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Converging technology for focused training and mentorship

  • Faye Setzer, CLSI

Presented at 21st Annual HuQAS Scientific Conference

Purpose

The training and mentorship program is a critical component to not only ensuring quality laboratory outcomes, but also to reaching and maintaining accreditation to ISO 15189:2012. The gold standard is good clinical laboratory practice in Quality Management System (QMS) and Clinical and Laboratory Standards Institute (CLSI) is on the forefront of laboratory QMS training and mentorship programs in compliance with ISO 15189:2012 all over the world.

Method

CLSI utilizes an integrated programmatic approach to combine training and mentorship for maximum technical assistance support and outcome success. This process begins with QMS training whereby laboratory personnel participate in intensive training workshops aimed at bolstering the essential knowledge, skills, and abilities for implementing QMS within their own laboratories. Example training workshop topics include the following: Mentors’ Training, Internal Audit, Root Cause & Corrective Action, and Method Evaluation & Quality Control. Then, laboratories move into the gap assessment and mentorship program phase to review the adequacy of their laboratory QMS in compliance with the ISO 15189 standard. Thereafter, follow-up mentorships are conducted in a synergistic hybrid format, which leverages in-person and virtual gap assessments, training, and mentorships to address and appropriately close identified gaps. The use of a continuous, blended in-person and virtual technical assistance support methodology has expanded our ability to ensure QMS implementation and sustainability effectively and efficiently within our targeted laboratories and facilities. This hybrid mentorship approach has allowed us to be both present physically in the laboratory as well as guaranteed continued support through virtual mentorship, which has culminated in a more robust, comprehensive, and realistic technical assistance model. 

Even more markedly, the inclusion of virtual mentorship between site visits has also created a sense of ownership of the QMS process for laboratory management and staff as it offers continual support and creates an active and prominent role for the laboratory in addressing and solving all identified concerns and issues. When the virtual mentorship is combined with inperson mentorship, the resulting continuity has vastly improved the scale-up of laboratory strengthening initiatives by enhancing QMS implementation and sustainment as well as shortening the timeline to accreditation.