About QCMD

Quality Control for Molecular Diagnostics (QCMD) is a not-for-profit, independent International External Quality Assessment (EQA) / Proficiency Testing (PT) organisation within the clinical molecular infectious disease diagnostics area.

QCMD is responsible for the management and distribution of over 100 schemes in over 120 countries with more than 15000 participant registrations annually.

The EQA/PT schemes cover both regulatory and educational proficiency testing requirements and are designed to offer laboratories a wide range of analytical and clinical challenges. These include a broad spectrum of pathogen target types, genotype variations as well as assessment of assay sensitivity and specificity.

QCMD also actively collaborates with many international and national scientific, public health and quality control organisations and provides custom EQA schemes to expert laboratory networks.

About EQA

The aim of External Quality Assessment schemes is to help monitor and improve quality within the clinical laboratory by assessing a laboratory’s ability to use molecular diagnostic technologies within the routine clinical setting.

The QCMD EQA schemes support the clinical laboratory’s regulatory requirements and are also educational in application. The reports and practical feedback QCMD provides participants allows them to identify and resolve potential problems whilst monitoring the effectiveness of their laboratory quality assurance processes.

 

The general objectives of QCMD and its EQA programmes are to:

  • Provide EQA schemes for the most clinically relevant targets detectable by molecular technologies.
  • Give a measure of general laboratory performance within these clinical areas.
  • Deliver information, upon request, for the monitoring of laboratory performance to appropriate authorities and, if required, individual laboratories.
  • Supply feedback and continuous education within the area of molecular EQA.
  • Initiate pilot EQA studies either directly or in conjunction with other EQA providers and/or recognised scientific experts for developing molecular targets and technologies.
  • Issue information to support the laboratory’s regulatory requirements and support the laboratory’s clinical accreditation process.

Accreditation

QCMD is accredited to ISO 17043 [Conformity assessment – General requirements for proficiency testing].

The accreditation status of the EQA schemes is available in the QCMD catalogue.

The Scope of accreditation is available on the UKAS website.

 

History Of QCMD

QCMD evolved from the successful European Union Concerted Action programmes which were initiated in the early 1990s to address quality control within the clinical diagnosis of viral Meningitis and Encephalitis.

The EQA schemes where expanded in 1998 through the establishment of a European Union funded project Quality Control Concerted Action (EU-QCCA). This enabled the issues of quality and standardisation to be reviewed in the wider context of diagnostic clinical virology and microbiology through the provision of QC material, proficiency testing (PT) or external quality assessment (EQA), and consensus best practice approaches.

One of the principal objectives of the EU-QCCA was to provide a mechanism for the long-term continuation of the international programmes.

Quality Control for Molecular Diagnostics (QCMD) was founded in June 2001 to continue and expand the work as an independent provider of External Quality Assessment programmes for molecular diagnostics.

QCMD Structure

QCMD Executive

The Executive is committed to the strategic vision of ‘building quality & creating participant value’ through the provision of ‘state of the art’, external quality assessment, and innovative quality solutions to the International diagnostic community.

Senior Management Group (SMG) & Central Office

Co-ordinates the daily operational activities of QCMD. The Central Office is the headquarters of the QCMD organisation and consists of key managerial, administrative, and technical staff with the appropriate skills and competencies necessary to administer the EQA service.

Neutral Office

In line with the aims and objectives defined in the QCMD Code of Practice and in compliance with the QCMD Quality Management System, the Neutral Office is responsible for the scientific management of the EQA programmes and processes.

Scientific Experts (SEs) & International Advisory Meeting

The QCMD Scientific Experts (SEs) comprise international experts from science, industry, governmental and public health organisations, integral for the scientific advancement and future development of the QCMD organisation.

Advisors to QCMD

QCMD is further supported through external, independent advisors. Advisors to QCMD are selected on the basis of their relevant scientific and technical expertise, providing relevant input to certain QCMD issues.

International Scientific & Quality Organisations

QCMD collaborates with many national and international scientific and quality control organisations. Each collaborative venture is dealt with individually and in accordance with specific agreements.