Identification of Reference Measurement Laboratories

_________________________________________JCTLM WG-2

Lothar SiekmannInstitute of Clinical Biochemistry – University of Bonn, Germany

SI-Unit Definition of the Measurand

BIPM, CGPM

Primary calibrator

Secondary calibrator

Manufacturer‘s working

(master) calibrator

Mf.´s product calibrator

Primary referencemeasurement procedure

NMI, ARML

NMI

Secondary reference measurement procedure

Manufacturer‘s standingmeasurement procedure

End-user´s routinemeasurement procedure

Routine sample

RESULT

NMI, ARML

ARML, ML

ML

ML

Manufacturerand/or End-user

ML,ARML

Trac

eabi

lity

End-user

End-user

Certification of a reference material (purity)

ML

µc(y)

BIPM:Bureau International ofWeights and Measures

CGPM:General Conferenceon Weights and Measures

NMI:National Metrology Institute

ARML:Accredited Reference Measurement Laboratory

ML:Manufacturer‘s Laboratory

Hierarchy of Laboratories

National Metrology Institutes

Accredited Reference (Calibration) Laboratories(universities, hospitals, manufacturers)

Routine (Testing) Laboratories

Calibration and Measurement Hierarchy in Laboratory Medicine

Reference (Calibration) Laboratories

Demonstration of Competence:a) Accreditation as Calibration Laboratories according to ISO/IEC 17025 and 15195,b) Use of JCTLM listed Reference Methods,c) Pariticipation in Ring Trials for Reference Laboratories

Listed:JCTLM List of Reference Laboratories

Services:Reference Measurement Service fora) Diagnostica Manufacturers,b) Regulatory Bodies,c) Certifying Reference Method Values for Ring Trials for Routine Laboratories

Routine (Testing) Laboratories

Demonstration of Competence:a) Accreditation according to ISO 15189,b) Pariticipation in Ring Trials of Proficiency Testing Organisations, Reference Method Values Certified by Reference Laboratories

Services:Measurement Service for Patient Samples

Responsibility: CIPM

Responsibility for Listing of Services: JCTLM

Responsibility:e.g. National Regulatory Bodies

Rev 05-04-05 Metroloy Institutes, listed in Appendix C of the BIPM KCDB acording to CIPM MRAmay also act as Reference Measurement Service providers; they will be listed by JCTLM without further review.

National Metrology Institutes

Demonstration of Competence:CIPM MRA Key Comparisons Data Base (KCDB)

Listed:CIPM KCDB List (Appendix C) of National Metrology Institutes Providing Calibration & Measurement Capabilities (CMCs)

Services:Realizations of the SI Units providing:a) Certified Values for Reference Materials, b) Calibration and Measurement Capabilities on the Highest Metrological Level for Comparative Measurements e.g. in Proficiency Testing for Reference Laboratories

Identification of Reference Laboratories ________________________________________________________________________________________________________________

Reference Measurement Laboratories will be Identified- according to the metrological level of the reference procedures applied; JCTLM –listed WG1,

- on the basis of accreditation according to ISO 17025 and ISO 15195 as reference/calibration laboratory;

or NMI listed in Appendix C of the CIPM MRA (peer reviewed),

- on the basis of their ability to demonstrate performance in regular inter-laboratory comparisons (ring trials) .

Reference Laboratory

Status of Reference Laboratory

Organisation Name of person

responsibleStreet City Post CodeState Country Phone Fax e-mail

indicate: Nat.Metrology Institute, EQAS

Organizer, Manufacturer,

Korea Research Institute of Standards and Science

Sang-Ryoul Park P.O.Box 102, Yuseong Daejeon 305-600 S. Korea 82-42-868-

565882-42-868-5042 srpark@kriss.re.kr Nat. Metrology Institute

DGKCProf.Dr. L. Siekmann, Dr. Anja Kessler

Im Mühlenbach 52a

Bonn 53127 NRW Germany 0049-228-2875911

0049-228-2875033

lothar.siekmann@ ukb.uni-bonn.de EQAS Organizer, University

LGC John Marriott Queens Road Teddington

TW11 0LY

Middlesex UK +44 (0)20 8943

7509+44 (0)20 8943 2767

john.marriott@lgc.co.uk

Designated Nat. Measurement Institute

Physikalisch- Technische Bundesanstalt (PTB)

Dr. Henrion Bundesallee 100

Braunschweig 38116 Germany + 49 531 592-

3210 + 49 531 592-3015

andre.henrion@ptb.de Nat. Metrology Institute

Centers for Disease Control and Prevention

Parvin P. Waymack

4770 Buford Hwy NE MS F25

Atlanta 30341 GA USA 770-488-7976 770-488-4192 pwaymack@cdc.gov

Governmental Reference Laboratory

Diagnostica e Ricerca S. Raffaele - Laboratorio Standardizzazione

Ceriotti Ferruccio

Via Olgettina, 60 Milan 20132 Italy +39-02-

26432850+39-02-26432640

ceriotti.ferruccio@hsr.it ferrero.carlo@hsr.it

CRMLN Member EQAS-Organizer

NIST W. E. MayMailstop 8390, 100 Bureau Drive

Gaithersburg 20899 MD USA (301)975-3108 willie.may@nist.go

v NMI

Address

Address & Identity

Reference Laboratories in Laboratory MedicineSection 1:

Type Status

of Measur

andAnalyte

System (e.g.:

Blood, Serum,

of Reference Procedure (a) primary

(b) secondary

SI-traceabl

e (Yes/No)

Principle of analytical procedure

Reference material(s) for

calibration

Reference material(s) for

trueness control

Literature Reference

M&S Total cholesterol Serum Yes IDMS Clinical Chemistry 43:10

pp 1896-1903 (1997)

M&S Total cholesterol

Serum, Plasma Yes Abell-Kendall SRM 911b CDC quality

control serum Abell,et al., JBC 1952

M&S Total cholesterol Serum Yes

1. Spectrophotometri

c; 2. HPLCNIST SRM 911b CDC Reference

Materials

1. Duncan IW, et al. Procedure for the Proposed Cholesterol Reference Method, Atlanta, GA: Centers for Disease

Control; 1982. 2. Chen W, et al. Clin Chem

M&S Total cholesterol Serum Yes IDMS CRM: GBW09203b Anal Chem 61, 1718-

1723 (1989)

M&S Total cholesterol Serum Yes

Abel-Kendall (hidrolysis of

cholesterol esters and extraction with

SRM 911b (NIST) CDC reference materials

M&S Total Cholesterol Serum Yes Abell Kendall NIST SRM 911 CDC Reference

Materials

Duncan IW, Mather A, Cooper GR, The Procedure for the

proposed cholesterol reference method. Atlanta, GA 30333: Centers for Disease Control,

1982

M&S Total cholesterol serum yes isotope dilution

GC/MSSRM 911b cholesterol

SRM 1951a lipids in fresh-frozen human serum

Measurand Reference Measurement Procedure

Reference Laboratories in Laboratory MedicineSection 2: Measurand and Procedure

ISO 15195: Requirements for Reference Measurement (Calibration) Laboratories

__________________________________________________________________________________________________

Management System

Requirements

• Quality management system

• Personnel

• Documentation and records

• Contracting

Technical Requirements

• Premises and environmental

conditions

• Handling of samples

• Equipment

• Reference materials

• Reference measurement procedures

• Metrological traceability – Uncertainty

• Quality assurance

• Reporting results

Status Compliance

of Laboratory Accreditation (a) calibration

(b) testing (c) no

based on ISO standard

(e.g. 17025):

as calibration laboratory (Yes/No)

as testing laboratory (Yes/No)

with National/ International Standards -

please indicate:

NMI Peer Review (Novem, 2002) NMI itself

Yes Yes

17025 National

ISO/IEC 17025 Yes No

ISO-17025 Yes No According to RiliBÄK-2002

ISO17025 No Yes

ISO 17025 (self declaration)

ISO/IEC 17025 Yes No

Accreditation

Section 3:

Reference Laboratories in Laboratory Medicine

Status of Accreditation

Remarks

in 2000 in 2001 in 2002

14 10 8

3 analytical batches / year

3 analytical batches / year

3 analytical batches / year

CRMs certification - Assignment of Target Values to EQA materials, *(*) the measurement system is compliant with EN ISO 18153

> 8000 > 8000 > 8000 Frequency for each enzyme except LDH where frequency is > 2000 per year

Frequency of Measurements

Section 4: Frequency of Measurements

Reference Laboratories in Laboratory Medicine

Status

of Comparative Measurements e.g.

in a network (a) regular

(b) occasionally (c) no

Organisation Name of Network

Participation in: Ring Trials, Certification

Campaigns, Key Comparisons

Frequency of participation

(months):

CCQM Organic W.G. KC of CCQM Organic Working Group - KC12

Survey hosted by Japan Medical Association, Survey

hosted by Japanese

Once a year Once a year Twice a year

PTB National Reference Network

National Reference Network, Key Comparison Pilot Study

(BIPM)18

Certification of values for EQAS 4x per annum

BIPM CCQM CCQM-P9, CCQM-K12

BIPM CCQM CCQM-P9, CCQM-K12 (IMEP 17) 18

Ring TrialsNetwork Membership

Reference Laboratories in Laboratory MedicineSection 5: Network Membership - Ring Trials

IFCC EQASfor Reference Laboratories

________________________________________

Lothar SiekmannInstitute of Clinical Biochemistry, Universität Bonn

Reference Institute of Bioanalysis

http://www.dgkl-rfb.de

WG-2)

Organisation: LaboratoryName of person

responsible: Name

Street:

City:

Post Code:

State:

Country:

Phone:

Fax:

e-mail:

Please return by August 15, 2004 to:

Dr. R. Kruse,Dr. W. GeilenkeuserDGKLIm Mühlenbach 52 aD-53127 Bonn - Germany

Fax: +49-228-211529E-mail: info@dgkl-rfb.de

Please switch to next table (Measurands) !

Reference Laboratory Address:

Reference Laboratories in Laboratory Medicine

Registration Form for Ring Trial RELA 01/2004

Reference Institute of Bioanalysis

11

12131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657

A B C

Measurand Participationplease indicate

"X"

METABOLITES & SUBSTRATESTotal Cholesterol Total Glycerol Creatinine x 2 x 5Uric Acid Urea Glucose Total Bilirubine ELECTROLYTESSodium Potassium x 2 x 5Chloride Calcium Lithium Magnesium

ENZYMESALT AST CK LDH GGT Amylase

Total Protein HORMONES Aldosterone Cortisol x 2 x 5Progesterone Testosterone Estradiol-17ß Estriol (non-conjugates) Total Thyroxine (TT4) Total Tri-iodothyronine (TT3) 17-Hydroxyprogesterone

THERAP.DRUGSDigoxin x 2 x 5Digitoxin Theophyllin

Number of Vials

registered participated

METABOLITES & SUBSTRATES Total Cholesterol 9 9Total Glycerol 2 2Creatinine 5 3Uric Acid 6 5Urea 3 3Glucose 4 3Total Bilirubine 2 2

ELECTROLYTES Sodium 8 6Potassium 7 4Chloride 4 3Calcium 4 1Lithium 5 2Magnesium 4 1

ENZYMES ALT 12 10AST 8 4CK 9 4LDH 9 4GGT 9 5Amylase 6 2

PROTEINS Total Protein 3 2Albumin 4 3

HORMONES Aldosterone 1 1Cortisol 3 3Progesterone 3 3Testosterone 1 1Estradiol-17ß 1 1Estriol (non-conjugates) 1 1Total Thyroxine (TT4) 1 1Total Tri-iodothyronine (TT3)17-Hydroxyprogesterone 1 1

THERAP.DRUGS Digoxin 1 1Digitoxin 3 3Theophyllin

Glyc. Proteins HbA1c 4 3SUM 143 97

LaboratoriesMeasurand

Reference Laboratories in Laboratory MedicineRELA 01/2003

registered participated

METABOLITES & SUBSTRATES Total Cholesterol 8Total Glycerol 2Creatinine 13Uric Acid 6Urea 3Glucose 6Total Bilirubine 3

ELECTROLYTES Sodium 6Potassium 12Chloride 4Calcium 3Lithium 4Magnesium 3

ENZYMES ALT 8AST 8CK 5LDH 19GGT 10Amylase 7

PROTEINS Total Protein 7Albumin

HORMONES Aldosterone 1Cortisol 8Progesterone 2Testosterone 1Estradiol-17ß 1Estriol (non-conjugates) 1Total Thyroxine (TT4) 1Total Tri-iodothyronine (TT3) 117-Hydroxyprogesterone 1

THERAP.DRUGS Digoxin 4Digitoxin 2Theophyllin 1

SUM 161 0

LaboratoriesMeasurand

Reference Laboratories in Laboratory MedicineRELA 01/2004

Meas. PrincipleSample A Sample B

mmol/l mmol/l

M (all) 141,24 135,60n 6 6SD (all) 0,81 0,83

RSD (%) 0,57 0,61

Sodium in Human Serum

IFCC RELA-1

All Results

ALT in Human Serum     

IFCC RELA-2003     

  Sample A Sample B    U/L U/L     M (all) 145.81 182.23n 10 10SD (all) 3.88 4.75RSD (%) 2.66 2.61     

Cholesterol in Human Serum             

  CCQM-K6 IFCC RELA-1             

Meas. Principle IDMS IDMS Abell-Kendall

  Sample A Sample B Sample A Sample B Sample A Sample B

         

  mg/g mg/g mg/dl mg/dl mg/dl mg/dl

             

M (all) 2,1981 1,7331 231,13 166,81 237,80 171,36

n 7 7 5 5 3 3

SD 0,0324 0,0206 1,76 0,92 0,25 0,45

RSD (%) 1,47 1,19 0,76 0,55 0,10 0,26

Range (%) 5,14 4,15 2,25 1,44 0,26 0,64             

      Bias (%): 2,9 2,7

RELA 0301 Cholesterol - Sample AIDMS

DGKL

Roche

PTBRUG

INSTAND

95

96

97

98

99

100

101

102

103

104

105

%

MeanMean +UMean -U

RELA 0301 - Sample BIDMS

DGKL

Roche

PTB

RUG

INSTAND

95

96

97

98

99

100

101

102

103

104

105

%

Mean

Mean +U

Mean -U

Cholesterol CCQM-K6 Sample A

LGC

NARL

NIST

NMI

NMIJ NRCCRM

PTB

96

97

98

99

100

101

102

103

104

105

%

Mean

Mean +U

Mean -U

Cholesterol CCQM-K6 Sample B

LGC

NARL

NISTNMI

NMIJ

NRCCRM

PTB

95

96

97

98

99

100

101

102

103

104

105

%

Mean

Mean +U

Mean -U