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If the Suspension concerns the analysis of blood Samples for the ABP, Samples collected prior to the Suspension date may be analyzed by the Laboratory .
The reporting of results for the relevant Sample(s) in ADAMS shall include a comment regarding the Suspension at the time of analysis so that the Testing Authority (or Results Manage ment Authority , if different) / APMU can take this information into account during the Results Management process.
[Comment: Due to the negative impact of time on the integrity of blood Samples for the ABP analysis, it is not normally feasible to send the ABP blood Samples to other Laboratory (-ies) for timely analysis.]
During a Suspension or Analytical Testing Restriction period, the Laboratory shall continue to participate in the WADA EQAS program.
WADA may require the Laboratory to analyze additional blind EQAS samples and/or perform a Laboratory assessment , at any time and at the expense of the Laboratory , in order to evaluate the Laboratory ’s status.
4.6.5.3 Revocation A laboratory whose WADA accreditation or approval for the ABP has been revoked is ineligible to perform Analytical Testing of Samples for any Testing Authority .
The Laboratory Internal Chain of Custody maintained by a revoked laboratory for stored Samples is valid until such time that arrangements can be ISL – January 2021 Page 56 of 160 made, in consultation with WADA , for the transfer 7 of relevant Samples to a Laboratory (-ies).
A laboratory whose WADA accreditation or approval for the ABP has been revoked shall arrange the transfer 7 of Samples in the laboratory ’s custody to a Laboratory (-ies) chosen by the Testing Authority or WADA , respectively, within thirty (30) days of being notified of the decision revoking its WADA accreditation.
In such circumstances, the Samples to be transferred shall be selected by the Testing Authority or WADA .
The laboratory transferring the Samples shall inform WADA and provide the relevant Sample codes and the identity of the relevant Testing Authority (-ies) and the chosen Laboratory (-ies).
In addition, the revoked laboratory shall assist the relevant Testing Authority (-ies) with the transfer of the relevant Sample data and records t o the Laboratory (-ies) that have been selected to receive the Samples .
[Comment: The revoked laboratory shall transfer all Samples in its custody for which the Analytical Testing process has not been completed at the time of the Revocation .
The Testing Authority may also choose to transfer additional Samples retained in the laboratory in accordance with Articles 5.3.11.1. or 5.3.
11.2, or other Samples for which it is the owner pursuant to Article 10.1 of the ISTI and that had been analyzed and were in long -term s torage at the time of the Revocation of the laboratory ’s WADA accreditation.
In addition, WADA may identify and request that Samples be transferred to another Laboratory (-ies).]
4.6.6 Reinstatement of Suspended Accreditation or Lifting of the Analytical Testing Restriction WADA shall lift the Suspension of the Laboratory ’s WADA accreditation or lift the Analytical Testing Restriction only when the Laboratory provides satisfactory evidence, as determined by WADA , that appropriate steps have been taken to remedy the noncompliance(s) that resulted in the Suspension of the Laboratory ’s WADA accreditation or the imposition of the Analytical Testing Restriction , and that proper measures have been implemented to satisf actorily address the condition(s) specified, if any, for reinstatement of WADA accreditation.
4.6.6.1 Extension of Suspension or Analytical Testing Restriction If a Laboratory whose WADA accreditation has been suspended or has been the subject of an Analytical Testing Restriction has not satisfactorily corrected the ISL and/or Technical Document (s) and/or Technical Letter (s) noncompliance(s) that resulted in the Suspension or Analytical Testing Restriction , or if WADA identifies any additional ISL and/or Technical Document (s) and/or Technical Letter (s) noncompliance(s) during a WADA Laboratory assessment conducted during the initial Suspension or Analytical Testing Restriction period, either the Suspension of the Laboratory ’s WADA accreditation or Analytical Testing Restriction shall be further extended or the Laboratory’s accreditation shall be revoked, as determined by WADA .
ISL – January 2021 Page 57 of 160 The Suspension or Analytical Testing Restriction period may be extended up to an additional six (6) months, if the Laboratory provides justifiable explanation(s) for the delay , as determined by the LabEG , in addressing the conditions to lift the Suspension or Analytical Testing Restriction (including the submi ssion of satisfactory corrective actions ).
The Suspension of a Laboratory ’s WADA accreditation or the Analytical Testing Restriction , including any extensions of a Suspension or Analytical Testing Restriction , shall not exceed twelve (12) months, unless the Laboratory is subject to Revocation proceedings in accordance with Article 4.6.5.3 or as otherwise determined by WADA .
If applicable, a delay in the delivery of the ISO/IEC 17025 accreditation to the Labora tory by the relevant Accreditation Body may also constitute grounds to extend the Suspension of the Laboratory ’s WADA accreditation.
The decision to extend the Suspension of a Laboratory ’s WADA accreditation or the period of the Analytical Testing Restriction shall be rendered by the Chair of the WADA Executive Committee on the basis of a recommendation from the LabEG .
WADA will provide the Laboratory with a decision of the Chair of the WADA Executive Committee extending the Suspension of the Laboratory ’s WADA accreditation or extending the period of the Analytical Testing Restriction .
The Laboratory may appeal WADA ’s decision to extend the Suspension of its WADA accreditation or to extend the period of the Analytical Testing Restriction in accordance with Article 4.6.4.
7.
If, in accordance with the terms of the extension of the Suspension of the Laboratory ’s WADA accreditation or the terms of the extension of th e Analytical Testing Restriction , the Laboratory provides evidence determined to be satisfactory by WADA that all of the identified ISL and/or Technical Document and/or Technical Letter noncompliance(s) have been corrected, the Laboratory’s accreditation shall be re -instated or the Analytical Testing Restriction may be lifted by decision of the Chair of the WADA Executive Committee.
If the Laboratory has not provided evidence determined to be satisfactory by WADA at the end of the extended Suspension or extended Analytical Testing Restriction period, the LabEG shall recommend the Revocation of the Laboratory ’s accreditation.
The decision to revoke a Laboratory ’s WADA accreditation shall be rendered by the WADA Executive Committee.
If the Laboratory is subject to Revocation proceedings either at the end of a six (6) month Suspension or Analytical Testing Restriction or at the end of a Suspension or Analytical Testing Restriction that has been extended to twelve (12) months, the Laboratory ’s WADA accreditation shall remain subject to the Suspension or Analytical Testing Restriction , as applicable, until the ISL – January 2021 Page 58 of 160 completion of the Revocation proceedings and pending the decision of the WADA Executive Committee regarding the Revocation of the Laboratory ’s WADA accreditation.
If the WADA Executive Committee confirms the Revocation of the Laboratory ’s WADA accreditation, then the Laboratory ’s WAD A accreditation shall remain subject to the Suspension or Analytical Testing Restriction , as applicable, until the Revocation comes into effect according to Article 4.6.4.7.
[Comment: For Revocation proceedings conducted at the end of a Suspension or Analytical Testing Restriction period, no resolution facilitation session, as described in Article 4.6.4.4, will be conducted.]
WADA shall not be required to take any other formal action to extend the Laboratory ’s Analytical Testing Restriction or Suspension beyond either the initial six (6) - month Suspension or Analytical Testing Restriction or beyond the end of the Suspension or Analytical Testing Restriction that has been extended to twelve (12) months, apart from formally instituting Revocation proceedings against the Laboratory .
Further, if Revocation proceedings are instituted against a Laboratory in such circumstances, the Laboratory may not appeal the ex tension of its Analytical Testing Restriction or Suspension beyond the initial six (6) - month Suspension or Analytical Testing Restriction period or beyond the end of the Suspension or Analytical Testing Restriction that has been extended to twelve (12) mo nths.
WADA will notify the Laboratory of the decision of the WADA Executive Committee to revoke the Laboratory ’s WADA accreditation in accordance with Article 4.6.4.
6.
The Laboratory may appeal WADA ’s decision to revoke its WADA accreditation in accordance with Article 4.6.4.
7.
4.6.6.2 Revoked Accreditation If a laboratory whose WADA accreditation has been revoked wishes to seek a new WADA accreditation, it must apply for WADA accreditation as a new laboratory in accordance with Article 4.1.
When seeking a new WADA accreditation, the laboratory may request that WADA expedite the laboratory re -accreditation procedure , which shall be approved by the WADA Executive Committee.
To do so the laboratory shall provide WADA , as part of its application for a new accreditation, information that it considers constitutes “exceptional circumstances” as justification for modifying the requirements of Articles 4.1 to 4.3 to expedite the entry of the laboratory into, and/or shortening the duration of , the probationary phase of accreditation.
At its sole discretion, WADA ’s Executive Committee may determine whether such modifications are justified, and which steps must be followed prior to granting approval to the laboratory to enter the probationary phase of accreditation.
ISL – January 2021 Page 59 of 160 4.6.7 Voluntary Cessation of Laboratory Operations A Laboratory may decide to voluntarily cease its anti-doping Analytical Testing operations on either a temporary or permanent basis despite not having been found to have committed any analytical failures or other ISL noncompliance (s) and not having been subject to an Analytical Testing Restriction or Suspension or Revocation of its WADA accreditation.
In such circumstances, the Laboratory shall inform WADA and provide , in writing, the reason (s) for the cessation of anti -doping Analytical Testing operations as soon as the decision is taken to cease its operations and no later than three (3) months prior to the date on which its decision shall take effect.
The Laboratory shall also take all necessary measures to notify all its clients of the decision to cease its operations and to arrange , in consultation with its clients , to transfer Samples to another Laboratory (-ies) in accordance with Articles 4.6.5.2 (temporary closure) or 4.6.5.3 (permanent closure).
If a Laboratory voluntarily ceases its anti-doping Analytical Testing operations on a temporary basis, the Laboratory shall maintain satisfactory performance in the analysis of EQAS samples during the period of inactivity.
The period of temporary cessation of Analytical Testing activities shall not exceed six (6) months, with one possible extension of up to six (6) months (as determined by the Chair of the WADA Executive Committee based on a recommendation from the LabEG ).
If the Laboratory is unable to resume its Analytical Testing operations within a twelve (12) - month period, the WADA Executive Committee shall revoke the Laboratory ’s accreditation , unless otherwise approved by WADA .
If a Laboratory decides to cease its operations on a permanent basis , the Laboratory shall assist the relevant Testing Authority (-ies) with the transfer of relevant Sample data and records to the Laboratory (-ies) that have been selected to receive the Samples .
ISL – January 2021 Page 60 of 160 4.7 Process and Requirements for WADA Laborator y Approval for the ABP The network of WADA -accredited laboratories may be geographically limited to fully serve the practical development of the ABP.
Therefore, non -WADA -accredited laboratories, which have the capacity to analyze blood Markers , may apply for WADA approval for the purposes of condu cting blood Samples analysis in support of the hematological module of the ABP in regions that cannot be served by a Laboratory .
This Article describes the specific requirements that a laboratory shall fulfill in the process of applying for, obtaining, and maintaining WADA approval for the ABP.
4.7.1 Applicant Laboratory for WADA Approval for the ABP In principle, any laboratory that satisfies the criteria listed below may apply to become a candidate laboratory for WADA approval for the ABP.
However, the WADA Executive Committee , in its sole discretion, may accept or deny a laboratory’s candidacy application based on the identified needs (or lac k there of) for anti -doping Analytical Testing for the ABP on a regional or national scale, or for any other reason(s).
4.7.1.1 Expression of Interest The applicant laboratory shall officially contact WADA in writing to express its interest in becoming a n ABP Laboratory .
4.7.1.2 Submit Initial Application Form The applicant laboratory shall submit a completed initial application form, provided by WADA , with supporting documentation for review by the LabEG .
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.
4.7.1.3 Provision of Letter(s) of Support Upon receipt of an application and verification of the conditions mentioned above, WADA shall request that the applicant laboratory submit letter(s) of support from one or more Signatory .
The letter(s) of support shall indicate the estimated number of ABP blood Samples that will be provided per year to the applicant laboratory, as well as the reason(s) why an existing Laboratory or ABP Laboratory is not a viable option for the Signatory ’s ABP program.
ISL – January 2021 Page 61 of 160 4.7.2 Candidate Laboratory for WADA Approval for the ABP The application materials described in Articles 4.7.1.1 to 4.
7.1.3 shall be evaluated by the WADA Executive Committee to determine whether the applicant laboratory will be granted WADA candidate laboratory status for the ABP and thereby continue within the WADA approval process.
4.7.2.1 Description of the Candidate Laboratory Once approved by the WADA Executive Committee, the candidate laboratory shall complete a detailed questionnaire provided by WADA and submit it to WADA within eight (8) weeks of receipt .
The questionnaire will include, but is not limited to, the following: - List of staff that will be responsible for the ABP analyses and their qualifications ; - Description of the physical laboratory facilities, including a description of the security considerations for Samples and records (see Art icle 5.2.3) ; o Physical Security: specific measures to maintain a secure laboratory environment ( e.g., CCTV monitoring, restricted access t o Sample storage areas); o IT Security: implementation of firewalls and other current cyber security measures consistent with best practice and any applicable governmental regulations; o Information Technology (IT) infrastructure: implementation of a data an d information management system (e.g.
LIMS), central server/intranet which allows for secure data handling.
- List of actual and proposed instrumental resources and equipment for the ABP, including year of purchase and conditions for technical support ( e.g.
contract/ access to instrument maintenance services); - Status of the ABP method development and validation.
Method validation report (if completed); - Status of ISO/IEC 17025 or ISO 15189 accreditation; - Status of Laboratory ’s independence and impartiality as described in ISL Article 4.7.2.2; - Description of customs regulations in the host country with respect to the reception of blood Samples and consumables from abroad and the ability to ship blood Samples outside the country as needed .
WADA may require an update of this documentation during the process of the ABP approval .
ISL – January 2021 Page 62 of 160 [Comment: Candidate laboratories for ABP approval are encouraged to establish agreement(s) with a Laboratory (-ies) for mentoring and training in order to ensure successful preparation towards obtaining the WADA approval .]
4.7.2.2 Laboratory Independence and Impartiality 8 In order to avoid potential conflicts of interest, the laboratory shall be administratively and operationally independent from any organization which could exert undue pressure on the laboratory and affect the impartial execution of its tasks and operations .
- Administrative independence requires that the laboratory be a separate legal entity , or a defined part of a legal entity, without any administrative links to an Anti-Doping Organization or any other s port organization or government Ministry of Sport or other government body responsible for sport performance (see Article 4.4.2.4) ; - Operational independence requires that the laboratory shall manage its ABP Analytical Testing activities without hindrance, interference or direction from any Person .
4.7.2.3 Compliance with the Code of Ethics (Annex A) The candidate laboratory shall implement and comply with the provision(s) of the Code of Ethics.
A letter of compliance with the Code of Ethics shall be signed by the laboratory Director and provided to WADA .
4.7.2.4 Participating in the WADA EQAS Program for the analysis of ABP blood Markers The candidate laboratory shall be required to participate in at least three (3) WADA EQAS rounds for the analysis of ABP blood Markers with satisfactory performance, as determined by the LabEG .
During this period, WADA may provide feedback to assist the laboratory to improve the quality of its Analytical Testing process.
4.7.2.5 Obtaining ISO/IEC 17025 or ISO 15189 Accreditation The applicant laboratory shall obtain ISO/IEC 17025 or ISO 15189 accreditation from an Accreditation Body, which is an ILAC full member and is a signatory to the ILAC MRA for testing laboratories according to ISO/IEC 17025 or for medical laboratories according to ISO 15189 .
The laboratory shall correct and document any identified nonconformities with the ISO/IEC 17025 or ISO 15189 requirements within defined timelines.
The 8 ABP Laboratories shall comply with these requirements of administrative and operational independence by 1 January 2022, unless otherwise approved by WADA .
ISL – January 2021 Page 63 of 160 Accreditation Body should send a summary of the Assessment Report and any corrective/preventive action documentation addressing identified nonconformities, in English or French, to WADA .
Should the applicant laboratory prefer to send the information directly to WADA , the laboratory shall do so within a reasonable time line.
A valid ISO/IEC 17025 or ISO 15189 Accreditation Certificate and Scope of Accreditation shall be provided to WADA before the WADA -approval can be granted.
4.7.2.6 WADA On-Site Assessment for the ABP Approval Prior to approval , WADA shall conduct an on -site assessment of the candidate laboratory at the laboratory’s expense.
The purpose of this assessment is to obtain information about different aspects of the laboratory’s competence and verify compliance with the relevant ISL and TD BAR (Technical Document on blood analytical requirements for the Athlete Biological Passport ) requirements for the ABP and to clarify any issues with regard to the approval process.
[Comment: At WADA’s discretion, the initial on-site assessment for the ABP approval may not be necessary or may be conducted on -line or as a document -based audit, in cases of previously accredited or WADA -approved laboratories ].
WADA shall provide an Assessment Report regarding the outcomes of the on -site assessment , including any identified nonconformity( -ies), in order to allow the applicant laboratory to implement the necessary improvements.
Corrective actions, if requested by WADA , shall be conducted and reported by the candidate laboratory to WADA within thirty (30) days, or as otherwise indicated by WADA .
The nonconformities identified in the WADA Assessment Report shall be satisfactorily addressed and the recommendations for improvement should be implemented before the laboratory can be accepted as a n ABP Laboratory .
The laboratory’s performance in the on -site assessment will be taken into account in the overall review of the laboratory’s status and may affect the timeliness of the WADA approval.
4.7.2.7 Professional Liability Insurance Coverage Before WADA grants approval, candidate laboratories shall provide documentation to WADA that professional liability risk insurance coverage has been obtained to cover liability of no less than two (2) million USD annually.
4.7.3 Granting of WADA Approval for the ABP The maximum length of time during which a laboratory can remain as a candidate laboratory for the ABP is one (1) year, unless WADA determines that there are exceptional circumstances that justify an extension of this period.
ISL – January 2021 Page 64 of 160 Upon successful fulfilment of the requirements stated in the preceding provisions by a candidate laboratory, the LabEG will submit a recommendation to the WADA Executive Committee to grant the laboratory the status of an ABP Laboratory .
4.7.3.1 Issuing and Publishing of WADA Approval Certificate for the ABP Upon granting of WADA approval for the ABP, a WADA Approval Certificate signed by a duly authorized representative of WADA (exclusive to Analytical Testing in support of the Hematological Module of the ABP) will be issued to the laboratory.
On an annual basis, if approval for the ABP is maintained , the ABP Laboratory shall receive a renewed WADA Approval Certificate signed by a duly authorized representative of WADA (exclusive to Analytical Testing in support of the Hematological Module of the ABP), which is issued in recognition of such approval .
The WADA Approval Certificate shall specify the name of the ABP Laboratory and the period of validity.
WADA Approval Certificates may be issued after the effective date of the WADA approval, with retroactive effect.
A list of ABP Laboratories shall be maintained on WADA ’s website and in ADAMS for stakeholder reference.
4.7.4 Maint aining Status as a n ABP Laboratory The laboratory shall meet the following requirements to maintain its WADA approval status for the ABP: - Satisfactory performance, as determined by WADA , in a WADA EQAS or similar WADA -approved quality assurance program for the analysis of ABP blood Markers and during routine Analytical Testing of ABP blood Samples; - Maintenance of a valid ISO accreditation (ISO/IEC 17025 or ISO 15189); - Availability of analytical instrumentation, which is compliant with the requirements of the hematological module of the ABP, as determined by WADA ; - Implementation of Analytical Testing Procedures for the measurement of individual Athlete blood Markers , which are in compliance with the TD BAR; - Compliance with relevant WADA documents, including the relevant articles of the Section 5 .0 relevant to the analysis of blood Samples ; - Documented compliance with the Code of Ethics (Annex A); - Maintenance of Professional Liab ility Insurance Coverage; - Implementation of Laboratory Internal Chain of Custody procedures, which are compliant with the Technical Document on Laboratory Internal Chain of Custody (TD LCOC); ISL – January 2021 Page 65 of 160 - Production of Laboratory Documentation Package s or Certificate s of Analysis for the Blood ABP in compliance with the Technical Document on Laboratory Documentation Packag es (TD LDOC ); - Cooperation in support of the administrative and legal processes instigated when anti-doping rule violations are issued and managed by Anti-Doping Organizations .
4.7.4.1 Suspension or Revocation of WADA approval for the ABP A laboratory’s WADA approval for the ABP may be suspended or revoked whenever the ABP Laboratory fails to comply with the ISL and/or applicable Technical Document (s) and/or Technical Letter (s), or where the Suspension or Revocation of the laboratory’s approved status is otherwise required in order to protect the integrity of the ABP blood Samples , the Analytical Testing process for the ABP and the interests of the Anti -Doping Community.
Disciplinary proceedings to suspend or revoke a laboratory’s WADA approval for the ABP (including notice, publication, and right to appeal) shall be conducted in accordance with the procedures described in Articles 4.6.4 and 4.6.5, applied and modified accordingly, and the Procedural Rules found in Annex C of the ISL.
ISL – January 2021 Page 66 of 160 5.0 Application of ISO/IEC 17025 to the Analysis of Samples 5.1 Introduction and Scope This section of the ISL is intended as an extension of the application of ISO/IEC 17025 to the field of Doping Control .
Any aspect of Analytical Testing or management not specifically discussed in this document or in the relevant Technical Document s, Technical Letters or Laboratory Guidelines shall be governed by ISO/IEC 17025 (or ISO 15189 , as applicable for ABP Laboratories ).