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WADA will communicate to the Laboratories and to the Accreditation Bodies which Analytical Testing Procedures are included in this category.
In such cases, the Analytical Testing Procedure shall be validated by the Laboratory .
The Laboratory may also be required to successfully participate in an inter -laboratory collaborative study or WADA -organized EQAS round in order to obtain an extension to the Scope of ISO/IEC 17025 Accreditation by a relevant Accreditation Body before introducing the Analytical Testing Procedure to the analysis of Samples .
However, once included within the scope, limited changes to these Analytical Testing Procedures may be allowed within the boundaries of a Flexible Scope of ISO/IEC 17025 Accreditation .
Nonetheless, this flexibility does not allow the Laboratories to introduc e new Analytes within these Analytical Testing Procedures if specific method performance and compliance decision criteria (e.g.
Decision Limits ) are needed and those criteria are not yet defined in an applicable Technical Document (e.g.
new target compound(s) for GC/C/IRMS analysis).
Inclusion of an Analytical Testing Procedure within the Laboratory ’s Scope of ISO/IEC 17025 Accreditation establishes that the Analytical Testing Procedure is Fit-for-Purpose , and the Laboratory shall not be required to provide Analytical Method validation documentation or EQAS performance data in support of an analytical finding .
Laboratories are expected to include Analytical Testing Procedures within their Scope of ISO/IEC 17025 Accreditation prior to application to the analysis of Samples .
However, u nder exceptional circumstances, a Laboratory may apply a method , which has been validated in accordance with applicable Technical Document (s), Technical Letter (s) or Laboratory Guidelines , to the analysis of Samples before inclusion into the Laboratory ’s Scope of ISO/IEC 17025 Accreditation .
However, in such cases, the Laboratory does not automatically benefit from the presumption that the method is Fit-for-Purpose , as would otherwise be the case if the Analytical Testing Procedure is included within the Laboratory ’s Scope of ISO/IEC 17025 Accreditation.
Consequently, any Adverse Analytical Finding reported by applying a Test M ethod , which is not within the Laboratory ’s Scope of ISO/IEC 17025 Accreditation, may require the ISL – January 2021 Page 35 of 160 Laboratory to provide method validation documentation or EQAS performance data in support of that Adverse Analytical Finding .
[Comment: Laboratories shall not apply a WADA -specific Analytical Testing Procedure to the analysis of Samples until such method is included in the Laboratory’s Scope of ISO/IEC 17025 Accreditation .]
4.4.2.3 Participate in the WADA EQAS Program Laboratories are required to participate in the WADA EQAS on a continuous basis and meet the performance requirements of the EQAS as described in Section 6 .0.
4.4.2.4 Laboratory Independence and Impartiality The Laboratory shall be administratively and operationally independent from any organization that could exert undue pressure on the Laboratory and affect the impartial execution of its tasks and operations 4.
In order to be administratively independent, the Laboratory cannot be administered by, connected or subject to an Anti-Doping Organization, sport organization or government Ministry of Sport or other government body responsible for sport performance , inclu ding their Board Members, staff, Commission Members or officials.
This is necessary to avoid potential conflicts of interest and ensure full confidence in the Laboratory ’s competence, impartiality, judgment and operational integrity, in compliance with ISO /IEC 17025.
In order to be operationally independent, the Laboratory shall manage its own affairs without hindrance, interference or direction from any Person .
The Laboratory shall, without limitation, control: the allocation of its budget, the procurement of equipment and other resources, Laboratory personnel decisions, the research conducted by the Laboratory and all Sample Analytical Testing and reporting of results.
The Laboratory shall have a dedicated budget allowing the implementation of an efficient approval process for the timely procurement of necessary Reference Materials , reagents, consumables and essential equipment, as well as independent Laboratory management de cisions concerning the recruitment, retention and training of staff, participation in scientific meetings and symposia, etc.
This does not prevent the Laboratory from receiving research grants or other financial support from their host organization (e.g.
4 Laboratories shall comply with these requirements of administrative and operational independence by 1 January 2022, unless otherwise approved by WADA .
ISL – January 2021 Page 36 of 160 university, hospital, public institution ), Anti-Doping Organizations , sport organizations, government, or other sponsors, while following applicable accounting regulations in connection with the receipt and management of those funds.
In accordance with ISO/IEC 17025, the Laboratory shall be a legal entity, or a defined part of a legal entity, which is legally responsible for its activities.
4.4.2.5 Document Compliance with the WADA Laboratory Code of Ethics The Laboratory shall annually provide to WADA a letter of compliance with the provisions of the Code of Ethics, signed by the Laboratory Director .
All staff employed at the Laboratory , permanent or temporary, shall also read, agree to and sign the Code of Ethics.
The Laboratory may be asked to provide documentation of compliance with the provisions of the Code of Ethics.
The Laboratory shall establish a system requiring Laboratory staff to report any alleged breaches of the Code of Ethics to the Laboratory Director , which the Laboratory Director shall report to WADA .
However, if Laboratory staff suspect that the Laboratory Director may have breached the Code of Ethics, the Laboratory staff shall report the alleged breaches of the Code of Ethics directly to WADA .
The Laboratory Director and/or the Laboratory ’s host organization and/or WADA , as applicable , shall immediately and thoroughly investigate any alleged breach of the Code of Ethics.
If the Laboratory ’s investigation determines that a breach of the Code of Ethics occurred, the Laboratory Director and/or the Laboratory ’s host organization shall immediately inform WADA of the results of the investigation and the disciplinary actions taken.
WADA may also request further sanctions or implement sanctions as a result of its own investigations.
Sanctions may range from a personal reprimand to the expulsion of the implicated Laboratory staff member(s), the reporting of the breach to the pertinent authorities ( e.g.
law enforcement) or the Suspension or Revocation of the Laboratory ’s WADA accreditation.
4.4.2.6 Document Implemented Research and Development Activities The Laboratory shall maintain a plan for research and development in the field of anti-doping science , including an annual budget in this area of at least 7% of the total annual operational budget allocated to activities associated with Signatories .
The Laboratory shoul d document the publication of results of the research in relevant scientific papers in the peer -reviewed literature (at least one publication every two (2) years).
The list of scientific papers shall be made available to WADA upon request.
The Laboratory may also demonstrate a ISL – January 2021 Page 37 of 160 research program by documenting successful or pending applications for research grants [at least one (1) application submitted every three (3) years].
[Comment: The validation or implementation of established anti -doping methods with only minor adjustments, or repetition of research previously published or presented by others, is not sufficient to be considered as a research and development activity .]
The Laboratory shall supply an annual progress report to WADA documenting research and development results in the field of anti-doping science .
The Laboratory shall also relate research and development plans for the following year.
4.4.2.7 Document Implemented Sharing of Knowle dge The Laboratory shall demonstrate its willingness and ability to share knowledge with other Laboratories .
The Laboratory shall disseminate the results of its research and development activities to other Laboratories .
The Laboratory should make at least one (1) annual contribution to an anti -doping symposium or conference.
Laboratories are encouraged to participate in collaborative research projects with other Laboratories , and to exchange experience, protocols, arrange for visits of specialists and provi de training to other Laboratories and probationary laboratories in specific areas of Analytical Testing .
The Laboratory shall supply an annual report on sharing of knowledge with other Laboratories to WADA .
A description of sharing of knowledge is provided in the Code of Ethics (Annex A).
4.4.2.8 Maintain Professional Liability Insurance Coverage Laboratories shall provide documentation to WADA including evidence that professional liability risk insurance coverage is maintained of no less than two (2) million USD annually (for example , evidence of timely payment of applicable fees and premiums ).
4.4.2.9 Providing renewed letter(s) of support Letter(s) of support, as described in Article 4.1.3, from Signatories shall be provided to WADA every two (2) years confirming three (3) years of support or unless otherwise approved by WADA.
4.4.2.10 Maintain Minimum Number of Samples In order to maintain proficiency in Analyti cal Testing , Laboratories are required to analyze a minimum of 3,000 Samples provided annually by Code -compliant Anti-Doping Organizations (as determined by WADA ) or as otherwise approved by WADA .
ISL – January 2021 Page 38 of 160 [Comment: To determine the minimum number of Samples, each urine Sample, blood Sample and ABP blood Sample analyzed by the Laboratory shall count as an individual Sample.]
WADA will monitor the number of Samples tested by the Laboratory .
If the number of Samples falls below 3,000 per year, the Laboratory ’s WADA accreditation may be suspended in accordance with Article 4.6.4.1 .2.
It is recognized that specific circumstances may affect a Laboratory ’s ability to analyze a minimum of 3,000 Samples annually, suc h as when an Anti-Doping Organization is declared non -compliant with the Code by WADA , or when the Laboratory is not operational for the full calendar year.
In such cases, WADA shall require that the Laboratory implement measures to maintain proficiency in Analytical Testing , for example by strengthening its internal Quality Assurance Scheme (iQAS) and internal audits program .
WADA may also provide additional EQAS samples and/or conduct a document ary audit and/o r an on -site or remote (on-line) assessment, at its discretion, in order to assess the status of the Laboratory ’s operations.
4.4.2.11 Publication of Laboratory Analytical Testing Procedures , services and fees Laboratories shall report and maintain in ADAMS an up -to-date list of Analytical Testing Procedures and service s, including standard prices, to assist Anti-Doping Organizations in developing Test Distribution Plans .
Upon request by an Anti-Doping Organization , Laboratories should cooperate with the Anti-Doping Organization by providing other relevant information regarding Testing plans ( e.g.
Laboratory analytical capabilities).
4.4.2.12 Participating in WADA / Accreditation Body Re -assessments and Continuous Assessments during the Accreditation Cycle • Accreditation Body Re -assessment and/or Continuous Assessment during the Accreditation Cycle The assessment team shall include at least one ISL-trained assessor selected by the Accreditation Body for the assessment/re -assessment.
The relevan t Accreditation Body should send copies of a summary of the Assessment Report, in English or French, as well as the Laboratory responses in a timely fashion to WADA .
Should the Laboratory prefer to provide the Assessmen t Report summary directly to WADA , it shall do so within thirty (30) days from receiving the Accreditation Body’s Assessment Report .
The Laboratory shall provide WADA with an updated copy of the ISO/IEC 17025 Certificate and Scope of ISO/IEC 17025 Accreditation as soon as it is obtained from the Accreditation Body.
ISL – January 2021 Page 39 of 160 • WADA Laboratory Assessment WADA reserves the right to conduct document ary audits as well as inspect and assess the Laboratory through on -site or remote (on-line) assessments at any time, at WADA ’s expense.
The notice of the WADA assessment will be made in writing to the Laboratory Director.
In exceptional circumstances, and at WADA ’s discretion, the assessment may be unannounced.
As part of an announced or unannoun ced Laboratory assessment, WADA retains the right to request copies of Laboratory documentation and/or request Further Analysis of selected “A” and/or “B” Samples either on-site or in a Laboratory (-ies) chosen by WADA .
4.5 Removal of Samples by WADA 4.5.1 Removal of Samples for Analysis or Further Analysis Within the context of an investigation or Laboratory performance monitoring activity (for example, during an on -site WADA Laboratory assessment) , WADA , initially at its expense, may remove Sample (s) from a Laboratory in order to conduct Further Analys is, or analysis of the Sample if the analytical results for that Sample have not yet been reported , for the purpose described in Code Article 6.2.
In such cases, WADA shall notify the Testing Authority , which shall retain ownership of the Sample (s) pursuant to the Article 10.1 of the International Standard for Testing and Investigations (ISTI) .
Notwithstanding the aforementioned, WADA shall retain the right to request analysis or Further Analysis , at its expense, as permitted by Code Article 6.6.
[Comment: If Laboratory nonconformities are revealed with respect to the Analytical Testing of any Sample, WADA retains the right to recover the expenses incurred in connection with the analysis or Further Analysis of the Samples from the Laboratory .]
WADA may delegate an observer to monitor the removal of the Samples , which shall be implemented in accordance with WADA ’s instructions.
During the removal of Samples , WADA shall be responsible for maintaining proper Sample chain of custody documentation and the safety and integrity of the Samples until receipt by the other Laboratory (-ies).
WADA may also require that the Laboratory transfer the Samples .
In such situations, the Laboratory shall be responsible for maintaining proper chain of custody documentation for all transferred Samples and the safety and integrity of the Samples until receipt by t he receiving Laboratory (-ies).
In connection with its monitoring of Laboratory performance, WADA may direct Further Analysis of a Sample which has resulted in a Code 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 that Further Analysis cannot be used against the Athlete (for example, re -analysis of Samples which a Laboratory ISL – January 2021 Page 40 of 160 has reported as Adverse Analytical Findings when the Laboratory has been determin ed to have reported False Adverse Analytical Findings using the same Analytical Method ).
4.5.2 Removal of Samples for Laboratory Quality Assessment WADA may also direct the re -analysis of anonymized Samples , which have met the conditions described in Article 5.3.12, for purposes of Laboratory quality assurance and education , including the implementation of a system of transfer of Samples reported as Negat ive Findings between Laboratories .
In this regard, the number of Samples directed by WADA for re -analysis may vary.
[Comment: A transfer of Samples with Negative Findings shall apply only to Samples collected by Signatories .]
4.6 WADA Monitoring of Accreditation Status WADA shall regularly review the compliance of Laboratories with the requirements listed in the ISL and related Technical Document s and Technical Letters .
In addition, WADA shall also conduct an annual review of EQAS results and of relevant routine Analytical Testing issues reported to WADA by stakeholders to assess the overall performance of each Laboratory and to decide its accreditation status.
4.6.1 Maintenance of WADA Accreditation Compliance with all the requirements established in Article 4.4.2, including satisfactory performance by a Laboratory in the EQAS and in routine Analytical Testing (see Sections 6 .0 and 7 .0), as determined by WADA , is a critical requirement for the maintenance of the Laboratory ’s WADA accreditation.
4.6.2 Re-accreditation Costs On an annual basis, WADA will invoice the Laboratory for a portion of the costs associated with the WADA re-accreditation process.
4.6.3 Issuing and Publication of Accreditation Certificate On an annual basis, when maintenance of accreditation is approved, the Laboratory shall receive a WADA Accreditation Certificate, signed by a duly authorized representative of WADA , which is issued in recognition of such accreditation.
The Accreditation Certificate shall specify the name of the Laboratory and the time period for which the Accreditation Certificate is valid.
WADA Accreditation Certificates may be issued after the effe ctive date, with retroactive effect.
The list of WADA -accredited Laboratories is maintained on WADA ’s website.
ISL – January 2021 Page 41 of 160 4.6.4 Withdrawal of WADA Accreditation A Laboratory ’s WADA accreditation may be suspended or revoked, or subject to an Analytical Testing Restriction , whenever the Laboratory fails to comply with the ISL and/or Technical Document s and/or Technical Letters , or where the Suspension , Revocation or Analytical Testing Restriction is otherwise required in order to protect the integrity of the Samples , the Analytical Testing process or the interests of the Anti -Doping Community.
The imposition of an Analytical Testing Restriction or the Suspension of a Laboratory ’s WADA accredita tion should not imply the automatic withdrawal of its ISO/IEC 17025 accreditation.
The status of the Laboratory ’s ISO/IEC 17025 accreditation is to be independently assessed by the relevant Accreditation Body.
4.6.4.1 Suspension of Accreditation and Analytical Testing Restriction The Chairman of the WADA Executive Committee may suspend a Laboratory ’s WADA accreditation or impose an Analytical Testing Restriction against a Laboratory if WADA identifies a noncompliance with the ISL and/or Technical Document s and/or Technical Letters based on the Laboratory ’s performance during the EQAS or during routine Analytical Testing .
The Laboratory ’s WADA accreditation shall be subject to a Suspension and not to an Analytical Testing Restriction , as determined by the LabEG , when the sanction imposed to the Laboratory impact s Analytical Methods or target Analytes that are included in the Laboratory ’s standard In-Competition or Out-of-Competition Analytical Testing menu s, because it would affect the analysis of all respective urine and/or blood Samples received by the Laboratory .
[Comment: If WADA determines that the noncompliance(s) leading to the Suspension of the Laboratory ’s WADA accreditation or to the imposition of an Analytical Testing Restriction against the Laboratory does not affect the Laboratory ’s ability to analyze blo od Samples for the ABP or to operate as an APMU , then the Laboratory may, at WADA’s discretion, continue operating in such a capacity.
In such cases, WADA will inform the Laboratory accordingly.]
4.6.4.1.1 Suspension of Accreditation and Analytical Testing Restriction – No Disciplinary Proceedings In the event that a Laboratory has accumulated the maximum allowed number of penalty points for the EQAS and/or Analytical Testing (as determined by the application of the Points Scale Table in Article 7.3), or if a Laboratory has reported a False Adverse Analytical Finding with Consequence s for an Athlete , the LabEG shall make a recommendation to the Chairman of the WADA Executive Committee that the Laboratory be subject to an Analytical Testing Restriction , ISL – January 2021 Page 42 of 160 Suspension or Revocation , as applicable and as determined by the LabEG .
If the LabEG recommends to the Chairman of the WADA Executive Committee that the Laboratory be subject to an Analytical Testing Restriction or Suspension when the specific above -mentioned nonconformities are present , the Laboratory may not challenge the recommendation of the LabEG before the Disciplinary Committee pursuant to Article 4.6.4.5 at any time .
However, i n the event that the Chairman of the WADA Executive Committee imposes an Analytical Testing Restriction or a Suspension against the Laboratory pursuant to this Article 4.6.4.1.1, the Laboratory may appeal the decision of the Chairman of the WADA Executive Committee to CAS in accordance with Article 4.6.4.7.
Notwithstanding the above, if the LabEG recommends the Revocation of a Laboratory ’s WADA accreditation in situations where the Laboratory has accumulated the maximum allowed number of penalty points for the EQAS and/or Analytical Testing (as determined by the application of the Points Scale Tab le in Article 7.3) or where the Laboratory report s a False Adverse Analytical Finding that results in Consequence s for an Athlete , the Laboratory may challenge the LabEG ’s recommendation before the Disciplinary Committee in accordance with Article 4.6.4.5 .
4.6.4.1.2 Analytical Testing Restriction and Suspension or Revocation of Accreditation – Disciplinary Proceedings .
The LabEG may also recommend to the Chairman of the WADA Executive Committee that a Laboratory be subject to an Analytical Testing Restriction or a Suspension or Revocation of its WADA accreditation even if the Laboratory has not reported a False Adverse Analytical Finding with Consequence s for an Athlete or has not attained the maximum number of penalty points detailed in the Points Scale Table in Article 7.3, but where the Laboratory ’s other Analytical Testing failure (s) and/or other identified nonconformities (as described in Articles 4.6.4.2 and 4.6.4.3, as applicable ) otherwise justifies that such action be taken to ensure the full reliability and accuracy of Analytical Testing and the accurate reporting of test results .