News from the Biological Stain Commission No. 11

Abstract

The 11th issue of News from the Biological Stain Commission (BSC) provides our first impressions of the REACH and ECHA programs. We intend to give a more thorough account of what these important programs actually mean in later editions of News from the Biological Stain Commission. Under the heading of Regulatory Affairs, the Biological Stain Commission’s International Affairs Committee presents information from the opening session of the meeting of the International Standards Organization ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on 2-4 June 2010 in Seoul, Republic of Korea.

Key words::

• antimicrobial susceptibility testing
• clinical laboratory testing
• ECHA
• ISO/TC 212
• in vitro diagnostic test systems
• quality and competence in the medical laboratory
• REACH
• reference systems

Closing debate on the Working Group reports

The debate centered particularly on ways forward to complete the publication of TS 25680 Medical laboratories-calculation and expression of measurement uncertainty. Several options were suggested. These included: 1) publish the TS as it is with the input from WG 1, 2) re-vote on the changes, because one third of the changes were accepted with changes to the text, 3) WG 1 and WG 2 work together to resolve the issues and re-vote as a TR (Technical Report), 4) it was indicated that ISO/TC 69 has a document DIS 21748 – Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation, and that this document should be reviewed for comparison of content with TS 25680, and 5) CLSI document C51, Expression of measurement uncertainty in laboratory medicine should be included also for comparison. Finally, it was decided that WG 1 and WG 2 should work together on the assessment of these documents, possibly at a meeting. It was suggested that Dr. A. Kallner (SE), Chair of C51, be invited to the meeting. It was suggested further that the seven countries that provided very strong comments against TS 25680 should be involved also.