Thursday, 2 February 2012

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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