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Additional supporting documentation may be requested by, and at the discretion of, the WADA Executive Committee.
4.2.1 Description of the C andidate 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 following receipt.
The questionnaire will include, but is not limited to, the following: - Staff list and their qualifications , including description of any relevant anti -doping experience and a list of relevant scientific publicatio ns by laboratory staff; - Description of the physical laboratory facilities, including a description of the security considerations for Samples and records.
The laboratory facilities shall include a mple analytical and administrative space to allow separate, restricted and dedicated areas for analytical and administrative operation s. o Physical Security: specific measures to maintain secure and restricted access ISL – January 2021 Page 26 of 160 to the laboratory facility and a controlled internal laboratory environment ( e.g.
dedicated and restricted Sample storage areas , CCTV monitoring ); o IT Security: implementation of firewalls and other cyber security measures consistent with best practice and any applicable governmental regulations (see Article 5.2.3.
5); o Information Technology (IT) infrastructure: implementation of a d ata and information management system (e.g.
LIMS ), central server /intranet which allows secure data handling (see Article 5.2.3.
5).
- List of actual and proposed instrumental resources and equipment , including year of purchase and conditions for technical support ( e.g.
contract/ access to instrument manufacturer maintenance services) ; - List of validated Initial Testing Procedures and Confirmation Procedures , including target Analytes and Limits of Detection (LODs), Limits of Identification (LOIs) and, where applicable, Limits of Quantification (LOQs) and Measurement Uncertainties (MU); - Status of method development and validation , including , at minimum, all mandatory Analytical M ethods and method validation reports ( if completed) ; - List of available Reference Materials and Reference Collections , or plans to acquire Reference Materials or obtain Reference Collections ; - Plans to ensure compliance with laboratory independence and impartiality requirements before receiving WADA accreditation (see Article 4.4.2.4 ); - List of laboratory sponsors; - Contract or Memorandum of Understanding with a Laboratory , which will provide mentoring and training for at least the period spanning the probationary phase of accreditation; [Comment: Candidate laboratories are encouraged to establish agreement(s) with a Laboratory (-ies) for mentoring and training, at least, up to the end of the probationary phase of accreditation in order to ensure successful preparation towards obtaining the WADA accreditation.
An authorization for the candidate laboratory to receive se nsitive anti -doping information ( e.g.
methodological or technological information, Technical Notes ) and/or to obtain access to specific, WADA -developed anti -doping tests or materials (e.g.
kits, Reference Materials ) may be approved by WADA on a case -by-case basis according to the documented roadmap , business plan and the progress made during the accreditation process and subject to the candidate laboratory entering into a confidentiality agreement with WADA and/or t he Laboratory (-ies) that will provide the information and/or access to the aforementioned tests and materials. ]
- Status of ISO/IEC 17025 accreditation; - Description of customs regulations in the host country with respect to the reception ISL – January 2021 Page 27 of 160 of urine and blood samples , Reference Materials and consumables from abroad and the ability to ship samples outside the country as needed; - A description of how the principles of the Code of Ethics (Annex A) are integrated into the laboratory Management System.
A letter of compliance with the Code of Ethics (Annex A) signed by the laboratory Director shall be provided .
WADA may require an update of this documentation during the process of accreditation.
4.2.2 Payment of Initial Accreditation Fee Prior to entering the probationary period, the candidate laboratory shall pay WADA a one-time non -refundable fee to cover the costs related to the initial accreditation process.
This fee shall be determined by WADA .
4.2.3 Compliance with the Code of Ethics (Annex A) The candidate laboratory shall implement and comply with the provision(s) of the Code of Ethics.
Candidate laboratories shall not conduct any anti -doping Analytical Testing activities for Signatories or WADA and shall not accept Samples directly from individual Athletes or from individuals or organizations acting on their behalf .
The Director of the candidate laboratory shall provide the Code of Ethics to all employees and ensure their understanding and compliance with all aspects of the Code of Ethics.
4.2.4 Laboratory Independence and Impartiality As a condition to enter the probationary period, the candidate labo ratory shall provide documentation to WADA demonstrating that , before obtaining WADA accreditation , they will comply with the requirements of Laboratory independence and impartiality indicated in Article 4.4.2.4 .
4.2.5 Pre-Probationary Test and On -Site Assessment Prior to entering the probationary period , WADA shall conduct a pre -probationary test (PPT) and on -site assessment of the candidate laboratory at the candidate laboratory’s expense.
The purpose of this assessment is to obtain information about different aspects of the laboratory’s competence and to clarify any issues with regard to the accreditation process, which are relevant for the WADA accreditation.
As part of the PPT, t he candidate laboratory shall be required to analyze at least ten (10) blind EQAS samples.
The general composition and content of the blind EQAS samples and the evaluation of laboratory EQAS results are described in Sections 6 .0 and 7 .0, respectively.
The candidate laboratory shall report the results for the PPT blind EQAS samples in ADAMS (in compliance with Art icle 6.3.1) within a period of twenty (20) days, unless otherwise notified by WADA .
ISL – January 2021 Page 28 of 160 - Upon request, the candidate laboratory shall provide WADA with a Laboratory Documentation Package for selected EQAS samples for which there is an Adverse Analytical Finding .
Additional data may be required upon WADA ’s request.
This documentation shall be submitted within ten (10) days of WADA ’s request or as otherwise indicated by WADA ; - For selected EQAS samples with Negative Findings , WADA may request all or a portion of the Initial Testing Procedure data.
After receiving the PPT EQAS results, WADA shall inform the candidate laboratory of the evaluation of its performance and provide guidance for improvement.
Corrective actions, if any, shall be conducted and reported by the candidate laboratory to WADA within thirty (30) days, or as otherwise indic ated by WADA .
In addition, WADA shall provide an Assessment Report regarding the outcomes of the on-site assessment , including any identified nonconformity( -ies), in order to allow the candidate laboratory to implement the necessary improvements.
Correctiv e 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 candidate laboratory can be accepted as a WADA probationary laboratory.
The candidate laboratory’s performance in the PPT and on -site assessment will be taken into account in the overall review of the candidate laboratory’s application and may affect the timeliness of the candidate laboratory’s entry into the probationary phase of accreditation.
The maximum length of time during which a laboratory can remain as a candidate laboratory is three (3) years, unless WADA determines that there are exceptional circumstances that justify an extension of this period.
Upon satisfactory completion of the candidate laboratory requirements (as per Article 4.2), as determined by the LabEG , a candidate laboratory enters the probationary phase of WADA accreditation as a “ WADA probationary laboratory”.
ISL – January 2021 Page 29 of 160 4.3 Probationary Laboratory for WADA Accreditation 4.3.1 Participating in the WADA EQAS Program During the probationary period, the laboratory shall successfully analyze at least fifteen (15) blind EQAS samples, distributed over multiple EQAS rounds within a period of twelve (12) months (see Section 6 .0 for a description of the EQAS ).
During this period, WADA shall provide feedback to assist the probationary laboratory to improve the quality of its Analytical Testing process.
The probationary laboratory shall successfully report the results for the blind EQAS samples to WADA in accordance with Article 6.3.1 within a period determined by WADA .
The general composition and content of the blind EQAS samples and the evaluation of laboratory EQAS results are described in Sections 6 .0 and 7 .0, respectively.
4.3.2 Planning and Implementing Research and Development Activities The probationary laboratory shall develop a plan for its research and development activities in the field of anti-doping science , for the initial three (3) -year period after obtaining WADA accreditation , allocating at least 7% of the operational annual budget expected from activities associated with Signatories .
At least two (2) research and development activities shall be initiated and implemented within the probationary period.
The research activities can either be conducted by the probationary laboratory alone or in cooperation with other Laboratories or other research organizations.
[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.]
As part of its laboratory monitoring activities, WADA may request documented evidence of the research and development activities in the field of anti-doping science implemented by the probationary laboratory.
4.3.3 Planning and Implementing Sharing of Knowledge During the probationary period, the probationary laboratory shall demonstrate its willingness and ability to collaborate and share knowledge with other Laboratories .
A description of this sharing of knowledge is provided in the Code of Ethics (Annex A).
4.3.4 Compliance with the Code of Ethics (Annex A) The probationary laboratory shall implement and comply with the provision(s) of the Code of Ethics.
Probationary laboratories shall not conduct any anti -doping Analy tical Testing activities for Signatories or WADA and shall not accept Samples directly from individual Athletes or from individuals or organizations acting on their behalf .
The Director of the probationary laboratory shall provide the Code of Ethics to all ISL – January 2021 Page 30 of 160 employees and ensure their understanding and compliance with all aspects of the Code of Ethics.
4.3.5 Obtaining ISO/IEC 17025 Accreditation by the Laboratory Before WADA grants accreditation, the probationary laboratory shall obtain ISO/IEC 17025 accreditation from an Accreditation Body, with primary reference to the interpretation and application of the ISO/IEC 17025 requirements to the analysis of Samples (see Section 5 .0).
The Accreditation Body shall be an International Laboratory Accreditation Cooperation (ILAC) full member that is a signatory to the ILAC Mutual Recognition Arrangement (ILAC MRA).
The probationary laboratory shall prepare and establish the required d ocumentation and Management System according to the requirements of ISO/IEC 17025 applicable to the analysis of Samples (see Section 5 .0).
Based on this, the laboratory shall initiate and prepare for the accreditation process by consulting with an Accredit ation Body.
The probationary laboratory shall correct and document any identified nonconformities with the ISO/IEC 17025 standard within the defined timelines.
The Accreditation Body should send a summary of the Assessment Report and any corrective/prevent ive action documentation addressing nonconformities, in English or French, to WADA .
Should the probationary laboratory prefer to send the information directly to WADA , the laboratory shall do so within a reasonable timeline.
The ISO/IEC 17025 accreditation shall be obtained before the end of the probationary period.
This is a critical and mandatory pre -requisite for obtaining WADA accreditation.
4.3.6 Analytical Testing Procedures Before WADA grants accreditation, probationary labor atories shall provide documentation to WADA demonstrating that all mandatory Test Methods (e.g.
GC/C/IRMS, hGH, GHRF and EPO methods) have been validated and included in the Laboratory ’s Scope of ISO/IEC 17025 accreditation.
4.3.7 Laboratory Independence and Impartiality Before WADA grants accreditation, probationary laboratories shall provide documentation to WADA demonstrating compliance with the requirements of Laboratory independence and impartiality established in Art icle 4.4.2.4.
4.3.8 Professional Liability Insurance Coverage Before WADA grants accreditation, probationary laboratories shall provide documentation to WADA demonstrating that professional liability risk insurance coverage has been obtained to cover liability of no less than two (2) million USD annually.
ISL – January 2021 Page 31 of 160 4.4 WADA -Accredit ed Laboratory 4.4.1 Obtaining WADA accreditation 4.4.1.1 WADA Accreditation Assessment - Final Accreditation Test Once WADA has determined that the laboratory has successfully completed the requirements of the probationary period, and upon request by the probationary laboratory stating its readiness to proceed further, a Final Accreditation Test (FAT) and on -site assessment sh all be conducted by WADA .
At WADA ’s discretion, the FAT and on -site assessment may be conducted separately or at the same time.
Representative(s) of the Accreditation Body may be invited as observers to the WADA on-site assessment .
As part of the FAT, the probationary laboratory shall analyze a minimum of fifteen (15) blind EQAS samples.
The genera l comp osition and content of the blind EQAS samples and the evaluation of laboratory EQAS results are described in Sections 6 .0 and 7 .0, respectively.
Compliance with the defined requirements in the Application of ISO/IEC 17025 to the analysis of Samples , the ISL and other WADA Laboratory standards ( Technical Document s, Technical Letters , Laboratory Guidelines ), and the practice and documentation of the laboratory will be assessed.
The FAT shall assess both the scientific competence and the capability of the probationary laboratory to manage multiple Sample s. Costs associated with the WADA on-site assessment and FAT shall be at the probationary laborator y’s expense.
The probationary laboratory shall successfully report the results for the blind EQAS samples in the FAT to WADA in accordance with Article 6.3.1 within seven (7) days of opening the samples, unless otherwise determined by WADA : - Upon request, the probationary laboratory shall provide WADA with a Laboratory Documentation Package for selected EQAS samples for which there is an Adverse Analytical Finding .
Additional data may be required upon WADA ’s request.
This documentation shall be submitted within ten (10) days of WADA ’s request or as otherwise indicated by WADA ; - For EQAS samples with Negative Findings , WADA may request all or a portion of the Initial Testing Procedure data.
After receiving the FAT EQAS results, WADA shall inform the probationary laboratory of the evaluation of its performance.
Corrective actions, if any, shall be conducted and reported by the probationary laboratory to WADA within thirty (30) days, or as otherwise indicated by WADA .
ISL – January 2021 Page 32 of 160 WADA shall provide an Assessment Report with the outcomes of the accreditation assessment, including any identified nonconformities in order for the probationary laboratory to implement the necessary improvements.
Corrective actions, if any, shall be conducted and reported by the probationary laboratory to WADA within thirty (30) days, or as otherwise indicated by WADA .
The nonconformities identified in the FAT EQAS and the Assessment Report shall be satisfactorily addressed by the laboratory and the recommendations for improvement should be implemented before accreditation can be granted.
4.4.1.2 WADA Recommendation for Accreditation Based on the relevant documentation received from the probationary laboratory, the Assessment Report(s) from WADA and from the relevant Accreditation Body, the LabEG shall evaluate the probationary laboratory’s progress in meeting all the requirements outline d in Art icles 4.3 and 4.4.1.1 .
Once all accreditation requirements have been satisfactorily met by the probationary laboratory, the LabEG will submit its recommendation that the laboratory be grant ed WADA accreditation to the WADA Executive Committee for approval.
However, if following the FAT and on -site assessment, and the review of any resulting Corrective Action Reports submitted by the probationary laboratory, the LabEG determines that the probationary laboratory should not be accredited, the laboratory will have a maximum of six (6) additional months to correct and improve any pending nonconformity( -ies).
The provision of documentation, the analysis of additional EQAS samples and/or an additional assessment (on-site, remotely or as a documentary audit , as determined by WADA ), may be required and conducted at the probationary laboratory’s expense .
A probationary laboratory that fails to provide satisfactory improvements, as determined by the LabEG , after six (6) months may be required to renew its candidacy as described in Article 4.2 or to re -start the probationa ry phase of accreditation in accordance with Article 4.3.
Once a laboratory becomes a WADA -accredited laboratory, the new Laboratory shall, for a period of one (1) year, obtain a second opinion from an(other) Laboratory (-ies) before reporting any Adverse Analytical Finding or Atypical Finding .
WADA may extend this requirement to obtain a second opinion beyond one (1) year.
4.4.1.3 Issuing and Publishing of WADA Accreditation Certificate An Accreditation Certificate signed by a duly authorized representative of WADA shall be issued in recognition of the WADA accreditation.
Such Accreditation Certificate shall specify the name of the Laboratory and the period for which the Accreditation Certificate is valid.
Accreditation ISL – January 2021 Page 33 of 160 Certificates may be issued after the effective date, with retroactive effect.
A list of WADA-accredited laboratories shall be published on WADA ’s website.
4.4.2 Maintaining WADA Accreditation In order to maintain WADA accreditation, a Laboratory shall comply with the following requirements.
4.4.2.1 Maintain ISO/IEC 17025 Accreditation The Laboratory shall m aintain accreditation to ISO/IEC 17025, with primary reference to the analysis of Samples (Section 5 .0), granted by a relevant Accreditation Body, which is an ILAC full member and signatory to the ILAC MRA for testing activities as defined in ISO/IEC 17025 .
4.4.2.2 Flexible Scope of ISO/IEC 17025 Accreditation 3 A Laboratory may modify or add Analytes to Analytical Testing Procedures , which are included within its Scope of ISO/IEC 17025 Accreditation or develop new Analytical Testing Procedure (s) that involve technology already included within the Scope of ISO/IEC 17025 Accreditation, without the need for approval by the Accreditation Body that provides the ISO/IEC 17025 accreditation of that Laboratory .
[Comment: The flexible system of ISO/IEC 17025 Laboratory accreditation shall be based on the overall assessment by the Accreditation Body of the demonstrated competence of the Laboratory in the implementation of Laboratory processes and procedures when following a Flexible Scope of ISO/IEC 1702 5 Accreditation system.
The flexible system of ISO/IEC 17025 Laboratory accreditation is important to ensure that Laboratories can adapt their Analytical Testing Procedures to the detection of new Prohibited Substances or Prohibited Methods, as well as to the application of new technical and scientific developments in Analytical Testing for Doping Control .]
The Laboratories are no t eligible to apply a Flexible Scope of ISO/IEC 17025 Accreditation to the analysis of Samples in the following scenarios: - New Analytical Testing Procedures : Any Analytical Testing Procedure , which is new to the field of anti -doping analysis, shall be approved as Fit-for-Purpose by WADA prior to implementation by any Laboratory .
WADA shall use whatever means deemed appropriate, including formal consultations with scientific expert working groups, publication(s) in peer -reviewed scientific journal(s), or participation in an inter -laboratory collaborative study or WADA -organized EQAS round to evaluate whether the test is Fit-for-Purpose prior to providing approval.
Before applying such a new Analytical Testing Procedure to the analysis of Samples, a 3 See ILAC -G29/06:2020 “Guidelines for harmonization of scopes of ISO/IEC 17025 accreditation of WADA anti-doping laboratories” .
ISL – January 2021 Page 34 of 160 Laboratory shall obtain an extension of the Scope of ISO/IEC 17025 Accreditation by the r elevant Accreditation Body and may be required to successfully participate in a WADA EQAS , if available ; - WADA -specific Analytical Testing Procedures : WADA may require an extension of the Scope of ISO/IEC 17025 Accreditation to include specific Analytical Testing Procedures before application to the analysis of Samples , even if the analytical technique involved is already incorporated in the Laboratory ’s Scope of ISO/IEC 17025 Accreditation .