by BARRY CRAIG
Q: What would you consider the top 5 criteria for someone choosing a chemistry analyzer for a POL running tests for 5-10 family practice or internal medicine providers? In working on this process I've been comparing the CV's for Proficiency testing for analytes on two systems. One is a system that has hundreds of sites; the other has fewer than 20 in their peer group. Do CV values become more significant with bigger peer groups?
by TERESA A. SCOTT, MT(ASCP)
According to the CLIA regulations, “laboratories eligible for a certificate of waiver must follow manufacturers' instructions for performing the test.” This is also a requirement for non-waived testing. Many people think that they are fulfilling this requirement if they follow the step-by-step procedure for the test process included in the instructions. However, there is much more involved than just following the procedural steps.
Manufacturer’s instructions are found in instrument operator’s manuals and in package inserts; however, this article focuses on the instructions found in package inserts. In addition to the procedural steps, the package inserts include information and instructions for