the Points Scale Table. |
Consequently, the Laboratory will be infor med by WADA , in writing, of the final amount of penalty points assigned in connection with the reporting of the False Negative Finding . |
However, If the Laboratory ’s Corrective Action Report is considered unsatisfactory by the LabEG , the LabEG shall provide feedback to the Laboratory and provide it with the opportunity to resubmit a revised Corrective Action Report within seven (7) days (or as otherwise agreed with WADA ). |
If the Laboratory is unable to resubmit a satisfactory revised Corrective Action Report in a timely manner, as determined by the LabEG , the Laboratory shall receive an additional five (5) penalty points in accordance with the Points Scale Table. |
In addition, WADA will requ est the Laboratory to analyze additional (blind and/or double -blind) EQAS sample(s). |
Depending on the nature of the error that caused the False Negative Finding , this additional analysis may be limited to one Analyte , a class of Prohibited Substances or Prohibited Methods , or may include any Prohibited Substance or Prohibited Method . |
The Laboratory shall report correc t results for the analysis of all EQAS samples. |
In addition, the Laboratory shall implement satisfactory corrective action(s) (as determin ed by WADA ) which ensures that the cause(s) of the nonconformity is eliminated, thus avoid ing repetition of the mistake in the future. |
Failure by the ISL – January 2021 Page 138 of 160 Laboratory to report correct results for the additional EQAS sample(s) will incur the imposition of additional penalty points in accordance with the Points Scale Table . |
The LabEG , considering the nature of the error that caused the False Negative Finding , shall make a recommendation to the Chair of the WADA Executive Committee to suspend the Laboratory ’s WADA accreditation or to impose an Analytical Testing Restriction against the Laboratory , as applicable. |
The reporting of False Negative Finding (s), irres pective of whether it relates to routine Analytical Testing or the EQAS , or whether or not it results in the Suspension of a Laboratory’s WADA accreditation or an Analytical Testing Restriction , may trigger a WADA Laboratory assessment and the requirement that the Laboratory analyses additional EQAS samples. |
7.2.3 Further Procedural Evaluations 27 If the LabEG considers that a Corrective Action Report is unsatisfactory, and the Laboratory is not able to provide a satisfactory revised Corrective Action Report within a reasonable time frame after receiving feedback from the LabEG , the Laboratory will receive two (2) penalty points . |
Corrective Action Reports related, for example, to nonconfor mities detected during WADA Laboratory assessments, or to procedural or reporting nonconformities with the ISL, Technical Document s or Technical Letters , or unsatisfactory performance in the analysis of EQAS samples (not related to a False Adverse Analytical Finding or False Negative Finding ), shall be submitted to WADA within thirty (30) days of WADA ’s notification to the Laboratory . |
Late submission of Corrective Action Reports , as determined by the LabEG , will result in the imposition of one (1) additional penalty point per seven (7) days beyond the applicable deadline , unless the Laboratory provides valid reasons for the delay, as determined by the LabEG . |
Unless otherwise agreed with WADA , the corrective and preventive action(s) reported to and approved by WADA shall be implemented in the routine operations of the Laboratory immediately. |
7.3 Overall Laboratory Evaluation WADA shall evaluate Laboratory EQAS performance for each EQAS round, as well as Laboratory performance for routine Analytical Testing , and assign penalty points for nonconformities or failures to perform as indicated in the Points Scale Table. |
The accumulation of the maximum allowed number of penalty points for the EQAS and/or routine Analytical Testing , as determined in the Points Scale Table below, shall prompt the LabEG to make a recommendation to the Chair of the WADA Executive Committee to impose 27 Article 7.2.3 does not apply to the evaluation of Correctiv e Action Reports for False Adverse Analytical Findings or False Negative Findings , which are covered in Arts. |
7.2.1 and 7.2.2, respectively. |
ISL – January 2021 Page 139 of 160 an Analytical Testing Restriction against the Laboratory or to impose a Suspension of the Laboratory ’s WADA accreditation, as applicable. |
When a Laboratory ’s WADA accreditation is suspended : - If a Laboratory under Suspension accumulates the maximum allowed number of penalty points in the EQAS , as determined in the Points Scale Table below, and the Laboratory is not capable of correcting the issue(s) before the end of the Suspension period, then the LabEG shall make a recommendation to the Chair of the WADA Executive Committee to extend the Laboratory ’s Suspension for up to an additional six (6) months or until such a time when the Laboratory can satisfactorily correct all the issues identified ; - If the Laboratory under Suspension accumulates the maximum allowed number of penalty points during an extended period of Suspension (beyond the initial six (6) months), then the LabEG may recommend the Revocation of the Laboratory ’s accreditation to the WADA Executive Committee; - Any accrue d penalty points leading up to the Suspension or further accumulated through the Laboratory ’s participation in the blind EQAS program during the Suspension period, are reset to zero (0) upon reinstatement of its WADA accreditation 28. |
When a Laboratory is subject to an Analytical Testing Restriction : - Laboratories under an Analytical Testing Restriction remain operational (except for the activity( -ies) under the Analytical Testing Restriction ) and, therefore, are evaluated during the Analytical Testing Restriction as any other, fully operational Laboratory ; - Any penalty points not related to the Analytical Testing Restriction , which were accumulated up to the imposition of the Analytical Testing Restriction or further accumulated during the Analytical Testing Restriction period (within a twelve ( 12)-month period 23), are carried over after the lifting of the Analytical Testing Restriction . |
Any penalty points accrued in relation to the Analytical Testing Restriction are removed after the lifting of the Analytical Testing Restriction . |
28 This provision does not apply to a voluntary cessation of Laboratory operations (see Article 4.6.7). |
ISL – January 2021 Page 140 of 160 Points Scale Table for Assessment of Laboratory and Probationary Laboratory Performance Analytical Testing Conditions Nonconformity Type of Error Outcome Penalty Points Actions and Sanctions Routine Analytical Testing (Art 7.2.1. |
1) False AAF + Consequence for the Athlete Technical / Methodological error or Clerical / Administrative error 20 Cease Analytical Testing and Suspension / Analytical Testing Restriction Routine Analytical Testing (Art 7.2.1. |
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