Iqcp istat verification#

Many of todayвЂ™s automated blood gas (ABG) instruments now have internal onboard QC. What qualifies as external quality controls vs.

Iqcp istat verification#

The laboratory must perform calibration verification at least twice per year, for documentation purposes, as well as whenever any of the following occurs: 1) after any major preventive maintenance 2) when critical parts affecting an instrumentвЂ™s performance are replaced 3) after the laboratory switches lot numbers on the reagents it used in conjunction with an instrument and 4) after the laboratory identifies an unusual trend or shift reflected in its control material, or results that fall outside of established acceptable limits. In addition to the daily QC requirement, the laboratory is also responsible for calibration verification for all non-waived вЂњmoderate to high-complexityвЂќ test systems. 1 The IQCP does not change this requirement. The minimum guidelines according to CLIA 88 (2003) require laboratories to perform external quality control at least one time per eight-hour shift. This article will cover the minimum requirements for use of external quality controls with regard to blood gas QC. There are many different aspects of the IQCP for laboratories to consider. All of the pre-analytical, analytical, and post-analytical systems requirements in the CLIA regulations will remain in effect. CLIA QC regulations will remain the same as published in 2003. The Centers for Medicare and Medicaid Services (CMS) has embraced a voluntary QC option for meeting CLIA quality control standards called Individualized Quality Control Plan (IQCP), which was implemented in January 2016 for all labs that have been utilizing Equivalent Quality Control (EQC). Quality Control (QC) and Quality Assurance (QA) in the clinical lab have changed.