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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 a n 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 : 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.
ISTI – Effective 1 January 2023 Page 82 of 92 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 .
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 ISTI – Effective 1 January 2023 Page 83 of 92 (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 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.
ISTI – Effective 1 January 2023 Page 84 of 92 ANNEX J - COLLECTION, STORAGE AND TRANSPORT OF DRIED BLOOD SPOT SAMPLES J.1 Objective To collect an Athlete’ s blood as a dried blood spot Sample in a manner that ensures: a) Consistency with relevant principles of internationally -recognized standard precautions in healthcare settings, and is collected by a suitably trained Person , so that the health and safety of the Athlete and Sample Collection Personnel are not compromised; b) The Sample is of a quality and quantity that meets the relevant analytical requirements; c) The Sample has not been manipulated, substituted, contaminated or otherwise tampered with in any way; d) The Sample is clearly and accurately identi fied; and e) The Sample is securely sealed in a Tamper Evident kit.
J.2 Scope The collection of a dried blood spot Sample begins with ensuring the Athlete is informed of the Sample collection requirements and ends with properly storing the Sample prior to transport to the Laboratory that will be analysing the Sample .
Dried blood spot Samples are collected by puncture/incision of the skin to access capillary vessels (small blood vessels).
One dried blood spot Sample consists of a series of small volumes of capillary blood, which are collected within the same Sample Collection Session and allowed to dry on an absorbent Sample support.
[Comment to J.2: In this context, the term “dried bl ood spot” refers to a capillary blood Sample that is collected and allowed to dry on an absorbent Sample support, including Samples collected by “spotting” capillary blood directly onto a cellulose- based card or other absorbent Sample support made of cellulose or of another material , as well as those collected via a specific device with integrated microneedle(s)/microlancet(s ).]
J.3 Responsibility Due to the absence of venipuncture during dried blood spot collection, dried blood spot Samples may be collec ted by a DCO without the need for a specialized BCO if standard precautions in healthcare settings are followed and the DCO is suitably trained.
Procedures for dried blood spot collection shall be consistent with local standards and regulatory requirements .
The DCO and/or the BCO have the responsibility for: a) Collecting the dried blood spot Sample; b) Ensuring that each Sample is properly identified and sealed; c) Answering relevant questions during the provision of the Sample; d) Properly disposing of dried blood spot sampling equipment that is opened but not used, or used pieces of equipment not sealed with the absorbent Sample support; and e) Properly storing and disp atching each Sample.
ISTI – Effective 1 January 2023 Page 85 of 92 J.4 Requirements for Dried Blood Spot Sample Collection Equipment The dried blood spot Sample Collection Equipment shall fulfill the following criteria: a) Contain a single -use Sample collection device ( e.g., disposable lancets to be used in conjunction with cellulose cards, devices with integrated microneedle(s)/microlancet(s)) for the puncture/incision and collection of capillary blood at the fingertip and/or from the upper arm (alternative sites of punctures may be authorized for Athletes with physical impairments, if required); b) The “A” and “B” absorbent Sample support shall allow the collection of distinct “A” and “B” spots (or equivalent) with a minimum total of approximately 40 µL of capillary blood in t he “A” spot(s) and with a minimum total of approximately 20 µL of capillary blood in the “B” spot(s) and; [Comment to J.4 (b): Depending on the dried blood spot Sample Collection Equipment used, the volume and number of spots may vary.
If a spot has a small volume (e.g., less than 20 µL), several spots may be combined to perform the required Analytical Testing Procedure (s).]
c) The Sample container and/or storage sleeves/packages/receptacles shall contain a desiccant to allow the spots to dry expeditiously when already sealed (without having to wait before sealing) and offering protection against possible premature degradation or contamination of the Sample .
[Comment to J.4: Additional guidanc e for dried blood spot Sample Collection Equipment can be found in WADA’s Guidelines for Sample Collection.]
J.5 Dried Blood Spot Sample Provision Procedures involving blood collection shall be consistent with the local standards and regulatory requirements regarding precautions in healthcare settings where those standards and requirements exceed the requirements set out below.
J.5.1 The DCO shall ensure that the Athlete is properly notified of the requirements of the Sample collection, including any modifications as provided for in Annex A - Modifications for Athletes with Impairments and/or in Annex B - Modifications for Athletes who are Minors .
J.5.2 The DCO /Chaperone and Athlete shall proceed to the area where the Sample will b e provided.
J.5.3 The DCO /BCO shall wear gloves during the Sample collection process and until the Sample is sealed.
J.5.4 The DCO /Chaperone shall, where practicable, ensure the Athlete thoroughly washes their hands with water only prior to the provision of the Sample.
[Comment to J.5.4 : Any traces of talcum powder, resin, or other products that Athletes use should be thoroughly cleaned, and alcohol pads or swabs may be used if needed.]
J.5.5 The DCO /BCO shall ensure that the Athlete is offered comfortable conditions for the ISTI – Effective 1 January 2023 Page 86 of 92 provision of the Sample .
[Comment to J.5.5: The requirement for the Athlete to be seated in an upright stationary position for at least 10 minutes with feet on the floor as contained in Annex D.4.5 prior to providing a blood Sample does not apply before the provision of a dried blood spot Sample. ]
J.5.6 The DCO /BCO shall instruct the Athlete to sel ect the Sample Collection Equipment required for collecting the Sample and to check that the selected equipment has not been tampered with and any seals are intact.
If the Athlete is not satisfied with the selected equipment , they may select another.
If the Athlete is not satisfied with any equipment and no other is available, this shall be recorded by the DCO .
If the DCO does not agree with the Athlete that all of the available equipment is unsatisfactory, the DCO shall inst ruct the Athlete to proceed with the Sample Collection Session .
If the DCO agrees with the Athlete that all available equipment is unsatisfactory, the DCO shall terminate the collection of dried blood spot Sample s and this shall be recorded by the DCO .
J.5.7 When a Sample collection kit has been selected, the DCO and the Athlete shall check that all Sample code numbers match and that this Sample code number is recorded accurately by the DCO on the Doping Control form.
If the Athlete or DCO finds that the numbers are not the same, the DCO shall instruct the Athlete to choose another kit.
The DCO shall record the matter.
J.5.8 The DCO /BCO shall assess the most suitable location for puncture at the fingertip and/or from the upper arm that is unlikely to adversely affect the Athlete or their sporting performance (e.g., non-dominant hand/arm).
This should be a site of puncture that is free of any calluses, cuts, scars and tattoos.
The DCO /BCO should select an alternative suitable sit e of puncture for Athletes with physical impairments if applicable.
[Comment to J.5.8: The DCO /BCO should decide whether the dried blood spot Sample be collected from the right or left hand/arm.
However, they may not be given the choice of the collection between the hand or arm, as this is dependent on the Sample Collection Equipment used by the SCA.]
J.5.9 The DCO /BCO shall instruct the Athlete to warm the Sample collection site by, for example, washing the hands in warm water, shaking the hand/arm, massaging the puncture site, or placing the hand/arm in a warm blanket or equivalent.
J.5.10 The DCO /BCO shall clean the skin with a sterile alcohol pad or swab.
Disinfectant gels shall not be used.
Once the skin is completely dried, the DCO /BCO shall take the capillary blood Sample from the fingertip or an area on the upper arm using the dried blood spot collection device in accordance with the instructions provided by the equipment manufacturers.
For dried blood spot Samples collected from the fingertip: a) The middle or ring finger should be selected if possible.
The little finger may also be selected but the collection may be more painful; b) The puncture should be done with a lancet, slightly lateral to the pad of the finger, on the last phalanx of the finger; ISTI – Effective 1 January 2023 Page 87 of 92 c) Blood flow can be increased by gently massaging the proximal portion of the finger in a distal direction.
However, squeezing or milking the finger should be avoided as it may cause hemolysis and dilution of the Sample; d) The first drop of blood shall be wiped away with a dry sterile compress/gauze pad; e) Only the drop of blood shall enter into contact with the dried blood spot absorbent Sample support, while the finger shall not touch it.
The drop of blood should not be smeared onto the absorbent Sample support; and f) Only one drop of blood shall be applied per spot, because the d ripping of several drops onto the same spot would cause an inhomogeneous Sample.
For dried blood spot Samples collected from the upper arm with a device with integrated microneedle(s)/microlancet(s) : g) The DCO /BCO shall be responsible for applying and removing the device from the Athlete’s arm.
The Athlete is permitted to press the button to engage the microneedle(s)/microlancet(s) after having received the necessary instructions from the DCO /BCO .
Otherwise, the DCO /BCO will press the button.
J.5.11 The volume of capillary blood removed shall be adequate to satisfy the relevant analytical requirements for the Sample analysis to be performed, i.e.
, a minimum total of approximately 40 µL of capillary blood in the “A” spot(s) and a minimum total of approximately 20 µL of capillary blood in the “B” spot(s) for chromatography -mass spectrometric Analytical Methods .
Other special analyses may require additional Samples and/or increased Sa mple volume.
J.5.12 The DCO /BCO shall verify that capillary blood is deposited on the absorbent Sample support and that a sufficient number of spots in the “A” and “B” Samples (to produce a sufficient amount of capillary blood, as described in Annex J.5.11 ) are saturated with blood.
J.5.13 If the volume of capillary blood collected from the Athlete at the first attempt is insufficient, the DCO /BCO shall repeat the procedure up to a maximum of three (3) attempts in total.
Should all three (3) attempts fail to produce a sufficient volume of capillary blood, the DCO shall terminate the collection of dried blood spot Samples and record the reasons for its termination.
If more than one attempt is needed, another site of puncture shall be selected by the DCO /BCO .
The skin shall be cleaned and a new lancet/ Sample Collection device shall be used for the puncture of the skin.
[Comment to J.5.13: An attempt is defined as the act of puncturing the skin, i.e., only if the lancet or microneedle(s)/microlancet(s) has(ve) been engaged and punctured the skin.]
J.5.14 After collection, the DCO /BCO shall apply pressure to the puncture site(s) or ask the Athlete to do so.
The DCO /BCO shall then apply a dressing(s).
J.5.15 The DCO /BCO shall dispose of used pieces of equipment that are not sealed with the absorbent Sample support in accordance with the required local standards for handling blood.
J.5.16 If the Sample requires further on- site processing, such as removal of the absorbent ISTI – Effective 1 January 2023 Page 88 of 92 Sample support ( e.g., cellulose paper, cartridge) from the collection device, the DCO /BCO shall do so and then transfer the Sample into the Tamper Evident kit.
The Athlete shall remain in the collection area and observe their Sample until it is sealed in a Tamper Evident kit.
J.5.17 The Athlete shall seal their Sample in the Tamper Evident kit as directed by the DCO .
In full view of the Athlete , the DCO shall check that the sealing is satisfact ory.
The Athlete and the DCO /BCO shall sign the Sample collection documentation ; and J.5.18 The sealed dried blood spot Sample can be stored at room temperature and shall be stored in a manner which minimizes the potential for Sample degradation due to factors such as time delays, exposure to light and extreme temperature variations.
J.6 Requirements for Transport J.6.1 Dried blood spot Samples shall be transported in accordance with Articles 9.1 to 9.3, with the following specifications: a) Dried blood spot Samples can be shipped as non-hazardous materials using regular mail or courier services, subject to any applicable regulations; b) While the Sample containers shall be transparent, it is recommended to transport dried blood spot Samples in a non -transparent transport box/bag to prot ect the Samples from light exposure; and c) Dried blood spot Samples can be transported at ambient temperature.
If collecting other blood Samples (e.g., blood Athlete Biological Passport Samples ) during the same Sample Collection Session, dried blood spot Samples can also be shipped refrigerated.
ISTI – Effective 1 January 2023 Page 89 of 92 ANNEX K - COLLECTION OF URINE SAMPLES IN A VIRTUAL ENVIRONMENT DURING A PANDEMIC1 K.1 ObjectiveTo provide a modified Sample collection procedure in a virtual environment that may only be implemented during a pandemic and/or a national epidemic when local or national government health restrictions in place allow an in- person notification of an Athlete but restrict in- person collection of a urine sample by a DCO.
[Comment to K.1: The ability to collect Samples during a pandemic may vary among countries based on the national approach to the pandemic and/or national epidemic, including the international, national and regional laws in place.
As a result, Sample collection in a virtual environment is not mandatory.
Before considering the implementation of Sample collection in a virtual environment an ADO should liaise with the applicable national health and data privacy authorities.