ISO/PAS 18873:1999

PUBLICLY ISO/PAS
AVAILABLE 18873
SPECIFICATION
First edition
1999-11-15
International protocol for doping control
Protocole international sur le contrôle du dopage
Reference number
ISO/PAS 18873:1999(E)
�
©
ISO 1999

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ISO/PAS 18873:1999(E)
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ISO/PAS 18873:1999(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a technical
committee may decide to publish other types of normative document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an
ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the
parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a
vote.
An ISO/PAS or ISO/TS is reviewed every three years with a view to deciding whether it can be transformed into an
International Standard.
ISO/PAS 18873 was prepared by the International Anti-Doping Arrangement (IADA) and was adopted, under a
special “fast-track procedure”, by the ISO member bodies.
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ISO/PAS 18873:1999(E)
Contents
Page
Preamble. v
1.0 The IADA Quality Concept. 1
2.0 Policies and Standards for the Doping Control Process . 4
2.1 Test Distribution Planning
2.2 Selection and Notification of Athletes
2.3 Preparing for and Conducting the Sample Collection Session
2.4 Handling of Samples
2.5 Sample Analysis
2.6 Results Management
2.7 Disciplinary Procedures, Sanctions and Appeals
3.0 Frame Conditions for Anti-Doping Organisations . 16
3.1 National Anti-Doping Organisations
3.1.1 Laws and Regulations
3.1.2 Organisational Responsibilities and Authorities
3.1.3 Plans
3.1.4 Resource Management
3.1.5 Sample Collection Personnel
3.2 International Sport Organisations
3.3 International Event Organisers
4.0 Policies and Standards for Applying ISO 9002 to Doping Control . 22
4.1 Policy Statement
4.2 Standards for Quality Management in Doping Control
5.0 Common International Quality Documentation . 24
6.0 Definitions. 25
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ISO/PAS 18873:1999(E)
Preamble
Australia, Canada, the Netherlands, New Zealand, Norway, Sweden and the United Kingdom
have established an international alliance in the area of anti-doping in sport. At the government
level they have signed a memorandum of understanding, the International Anti-Doping
Arrangement (IADA), outlining their commitment to co-operatively pursue and promote anti-
doping in sport.
The IADA mission is to ensure the development and harmonisation of the domestic doping
control programmes of the seven signatories and through this concrete example of good practice,
positively influence the broader international sports community.
The IADA Strategic Plan for 1995-1998 emphasised the need for developing and implementing
quality systems for national anti-doping programmes. Such systems will contribute to uniform
practices and also increase world-wide confidence in doping control procedures.
At the July 1995 IADA meeting in Oslo, Norway, the IADA countries agreed to take part in the
IADA Quality Project with the goals of developing and implementing quality systems for the
participating countries’ domestic doping control programmes, and having the quality systems
certified by an internationally recognised and accredited ISO certifying agency. The ISO 9002
standard in the ISO 9000 series was recommended to be the reference standard for establishing
quality systems in each IADA country.
The IADA Standard for Doping Control, version 2.0, was approved by the members of the IADA
Steering Group at their March 1998 meeting in Sydney, Australia. In the IADA Standard for
Doping Control, the IADA member countries have defined the overall quality policy for doping
control programmes as follows:
«Through the implementation of quality systems for doping control which satisfy the
requirements in the IADA Standard for Doping Control, the doping control procedures and
practices will be consistent, secure and reliable in all phases of the doping control process.»
The IADA Standard for Doping Control shall be reviewed according to the «Procedure for
Changing and Controlling the Quality Manual» which was approved by the IADA Steering
Group in Canberra, Australia on 10 February, 1997.
Any departure from the policies and/or standards set out in the IADA Standard for Doping
Control shall not invalidate the finding of a positive test result or failure to comply with a request
to provide a sample unless such a departure casts real doubt on the reliability of the finding.
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ISO/PAS 18873:1999(E)
1.0 The IADA Quality Concept
The IADA Quality Concept presents a comprehensive approach for managing and improving
quality control in doping control programmes.
By setting policies and standards for carrying out the doping control process and by ensuring
that the doping control procedures in different anti-doping organisations are in compliance
with these policies and standards, it will be possible to develop high quality, harmonised
doping control practices world wide.
The IADA Quality Concept is comprised of the following elements:
The IADA Standard for Doping Control
ISO Certified Quality Systems for Doping Control
Guidelines for Implementing ISO Certified Quality Systems.
The IADA Standard for Doping Control
The objectives for the IADA Standard for Doping Control are to improve and harmonise
doping control practices, particularly as they directly affect the athlete.
The IADA Standard for Doping Control prescribes policies and standards for the doping
control process and for the quality management of doping control procedures and
programmes. The IADA Standard for Doping Control was designed and developed at the
international level with the support and joint commitment of the IADA countries. The
Standard includes:
Policies and Standards for the Doping Control Process
Frame Conditions for Anti-Doping Organisations
Policies and Standards for Applying ISO 9002 to Doping Control.
Policies and Standards for the Doping Control Process
represent world best practices for doping control in sport and will be essential in
harmonising doping control procedures and practices in the international sport community.
The doping control process has been divided into seven phases. Each of these phases
focuses on activities that have a strong impact on the overall quality of the doping control
process. The seven phases are: test distribution planning; selection and notification of
athletes; preparing for and conducting the sample collection session; handling of samples;
sample analysis; results management; and disciplinary procedures, sanctions and appeals.
These seven phases represent a natural activity flow in the doping control process.
The main customers of the doping control process are the athletes.
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ISO/PAS 18873:1999(E)
Frame Conditions for Anti-Doping Organisations
include areas that have a considerable influence on the various phases in the doping control
process. Frame conditions are not part of the natural activity flow in the doping control
process but are prerequisites for conducting doping control programmes and procedures.
Every anti-doping organisation must have these prerequisites in place in order to carry out
doping controls in compliance with the policies and standards for the doping control process
prescribed in the following chapter.
The frame conditions will vary depending on the type of organisation conducting doping
controls. The IADA Standard for Doping Control distinguishes between frame conditions for
anti-doping organisations at the national level, anti-doping organisations acting on behalf of
international sport organisations and anti-doping organisations acting on behalf of major
international event organisers.
Policies and Standards for Applying ISO 9002 to the Doping Control Process
introduce quality management principles. The objective of these policies and standards is to
manage the doping control process using quality systems that are developed at the national or
organisational level and that are in compliance with ISO 9002.
Through the implementation of quality systems for doping control that satisfy requirements in the
IADA Standard for Doping Control, doping control procedures and practices will be consistent,
secure and reliable in all phases of the doping control process. In turn, by applying the
requirements in the ISO 9002 standard to the doping control process, a quality system will be
developed that ensures the effective implementation of the IADA Standard for Doping Control at
the national or organisational level. The ISO 9000 series standards are widely recognised and
have been adopted by more than 70 countries. There is a growing interest in international quality
standards in many industries, including the service sector. Quality systems developed in
compliance with the ISO 9000 series will increase both the impact of doping control programmes
and confidence in doping control practices.
The IADA Standard for Doping Control is the main reference document in the IADA Quality
Concept. Therefore, any country or organisation participating in the IADA Quality Concept is
committed to following the policies and standards prescribed in the IADA Standard for Doping
Control.
ISO Certified Quality Systems for Doping Control
The policies and standards for applying ISO 9002 to the doping control process define the
requirements for the development and implementation of quality systems that are in compliance
with the IADA Quality Concept. Anti-doping organisations must implement quality systems
according to these standards in order to be part of the IADA Quality Concept.
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ISO/PAS 18873:1999(E)
The quality systems shall be certified in accordance with ISO 9002 by an accredited certifying
agency. Doping control is a new area of application for ISO 9000 quality systems. It is therefore
necessary to adapt the requirements of the ISO 9002 standard in a manner that is appropriate for
the doping control process.
The quality systems represent the operational level in the IADA Quality Concept. The
development and implementation of required quality system documentation such as the quality
manual, quality policies, procedures, work instructions, specifications, etc. are critical for the
effective application of the IADA Standard for Doping Control. The quality system
documentation is the main tool for ensuring that doping control activities are carried out in
accordance with the prescribed standards.
The quality systems shall be audited and reviewed according to specific procedures in order to
confirm that the critical activities in the doping control process are controlled, assured, improved
and properly managed.
Guidelines for Implementing ISO Certified Quality Systems
In order to have a certified quality system, the IADA Quality Concept requires quality systems to
be in compliance with the standards prescribed in the IADA Standard for Doping Control and the
ISO 9002 standard.
The objectives of these guidelines are to ensure the effective and homogeneous implementation of
quality systems within different anti-doping organisations such as national anti-doping
organisations, international sport organisations and international event organisers, and to ensure
that the quality systems are appropriately adapted to meet each anti-doping organisation’s specific
needs and requirements.
The guidelines describe the process of developing a quality system and provide direction on how
to establish a quality system in practice.
The following model demonstrates the various elements in the IADA Quality Concept and how they interrelate:
The IADA Quality Concept
IADA Standard for Doping Control
Policies and Standards for the Frame Conditions for Policies and Standards for Applying
Doping Control Process Anti-Doping Organisations ISO 9002 to Doping Control
�� �
Guidelines for Implementing ISO Certified Quality Systems
�� �
Quality Systems for Doping Control
National Anti-Doping International Sport International Event
Organisations Organisations Organisers
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ISO/PAS 18873:1999(E)
2.0 Policies and Standards for the Doping Control Process
2.1 Test Distribution Planning
Policy Statement
The objective is to plan and implement an independent and effective distribution of athlete tests.
This phase starts with developing criteria for the distribution of athlete tests and ends prior to the
selection of individual athletes for testing.
The main activities are consultations with relevant stakeholders, information gathering,
development of test distribution criteria, development of the test distribution plan, and
monitoring, evaluation and modification of the plan.
The ADO is responsible for the development of the test distribution plan.
Standards
2.1.1 The ADO shall consult, at least annually, with priority sports about the effectiveness of
the test distribution plan and document the outcome of those consultations.
2.1.2 The ADO shall establish a system for collecting information necessary to develop an
effective test distribution plan (eg., NSO information, historical information, research
information and information from other relevant organisations).
2.1.3 The ADO shall develop and document a comprehensive set of criteria which will give
direction to the test distribution plan. These criteria shall include:
� in a systematic way, assigning all sports to be tested into (i) high (ii)
medium and (iii) low risk categories;
� giving high priority to high level athletes with a focus on high risk sports
and high risk situations;
� in a systematic way, assigning the most effective testing method for each
sport;
� giving priority to no-notice testing as the main testing method, particularly
for high risk athletes with a focus on high risk sports and high risk
situations;
� giving priority to «out of competition» testing.
2.1.4 The ADO shall develop and document an annual test distribution plan.
2.1.5 The ADO shall maintain testing statistics and monitor progress against the test
distribution plan, and make modifications if necessary.
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ISO/PAS 18873:1999(E)
2.2 Selection and Notification of Athletes for Doping Controls
Policy Statement - Selection of Athletes
The objective of selecting athletes for sample collection is to detect and deter the use of banned
substances and methods through an independent and unpredictable selection process.
The scope of the selection activities starts with requiring specific athlete contact information and
event details from NSOs and other sources, and ends with deciding which athletes will be tested.
The main activities are: the continuous updating of athlete contact and event information from the
NSOs and other sources, determining the criteria for selecting athletes, and the final selection of
athletes.
The ADO has the main responsibility for determining the selection criteria and for selecting
athletes, taking into account requirements from sport federations. The DCO has responsibility for
applying the criteria when selecting the athletes for testing. The NSOs are responsible for
providing the ADO with updated athlete contact information and information about events,
competitions and training camps and programmes. NSOs are also responsible for requiring their
athletes to provide updated contact information on a regular basis.
Standards - Selection of Athletes
2.2.1 The ADO shall define criteria and procedures for collecting event and athlete contact
information (eg., the athlete’s name, home address, alternate addresses, home and work
telephone numbers, coach’s name and contact telephone numbers, etc.) from the NSOs.
2.2.2 The ADO shall establish a system that requires NSOs to provide the ADO with athlete
contact information in an appropriate and timely manner. This system shall require NSOs for
high risk sports and specific athlete target groups to immediately provide updated contact
information for any athlete in their respective athlete pools who change address for a period of 5
or more days.
2.2.3 A system shall be established to enforce the availability and provision of updated athlete
contact information to the ADO, wherein non-compliance by NSOs or athletes will be
investigated and appropriate action taken.
2.2.4 The ADO shall define the criteria for athletes to be registered in an athlete testing pool.
2.2.5 The ADO shall establish a system for testing athletes who are suspended or disqualified
because of a doping infraction during their period of suspension and/or disqualification.
2.2.6 The ADO shall establish a system for testing athletes who are coming out of retirement or
who are seeking reinstatement during a designated period before they can return to competition.
2.2.7 The ADO and the DCOs shall ensure that the athlete selection decisions are not disclosed
to any unauthorised person before notification of the selected athletes.
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ISO/PAS 18873:1999(E)
2.2.8 When defining selection criteria, the following elements shall be included:
� national level athletes
� athletes with unusual improvement in performance
� athletes with behaviour indicating doping
� gender
� sport
� minimum level of testing
� the competition cycle.
2.2.9 The ADO shall review the specific selection criteria annually.
2.2.10 The ADO shall give written authorisation to the DCOs specifying the selection criteria,
and the DCOs shall select athletes according to these criteria.
Policy Statement - Notification of Athletes
The objective of the notification process is to ensure that the selected athlete is notified, that the
rights of the athlete are observed, that opportunities to manipulate the sample are minimised and
that the notification is documented.
Notification of athletes starts with locating and identifying the selected athletes, and ends prior to
starting the registration procedure for collecting the samples.
The main activities are:
� locating and identifying the athlete
� informing the athlete that he/she has been selected for doping control testing
� informing the athlete of his/her rights and responsibilities
� for testing where no advance notice is given, escorting the athlete from the time of
notification to the arrival at the designated doping control station
� documenting the notification.
The DCO has the main responsibility for managing the notification process, including assigning
responsibilities to the chaperones. The DCO also is responsible for seeking assistance from event
organisers, coaches or team leaders in locating athletes.
Standards - Notification of Athletes
2.2.11 No-notice notification shall be the main notification method, particularly for high risk
sports and high risk situations. Notification by telephone, fax or post can be used only in
specified circumstances. Notification by telephone, fax or post shall be documented through a log
system.
2.2.12 The ADO shall establish a system to confirm that the athlete selected is the athlete
notified.
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ISO/PAS 18873:1999(E)
2.2.13 At the time of notification, the DCO shall ensure that the athlete is informed:
that he/she is required to provide a sample
of his/her rights and responsibilities, including the right to have a representative
of the possible consequences of failure to comply
that he/she has access to more detailed information about the doping control process.
2.2.14 A written notification form shall be presented to the athlete by a person authorised by the
ADO and signed by the athlete.
2.2.15 If the athlete refuses to sign the notification form, the DCO shall provide the ADO with
written documentation of the refusal, and the ADO shall deal with the refusal according to the
procedures prescribed in 2.6 Results Management.
2.2.16 Sample collection shall take place as soon as possible after the notification process has
been completed.
� For no-notice notification in both «in competition» and «out of competition» testing,
the sample collection procedure shall begin as soon as possible but no later than 60
minutes after notification.
� For notification by telephone, fax or post, the sample collection procedure shall
begin as soon as possible but no later than 24 hours after notification.
2.2.17 From the time of notification for a no-notice test until provision of the sample, the athlete
shall be escorted to the designated doping control station by a person authorised by the ADO in
such a way that the athlete is always within sight and not able to manipulate the sample to be
given.
2.2.18 Following notification by telephone, fax or post, the athlete shall be escorted by a person
authorised by the ADO in such a way that the athlete is always within sight and not able to
manipulate the sample to be given from the time of the athlete’s arrival at the designated doping
control station until provision of the sample.
2.2.19 The DCO reserves the right to allow the athlete to accommodate special circumstances
that may arise during the sample collection session. Should the athlete be required to leave the
doping control station, he/she must be observed at all times by an ADO authorised person. The
DCO shall record all such circumstances and report these circumstances to the ADO.
2.3 Preparing for and Conducting the Sample Collection Session
Policy Statement
The objective is to prepare and conduct the sample collection session in a manner that ensures
the integrity, validity and identity of the sample.
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ISO/PAS 18873:1999(E)
The scope of this objective starts with the selection and preparation of the area in which the
samples are to be collected, and ends with sealing the samples in their transport bag at the doping
control station and completing associated doping control documentation.
The main activities can be subdivided into three areas: pre-collection administration, collection
procedures and post-collection administration.
General responsibility for the preparation and conduct of the sample collection session lies with
the ADO, while specific responsibility to fulfill these duties is delegated to the DCO. The NSOs
and relevant authorities have a responsibility to assist with the provision of facilities and access
to athletes.
Standards
2.3.1 The ADO shall establish a system for obtaining all the information necessary to ensure
that the sample collection session can be conducted effectively.
2.3.2 The ADO shall appoint one or more DCOs to be responsible for managing the sample
collection session. Where more than one DCO will be conducting tests at a sample collection
session, the ADO shall appoint one DCO as the senior DCO who shall have overall
responsibility for the conduct of testing at that session.
2.3.3 When appointing DCOs to be responsible for managing the conduct of sample collection
sessions, the ADO shall not appoint a DCO who has an interest in the outcome of the collection
or testing of a sample from any athlete who might provide a sample at that session. For the
purpose of this standard, a DCO is deemed to have an interest in the collection or testing of a
sample if he/she is involved in the administration of the sport or sport organisation for which
testing is being conducted, or is related to or involved in the personal affairs of any athlete who
might provide a sample at that session.
2.3.4 DCOs may personally perform any of the functions for conducting testing, or they may
direct a chaperone to perform specified functions which fall within the scope of the chaperone’s
authorised duties.
2.3.5 Only DCOs and chaperones who have an accreditation recognised by the ADO shall be
authorised by the ADO to carry out sample collection procedures.
2.3.6 The ADO shall establish criteria and specifications for sample collection equipment and
documentation and use only sample collection equipment and documentation which meet the
defined criteria and specifications.
2.3.7 The ADO shall define criteria for the designated doping control station where a sample is
collected. The DCO must endeavour to use a venue for the sample collection that is in
accordance with these criteria.
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ISO/PAS 18873:1999(E)
2.3.8 The athlete is entitled to have a representative present during the sample collection
session. The ADO shall establish criteria for who may be authorised to be present at the sample
collection session.
2.3.9 The DCO must ensure that the athlete has no opportunity for sample manipulation by
observing the athlete from the time of arrival at the designated doping control station until
provision of the sample.
2.3.10 The DCO must ensure that the athlete is offered a choice of sample collection equipment
and also must provide the athlete with the opportunity to hydrate.
2.3.11 The DCO must ensure that the athlete is advised of the requirements of the sample
collection procedures at the time of notification and throughout the sample collection session.
2.3.12 The DCO or chaperone shall witness the actual provision of the sample by the athlete and
confirm the witnessing in writing. The person who witnesses the actual provision of the sample
shall be the same gender as the athlete providing the sample.
2.3.13 The DCO shall declare a sample invalid if he/she has doubts about its origin or
authenticity. The DCO shall document the reasons for invalidating the sample.
2.3.14 The DCO must ensure that the Doping Control Form includes a record of all details
relating to the identity of the sample, medications taken by the athlete being tested, and persons
present during the sample collection session. The Doping Control Form shall be signed by the
athlete and the DCO and, if present, the athlete’s representative. Copies of the Doping Control
Form must be distributed to the relevant parties at the end of the sample collection session.
2.3.15 The DCO shall ensure that all samples collected during a sample collection session are
securely stored from the time they are collected until the completion of the sample collection
session.
2.3.16 The DCO must complete a report
...