text stringlengths 1 17.8k |
|---|
At a minimum, t he splitting process shall be conducted in the presence of an appointed Independent Witness . |
Even if present during the splitting procedure, the Athlete and/or his/her representative has no right to attend the Analytical Testing Procedures to be performed on the first split fraction of the “B” Sample , which shall be deemed as the “ A” Sample . |
In the event an Adverse Analytical Finding is notified based on the results of a Confirmation Procedure of the first fraction of the “B” Sample , the second split fraction of the “B” Sample shall be deemed as the “B” Sample . |
If applicable, a “B” confirmation shall be decided and performed in accordance with Article 5.3.6.2.3. |
[Comment: Since the first split fraction of the “B” Sample is considered as an “A” Sample, analysis of Aliquots taken from this Sample may include t he performance of Initial Testing Procedure (s) and “A” Confirmation Procedures or “A” Confirmation Procedures only (if the Initial Testing Procedure (s) was/were already performed using the “A” Sample).] |
5.3.6.4 Alternative Biological Matrices Any negative Analytical Testing results obtained from hair, nails, oral fluid or other biological material shall not be used to counter Adverse Analytical Findings or Atypical Finding s from urine or blood (including whole blood, plasma or serum). |
5.3.7 Assuring the Validity of Analytical Results The Laboratory shall monitor its analytical performance and the validity of test results by operating quality control schemes, which are appropriate to the type and frequency of Analytical Testing performed by th e Laboratory . |
The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. |
All quality control procedures shall be documented by the Laboratory . |
The ran ge of quality control activities include, but are not limited to: - Use of appropriate quality control samples (QCs) [Comment: Appropriate positive and negative QCs shall be included in every analytical run ISL – January 2021 Page 102 of 160 both for the Initial Testing Procedure (s) and Confirmation Procedure (s) 17. |
Appropriate internal standard(s) shall be used for chromatograph ic methods. |
For Threshold Substances , quality control charts (QC -charts) referring to appropriate control limits depending on the Analytical Testing Proce dure employed (e.g. |
+/ - 2SD; +/ - 3SD; +/ - U95%), shall be regularly used to monitor method performance and inter -batch variability (when applicable).] |
- Implementation of an Internal Quality Assurance Scheme (iQAS) [Comment: The Laboratory shall establish a functional and robust iQAS program, in accordance with the requirements of ISO/IEC 17025, which challenges the entire scope of the Analytical Testing process (i.e. |
from Sample accessioning through result reporting). |
The Laboratory shall implement a procedure that prevents the submission of iQAS results into ADAMS. |
The iQAS plan shall include and evaluate as many Laboratory procedures as possible, including the submission of a sufficient number of test samples on a regular basis (e.g. |
monthly) and shall incorporate as many categories of Prohibited Substances and Prohibited Methods as possible. |
The Laboratory shall have a dedicated SOP for the iQAS program, which incorporates a detailed procedure fo r the planning, preparation, (blind and/or double -blind) introduction of the iQAS samples and management of the iQAS results (reviewing and follow -up of nonconformities).] |
- Mandatory participation in the WADA EQAS (see Section 6.0). |
- Implementation of Internal Audits [Comment: Internal audits shall be conducted in accordance with the requirements of ISO/IEC 17025, and shall have a dedicated SOP incorporating a detailed procedure for the planning and performance of the audits, the trai ning and selection of internal auditors, specification of their auditing activities, as well as for management of the internal audit conclusions (reviewing and follow -up of nonconformities). |
Internal audit responsibilities may be shared amongst personnel provided that any Laboratory staff member does not audit his/her own area. |
Internal audits shall be carried out by qualified Laboratory staff members. |
In addition, qualified members of the Laboratory 's host organization (e.g., university, institute, company) may also be included in the internal auditing teams. ] |
- Implementation of External Audits [Comment: Laboratories may also consider having their procedures and systems audited by other Laboratory Directors or external audit ors. |
However, th is shall not replace the performance of internal audits by the Laboratory .] |
17 Unless otherwise specified in a Technical Document , Technical Letter or Laboratory Guidelines . |
ISL – January 2021 Page 103 of 160 5.3.8 Results Management 5.3.8.1 Review of Results The Laboratory shall conduct a minimum of two (2) independent reviews of all Initial Testing Procedure raw data and results . |
The review process shall be recorded. |
A minimum of two (2) Certifying Scientists shall conduct an independent review of all Adverse Analytical Findings and Atypical Finding s before a test result is reported. |
Evidence of the review and approval of the analytical run/batch shall be recorded. |
- Second Opinion The Laboratory may request a second opinion from other Laboratory (-ies) before reporting an Adverse Analytical Finding or Atypical Finding . |
Such requests for second opinions may be required by specific Technical Document (s), Technical Letters or Laboratory Guidelines , required by WADA from certain Laboratory (-ies) for all or for specific Analytical Testing Procedures under certain conditions ( e.g. |
following the recent obtaining of WADA accreditation or after a period of Suspension or Analytical Testing Restriction ), or requested at the discretion of the Laboratory (e.g. |
for firstly detected Analytes or for difficult t o interpret findings). |
In any case, the request for a second opinion shall be made in writing and the second opinion received shall be recorded as part of the Sample ’s documentation. |
Any transfer of data and information necessary for the second opinion sha ll be made securely and respecting the confidentiality of the analytical data and any other information. |
The Laboratory that performed the analysis is responsib le for the result and for issuing the final Test Report. |
- Laboratory Review of Adverse Analytical Findings and Atypical Finding s At a minimum, the review of Adverse Analytical Findings and Atypical Finding s shall include: o Documentation linking the Sample external code (as specified in the DCF) to the Laboratory internal Sample code; o Laboratory Internal Chain of Custody documentation; o Initial Testing Procedure (s) and Confirmation Procedure (s) analytical data and calculations; o Quality control data; o Completeness of technical and analytical documentation supporting the reported findings; ISL – January 2021 Page 104 of 160 o Compliance of test data with the Analytical Testing Procedure ’s validation results ( e.g. |
MU); o Assessment of the existence of significant data or information that would cast doubt on or refute the Laboratory findings ; [Comment: The Laboratory should consider the prevailing scientific knowledge regarding, for example, the possibility of Sample or Aliquot contamination, the presence of analytical artifacts, the possible natural occurrence of the Analyte at low concentrations, microbial or chemical degradation, the detection of Metabolites which may be common to non -prohibited substances or the absence of characteristic Phase -I or Phase -II Metabolites.] |
- When the Confirmation Procedure result(s) are rejected as Adverse Analytical Finding (s) or Atypical Finding (s) based on the results review, the reason(s) for the rejection shall be recorded. |
5.3.8.2 Traceability of Results and Documentation The Laboratory shall have documented procedures to ensure that it maintains a record related to each Sample analyzed. |
In the case of an Adverse Analytical Finding or Atypical Finding , the record shall include the data necessary to support the conclusions reported as set forth in and limited by the TD LDOC . |
- Each step of Analytical Testing shall be traceable to the staff member who performed that step ; - Significant deviation from a written SOP shall be recorded ; - Wher e instrumental analyses are conducted, the operating parameters for each run shall be included as part of the record ; - Requ ests for information by the Testing Authority , Results Management Authority or WADA to a Laboratory shall be made in writ ing; - Laboratory Documentation Packages and Certificates of Analysis shall be in compliance with the TD LDOC . |
Laboratories are not required to produce a Laboratory Documentation Package for a Sample in which no Prohibited Substance or Prohibited Method or their Metabolite (s) or Marker (s) was detected , unless requested by a hearing body or disciplinary panel as part of a Results Management process or Laboratory disciplinary proceedings . |
5.3.8.3 Confidentiality of the Analytical Data and Athlete ’s Identity Confidentiality of the analytical data and Athlete ’s identity shall be observed by all parties ( e.g. |
Laboratory , Testing Authority , Results Management Authority , WADA, other parties informed including, where different, International Federations, National Olympic Committe es, National Federations). |
The Laboratory shall not make any attempt to identify an Athlete that has provided a Sample . |
ISL – January 2021 Page 105 of 160 Information sent by a facsimile is acceptable provided that the correct facsimile number is verified prior to transmission and the receipt is verified after the facsimile has been transmitted. |
Encrypted emails or documents shall be used for reporting or d iscussion of Adverse Analytical Findings or Atypical Finding s if the Athlete can be identified or if any information regarding the identity of the Athlete is included. |
Whenever the Laboratory handles analytical data or information where an Athlete is identified or identifiable, the Laboratory shall treat such data in accordance with the requirements of the International Standard for the Protection of Privacy and Personal Information (ISPPPI). |
5.3.8.4 Reporting Test Results A Laboratory shall not conduct an y additio nal Analytical Testing on a Sample for which the Athlete has been charged with a Code Article 2.1 anti -doping rule violation unless consent from the Athlete or approval from a hearing body is obtained by the Testing Authority or Results Management Authority (if different) – see also Article 5.3.6.3 . |
Unless specifically requested to make a partial submission of test results by the Testing Authority or Results Management Authority (if different), a Laboratory shall not report analytical results for any Sample until all analyses detailed in the Analytical Testing menu of the relevant DCF have been completed (e.g. |
ongoing analysis for EPO). |
Therefore: a) If a Laboratory is requested to report an Adverse Analytical Finding (s) for a Sample (s) before all analyses on that Sample have been completed, then the Laboratory shall advise the Testing Authority or Results Management Authority (if different) that Sample analysis has not been completed and, in addition, that if the Athlete is charged with a Code Article 2.1 anti -doping rule violation before the additional analys es on the Sample have been completed, then the additional analys es cannot be conducted until consent from the Athlete or approval from a hearing body is obtained ; b) If the Laboratory receives a request to conduct Confirmation Procedures for an atypical or suspicious steroid profile of a Sample , which are triggered by ADAMS notifications after the “A” Sample has already been reported as an Adverse Analytical Finding , then the Laboratory shall advise the Testing Authority or Results Management Authority (if different) that if the Athlete is charged with a Code Article 2.1 anti -doping rule violation, the additional Confirmation Procedures cannot be performed until consent from the Athlete or approval from a hearing body is obtained. |
- Reporting Times Reporting of “A” Sample results should occur in ADAMS within twenty (20) ISL – January 2021 Page 106 of 160 days of receip t of the Sample . |
The reporting time required for specific occasions ( e.g. |
for Major Events , see Annex B ) may be substantially less than twenty (20) days. |
The reporting time may be altered by agreement between the Laboratory and the Testing Authority . |
The Testing Authority should be informed of any delay in the reporting of “A” Sample results. |
The Laboratory Documentation Packages and/or Certificates of Analysis should be provided by the Laboratory only to the relevant Results Management Authority or WADA upon request and should be provided within fifteen (15) days of the request, unless a different deadline is agreed upon with the Results Management Authority or WADA , respectively. |
- Reporting Requirements The Laboratory shall record the test result for each individual Sample from Signatories or WADA in ADAMS . |
[Comment: Test results for samples from non-Signatories , except WADA, shall not be reported in ADAMS]. |
When reporting test results in ADAMS , the Laboratory shall include, in addition to the mandatory information stipulated in ADAMS , in the relevant Technical Document (s), Technical Letter (s) or Laboratory Guidelines , and in the ISO/IEC 17025 standard , the following: - The SG of the Sample (Initial Testing Procedure and “A” and “B” Confirmation Procedures ); - The name of the Results Management Authority , if provided; - Relevant comments , if necessary, for proper interpretation of the test result or recommendations to the Testing Authority (for example, for Target Testing of the Athlete ); [Comment: The Laboratory shall have a policy regarding the provision of opinions and interpretation of data. |
An opinion or interpretation may be included in the ADAMS Test Report provided that the opinion or interpretation is clearly identified as such. |
The basis upon which the o pinion has been made shall be documented. |
An opinion or interpretation may include, but not be limited to, recommendations on how to use results, information related to the pharmacology, metabolism and pharmacokinetics of a substance, whether the observed results may suggest the need for additional investigations regarding potential environmental contamination causes and/or Further Analysis and whether an observed result is consistent with a set of reported conditions.] |
- Specific tests performed, in addition to the Laboratory routine Analytical Testing menu ( e.g. |
EPO GC/C/IRMS, hGH, blood transfusions, DNA, genomic profiling, etc. |
); - Any irregularities noted on Samples ; ISL – January 2021 Page 107 of 160 - Any refusal by the Athlete and/or his/her representative (s) or the Independent Witness , as applicable, to sign the Laboratory documentation for the “B” Sample opening , aliquoting or re -sealing procedures (see Article 5.3.6.2.3). |
The Laboratory is not required to provide any additional Test Report, either in hard-copy or digital format, other than the submission of test results in ADAMS . |
All Anti-Doping Organizations shall access the Test Reports of their Samples in ADAMS . |
Upon request by WADA , the Laboratory shall report a summary of the results of analyses performed in a format specified by WADA . |
In addition, the Laboratory shall also provide any information requested by WADA in relation to the Monitoring Program ( Code Article 4.5). |
The Laboratory shall qualify the result(s) of the analysis in the ADAMS Test Report as: a) Adverse Analytical Finding ; or b) Atypical Finding ; or c) Negative Finding ; or [Comment: In cases when the Testing Authority confirms to the Laboratory the existence of an approved TUE for the Prohibited Substance , which is consistent with the Presumptive Adverse Analytical Finding results obtained in the Initial Testing Procedure (see Art 5.3.6.2.2), the Laboratory shall report the result as a Negative Finding as instructed by the Testing Authority .] |
d) Not Analyzed [Comment: Any Sample received at the Laboratory and not subject to Analytical Testing for a valid, documented reason ( as instructed by or agreed with the Testing Authority ) such as Sample irregularities, intermediate Samples of a Sample Collection Session , etc. |
(see Article 5.3.3).] |
- Test Report for Non-Threshold Substances a) “A” Sample Test Report The Laboratory is not required to report concentrations for Non-Threshold Substances . |
The Laboratory shall report the actual Prohibited Substance (s) and/or its Metabolite (s), or Marker (s) of the Use of Prohibited Substance (s) or Prohibited Method (s) present ( i.e. |
identified, as per the TD IDCR) in the Sample and in accordance with the reporting requirements established in the TD MRPL . |
[Comment: When applicable, the Laboratory shall record in the ADAMS Test Report the specific Metabolite(s) or Marker(s) of the Non-Threshold Substance that were identified in the Sample.] |
ISL – January 2021 Page 108 of 160 However, the Laboratory should provide estimated concentrations when possible and for information purposes only, upon request by the Testing Authority , Results Management Authority or WADA, if the detected level of the Non-Threshold Substance (s), its Metabolite (s), or Marker (s) may be relevant to the Results Management of an anti -doping case. |
In such instances, the Laboratory should indicate the estimated concentration while making it clear to the Testing Authority , Results Management Authority or WADA that the concentration was obtained by an Analytical Testing Procedure , which has not been validated for quantitative purposes. |
b) “B” Sample Test Report For Non-Threshold Substances , irrespective o f whether or not they have a Minimum Reporting Level, the Laboratory result for the “B” Sample shall only establish the presence ( i.e. |
the identity) of the Prohibited Substance (s) or its Metabolite (s) or Marker (s) in accordance with the TD IDCR or other applicable Technical Document (s). |
The Laboratory is not required to quantif y or estimate the concentration of such Prohibited Substance , or its Metabolite (s) or Marker (s). |
- Test Report for Threshold Substances a) “A” Sample Test Report For Threshold Substances , the Laboratory Test Report for the “A” Sample shall establish that the identified Prohibited Substance (s) or its Metabolite (s) or Marker (s) is present at a concentration and/or ratio and/or score of measured analytical values greater than the Decision Limit , and/or that the Prohibited Substance (s) or its Metabolite (s) or Marker (s) is of exogenous origin. |
In the event that the Threshold Substa nce(s), which are identified as such in the Prohibited List and the TD DL, is (are) detected in the presence of (a) diuretic(s) or masking agent(s), the Laboratory shall establish the presence ( i.e. |
the identity) of the Prohibited Substance (s) and/or its Metabolite (s) in accordance with the TD IDCR and the TD DL and report it as an Adverse Analytical Finding , in addition to the reporting of the diuretic(s) or masking agent(s). |
In such cases, the Laboratory should report the estimated concentration of the Threshold Substance( s), indicating that the levels detected may have been impacted by the presence of the diuretic(s) or masking agent(s). |
b) “B” Sample Test Report For exogenous Threshold Substances , the Laboratory Test Report for the “B” Sample shall only establish the presence ( i.e. |
the identity) of the ISL – January 2021 Page 109 of 160 Prohibited Substance (s) or its Metabolite (s) or Marker (s) in accordance with the TD IDCR. |
For endogenous Threshold Substances , the Laboratory Test Report for the “B” Sample shall establish that the identified Prohibited Substance (s) or its Metabolite (s) or Marker (s) is present at a concentration and/or ratio and/or score of measured analytical values greater than the Threshold , and/or that the Prohibited Substance (s) or its Metabolite (s) or Marker (s) is of exogenous origin. |
In the event that the Threshold Substance (s), which are identified as such in the Prohibited List and the TD DL, is (are) detected in the presence of (a) diuretic(s) or masking agent(s) , the Laboratory shall establish the presence ( i.e. |
the identity) of the Prohibited Substance (s) and/or its Metabolite (s) in accordance with the TD IDCR and the TD DL and report it as an Adverse Analytical Finding , in addition to the reporting of the maski ng agent(s). |
In such cases, the Laboratory shall report the estimated concentration of the Threshold Substance (s), indicating that the levels detected may have been impacted by the presence of the diuretic(s) or masking agent(s). |
5.3.9 Control of Nonconformities in Analytical Testing The Laboratory shall have policies and procedures that shall be implemented when any aspect of its Analytical Testing does not comply with set requirements. |
Any nonconformities in Analytical Testing shall be recorded and kept as part of the documentation of the Sample(s) involved. |
- Risk Minimization Laboratories shall take corrective actions in accordance with ISO/IEC 17025 and WADA Laboratory Guidelines for Corrective Action Investigation and Reporting. |
When conducting a corrective action investigation, the Laboratory shall perform and record a thorough Root Cause Analysis of the nonconformity. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.