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This maintains the Athlete’s anonymity for potential Athlete Passport Management Unit and Expert Panel reviews conducted in the future.
C.7.2 When an Athlete is found to have committed an anti-doping rule violation on any basis other than the Athlete Biological Passport , the Passport will remain in effect, except in those cases where the Prohibited Substance or Prohibited Method may have altered Passport Markers (e.g.
for an AAF reported for anabolic androgenic steroids, which may affect the Markers of the steroid profile, or for the Use of Agents Affecting Erythropoiesis or blood transfusions, which would alter the haematological Markers ).
The Passport Custodian shall consult with their Athlete Passport Management Unit following an Adverse Analytical Finding to determine whether a Passport reset is warranted.
In such instances, the Athlete’s profile(s) would be reset from the time of the beginning of the sanction.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 66/91 3.8.
Athlete Passport Management Unit Requirements and Procedures WADA Technical Document – TD2023APMU Document number : TD2023APMU Version number: 1.0 Written by : WADA Approved by: WADA Executive Committee Date: November 2022 Effective date : 1 January 2023 1.0 Introduction This Technical Document (TD) has been established to harmonize effective management of Athlete Passports by providing specific requirements that an Athlete Passport Management Unit (APMU) shall meet in order to be a WADA -approved APMU .
2.0 APMU Roles and Responsibilities 2.1 The APMU is the dedicated unit that is responsible for the timely management of Passports in the Anti-Doping Administration and Management System (ADAMS) on behalf of the Passport Custodian.
Passport management by the APMU involves: • Performing Passport assessment s to make timely Target Testing recommendations to the Passport Custodian via the APMU Report in ADAMS when appropriate; and • Managing the review of atypical Passports according to Annex C of the International Standard for Results Management (ISRM) [1], including, but not limited to, the following: o Issuing and updating APMU Reports in ADAMS, o In case of an Atypical Passport Finding ( ATPF) , or when a review is otherwise justified, assigning and liaising with the Expert panel as required, o Compiling all necessary information to establish an Athlete Biological Passport (ABP) Documentation Package, and o Declaring Adverse Passport Findings (APFs ) to the Passport Custodian and WADA .
2.2 The APMU shall assess and manage Passport Sample validity in ADAMS, in consultation with the Experts or Laboratories when necessary, per Article 8.2 of this TD .
2.3 The APMU shall provide support to the Passport Custodian in defining priorities in order to optimize the efficiency of their ABP program.
These priorities may include, but are not limited to, cost efficiency, special analyses, Test Distribution Plans (TDP), and Target Testing.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 67/91 3.0 APMU Hosting 3.1 An APMU shall be hosted by a Laboratory .
[Comment: Hosting in this context is defined as the provision of facilities and resources for the efficient functioning of the APMU .]
3.2 APMU hosting by a Laboratory does not preclude the use of qualified APMU managers employed by ADOs or other Laboratories .
3.3 Passport management shall be carried out in ADAMS using dedicated APMU accounts associated with the host Laboratory regardless of the physical location of the APM U manager(s).
3.4 The host Laboratory shall implement procedures to maintain the operational independence of the APMU , including the appointment of dedicated personnel with a specified time commitment to the APMU and a separate allocation in the budget so tha t the APMU can continue to function should the WADA accreditation of the Laboratory be suspended (see Article 7.1.5 of this TD ).
4.0 APMU Personnel 4.1 The host Laboratory shall have a Person qualified to function as the designated head of the APMU by assuming professional, organizational, educational, and administrative responsibility of the APMU .
The APMU Director is responsible for ensuring the APMU operates in compliance with this TD and applicable International Standards .
In particular, the APMU Director assumes the responsibility of signing and delivering all APFs to the Passport Custodian and WADA .
[Comment: The head of the APMU is termed “Director” herein, however use of this title is not a requirement and can be adjusted according to the needs of the organization. ]
4.1.1 The APMU Director’s qualifications shall ensure that this individual is competent and capable of leading the APMU operations, including: • A doctoral degree (or equivalent) in one of the natural sciences or medicine, or in the absence of a doctoral degree, a master’s degree (or equivalent) with extensive and appropriate anti -doping science experience and training ( i.e., minimum of five (5) years); • Management experience; • Ability to oversee compliance with quality management practices; and • Good command of at least one of WADA ’s two official languages, English and French.
It is acknowledged that the APMU Director plays an essential role in the APMU operations and that WADA APMU approval is delivered based upon appointment of a proper candidate.
WADA reserves the right to review the credentials of such appointment in accordance with the above qualifications.
4.1.2 The APMU Director is responsible for maintaining documentation for each personnel employed by, or under contract to, the APMU .
Such documentation shall contain copies of the curriculum ABP Operating Guidelines – Version 9.0 – July 2023 Page 68/91 vitae or qualification form, a job description, and records of initial and ongoing training related to anti -doping.
4.1.3 Any personnel changes to the position of APMU Director shall be communicated to WADA no later than one (1) month prior to the date the APMU Director is scheduled to vacate the position.
A succession plan shall be submitted to WADA .
4.1.4 The APMU Director is notably responsible for monitoring the quality of Passport management and ensuring that other APMU personnel have the experience and training necessary to perform their duties.
4.2 The APMU shall use qualified scientific personnel to serve as APMU manager(s) to manage the Passport review process and Sample validity, and to provide Target Testing and Analytical Testing recommendations through APMU Reports in ADAMS.
APMU manager(s) shall be employed by the host Laboratory or be under contract by an ADO or another Laboratory .
The APMU should have at least one APMU manager per module of the ABP, where one manager may supervise multiple modules based on their qualifications.
[Comment: The designation of “manager” is used herein, however use of this title is not a requirement and can be adjusted according to the needs of the organization.
The APMU Director can also serve in the role of APMU manager as required.
Where the APMU manager is employed by an ADO, it is assumed that this individual will have access to the identity and other privileged or confidential information about the Athlete, past Testing and/or Results Management and investigations history.
This additional infor mation shall not be shared by the APMU manager in the APMU Report but is recognized to be important to contribute to effective Target Testing. ]
4.2.1 APMU manager(s) shall have qualifications in one or more modules of the ABP.
The qualifications are at minimum: • Bachelor’s degree (or equivalent) in one of the natural or health sciences.
Documented experience of three (3) years or more in anti -doping or similar scientific training is equivalent to a Bachelor’s degree for this position; and • Adequate training in one or more modules of the ABP, capacity to understand and evaluate analytical results and the physiological response to the Use of Prohibited Substances and Prohibited Methods , as well as criteria relevant for Target Testing.
4.2.2 Where the APMU manager has strong qualifications in Laboratory steroid analysis, steroid doping and metabolism and/or clinical endocrinology, and is not employed by the Passport Custodian, the APMU manager can act as a first Expert for the Steroidal Module of the ABP.
4.3 The APMU should have administrative personnel to coordinate with the Passport Custodian to compile the necessary documentation required for the ABP Documentation Packages , manage communication with various stakeholders and assist with the organization of APMU -related documentation.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 69/91 5.0 APMU Confidentiality and Security 5.1 All APMU related activities shall be carried out in accordance with the confidentiality requirements of the Code and International Standards .
5.2 While APMU activities are typically carried out using Passport data associated with a unique ID, and while APMU staff gen erally do not have access to data that would enable them to identify Athletes in ADAMS, APMUs may access Personal Information where additional information is needed to assess a Passport (e.g., when assessing a Passport that has generated an ATPF ).
In such contexts, Personal Information shall only be processed for the purposes set out in this TD, and shall be handled by the APMU in accordance with the International Standard for the Protection of Privacy and Personal Information (ISPPPI) [2] and applicable laws.
5.3 Without limiting the above, the APMU shall adhere to those information retention times set forth in Annex A of the ISPPPI.
In consultation with the Passport Custodian , the APMU shall develop specific plans and procedures to ensure the secure retention and eventual destruction of Personal Information .
5.4 The APMU shall develop, maintain, implement and ensure ongoing compliance with a written information security program that includes physical, organizational, technical, environmental and operational safeguards appropriate to the sensitivity of the information in its custody or to which it has access.
Such program shall be based on a threat and risk assessment by expert(s) in the relevant field, and shall ensure the confidentiality of its p rocedures and security of its information systems regardless of the physical location of the APMU personnel at the time of Passport management, such as when the APMU manager is physically located in an ADO , another Laboratory or when travelling.
6.0 ABP Expert Panel 6.1 The APMU shall engage the services of qualified Experts for the review of Passports in accordance with Annex C of the ISRM [1] 6.2 The APMU should inform WADA about any changes in their pool of Experts .
6.3 The APMU shall establish, in consultation with th e Passport Custodian, a list of Experts who are qualified to comprise an Expert panel for the review of Passports .
• For the Hematological Module, the Expert panel should consist of at least three (3) Experts who have qualifications in one or more of the fields of clinical and laboratory hematology, sports medicine and exercise physiology, as they apply to blood doping.
• For the Steroidal Module, the Expert panel should be composed of at least three (3) Experts with qualifications in the fields of Laboratory steroid analysis, steroid doping, and/or clinical endocrinology , as it applies to steroid Marker metabolism.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 70/91 • For the Endocrine Module, the Expert panel should be composed of at least three (3) Experts with q ualifications in the fields of endocrine biomarker analysis, doping with growth hormone and related compounds , and/or clinical endocrinology , as it applies to growth hormone Marker metabolism.
For each module, an Expert panel should consist of Experts with complementary knowledge such that all relevant fields are represented.
All three (3) Experts forming an Expert panel assigned to review a particular Passport shall not be of one and the same nationality and no two (2) Experts shall have a primary affiliation with the same organization, institution or company, including, but not limited to, universities, hospitals and research institutes.
Where applicable, at least one Expert on the Expert panel should currently serve or have previously served as an Expert and reviewed Passports for a WADA -approved APMU .
6.4 The APMU shall ensure that each Expert : • Has access to relevant ABP Expert education resources provided by WADA ; • Has an Expert account in ADAMS for the anonymous review of Passports assigned by the APMU ; • Is independent of the Passport Custodian and has no conflicts of interest in reviewing Passports , as documented in a conflict -of-interest declaration; and • Has signed the WADA ABP Expert Code of C onduct Declaration.
[Comment: An APMU manager may also concurrently serve as an Expert for other APMUs , provided all requirements of Article 6.0 of this TD are met.]
7.0 Process and Requirements for WADA APMU Approval Passports shall only be managed by APMUs that have been approved by WADA .Applying for WADA APMU Approval 7.1.1 Expression of Interest The candidate APMU shall officially contact WADA in writing to express its interest in the WADA APMU approval process.
7.1.2 Preliminary Disc ussion with WADA The purpose of this discussion is to clarify issues with regard to the approval process and to obtain information about different aspects of the APMU relevant to the approval process.
Such a discussion could be conducted prior to or during the approval process.
7.1.3 Description of the Candidate APMU The candidate APMU shall then complete a detailed application form provided by WADA and submit it to WADA no later than eight (8) weeks following receipt.
The application form includes, but is not limited to, the following: ABP Operating Guidelines – Version 9.0 – July 2023 Page 71/91 • List of staff, their qualifications and intended role within the APMU ; • Description of the APMU information security program (see Article 5.
4 of this TD ), including a description of the physical, organizational, technical, environmental and operational security measures implemented to protect records and computer systems; • List of external Experts , their contact information, their qualifications and signed ABP Expert Code of Conduct Declaration; • Business Plan for the APMU and letters of support from ADOs that demonstrate a commitment to manage, according to Article 2.0 of this TD, a minimum of 100 active hematological Passports and 500 active st eroidal Passports from Signatories annually, within one year of receiving approval.
An eligible Business Plan shall demonstrate a commitment to provide at least 200 APMU Reports for hematological Passports and 500 APMU Reports for steroidal Passports per year.
[Comment: A Passport is considered active when at least one Sample collection is planned during the first year of operation of the APMU .
There is no minimum number of active endocrine Passports required for the business plan.]
7.1.4 Liabil ity Insurance Coverage The APMU shall provide documentation to WADA that professional liability risk insurance coverage or equivalent has been obtained which covers the APMU to an amount of no less than (≥) 2 million USD annually, and should ensure that the Expert panel has suitable professional liability risk insurance o r equivalent coverage.
7.1.5 Operational Independence The APMU shall ensure a degree of operational independence from the host Laboratory such that the APMU can continue to fulfil its responsibilities in compliance with this TD should the WADA accreditation of the Laboratory be suspended, where the reason for the Suspension does not have an impact on the function of the APMU .
Operational independence implies that the APMU shall have a separate allocation in the budget and sufficient technical and human resources to permit the APMU to manage its own affairs without hindrance or interference by host Laboratories .
7.1.6 Compliance with the WADA APMU Code of Ethics The candidate APMU shall implement and comply with the provisions in the WADA APMU Code of Ethics.
The APM U shall provide the APMU Code of Ethics to APMU personnel and ensure their understanding and compliance with all aspects.
The candidate APMU shall provide to WADA a letter of compliance with the APMU Code of Ethics, signed by the APMU director.
7.1.7 WADA Recommendation for Approval After receipt of the application form, WADA will complete and submit a report to the candidate APMU .
The report will include a recommendation concerning approval of the candidate APMU .
In the case where the recommendation is t hat the APMU should not be approved, the report ABP Operating Guidelines – Version 9.0 – July 2023 Page 72/91 will identify improvements required in order to be re- considered for designation as a WADA -approved APMU .
In the case where the recommendation is that the APMU should be approved, the report and recommendation will be submitted to the WADA Executive Committee for approval.
7.1.8 Issuing Approval Letter and Publishing APMU List on WADA ’s Website A letter signed by a duly authorized representative of WADA shall be issued in recognition of approval of an APMU, specifying the name of the APMU Approval may be granted with retroactive effect.
An updated list of approved APMUs shall be published by WADA on WADA ’s website.
7.2 Maintaining WADA Approval An APMU shall continue to function if the Laboratory’s accreditation is suspended, provided that the APMU continues to meet other criteria for approval, and that any non- conformities related to the Suspension of the Laboratory’s accreditation do not have an impac t on the APMU .
The APMU ’s approval shall be revoked if the WADA accreditation of the associated Laboratory is revoked.
[Comment: Suspension or Revocation of APMU approval shall not be considered in decisions on Suspension or Revocation of Laboratory accreditation unless the APMU non-compliance has a clear impact on the function of the Laboratory .]
7.2.1 Minimum Number of Passports and APMU Reports In order to maintain proficiency, WADA -approved APMUs are required to review a minimum number of Passports and provide APMU Reports for Passports of Signatory Passport Custodians .
WADA shall monitor the total number of Passports under the responsibility of the APMU and the number of APMU Reports issued by the APMU .
If the annual number falls below 100 active hematological Passports , 500 active steroidal Passports , 200 hematological APMU Reports or 500 steroidal APMU Reports , WADA APMU approval may be suspended or revoked.
[Comment: For the purposes of WADA APMU monitoring, a Passport is considered active when at least one Sample is collected during the previous twelve months period at the time of the assessment .
There is no minimum number of active endocrine Passports or APMU Reports required to maintain APM U approval.]
7.2.2 Documenting Compliance with the WADA APMU Code of Ethics The APMU shall annually provide to WADA a letter of compliance with the provisions of the APMU Code of Ethics, signed by the APMU Director.
All APMU personnel shall sign the WADA APMU Code of Ethics on a yearly basis and the signed documents shall be kept as part of their personnel file.
The APMU may be asked to provide documentation demonstrating compliance with the provisions of the APMU Code of Ethics.
ABP Operating Guidelines – Version 9.0 – July 2023 Page 73/91 7.2.3 Documenting Sharing of K nowledge The APMU shall proactively share knowledge with other WADA -approved APMUs .
The APMU should participate at least once annually in a WADA Working Group or an anti -doping symposium or conference.
The APMU shall supply an annual report on sharing of knowledge with WADA .
A description of this sharing of knowledge is provided in the WADA APMU Code of Ethics.
7.2.4 Maintaining Professional Liability I nsurance Coverage The APMU shall maintain an ongoing professional liability risk insurance coverage or equivalent which covers the APMU to an amount of no less than (≥) 2 million USD annually, and should ensure that the Expert panel has suitable professional liability risk insurance or equivalent coverage.
Proof of the corresponding coverage shall be provided to WADA upon request.
7.2.5 APMU Compliance Monitoring by WADA WADA shall monitor the compliance of APMUs against the requirements listed in applicable International Standards and TDs.
In addition, WADA shall also conduct periodic audits of APMU compliance to assess the overall performance of each APMU and to decide its approval status.
7.2.6 APMU Assessment by WADA WADA reserves the right to conduct document -based audits as well as inspect and assess the APMU through on- site or remote assessments at any time, at WADA ’s expense.
The notice of an on -site assessment will be made in writing to the APMU Director.