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Section 3. |
2 sets out the minimum requirements for Sample collection and Sample transport that an ADO shall fulfil to run the Hematological Module of the ABP program (Annex I of the ISTI). |
Sections 3.3-3.6 are Technical Documents and Laboratory Guidelines intended for Laboratory or ABP Laboratory personnel that aim to harmonize the analysis of blood ABP, blood or urine Samples collected for the measurement of the Markers of the Hematological , Endocrine and Steroidal Modules of the ABP. |
Section 3. |
7 sets out the requirements and procedures that the Passport Custodian and its APMU shall follow for Result Management for the ABP (Annex C of the ISRM). |
Finally, Section 3. |
8 outlines the requirements and procedures for WADA -approved APMUs . |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 20/91 3.2. |
Collection, Storage and Transport of Blood Athlete Biological Passport Samples (ISTI Annex I) I.1 Objective To collect an Athlete’s blood Sample by venipuncture, intended for use in connection with the measurement of individual Athlete blood variables within the framework of the hematological module of the Athlete Biological Passport program, in a manner appropriate for such use. |
The requirements of this Annex are additional requirements to those contained in Annex D - Collection of Venous Blood Samples . |
I.2 Requirements I.2.1 Planning shall consider the Athlete ’s whereabouts information to ensure Sample collection does not occur within two (2) hours of the Athlete’ s training, participation in Competition or other similar physical activity. |
If the Athlete has trained or competed less than two (2) hours before the time the Athlete has been notified of their selection, the DCO or other designated Sample Collection Personnel shall chaperone the Athlete until this two -hour period has elapsed. |
I.2.2 If the Sample was collected within two (2) hours of training or Competition , the nature, duration and intensity of the exertion shall be recorded by the DCO to make this information available to the APMU . |
I.2.3 Although a single blood Sample is sufficient within the framework of the hematological module of the Athlete Biological Passport , it is recommended to collect an additional (B) Sample for a possible subsequent analysis of Prohibited Substances and Prohibited Methods in whole blood (e.g., detection of homologous blood transfusion (HBT) and/or erythropoietin receptor agonists (ERAs)). |
I.2.4 For Out-of-Compe tition Testing, A and B urine Samples should be collected together with the blood Athlete Biological Passport Sample(s) in order to permit Analytical Testing for ERAs unless otherwise justified by a specific intelligent Testing strategy . |
[Comment to I.2.4: WADA’s Guidelines for Sample Collection reflect these protocols and include practical informa tion on the integration of Athlete Biological Passport Testing into “traditional” Testing activities. |
A table has been included within WADA’s Guidelines for Sample Collection that identifies which particular timelines for delivery are appropriate when combining particular types of analysis (e.g, blood Athlete Biological Passport and growth hormone (GH), blood Athlete Biological Passport and HBT, etc. |
), and which types of Samples may be suited for simultaneous transport.] |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 21/91 I.2.5 The Sample shall be refrigerated from its collection until its analysis with the exception of when the Sample is analyzed immediately following collection. |
The storage procedure is the DCO ’s responsibility. |
I.2.6 The storage and transport device shall be capable of maintaining blood Athlete Biological Passport Samples at a cool temperature during storage. |
Whole blood Samples shall not be allowed to freeze at any time. |
In choosing the storage and transport device, the DCO shall take into account the time of storage, the number of Samples to be stored in the device and the prevailing environmental conditions (hot or cold temperatures). |
The storage device shall be one of the following: a) Refrigerator; b) Insulated cool box; c) Isotherm bag; or d) Any other device that possesses the capabilities mentioned above. |
I.2.7 A temperature data logger shall be used to record the temperature from the collection to the analysis of the Sample except when the Sample is analyzed immediately following collection. |
The temperature data logger shall be able to: a) Record the temperature in degrees Celsius at least once per minute; b) Record time in GMT; c) Report the temperature profile over time in text format with one line per measurement following the format “YYYY -MM-DD HH:MM T”; and d) Have a unique ID of at least six characters. |
I.2.8 Following notification to the Athlete that they have been selected for Sample collection and following the DCO/BCO ’s explanation of the Athlete’s rights and responsibilities in the Sample collection process, the DCO/BCO shall ask the Athlete to remain still, in an upright, stationary seated position, with feet on the floor for at least ten (10) minutes prior to providing a blood Sample. |
If the Athlete’s feet cannot reach the floor and/or the Athlete’s impairment does not allow feet on the floor, the Athlete shall remain in an upright, stationary seated position. |
[Comment to I.2.8: The Athlete shall not stand up at any time during the ten (10) minutes prior to Sample collection. |
To have the Athlete seated during ten (10) minutes in a waiting room and then to call the Athlete into a blood collection room is not acceptable.] |
I.2.9 The DCO /BCO shall collect and record the following additional information on an Athlete Biological Passport supplementary form, Athlete Biological Passport specific Doping Control form or other related report form to be signed by the Athlete and the DCO/BCO : ABP Operating Guidelines – Version 9.0 – July 2023 Page 22/91 a) Has the Athlete been seated for at least ten (10) minutes with their feet on the floor prior to blood collection, as per Annex I.2.8? |
b) Was the Sample collected immediately following at least three (3) consecutive days of an intensive endurance Competition , such as a stage race in cycling? |
c) Has the Athlete had a training session or Competition in the two (2) hours prior to the blood collection? |
d) Did the Athlete train, compete or reside at an altitude greater than 1,500 meters within the prior two (2) weeks? |
If so, or if in doubt, the name and location of the place where the Athlete had been, and the dates and the duration of their stay shall be recorded. |
The estimated altitude shall be entered, if known. |
e) Did the Athlete use any form of altitude simulation such as a hypoxic tent, mask, etc. |
during the prior two (2) weeks? |
If so, as much information as possible on the type of device and the manner in which it was used (e.g., frequency, duration, intensity) should be recorded. |
f) Did the Athlete receive any blood transfusion(s) during the prior three (3) months? |
Was there any blood loss due to accident, pathology or donation in the prior three (3) months? |
If so, the estimated volume should be recorded. |
g) Has the Athlete been exposed to any extreme environmental conditions during the last two (2) hours prior to blood collection, including any sessions in any artificial heat environment, such as a sauna? |
If so, the details should be recorded. |
I.2.10 The DCO/BCO shall start the temperature data logger and place it in the storage device. |
It is important to start recording the temperature before Sample collection. |
I.2.11 The storage device shall be located in the Doping Control Station and shall be kept secure. |
I.2.12 The DCO/BCO instructs the Athlete to select the Sample Collection Equipment in accordance with Annex D.4.6 and continue the Sample Collection Session in accordance with Annex D.4.7. |
I.3 The Sample Collection Procedure I.3.1 The Sample collection procedure for the collection of blood for the purposes of the Athlete Biological Passport is consistent with the procedure set out in Annex D.4, including the ten (10) minute (or more) seated period. |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 23/91 I.3.2 The Athlete and the DCO/BCO sign the Doping Control and Athlete Biological Passport supplementary form(s), when applicable. |
I.3.3 The blood Sample is sealed and deposited in the storage device containing the temperature data logger. |
I.4 Transportation Requirements I.4.1 Blood Samples shall be transported in a device that maintains the integrity of Samples over time, due to changes in external temperature. |
I.4.2 The transport procedure is the DCO ’s responsibility. |
The transport device shall be transported by secure means using a Sample Collection Authority authorized transport method. |
I.4.3 The integrity of the Markers used in the hematological module of the Athlete Biological Passport is guaranteed when the Blood Stability Score (BSS) remains below eighty -five (85), where the BSS is computed as: BSS = 3 * T + CAT with CAT being the Collection to Analysis Time (in hours), and T the average Temperature (in degrees Celsius) measured by the data logger between Sample collection and analysis. |
I.4.4 Within the framework of the BSS, the following table can be used by the DCO/BCO to estimate the maximal transport time to a Laboratory or ABP Laboratory , called the Collection to Reception Time (CRT), for a given average temperature (T), e.g., if shipped at 4°C, the maximal CRT is 60 h.: T [°C] CRT [h] 15 27 12 36 10 42 9 45 8 48 7 51 6 54 5 57 4 60 ABP Operating Guidelines – Version 9.0 – July 2023 Page 24/91 I.4.5 The DCO/BCO shall as soon as possible transport the Sample to a Laboratory or ABP Laboratory . |
I.4.6 The Testing Authority or Sample Collection Authority shall report without delay into ADAMS: a) The Doping Control form, as per Article 4.9.1 b); b) The Athlete Biological Passport supplementary form, and/or the additional information specific to the Athlete Biological Passport collected on a related report form; c) In the Chain of Custody , the temperature data logger ID (without any time reference) and the time zone of the Testing location in GMT. |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 25/91 3.3. |
Analytical Requirement for the Hematological Module of the Athlete Biological Passport WADA Technical Document – TD2021BAR Document Number: TD2021BAR Version Number: 2.0 Written by: Reviewed by: WADA Science WADA Laboratory Expert Group Approved by: WADA Executive Committee Date: 20 May 2021 Effective Date: 01 June 2021 1.0 Introduction The purpose of this Technical Document (TD) is to harmonize the analysis of ABP blood Samples collected, both In-Competition and Out-of-Competition , for the measurement and reporting of individual Athlete blood Markers within the framework of the hematological module of the Athlete Biological Passport ( ABP). |
The International Standard for Laboratories (ISL) [1] is applicable to the analysis of ABP blood Sample s carried out in connection with the measurement of individual Athlete blood Markers within the framework of the ABP. |
This TD describes certain specificities of blood analysis related to the ABP. |
In order to standardize analytical results in the ABP , ABP blood Sample s shall only be analyzed with analyzers of comparable technical characteristics in the dedicated network of laboratories ( i.e. |
WADA -accredited laboratories or ABP Laboratories ). |
The Analytical Method for measuring ABP blood variables shall be included within the Laboratory or ABP Laboratory’ s Scope of ISO/IEC (17025 or 15189) Accreditation, and the Laboratory or ABP Laboratory shall s atisfactorily participate in the relevant WADA External Quality Assessment Scheme (EQAS), as determined by WADA , prior to applying the Analytical Method to ABP blood Samples. |
Sample handling shall be conducted in compliance with the TD on Laboratory Inter nal Chain of Custody (TD LCOC) [2]. |
If not reasonably possible for ABP blood Sample s to be analyzed in a Laboratory or ABP Laboratory for technical and/or geographical reasons, ABP blood Samples can be analyzed at a satellite facility of a Laboratory or using mobile units operated by a Laboratory under their applicable ISO/IEC accreditation (17025 or 15189). |
Satellite facilities and mobile units shall also be ISO/IEC (17025 or 15189) accredited and participate in the WADA EQAS for blood Markers for the ABP prior to analysis of ABP blood Sample s. 2.0 ABP blood Sample Reception and Timing of Analysis Upon reception at the Laboratory or ABP Laboratory, the ABP blood Sample shall be analyzed as soon as possible and no later than twelve (12) hours after reception unless the Sample Collection Authority (SCA) provides specific information regarding the Sample collection and transportation ABP Operating Guidelines – Version 9.0 – July 2023 Page 26/91 conditions (for example, the SCA provides a projected time window for analysis during which the projected Blood Stability Score (BSS) should remain acceptable) that would allow the Laboratory or ABP Laboratory to analyze the Sample beyond twelve (12) hours after reception without compromising t he ABP blood Sample validity. |
In cases when the Laboratory or ABP Laboratory is unable to analyze the ABP blood Sample immediately after reception, the Laboratory or ABP Laboratory is responsible for maintaining the ABP blood Sample(s) at a cool temperature (approximately 4°C) between reception and the start of the analysis . |
The temperature data logger shall accompany the ABP blood Sample(s) until homogenization. |
The ABP blood Sample shall not be aliquoted before the ABP analysis is sa tisfactorily conducted. |
Only after the analysis for the ABP has been satisfactorily completed may the Laboratory or ABP Laboratory aliquot the ABP blood Sample for the performance of other Analytical Testing Procedures (e.g. |
test for homologous blood transfusion, EPO and agents affecting erythropoiesis). |
If there is a Laboratory or ABP Laboratory deviation from the aforementioned procedure, the Laboratory or ABP Laboratory shall proceed with the analysis and report the result s into ADAMS with a detailed description of the deviation. |
If the ABP blood Sample cannot be analyzed, the Laboratory or ABP Laboratory shall report the Sample as “Not Analyzed” and provide a description of why it could not be analyzed in ADAMS . |
3.0 Instrument Check The Laboratory or ABP Laboratory shall maintain an instrument maintenance schedule to ensure proper performance; particularly if an analysis has not been recently conducted and the instrument remains idle for an extended period of time. |
The analyst shall ensure that all reagents are within their expiration dates and comply with the reagent manufacturer’s recommendations before performing an analysis. |
Operational parameters of the instrument (background level, temperature of the incubation chambers, pressure, etc.) |
shall be verified as com pliant with manufacturer’s specifications. |
In each analysis session: • All internal quality controls (QC levels 1, 2 and 3) shall be analyzed twice, following the specifications provided by the manufacturer, prior to the analysis of Samples . |
• If more than 30 Samples are analyzed, at least one internal QC from the manufacturer (either level 1, 2 or 3) shall be analyzed in the middle of the analytical session, and every 30 - 50 Samples for larger batches. |
• At the end of each analysis session and after all blood Sample analyses are completed, one internal QC (either level 1, 2 or 3) shall be analyzed once again to demonstrate the continuous stability of the instrument and the quality of the analyses done. |
All results relevant to the ABP shall be i n agreement with the reference value ranges of the manufacturer. |
These internal QCs shall be furnished exclusively by the instrument manufacturer and handled in strict accordance with the manufacturer specifications ( e.g. |
expiration dates, storage ABP Operating Guidelines – Version 9.0 – July 2023 Page 27/91 conditions). |
The analysis of internal QCs shall be monitored via QC -charts with appropriate control limits. |
At least once a month, following the satisfactory analysis of all internal QCs (levels 1, 2 and 3) as described above, one fresh blood sample shall be homogenized for a minimum period of fifteen (15) minutes on an appropriate mixer ( e.g. |
roller mixer). |
The fresh blood sample shall be analyzed at least seven (7) consecutive times under Repeatability conditions. |
The Repeatability of the determinations, expressed as coefficients of variation (CV %), shall be below 1.5% for Haemoglobin (HGB) and Haematocrit (HCT), and below 15% for Reticulocyte percentage (RET%). |
[Comment: Samples from Athletes shall not be used as a fresh blood sa mple to conduct the Repeatability analysis .] |
4.0 External Quality Assessment Scheme (EQAS) The Laboratories or ABP Laboratories shall participate in and meet the requirements of WADA’s EQAS for blood Markers for the ABP. |
WADA’s EQAS program is the only EQAS relevant to the Laboratory’s or ABP Laboratory’s compliance with the requirements for the analysis of blood Markers within the framework of the hematological module of the ABP (in case of discrepancy with other blood EQAS programs ). |
All internal QCs (levels 1, 2 and 3) shall be analyzed twice following the specifications provided by the manufacturer prior to the analysis of EQAS samples. |
All results relevant to the ABP shall be in agreement with the reference value ranges of the manufacturer. |
The EQAS sample shall be homogenized for a minimum period of fifteen (15) minutes using an appropriate mixer ( e.g. |
roller mixer) prior to analysis. |
The external QCs shall be analyzed multiple times consecutively (based on the EQAS rules), and t he mean results of the following blood variables (full blood count) shall be returned: Red Blood Cell (Erythrocyte) Count RBC Mean Corpuscular Volume MCV Haematocrit HCT Haemoglobin HGB Mean Corpuscular Haemoglobin MCH Mean Corpuscular Haemoglobin Concentration MCHC White Blood Cell (Leukocyte) Count WBC Platelet (Thrombocyte) Count PLT Reticulocytes Percentage RET% Laboratories or ABP Laboratories may also participate in ring tests with other laboratories (hospitals, clinics, etc.) |
using the same technology and the same procedure. |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 28/91 5.0 Analysis of ABP Blood Samples 5.1 Temperature Data Logger The temperature data logger shall be stopped before ABP blood Sample homogenization, upon removal of the ABP blood Sample(s) from the cooling device or refrigerator. |
The ABP blood Sample shall be homogenized prior to analysis and for a minimum period of fifteen (15) minutes using an appropriate mixer ( e.g. |
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