Legislation Issues

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Legislation Issues

• Brian Brookman
• LGC

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Legislation Issues

• Legislation or regulation driving PT requirements
• Legislation or regulation governing PT providers
• PT Networks National, European, International

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PT Drivers

• International legislation
• Laboratory standards and guides
• Laboratory accreditation
• Sector specific regulation and guidance
• Quality standards and guides
• Regulatory and standard bodies
• Business requirements

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International PT Drivers

• ISO/IEC 17025
• General requirements for the competence of
  calibration and testing laboratories
• 5.9.1. The laboratory shall have quality control
  procedures for monitoring the validity of tests
  and calibrations undertaken
• A list of potential monitoring mechanisms are
  given, all of which are internal except
• Participation in interlaboratory comparison or
  proficiency testing programmes
• PT participation is the only external and
  therefore fully independent monitoring mechanism

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International PT Drivers

• ISO 15189 (2003)
• Medical laboratories Particular requirements
  for quality and competence

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Sector Specific PT Drivers

• Specific sectors may drive quality improvements
  through sector regulation, standards or guides
• Important for PT providers to be aware of such
  sector specific drivers
• Important analytes
• Methodology
• Performance requirements

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Example - Environment
MCERTS aims to deliver high quality environmental
measurements. The scheme provides for the product
certification of instruments, the competency
certification of personnel and the accreditation
of laboratories based on international standards.

• A laboratory shall participate in an appropriate
  external quality control or inter-laboratory
  proficiency-testing scheme.

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MCERTS Standard
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Examples - Food

• EU Regulation 882/2004 Official Controls
  Performed to Ensure the Verification of
  Compliance with Feed and Food Law, Animal Health
  and Animal Welfare Rules
• EU Directive 94/35/EC for sweeteners
• EU Directive 94/36/EC for colours
• EU Directive 95/2/EC for all other additives
  including preservatives
• EU Directive 90/496/EC for nutritional labelling

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PT Scheme Literature
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PT Scheme Literature
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Sector Specific PT Drivers

• PT providers can also provide valuable input to
  industry bodies e.g. provision of data on method
  performance, problems etc
• e.g. LGC has provided data from the sugar PT
  scheme to ICUMSA to assist development of new
  methodology

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Sector Specific PT Drivers

• PT participation can often be encouraged or
  mandated by regulatory and standard bodies within
  a specific sector
• e.g. UK National Health Service Quality Assurance
  Committee strongly encourages PT participation
• e.g. UK Drinking Water Inspectorate mandates
  participation in Cryptosporidium PT scheme

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Sector Specific PT Drivers

• Important for PT providers to develop good
  relationships with such bodies
• e.g. European Brewery Convention (EBC)
  represented on LGCs BAPS and MAPS Advisory
  Groups
• UK Drinking Water Inspectorate provides an
  advisor to the Aquacheck PT scheme

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Sector Specific PT Drivers

• Business requirements or regulation can drive PT
  participation
• PT can play a part in major business to business
  commercial contracts
• e.g. Major brewery groups mandate participation
  of their malt providers in the MAPS PT scheme
• PT provider needs to provide appropriate tools
• Trend graphs illustrating ongoing performance
• Certificates of participation

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PT Provider Guidelines

• A number of guidance documents available to PT
  providers
• ISO/IEC Guide 43 Part 11997
• Proficiency testing by interlaboratory
  comparisons Development and operation of
  proficiency testing schemes
• ILAC Guide 132000
• Guidelines for the Requirements for the
  Competence of Providers of Proficiency Testing
  Schemes

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PT Provider Guidelines

• ISO 135282005
• Statistical methods for use in proficiency
  testing by interlaboratory comparisons
• IFCC/EMD/C-AQ
• Guidelines for the requirements for the
  competence of EQAP organizers in medical
  laboratories
• The International Harmonized Protocol for the
  Proficiency Testing of Analytical Chemistry
  Laboratories (2006)

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PT Provider Guidelines

• Standards for EQA schemes in laboratory medicine
  (2004)
• National Occupational Standards for External
  Quality Assessment
• National guidance documents
• e.g. UKAS PT1 Accreditation of Providers of
  Proficiency Testing Schemes for Laboratory
  Testing

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Accreditation of PT

• Accreditation of PT providers is continuing to
  increase
• Increasing number of accreditation bodies
  providing the service
• Increasing number of PT providers (and the number
  of schemes) being accredited
• Accreditation to ISO/IEC Guide 43 in combination
  with ILAC G13 or ISO/IEC 17025 is the most common

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PT Networks

• PT underpins quality assurance and is an
  important requirement for laboratory
  accreditation.
• Given this crucial role for PT, it is essential
  that an appropriate international infrastructure
  exists to ensure the quality of PT provision, and
  its use in the accreditation process, around the
  world.

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European PT Network
EURACHEM Executive GA
International European Bodies
EA Laboratory Committee
EURACHEM PT Working Group
EA
EA/EURACHEM/Eurolab PT Working Group
Eurolab
National Representatives
National PT Working Group
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EURACHEM PT WG- Purpose

• To improve the organisation of proficiency
  testing in Europe
• To promote best practice in proficiency testing
  using appropriate mechanisms such as
  publications, workshops etc
• To provide a forum for organisers and users of
  proficiency testing schemes on issues affecting
  the practice of proficiency testing
• To provide input and disseminate output, on
  proficiency testing, between EURACHEM and other
  international organisations
• To provide input into international activities
  related to proficiency testing

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EURACHEM PT WG Activities - Workshops

• Organisation of the EURACHEM International
  Workshops on Proficiency Testing in Analytical
  Chemistry, Microbiology and Laboratory Medicine
• Borås, Sweden, September 2000
• Bracknell, UK, February 2003
• Portoro, Slovenia, September 2005
• Rome, Italy, October 2008
• Through a series of lectures, working group
  discussions and poster sessions key topics on
  proficiency testing are addressed

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EURACHEM PT WG Activities - Publications

• Guide to the Selection, use and interpretation
  of proficiency testing (PT) schemes by
  laboratories, 2000
• Input into the ILAC document ILAC G222004 Use
  of Proficiency Testing as a Tool for
  Accreditation in Testing
• Development of an general information leaflet on
  PT
• Currently translated into various European
  languages including Turkish

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PT Leaflet
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EURACHEM PT WG Activities

• Producing a bibliographic listing of references
  relating to PT
• Writing a paper on fundamental terms relating to
  PT
• Preparing a discussion paper on setting the
  Standard Deviation for Proficiency Assessment
  (quality goals for PT)

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EA/EURACHEM/Eurolab PT WG

• Working group on Proficiency Testing in
  Accreditation Procedures
• Aim to develop common policy and technical
  advice covering proficiency testing in all areas
  of testing, measurement and analytical results to
  meet the European needs
• Purpose to provide a discussion forum in order
  to develop support in the form of guidelines and
  policy papers covering proficiency testing in
  accreditation procedures

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International PT Network
ILAC PT Consultative Group
External PT Providers
ILAC Committees
Regional Cooperations
Interest Groups
e.g. EA APLAC
E.g. EEE-PTWG
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ILAC PT Consultative Group

• Terms of reference
• To organise or contribute workshops, seminars,
  and conferences dealing with PT issues for all
  parties, particularly accreditation bodies, PT
  providers and laboratories
• To advise the ILAC Executive, ILAC AMC and
  General Assembly on PT Policy, coordination and
  technical issues relevant to the ILAC Arrangement
  and more generally on the use of PT by
  accreditation bodies and other users
• To advise ILAC on the relevance of PT providers
  to the ILAC Arrangement

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ILAC PT Consultative Group

• To review the policies on PT developed within
  Regional Cooperations for possible adoption by
  ILAC
• To assist in the coordination of Region to Region
  participation in PT by laboratories and potential
  involvement of unaffiliated bodies in Regional
  PTs
• To identify needs for PT access for developing
  countries and unaffiliated bodies and cost
  effective mechanisms for including them in PT
  programs operated by, or on behalf, of ILAC
  members

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ILAC PT Consultative Group

• To encourage all PT providers to use consistent
  or harmonised international criteria for
  operation of PT programs and to contribute to the
  development in ISO, ILAC, the Regional
  Cooperations of ILAC etc of such criteria
• To advise ILAC on the appropriate harmonised
  criteria to be used to accredit PT providers
• To draft documents, policies etc on PT for
  possible adoption by ILAC and other relevant
  bodies
• To serve as a forum for discussion(s) of
  accreditation oriented items or other issues
  relevant to the collective interests of PT
  Providers

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Summary

• PT participation is driven by laboratory
  accreditation and other sector specific
  regulation or guidance
• Provision of PT is guided by a number of
  international standards and guides
• Increasing number of PT providers seeking and
  achieving accreditation
• Comprehensive global network of organisations
  concerned with the development of best practice
  in PT provision