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Bureau International des Poids et Mesures. Worldwide Infrastructure for Facilitating Traceability and Comparability of Chemical Measurements Robert Wielgosz. A Worldwide Infrastructure. International activities MRA CCQM BIPM Key Comparison Database BIPM-NIST collaboration JCTLM and WHO

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Bureau International des Poids et Mesures

Worldwide Infrastructure for Facilitating Traceability and Comparability of Chemical Measurements

Robert Wielgosz


A worldwide infrastructure
A Worldwide Infrastructure

  • International activities

    • MRA

    • CCQM

    • BIPM Key Comparison Database

    • BIPM-NIST collaboration

    • JCTLM and WHO

  • National activities

    • Example 1: PTB, Germany

    • Example 2: LGC, UK

  • Conclusions

    • Designation of laboratories

    • Benefits of MRA participation


International activities
International activities

  • MRA

  • Signed October 1999

  • October 2002

  • 42 member states of the Metre Convention

  • 7 Associates of the CGPM

  • 2 International Organizations

  • Growing number of designated institutes

  • www.bipm.org


Objectives of the mra are to
Objectives of the MRA are to:

  • establish the degree of equivalence of measurement

  • standards maintained by NMIs;

  • provide for the mutual recognition of calibration and

  • measurement certificates issued by NMIs; thereby to

  • provide governments and other parties with a secure

  • technical foundation for wider agreements related to

  • international trade, commerce and regulatory affairs




Published cmcs by chemical category
Published CMCs by Chemical Category

2137 CMCs in Chemistry currently published


Ccqm organizational structure

WG on Gas Analysis

WG on Inorganic Analysis

Chairman: Dr E de Leer (

NMi)

Chairman: Dr M Sargent (LGC)

WG on Bioanalysis

WG on Surface Analysis

ad hoc

Chairpersons:

Chairman: Dr M

Seah (NPL)

Dr G

Gilliland (NIST)

Dr H

Parkes (LGC)

CCQM Organizational Structure

CCQM

President: Dr R

Kaarls (CIPM)

Executive Secretary: Dr R I Wielgosz (BIPM)

WG on Key Comparisons

Chairman: Dr H Semerjian (NIST)

WG on Organic Analysis

WG on Electrochemical Analysis

Chairman: Dr W E May (NIST)

Chairman: Dr M Mariassy (SMU)




National and international networks for atmospheric ozone measurements

  • NIST-EPA Standard Reference Photometer (SRP) provides a mechanism for worldwide traceability of ozone measurements

    • US ambient O3 measurements under EPA regulations

    • an increasing number of worldwide national metrology labs maintain SRPs

Joint NIST-BIPM programme to maintain the comparability of the worldwide network of ozone reference standards


CCQM-P28 Ozone ambient level measurements

NIST Standard Reference Photometer (SRP) Network

National Institute of

Standards and Technology


National capabilities for ozone reference standards
National capabilities for ozone reference standards measurements

CCQM-28 Questionnaire

NMI or designated Laboratory = 13

Nominated but not yet designated = 9

Countries with activities, nomination expected = 10


Ozone reference standard comparison facilities at the BIPM measurements

SRPs maintained by the BIPM

SRP 27

SRP 28

SRP 19 (PTB)



JOINT COMMITTEE on TRACEABILITY measurementsin LABORATORY MEDICINE (JCTLM)andMemorandum of Understanding between theWHO and the CIPM


Mission Statement measurements

  • “The aim of the Joint Committee is to support world-wide comparability, reliability and equivalence of measurement results in Laboratory Medicine, for the purpose of improving health care, by:

    • promoting the concept of traceability of measurement results to the Système International d’Unités (SI) or, where necessary, to other internationally agreed references;

    • promoting close links between Reference Laboratories in Laboratory Medicine and National Metrology Institutes;

    • co-ordinating and giving guidance in the establishment of Reference Measurement Systems with respect to medical needs;


Jctlm
JCTLM measurements

  • Implementation of

    • EC-IVD Directive (98/79/EC)

    • prEN ISO 17511

  • EC-IVD Directive, Annex I, Essential requirements A.3

  • '...The traceability of values assigned to calibratorsand/or control materials must be assured throughavailable reference measurement procedures and/oravailable reference materials of a higher order.'


Membership
Membership measurements

  • Principal promoters and stakeholders :

  • Worldwide International Organizations(to provide the essential formal international references):

    • BIPM, IFCC, ILAC, WHO(to be confirmed)

  • Other Key Stakeholders:

    • CRM-producers (notably IRMM and NIST)

    • IVD Industry (AdvaMed, EDMA, JACR)

    • EQA/Proficiency Organizations, Regulatory bodies, …

    • WASPaLM, ISTH

    • EC-DG Enterprise

    • ISO


Organization structure
Organization Structure measurements

  • JCTLM Executive

    • Priority setting

    • Decision on projects

    • Identification of appropriate organizations

  • 2002-2004:

  • Chairman - IFCC:Prof Joseph H H Thijssen

  • Secretariat - BIPM: Dr Angela E Samuel

  • Working Groups:

    WG 1: Reference Materials and Reference Procedures

    WG 2: Reference Measurement Laboratories


National activities
National activities measurements

  • Example 1: PTB, Germany

  • Clinical Chemistry


our aim measurements

our strategy

our competence

Metrology in Chemistry in PTB

Metrology in Chemistry in PTB

reliability of chemical measurements

sharing responsibilities

Establishing traceability in analytical chemistry


Metrology in Chemistry: aims and route measurements

  • Metrology in Chemistry

method

route

aim

Installation of

national traceability structures

for

chemical measurements

(traceability to SI-units or other accepted reference points)

establishment of

international comparability/equivalency

of national traceability structures

  • Reliable measurements:

  • sufficiently accurate

  • accuracy quantified

  • worldwide acceptance based on trust in accuracy

  • measured once -

  • accepted everywhere

  • application of metrological concepts

  • traceability

  • meas. uncertainty

  • in chemical analytics


National infrastructure - International comparability measurements

NMI:

Primäre Messverfahren + Prozeduren

Primäre Referenzmaterialien

NMI:

primary measurement systems + devices

primary reference materials

accredited calibration laboratories, reference laboratories

certified reference materials (CRMs)

-

SIM

chemical test laboratories, which have to demonstrate their traceability

(ISO 17025)

BIPM


Sharing responsibilities: a national network measurements

  • BAMBundesanstalt für Material- forschung und -prüfung

  • primary pure substances

  • (elements)

  • primary gas mixtures

  • certified reference materials

Large application fields require cooperation:

health

environment

food

high-tech materials

commodities

forensics

  • coordinator

  • our competence:

  • organics

  • element solutions

  • gases

  • electrochemistry

  • clinical chemistry

  • UBA Umweltbundesamt

  • primary gases for the

  • environment

  • DGKC Deutsche Gesellschaft für klinische Chemie

  • primary clinical

  • reference materials: - hormones - enzymatic activities - new diagnostic markers


Activities in Clinical Chemistry measurements

PTB activity does not focus on issuing Reference Materials.

Responsability is shifted to ,,Reference Laboratories‘‘.

PTB coordinates and supports a network such laboratories by engaging in:

  • Measurement comparisons

  • Scientific dialogue

  • Research


Regulations relevant to laboratory medicine measurements

  • EC- Directive on In-Vitro Diagnostika 98/79/EG

  • Medizinproduktegesetz, Betreiberverordnung

  • Regulations of the Federal Physicians Association


Measurands for which QA is mandatory measurements

Regulation, Appendix 1 (permanently updated)

Selection for entry

into Appendix:

  • Frequency of measurement

  • Medical importance of measurand

  • 55 measurands listed

Uric acid

Urea


Assuring the quality of clinical measurements measurements

  • Clinical Routine Laboratories purchase calibrators

  • from IVD industry.

  • Participate in comparisons (as a measure of

  • external quality control) organized by Reference Institutions.

  • Target values certified by Reference Laboratories.

  • Accreditation needed according to ISO 17025 or ISO 15195

  • Comparisons PTBReference Laboratories.

  • Comparisons PTB  Community of NMIs.

  • CCQM


Glucose measurements

Creatinine

Uric Acid

Urea

Cholesterol

Cortisol

Testosterone

Progesterone

Estradiol

Aldosterone

Thyroxin

Digitoxin/ Digoxin

Theophylline

Phenobarbital

CCQM-K11

CCQM-K21

Substrates/

Metabolites

i.p.

i.p.

CCQM-K6

i.p.

Low

Molecular Weight

Hormones

i.p.

Therapeutic

Drug

Monitoring

i.p.: in preparation


National activities1

LGC measurements

Setting standards

in analytical science

National activities

  • Example 2: LGC, UK

  • UK Chemical Calibration Facility


Rationale for uk programme
Rationale for UK Programme measurements

  • Analytical measurement sector is large and vital to the UK economy

    • ~£7.5bn of analysis p.a.

    • ~100,000 analysts in ~15,000 laboratories

  • Agreement between laboratories/countries is essential for commerce and international trade

  • Chemical measurement infrastructure poorly developed

  • Not all measurements are valid (fit for purpose)


Chemical measurement infrastructure activities
Chemical Measurement Infrastructure Activities measurements

  • National:

    • VAM working groups (RM, PT, Training, Mass Spec.)

    • collaborative development of RMs

    • laboratory and knowledge networks with RSC

    • UK Chemical Calibration Facility

    • achieving traceability in ISO 17025 accredited laboratories

  • International:

    • established EURACHEM and CITAC

    • founder member of CCQM

    • participation in CIPM MRA and EUROMET


Uk chemical calibration facility 1 purpose
UK Chemical Calibration Facility: measurements 1. Purpose

  • Support the development of traceable chemical measurements by UK analytical laboratories, in particular to meet the requirements of ISO 17025

  • Link UK laboratories into the national and international chemical measurement systems to ensure the future world-wide acceptance of their data

  • Provide a single point of focus for a wide range of chemical measurement services


Uk chemical calibration facility 2 principal services
UK Chemical Calibration Facility: measurements2. Principal Services

  • Provision of high level calibration services and/or standards to suppliers offering secondary services or standards

  • Preparation of standards and reference materials

  • Limited services direct to field laboratories, where necessary

  • Service provision in accordance with the CIPM Mutual Recognition Arrangement (MRA)


Uk chemical calibration facility 3 initial activities
UK Chemical Calibration Facility: measurements3. Initial Activities

  • Purity determination, including

    • Certification or provision of natural or isotopically enriched single substance calibration materials

  • Analytical standards, including

    • Certification or provision of solution calibration standards

  • Preparation and certification of complex matrix CRMs

  • Provision of reference values for matrix samples

    • CRMs, PT scheme artefacts, validation samples, etc


Conclusions
Conclusions measurements

  • MRA providing a basis for developing a worldwide infrastructure for chemical measurements

  • Linked National Activities vital to the process

  • Designation of laboratories: emerging mechanism


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