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1) Or EQAS (blind or double blind) round (Art 7.2.1.
2) False AAF + No Consequence for the Athlete Technical / Methodological error 20 Cease Analytical Testing • Self-reporting 29 - 5 Resume Analytical Testing • Satisfactory and timely CAR - 10 • Unsatisfactory CAR + 5 Suspension / Analytical Testing Restriction Clerical / Administrative error 15 Cease Analytical Testing • Self-reporting 29 - 5 Resume Analytical Testing • Satisfactory and timely CAR - 10 • Unsatisfactory CAR + 10 Suspension / Analytical Testing Restriction Routine Analytical Testing Or EQAS (blind or double blind) round False Negative Finding (Art 7.2.2) False Negative Finding 10 Additional EQAS samples 30 • Self-reporting 29 - 5 • Satisfactory and timely CAR - 5 • Unsatisfactory CAR + 5 29 Voluntary self-reporting is not applicable to blind EQAS samples.
30 The results of the analysis of the additional EQAS samples will be evaluated in accordance with this Points Scale Table.
ISL – January 2021 Page 141 of 160 EQAS Evaluation Result Penalty Points Steroid Profile Markers |z-score| ≥ 3.0 (Occurrences*) |z-score| ≥ 3.0 and CAR 4-7 Unsatisfactory CAR 2 Satisfactory and timely CAR 1 8-12 Unsatisfactory CAR 4 Satisfactory and timely CAR 2 13-18 Unsatisfactory CAR 6 Satisfactory and timely CAR 3 ≥ 19 Unsatisfactory CAR 8 Satisfactory and timely CAR 4 GC/C/IRMS δ13C (≥ 3 Occurrences**) Threshold Substances (per occurrence) 2.0 < |z -score| < 3.0 Internal Investigation 0 |z-score| ≥ 3.0 31 Unsatisfactory CAR 5 |z-score| ≥ 3.0 31 Satisfactory and timely CAR 0 SG determination (per occurrence) |z-score| ≥ 3.0 Unsatisfactory CAR 1 Documentation*** or Technical Issue (per occurrence) ISL, TD or TL Nonconformity 2 Unsatisfactory CAR 2 Late Submission of CAR (per 7 days beyond the deadline) 1 Late reporting of blind or double -blind EQAS results 32 (late reporting 8 to 14 days beyond the deadline) 2 2 Evaluation Penalty Points Sanction Point Total for single EQAS round (blind or double -blind****) ≥ 20 Suspension Or Analytical Testing Restriction Point Total for double -blind EQAS **** for 12 -month period 23 Point Total for routine Analytical Testing **** for 12 -month period 23 Point Total (blind and double -blind EQAS and routine Analytical Testing )**** for 12-month period 23 ≥ 30 * Based on a total of 6 determinations: Androsterone (A), Etiocholanolone (Etio), Testosterone (T), Epitestosterone (E), 5 -androstane -3,17β-diol (5Adiol) and 5β -androstane -3,17β-diol (5βAdiol ) per EQAS sample.
** Per EQAS sample subjected to GC /C/IRMS analysis.
*** Documentation includes but is not limited to Laboratory Documentation Packages , Corrective Action Reports and Test Reports.
**** Probationary laboratories are exempt from the double -blind EQAS program and routine Analytical Testing .
31 When an unsatisfactory ( |z-score| ≥ 3.0) quantification result leads to the misreporting of the EQAS sample as a False Adverse Analytical Finding or as a False Negative Finding , then penalty points will be assigned in accordance with Arts.
7.2.1.2 and 7.2.2, respectively.
32 See Arts.
6.3.1 and 6 .3.2.
ISL – January 2021 Page 142 of 160 7.4 Probationary Period and Probationary Laboratory Evaluation The probationary EQAS is a part of the initial evaluation of a probationary laboratory seeking WADA accreditation.
In addition to providing blind EQAS samples, WADA may provide, upon request and at the expense of the probationary laboratory , samples from past EQAS rounds in order to allow the probationary laboratory an opportunity to evaluate its performance against the recorded performance of Laboratories .
Composition of the probationary EQAS samples corresponds to the criteria described in Article 6.2.2.
Successful participat ion in WADA probationary EQAS , based on the Points Scale Table (less than twenty (20) points accumulated within a single blind EQAS round and less than thirty (30) points for the most recent and consecutive twelve ( 12)-month 23 period) is required before a probationary laboratory is eligible to be considered for WADA accreditation.
The LabEG may decide, based on its evaluation of the overall performance of the probationary laboratory, to exten d the probationary period of accredit ation, even if the probationary laboratory did not reach the maximum number of penalty points based on the Points Scale Table.
However, once a laboratory is granted WADA accreditation, penalty points accumulated during the probationary period are annulled and are not carried forward onto the accredited phase.
The blind EQAS samples shall be distributed in multiple rounds each year and will consist of a minimum of fifteen (15) blind samples.
At least three (3) blind EQAS samples will contain Threshold Substa nces.
Blank samples may also be included.
7.4.1 Analytical Testing Procedures Utilized by Probationary Laboratories for the Analysis of EQAS samples All procedures associated with the handling and analysis of the EQAS samples by the probationary laboratory are to be conducted using validated procedures in a manner identical to those expected to be applied during routine Analytical Testing , unless other wise specified by WADA .
7.4.2 False Adverse Analytical Finding Result Any False Adverse Analytical Finding of a technical/methodological nature reported automatically suspends a probationary laboratory from further consideration for WADA accreditation.
The probationary laboratory will only be eligible for re -instatement into the accreditation process upon providing documentation to WADA that appro priate corrective and preventive action(s) have been implemented , as determined by the LabEG .
WADA may decide to send a set of EQAS samples and/or perform an assessment of the probationary laboratory prior to its re -instatement to the probationary status.
7.4.3 False Negative Finding Any probationary laboratory reporting a False Negative Finding in a blind EQAS round shall be informed by WADA as soon as possible.
The probationary laboratory shall take and report proper corrective and preventive action(s) within t en (10) days of the date of the letter from WADA (unless informed otherwise by WADA ).
The corrective ISL – January 2021 Page 143 of 160 action, if approved by WADA , shall be implemented in the routine operations of the probationary laboratory as soon as possible.
7.4.4 Threshold Substance Result A probationary laboratory shall achieve satisfactory quantitative EQAS results reported based on the mean of three (3) independent determinations.
7.4.5 Overall Probationary Laboratory Evaluation WADA will evaluate probationary laboratory EQAS performance for each round and assign points for each noncompliance or failure to perform in accordance with the Points Scale Table, with the exception of the double -blind EQAS and routine analysis evaluation.
The Suspension period of a probationary l aboratory’s participation in the EQAS shall be determined by WADA.
Serious and repeated issues in the probationary EQAS shall result in the removal of the laboratory’s status as a probationary laboratory by WADA.
When the performance of a probationary lab oratory is considered to be satisfactory in the EQAS over the most recent and consecutive twelve ( 12)-month 23 period ( e.g.
at least fifteen (15) blind EQAS samples), and provided that all of other necessary conditions have been fulfilled, WADA will provide the probationary laboratory with a minimum of a further fifteen (15) blind EQAS samples to be analyzed as part of a Final Accreditation Test (FAT) .
In addition, the laboratory will be audited by an assessment team appointed by WADA .
At WADA ’s discretion, the FAT and on -site assessment may be conducted separately or at the same time.
The results of the FAT will be evaluated by WADA as satisfactory if: - No False Adverse Analytical Finding is reported; - Less than twenty (20) penalty points are assigned for the EQAS samples tested; - Any corrective actions required as a result of the WADA assessment and/or the analytical performance and/or the presentation of the requested Laboratory Documentation Package( s) shall be submitted within thirty (30) days, unless otherwise specified by WADA , and shall be considered satisfactory by WADA .
A suspended probationary laboratory wishing to re -enter the probationary EQAS is required to provide documentation of corrective and preventive action(s) no later than thirty (30) days prior to the end of the Suspension period (unless otherwise indicated by WADA ).
Failure to do so will preclude the laboratory from participating in the probationary EQAS .
Lifting of the Suspension occurs only when proper corrective and preventive actions have been implemented and reported to WADA .
WADA may choose, at its sole discretion, to submit additional EQAS samples to the laboratory and/or to require that the laboratory be re -assessed, at the expense of the laboratory.
Laboratories re - ISL – January 2021 Page 144 of 160 entering the probationary EQAS shall be considered as candidate laboratories and are subject to provide the applicable accreditation fee and the required documentation to WADA (see Art icle 4.2).
ISL – January 2021 Page 145 of 160 PART THREE: ISL ANNEXES ISL ANNEX A - CODE OF ETHICS FOR LABORATORIES and ABP LABORATORIES 1.0 Confidentiality Directors of Laboratories and ABP Laboratories , their delegates and all Laboratory staff shall respect and comply with ISL Article 5.3.8.3 and Code Article 14.3.
6.
2.0 Research in Support of Doping Control Laboratories shall participate in research programs, provided that the Laboratory Director is satisfied with their bona fide nature and the program(s) have received proper ethical approval, if applicable .
The Laboratory shall not engage in any research activity that undermines or is detrimental to the World Anti -Doping Program.
The Laboratories are expected to develop a research and development program to support and expand the scientific foundation of Doping Control .
This research may consist of the development of new methods or technologies, the pharmacological characterization of a n ew doping agent, the characterization of a masking agent or method, and other topics relevant to the field of Doping Control .
2.1 Research on Human Subjects The Laboratories and ABP Laboratories shall follow the Helsinki Declaration and any applicable national standards as they relate to the involvement of human subjects in research.
Voluntary informed consent shall also be obtained from human subjects in any drug administration studies for the purpose of development of a Reference Collection or proficiency testing materials.
Athletes who may undergo Doping Control Testing by Anti-Doping Organizations shall not be the subjects of drug administration studies that includ e Prohibited Substances or Prohibited Methods .
2.2 Controlled Substances The Laboratories are expected to comply with the relevant and applicable national laws regarding the handling , storage and discard ing of controlled (illegal) substances.
3.0 Analysis The Laboratory or ABP Laboratory shall not engage in any analysis or activity that undermines or is detrimental to the World Anti -Doping Program.
[Comment: The World Anti -Doping Program comprises the anti -doping programs of WADA and all Signatories, including International Federations, N ational Anti -Doping Organizations, Regional Anti -Doping Organizations, Major Event Organizations, the International Olympic Committee (IOC) or the International Paralympic Committee (IPC).]
ISL – January 2021 Page 146 of 160 3.1 Analytical Testing for Anti-Doping Organizations (Signatories or WADA ) The Laboratories and ABP Laboratories shall accept Samples for Analytical Testing from Anti-Doping Organizations only if all of the following conditions have been met: - The Sample matrix is of the proper type ( e.g.
blood, urine) for the requested analyses; - The Samples have been collected, sealed and transported to the Laboratory or ABP Laboratory in accordance with the ISTI; and - The collection is a part of a legitimate anti-doping program , as determined by WADA , or satisfies any of the conditions for Sample analysis indicated in ISL Article 5.3.6 .
3.2 Analytical Testing for non -Signatories Laboratories and ABP Laboratories shall not accept Samples directly from individual Athletes or from individuals or organizations acting on their behalf.
Laboratories or ABP Laboratories may accept samples from non -Signatories for analysis ; however, any such analysis shall not be conducted under the Laboratory ’s WADA accreditation or under the ABP Laboratory ’s WADA approval and test results shall not be reported in ADAMS .
In addition, such analyses shall not negatively affect the Analytical Testing of Samples from Anti-Doping Organizations , concerning, in particular, the allocation of resources ( e.g.
human, financial, instrumental resources) and the reporting of results in a reliable and timely manner .
[Comment: A Laboratory or ABP Laboratory shall only refer to its WADA accreditation or approval status, as applicable , for an activity that falls under its Analytical Testing activities for Anti-Doping Organizations .
For the avoidance of doubt, laboratory test reports or other documentation or correspondence related to samples from non-Signatories shall not declare or represent that any such testing is covered under the laboratory’s WADA -accredited or -approved status ].
3.3 Clinical or Forensic Analysis Occasionally the Laboratory may be requested to analyze a sample for a banned drug or endogenous substance coming from a hospitalized or ill Person in order to assist a physician in the diagnostic process.
In such circumstances, the Laboratory Director sha ll agree to analyze the sample only if the organization making the request provides a letter explaining the medical reason for the test and explicitly certifying that the requested analysis is for medical diagnostic or therapeutic purposes.
The Laboratory may conduct w ork to aid a forensic and/or legal investigation, but due diligence should be exercised to ensure that the work is requested by an appropriate agency or organization.
The Laboratory should not engage in analytical activities or expert testimony that would intentionally question the integrity of an indivi dual or the scientific validity of work performed in the anti -doping program .
3.4 Other Analytical Activities The Laboratory or ABP Laboratory shall not provide analytical services in a Doping Control adjudication, unless specifically requested by the responsible Testing Authority or Results ISL – January 2021 Page 147 of 160 Management Authority (if different), WADA or a hearing body.
The Laboratory shall not engage in analyzing commercial material or preparations ( e.g.
dietary or herbal supplements), unless: - Specifically requested by a n Anti-Doping Organization or a hearing body as part of a Results Management or adjudication process ; or - If done as part of a legitimate anti-doping research program , as determined by WADA ; or - If a request is made by an Athlete , the Laboratory may conduct the analysis if agreed by the Anti-Doping Organization , which may also specify conditions that must be followed prior to or during the analysis ( e.g.
verification of original sealed packages , product batch number ).
The Laboratory shall not provide results, documentation or advice that, in any way, could be used as an endorsement of products or services.
Analytical activities performed under Art icles 3.3 and 3.
4 of Annex A will not fall under the WADA -accredited or -approved status of the laboratory and shall not negatively affect the Analytical Testing of Samples from Anti-Doping Organizations .
[Comment: For the avoidance of doubt, laboratory test reports or other documentation or correspondence related to these other analytical activities shall not declare or represent that any such testing is covered under the laboratory’s WADA -accredit ed or -approv ed status.]
3.5 Sharing of Knowledge When information on new doping substance(s), method(s), or practice(s) is known to the Laboratory , such information shall be shared with WADA within sixty (60) days .
When possible, the Laboratories shall share information with WADA regarding the detection of potentially new or rarely detected doping agents as soon as possible.
Immediately after having been notified of the Use of a new substance or method as a doping agent, WADA will inform all Laboratories .
The Laboratory Director or staff shall participate in developing standards for best practice and enhancing uniformity of Analytical Testing in the WADA -accredited laboratory system.
[Comment: Sharing of knowledge can occur in various ways, including but not limited to d irectly communicating with WADA, participating in scientific meetings, publishing results of research, sharing of specific details of Analytical Methods , working with WADA to produce and/or distribute new Reference Material (s) or Reference Collection (s) or disseminating information regarding the chromatographic behaviour and mass spectra of the Analytes .]
4.0 Duty to Preserve the Integrity of the World Anti -Doping Program and to Avoid any Detrimental Conduct The personnel of Laboratories and ABP Laboratories shall not engage in conduct or activities that undermine or are detrimental to the World Anti -Doping Program.
Such conduct could include, but is not limited to, fraud, embezzlement, perjury, etc.
that would cast doubt on the integrity of the anti-doping program.
ISL – January 2021 Page 148 of 160 All employees of Laboratories and ABP Laboratories shall strictly respect the confidentiality of Analytical Testing results, as well as of all other Laboratory or Testing Authority information , including information provided by WADA under confidentiality.
No employee or consultant of Laboratories and ABP Laboratories shall provide counsel, advice or information to Athletes or others regarding techniques or methods used to mask or avoid detection of, alter metabolism of, or suppress excretion of a Prohibited Substance or its Metabolite (s), or Marker (s) of a Prohibited Substance or Prohibited Method in order to avoid an Adverse Analytical Finding .
No employee or consultant of Laboratories and ABP Laboratories shall provide information about a Test Method to an Athlete or Athlete Support Personnel , which could be used to avoid the detection of doping.
No staff of Laboratories and ABP Laboratories shall assist an Athlete in avoiding collection of a representative Sample (e.g.
advice on masking strategies or detection windows) .
[This does not prohibit the publication and/or presentation of scientific research results, general presentations to educate Athletes , students, or others concerning anti -doping programs and Prohibited Substances or Prohibited Methods .]
If a staff member of a Laboratory or ABP Laboratory is requested to provide evidence in anti -doping proceedings, they are expected to provide independen t, scientifically valid expert testimony.
The Laboratory or ABP Laboratory shall not issue any statements related to its analytical processes or findings, unless otherwise provided in Code Article 14.3.
6.
The responsibility for evaluation of these finding s with further action and publication, if considered necessary, shall be the sole responsibility of the responsible Anti-Doping Organization (s).
5.0 Breach and Enforceability A failure to respect any of the provisions of this Code of Ethics may result in the Laboratory or ABP Laboratory being subject to Disciplinary Proceedings instituted by WADA to either suspend or revoke its WADA accreditation or its WADA approval, as applic able, in accordance with ISL Article 4.6.4.5.
In addition, a failure to respect any of the provisions of this Code of Ethics may result in staff of the Laboratory or ABP Laboratory being subject to disciplinary action by the Laboratory or ABP Laboratory , respectively, resulting in consequences beyond those stipulated under the ISL, including potential termination of employment or, where applicable, the imposition of criminal charges .
ISL – January 2021 Page 149 of 160 ISL ANNEX B – ACCREDITATION REQUIREMENTS FOR MAJOR EVENTS The accreditation requirements described herein apply to those Major Events which , in order to conduct appropriate Doping Control , would require either a significant increase of the existing Laboratory ’s resources and capacity or the establishment of a temporary “satellite facility” by an existing Laboratory .
Major Event Organizations should give preference to the use of an existing Laboratory for the analysis of Samples .
However, i n some cases, the reporting time requirements for a Major Event may require that a Laboratory facility be located in proximity to the Major Event such that Samples can be delivered by Doping Control staff.
This may require the creation of a temporary “satellite facility” by an existing Laborator y, which shall have appropriate capabilities for the Major Event and be established sufficiently in advance to allow for the timely transfer and validation of Laboratory operations and Test Methods .
In addition, the Laboratory operations necessary for a Major Event may be such that the existing Laboratory ’s analytical and Sample handling capacity are not adequate.
This may require the expansion of existing facilities, re -location of the Labo ratory to a new permanent facility, the addition of personnel, and/or the acquisition of additional equipment.
The Director of the Laboratory designated to perform the Analytical Testing shall ensure that a proper Management System, performance, security a nd safety are maintained.