GEM 5000 CAP Competency Assessment
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Hello, I am wanting information on how others meet the standard " Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples". When competing the 6,12 month and annual competency, what materials do you use? If you make up samples, how do you establish acceptable results? How many samples do you observe them perform? Thanks Stephen
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We don't use the GEM 5000. For our POC gas platform, RP500, we use external QC and have them run it as internal blind sample. It is clearly defined in our policy what materials are used for competency and what the acceptable results would be. In this case it is Complete Level 1, 2 or 3 with acceptability that falls within the established 2SD from the manufacturers QC package insert.