On 14 October 2016, the Workshop “INTERPRETATION OF CRITICAL REQUIREMENTS OF ISO 15189-2012” was held at the University of Santiago de Chile (USACH)
and as a Video Conference sponsored by Physikalisch-Technische Bundesanstalt (PTB) and organized by USACH, Chilean Society of Clinical Chemistry (SCHQC)
and the Accreditation Division of the Chilean National Institute of Standardization (INN). The purpose was to harmonize the interpretation of the technical requirements of ISO 15189-2012.
The participants in this workshop were the Scientific Societies of Clinical Laboratories, the Accreditation Bodies and Metrological entities in each country in Latin America and the Caribbean region.
The speakers and moderators of the event from Chile, were Manfred Kindler, representing the PTB; Rosa Sierra Amor, IFCC EB Member; Stella Raymondo, Vice
President, COLABIOCLI; Carlos Rozas, USACH faculty; Maria Elena Arredondo, Vice president, SCHQC; Roberto Carboni, member of SCHQC and Cristina Herrera, National Institute of Standars (Insituto Nacional de Normalización), and coordinator of the working group of clinical laboratories of the InterAmerican Accreditation Cooperation (IAAC).
Coordination of the topics were performed on a web platform based on Moodle software (www.iso15189foro.org) with the Latin American videoconference rooms connected to the Chilean Universities Network (REUNA), which simultaneosly transmitted via Live Stream to everyone.
The workshop program focused on clauses reviewing the technical requirements of ISO 15189-2012: 5.4 pre examination processes; 5.5 Review processes;
5.6 Quality assurance of results; 5.7 post examination processes. A survey was sent to each country, and during the video conference they were addressed and discussed in more detailed by each country invited to suggest how to move forward. The workshop was held in four sessions during the day from 09h00-16h00.
The participant countries (15) in the live workshop were: Argentina, Barbados, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras,
Mexico, Paraguay, Peru, Uruguay and Venezuela. In each video conferencing venue, in addition to the participants of the discussion, professionals were also invited as observers. A total of 246 professionals attended. All of them received a certificate of remote attendance.
The enthusiastic participation, seriousness and commitment of each participant country in the region was noteworthy. The event was much more successful
than expected, although in the opinion of the participants a future event of this type will require at least 2 days. Interestingly, there was consensus in most of the topics, however, specific topics such as reference materials, traceability, amongst others will require further discussion.
This activity certainly complies with the essential objective, which was to generate positions and reach consensus on these complex issues, leading to the best interpretation and approach for three entities: clinical laboratories, accreditation bodies and metrology institutes.