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The application focuses on the specific parts of the processes that are critical with regard to the quality of the laboratory’s performance as a Laboratory or ABP Laboratory , and are therefore significant in the evaluation and accreditation process.
This section introduces the specific performance standards for a Laboratory or ABP Laboratory , as applicable .
The conduct of Laboratory Analytical Testing is considered a process within the definitions of ISO 17000.
Performance standards are defined according to a process model where the Laboratory practice is structured into three (3) main categories of processes: - Structural and Resource Requirements , - Process Requirements , - Management Requirements.
5.2 Structural and Resource Requirements 5.2.1 General General structure and resource requirements shall be provided in accordance with the requirements of ISO/IEC 17025.
The Laboratory shall have available the personnel, facilities, equipment, systems and support services necessary to manage and perform its Laboratory activities.
5.2.2 Laboratory Personnel The Laboratory Director is responsible for ensuring that the Laboratory personnel are adequately trained and have the experience and skills necessary to perform their duties.
All personnel shall have a thorough knowledge of their responsibilities including the security of the Laboratory , the Code of Ethics, confidentiality of Analytical Testing results, Laboratory Internal Chain of Custody protocols, and the Standard Operating Procedures (SOPs) for any Analytical Testing Procedure that they perform.
The Laboratory shall have access to records for every Person employed by, or under contract with, the Laboratory including a curriculum vitae or qualification form(s)/certificate(s), a job description, records of completed and ongoing training and records of a uthorization to perform their defined duties.
ISL – January 2021 Page 67 of 160 Specific criteria shall be met by the Laboratory Director, Laboratory Quality Manager, Laboratory Certifying Scientists, and Laboratory Supervisory Personnel, as outlined below.
5.2.2.1 Laboratory Director The Laboratory shall have a qualified Person as the Laboratory Director , whose priority is to assume and focus on the professional, organizational, educational, operational and administrative responsibilities of the Laboratory ’s operations .
The Laboratory Director plays an essential role in the anti -doping Laboratory ’s operations and the WADA accreditation is delivered based upon such qualification as well as on the Laboratory ’s operational performance.
The Laboratory Director shall be a full-time appointment and his/her qualifications shall include: - Doctoral degree (Ph.D. or equivalent) in one of the natural sciences with appropriate experience and/or training in chemical and/or biochemical analysis, preferably in the anti -doping area ; or - In the ab sence of a Doctoral degree, a postgraduate degree ( e.g.
Master’s degree ) in one of the natural sciences and appropriate anti -doping science experience and training ( e.g.
a senior Laboratory position for a minimum of five (5) years), including the documented ability to develop analytical methodology and oversee research projects ; or - In the absence of a postgraduate degree, a Bachelor degree in one of the natural sciences and extensive and appropriate anti -doping science experience and training ( e.g.
a senior Laboratory position for a minimum of ten (10) years), including the documented ability to develop analytical methodology and oversee research projects; - Experience and competence in the analysis of chemical and biological material for the classes of substances and methods used in doping; - Demonstrated working k nowledge of drug metabolism and pharmacokinetics; - Proficiency in English to an extent that allows adequate perform ance of functions as part of the international anti -doping community and in accordance with the Code , the ISL, Technical Document s, Technical Letters and Laboratory Guidelines .
Any personnel changes to the position of Laboratory Director shall be communicated to WADA no later than one (1) month prior to the scheduled date the Laboratory Director vacates his/her position.
A succession plan shall be forwarded to WADA .
WADA reserves the right to review the credentials of such appointment and either approve it or reje ct it in accordance with the above qualifications.
ISL – January 2021 Page 68 of 160 5.2.2.2 Laboratory Quality Manager The Laboratory shall have a single staff member appointed as the Laboratory Quality Manager .
The Quality Manager shall have responsibility and authority to implement and ensure compliance with the Management System .
The Quality Manager’s priority and functions shall be focused on quality assurance and quality control activities.
The Quality Manager should remain independent, as much as possible, from routine Laboratory analytical activities.
The Laboratory Quality Manager qualifications shall include: - At least a Bachelor degree (or similar) in one of the natural sciences with appropriate experience and/or training in chemical and/or biochemical sciences; - Appropriate experi ence of two (2) years or more in laboratory analytical procedures; - Appropriate documented qualifications and training in laboratory quality management, including ISO/IEC 17025; - Ability to ensure compliance with the Management System and quality assurance processes.
5.2.2.3 Laboratory Certifying Scientists The Laboratory shall have qualified personnel to serve as Certifying Scientists to review all pertinent analytical data, Analytical Method validation results, quality control results, Laboratory Documentation Packages , and to attest to the validity of the Laboratory ’s test results.
The qualifications of Certifying Scientists shall include: - At least a Bachelor degree (or similar) in one of the natural sciences with appropriate experience and/or training in chemical and/or biochemical analysis, preferably in the anti -doping area.
In the absence of a Bachelor degree, documented experience of five (5) years or more in a Laboratory as senior scientist ( e.g.
supervisor, section head) may be considered equivalent to a Bachelor degree for this position ; - Appropriate training and experience (e.g.
three (3) years or more ) including theoretical knowledge and technical competence in the analysis and interpretation of results for chemical or biological materials, including the classes of substances and methods used in doping; - Knowledge of relevant Technical Document s, Technical Letters , Laboratory Guidelines and other technical standards; - Experience in the use of relevant analytical techniques such as chromatography, immunoassays, electrophoresis or mass spectro metry; ISL – January 2021 Page 69 of 160 - Adequate training in the Laboratory ’s Management System and thorough understanding of its application into Laboratory processes.
5.2.2.4 Laboratory Supervisory Personnel The Laboratory shall have qualified personnel to serve as Laboratory Supervisors .
All Laboratory Supervisors shall have a thorough understanding of the Laboratory ’s Management System including the review, interpretation and reporting of test results, the maintenance of Laboratory Internal Chain of Custody , and proper implementation of corrective and preventive actions in response to analytical problems.
The qualifications for a Laboratory Supervisor shall include: - At least a Bachelor degree (or similar) in one of the na tural sciences with appropriate experience and/or training in chemical and/or biochemical analysis, preferably in the anti -doping area.
Documented experience of two (2) years or more in a Laboratory may be considered equivalent to a Bachelor degree for this position; - Experience in the use of relevant analytical techniques such as chromatography, immunoassays, electrophoresis or mass spectrometry; - Ability to comply with the Management System and quality assurance processes.
5.2.3 Laboratory Facilit ies and Environmental Conditions 5.2.3.1 Laboratory Facilities The Laboratory shall have Fit-for-Purpose facilities including sufficient space for dedicated administrative, Sample handling, Sample storage and analytical areas, which comply with the security requirements outlined below: - A Person shall be assigned as the security officer, who has overall knowledge of the security system and/or serves as the liaison Person with the security services of the host organization ( e.g.
university, hospital, research institute) ; - The Laboratory shall have a policy for the security of its facilities, equipment and systems against unauthorized access, which may include a threat and risk assessment performed by expert(s) in the relevant field ; - Two (2) main levels of access shall be defined in the Management System and evaluated in the threat assessment plan: o Reception Zone: An initial point of c ontrol beyond which unauthorized individuals shall not be permitted ; The Laboratory shall have a system to register visitors and authorized individuals to the Laboratory .
They shall be supplied with an ISL – January 2021 Page 70 of 160 identification badge while in the Laboratory faciliti es.
o Controlled Zones: Access to these areas shall be monitored ( e.g.
through the use of electronic access system(s) such as biometric and/or personal identification cards) and records of access by visitors shall be maintained ; Access to the Laboratory Controlled Zones shall be monitored and restricted to Laboratory staff and temporarily approved/authorized personnel ( e.g.
maintenance engineers, auditing teams ).
All other visitors to the Laboratory Controlled Zones shall be continuously escorted by Laboratory staff member(s).
Access to the Laboratory Controlled Zones shall be defined in the Laboratory ’s Management System.
- The Laboratory shall have a dedicated and restricted area within the Controlled Zone for Sample receipt and Aliquot preparation ; Access to the Laboratory ’s Sample receipt and Aliquot preparation area shall be restricted to authorized personnel, based on a risk assessment by the Laboratory .
- The Laboratory shall have a dedicated and restricted Sample storage area; Access to stored Samples 9 shall be restricted to authorized personnel, based on a risk assessment by the Laboratory .
Samples may be transported for long -term storage to a specialized, secure Sample storage facility, which is located outside the Laboratory ’s permanent controlled zo ne, to another Laboratory , or to another Fit-for-Purpose facility under the responsibility of the Testing Authority , which has ownership of the Sample (s) pursuant to Art icle 10.1 of the ISTI.
Long -term storage facilities shall maintain security requirements comparable to the security requirements applicable to a Laboratory ’s short -term storage of Samples .
If the external Sample storage facility is not covered by the Laboratory ’s ISO/IEC 17025 accreditation, then the subcontracted external storage facility shall have its own ISO accreditation or accredited certification ( e.g.
17025, 20387, 9001).
The transfer of the Samples to the long -term storage facility shall be recorded.
- The Laboratory may implement additional security measures, which should be assessed on a case -by-case basis.
9 This refers to “A” and “B” Samples stored in Sample collection containers (urine collection bottles, blood collection tubes) and should not be confused with access to Aliquots , which should be accessible to analysts for the performance of Analytical Testi ng Procedures .
ISL – January 2021 Page 71 of 160 5.2.3.2 Relocation of Laboratory Facilities In cases where a Laboratory is to relocate to a new physical space, on a permanent or temporary basis, a report containing the following information shall be provided to WADA no later than three (3) months prior to the relocation: - Description of the circumstances for moving Laborato ry operations into a new space and anticipated effect on capabilities; - Relocation date(s) including date of closing of existing facility operations and date of opening of future facility operations; - Expected date(s) of assessment of the new facilities by t he Accreditation Body (evidence of continued accreditation and/or acceptance of suitability of the new Laboratory facilit ies required when made available by the Accreditation Body); - New Laboratory contact information and coordinates; - Assessment of the effe ct of the Laboratory relocation on client operations.
5.2.3.3 Environmental Control The Laboratory shall have a written safety policy and compliance with Laboratory safety policies shall be enforced.
The Laboratory ’s storage and handling of controlled substances shall comply with applicable national legislation.
The Laboratory shall: - Ensure appropriate electrical service (for example, by provision of an alternative power supply such as an UPS system and/or power generators) and environmental conditions (space, temperature, humidity, as applicable) for all Laboratory instrumentation and equ ipment critical to Laboratory operations , such that service is not likely to be interrupted ; - Have policies in place to ensure the integrit y of refrigerated and/or frozen stored Samples in the event of an electrical or freezer/ refrigerator equipment failure.
5.2.3.4 Confidentiality of Data, Information and Operations The Laboratory should implement a clean desk policy and either file securely any confidential or sensitive information or properly destroy it before disposal.
Laboratory staff shall be trained on how to comply with a clean desk policy, on how to ensure confidentiality o f information and operations, as well as on the risks of corruption attempts by third parties.
Laboratory staff shall be trained to protect their personal access badge during and out side of working hours.
ISL – January 2021 Page 72 of 160 In order to minimize any attempts of fraud or counterfeit, the Laboratory should implement a policy to ensure that discarded urine and blood Sample containers, as well as the seals and rings, cannot be collected by unauthorized Persons or recovered after dis posal (for example, bottles should be destroyed, or trash container s should be properly secured).
5.2.3.5 Control and Security of Electronic Data and Information The Laborator y shall implement a ll reasonable measures, based on a thorough risk and vulnerability assessment s (e.g., by a competent third party) , to prevent and to detect unauthorized access and copying of Laboratory data and information from local and/or cloud -based computerized systems.
Laboratories shall implement technical and organizational safeguards consistent with best practice and any applicable governmental regulations.
Access to Laboratory computer terminals, computers, servers or other operating equipment shall be restricted to authorized personnel ( e.g.
by using access passwords).
The Laboratory shall implement a data and information management system, a software -based solution that supports and maintains proper traceability of Laboratory operations ( e.g.
a Laborat ory Information Management System, LIMS) with secure and restricted access to stored electronic data by authorized personnel as well as information and data exchange capabilities including between the Laboratory and ADAMS .
[Comment: The data and information management system may also feature workflow management, data tracking support, Sample and Aliquot Laboratory Internal Chain of Custody , control of stocks of Reference Materials , etc.]
The Laboratory shall utilize a secure data storage system that prevents unauthorized access and data loss ( e.g.
failed hard drive , fire, flooding).
The Laboratory shall ensure that at least two (2) independent, regularly backed -up copies of all relevant analytical/LIMS/instrument software files are available.
- If the Laboratory is utilizing a non -cloud -based system, then at least one (1) backup copy shall be stored in a restricted and secure environment either in the Laboratory (e.g.
fire and waterproof s afe) or in a secure off -site location ( e.g.
in a mirrored server that guarantees the integrity of the server and the stored data) ; - If the Laboratory is using a cloud -based system, the Laboratory data shall be, at a minimum, replicated in two different phys ical locations ( e.g.
between two different availability zones within the same region or between different regio ns) in order to minimize the possibility of data loss.
The software utilized by the Laboratory shall prevent the changing of data and test results, unless there is a system to record the change with audit trail capabilities which is limited to users with authorized access .
The audit trail shall ISL – January 2021 Page 73 of 160 record the Person performing the editing task, the date and time of the edit , the reason (s) for the change to the original data and allow the retention of the original data.
If the Laboratory utilizes third-party computerized system s or software , the Laboratory shall ensure the provider or operator complies with all applicable requirements of th e Code and the ISL and shall implement and maintain technical and organizational controls necessary to safeguard Laboratory data.
5.2.4 Laboratory Equipment The Laboratory shall have access to equipment that is required for the correct performance of Analytical Testing activities.
The Laboratory shall maintain sufficient instrumental capacity to minimize the risk of operational delays and meet the analytical and results reporting obligations of the ISL and its related Technical Documents , Technical Letters and Laboratory Guidelines .
A list of available equipment shall be established and maintained.
As part of its Management System, the Laboratory shall operate a program for the maintenance and calibration of equipment according to ISO/IEC 17025.
Calibrations are only required where the setting can change the test result.
A maintenance schedule, at least in accordance with the manufacturer’s recomm endations or local regulations, if available, shall be established for general Laboratory equipment that is used in Analytical Testing Procedure (s).
General Laboratory equipment (fume hoods, centrifuges, evaporators, etc.)
that is not used for analytical measurements should be maintained by visual examination, safety checks, performance verification and cleaning , as necessary.
Equipment or volumetric devices used in me asuring shall have periodic performance checks and/or calibrations along with servicing, cleaning, and repair.
Qualified vendors may be contracted to service, maintain, and repair equipment.
All maintenance, service, and repair of equipment shall be record ed.
5.2.5 Metrological Traceability 5.2.5.1 Reference Materials When available, Reference Materials of substances traceable to a national standard or certified by a body of recognized status ( e.g.
USP, BP, Ph.Eur.
WHO) or a Reference Material producer accredited to ISO 17034 should be used.
When a Reference Material is not certified, the Laboratory shall verify its identity and check its purity by comparison with published data and/or by chemical characterization.
ISL – January 2021 Page 74 of 160 5.2.5.2 Reference Collections Samples or isolates may be obtained from in vitro or in vivo sources [ e.g.
(i) an external quality control sample, (ii) an isolate from a urine or blood sample after an authenticated administration, or (iii) an “ in-vitro” incubation with liver cells, microsomes or biological fluids] and be used as Reference Collections .
Reference Col lections shall be traceable to a Prohibited Substance or a Prohibited Method , and the analytical data shall be sufficient to establish the identity of the Analyte .
5.2.6 Subcontracting of Analysis A Laboratory or ABP Laboratory shall perform all work with qualified personnel and equipment within its accredited or approved facility, respectively.
A Laboratory may subcontract an analysis to another Laboratory , in consultation with the Testing Authority .
The conditions that justify subcontracting include, for example: - A specific technology or Analyte (s) that are not within the Laboratory ’s Scope of ISO/IEC 17025 Accreditation; - An Analytical Testing Restriction decision; - Other justifications such as a need for higher sensitivity or specific equipment or expertise, temporary workload or technical incapacity); - In exceptional circumstances, WADA may elect to grant specific authorization to subcontract analyses using specific methods to an ISO/IEC 17025 -accredited laboratory approved by WADA , which has the necessary technique within its Scope of ISO/IEC 17025 Accreditation (for example, DNA analysis or genomic profiling) ; - Other specific investigations, such as, without limitati on, forensic examinations which need to be performed in the course of the Analytical Testing process may also be subcontracted by the Laboratory .
[Comment: Alternatively, the analysis may be contracted by the Testing Authority .
In this case, the Laboratory shall nevertheless be in charge of ensuring the Sample chain of custody in connection with the transfer of the Sample(s) to the other Laboratory (-ies) or e xpert(s) as the case may be.]
In all such cases, the Laboratory subcontracting the analysis is only responsible for the maintenance of the appropriate chain of custody up to Sample reception by the subcontracted Laboratory .
Such arrangements shall be clear ly recorded as part of the Sample’s documentation and included in the Laboratory Documentation Package , if applicable.