Atelier du JCTLM-ICHCLR-IFCC: 'Overcoming challenges to global standardization of clinical laboratory testing: reference materials and regulations'

Location: Virtual sessions

Format: Two 2-hour discussion sessions on three separate topics with a final combined session to develop workshop recommendations

Organizing committee: Philippe Gillery, Christa Cobbaert, Greg Miller, Gary Myers, Joe Passarelli, Robert Wielgosz, Ian Young, Elvar Theodorsson.

Workshop goals

The workshop will develop and publish recommendations how the laboratory medicine community can address challenges related to reference materials and to country and region specific regulations to more effectively achieve standardized results on a global basis.

Achieving equivalent results in laboratory medicine is reliant in part on development and global availability of commutable certified reference materials. Ensuring such materials are available for more analytes is a key challenge, which when met will allow the application of fit-for-purpose calibration hierarchies to more end-user measuring systems.

Regulations to enable use of IVD devices differ between countries and regions and can be a challenge to implementing international standardization programs. This workshop focuses on the situation when recalibration of existing end-user measuring systems is needed to conform to internationally agreed standardization goals. Developing harmonized and simplified regulations for this situation will enable faster and less costly standardization of results to improve patient care and safety.

Session 1: What are the needs and logistical challenges for standardized results?

Virtual sessions for discussions and developing recommendations will be held on:

• December 6 at 5 pm - 7 pm; Paris time (CET, UTC+1).
• December 7 at 8 am - 10 am; Paris time (CET, UTC+1).

Background pre-recorded presentations available for consultation prior to discussion sessions will be:

1. Workshop overview and organization
   – Greg Miller, JCTLM Chairman
2. Introduction; workshop goals and outcome
   – Khosrow Adeli, President of the IFCC
3. Medical needs for standardized test results from laboratory measurement procedures
   – Andrea Rita Horvath, New South Wales Health Pathology, Prince of Wales Hospital, Sydney, Australia
4. What are the challenges to achieve standardized results?
   – Gary Myers, USA
5. How do IVD manufacturers implement metrological traceability?
   – Christian Vogl, Manager R&D Assay Development Bonemarker, Roche Diagnostics, Germany
6. What is the availability and suitability of matrix-based CRMs? An IVD industry view
   – Geoffrey Wilkins, Siemens Healthineers, USA

Session 2: What are the challenges for CRM producers?

Virtual sessions for discussions and developing recommendations will be held on:

• December 7 at 5 pm -7 pm; Paris time (CET, UTC+1).
• December 8 at 8 am -10 am; Paris time (CET, UTC+1).

Background pre-recorded presentations available for consultation prior to discussion sessions will be:

7. How to coordinate the effort among different NMIs to meet the needs of IVD manufacturers
   – Gavin O’Connor, PTB, Germany
8. How to bring IVD manufacturers into the process to develop commutable CRMs for use in calibration hierarchies according to ISO 17511
   – Liesbet Deprez, EU-JRC, Belgium
9. New metrological traceability tools; ISO 21151 harmonization protocol and IFCC recommendations for correction for non-commutability of matrix-based CRMs
   – Greg Miller, USA
10. How to prioritize needs for harmonization/standardization of measurands
    – Ian Young, United Kingdom

Session 3: What are the challenges to meet regulatory requirements in different countries or regions?

Virtual sessions for discussions and developing recommendations will be held on:

• December 8 at 5 pm - 7 pm; Paris time (CET, UTC+1).
• December 9 at 8 am - 10 am; Paris time (CET, UTC+1).

Background pre-recorded presentations available for consultation prior to discussion sessions will be:

11. EU regulations
    – Marta Carneilli, Technical Officer, TUV SUD, Germany
12. US FDA regulations
    – Marianela Perez-Torres, Acting Deputy Director Division of Chemistry and Toxicology Devices, FDA, USA
13. China CMDE regulations
    – Lv Yunfeng, Director of Clinical Evaluation and Biometrics Division II, Center for Medical Device Evaluation, China
14. IMDRF role in promoting collaboration in regulations
    – Petra Kaars-Wiele, Consultant, Germany

Session 4: Develop workshop recommendations for publication and follow up actions

The virtual session for discussions and developing recommendations will be held on:

• December 10 at 12 - 2 pm; Paris time (CET, UTC+1)