S2E18 - Practical check list of the implementation of an instrument in your lab
Welcome to Ask Stago, The Podcast dedicated to provide expert answers to your expert questions in coagulation.
In today’s episode, our expert Pauline Vasselon, US & Projects Registration Coordinator within Stago Market Access team, will provide us the key steps to implement a new instrument in your laboratory.
Literature sources:
- ISO 15189 Medical laboratories — Requirements for quality and competence
- ISO 22870:2010 Intelligent transport systems — Devices to aid reverse manoeuvres — Extended-range backing aid systems (ERBA)
- CLSI Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition, CLSI document EP09c, Wayne PA, 2018.
- CLSI Evaluation of Precision of Quantitative Measurement Procedures, Approved guideline, 3rd Edition CLSI document EP05-A3, Wayne PA, 2014.
- CLSI Evaluation of Linearity of Quantitative Measurement Procedures, 2nd edition, CLSI document EP06, Wayne PA, 2020.
- CLSI Protocol for the Evaluation, Validation, and Implementation of Coagulometers, Approved Guideline, CLSI document H57-A, Wayne PA, 2008.
Related podcasts:
Uncertainty of measurement -
https://www.podcastics.com/podcast/episode/s2e12-demystifying-measurement-uncertainty-78471/
Manage lot conversion -
Manage your pre-analyticals -
Control the reference ranges of your method -
Manage HIL interferences -
Understand the sensitivity and specificity -
Calculate your MNPT -
Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.