Equipment part 2

$ The accessory package includes the specified collection tubes and other accessories (e.g. needle, disinfection pads, etc); § For Blood Transfusion (BT) and the ABP, whole non-coagulated blood is used; for HBOCs /CERA the centrifugation of the Blood Sample (on e.g. Ficoll gradient) is required to separate the plasma fraction from the cellular components. These tests may be combined by conducting primary ABP and/or BT analyses prior to centrifugation; * When testing the blood variables of the ABP only, one (1) EDTA tube is sufficient; however the collection of two (2) EDTA tubes is recommended to allow the simultaneous testing for CERA/HBOCs (for example) in cases of abnormal results for the blood variables included in the ABP. Possible Test combinations The following matrix, details the equipment requirements for possible combinations of multiple analysis types:

hGH/ HBOCs / CERA (Serum)		BT (Whole blood) HBOCS / CERA (Plasma)			ABP (Plasma)
hGH/ HBOCs / CERA (Serum)	• 2 x serum tubes • Total volume: 10mL		• 2 x serum tubes • 2 x EDTA tubes • Total volume: 16mL			• 2x serum tubes • 1-2x EDTA tubes • Total volume: 13-16mL
BT (Whole blood) HBOCS / CERA (Plasma)	• 2 x serum tubes • 1-2 x EDTA tubes • Total volume:13-16mL		• 2 x EDTA tubes • Total volume: 6mL			• 2-3 x EDTA tubes • Total volume:6-9 mL
ABP (Whole Blood)	• 2x serum tubes • 1-2x EDTA tubes • Total volume: 13-16mL		• 2-3 x EDTA tubes • Total volume:6-9 mL			• 1 EDTA tube • Total volume: 3mL
All analysis types				• 2 x serum tubes • 2-3 x EDTA tubes • Total volume: 16-19 mL

[Comment: The analysis of HBOCs and CERA can be conducted in either serum or plasma. The analytical matrix used in the assay will vary depending on the Laboratory. Please contact the Laboratory that is to conduct the analysis to determine this information.] [Comment: When using both types of tubes for multiple test types, the specific procedures followed for each type of tube – for example number of inversions – should still be followed]. [Comment: These specifications should serve for general guidance only. When wishing to collect blood to test for different prohibited Substances and/or Methods at the same Sample Collection Session, it is recommended that the ADO in charge of sample collection contact the Laboratory that is to conduct the analyses to ascertain the type and total number of tubes and total volume of blood to collect].

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Equipment

Equipment The following matrix details the equipment required for all blood collection and analysis types (including the Athlete Biological Passport tests): Test	Analysis Matrix	Tubes#	V / tube (mL)	# tubes	Tube inversion	Transport kit
hGH / HBOCs / CERA&	Serum	BD Vacutainer® SST II Plus (cat. # 367955)	5	2+	X5	BEREG-KIT small (94-1094) or similar Accessory package$ (94-1096)
BT§ / HBOCs / CERA	Blood§/ Plasma	BD Vacutainer® EDTA (CE #368856, US #367856)	3	2*, +	X8-10	BEREG-KIT small (94-1094) or similar Accessory package $ (94-1095)
Athlete Biological Passport (ABP) §/ HBOCs /CERA§	Blood§/ Plasma	BD Vacutainer® EDTA (CE #368856, US #367856)	3	1-2*, +	x8-10	BEREG-KIT small for two tubes (94-1094) OR BEREG-KIT small single for one tube (90-1098) or similar Accessory package$ (94-1095) OR (94-1093 / 94-1099) for one tube or similar

Appendix 1: Integration of Multiple Blood Testing Types

When planning and conducting a Sample Collection Session, an ADO may wish to collect sufficient volume of blood to enable multiple types of analysis to be conducted simultaneously. Additionally, conduct of an Athlete Biological Passport test may reveal abnormal variables that warrant immediate analysis for prohibited substances or methods. In such cases it is prudent to have a complementary sample available in the event a "B" sample analysis is required. Conducting multiple types of analyses however will require careful consideration, especially in relation to the Sample Collection equipment needed. This section seeks to offer guidance to ADOs on integrating multiple blood testing types.
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Transport/handover of Samples

7.7 Transport/handover of Samples

7.7.1 The Blood Samples shall be transported to the Laboratory in a refrigerated state. No sample should be allowed to freeze, and should ideally be kept at a temperature of approximately 4 degrees. Temperature should be maintained between 2 – 12 degrees Celsius. A temperature recording device is recommended to be included with the transported samples to ensure the appropriate temperature range has been maintained during transport.

7.7.2 Samples should remain in an upright position during transportation, whenever possible.

7.7.3 Samples may be taken directly to the Laboratory by the DCO, or handed over to a third party for transportation. This third party must document the chain of custody of the samples. If an approved courier company is used to transport the samples, the DCO shall record the waybill number.

7.7.4 Due to the more stringent temperature and analysis requirements for blood, blood and urine samples may be transported separately. The relevant paperwork linking the two samples shall be included with each shipment, however.

7.7.5 Transport of Blood Sample(s) from site of collection to Laboratory should be made as soon as possible and preferably within 36 hours of collection.

7.7.6 The Laboratory is required to document receipt and the subsequent chain of custody of samples. Samples are reviewed for evidence of tampering or damage, and stored in appropriate conditions until analysis in accordance with the International Standard for Laboratories.

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Sample storage part 2

7.6.6 The DCO shall accurately complete appropriate documentation for each transport bag/container to ensure that the Laboratory can verify the contents of the bag/container.

7.6.7 The DCO shall follow the ADO’s system to ensure that analysis instructions (e.g. type of analysis to be conducted) are provided to the Laboratory.

7.6.8 The DCO shall complete the Laboratory advice form/chain of custody form. The Laboratory copy of this form and the Laboratory copy of the doping control form shall be placed in the transport bag with the samples, and sealed, preferably in the presence of a witness. Documentation identifying the Athlete shall not be included with the samples.

7.6.9 If relevant, the DCO shall record the time(s) the transport bag is opened and resealed, on the Laboratory advice form or chain of custody form.

7.6.10 The DCO shall keep the samples under his/her control until they are passed to the courier. Blood Samples should be dispatched as soon as possible after collection to arrive at the Laboratory ideally on the same day, and preferably within 36-48 hours of collection.
7.6.11 All documentation relevant to the testing session shall be forwarded to the ADO by the approved method as soon as possible after sample collection.


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Sample storage

7.6 Sample storage

7.6.1 The DCO is responsible for ensuring, in accordance with the ADO’s criteria for Blood Sample storage, that all samples are stored in a manner that protects their identity, integrity and security whilst in the Blood Collection Facility.

7.6.2 Samples must not be left unattended, unless they are locked away, in a refrigerator or cupboard, for example. Access shall be restricted to authorized personnel.

7.6.3 The Blood Samples must be stored in a cool location, preferably in a refrigerator or cool box. Temperature should be maintained between 2 – 12 degrees Celsius.

7.6.4 If the conditions of storage did not meet the guidelines for temperature in section 7.6, the DCO shall document this, and shall also contact the ADO immediately to inform them of the variation in temperature, and the length of time the samples were affected.

7.6.5 If the temperature deviates outside the recommended 2 -12 degrees for a period of time likely to affect the composition of a Blood Sample, the ADO and Laboratory shall determine whether or not analysis should proceed on the sample.


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Paperwork

7.5 Paperwork

7.5.1 The DCO shall instruct the BCO to sign the form to confirm that he/she collected a Blood Sample from the Athlete in accordance with procedures.

7.5.2 The Athlete shall be provided an opportunity to document any blood transfusions over the last six months, and to indicate any medications, including those which may affect the ability of the blood to clot, taken over the past seven days.

7.5.3 The DCO shall check all information on the form and sign to confirm that the Blood Sample collection was conducted in accordance with procedures.

7.5.4 The Athlete and the Athlete Representative, if present, shall be invited to check that all information on the form accurately reflects the details of the sample collection session. The Athlete shall be invited to complete the comments section of the form if he/she has any concerns or comments regarding the procedure. If there is insufficient space on the form, the Athlete shall be invited to complete a supplementary report form.

7.5.5 Blood-only doping control form:

- The DCO, the Athlete Representative, if present, and the Athlete shall then sign the doping control form.

7.5.6 Combined urine/blood doping control form:

- If the urine sample has already been collected, the DCO, the Athlete Representative, if present, and the Athlete shall sign the doping control form.

- If the urine sample has not yet been collected, the Athlete shall proceed to provide a urine sample before the DCO, the Athlete Representative, if present, and the Athlete shall sign the doping control form.

7.5.7 The DCO must give a full copy of the form to the Athlete.
7.5.8 The Athlete shall then proceed to provide a urine sample if required, or is free to leave the Blood Collection Facility.


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Sealing of the Blood Samples

7.4 Sealing of the Blood Samples

7.4.1 The Athlete shall take the secure transport kit already selected in, or, if not yet selected, shall choose a transport kit from a selection of kits in accordance with the process outlined.

7.4.2 The DCO shall instruct the Athlete to place one Blood Sample into each of the A and B tamper evident sample transport kits. The Athlete may request the DCO or the
Athlete Representative to complete this process on their behalf.
7.4.3 Both the DCO and the Athlete shall check that the kits are securely sealed. Where possible, care must also be taken so that the samples are stored upright.

7.4.4 The DCO and Athlete should ensure that the equipment code numbers are accurately recorded on the Doping Control documentation. The Athlete and DCO should initial or sign the documentation to show they are satisfied with the procedure.

7.4.5 The DCO shall ensure the Blood Sample is stored in a secure, preferably cooled (2-12 degrees Celsius), location (i.e. transport bag) until ready to proceed to section 7.7 - Transport of samples.


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Analysis of serum

7.3.2 Analysis of serum

For the analysis of serum, the 2 x 5mL Blood Samples, comprising of an "A" and a "B" Sample should be inverted gently five (5) times to initiate clotting and remain at room temperature for the time recommended by the tube manufacturer (15 minutes for BD Vacutainer® SST II advance tubes) before being sealed and made ready for transportation in accordance with section 7.4.

[7.3.2 Comment: For Samples collected that require being left at room temperature for a pre-determined length of time (as specified by the tube manufacturer), the Athlete should be asked and encouraged to remain and observe his/her Samples for this period of time. If the Athlete declines to do so, this in no way invalidates the test. The DCO should maintain these Samples under their observation and monitor the pre-determined period of time. The ADO may wish the DCO to record details of any Athlete that does not remain to observe their Samples during this period.]

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Post collection processing for the purpose of:

7.3 Post collection processing for the purpose of:

7.3.1 Analysis of whole blood (or plasma)

For the analysis of whole blood or plasma, the 2 x 3mL Blood Samples, comprising of an "A" and a "B" Sample (or the Sample collected for the purposes of the Athlete Passport) should be inverted gently eight (8) to ten (10) times to mix the blood with the anti-coagulant contained in the tube in order to avoid clot formation. This step shall be taken as soon as possible. The Blood Samples then be sealed and made ready for transportation in accordance with section 7.4.

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Aftercare procedure

7.2 Aftercare procedure

7.2.1 After withdrawing the needle from the Athlete’s arm, the BCO shall place a pad over the puncture site and instruct the Athlete to press firmly on the pad. The BCO may also choose to apply pressure to the wound.
7.2.2 If necessary, pressure shall be applied for 2–3 minutes prior to undertaking the sample sealing procedure. The BCO shall assess the wound and indicate to the Athlete and the DCO when the Athlete is ready.

7.2.3 The BCO or the DCO shall advise the Athlete not to undertake any strenuous exercise using the arm for at least 30 minutes. This minimizes any potential bruising.

7.2.4 The BCO shall be prepared to conduct first-aid if necessary.

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Conducting the Blood Sample Collection Session part 4

7.1.14 The BCO shall assess the most suitable arm for Venipuncture. This will always be the non-dominant arm, unless the BCO assesses the other arm to be more suitable or the Athlete requests a specific arm.

7.1.15 If the BCO believes that a Butterfly Needle is required for Venipuncture, the Athlete shall be asked to select a Butterfly Needle from a selection of sealed needles. The procedure then continues as normal.

7.1.16 If necessary, the BCO shall apply a tourniquet to the Athlete’s upper arm. If the Athlete has a skin problem, the tourniquet shall be applied over thin clothing or a paper tissue so that the skin is not pinched.

7.1.17 The skin at the puncture site shall be cleaned with a sterile disinfectant wipe or swab.

7.1.18 The needle shall be inspected visually before insertion. After the BCO has inserted the needle into the antecubital vein, the tourniquet shall be removed.

7.1.19 The BCO shall collect the amount of blood advised by the relevant Laboratory or ADO for the type of sample analysis to be conducted. The collection vessel (s) shall always be kept in full view of the Athlete.

7.1.20 In the event that the BCO is unable to draw sufficient blood from the first attempt, the procedure shall be repeated and up to three attempts in total shall be made before the DCO, in consultation with the BCO, decides to terminate collection. No more than three attempts to insert a needle into the Athlete’s body shall be made. The DCO shall record the reasons for terminating the collection attempt.

7.1.21 The blood shall be collected into one or more vessels, depending on the requirements of the ADO regarding intended analyses.

7.1.22 Blood collection equipment must be disposed of in accordance with the required standards for handling blood and the BCO’s protocol. 7.1.23 The recommended temperature recording device used to monitor the transport conditions should be turned on to ensure temperature reaches 2-8 degrees Celsius before Samples are placed inside cool-box.


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Conducting the Blood Sample Collection Session part 3

7.1.7 If both the DCO and the Athlete agree that none of the equipment is satisfactory, the DCO shall terminate sample collection, and record the reasons.

7.1.8 When the Blood Sample collection kit has been selected, the Athlete and the DCO shall proceed with the selection of the sealed, tamper evident Sample transport kit. Selection will proceed in the same manner as 7.1.4 to 7.1.7.

7.1.9 If the secure transport kit includes pre-printed bar code labels, the Athlete shall remove these labels from the secure transport kit, and shall verify with the DCO that the code numbers match the transport kit numbers.

7.1.10 If the Athlete or DCO find that the numbers are not the same, the DCO shall instruct the Athlete to choose another secure transport kit, and shall document the occurrence.

7.1.11 The Athlete shall place one label longitudinally on each of the vacutainer tubes. The label shall be placed towards the top of the tube(s), near the cap. The Athlete may authorize the DCO, or the Athlete Representative to place the labels on the tubes.

7.1.12 The DCO shall record the numbers, and the Athlete and the DCO shall check the documentation to ensure that the DCO has accurately recorded the information.

7.1.13 The Athlete shall give the BCO the Blood Sample collection equipment, including the vacutainer(s). The BCO shall assemble the equipment in sight of the Athlete.


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Conducting the Blood Sample Collection Session part 2

7.1.3 Collection of blood for analysis of the variables of the Athlete Biological Passport:

Number of Samples: 1 (no "B" Sample required)

Volume required: 1 x 3mL (or as specified by relevant Laboratory).

The tube used contains solid EDTA as anti-coagulant. The contents must be homogenized as soon as possible after collection (e.g. tubes should be gently inverted t eight (8) to ten (10) times). The contents shall then be sent to Laboratory or WADA approved laboratory with no further action.

7.1.4 After the required rest period, and the DCO/BCO explanation of procedure, the DCO shall direct the Athlete to choose the appropriate number of Blood Sample collection kits, as required by the ADO. It is recommended that
there are at least three (3) Blood Sample collection kits from which to choose.

[7.1.4 Comment: The kit will typically include the sterile needle, syringe and the relevant vacutainer tubes packaged together in a sealed bag. If kits contain only one vacutainer, and an A and B sample are required, the Athlete shall choose two Blood Sample collection kits.]

7.1.5 The Athlete and DCO shall check that the equipment is clean and intact. If either the Athlete or DCO is not satisfied with the equipment, the Athlete should make another selection.

7.1.6 If the Athlete is not satisfied with any of the equipment, and the DCO does not agree with the Athlete’s opinion that all of the available equipment is unsatisfactory, the DCO shall instruct the Athlete to proceed with the sample collection session and the Athlete’s views must be recorded on the doping control documentation by the DCO.

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Conducting the Blood Sample Collection Session

7. Conducting the Blood Sample Collection Session

7.1 Venipuncture

The type of equipment used for blood collection, and the post-collection process, will differ depending on the type of analysis required. The vaccutainers identified below are recommended as they have been fully validated by WADA and or WADA accredited laboratories. Alternate equipment which may meet the same criteria to those identified herein may be permissible but should be validated by WADA and/or the relevant laboratory, and consistent with the collection methodology presented herein, prior to use. In summary:

7.1.1 Collection of blood for analysis of Prohibited Substances and Methods in whole blood (e.g. detection of blood transfusion) or in plasma (e.g. HBOCs and CERA):

Number of Samples: 2 ("A" Sample and "B" Sample)

Volume required: 2 x 3mL (or as specified by relevant Laboratory)

(BD Vacutainer K2EDTA (K2) CE cat no 368856/ref US 367856) The tube used contains EDTA as anti-coagulant. The contents must be homogenized as soon as possible after collection. E.g. tubes should be gently inverted eight (8) to ten (10) times. The contents shall then be sent to Laboratory with no further action.

7.1.2 Collection of blood for analysis of Prohibited Substances and Methods in serum (e.g. detection of hGH, HBOCs and CERA):

Number of Samples: 2 ("A" Sample and "B" Sample)

Volume required: 2 x 5mL (or as specified by relevant Laboratory) Blood is drawn into a tube that has an inert polymeric serum separator gel and a clotting activation factor (BD Vacutainer® SST II, EU ref 367955).

The contents must be homogenized as soon as possible after collection (e.g. tubes should be gently inverted up-side down at least five (5) times). The contents shall then be sent to Laboratory with no further action.

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Athlete arrival at the Blood Collection Facility part 2

6.3.6 Irrespective of the Testing type, once the Athlete has arrived at the Blood Collection Facility/Doping Control Station he/she must be under observation at all times until sample collection is completed.

6.3.7 In order to ensure the same conditions for all, the Athlete shall remain seated and relaxed for at least 10 minutes before undergoing Venipuncture.

[6.3.7 Comment: DCOs should assign a member of the Sample Collection Personnel to the role of monitoring the 10 minute seated rest period for each Athlete where possible.This may be conducted in conjunction with maintaining an entry and exit log.]

6.3.8 The Athlete may request to leave the Blood Collection Facility for a time, for reasons defined in section 6.1.10. The Athlete must be escorted continuously at such times, and the purpose of leaving, agreed time of return, and actual time of return shall be documented by the DCO. If a Chaperone is not available, the DCO shall ask the Athlete to remain in the Blood Collection Facility. If an Athlete insists on leaving the Blood Collection Facility, the circumstances shall be documented by the DCO.

6.3.9 Before sample collection, the DCO should ask the Athlete whether they have been tested before, and whether they require an explanation of the Blood Sample collection procedure.

6.3.10 If the Athlete has not been tested before, or requests an explanation of the procedure, the DCO should explain the Blood Sample collection procedure to the Athlete.

6.3.11 As a minimum, the DCO shall ensure the Athlete is informed of the requirements of the Sample Collection Session and his/her rights and responsibilities.


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Athlete arrival at the Blood Collection Facility

6.3 Athlete arrival at the Blood Collection Facility

6.3.1 The Athlete arrives at the Blood Collection Facility with a DCO/Chaperone and, if requested, an Athlete Representative and/or interpreter. At this time,
the Athlete should present photo ID to the DCO. An Athlete’s inability to provide photo ID shall not invalidate a test. Alternative methods of Athlete identification are outlined in section 6.1.3.

6.3.2 An entry and exit log should be maintained to record the names of the persons entering facility, their position, and the times of arrival and departure in instances where multiple Athletes will be tested in a short period of time.

6.3.3 A Blood Sample shall be collected from one Athlete at a time. Each Athlete’s privacy shall be ensured.

6.3.4 If the Athlete is also providing a urine Sample at the same session, the DCO may request that the Athlete provide the Blood Sample first.

6.3.5 The Athlete shall be provided with the opportunity to hydrate.


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Chaperoning the Athlete to the Blood Collection Facility.

6.2 Chaperoning the Athlete to the Blood Collection Facility. 6.2.1 The DCO/Chaperone shall ensure that the Athlete is escorted from the place of notification to the Blood Collection Facility under constant supervision. [6.2.1 Comment: The DCO should take into consideration relevant sport-specific and venue specific factors that could affect the chaperoning process, for example sports in which Athletes often compete in more than one Event potentially prolonging the chaperoning process.]

6.2.2 The DCO/Chaperone cannot prevent the Athlete from eating or drinking products of their choice, but should recommend that the Athlete chooses from a selection of individually sealed, non-alcoholic beverages in order to hydrate. The DCO/Chaperone should not handle food or drink items for the Athlete.



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6.2.3 The DCO/Chaperone shall escort the Athlete at all times until the sample collection procedures have been completed, or shall ensure that another DCO/Chaperone has taken over escorting the Athlete.

6.2.4 The Chaperone shall inform the DCO as soon as practical without leaving the Athlete unattended, and ensuring discretion, of any irregularities in notification and/or suspicious Athlete behavior during the observation period. Irregularities shall be documented by the DCO if relevant.

[6.2.4 Comment: The ADO is responsible for establishing guidelines for what constitutes suspicious Athlete behavior – examples might be; evading observation, ingesting an unidentified substance, a distressed call to a coach or other unusual behavior.]