JCTLM REFERENCE LABORATORY SERVICES Report of WG2 November 14, 2005 _________________________________________.

JCTLM REFERENCE LABORATORY SERVICES

Report of WG2November 14, 2005

_________________________________________

Joint Committee for

Traceability in Laboratory Medicine

______________________________________________________

Working Group I: - Reference Materials, - Reference Measurement Procedures

Working Group II: - Reference Measurement Laboratories

______________________________________________________

Joint Committee for Traceability in

Laboratory Medicine Declaration of CooperationAppendix III:

… The technical competence of the laboratories shall be demonstrated by their performance in international comparisons, and their operation of an appropriate quality system. International recognition of the implementation of the quality system is achieved via accreditation or equivalent documented peer review. …

______________________________________________________


Laboratory Medicine

Working Group II Objectives:

- to prepare a procedure manual describing the processes for nomination, listing and

de-listing of reference laboratory services, - to publish an open call for nomination of

reference laboratory services

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Laboratory Medicine Working Group II Procedure Manual

JCTLM WG2 P-00:

Outline of the Calibration and Measurement Hierarchy in Laboratory

Medicine-

Quality Policy and Definitions

______________________________________________________

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

Tra

ceab

ilit

y

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

Outline of the Calibration and Measurement Hierarchy in Laboratory Medicine

WG-2 P-00

Reference (Calibration) Laboratories

Demonstration of competence:a) Accreditation as Calibration Laboratories according to ISO 17025 and 15195 by ILAC Full Member,b) Use of JCTLM listed Reference Methods (JCTLM-WG1),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) Proficiency Testing Organisations, Certifying Reference Method Values for Proficieny Testing of Routine Laboratoriesd) Routine Medical Laboratories (certified values for calibrators and controls)


Demonstration of Competence:a) Accreditation according to ISO 15189/ ISO-IEC 17025,b) Pariticipation in Proficiency Testing Schemes, Reference Method Values Certified by Reference Laboratories that use Validate Reference Measurement Procedures

Services: Measurement Service for Patient Samples

Responsibility: CIPM

Responsibility: JCTLM

Responsibility:National Regulatory Bodies

Rev 05-11-02*Metrology Institutes, listed in Appendix C of the BIPM KCDB acording to CIPM MRA may also act as Reference Measurement Service providers; they will be listed by JCTLM without further review of their status of accreditation.


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)* for appropriate scope (peer review and/or accreditation to the core requirements of ISO 17025/ ISO 15195).

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


WG-2 P-00


Demonstration of competence:a) Accreditation as Calibration Laboratories according to ISO 17025 and 15195 by ILAC Full Member,b) Use of JCTLM listed Reference Methods,c) Pariticipation in Ring Trials for Reference Laboratories















WG-2 P-00


Demonstration of competence:a) Accreditation as Calibration Laboratories according to ISO 17025 and 15195 by ILAC Full Member,b) Use of JCTLM listed Reference Methods (JCTLM WG1),c) Pariticipation in Ring Trials for Reference Laboratories













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 LaboratoriesJCTLM WG2 – P-02


WG-2 P-00


Demonstration of competence:a) Accreditation as Calibration Laboratories according to ISO 17025 and 15195 by ILAC Full Member,b) Use of JCTLM listed Reference Methods,c) Pariticipation in Ring Trials for Reference Laboratories




Demonstration of Competence:a) Accreditation according to ISO 15189/ ISO-IEC 17025,b) Pariticipation in Proficiency Testing Schemes, Reference Method Values Certified by Reference Laboratories that use Validated Reference Measurement Procedures











Laboratory Medicine

Working Group II Procedure Manual

JCTLM WG2 P-01:

Outline of the JCTLM Procedures for Identifying and Listing Reference

Measurement Services Provided by Reference Laboratories

______________________________________________________

Procedure CodeProcess for Requesting, Processing and Re-reviewing Nominations for

Services of Reference Measurement Laboratories (RMLs)

and Appeals to the decisions of WG2 and Review Teams

WG2 P-03

Notify Laboratory

List Laboratoryon BIPM & IFCC Websites

OUTLINE - WG-2 P-01

Process for Review and Acceptance of Nominated RML Services

WG2 P-02

Nomination Accepted?

No

Yes

Process for Listing Reference Measurement Services

by WG-2 and JCTLM Executive

WG2 P-04

Responsibility: JCTLM Executive, WG-2, Review Teams

WG2 P-05

Process for the Delisting of Acceptance Status for Particular

Service of a RML


Laboratory Medicine


JCTLM WG2 P-02:

Process for Requesting and Processing Nominations for JCTLM Listing of Reference Measurement

Services

______________________________________________________

REQUESTING AND PROCESSING NOMINATIONS WG-2 P-02

JCTLM Secretariat/ WG-2 Solicit Nominations

Annually from Laboratories that Provide Reference Measurement Services

Laboratory Obtains, Completes, and Submits Nomination Form by Date

Specified

JCTLM Secretariat Receives Nomination Forms

Form Complete?

No

JCTLM Secretariat Distributes Forms to the Appropriate WG2 Review

Team Leaders

WG-2P-03-B

Yes

Laboratory isAccredited as Calibration

Laboratory (ISO/IEC 17025 and 15195)

by ILAC Full Member

Yes

Laboratory Declares that it is

Preparing for Accreditation as

Calibration Laboratory (ISO 17025 and 15195)

by 1 January 2009

JCTLM Secretariat Distributes Forms to the Appropriate WG2

Review Team Leaders And Informs Laboratory that the Service

will be Delisted if Accreditation cannot be Gained by 1 January

2009

WG-2P-03-C

Yes

No

Rev 05-11-02

No

JCTLM Secretariat/ WG2 Chair Informs Laboratory

on Deficiency

Responsibility: JCTLM Secretariat/ WG-2

Laboratory Is a National Metrology

InstituteNo

Yes

WG-2P-03-A

JCTLM Sectreatiat sends forms to the CCQM

Executive Secretariat

7.1 The process for nominating and reviewing RML services for recommendation by the JCTLM for listing will occur annually (see flow chart in the Attachment).

7.2 Solicitation of Nominations from RMLs wishing their services to be listed on the JCTLM List: 7.3 Obtaining Nomination Forms:

7.4 Submitting Nomination Forms for Consideration by WG2.

7.5 Preliminary Review of submitted nominations for completeness by the JCTLM Secretariat.

7.6 The JCTLM Secretariat and the WG2 Chair or the Chair’s designee review nominations within six weeks of their receipt.

7.7 Distributing Nominations from National Metrology Institutes to the JCTLM/CCQM Executive Secretariat.

7.8 Distributing Nominations from Accredited Laboratories (or Laboratories preparing for Accreditation) to Review Teams.

7.9 Any Review Team member affiliated to a nominating organization will not participate in the evaluation of that reference measurement laboratory service if a potential conflict of interest exists or is perceived to exist.

7. Procedure

JCTLM WG2 – P-02

7.10 The distributed nominations from National Metrology Institutes are verified by the JCTLM/CCQM Secretariat.

7.11 The distributed nominations of Reference Measurement Service providers are reviewed by the Review Teams.

7.12 For laboratories where accreditation is pending (7.7.1.2) the status of accreditation is re-examined in 2009 by the JCTLM Secretariat after consulting WG2 chair.

7.13 Reference measurement services listed on the JCTLM website will be re-reviewed every three years.

7.14 Any appeal against decisions of WG2 chair or review teams will be submitted to the Secretariat and finally decided by the JCTLM Executive after consulting the WG2 chair.

7. Procedure (continued)

JCTLM WG2 – P-02

8. Requirements for acceptable proficiency testing scheme providers

8.1 The proficiency testing provider should organize intercomparisons dedicated to reference measurement laboratory services.

8.2 The proficiency testing provider should be accredited according to ISO Guide 43-1 (1997) and ILAC Guide G-13 (2000) by an ILAC member.

8.3 The proficiency testing provider should have an international scientific advisory board.

8.4 The proficiency testing provider should conduct intercomparisons regularly (at least annually).

8.5 The proficiency testing provider should ensure that communication is established and that scientific advice is available to resolve inter-laboratory discrepancies.

8.6 The proficiency testing provider should make publicly available the identity of the participating laboratories with their results and uncertainties.

JCTLM WG2 – P-02


Laboratory Medicine


JCTLM WG2 P-03-A: Process for Verification and Publication of

Calibration and Measurement Capability (CMC) Claims in the JCTLM Database

(National Metrology Institutes)

______________________________________________________

National Metrology Institutes P-03-A

No

Form forwarded to the CCQM Executive Secretary

Is the CMC published in the BIPM-KCDB?

JCTLM secretariat recieves

nomination based on a

CIPM-MRA CMC

Yes

Is the CMC based on a Reference Measurement Method

published in the JCTLM WG1 list?

No

Yes

Inform Nominator of Deficiency

Inform Nominator of Deficiency

CCQM Secretary recommends Listing of the Service from a National Metrology Institute to

JCTLM Secretariat for final decision by the JCTLM Executive

WG2 P-04

Responsibility: CCQM Executive Secretary

Rev 05-11-02

Inform Laboratory

of Deficiencies

Laboratoryparticipates in

appropriate interlaboratory Comparisons

No

Yes


Laboratory Medicine Working Group II Procedure Manual

JCTLM WG2 P-03-B:

Process for Review of Reference Measurement Services from Laboratories that

are Accredited as Calibration Laboratories(ISO/IEC 17025 and ISO 15195)

______________________________________________________

ACCREDITED AS CALIBRATION LABORATORIES WG-2 P-03-B

WG2 Review Teams Receive Nominations for Services from

Accredited Calibration Laboratories

Laboratory Performs JCTLM Listed RMP

Direct Laboratoryto WG1-P-02

Inform Laboratory

of Deficiencies

Yes

Yes

LaboratoryParticipates in appropriate

Interlaboratory Comparisons

Yes

No

Rev 05-11-02

No

Review Team Recommends Listing of the Service of a Nominated Reference Laboratory to the JCTLM Secretariat/WG-2 chair for final

decision by the JCTLM Executive

Responsibility: JCTLM Review Teams

Laboratory is AccreditedAccording to ISO/IEC 17025 and ISO 15195 for specified service

Inform Laboratory

of Deficiency

No

Yes

WG2 P-04

7. Procedure

7.1 The process for reviewing RML services by the Review Teams will take place annually. WG2 chair will send documentation from the candidate RMLs to the review teams. They will assess the documentation and other publicly available information according to the following criteria:

7.1.1 Review teams ascertain that the RML is accredited according to ISO/IEC 17025 and ISO 15195 as calibration laboratory including on-site assessment by ILAC full members on the basis of on-site assessments by technical and management experts from accreditation bodies which are ILAC full members.

7.1.2 Review teams ascertain whether the Reference Method applied by the candidate laboratory is listed by the JCTLM according to the WG1 procedure. If the applied method has not yet been included in the WG1 reference method list the laboratory will be notified to nominate the procedure for acceptance by JCTLM WG1.

7.1.3 Review teams ascertain regular (at least annual) participation of the candidate laboratory in interlaboratory comparisons provided by an appropriate proficiency testing/external quality assessment scheme for reference laboratories which fulfills the requirements of WG-2 P-02-8.

The results of the inter-comparisons as well as the result of the individual laboratory related to its identity shall be publicly available.

It is also acceptable that a laboratory participates for another measurand of the same group of quantities (e.g., metabolites & substrates, low-molecular hormones, therapeutic drugs, enzymes) provided the same principle of measurement - e.g., IDMS, kinetic spectrophotometry for enzyme activities - is applied.

JCTLM WG2 – P-03-B


Laboratory Medicine


JCTLM WG2 P-03-C:

Process for Review of Reference Measurement Services from Laboratories Preparing for

Accreditation

______________________________________________________

LABORATORIES PREPARING FOR ACCREDITATION WG-2 P-03-C

Yes

Laboratory Performs JCTLM Listed RMP ?

Direct Laboratoryto WG1-P-02

Inform Laboratory

of Deficiencies

LaboratoryParticipates in appropriate

Interlaboratory Comparisons?

No

WG-2 Review Teams Receive Nominations for Services from a

Laboratory which is Preparing for Accreditation

No

Laboratory Declaresthat it is Preparing for

Accreditation as Calibration Laboratory According to

ISO 17025 and 15195.

Yes

Inform Laboratory

of Deficiencies

No

Yes

Rev 05-11-02

WG-2 Review Team Recommends Listing of the Reference Laboratory Service

With the Remark: “Accreditation Pending“to the JCTLM Secretariat/WG-2 for final decision

by the JCTLM Executive

Responsibility: JCTLM Review Teams

WG2 P-04


Laboratory Medicine


JCTLM WG2 P-04:

Process for Listing Reference Measurement Laboratory Services

______________________________________________________

PROCESS FOR LISTING WG-2 P-04

JCTLM Secretariat Informs Laboratory, WG2RT of

Deficiencies

JCTLM Executive decides on Recommendation

JCTLM Secretariat Lists Laboratory

on JCTLM Data Base

Yes

JCTLM Secretariat/WG-2 Recommend Laboratory Service for Listing

No

JCTLM Secretariat/WG2 chair receives Recommendations for Nominations of Reference Laboratory Services

From Review Teams (P-03-B, P-03-C)Or

Nomination of a National Metrology InstituteProviding Relevant CMC and Listed in Appendix C

of the BIPM KCDB from the CCQM Executive Secretary (P-03-A)

Yes

Rev 05-11-02

Responsibility: JCTLM WG-2, Executive


Laboratory Medicine

Working Group II Procedure Manual:

JCTLM WG2 P-05:

Process for Delisting Reference Measurement Laboratory Services

______________________________________________________

PROCESS FOR DELISTING WG-2 P-05

Rev 05-11-02

Responsibility: JCTLM WG-2, Executive

JCTLM Secretariat receives Request to remove RMS from

the JCTLM list

Validate request and confirm information

Is request from the reference measurement

service provider?

Secretariat to remove RMS from

the JCTLM list after final decision

of the JCTLM Executive

Forward request to RMS provider

Does the RMS provider agree?

WG2 forwards request to the appropriate

Review Team for discussion and

recommendations

Recommend removal from list?

Inform requestor / RMS provider

Inform requestor / RMS provider

Yes No

No

NoYes

Yes

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 including on-site assessments by ILAC full members

(signatories); or NMI listed in Appendix C of the CIPM MRA

(peer reviewed),

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

Candidate Reference Laboratories in Laboratory Medicine

Questionnaire Database

(Do not use the 'return key' within a cell; continuous writing will fill up additional lines!)

(Please use one entry (line) for each measurand!)

Reference Laboratory

AddressStatus of

Reference Laboratory

Organisation

Name of person

responsibleStreet City

Post Code

State Country Phone Fax e-mail

indicate: Nat.Metrology Institute, EQAS

Organizer, Manufacturer,

University, Hospital

Procedure Manual: P-02-7.4.4.1

Measurand Reference Measurement Procedure

Type of

Measurand

Analyte

System (e.g.: Blood, Serum, Plasma, Urine)

SI-traceable (Yes/No)

Principle of analytical

procedure (Please attach a short outline of the procedure

in a separte document!)

Reference Method listed in

JCTLM List of

Reference Methods (Yes / No)

Reference material(s)

for calibration

Reference material(s)

for trueness control

Literature Reference

Range of Concentration

(Activity)

Uncertainty of Results

Status: Reference Procedure Acceptable

and Listened by JCTLM

WG-1

(Yes / No)

P-02-7.4.4.2P-02-

7.4.4.3P-02-7.4.4.4/5

P-02-7.4.4.6

P-02-7.4.4.7

P-02-7.4.4.8P-02-

7.4.4.9P-02-7.4.4.10

P-02-7.4.4.11

Status of Laboratory

NMI with CMC listed in Appendix C of BIPM KCDB

(Yes/No)

According to ISO 17025 and ISO 15195 as

Calibration Laboratory (Yes/No)

Laboratory declares that it is preparing for

Accreditation until 2008 Proc. Manual P-03-C

(Yes / No)

Status of Laboratory (a) NMI listed in BIPM KCDB

(b) Accredited (ISO 17025+15195) (c) Accreditation in Preparation

(d) NO

P-02-7.4.4.12 P-03-A

P-02-7.4.4.13 P-03-B

P-02-7.4.4.14 P-03-C

Participation in Intercomparison Surveys for Reference Laboratories

Survey Organisation, NetworkResults of intercomparisons publically available e.g. on a

Website? (Yes / No)

Identity of the Laboratory

Disclosed and Related to its

Results? (Yes / No)

Frequency of participation für one or more measurands in the relevant group of

measurands

Status: participation in intercomparison

surveys acceptable ? (Yes / No)

P-02-7.4.4.15 - P-03-A - P03-B - P-03-C

Frequency of Measurements

Remarks Comments of Review Teams

in 2003 in 2004 in 2005

Estriol

-50

-30

-10

10

30

50

70

Year

Dev

iatio

n [

%]

1980 1981 1982 1983 1984 1985 1986 1987

17-OH-Progesterone Ring Trial HM4/2004 Test Kit 111

JCTLM REFERENCE LABORATORY SERVICES Report of WG2 November 14, 2005 _________________________________________.

Documents

manufacturers laboratory

reference laboratories

reference materials

measurement hierarchy

arml traceability

joint committee

procedure manual jctlm

reference material purity