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Performance Evaluation Laboratories

Performance Evaluation Laboratories

Why participate?

Independent laboratory performance evaluation of in vitro diagnostics (IVDs) submitted for prequalification assessment enables WHO to verify certain standards of performance that are considered essential for resource-limited settings.

Manufacturers who wish to submit a product for prequalification have two options with respect to meeting the performance evaluation requirement of prequalification assessment: performance evaluation coordinated and financed by WHO (option 1), or performance evaluation coordinated and paid for by themselves (option 2). But whichever option a manufacturer chooses, the evaluation must be performed by a designated Performance Evaluation Laboratory (PEL).

Laboratories that successfully apply to become a performance evaluation laboratory contribute to WHO's aim to increase access to IVDs for accurate diagnosis and monitoring of priority disease and conditions. In brief, such laboratories are a key partner for WHO prequalification.

Who can apply for listing as a performance evaluation laboratory?

Applications are open to laboratories with experience in conducting independent performance evaluations of IVDs, including:

  1. WHO Collaborating Centres.
  2. National laboratories or laboratories that provide testing services to the government in their respective country.
  3. Laboratories located in geographical areas corresponding to the intended setting of use of the IVDs submitted for assessment.

Due to a sufficient number of PELs for the evaluation of IVDs for the diagnosis and/or monitoring of infection for HIV (including CD4), syphilis, hepatitis B, hepatitis C, applications for these analytes are currently closed.

Currently, applications are open for the following types of tests:

  • Human papilloma virus molecular tests
  • G6PD deficiency
  • TB molecular tests.

Requirements for WHO listing

WHO requirements for listing of a performance evaluation laboratory are specifically related to performance evaluations. An assessment will ascertain the potential for a laboratory to undertake a performance evaluation according to the relevant WHO protocol, as well as the laboratory’s compliance with the principles of ISO/IEC 17025:2005 and ISO 15189:2012. Additional references relating to good practice for laboratories performing IVD evaluations, including other ISO standards, will be referred to during the audit. The auditing process is based on the principles outlined in ISO 19011:2018.

More information about audit Stages 1 and 2, WHO and laboratory responsibilities (with respect to the on-site audit), organization and output of the on-site audit, and the principles that audits adhere to, are given below.

Assessment process

Assessment of a candidate laboratory consists of:

  • Submission by the laboratory of an EOI.
  • Stage 1 audit: assessment by WHO of the EOI and the specific quality management system (QMS) documentation submitted by the manufacturer.
  • Stage 2 audit: on-site audit by WHO of the laboratory to assess compliance with WHO requirements.
  • If the laboratory meets all requirements, listing of the laboratory as a WHO Performance Evaluation Laboratory.

Laboratories that meet assessment requirements will be informed by letter of their listing as a WHO Prequalification Evaluating Laboratory.

Maintaining compliance

Performance Evaluation Laboratories must ensure ongoing compliance with WHO requirements following listing.

Mandatory re-assessment, to verify ongoing compliance with WHO requirements and relevant standards, takes place every three to five years after laboratory listing. It takes the form of a partial or full audit.  However, re-assessment may be carried out sooner than this if deemed necessary. In addition, WHO may decide to delist laboratories should they fail to deliver the agreed work (compliance with the protocol, agreed timeline) or to communicate adequately with WHO.

The Stage 1 audit is a desk-top audit. During this audit, general information about the documented QMS, including the quality manual, relevant standard operating procedures for the specific validated methodology(ies), relevant validation reports and proficiency testing evaluation reports of the specific method(s), organigram, and floor plan (and submitted with the EOI), will be assessed. Specific records may also be requested by letter to evaluate effective implementation of specific laboratory procedures. The laboratory will be given one opportunity to provide extra documentation, if needed. Documentation must be received within the time period specified if the assessment process is to proceed. A report describing the outcome of the Stage 1 audit will be forwarded to the laboratory. A satisfactory Stage 1 audit is a pre-condition for proceeding to a Stage 2 audit. 

The Stage 2 audit is on-site audit to verify that QMS implementation is effective and to confirm the ability of the laboratory to conduct performance evaluations of specific types of IVD(s). The specific objectives are to:

  • verify the information supporting the claims presented in the EOI submission and other Stage 1 audit documentation
  • determine the effectiveness of the implemented QMS in meeting appropriate quality standards and the laboratory's own requirements.

All organizational units, activities and processes associated with specified IVD performance evaluations may be audited. Documents and records from all levels of the QMS will be sampled and reviewed. Informal interviews of personnel at all levels and discussions with persons selected by the auditor will form part of the audit process.

Responsibilities of WHO

It is generally the WHO lead auditor who undertakes to:

  • plan and prepare the audit
  • communicate with the laboratory
  • define the scope of the audit
  • prepare the audit plan, working documents, briefing documents and supervise the travel arrangements for the auditors
  • communicate any challenges regarding the audit to the laboratory management prior to or during the audit
  • prepare and present the draft audit report to the laboratory management at the closing meeting on the final day of the audit
  • submit the final report to the laboratory
  • follow-up on nonconformities with a request for a detailed corrective action plan from the laboratory.

Note: The WHO audit team will have experience and knowledge in laboratory QMS, performance evaluations and the specific IVDs for which the laboratory conducts performance evaluations. A WHO audit team usually consists of two members. The laboratory will be informed of the identity of the proposed audit team members before the site audit and receive their curriculum vitae to ensure that any conflict of interest, or other issues that may compromise the audit, are avoided. The laboratory will have the opportunity to express any concerns about the audit team before the audit takes place. If concerns about an individual auditor cannot be resolved in discussion with WHO, the laboratory should notify WHO in writing of its objection to that individual's member's participation in the site visit within 10 days of receipt of the proposed audit team composition. All members of the audit team are obliged to act according to the requirements of the International Civil Service Commission's Standards of Conduct for the International Civil Service.

Responsiblities of laboratory

Responsibilities of the laboratory will be communicated to the laboratory before the audit. In general, the laboratory's responsibilities will be to:
  • agree upon the objectives and the scope of the audit with the WHO team
  • inform WHO of any major changes to the QMS since the document review was performed
  • inform the WHO team of any issues that may affect an effective and efficient audit process
  • cooperate with the auditors to ensure that the audit objectives are achieved
  • identify a person responsible for coordinating and facilitating the audit process
  • inform relevant employees about the objectives and the scope of the audit
  • appoint responsible members of staff to accompany members of the audit team and to ensure auditors are aware of health, safety and other applicable requirements
  • provide on-site resources, for the audit team, to ensure an effective and efficient audit process, such as meeting rooms
  • provide access to the laboratory facilities, documents and records and other evidence as requested by the auditors in a timely manner to ensure an effective and efficient audit process and so that the audit timetable can be met.

Independence

The auditors (WHO staff and QMS and technical experts) shall be impartial and free from influences that could affect their objectivity.

Audit objectives and scope

The audit objectives and scope shall be defined in a general audit plan provided to the laboratory and agreed upon with the laboratory prior to the audit. Modification of the plan may occur, to accommodate the laboratory processes and to follow audit trails depending on the observations made at the time of the audit.

Roles and responsibilities

Roles and responsibilities of all personnel involved in the assessment shall be clearly defined so that expectations can be met and accountability maintained.

Resources

Resources shall be adequate in terms of competent auditors, expertise as deemed necessary, time allocation, and access to external technical and other information. The resources used shall ensure that the audit results are highly reliable.

Competence of the audit team

The audit team shall consist of auditors with appropriate skills, education and experience in QMS auditing and IVDs.

Consistency of procedures

The audit procedure shall be performed according to defined guidelines (ISO 19011:2018) using a WHO checklist to ensure consistency for all audits.

Confidentiality and standard of conduct

The auditors shall maintain confidentiality with regard to information and documentation related to the audit and the laboratory/organization and shall comply with the defined WHO standards of conduct. Within these considerations, the audit process is to be transparent to all participants.

Audit results and conclusions

The results and conclusions of the audits shall be consistent and accurate, subject to the normal limitations of an audit, noting that the objective evidence collected during the audit is generally a sample.

Quality system

Audits are conducted in compliance with the relevant auditing standards.