Datasets:
timotheeplanes
/
doping

Dataset card Data Studio Files
xet
 Community
1
text
stringlengths
1
17.8k
Recommendations to facilitate the implementation of subcontracted analyses and Further Analysis are provided in the WADA Laboratory Guidelines on “Conducting and Reporting Subcontracted Analysis and Further Analysis for Doping Control ”.
ISL – January 2021 Page 75 of 160 5.2.7 Purchasing of Services and Supplies Chemicals and reagents shall be Fit-for-Purpose and be of appropriate purity.
Documentation indicating the purity of Reference Materials /Standards shall be obtained when available and retained in the Management System documentation.
Chemicals, reagents and kits labelled e.g.
“Research Only” or “Forensi c Use Only” may be utilized for the purposes of Doping Control as long as they are demonstrated to be Fit-for-Purpose by the Laboratory and/or WADA.
In the case of rare or difficult to obtain Reference Materials , or Reference Collections for use in qualitative Analytical Testing Procedure s, the expiration date can be extended if adequate documentation exists confirming that no significant deterioration has occurred or that appropriate purification or verification of Fitness -for-Purpose has been pe rformed.
The process to extend the expiration date of a Reference Material , Reference Collection , or solution shall be described in the Laboratory ’s Management System documentation.
The Laboratory shall maintain control and proper records of use of contro lled chemicals and reagents in accordance with national laws and other relevant regulations.
Waste disposal shall be in accordance with national laws and other relevant regulations.
This includes biohazard materials, chemicals, controlled substances, and radioisotopes, if used.
Environmental health and safety policies shall be in place to protect the staff, the public, and the environment.
5.3 Process Requirements The Laboratory shall maintain paper or electronic Laboratory Internal Chain of Custody in compliance with the Technical Document TD LCOC.
5.3.1 Reviewing of Requests, Tenders and Contracts Review of legal documents or agreements related to Analytical Testing shall meet the requirements of ISO/IEC 17025.
5.3.2 Reception, Registration and Handling of Samples The Laboratory may receive Samples , which have been collected, sealed and transported to the Laboratory according to the ISTI.
The transfer of the Samples from the courier or other delivery Person shall be recorded including, at a minimum, the date , the time of receipt, the initials or (electronic) signature of the Laboratory representative receiving the Samples and the courier company tracking number, if available .
This information shall be included into the Laboratory Internal Chain of Custody record(s) of the Sample (s).
The Sample transport container shall be inspected, and any irregularities recorded.
ISL – January 2021 Page 76 of 160 Each individual Sample shall be inspected, and any irregularities recorded (see Article 5.3.3.1).
However, Samples transferred for long -term storage purposes are not subject to an individual inspection by the receiving Laboratory until a Sample has been selected for Further An alysis .
The Laboratory shall have a system to uniquely identify the Samples and associate each Sample with the collection document or other external chain of custody information.
5.3.3 Acceptance of Samples for Analysis The Laboratory shall analyze each Sample received, unless the Sample meets any of the following conditions : - In cases where the Laboratory receives two (2) urine Samples , which are linked to a single Sample Collection Session from the same Athlete according to the Doping Control Forms (DCF), the Laboratory shall analyze both Samples collected, unless otherwise instructed by the Testing Authority ; [Comment: The Laboratory may combine Aliquots from the two (2) Samples, if necessary, in order to have sufficient volume to perform the required Analytical Testing Procedure (s).]
- In cases where the Laboratory receives three (3) or more urine Samples , which are linked to a single Sample Collection Session from the same Athlete according to the DCF(s), the Laboratory shall prioritize the analysis of the first and the subsequent collected Sample with the highest specific gravity (SG), as recorded on the DCF: [Comment: The Laboratory may conduct analyses on the additional collect ed Samples, if deemed necessary, with the agreement of the Testing Authority .
The Laboratory may also combine Aliquots from multiple Samples, if necessary, in order to have sufficient volume to perform the required Analytical Testing Procedure (s).
With the agreement of the Testing Authority , the Laboratory may store the additional collected, non -analyzed Samples for Further Analysis .]
- If the Sample (s) meet documented Sample rejection criteria, which have been agreed with the Testing Authority .
[Comment: If justified by the Sample irregularities observed (see Article 5.3.3.1), the Laboratory shall seek instructions from the Testing Authority on the performance of Analytical Testing on the Sample.
The Testing Authority shall inform the Laboratory in writing within seven (7) days whether a Sample with noted irregularities should be analyzed or not, and/or of any further measures to be taken (e. g. splitting the Sample in accordance with Article 5.3.3.2, forensic analysis, DNA analysis), or that the Sample should be stored for Further Analysis .
The communication between the Laboratory and the Testing Authority shall be recorded as part of the Samp le’s documentation.]
- Except as provided in this Article 5.3.3, Samples shall not be accepted by a Laboratory for the sole purpose of being put into long -term storage or for later analysis without first being subject to an Analytical Testing Procedure .
ISL – January 2021 Page 77 of 160 5.3.3.1 Samples with Irregularities With the exception of the situation when a large number of Samples , which have already been analyzed , are received for long -term storage only ( e.g.
from a Major Event Organiz ation ), as described in Article 5.3.11.3, the Laboratory shall observe and document conditions that exist at the time of Sample reception or registration that may adversely impact on the integrity of a Sample or on the performance of Analytical Testing Procedures .
Only unusual conditions shall be recorded.
Irregularities to be noted by the Laboratory may include, but are not limi ted to: - Sample transport conditions ( e.g.
delivery time, temperature), which may impact the integrity of the Sample for Analytical Testing , as determined by the Laboratory ; - Sample collection information (including Sample identification code), which is necessary to conduct the requested Analytical Testing menu, is not provided, e.g.
missing or incomplete DCF; - Sample identification is questionable.
For example, the number on the Sample container does not match the Sample identification number on the DCF; - Athlete information is visible on the Laboratory copy of the DCF or any other document transferred to the Laboratory ; - Sample identification numbers are different between the “A” and the “B” Sample containers of the same Sample ; - Tampering or adulteration of the Sample is evident; - Sample is not sealed with tamper -evident device or not sealed upon receipt; - Sample volume does not me et the Suitable Volume of Urine for Analysis or is otherwise inadequate to perform the requested Analytical Testing menu; - The Sample condition(s) is unusual – for example: color, odor, presence of turbidity or foam in a urine Sample ; color, haemolysis, fre ezing or clotting of a blood Sample ; unusual differences in Sample appearance ( e.g.
color and/or turbidity) between the “A” and the “B” Samples 10.
When an analysis on a Sample with documented irregularities is performed, the Laboratory shall record the irregularities in the Test Report .
10 Further guidance on assessing the differences between “A” and “B” Samples is provided in a Technical Letter .
ISL – January 2021 Page 78 of 160 5.3.3.2 Sample Splitting Procedure In cases when either the “A” or “B” Sample is not suitable for the performance of the analyses ( e.g.
there is insuf ficient Sample volume; the Sample container has not been properly sealed or has been broken; the Sample ’s integrity has been compromised in any way; the Sample is heavily contaminated , the “A” or “B” Sample is missing ), the Laboratory shall notify and seek authorization from the Testing Authority to split the other Sample container (“A” or “B”, as applicable), provided that it is properly sealed.
The Testing Authority shall inform the Laboratory of its decision in writing within seven (7) days of notification by the Laboratory .
If the Testing Authority decides not to proceed with the Sample splitting procedure, then the Laboratory shall report the Sample as Not Analyzed in ADAMS , including the noted Sample irregularities and the documented reasons if provided by the Testing Authority .
The first fraction of the split Sample shall be considered as the “A” Sample and shall be used for the Initial Testing Procedure (s), unless the Initial Testing Procedure (s) have already been performed, and the “A” Confirmation Procedure (s), if necessary.
The second fraction, considered as the “B” Sample , shall be resealed and stored frozen for “B” Confirmation Procedure (s), if necessary.
The process of opening and splitting the Sample and resealing of the remaining second fraction shall be conducted in accordance with Article 5.3.6.2.3 as for a customary “B” Sample opening, including an attempt to notify the Athlete that the opening of the Sample to be split will occur on a specified date and time and advising the Athlete of the opportunity to observe the process in person and/or through a representative .
When the Athlete cannot be located, does not respond or the Athlete and/or his/her representa tive does not attend the opening and splitting of the Sample , the procedure shall be done in the presence of an Independent Witness that is assigned by the Laboratory .
[Comment: If the Athlete chooses to witness the Sample splitting procedure, the Athlete takes responsibility for forfeiting his/her anonymity.]
When the splitting procedure concerns blood Samples , which have been collected for Analytical Testing on the blood serum/plasma fraction , the sealed, intact (“A” or “B”) Sample shall be centrifuged as soon as practical after Laboratory reception to obtain the serum or plasma fraction.
The centrifuged Sample shall be stored frozen in the sealed Sample collection tube according to establishe d protocols until the Sample opening/splitting procedure can be conducted .
The opening of the Sample for the splitting of the serum/plasma fraction and resealing of the second fraction shall be carried out as described immediately above.
ISL – January 2021 Page 79 of 160 5.3.4 Initial Storage a nd Sample Aliquoting for Analysis It is recommended that the Laboratory assign specific staff member(s) to Sample aliquoting, and that the process of aliquoting is performed in a specifically designated area (see Art icle 5.2.3.1 ).
The Aliquot preparation procedure for any Initial Testing Procedure or Confirmation Procedure shall minimize the risk of contamination of the Sample or Aliquot .
The Laboratory shall use new material(s) ( e.g.
new test tubes) to take Aliquots for Confirmation Procedures .
5.3.4.1 Urine Samples In order to maintain the stability and integrity of the urine Samples , the Laboratory shall implement Sample storage procedures that minimize storage time at room and refrigerated temperatures as well as Sample freeze/thaw cycles.
For urine Samples , the Laboratory shall obtain, following proper homogenization of the Sample , an initial Aliquot containing enough Sample volume for all analytical procedures (all Initial Testing Procedures or all intended Confirmation Procedures , as applicable), by decanting the Aliquot from the urine Sample container into a secondary container ( e.g.
a Falcon tube).
Procedure -specific Aliquot (s) shall then be taken from the s econdary container.
The Laboratory shall measure the pH and SG of urine Samples once, using one Aliquot , during the Initial Testing Procedure and the Confirmation Procedure (s) (“A” and “B” Samples ).
Other tests that may assist in the evaluation of adulteration or manipulation may be performed if deemed necessary by the Laboratory (refer to the Technical Document on measuring and reporting the steroid profile , TD EAAS).
Urine “A” Samples should be frozen after Aliquots are taken for the Initial Testing Procedure (s) to minimize risks of Sample microbial degradation.
Urine “B” Samples shall be stored frozen after reception until analysis, if applicable.
5.3.4.2 Blood Samples The Laboratory shall fo llow the applicable Technical Document (s), Technical Letter (s) or Laboratory Guidelines for handling and storing blood Samples .
For blood Samples, the Laboratory shall obtain Aliquot (s) from the blood Sample container by using disposable pipettes or pipettes with disposable, non-reusable tips.
a) Sample s for which Analytical Testing will be performed on blood serum/plasma fraction only (not on cellular components) .
Blood Samples (“A” and “B” Samples ), for which Analytical Testing will be ISL – January 2021 Page 80 of 160 performed on the plasma/serum fraction only should be centrifuged as soon as practical after Laboratory reception to obtain the serum or plasma fraction 11.
The “A” Sample serum or plasma fraction (contained in the “A” Sample collection tube) and/or the “A” Sample serum or plasma Aliquots may be stored refrigerated for a maximum of 24 hours (but not surpassing the maximum allowed time from Sample collection established in the applicable Technical Document , Technical Letter or Laboratory Guidelines ) or frozen until analysis.
In all circumstances, the Laboratory shall take the appropriate steps to maintain the integrity of the Sample .
“A” Sample serum or plasma Aliquots used for “A” Confirmation Procedures shall be analyzed as soon as possible after thawing.
The “B” Sample serum or plasma fractions shall be immediately stored frozen in the collection tube according to established protocols until analysis, if applicable 11. b) Sample s for which Analytical Testing will be performed on the cellular fraction of whole blood .
Whole blood Samples shall be maintained refrigerated and shall be analyzed according to established protocols.
After Aliquots have been taken for analysis, Samples shall be returned to refrigerated storage.
Whole blood Samples shall not be frozen.
In all circumstances, appropriate steps to ensure the integrity of the Sample(s) shall be taken by the Laboratory .
If, after completion of analyses on the cellular components of whole blood, the Sample is centrifuged to obtain the plasma fraction for additional analyses ( e.g.
EPO ), then the plasma Sample shall be stored as described above.
5.3.5 Selection and Validation of Analytical Testing Procedures Standard methods are generally not available for Doping Control analyses.
The Laboratory shall select, validate and document Analytical Testing Procedures , which are Fit-for-Purpose for the analysis of representative target Analytes of Prohibited Substances and Prohibited Methods .
Validation results for Analytical Testing Procedures shall be summarized in a Validation Report and supported by the necessary documentation and analytical data.
The Validation Report shall indicate whether the Analytical Testing Procedure is Fit- 11 Unless otherwise specified in a Technical Document , Technical Letter or Laboratory Guidelines .
ISL – January 2021 Page 81 of 160 for-Purpose and shall be approved at least by the Laboratory Director and the Laboratory Quality Manager , or other qualified senior Laboratory staff, e.g.
the Deputy Scientific Director, as designated by the Laboratory Director .
The Laboratory shall define and document the conditions that would trigger the revalidat ion of an Analytical Testing Procedure (e.g.
change of internal standard, modified extraction procedure or chromatographic methodology, change in detection technique) or a partial re -assessment of the validation process ( e.g.
replacement or upgrade of instrument, addition of new Analyte to the Analy tical Method ).
This Article applies only to the validation of Analytical Testing Procedures , and not to the review of the analytical results for any Sample (s).
5.3.5.1 Validation of Analytical Testing Procedures for Non-Threshold Substances The Laboratory shall develop, as part of the method validation process, appropriate standard solutions for detection and/or identification and estimation of the concentration of Non-Threshold Substances using Reference Materials .
In the absence of suitable Reference Materials , Reference Collections may be used for detection and identification.
a) Validation of Initial Testing Procedures for Non-Threshold Substances The Laboratory shall validate the Selectivity , carryover, reliability of detection at the MRPL and Limit of Detection (LOD) for the Initial Testing Procedure from the analysis of an adequate number of representative samples prepared in the appropriate matrix of analysis.
For chromatograph ic-mass spectrometr ic Analytical Meth ods, the Initial Testing Procedure shall allow the detection of each Non-Threshold Substance or its representative Metabolite (s) or Marker (s) at 50% or less of the Minimum Required Performance Levels (MRPL ) (see the Technical Document on Minimum Required P erformance Levels , TD MRPL) .
For Non-Threshold Substances with Minimum Reporting Level s (MRL ), the Laboratory shall validate and document the concentration levels that will require a Confirmation Procedure .
If there is no available Reference Material , an estimate of the detection capability of the Initial Testing Procedure (i.e.
the LOD) for the Non-Threshold Substance or its representative Metabolite (s) or Marker (s) may be provided by assessing a representat ive substance from the same class of Prohibited Substances with a similar chemical structure.
ISL – January 2021 Page 82 of 160 b) Validation of Confirmation Procedures for Non-Threshold Substances Factors to be investigated in the method validation procedure to demonstrate that a Confirma tion Procedure for Non-Threshold Substances is Fit-for-Purpose include, but are not limited to: - Selectivity : The ability of the Confirmation Procedure to detect and identify the Analyte of interest, taking into account interference(s) from the matrix or from other substance(s) present in the Sample .
Selectivity shall be determined and documented from the analysis of an adequate number of representative samples prepared in the matrix of Sample analysis, in compliance wit h the Technical Document on chromatographic -mass spectrometric identification criteria (TD IDCR) or other applicable Technical Document , Technical Letter or Laboratory Guidelines .
The Confirmation Procedure shall be able to discriminate between Analytes of closely related structures ; - Limit of Identification (LOI): When the analyses of Non-Threshold Substances are based on chromatographic -mass spectrometric techniques, the Laboratory shall determine the lowest concentration at which each Non-Threshold Substance or its representative Metabolite (s) or Marker (s), for which a Reference Material is available, is identified at no more than 5% false negative rate (in compliance with the TD IDCR or other applicable Technical Document , Technical Letter or Laboratory Guidelines ).
The LOI shall be lower than the applicable MRPL ; [Comment: The TD MRPL requirement that the LOD, estimated during method validation, shall be equal to or less than (≤) 50% of the MRPL , is applicable to the Initial Testing Procedures and not to the Confirmation Procedures .
This ensures the detection of the Non-Threshold Substance (or its representative Metabolite or characteristic Marker, as applicable) at the MRPL at all times, which t hen triggers the subsequent performance of a Confirmation Procedure .
Due to inherent differences between the procedures (e.g.