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BIPM Brochure

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BIPM JCTLM_DB_WG_P-02A : 2020
Requesting and accepting nominations for Certified Reference Materials and Reference Measurement Methods/Procedures
JCTLM
Robert Wielgosz ().
BIPM Brochure

In Force

© Bureau International des Poids et Mesures 2020 all rights reserved

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Requesting and accepting nominations for Certified Reference Materials and Reference Measurement Methods/Procedures

1.  Purpose

This document describes the process employed by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) for soliciting, receiving and verifying the completeness of the nominations of certified reference materials (CRMs) and reference measurement methods/procedures (RMM/Ps) to be listed as being of a higher metrological order.

2.  Scope

This procedure applies to all nominations of certified reference materials and reference measurement methods/procedures for classification as being of a higher metrological order by the JCTLM DB WG review teams according to the criteria given in the normative ISO standards.

3.  Acronyms and definitions

All acronyms and definitions employed in the procedures of the JCTLM DB WG Quality Manual are given in the procedure document JCTLM EXE-G01, Glossary of terms and definitions.

4.  Responsibilities and Authorizations

4.1.

Oversight responsibility and authority for the operations of the DB WG resides with the DB WG Chair, and vice-chairs(s).

4.1.1.

Communicating recommendations to the JCTLM Secretariat for listing CRMs and RMM/Ps of a higher metrological order is the responsibility of the DB WG vice-chair(s)

4.1.2.

Communicating recommendations of nominated materials and methods/procedures to the DB WG vice-chair(s) based on their fulfillment of the criteria specified by ISO 15194:2009(E) and ISO 15193:2009(E) is the responsibility of the team leaders of the review teams.

4.2.

Oversight responsibility for the DB WG Chair and vice-chair(s) resides with the JCTLM Executive.

4.3.

Authority for deciding that recommended CRMs and RMM/Ps be listed resides with the JCTLM Executive.

4.4.

Responsibility for the maintenance of procedures employed by DB WG resides with the Quality System Development Team

4.5.

Authority to approve procedures of the JCTLM DB WG resides with the Executive.

5.  Procedure

5.1.

The process for nominating and reviewing materials and methods/procedures of a higher metrological order for recommendation by the JCTLM for listing in the database will occur annually.

5.2.

Nominations are solicited exclusively from producers of CRMs and developer/owners of RMM/Ps The Secretariat announces an open solicitation for nominations of CRMs and RMM/Ps for inclusion in the JCTLM database of available materials and methods/procedures of a higher metrological order. The solicitation is made each year from February to the end of May. The solicitation announcement is found on the website of the BIPM at : https://www.bipm.org/en/committees/jc/jctlm/jctlm-nominations-and-review.html

5.2.1.

A fixed date for receiving completed nominations will be specified in the announcement. Nominations received after the date specified in the solicitation announcement may be deferred for review in a subsequent review cycle.

5.2.1.1.

The deadline for submitting nominations is 30th May. In the case of reference method nominations, the submission deadline remains 30th May, but it is possible to submit the final version (non-changeable format) of its supporting documentation or publication by the 30th September.

5.3.

Obtaining Nomination Forms: Providers of CRMs and developer/owners of RMM/Ps can obtain nomination forms from download on the BIPM website:

Reference Material Nomination Form available at:
https://www.bipm.org/utils/common/pdf/JCTLM/DBWG-P-02A-F-01.xls

Reference Method/Procedure Nomination Form available at:
https://www.bipm.org/utils/common/pdf/JCTLM/DBWG-P-02A-F-02.xls

5.4.

Submitting Nomination Forms for consideration by the DB WG:

5.4.1.

Nominating forms must be submitted by email to the JCTLM Secretariat at jctlm@bipm.org. Additional information and instructions for completing the forms are found on the BIPM website at https://www.bipm.org/utils/common/pdf/JCTLM/DBWG-P-02A-I-01.pdf

5.4.2.

Only nominations submitted from producers of CRMs or developer/owners of RMM/Ps will be accepted for review by the review teams.

5.4.3.

Producers of reference materials and developer/owners of RMM/Ps acknowledge that a submitted nomination constitutes consent to include the material or method/procedure on the JCTLM List I of CRMs and RMM/Ps, or JCTLM List II of CRMs, or JCTLM List III of CRMs.

5.4.3.1.

Distinctions between List I, List II, and List III materials are given in the Preamble to the JCTLM DB WG Quality Manual.

5.4.3.2.

JCTLM DB WG will recommend on which list nominated CRMs are to be included.

5.4.4.

Only materials for which the requisite information required by ISO 15194 for evaluation is publicly available can be candidates for listing.

5.4.5.

Materials can be listed only if the producer consents to comparison studies with the same measurand(s) in other materials already listed or that are nominated.

5.4.5.1.

When submitting a nomination of a CRM, the producer must identify if currently listed CRMs are intended for the same purpose, and subsequently carry out a comparison study for comparing certified values of the same measurand in multiple Reference Materials. See document DBWG P-04A which describes methods to ascertain comparability of CRM values.

5.4.6.

By submitting a nomination of a CRM the producer acknowledges that the results of comparison studies with other listed CRMs for the same measurand(s) will be publicly available for review on the JCTLM website and consents to this requirement.

5.4.7.

Only methods for which the requisite information for performing the RMM/P is publicly available can be considered for listing.

5.4.8.

Methods can be listed only if the developer consents to comparison studies with other methods already listed or nominated for inclusion in JCTLM lists that are fit for the same purpose. See procedure DBWG-P-04B.

5.4.8.1.

When submitting a nomination of a RMM/P, the developer must identify if currently listed RMM/Ps are intended for the same purpose, and subsequently carry out a comparison study of methods for the same measurand when appropriate.

5.4.8.2.

If subsequently obtained comparison results indicate that variability greater than expected from the combined uncertainties of compared methods exists, the developers of the concerned methods shall be informed and are required to investigate and resolve the differences. The need for corrective actions shall be reported and may result in temporary delisting until the discrepancies are resolved, and the developer consents to this requirement.

5.4.9.

By submitting a nomination for a RMM/P the developer acknowledges that the results of comparison studies with other listed RMM/Ps that are fit for the same purpose will be publicly available for review on the JCTLM website and consents to this requirement.

5.4.10.

When submitting a nomination for a RMM/P for a measurand not yet covered by JCTLM the developer shall state the expected impact of the method within a calibration hierarchy on available routine laboratory measurement results.

5.4.11.

Nominations for CRMs or RMM/Ps are to be made by completing in full the following forms.

5.4.11.1.

Materials nomination spreadsheet (Microsoft Excel) form (DBWG-P-02A-F-01 Reference Material Nomination Form) is referenced to ISO 15194.

5.4.11.1.1.

A Compliance demonstration spreadsheet included in the reference material nomination form being submitted, must be completed by the nominating organization to describe how compliance is met for all requirements listed in ISO 15194:2009(E).

5.4.11.2.

Reference method/procedure nomination spreadsheet (Microsoft Excel) form (DBWG-P-02A-F-02 Reference Measurement Method/Procedure Nomination Form) is referenced to ISO 15193.

5.4.11.2.1.

A Compliance demonstration spreadsheet included in the reference method/procedure nomination form being submitted, must be completed by the nominating organization to describe how compliance is met for all requirements listed in ISO 15193:2009(E).

5.4.12.

Submission is to be made to the JCTLM Secretariat as an attachment to an email message to jctlm@bipm.org

5.5.

The Secretariat reviews nominations for completeness within one month of their receipt.

5.5.1.

The preliminary review is only concerned with completeness and is NOT a review of the qualification of the nominated material or method/procedure.

5.5.2.

Incomplete forms will be returned to the individual making the nomination.

5.5.3.

Returned nomination forms that are incomplete may be amended and resubmitted once during a review cycle.

5.5.4.

Resubmissions must be received by the date specified on the solicitation.

5.5.5.

Nominations or resubmissions which are incomplete will not be reviewed in the current cycle.

5.5.6.

Nominations or resubmissions which are received after the date specified may be held until the next review cycle.

5.6.

Distributing Nominations to the DB WG review teams

5.6.1.

The Secretariat distributes in consultation with the DB WG vice-chair(s) the nominations to the team leaders of the appropriate review teams to perform the review.

5.6.2.

Any DB WG review team member affiliated with a nominating organization will not participate in the evaluation of a material or method/procedure from that organization. See JCTLM DB WG-P-06 for dealing with potential or perceived conflicts of interest.

5.6.2.1.

Should a lack of experts make this restriction unenforceable, an exception can be made only with prior consent of the JCTLM Executive.

5.7.

The distributed nominations are reviewed by the DB WG review teams according to JCTLM DBWG-P-03A.

6.  Revision History

Version number Date of Issue/Review Summary of change
1.0 01/08/2004 Initial issue of WG1 Quality System Procedures
2.0 10/15/2005 Transfer of Section 6.3 to a FAQ file to be available on JCTLM website, introduction of website links into document for nomination forms and contacts for JCTLM. Clarification of ambiguous wording. Formalization of Secretariat as official for receipt of nomination and communication with nominators of CRMs and RMM/Ps.
2.1 24/01/2006 Correction of minor textual errors
3.0 09/11/2009 Revised to comply with ISO 15194:2009(E) and ISO 15193:2009(E)
4.0 27/01/2011 Corrections made in version 3.0 accepted
4.1 30/04/2013 Modifications made following the 10th Executive Committee meeting decisions with addition of paragraphs 7.2.2.1 and 7.2.2.2
5.0 03/02/2014 Modifications made following the 11th Executive Committee meeting decision that nominating organizations must declare compliance with ISO 15194:2009(E) and ISO 15193:2009(E)
6.0 27/01/2017 Document revised after implementation of new organizational structure of JCTLM and its Working Groups
6.1 01/02/2019 Update of hyperlinks
6.2 11/06/2020 Modification made following the 21st Executive Committee meeting: Revision of paragraph 6.6.2 to include a clause on conflict of interest and confidentiality which would applied during the review process

7.  Flow chart

Process for Requesting and Accepting Nominations for Certified Reference Materials and Reference Measurement Methods/Procedures (DB WG-P-02A — January 2017)


Related documents

[1]  ISO 15193:2009 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures [ISO 15193:2009]

[2]  ISO 15194:2009 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and content of supporting documentation [ISO 15194:2009]

[3]  ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials [ISO 18153:2003]

[4]  JCTLM Preamble JCTLM Preamble Available at — https://www.bipm.org/utils/common/pdf/JCTLM/Preamble.pdf [JCTLM Preamble]

[5]  JCTLM DBWG-P-00 JCTLM DBWG-P-00 Quality Policy of the JCTLM Database working group (DB WG) [JCTLM DBWG-P-00]

[6]  JCTLM DBWG-P-01A JCTLM DBWG-P-01A Outline of JCTLM DB WG process for evaluating and listing higher order materials and methods [JCTLM DBWG-P-01A]

[7]  JCTLM DBWG-P-03A JCTLM DBWG-P-03A Process for the review and approval of nominated Certified Reference Materials (CRMs) and Reference Measurement Methods/Procedures (RMM/Ps) [JCTLM DBWG-P-03A]

[8]  JCTLM DBWG-P-04B JCTLM DBWG-P-04B Process for demonstrating the extent-of-equivalence of Reference Measurement Methods/Procedures for the same measurand [JCTLM DBWG-P-04B]

[9]  JCTLM DBWG-P-02A-F-01 JCTLM DBWG-P-02A-F-01 Reference Material Nomination Form, Microsoft Excel Spreadsheet available at: https://www.bipm.org/utils/common/pdf/JCTLM/DBWG-P-02A-F-01.xls [JCTLM DBWG-P-02A-F-01]

[10]  JCTLM DBWG-P-02A-F-02 JCTLM DBWG-P-02A-F-02 Reference Measurement Method/Procedure Nomination Form, Microsoft Excel Spreadsheet — available at: https://www.bipm.org/utils/common/pdf/JCTLM/DBWG-P-02A-F-02.xls [JCTLM DBWG-P-02A-F-02]

[11]  JCTLM DBWG-P-02A I-01 JCTLM DBWG-P-02A I-01 Instructions for completing Excel files for the nomination of Reference Materials and Reference Measurement Method/Procedures for the JCTLM Database [JCTLM DBWG-P-02A I-01]

[12]  JCTLM DBWG-P-06 JCTLM DBWG-P-06 Application, nomination and approval for membership on JCTLM review teams [JCTLM DBWG-P-06]