This presentation covers the "Individualized Quality Control Plan” (IQCP) implemented by The Centers for Medicare & Medicaid Services (CMS) on January 1, 2016. The guidance and concepts for IQCP are a ...

Sigma metrics constitute a quantitative approach that integrates bias, imprecision and total allowable error to evaluate the performance of clinical laboratory assays ...

This report is intended as a guide for laboratory professionals tasked with setting up a cell processing laboratory (CPL) to support a new hematopoietic stem cell transplant program; especially in a ...

Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...

The modern quality control (QC) laboratory has advanced significantly in the last 10 years. Fast forward to 2022 and the modern QC laboratory is testing highly complex drug products using a wide range ...