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6.2.2 Composition of EQAS Samples EQAS samples may or may not contain Prohibited Substance(s) and/or Metabolite(s) of Prohibited Substance (s) and/or Marker (s) of Prohibited Substance (s) or Prohibited Method (s).
6.2.2.1 Blank EQAS Samples Blank EQAS samples do not contain Prohibited Substances or their Metabolites or Markers of Prohibited Substances or Prohibited Methods.
6.2.2.2 Adulterated EQAS Samples Adulterated EQAS samples are those which have been deliberately adulterated by the spiking of non -characteristic Metabolite (s) or by the addition of extraneous substances designed to dilute or concentrate the sample, degrade or mask the Analyte prior to or during the analytical determination.
Adulterated EQAS samples may also be obtained from the controlled administration or the addition of non -prohibited substances, which share common Metabolite (s) with Prohibited Substance (s).
ISL – January 2021 Page 122 of 160 6.2.2.3 EQAS Samples Containing Prohibited Substance(s) , their Metabolite(s) or Marker(s) , or the Marker(s) of Prohibited Method(s) The concentration(s) of selected Analyte (s) are those that may be encountered in the urine or blood after Use of Prohibited Substance (s) or Prohibited Method (s).
For some Analyte s, the EQAS sample may contain the parent Prohibited Substance and/or its Metabolite (s) and/or its Marker (s).
EQAS samples may be spiked with Prohibited Substance (s) and/or their Metabolite (s) or Marker (s) but would be preferably prepared from controlled administration studies.
The EQAS sample composition shall reflect as closely as possible the expected target Analyte Metabolite pattern and concentrations usually found in Samples .
An EQAS sample may contain more than one Prohibited Substance , Metabolite (s), or Marker (s) of a Prohibited Substance or Prohibited Method .
It may also contain mult iple Metabolites or Markers of a single Prohibited Substance or Markers of a Prohibited Method , which would represent the presence of a single Prohibited Substance or the Use of a single Prohibited Method .
[Comment: Double -blind EQAS samples should be representative of Samples.
Therefore, to the extent possible (in consideration, for example, of technical or ethical constraints, availability of the pharmaceutical grade substance, etc.
), double -blind EQAS samples containing Prohibited Substance(s) and/or Metabolite(s) of Prohibited Substance(s) and/or Marker(s) of Prohibited Substance(s) or Prohibited Method(s) should be prepared from controlled administration studies performed in human subjects .
However, if this is not possible, then the double -blind EQAS sample(s) may be prepared by spiking expected target Analyte (s) in the Sample matrix in consideration of the representative metabolic profile(s) .]
- EQAS samples for Non-Threshold Substances For Non-Threshold Substances , the concentration in the EQAS sample will be guided by, but not limited to, one of the following criteria: o Concentrations of the Prohibited Substance and/or its Metabolite (s) or Marker (s) equal to or greater than (≥) the applicabl e MRPL (refer to TD MRPL); o Concentrations of the Prohibited Substance and/or its Metabolite (s) or Marker (s) between 50% of the MPRL and the MRPL (applicable only to Non-Threshold Substances prohibited at all times and with no Minimum Reporting Levels , as per TD MRPL); o Non-Threshold Substances with Minimum Reporting Levels as stated in the TD MRPL ( e.g.
substances prohibited In-Competition only), will normally be present in estimated concentrations greater than (>) 120% of the applicable Minimum Reporting L evel; ISL – January 2021 Page 123 of 160 o Concentrations of the Prohibited Substance and/or its Metabolite (s) or Marker (s) below (<) 50% of the applicable MRPL (for Non-Threshold Substances prohibited at all times with no Minimum Reporting Levels , for educational purposes).
- EQAS samples for Threshold Substances For Threshold Substances , the concentration in the EQAS sample will be guided by, but not limited to, one of the following criteria: o Greater than (>) 50% of the Threshold as established in the relevant Technical Document (s) or Laboratory Guidelines ; o At less than (<) 50% of the Threshold for those exogenous Threshold Substances specified in the TD DL whose presence shall be reported if detected in the presence of diuretics or masking agents.
Laboratories shall determine the Markers of the “steroid profile” in all urine EQAS samples (unless specifically noted as not required in an educational EQAS sample).
6.2.2.4 Blood EQAS Samples for the analysis of ABP blood Markers These EQAS samples are distributed to Laboratories and ABP Laboratories on a regular basis ( e.g.
monthly) with the purpose of evaluating their proficiency in the analysis and reporting of the blood Markers that constitute the hematological module of the ABP.
6.2.3 Laboratory Analytical Testing Procedures Used in EQAS All procedures associated with the Analytical Testing of the EQAS samples by the Laboratory are to be conducted in a manner similar to that applied to routine Samples , unless otherwise specified by WADA .
No effort shall be made to optimize instrument (e.g.
change multipliers or chromatographic columns) or method performance prior to analyzing th e EQAS samples unless it is a scheduled maintenance activity.
Only validated , Fit-for-Purpose Analytical Testing Procedures described in the Laboratory ’s SOPs are to be employed in the analysis of EQAS samples ( i.e.
using the Initial Testing Procedures and Confirmation Procedures applied in routine Analytical Testing ).
6.3 Reporting of EQAS results The purpose of the EQAS program is to ensure that all Laboratories maintain proficiency in the performance of their Analytical Testing Procedures and report valid results to WADA and the Testing Authority in a timely manner.
A Laboratory shall not communicate with other Laboratories regarding the identity or content of substances present in or absent from blind EQAS samples prior to the submission of EQAS results to WADA .
This prohibition also applies to Laboratory requests for second opinions, which shall not be requested for blind EQAS samples.
ISL – January 2021 Page 124 of 160 Contact between Laborator ies regarding any aspect of blind EQAS analysis (including the results obtained) prior to reporting by all Laboratories to WADA will be considered an attempt to circumvent the quality assessment .
Engaging in such discussions will subject the Laboratories involved to disciplinary procedures, which may lead to Suspension or Revocation of WADA accreditation.
For double -blind EQAS samples, which are indistinguishable from routine Samples , consultation between Laboratories before reporting such EQAS results to WADA may occur.
However, such consultation shall not involve identifying the sample as a WADA double -blind EQAS sample (in cases when, for any reason, the Laboratory identifies the EQAS nature of the sample).
6.3.1 Reporting Blind EQAS Results The Laboratory shall report the results of blind EQAS samples to WADA in ADAMS in the same manner as specified for routine Samples (see Article 5.3.8.4) unless otherwise notified by WADA .
For some blind EQAS samples or sample sets, additional information may be requested from the Laboratory (e.g.
LODs, LOQs, MU estimations, etc.).
The results of the blind EQAS shall be submitted to WADA on or before the specified reporting date unless an extension is granted by WADA for valid reasons.
For a failure to report results of blind EQAS samples by the established deadline, without prior approval by WADA or without justified grounds , as determined by WADA , the Laboratory shall receive two (2) penalty points, and an additional two (2) penalty points for reporting eight (8) to fourteen (14) days beyond the applicable deadline (refer to the Points Scale Table in Article 7.3).
Failure to report blind EQAS results within fifteen (15) days beyond the WADA -established or WADA -approved deadline (based on valid justification , as determined by WADA ) will result in the evaluation of the corresponding EQAS sample (s) as False Negative Finding (s) (for those findings produced by different and unrelated root causes) and the assignment of penalty points in accordance with the Points Scale Table in Article 7.3.
In such cases, no penalty points will be accumulated for late reporting , in addition to those assigned for the False Negative Finding (s).
6.3.2 Reporting Double -Blind EQAS Results The Laboratory shall report the results of double -blind EQAS samples in ADAMS as per Art icle 5.3.8.4.
Reporting of double -blind EQAS results should occur within twenty (20) days of receipt of the samples, unless an extension has been agreed with the Testing Authority after the Laboratory has provided the Testing Authority with a valid reason for the delay in the reporting of t he results or a postponement has been established or approved by ISL – January 2021 Page 125 of 160 WADA based on justified grounds ( e.g.
double -blind EQAS samples for which a second opinion may be required before reporting an Adverse Analytical Finding ).
Failure to report double -blind EQAS results within twenty (20) days of receipt of the samples or, subject to an extension of this deadline by agreement with the Testing Authority or approval by WADA based on justified ground s, within the agreed or WADA -approved deadline , shall carry two (2) penalty points and an additional two (2) penalty points for reporting eight (8) to fourteen (14) days beyond the applicable deadline (refer to the Points Scale Table in Article 7.3).
Failure to report double -blind EQAS results within thirty -five (35) days of receipt of the samples , or otherwise within fifteen (15) days beyond the agreed or WADA -approved deadline , will result in the evaluation of the corresponding EQAS sample(s) as False Negative Finding (s) (for those findings produced by different and unrelated root causes) and the assignment of penalty points in accordance with the Points Scale Table in Article 7.3.
In such cases, no penalty points will be accumulated for late reporting, in addition to those assigned for the False Negative Finding (s).
6.3.3 Reporting Educational EQAS Results The Laboratory shall report the results of open or blind educational EQAS samples on or before the specified reporting deadline and in a format specified by WADA .
Results received after the deadline will not be included in the assessment of EQAS results nor in the subse quent educational EQAS report.
6.3.4 Reporting Results for EQAS Samples Containing Non-Threshold Substance s Unless otherwise specified by WADA (for example, for an educational EQAS ), the report of EQAS results for Non-Threshold Substances shall include all the Analytes whose presence in the EQAS sample has been confirmed by the Laboratory in accordance with the TD IDCR or other applicable Technical Document , including the Prohibited Substance (s) (i.e.
parent compound(s), if applicable) and all identified Metabolite (s) and/or Marker (s) of the Prohibited Substances or Marker (s) of Prohibited Method (s).
WADA may also require that the Laboratory report the estimated concentrations of the confirmed Analyte (s).
For open educational and blind EQAS samples , the Laboratory shall report the LODs of the identified Non-Threshold Substance (s) and/or Metabolite (s) and/or Marker (s), or of the identified Marker(s) of Prohibited Method (s), as estimated during method validation of the Initial Testing Procedure .
6.3.5 Reporting Results for EQAS Samples Containing Threshold Substances For educational and blind EQAS samples, the report of EQAS results for Threshold Substances shall include the values measured for each Aliquot analyzed, whenever the measured mean value of all replicates is greater than or equal to (≥) 50% of the applicable Threshold .
ISL – January 2021 Page 126 of 160 [Comment: Unless otherwise specified by WADA (for example, for educational purposes), this provision does not apply to EQAS samples containing exogenous Threshold Substances whose presence shall be reported, without the need for quantitative confirmation, if detecte d in the presence of diuretics or masking agents. ]
For double -blind EQAS samples, the Laboratory shall report the quantitative results in ADAMS as done for routine Samples , in accordance with the relevant Technical Document (s), Technical Letter (s) or Labor atory Guidelines .
ISL – January 2021 Page 127 of 160 7.0 Evaluation of Laboratory EQAS and Routine Analytical Testing Performance The WADA system of Laboratory EQAS and routine Analytical Testing performance (see Points Scale Table in Article 7.3 below) has been developed by the LabEG with the objective of setting a transparent and balanced procedure for evaluation of Laboratory and probationary laboratory operations.
It is based on the principle of proportionality and is focused on improving Laboratory ’s Analytical Testing capabilities and, in the case of probationary laboratories, their readiness for obtaining WADA accreditation.
It is ultimately aimed at maintaining the confidence in and strengthening of the anti -doping Laboratory system to benefit clean Athletes .
7.1 Evaluation of EQAS Results Satisfactory EQAS performance in single EQAS rounds and over a consecutive twelve ( 12)-month period 23 is necessary for maintaining WADA accreditation.
[Comment : An EQAS Round is a distribution of EQAS sample(s) to the Laboratories and the probationary laboratories for Analytical Testing as defined by WADA.]
Unsatisfactory performance in an educational EQAS for a new or WADA -specific Analytical Testing Procedure may preve nt the Laboratory from seeking an extension of the Laboratory ’s Scope of ISO/IEC 17025 Accreditation for the Analytical Testing Procedure and from its application in routine Analytical Testing (see Art icle 4.4.2.2) .
In such circumstances, t he Laboratory may only apply the newly WADA -approved method or procedure for routine Sample analysis when it properly corrects the deficiencies identified in the educational EQAS (as determined by WADA ) and the method is included in the Laboratory ’s Scope of ISO/IEC 17025 Accreditation.
[Comment: Some Analytical Testing Procedures are not eligible for a Flexible Scope of ISO/IEC 17025 Accreditation and require specific WADA approval before the Laborator y can apply the procedure to the analysis of Samples.
WADA approval will be based on its assessment of the Fitness -for-Purpose of the Analytical Testing Procedure , method validation by the Laboratory , and the successful Laboratory participation in an inter -laboratory collaborative study or WADA EQAS round.
WADA will communicate which Analytical Testing Procedures fall into this category to the Laboratories and to the Accreditation Bodies (see Art icle 4.4.2.2).]
23 The twelv e (12)-month period to account for the total number of penalty points accumulated by a Laboratory or probationary laboratory according to the Points Scale Table is defined as the most recent consecutive twelve ( 12)-month interval starting either from the d ate that the Laboratory or the probationary laboratory reported the nonconforming result ( EQAS or routine Analytical Testing , as applicable) in ADAMS or from the date that the Laboratory or probationary laboratory is informed, in writing, of the assigned p enalty points total by WADA , whichever is more favorable to the Laboratory or the probationary laboratory.
Any assigned penalty points will expire after a twelve ( 12)-month period; however, the total number of penalty points within any consecutive twelve ( 12)-month period shall not reach the maximum allowed number of penalty points established in the Points Scale Table.
ISL – January 2021 Page 128 of 160 7.1.1 EQAS Samples Containing Non-Threshold Substances When a qualitative determination of a Non-Threshold Substance has been reported, the Laboratory result will be evaluated on the basis of the correct reporting of the finding ( e.g.
Adverse Analytical Finding , Negative Finding ) as intended in the preparation of the EQAS sample.
The results for any Non-Threshold Substance and/or its Metabolite (s) and/or Marker (s) at concentrations greater than (>) the MRPL (or exceeding 120% of the Minimum Reporting Level , when applicable) shall be evaluated in accordance with the Points Scale Table.
The results for any Non-Threshold Substance and/or its Metabolite (s) and/or Marker (s) at concentrations between 50% of the MRPL and the MRPL (or less than 120% of the Minimum Reporting Level , when applicable) shall not be considered for evaluation for the purposes of the EQAS points system.
However, WADA may require an internal investigation and Corrective Action Report from the Laboratory .
The results for any Non-Threshold Substance and/or its Metabolite (s) and/or Marker (s) at concentrations below (<) 50% of the applicable MRPL in an EQAS sample shall not be evaluated for the purposes of the EQAS points system.
Nonetheless, the Laboratory should report their finding(s) if the analyses ar e compliant with its validation data, SOPs, the ISL and the TD IDCR.
Laboratories unable to report such substance(s) are encouraged, on receipt of the EQAS report, to consider re -assessment of their Analytical Testing Procedure .
7.1.2 EQAS Samples Containing Threshold Substances For EQAS samples containing Threshold Substances at levels greater than (>) 50% of the Threshold , the quantitative determination will be statistically evaluated (e.g.
z-score, degree of equivalence analysis) to determine the compatibility of the reported result with the assigned value (reference, nominal or consensus value, as applicable).
Results shall be evaluated as per the Points Scale Table.
[Comment: This provision does not apply to the reporti ng of results for certain exogenous Threshold Substances , identified in the TD DL, if detected in the presence of diuretics or masking agents.
In such cases, the detection and identification of the exogenous Threshold Substance shall be reported in accorda nce with the TD DL.
The failure to report the presence of the Threshold Substance (s), as applicable, will be considered as a False Negative Finding .]
A Laboratory is to achieve a satisfactory statistical evaluation of quantitative results reported based on the mean of three (3) replicate determinations.
The overall evaluation of the quantitative performance is based on the criteria indicated in the effective version of the TD DL or other relevant Technical Document , Technical Letter or Laboratory Guidelines .
[Comment: The main criterion applied for the evaluation of EQAS results for the quantification of Threshold Substances is the compatibility of the reported Laboratory result with the assigned value.
Therefore, the incorrect reporting of an EQAS sample as a Negative Finding or as an Adverse Analytical Finding, as applicable, when the assigned value of the Threshold ISL – January 2021 Page 129 of 160 Substance in the EQAS sample is close to the Decision Limit, is not considered as a False Negative Finding or False Adverse Analytica l Finding, respectively, if the absolute z -score (truncated to one (1) decimal place ) for the Laboratory 's quantitative result is < 3.0 (see footnote 31).]
7.1.2.1 Unsatisfactory Quantitative Result for Threshold Substances (absolute z-score ≥ 3 .0) 24 The Laboratory shall provide WADA with a satisfactory Corrective Action Report for an unsatisfactory quantitative result.
The Corrective Action Report shall be submitted within fifteen (15) days of receiving a written notification about the unsatisfactory resu lt from WADA .
Failure to submit a satisfactory Correction Action Report or the late submission of the Correction Action Report without prior approval by WADA shall result in the imposition of further penalty points in accordance with the Points Scale Table .
[Comment: A Corrective Action Report will be considered as satisfactory when it meets all of the following criteria, as determined by the LabEG : - Properly and concisely identifies the root cause(s) of the nonconformity, following an appropriate investigation into all the factors that may have caused the problem (Root Cause Analysis ); - Leads to the documented implementation of effective corrective action(s) to solve the problem; and - Leads to the documented implementation of appropriate preventive a ctions, if applicable, to minimize the risk of recurrence of the problem.
A satisfactory Corrective Action Report shall include only the necessary supporting documentation (e.g.
raw analytical data, data review files, evidence of procurement of Reference M aterials ) which demonstrates the implemented actions described in the Corrective Action Report .]
7.1.2.2 Questionable Quantitative Result (absolute z-score > 2.0 and < 3 .0) The Laboratory shall perform an internal investigation to determine the root cause(s) of the questionable result and implement appropriate corrective measures to resolve them.
24 The z–score is calculated according to the foll owing formula and truncated to one (1) decimal place : 𝑧= ȳ−ŷ Where: ȳ is the mean value of the Laboratory ’s replicate determinations; ŷ is the assigned value (reference, nominal or consensus value, as applicable);  is the target standard deviation ( e.g.
uc_Max or robust Reproducibility sR of results from all participant Laboratories ).
ISL – January 2021 Page 130 of 160 7.2 Evaluation of Laboratory Performance 7.2.1 False Adverse Analytical Finding A False Adverse Analytical Finding is not acceptable for any blind or double -blind EQAS sample or during the course of routine Analytical Testing conducted by a Laboratory .
7.2.1.1 False Adverse Analytical Finding during routine Analytical Testing If the Laboratory discovers that it reported a False Adverse Analytical Finding during routine Analytical Testing , the Laboratory shall inform WADA immediately.
When the False Adverse Analytical Finding is identified by WADA, based on information received from a Testing Authority , a Results Management Authority , through WADA ’s own Results Management activities or through any other means, WADA shall inform the Laboratory immediately.
In either case, the Laboratory shall cease all Analytical Testing activities applied to the affected Analytical Testing Procedure (s) and/or Laboratory process(es) ( e.g.
Sample aliquoting, reporting of results) as soon as it becomes aware or is informed by WADA that a False Adverse Analytical Finding has been reported .
The Laborator y shall provide WADA with a Corrective Action Report , including a Root Cause Analysis of the incorrect results and the corrective action(s) implemented for its rectification, within seven (7) days of informing WADA or being informed by WADA , as applicable , or, in exceptional cases, as otherwise agreed with WADA .
The LabEG shall review the Laboratory ’s Corrective Action Report within seven (7) days, or within a timeline otherwise determined by WADA , and establish the source of the incorrect result as either a technical/methodological error or a clerical/administrative error .