ISO TC 212 Working Group 2, Reference systems and revisions to the IVD harmonized standards

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1 ISO TC 212 Working Group 2, Reference systems and revisions to the IVD harmonized standards Gerhard Schumann (ISO/TC212/WG2 convenor s report included) BIPM, JCTLM December

2 ISO/TC212/WG2 Convenor s Report & Resolutions Neil Greenberg, PhD, DABCC*, Convenor 21 November, 2013 Singapore ISO/TC 212 N329 November 2013 *) Diplomate of the American Board of Clinical Chemistry

3 ISO TC 212 Working Group 2, Reference systems ISO In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Presentation of reference measurement procedures ISO In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for reference materials of higher order and the content of supporting documentation ISO Laboratory Medicine Requirements for reference measurement laboratories ISO Metrological traceability of values assigned to calibrators and control materials ISO Traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

4 Project Report Measurement Uncertainty (Dr G White, Project Lead) joint project of WG2 / WG1 Working draft - Practical Guide to MU - accepted as suitable working draft for continued work. A project team parallel break-out session progressed through approximately the first third of the draft MU document, with useful discussions and proposed changes. Planning to hold one or possibly two Project Team WebEx teleconferences early in 2014 with aim of completing revised draft by mid-year.

5 ISO In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials WG2 Working Draft from October 2013 (prepared by Dr G Miller) (ISO TC 212/WG2/N230) Working title: In vitro diagnostic medical devices (Measurement of quantities in biological samples ) Metrological traceability of measured or assigned values in product calibrators, trueness control materials and human samples

6 ISO Major Changes 1 Scope human samples 3 Terms and definitions measurand - particular quantity subject to measurement (VIM 1993) - quantity intended to be measured (VIM 3) equivalence, numerical (definition missing) 4 Concepts and principles in establishing metrological traceability Text and figures under revision

7 Project Report: ISO Traceability of Assigned Values Calibrators, Controls, Patient Samples WG2 reviewed portions of the revised text (internal working draft), including extensively revised descriptive figures of traceability schemes; numerous recommendations and changes were agreed Significant progress achieved and issues resolved that will lead to further revisions to the draft (to be progressed post-meeting by Project Teams) Two project teams assigned to develop new draft for review at next formal WG meeting: Team 1: Consolidated Terms & Definitions chapter (A Quintenz, Proj Lead) Team 2: Further revisions to substantive text and figures (G Miller, Proj Lead)

8 ISO 15195:2003 Laboratory Medicine Requirements for reference measurement laboratories ISO/TC 212/N234 Amendment proposal prepared by Prof. L. Siekmann Main objective: ISO as normative reference in ISO 15195

9 ISO Laboratory Medicine Requirements for reference measurement laboratories

10 ISO Laboratory Medicine Requirements for reference measurement laboratories

11 ISO Laboratory Medicine Requirements for reference measurement laboratories Comparison of the checklists for ISO and ISO from DAkkS-DKD Written in red: Requirements which are not or not sufficiently covered in ISO/IEC ISO Technical requirements 5.2 Handling of sample 6th paragraph: When the uncertainty of weighing of reference materials or other items necessary for calibration is a significant element in the combined uncertainty, corrections for the lift of the materials in the air according to their density relative to that of the test weight pieces (correction for the buoyancy) should be applied when this is relevant for the result or its uncertainty. Temperature, atmospheric pressure and humidity should be taken into account, as relevant. ISO Equipment Equipment.shall be capable of achieving the accuracy required and shall

12 ISO 15195:2003 Laboratory Medicine Requirements for reference measurement laboratories ISO is normative reference to ISO ISO as normative reference to ISO 15195? TC 212 requests respective information from the board of ISO (until Feb. 2014). Revision and improvement of ISO depends strongly on the information from the board of ISO.

13 Project Report: ISO 15195, Requirements for Reference Measurement Laboratories Reviewed a portion of the revised text (internal working draft) provided by Prof Siekmann Significant progress was achieved and issues resolved, leading to an understanding regarding further revisions that will result in a leaned-out text, eliminating redundancies with ISO (a normative reference) A stakeholder s workshop was proposed to be organized as a WG2 collaboration with JCTLM, to engage key constituencies (especially accreditation bodies) to assist in further developing the document A project team headed by Dr Wielgosz was assigned to progress further revisions postmeeting, with goal of producing new draft for review at next meeting of WG2 Project team tentatively plans to meet in March (location TBD)

14 Resolution 1 WG2 recommends to TC212 that WG2 should liaise with the newly defined WG4* with respect to initiatives related to reference systems. *) WG4: Antimicrobial Susceptibility Testing

15 Resolution 2 WG2 should work with JCTLM to organize a workshop with major stakeholders (users) for ISO (including reference measurement laboratories and accreditation bodies intending to provide accreditation services to labs for a combination of ISO and ISO 17025) to elucidate best practices and challenges in this area, and to solicit proposals/ideas for revisions and improvements to ISO WG2 is seeking endorsement from TC212 to pursue this activity with JCTLM.

16 Resolution 3 WG2 recommends to move forward on the PWI* for Measurement Harmonization Protocols. WG2 requests approval from TC212 to initiate this project, with Dr G Miller as Project Lead. *) Preliminary Work Item

17 Resolution 4 To ensure future automated electronic receipt of WG materials and working documents, WG2 requests that the TC212 secretariat coordinate with the ISO Central Secretariat to ensure that all TC212 liaisons are properly registered not only with the TC but also with their respective participating WG s.

18 (Tentative) Next WG2 Meeting (s) Planned May Paris, France (at invitation of BioRad) October in conjunction with next TC 212 Plenary - Toronto, Canada