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There shall be an agreement , sufficiently ahead of the Major Event , between the Major Event Organization and the Laboratory with respect to Analytical Testing requirements such as test result turn -around time, the expected number of blood and urine Samples to be analyzed, or the number of specific analyses ( i.e.
not considered as part of the routine Analytical Testing menu) required for the Major Event .
The Laboratory shall be responsible for providing WADA with regular and timely progress reports regarding its preparations for the Major Event .
1.0 Major Event Analytical Testing in the Laboratory Facilities When Analytical Testing services for a Major Event are provided in the existing facilities of a Laboratory , the WADA accreditation status of the Laboratory shall apply, and no additional WADA Accreditation Certificate for the Major Event is requir ed.
However, the Laboratory shall meet the requirements listed below in Annex B Articles 1.1 to 1.4.
All new Test Methods for the Major Even t shall be validated at least one (1) month prior to start of Analytical Testing for the Major Event .
In addition, a ny changes to Test Methods , equipment or other procedures in the Management System shall also be validated prior to the start of Analytical Testing for the Major Event .
1.1 Participation in WADA Assessment(s) WADA may perform one or more assessment(s) (prefer ably on-site) of the Laboratory ’s existing facilities with the aim to evaluate the Laboratory operations and capability to provide Analytical Testing services for the Major Event .
The number and type of assessments (on-site, remote and/or documentary audit) will be determined by WADA based on the scale of the Major Even t’s Test Distribution Plan and the Laboratory ’s progress in preparing for the ISL – January 2021 Page 150 of 160 Major Even t. These assessment(s) may include analysis of a set of EQAS samples.
Costs related to the WADA assessment(s) shall be at the Laboratory ’s expense.
A first WADA assessment should be conducted at least six (6) months before the scheduled start of the Analytical Testing for the Major Even t. Emphasis will be placed on the complet ed and planned implementation of the following: - The physical layout of the Laboratory space to ensure that there is adequate analytical and Sample handling capacity (based on the expected number of Samples and reporting deadlines) , including the separation of analytical and administrative areas of the Laboratory ; - The adequacy of the Laboratory ’s external and internal security plans, including: o Secure Laboratory entry and exit points which are restricted to authorized personnel only; o Secure and restricted Laboratory controlled zones (in particular , the analytical area(s), the Sample reception/processing room and the Sample storage units) ; o Adequate Laboratory space and security measures for the “B” Sample opening procedure, including appropriate provisions to ensure the confidentiality of the Athlete (s); o If requested by the Major Event Organization and in accordance with applicable national laws or workplace regulations, Laboratorie s providing Analytical Testing services during a Major Event or storing Samples collected at a Major Event should, when justified, monitor the Laboratory perimeter and the access point(s) to Sample storage room(s) (e.g.
through the use of CCTV cameras).
- The adequacy of the Laboratory ’s IT security system, including restricted and secure central server (s), data management system ( e.g.
LIMS), internal network and controlled access to the internet , if applicable ; - The Laboratory ’s organizational chart for the Major Event , which includes the Laboratory staff and planned expansion of staff including external expert s. Details shall include name s, qualifications, area(s) of operation and responsibilities .
In addition, the organizational chart shall identify the Certifying Scientists (internal and external experts) per Analytical Testing Procedure ; - The r ecruitment and logistics plans for the external scientists , including the name s, expertise and area(s) of responsibility for the Major Event ; - The existing instrumentation and equipment including the plan and timelines to order, install and qualif y any new instruments ; - The status of the Laboratory’s Analytical Testing Procedures , including plans and timelines for method development and validation (including responsible scientific staff) to meet any additional Analytical Testing requirements for the Major Event ; - The Labor atory ’s scope of ISO/IEC 17025 accreditation including any planned additions to the scope of accreditation ; ISL – January 2021 Page 151 of 160 - The status of the stock of Reference Materials , including the plans to order and implement any new Reference Materials and/or Reference Collections ; - The Laboratory ’s internal EQAS program (iQAS) , including plans for the conduct of “stress tests” .
One or more stress tests are recommended to be completed by the time the Laboratory is in its final configuration for the Major Event ; - To assess compliance with the ISL and its related Technical Documents , Technical Letters and applicable Laboratory Guidelines .
A second WADA assessment, if necessary, sh ould be conducted at least two (2) months before the start of Analytical Testing for the Major Even t. At this stage, the Laboratory shall be ready to begin Analytical Testing for the Major Even t, including pre -Event Testing , if applicable.
The focus of the assessment is to verify that : - All construction requirements are completed, including any specific measures to ensure the adequacy of the physical layout and the security of the “B” Sample opening procedure ; - All measures have been implemented to ensure the adequacy of the Laboratory ’s IT security system ; - All Analytical Methods are validated and incorporated in the Laboratory’s ISO/IEC 17025 scope of accreditation ; - All equipment and supplies are received , including Reference Materials and/or Reference Collections ; - All staff recruitment is completed, including agreements , logistics and schedules for external experts ; - All corrective actions from the prior WADA assessment (s) have been satisfactorily addressed ; - The Laboratory has successfully conducted “stress tests” in order to evaluate its readiness for the Major Event ; - Any remaining issue(s) will be addressed by the Laboratory before any Major Event related Analytical Testing is scheduled to begin .
WADA , at its sole discretion and depending on the progress of the Laboratory in preparation for the Major Event , may conduct additional assessments of the Laboratory before the scheduled start of the Analytical Testing for the Major Event .
An Assessment Report will be issued to the Laboratory and the LabEG for each WADA assessment .
The Assessment Reports may include requests for Corrective Action Reports , Actions and provide guidance as applicable.
The Laboratory shall address and satisfactorily correct all noncompliance s identified during the WADA assessment(s) and/or resulting from its analysis of EQAS samples.
The documentation of the corrective actions shall be submitted to WADA as instructed and prior to star t of the scheduled Analytical Testing for the Major Event .
ISL – January 2021 Page 152 of 160 1.2 Participation in the WADA EQAS At its sole discretion, WADA may submit EQAS samples to the Laboratory for analysis.
The Laboratory shall implement, document, and provide to WADA satisfactory corrective action(s) for any noncompliance(s) identified in the EQAS .
Unsatisfactory responses and/or required action shall result in disqualification of the Laboratory from performing the Analyt ical Testing for the Major Event .
The EQAS should be conducted at a time which include s as many Major Event staff (Laboratory staff and temporary external experts) as possible .
The EQAS samples shall be analyzed using the same Analytical Testing Procedures that will be applied in the analysis of Samples for the Major Event .
1.3 Pre-Event Report At least two (2) months prior to the start of Analytical Testing for the Major Event , WADA may require that the Laboratory provide a report consisting of the following: - A valid signed contract between the Laboratory and the responsible Testing Authority /Major Event Organization including a Test Distribution Plan detailing the Sample collection schedule, number of urine and blood Samples and requests for specific analyses ( e.g.
EPO ); - An organizational chart including Laboratory staff and temporary scientists employed by the Laboratory for the Major Event .
Supporting information such as job titles and responsibilities shall be included ; - A list of all senior personnel temporarily working in the Laboratory for the Major Event (including name, qualifications and areas(s) of responsibility) ; - A training plan with timelines for new staff, including temporary staff and invited external experts .
The Laboratory Director shall ensure that these personnel are adequately trained in the methods, policies, and procedures of the Laboratory .
Particular em phasis should be given to the Code of Ethics and the confidentiality of the Results Management process.
Adequate documentation of training of these temporary employees shall be maintained by the Laboratory ; - A list of instrumental resources and equipment in cluding identification of ownership ; - A summary of the Results Management process including criteria for determining analytical results ( Adverse Analytical Findings , Atypical Findings , etc.
); and - A list of Analytical Testing Procedures within the Laboratory ’s Scope of ISO/IEC 17025 Accreditation and other method details as requested by WADA .
Any changes to the elements included in the Laboratory report shall be immediately reported to WADA .
ISL – January 2021 Page 153 of 160 1.4 Additional Professional Liability Insurance Coverage Laboratories performing Analytical Testing during a Major Event shall verify their professional liability risk insurance coverage and, if appropriate, obtain complementary coverage to adequately cover liability associated with the analysis of Samples and the hiring of additional temporary staff during the Major Event .
1.5 “B” Confirmation The Laboratory shall implement a SOP for conducting “B” Confirmation Procedure s, which ensures the maintenance of the Athlete ’s confidentiality in consideration of the increased media and public attention that might be expected during the Major Event .
The SOP shall address the following topics: - An entry and exit plan for Athletes , which ensures anonymity from external attention ; - In addition to the requirements of ISL Article 5.3.6.2.3, a representative from WADA or WADA ’s Independent Observers (IO) Team for Major Event s (if requested by WADA or the IO team, respectively) shall be authorized to attend the “B” Sample Confirmation Procedure ; - The scheduling of the “B” Sample Confirmation Procedure shall be made as soon as possible, in consultation with the Major Event Organizer , and taking into account that postponement could significantly increase the risk of Sample degradation and/or inadequately delay the decision -making process in the given circumstances .
1.6 Documentation and Reporting The reporting time required for Major Events may be substantially less than twenty (20) days (see also ISL Article 5.3.8.4).
The agreement between the Laboratory and the Major Event Organiz ation shall clarify the reporting timelines for Negative Findings , Adverse Analytical Findings , Atypical Findings and the reporting of specifi c test results (e.g., GC/C/IRMS, EPO).
2.0 Major Event Analytical Testing in “Satellite” Laboratory Facilities In addition to the accreditation requirements for Major Event s listed in Annex B Art 1.0 , a Laboratory which is required to move or extend its operations temporarily to a new physical location (“satellite facility”), shall also meet the following requirements: 2.1 Participating in WADA Assessment(s) WADA shall perform assessment(s) (preferably on -site) of the “satellite facility”.
The number and type of assessments (on-site, remote and/or documentary audit) will be determined by WADA based on the scale of the Major Event ’s Test Distribution Plan and the Laboratory ’s progress in preparing for the Major Event .
These assessment(s) may include analysis of a set of EQAS samples.
Expenses related to such visit(s) shall be at the Laboratory ’s expense.
ISL – January 2021 Page 154 of 160 2.1.1 Initial WADA Assessment WADA may perform an initial assessment of the Laboratory “satellite facility” as soon as it is available in order to determine whether the new facility is adequate in relation to the expected security, analytical and Sample handling requirements for a Major Event .
Emphasis will be placed on the adequacy of security considerations, the physical layout of the space to ensure that adequate separation of various parts of the Laboratory are maintained, and to provide a preliminary review of other key support elements and to asse ss compliance with the ISL and ISO/IEC 17025.
2.2 Documenting ISO/IEC 17025 Accreditation of the Satellite Facility At least one (1) month prior to the start of the scheduled Analytical Testing for the Major Event , the Laboratory must provide documentation th at the relevant Accreditation Body has approved the continued accreditation or accepted the suitability of the “satellite facility”.
An ISL trained assessor shall participate in the Accreditation Body assessment of the “satellite facility”.
2.3 Professional Liability Insurance Coverage Before WADA grants accreditation for Analytical Testing during the Major Event , “satellite” laboratories shall provide documentation to WADA that professional liability risk insurance coverage has been obtained to cover liability associated with the analysis of Samples during the Major Event .
2.4 Obtaining a Temporary and Limited WADA Accreditation Certificate The Laboratory ’s “satellite facility” shall obtain a Temporary and Limited WADA Accreditation Certificate for the Major Event .
All Test Methods or equipment unique to the “satellite facility” shall be validated or qualified at least one (1) month prior to the “satellite facility’s” final assessment for WADA accreditation.
Any changes to Test Methods , equipment or other procedures in the Managemen t System shall also be validated prior to the assessment.
Based on the documentation provided, WADA reserves the right to make a decision regarding accreditation of the Laboratory “satellite facility”.
In the event that the accreditation is awarded, WADA shall issue a Temporary and Limited WADA Accreditation Certificate for the period of the Major Event , which includes an appropriate time before and after the duration of the Major Event .
In the event that the accreditation is not awarded, it is the responsibility of the Testing Authority /Major Event Organization to activate a contingency plan in order to ensure Analytical Testing of Samples in compliance with ISL requirements during the Major Event .
ISL – January 2021 Page 155 of 160 3.0 Monitoring and Assessment during a Major Event WADA may choose, at its sole discretion, to have one (1) or more observer(s) in the Laboratory during the Major Event .
The Laboratory Director and staff shall provide full cooperation and access to the observe r(s).
WADA , in conjunction with the Major Event Organization or relevant International Federation, may submit double -blind EQAS samples to the Laboratory .
3.1 Reporting of False Analytical Findings during a Major Event In the event of a False Adverse Analytical Finding , the Laboratory shall immediately cease Analytical Testing for the relevant class of Prohibited Substances or Prohibited Methods .
The Laboratory shall apply corrective action(s) within twelve (12) hours of notification of the False Adverse Analytical Finding .
All Samples analyzed prior to the reporting of the False Adverse Analytical Finding and reported with an Adverse Analytical Finding for the class of Prohibited Substances or Prohibited Methods for which the noncompliance occurred shall be re -analyzed.
The results of the investigation and analysis shall be presented to WADA within twenty -four (24) hours unless otherwise agreed in writing.
In the event of a False Negative Finding , the Laboratory will be required to investigate the root cause and apply corrective actions within twenty -four (24) hours of notification of the False Negative Finding .
An appropriate number of Samples reported as a Negative Finding for the class of Prohibited Substances and Prohibited Methods for which the noncompliance occurred shall be re -analyzed.
The results of the investigation and analysis shall be presented to WADA within forty -eight (48) hours unless otherwise agreed in writing.
ISL – January 2021 Page 156 of 160 ISL ANNEX C – PROCEDURAL RULES FO R THE DISCIPLINARY COMMITTEE OF THE INTERNATIONAL STANDARD FOR LABORATORIES Preamble These Procedural Rules for the Disciplinary Committee (DC) of the ISL (the “Procedural Rules”) outline the process to be followed when a Laboratory challenges a recommendation of the LabEG in accordance with ISL Articles 4.6.4 .1.2 or 4.6.4.5 , when a Laboratory is subject to Revocation proceedings in accordance with ISL Article 4.6.4.3 or, when and where applicable, Disciplinary Proceedings are instituted against a n ABP Laboratory in accordance with ISL Article 4.7.4.1.
In such circumstances, any reference made to a Laboratory in these Procedural Rules shall also be understood as a reference to a n ABP Laboratory , unless such reference is not applicable due to the circumstances, specific nature or rules indicated in this ISL in relation to ABP Laboratories .
These Procedural Rules shall be considered as an integral part of the ISL.
PART I - Composition of the Committee Article 1 For each individual case, a DC shall be constituted.
It shall be composed of three (3) members including a Chairperson.
WADA ’s Director General shall appoint the three (3) -member DC for each case and select one member to serve as Chairperson.
The appointed members shall have a legal and/or scientific background with at least one member being an anti -doping laboratory expert an d one with legal training and education (including the Chairman).
The Chairman shall have experience in the conduct of disciplinary or legal proceedings.
All appointed members of a DC shall be free of any conflict of interest with WADA , the Laboratory concerned, or any other Laboratory , entity, organization or individual that could potentially benefit from the concerned Laboratory ’s Suspension , Revocation or Analytical Testing Restriction , and must otherwise be impartial in relation to WADA and the Laboratory concerned.
The anti -doping laboratory expert(s) may be member(s) of the LabEG , unless the case has been the subject of previous discussion or recommendation by the LabEG .
All DC membe rs shall sign a declaration in which they agree to maintain the confidentiality of the disciplinary process and any information related thereto , confirm their impartiality and mention any circumstance that may be relevant in this respect.
Article 2 If the impartiality of any member of the DC is challenged (for example, by the Laboratory ), the matter shall be decided by the Chairperson if he /she is not the concerned DC member or by the two other DC members if the challenge concerns the Chairperson.
In the event the two DC members cannot agree, ISL – January 2021 Page 157 of 160 WADA ’s Director General shall make the final decision.
The decision is not subject to an independent challenge.
PART II - General Provisions Article 3 Once the DC is constituted, WADA will provide it with the case file which includes the evidence it wishes to submit in support of the disciplinary action being taken against the Laboratory .
WADA may send the case file and any relevant information to the DC electronically or by registered mail.
Simultaneously, WADA shall provide the Laboratory with the case file and with all of the available supporting evidence.
WADA may send the case file and any information to the Laboratory electroni cally or by registered mail.
Within seven (7) days of receiving the case file, the Laboratory may respond in writing and provide its evidence to the DC and simultaneously to WADA ’s Legal Department.
Any requests to extend the deadline shall be addressed b y the Laboratory to the Chairperson of the DC, who shall have the discretion to grant or reject the requested extension.
Upon receipt of the Laboratory ’s submissions and evidence, WADA shall have seven (7) days to make rebuttal submissions to the Discipli nary Committee.
Any requests by WADA to extend this deadline shall be addressed to the Chairperson of the DC, who shall have the discretion to grant or reject the requested extension.
If the Laboratory fails or chooses not to respond or provide evidence wi thin the required time frame, the disciplinary proceedings will continue on the basis of the evidence at the disposal of the DC.
Article 4 Unless both parties agree or the Chairperson , at his/her discretion and following consultation with the other DC members, orders otherwise on the basis of justified grounds , the parties shall not be permitted to include additional material after the submission of the evidence packages in accordance with the procedure described in Annex C Article 3 above.
Any determination made by the Chairperson pursuant to this article is not subject to challenge or appeal.
Article 5 The working language of the DC shall be English.
The DC may accept documents in other languages at its discretion.
PART III - Scope of the Committee’s Review Article 6 The DC shall have the authorization to review the evidence of the case and to make a recommendation regarding the status of the Laboratory ’s WADA accreditation.
ISL – January 2021 Page 158 of 160 To the extent not otherwise provided in these “Procedural Rules”, the Chairperson may issue di rections regarding procedural matters to the parties.
The DC shall have the right to appoint one or more independent expert(s) should it consider that particular expertise is required in order for it to make its recommendation to maintain, suspend or rev oke a Laboratory ’s WADA accreditation or to impose an Analytical Testing Restriction .
After consulting the parties, the DC may, if it deems itself to be sufficiently well informed, decide not to hold a hearing and it may determine its recommendation based on the parties’ written submissions and the available documents.
The DC shall make its recommendation in accordance with the applicable regulations, including the Code , the ISL and any relevant Technical Document s or Technical Letters , or any other rules or law agreed to by WADA and the Laboratory , and by default, Swiss law.
The DC’s decisions, including the content of its recommendation, shall be by majority.
PART IV - Recommendation Article 7 The recommendation of the DC shall be i ssued in writing, with reasons 33, within fourteen (14) days of the conclusion of the hearing.