ISO/TC 212 N334 (RESOLUTIONS) MEETING REPORT. Prof Stewart Bryant. Transfusion Medicine Specialist. Australian Red Cross Blood Service

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1 MEETING REPORT Date 9 January, 2014 Delegate Details For a multi person delegation please provide details of the head of delegation only. Name Position/Title Company Postal Address Address International Committee Details Prof Stewart Bryant Transfusion Medicine Specialist Australian Red Cross Blood Service P.O. Box 145 KELVIN GROVE QLD 4059 stewartbryant@optusnet.com.au ISO/TC 212 Clinical Laboratory Testing and In Vitro Diagnostic Test Systems Is this a: Technical Meeting or Governance Committee For example, ISO Council, IEC Council, IEC SMB WASPaLM Status Liaison Meeting Date and Venue Date to Venue Details WASPaLM Liaison Purpose of Meeting Attendees at the meeting Merchant Court Hotel, Singapore Prof Stewart Bryant The meeting was the annual plenary meeting of the committee. Meetings of Working Groups were held in conjunction. The meeting approves proposals and recommendations from the Working Groups which include progress reports, recommendations in respect to current documents and new work items. (details in agenda and reports. A detailed list of individual attendees has not yet been provided by the secretariat. However, as usual, delegates from a significant number of the P and O member countries were present.

2 Key items discussed Opening Plenary The publication of ISO 15189:2012 in November 2012 was noted with satisfaction. Liaison Activities (agenda Item 8) The chair and the secretariat reported that they believed that the liaison with other ISAO Committees was not as robust and productive as it should be in some cases. This issue also related to liaisons with NGOs. The secretariat reported that the input from many of these was negligible and efforts to improve the relationships were discussed.(resolutions , 340 & 351) Structure of TC212 and the Working Groups. (Agenda Item 9) At previous meetings this was discussed, with the proposition put forward that the Working Groups (WG) become sub-committees. Such a change was not necessary according to ISO rules, and indeed would impose a greater financial impost that was unsustainable. (See Resolution 341) Future of WG 4. (Agenda Item 9) The current remit of WG4 (Antimicrobial susceptibility testing) has always been somewhat anomalous as it was too specific. In addition there are a number of Approved and Proposed Work Items mainly related to nucleic acid testing that did not sit well with any of the existing WGs. It was therefore proposed, and agreed to (Resolution 341) that the remit of this WG become Medical laboratory examination procedures. The number of work items assigned to this WG are to be found in several resolutions. Proposal from EU SPIDIA Project and CEN/TC 140/WG3 (Agenda Item 10) There was much discussion of this proposal, not that there was not agreement that it was valid but where it would fit in the Work Program of the TC. The agreement to change the remit of WG4 (as above) provided a very acceptable environment to progress this project. (Resolutions 342, 358 & 359) Working Group 1 PWI Specimen procurement This document was progressed and will be sent around WG1 for comment. It was agreed that this document would be proposed as a Technical Report and not a Standard. To be further considered in May Revision of ISO Point of care testing (POCT) Requirements for quality and competence

3 An updated working draft document was agreed upon which is still broad enough to be used by laboratory supervised and non-laboratory supervised PoCT services. There will now only be one document and not Parts 1 and 2 as considered in London in May The draft will be sent for comment by mid-december 2013 with 3 months allowed for comments. Due to the timeframe another meeting has been scheduled for May 2014 to progress this document such that a CD (committee draft) can be released for broader comment. It is imperative NATA attend this meeting as the document needs support in allowing a broader scope to remain. To be further considered in May Revision of ISO/TS Reduction of error through risk management and continual improvement. A revised draft will be circulated by the drafting chair (Mike Noble) for comment. A number of working parties were convened to identify areas of greatest risk in different laboratory environments. Australia is to participate in these working parties (Andy Griffin and Stewart Bryant). To be further considered in May PWI Laboratory biorisk management system A PWI was prosed to draft an ISO CEN within WG1 for Laboratory biorisk management. This PWI will substantially utilise CWA 15793:2011. The objective of this CEN Workshop was to develop and promote the adoption of recognised standards for management of biological risks. Specifically, the objectives proposed will allow laboratories to: Establish a biosafety and biosecurity management system to minimise risk to employees, the community and the environment that may be exposed to biological materials as a consequence of its activities; Implement, maintain and continually improve biosafety and biosecurity management; Assure itself of conformance with its stated biosafety and biosecurity policy Demonstrate such conformance to others; Make a self-determination and declaration of conformance; Seek internationally recognised third party certification of its biosafety and biosecurity management system. (see Resolutions 344 & 345) Working Group 2 Project Report Measurement Uncertainty (Dr White, Project Lead)

4 Working draft of the document Practical Guide to Measurement Uncertainty was 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. It is planned to hold one or possibly two Project Team WebEx teleconferences early in 2014 with aim of completing revised draft by midyear. 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 Two project teams assigned to develop new draft for review at next formal WG meeting: Team 1: Consolidated Terms & Definitions chapter (A Quintenz - Project Lead, G White, R Wielgosz) Team 2: Further revisions to substantive text and figures (G Miller, Project Lead) 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 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 post-meeting, with goal of producing new draft for review at next meeting of WG2. The Project team tentatively plans to meet in March (location TBD) WG2 Recommendations to Plenary A number of recommendations were made to the closing plenary which were accepted:- Resolutions 343, 347, 349, 350 & 351. Next WG2 Meeting (s) (Tentative) l May Paris, France (at invitation of BioRad) l October in conjunction with next TC 212 Plenary - Toronto, Canada

5 WG4 Did not meet Closing Plenary A copy of the resolutions is appended to this report. At the discussion of the WG1 recommendation on the way forward for the PoCT document (ISO 22870). After a considerable period of time the TC agreed that the project should progress as recommended. No Resolution was necessary. Resolution 354 reflects the unanimous agreement that ISO 7610:1995 should be reviewed by ISO TC 67 with a liaison from TC212.

6 Other Observations/Comments The work achieved at this meeting was productive. However some intransigence on behalf of some attendees did not allow for as much progress on the PoCT document (ISO 22870) as was expected. The point of contention is that some countries wish this standard to apply only to PoCT activities controlled by medical laboratories. To some of the attendees this approach was strongly rejected because it appeared to be more related to restriction of trade rather that quality and competence of measurement. This restrictive approach flies in the face of the situation in many countries where some PoCT is not conducted under the umbrella of a traditional laboratory (and never will). An unscheduled meeting of Wg1 is required in May to further progress this to a Committee draft document. It is imperative to ensure the document remains broad enough to allow use by non-pathology services. It is likely some countries will try and stifle the progress made to date. Meeting: 19 th Meeting of ISO/TC 212, CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS Singapore, Singapore, 19 and 21 November 2013 Resolution 334 Description: Appointment of the Drafting Committee ISO/TC 212 appoints Dr. Claude Giroud (France) and Mr. John James (United Kingdom) to assist the Secretary with drafting the resolutions of the meeting. Resolution 335 Description: Summary of the Eighteenth Meeting of ISO/TC 212 ISO/TC 212 approves the summary of the eighteenth meeting of ISO/TC 212 held in Berlin, Germany on 22 and 24 August 2012 (circulated as document N299) with the following addition related to the revision of ISO 22870: Scope of the proposed deliverable: This standard gives specific requirements applicable to the performance of point of care testing. This standard also includes the principles of quality management as described in documents such as ISO Purpose and justification for the proposal There have been significant developments since ISO 22870:2006, in the type and provision of point of care (ie, near patient) testing. These developments were outlined by some stakeholders in the 3- year systematic review in 2009, and are becoming increasingly important. There is growth of "on demand"

7 testing for self- referred patients. In some countries, this testing, often outside the direct control and influence of medical laboratories, still has a bearing on the safety, treatment, and health of patients. Quality management documents such as ISO will provide the basis of a revised standard for point of care testing. Resolution 336 Description: Report of the Secretariat ISO/TC 212 accepts the 2013 Report of the Secretariat as provided (circulated as document N308). Resolution 337 Description: Reports of the Working Groups ISO/TC 212 accepts the reports of the working group convenors (circulated as documents N328, N329, N330, and N331) and extends thanks to the convenors for their continued commitment to the work programme of ISO/TC 212: WG1, Quality and competence in the medical laboratory (Mr John James, United Kingdom) WG2, Reference systems (Dr Neil Greenberg, United States) WG3, In vitro diagnostic products (Dr Claude Giroud, France) WG4, Antimicrobial susceptibility testing (Mr David Sterry for WG4) Resolution 338 Description: Reports of Liaison Organisations ISO/TC 212 acknowledges the reports of ISO/CASCO, ISO/REMCO, ILAC, World Health Organisation, ISO/TC 76, ISO TC 150/SC7, ISO/TC 176, and IEC/TC 66/MT10 (circulated as document N332), and extends its thanks for their ongoing collaborations with ISO/TC 212. Resolution 339 Description: Liaison with ISO/TC 276 Biotechnology ISO/TC 212 acknowledges and accepts the invitation to develop a liaison relationship with ISO/TC 276, authorizes the Secretariat to establish a liaison with ISO/TC 276, and appoints Dr Donald Powers as delegate to the inaugural meeting of ISO/TC 276. Resolution 340 Description: Liaison with AHWP and PAHWP ISO/TC 212 proposes establishing liaison relationships with Asian Harmonization Working Party (AHWP) and the Pan African Harmonization Working Party (PAHWP), and requests the Secretariat to extend invitations to these organizations to apply to ISO/CS for Category A liaison status. Resolution 341 Description: Technical Committee Structure ISO/TC 212 endorses the recommendation to maintain its current working group structure, including WG1, Quality and competence in the medical laboratory; WG2, Reference systems; and, WG3, In vitro diagnostic products. In addition, ISO/TC 212 endorses the recommendation for the expansion of WG4 to include all projects related to laboratory examination procedures, ie, WG4, Medical laboratory examination procedures. The structure will be adopted immediately following ISO/CS approval.

8 Resolution 342 Description: Convenorship of ISO/TC 212/WG4 ISO/TC 212 endorses the appointment of Dr Uwe Oelmüeller as the convenor of ISO/TC 212/WG4. Resolution 343 Description: Deputy Convenorship of ISO/TC 212/WG2 ISO/TC 212 endorses the appointment of Dr Graham White as the deputy convenor of ISO/TC 212/WG2. Resolution 344 Description: Laboratory biorisk management ISO/TC 212 agrees to the development of a preliminary work item by Working Group 1 based on the conversion of CWA 15793, Laboratory biorisk management, to an ISO deliverable (circulated as N326). Resolution 345 Description: Liaison with IFBA ISO/TC 212 proposes establishing a Category D liaison relationship with the International Federation of Biosafety Associations (IFBA) and other appropriate organizations, and requests the Secretariat to extend an invitation to the IFBA to apply to the ISO/TC 212 Secretariat for Category D liaison status with ISO/TC 212/WG1. Resolution 346 Description: Use of conformity and certification and management system standards as normative references The ISO/TC 212 Secretariat shall request clarification from the ISO Central Secretariat regarding the appropriate inclusion of conformity and certification and management system standards as normative references. Resolution 347 Description: Revision to Working Group 4 mission On the recommendation of Working Group 2, ISO/TC 212 agrees with the liaison of Working Group 2 with the newly defined Working Group 4 with respect to initiatives related to reference systems. Resolution 348 Description: Nucleic acid based in vitro diagnostics for the detection and identification of microbial pathogens On the recommendation of Working Group 1, ISO/TC 212 approves the circulation of Nucleic acid based in vitro diagnostics for the detection and identification of microbial pathogens Part 1 General requirements: Terms and definitions as a committee draft. Resolution 349 Description: Stakeholder workshop for ISO On the recommendation of Working Group 2, ISO/TC 212 agrees to support JCTLM's organization of 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 invite

9 proposals/ideas for revisions and improvements to ISO activity with JCTLM. Resolution 350 Description: PWI for Measurement Harmonization Protocols On the recommendation of Working Group 2, ISO/TC 212 agrees to progress the PWI for Measurement Harmonization Protocols with Dr Greg Miller (USA) as Project Lead. Resolution 351 Description: Registration of liaison groups The ISO/TC 212 Secretariat shall coordinate with the ISO Central Secretariat to ensure that all TC 212 liaisons are properly registered, not only with ISO/TC 212, but also with their respective participating Working Groups. Resolution 352 Description: DIS vote on ISO 17518, In vitro diagnostic medical devices Guidance for users of in vitro diagnostic reagents for staining in biology ISO/TC 212 approves ISO 17518, In vitro diagnostic medical devices Guidance for users of in vitro diagnostic reagents for staining in biology to proceed directly to TS (DIS) vote. Resolution 353 Description: Reports of the Working Groups ISO/TC 212 accepts the reports of Working Groups 1, 2, and 3 from their meetings. Working Group 4 did not meet in conjunction with the plenary. Resolution 354 Description: NWIP on colour coding for safety caps on evacuated receptacles ISO/TC 212 unanimously accepts the recommendation from ISO/TC 76 of a revision of ISO 6710:1995, Single- use containers for venous blood specimen collection, in ISO/TC 76 (Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use) including a liaison from TC 212, in order to include colour- coding recommendations (see N309). 19 P- member countries (Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Japan, Kenya, Netherlands, New Zealand, Saudi Arabia, Singapore, South Africa, South Korea, Sweden, United Kingdom, and United States) voted in favour of the recommendation. Resolution 355 Description: PWI on multiplex molecular analysis ISO/TC 212 agrees to development of a preliminary work item by Working Group 4 on In vitro diagnostic medical devices General requirements and definitions for multiplex molecular analysis: Evaluation method of nucleic acid quality (circulated as N311). Resolution 356 Description: PWI for nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens ISO/TC 212 agrees to the development of the following preliminary work item by Working Group 4: Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens Part 2: Quality practice guide (circulated as N312, N313, and N314, merged at the WG1 meeting).

10 Resolution 357 Description: PWI on traceability of measured values ISO/TC 212 agrees to the development of a preliminary work item by Working Group 2 on In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for traceability of measured values when using harmonized measurement procedures not supported by SI- traceable references (circulated as N315). Resolution 358 Description: Technical specifications developed through the EU SPIDIA project At the request of CEN/TC 140, ISO/TC 212 agrees to assume responsibility for the technical specifications for pre- examination processes developed through the EU SPIDIA standardisation project. These work items will be assigned to WG4 (see Resolution 359). Resolution 359 Description: PWIs for pre- examination processes ISO/TC 212 agrees to the development of preliminary work items by Working Group 4 for conversion of the following CEN Technical Specifications to ISO Technical Specifications upon completion of the CEN documents: Molecular in vitro diagnostic examinations Specifications for pre- examination processes for blood Circulating cell free DNA (circulated as N316) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for blood Genomic DNA (circulated as N317) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for blood Cellular RNA (circulated as N318) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for metabolomics in urine, serum and plasma (circulated as N319) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for frozen tissue RNA (circulated as N320) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for FFPE tissue RNA (circulated as N321) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for FFPE tissue Proteins (circulated as N322) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for frozen tissue RNA (circulated as N323) Molecular in vitro diagnostic examinations Specifications for pre- examination processes for frozen tissue Proteins (circulated as N324) Resolution 360 Description: PWI on clinical performance studies ISO/TC 212 agrees to the development of a preliminary work item by Working Group 3 on In vitro diagnostic medical devices Clinical performance studies involving specimens from human subjects Good study practice (circulated as N327). Resolution 361 Description: NWIP on colour coding of automatic lancets

11 On the recommendation of WG3, ISO/TC 212 agrees to reject PWI N310, Color- coding of automatic lancet devices, believing it more appropriately belongs to ISO/TC76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. (see N309). 19 P- member countries (Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Japan, Kenya, Netherlands, New Zealand, Saudi Arabia, Singapore, South Africa, South Korea, Sweden, United Kingdom, and United States) voted in favour of the recommendation. This will be communicated to ISO/TC 76. Resolution 362 Description: 2014 Meeting of ISO/TC 212 and subsequent meeting ISO/TC 212 gratefully accepts the invitation of Standards Council of Canada (SCC) to hold the 20 th meeting of ISO/TC 212 in Toronto on 15 and 17 October 2014, and acknowledges the tentative invitation of South African Bureau of Standards (SABS) to host the 21 st meeting as a provisional venue. Resolution 363 Description: Expression of thanks to host and sponsors ISO/TC 212 extends thanks to SPRING Singapore for hosting the meeting, and to the sponsors, Philips Healthcare, SGS, and TUV SUD PSB Singapore for providing funding to support the meeting.

Contact: Title: Resolutions of ISO/TC th plenary meeting held on in Tokyo (Japan) Source: TC secretariat. Project(s): Status:

Contact: Title: Resolutions of ISO/TC th plenary meeting held on in Tokyo (Japan) Source: TC secretariat. Project(s): Status: Date 2007-11-26 Supersedes document Reference number ISO/TC 224 N 360 This document is still under study and subject to change. It should not be used for reference purposes. ISO/TC 224 Title: Service activities