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- Improvement The Laboratory shall maintain, and when appropr iate improve, the effectiveness of its Management System in accordance with ISO/IEC 17025.
5.3.10 Complaints Complaints shall be handled in accordance with ISO/IEC 17025 .
ISL – January 2021 Page 110 of 160 5.3.11 Storage of Samples 18 5.3.11.1 Storage of Urine Samples All urine S amples retained for storage in the Laboratory shall be stored frozen in a secure location under continuous chain of custody.
The Laboratory shall keep all chain of custody and other records (either as hard -copy or in digital format) pertaining to those Samples.
a) Urine Sample (s) without an Adverse Analytical Finding or Atypical Finding : The Laboratory shall retain the “A” and “B” urine Sample (s) without an Adverse Analytical Finding or Atypical Finding for a minimum of three (3) months after reporting the final analytical result in ADAMS , or for a maximum of ten (10) years after the Sample collection date, if the long -term storage of the Sample (s) has been requested, in writing, by the relevant Testing Authority or WADA 19. b) Urine Samples with Irregularities : The Laboratory shall retain the “A” and “B” urine Sample (s) with irregularities for a minimum of three (3) months after reporting in ADAMS , or for a longer period as determined by the Testing Authority , Results Management Authority or WADA 19. c) Urine Sample (s) with an Adverse Analytical Finding or Atypical Finding : The Laboratory shall retain the “A” and “B” urine Sample (s) with an Adverse Analytical Finding or Atypical Finding for a minimum of six (6) months after reporting the final analytical result (for the “A” or the “B” Sample , as applicable) in ADAMS 20, 21, or for a longer period as informed to the 18 This refers to “A” and “B” Samples stored in Sample collection containers (urine collection bottles, blood collection tubes) and should not be confused with a ccess to Aliquots , which should be accessible to analysts for the performance of Analytical Testing Procedures .
However, minimum and maximum retention times apply to any Aliquot (s) of a Sample that remains after completion of the Analytical Testing .
19 The Laboratory may charge storage costs to the Testing Authority or WADA , as applicable, for the storage of Samples for periods longer than the stated minimum storage times.
However, the Laborator y may store Samples beyond the applicable minimum storage times at their own discretion and expense.
In such cases, the Laboratory shall inform the responsible Testing Authority .
Any Further Analysis on these Samples will require the approval of the Testin g Authority or WADA .
20 If the “B” Sample Confirmation Procedure is not performed, the Laboratory may dispose of both the “A” and “B” Samples six (6) months after reporting the “A ” Sample analytical result.
However, if the “B” Sample Confirmation Procedure is performed, then the Laboratory shall retain both the “A” and “B” urine or plasma/serum Sample (s) for a minimum of six (6) months after reporting the “B” Sample analytical result.
21 Nevertheless, the Laboratory shall contact and inform the relevant Testing Authority and WADA before disposing of any Samples with Adverse Analytical Findings for which the Testing Authority or Results Management Authority ISL – January 2021 Page 111 of 160 Laboratory , in writing, by the relevant Testing Authority , Results Management Authority or WADA 19. d) Urine Samples under challenge, dispute or investigation : If the Laboratory has been informed by the Testing Authority , the Results Management Authority or WADA (in writing and within the applicable storage period as defined in this Article 5.3.11.1) that the analysis of a urine Sample is challenged, disputed or under investigation, the Laboratory shall retain both the “A” and “B” Samples until further notice by the Testing Authority , the Results Management Authority or WADA , as applicable 19.
5.3.11.2 Storage of Blood Samples A.
Sample s for which Analytical Testing has been performed on blood serum/plasma fraction only (not on cellular components): All serum or plasma S amples retained for storage in the Laboratory shall be stored frozen according to established protocols in a secure location under continuous chain of custody .
The Laboratory shall keep all chain of custody and other records (either as hard -copy or in digital format) pertaining to those Samples .
a) Serum/plasma “A” and “B” Samples without an Adverse Analytical Finding or Atypical Finding : The Laboratory shall retain the serum/plasma “A” and “B” Samples without an Adverse Analytical Finding or Atypical Finding for a minimum of three (3) months after reporting the final analytical result in ADAMS , or for a maximum of ten (10) years after the Sample collect ion date, if the long -term storage of the Sample (s) has been requested by the relevant Testing Authority or WADA 19. b) Serum/plasma Sample s with irregularities: The Laboratory shall retain the serum/plasma Sample s with irregularities for a minimum of three (3) months after reporting the final analytical result in ADAMS , or for a longer period as determined by the Testing Authority , Results Management Authority or WADA 19. c) Plasma /serum “A” and “B” Sample(s) with an Adverse Analytical Finding or Atypical Finding : The Laboratory shall retain “A” and “B” plasma/serum Sample(s) with an Adverse Analytical Finding or Atypical Finding for a minimum of six (6) months after reporting the final analytical result (for the “A” or the “B” Sample , as applicable) (if different) has not provided instructions about the performance o r not of the “B” Confirmation Procedure (see Article 5.3.6.2.3) .
ISL – January 2021 Page 112 of 160 in ADAMS 20, 21 or for a longer period as informed to the Laboratory , in writing, by the relevant Testing Authority , Results Managem ent Authority or WADA 19. d) Plasma /serum “A” and “B” Sample(s) under challenge, dispute or investigation: If the Laboratory has been informed by the Testing Authority , the Results Management Authority or WADA (in writing and within the applicable storage period as defined in this Article 5.3.11.2) that the analysis of a serum/plasma Sample is challenged, disputed or under investigation, the Laboratory shall retain both the “A” and “B” Samples until further notice by the Testing Authority the Results Management Authority or WADA , as applicable 19.
B.
Samples for which Analytical Testing has been performed on cellular fractions of whole blood .
a) Whole blood “A” and “B” Samples without an Adverse Analytical Finding or Atypical Finding : The Laboratory shall retain the whole blood Samples without an Adverse Analytical Finding or Atypical Finding for a minimum of one (1) month after reporting the final analytical result in ADAMS 19. b) Whole blood Sample s with irregularities : The Laboratory shall retain the whole blood Sample s with irregularities for a minimum of one (1) month after reporting the final analytical result in ADAMS , or for a longer period as determined by the Testing Authority , Results Management Authority or WADA 19. c) Whole blood “A” and “B” Sample(s) with an Adverse Analytical Finding or Atypical Finding : The Laboratory shall retain “A” and “B” whole blood Sample(s) with an Adverse Analytical Finding or Atypical Finding for a minimum of three (3) months after reporting the final analytical result (for the “A” or the “B” Sample , as applicable) in ADAMS 21, 22 or for a longer period as informed to the Laboratory , in writing, by the relevant Testing Authority , Results Management Authority or WADA 19. d) Whole blood “A” and “B” Sample(s) under challenge, dispute or investigation : If the Laboratory has been informed by the Testing 22 If the “B” Sample Confirmation Procedure is not performed, the Laboratory may dispose of both the “A” and “B” whole blood Samples three (3) months after reporting the “A ” Sample analytical result.
However, if the “B” Sample Confirmation Procedure is performed, then the Laboratory shall retain both the “A” and “B” whole blood Sample (s) for a minimum of three (3) months after reporting the “B” Sample analytical result.
ISL – January 2021 Page 113 of 160 Authority , the Results Management Authority or WADA (in writing and within the applicable storage period as defined in this Art icle 5.3.11.2) that the analysis of a whole blood Sample is challenged, disputed or under investigation, the Laboratory shall retain both the “A” and “B” Samples until further notice by the Testing Authority , the Results Management Authority or WADA , as applicable 19.
5.3.11.3 Long -term Storage of Samples At the direction of the Testing Authority or WADA , any urine or serum/plasma Sample may be stored in long -term storage for up to ten (10) years after the Sample collection date for the purpose of Further Analysis , subject to the conditions set out in Ar ticles 5.3.6.3, 5.3.11.1 and 5.3.11.2.
Sample (s) may be stored in long -term storage under the custody of either a Laborator y or another Fit-for-Purpose facility under the responsib ility of the Testing Authority , which has ownership of the Sample (s) pursuant to Article 10.1 of the ISTI.
The Testing Authority shall retain the Sample collection records pertaining to all stored Samples for the duration of Sample storage.
- Laboratories as Sample Custodians The Laboratory shall ensure that Samples are stored according to established protocols in a secure location in the Laboratory ’s permanent controlled zone and under continuous chain of custody.
The written request from the Testing Authority or WADA for long -term storage of Samples shall be properly documented.
Samples may also be transported for long -term storage to a specialized, secure Sample storage facility, which is located outside the Laboratory ’s permanent controlled zone and is under the responsibility of the Laboratory or may be transported to another Laboratory .
If the external Sample storage facility is not covered by the Laboratory ’s ISO/IEC 17025 accreditation, then the subcontracted external storage facility shall be Fit-for Purpose and have its own ISO accreditation o r certification ( e.g.
17025, 20387, 9001).
The transfer of the Samples to the external long-term storage facility or Laboratory shall be recorded.
If Sample (s) are to be transported for storage at a location outside the secured area of the Laboratory that first analyzed the Sample (s), the Laboratory shall secure the “A” Sample (s) to be shipped either by re -sealing individual “A” Sample container (s) with a tamper -evident sealing system, which has similar capabilities for security and integrity as the original sealing system , or by sealing the box in which the Sample (s) are shipped in a manner that maintains Sample integrity and chain of custody.
Neit her the Athlete nor his or her representative nor ISL – January 2021 Page 114 of 160 an Independent Witness is required to be present for this procedure.
[Comment: For example, Sample (s) may be resealed with new resealing systems (e.g.
new bottlecaps) produced by the manufacturer of an appropriate Sample collection equipment that replicates the security and tamper -evident functionality of the original seal.
The resealing system of shipped “A” Sample (s) shall be tamper evident.]
“B” Sample (s) to be shipped shall be individually sealed, either in the original, sealed “B” Sample container (s) or, if previously opened, by re -sealing the individual “B” Sample container (s) with a tamper -evident sealing system, which has similar capabilities for security and integrity as the original sealing system .
The resealing of the “B” Sample (s), if necessary, shall be witnessed by either the Athlete or his/her representative or by an appointed Independent Witness .
During transport and long -term storage, Sample (s) shall be stored at a temperature appropriate to maintain the integrity of the Sample (s).
In any anti -doping rule violation case , the issue of the Sample ’s transportation or storage temperature shall be considered where failure to maintain an appropriate temperature could have caused the Adverse Analytical Finding or other result upon which the anti -doping rule violation is based.
The Laboratory shall reta in all Laboratory Internal Chain of Custody and technical records (as per ISO/IEC 17025) pertaining to a stored Sample for the duration of Sample storage, either as hard -copy or in digital format.
In addition, the Laboratory may retain Sample analytical da ta which would allow retrospective analysis of such data, for example, for the purpose of identifying signals for novel Metabolit e(s) of Prohibited Substance (s) or Marker (s) of Prohibited Substance (s) or Prohibited Method (s) (e.g.
full-scan mass spectromet ry data) as detailed in Art icle 5.3.6.3.
If Sample (s) are transported to another Laboratory for long -term storage, the Sample’ s external chain of custody and other non -analytical records ( e.g.
DCF), available to the transferring Laboratory , shall also be transferred, immediately or upon later request, to the Laboratory storing the Samples or to the Testing Authority , either as originals or copies.
- Testing Authorities as Sample Custodians Sample (s) may also be transported for long -term storage to a Fit-for-Purpose , secure Sample storage facility, which is under the responsibility of the Testing Authority that has ownership over the Samples .
In such cases, the external storage facility shall have its own ISO accreditation or certification ( e.g.
17025, 20387, 9001) and shall ISL – January 2021 Page 115 of 160 maintain security requirements comparable to those applicable to a Laboratory .
The Testing Authority shall ensure that Samples are stored according to established protocols in a secure location under continuous chain of custody.
The written request from the Testing Authority for the transfer of the Sample (s) to long-term storage shall be properly documented.
The transfer of the Samples to the external long -term storage facility shall also be recorded.
The Laboratory shall secure the Sample (s) for transportation to t he long -term storage facility as described above.
The Laboratory shall retain all Laboratory Internal Chain of C ustody and technical records (as per ISO/IEC 17025) pertaining to a ll Sample s transferred for long -term storage for the duration of Sample storage, either as hard -copy or in digital format .
In addition, the Laboratory may retain Sample analytical data which would allow retrospective analysis of such data.
The Laboratory shall transfer the Sample’ s external chain of custody and other non -analytical records to the Testing Authority , either as originals or copies, immediately or upon reque st. 5.3.12 Secondary Use or Disposal of Samples and Aliquots The Laboratory shall maintain SOP(s) pertaining to the secondary use of Samples or Aliquots for research or quality assurance , as well as for the disposal of Samples and Aliquots .
The requirements of this Article 5.3.12 apply mutatis mutandis to an Anti-Doping Organization that takes custody of Samples for long -term storage .
When the minimum applicable Sample storage period has expired (see Art icles 5.3.11.1 and 5.3.11.2) , and neither the Testing Authority , the Results Management Authority nor WADA have requested the long -term storage of the Sample for the purpose of Further Analysis or have informed the Laboratory that a challenge, dispute, or longitudinal study is pending, or if the Laboratory has not made its own decisio n to keep the Samples for long-term storage, the Laboratory shall do one of the following with the Sample (s) and Aliquots as soon as practicable : 5.3.12.1 Dispos al of the Sample(s) and Aliquots Disposal of Samples and Aliquots shall be recorded under the Laboratory Internal Chain of Custody .
5.3.12.2 Secondary use of Samples and Aliquots for Research and Quality Assurance Sample s and Aliquots shall be anonymized to ensure that any subsequent results cannot be traced back to a particular Athlete (see Code Article 6.3).
Only after anonymiz ation, may a Sample or Aliquot be used for: ISL – January 2021 Page 116 of 160 a) Anti-doping research , if the Athlete c onsented to the use of his or her Sample for research; or [Comment: Athlete consent for research , as declared in the DCF or as obtained by other means , shall be recorded in the Laboratory ’s documentation for reference .]
b) Quality assurance, quality improvement of existing Test Methods , development or evaluation of Analytical Testing Procedures for Prohibited Substances or Prohibited Methods included in the Prohibited List at the time of Sample collection, or to establish reference population ranges or Thresholds or other statistical purposes.
Athlete ’s consent is not required for these purposes.
The use of Sample s and Aliquots for the purposes of this Art icle 5.3.12.2 is subject to the following conditions: a) The Laboratory must respect Code Article 19 and the ISL Code of Ethics requirements related to research, types of permitted research, and respect of ethical standards for research or quality assurance studies involving human subjects; b) The Laboratory must not make any attempt to re -identify an Athlete from Samples or Aliquots used for the purposes of this Art icle 5.3.12.2 or data arising from any research or quality assurance analysis; c) The Laboratory must consult the applicable national regulations, guidance, or authorities to determine whether a study should be considered as falling under 5.3.12.2 a) or 5.3.12.2 b); [Comment: If the Laboratory is unsure whether a study can proceed without Athlete consent after consulting the foregoing sources, the Laboratory shall consult with WADA].
d) In the event the Laboratory wishes to transfer Sample(s) or Aliquots to be used for the purposes of this Art icle 5.3.12.2 to another Laboratory or a third -party research institution or group, or wishes to partner with another Laboratory or research institution or group for the purpose of an Art icle 5.3.12.2 study, the Laboratory shall subject the receiving party to the conditions described in this Article 5.3.12.2 by way of a written agreement and shall prohibit the receiving party from further transferring any Sample (s) or Aliquots or related data to another party .
ISL – January 2021 Page 117 of 160 5.4 Management Requirements 5.4.1 Organization Within the framework of ISO/IEC 17025, the Laboratory shall be considered as a testing laboratory.
5.4.2 Management Reviews Management reviews will be conducted to meet the requirements of ISO/IEC 17025.
5.4.3 Document Control The control of documents that make up the Management System shall meet the requirements of ISO/IEC 17025.
The Laboratory Director (or designee) shall approve the Management System documentation and all other documents used by Laboratory staff members involved in Analytical Testing .
The Laboratory shall implement a procedure in its Management System to ensure that the contents of ISL, Technical Document s, Technical Letters and Laboratory Guidelines are incorporated into the Laboratory’s SOPs by the applicable effective date and that implementation is completed, recorded and assessed for compliance .
If this is not possible, the Laboratory shall send a written request for an extension beyond the applicable effective date for consideration by WADA .
Any failure by the Laboratory to implement mandatory requirements by the established effective date, without a prior approval by WADA , shall be consider ed a noncompliance and may affect the Laboratory accreditation status.
5.4.4 Control and Storage of Technical Records The Laboratory shall keep a copy of all Sample records to the extent needed to produce Laboratory Documentation Packages or Certificates of Analysis , in accordance with the TD LDOC , in a secure storage until Sample disposal or anonymization ( see Article 5.3.12).
In addition, this information shall be stored for ten (10) years from collection date for all Sample data and chain -of-custody information related to the Athlete Biological Passport (e.g.
hematological and steroid profi le Markers ) 5.4.5 Cooperation with Customer s and with WADA Cooperation with customers shall be handled in accordance with ISO/IEC 17025.
- Ensuring Responsiveness to WADA The Laboratory Director or his/her designee shall: - Ensure adequate communication with WADA in a timely manner; - Provide complete, appropriate and timely explanatory information as requested ISL – January 2021 Page 118 of 160 by WADA ; - Report to WADA any unusual circumstances or information with regard to Analytical Testing , patterns of irregularities in Samples , or potential Use of new substances; - Provide documentation to WADA [e.g.
Management System documentation, SOPs, contracts (not including commercial or financial information) with Signatories , or with Sample Collection Authorities or Delegated Third Parties working on behalf of Signatories ] upon request to ensure conformity with the rules established under the Code as part of the maintenance of WADA accreditation.
This information shall be treated in a confid ential manner.
- Ensuring Responsiveness to Testing Authority and/or Results Management Authority The Laboratory Director shall be familiar with the Testing Authority rules and the Prohibited List.
The Laboratory Director shall interact with the Testing Authority and/or Results Management Authority in regard to specific timing, report information, or other support needs.
These interactions should occur in a timely manner and should include, but are not limited to, the following: - Communicating with the Testing Authority and/or Result s Management Authority concerning any significant question of Analytical Testing needs or any unusual circumstance in the Analytical Testing process (including delays in reporting); - Providing complete, timely and unbiased explanations to the Testing Authority and/or Result s Management Authority when requested or when there is a potential for misunderstanding of any aspect of the Analytical Testing process, Laboratory Test Report, Certificate of Analysis or Laboratory Documentation Package ; - If requested by the Testing Authority , the Laboratory shall provide advice and/or opinion to the Testing Authority regarding the Prohibited Substances and Prohibited Methods included in the Analytical Testing Procedures ; - Providing evidence and/or expert testimony on any test result or report produced by the Laboratory as required in administrative, arbitration, or legal proceedings .
The reques ts from such expert testimonies shall originate, in writing, from the Testing Authority , Results Management Authority , WADA or hearing bodies as part of the Results Management process.
The Laboratory shall not provide expert testimony to Athletes or Athletes ’ representatives, including their legal counsels ; - Responding to any complaint submitted by a Testing Authority or Results Management Authority concerning the Laboratory and its operation.
ISL – January 2021 Page 119 of 160 As required by ISO/IEC 17025, the Laboratory shall actively monitor the quality of the services provided to the relevant Anti-Doping Organizations , including the introduction of an annual questionnaire to clients to assess their satisfaction (or otherwise) with the performance of the Laboratory .
There should be documentation that the Testing Authority or Results Management Authority concerns have been incorporated into the Laboratory’ s Management System where appropriate.
ISL – January 2021 Page 120 of 160 6.0 WADA External Quality Assessment Scheme (EQAS ) WADA regularly distributes urine or blood External Quality Assessment Scheme (EQAS ) samples to Laboratories and, when applicable, to probationary laboratories.
The WADA EQAS is designed to continually monitor the capabilities of the Laboratories and probationary laboratories, to evaluate their proficiency, and to improve test result uniformity between Laboratories .
EQAS samples are used to assess Laboratory routine analytical capacity and performance, reporting turn -around times and overall compliance with WADA Laboratory standards ( e.g.
ISL, Technical Document s and Technical Letters ), as well as other, non -analytical performance criteria.
At the same time, the EQAS also represents, via its educational components, a source of continuous improvement for the effectiveness of the Analytical Testing Procedures .
6.1 Types of EQAS 6.1.1 Blind EQAS The Laboratory will be aware that the sample is an EQAS sample since it is delivered by WADA ’s EQAS sample provider.
However, the Laboratory will not know the content of the sample.
6.1.2 Double -Blind EQAS The Laboratory will not be aware that the sample is an EQAS sample since it is delivered by a Testing Authority and is indistinguishable from routine Samples .
6.1.3 Educational EQAS Educational EQAS samples may be provided as open (in which case the content of the EQAS sample is known), blind or double -blind samples.
This approach is used for educational purposes or for data gathering.
As part of the educational EQAS , WADA may provide Laboratories with new Reference Materials , Reference Collections or quality control (QC) samples for a prompt implementation of existing or new Analytical Testing Procedures .
WADA may require the successful participation of Laboratories in an educational EQAS for WADA -specific Analytical Testing Procedures in order for Laboratories to seek an extension of the Laboratory ’s Scope of ISO/IEC 17025 Accreditation by an Accreditation Body (see Art icle 4.4.2.
2) before the subsequent application of the Analytical Testing Procedure to the routine analysis of Samples .
6.2 EQAS Sample Number and Composition 6.2.1 Number of EQAS Samples The actual composition and number of EQAS samples supplied to different Laboratories may vary; however, within any calendar year, all Laboratories ISL – January 2021 Page 121 of 160 participating in the EQAS are expected to have analyzed the minimum total number of EQAS samples.
Each year, the EQAS program will consist of: - At least fifteen (15) blind EQAS samples, distributed by WADA in multiple rounds; - At least five (5) double -blind EQAS samples distributed by various Testing Authorities in several rounds; - At least three (3 ) of the above EQAS samples will contain Threshold Substances .
As part of WADA ’s Laboratory monitoring activities, and with the main purpose of assisting Laboratories in their continuous improvement of performance, WADA may increase the number of annual EQAS samples (mainl y for educational purposes) for certain Laboratories , according, but not limited, to the following criteria: - Monitoring the effectiveness of corrective action implementation after questionable or unsatisfactory performance in WADA EQAS or in routine Analytical Testing ; - Substantiated intelligence information received by WADA indicating questionable or unsatisfactory Laboratory performance; - Laboratories which do not receive enough Samples (< 100 annual Samples ) for a specific Analytical Testing Procedure , which is not part of the Laboratory ’s routine Analytical Testing menu; - As part of WADA Laboratory assessments.