Nearly 5 years ago, the U.S. Centers for Medicaid and Medicare Services (CMS) introduced a new option for laboratory quality control (QC) called the Individualized Quality Control Plan (IQCP). Laboratories could create an IQCP as an alternative to performing two levels of external QC per day of patient testing (default QC), as long as their risk assessment supported a longer QC interval and it complied with manufacturers’ instructions.

The catch? Equivalent quality control (EQC), an option that had been available since 2004, was being eliminated. EQC allowed labs to run external QC on a weekly or monthly basis for tests with built-in QC features, as long as the schedule met minimum manufacturers’ recommendations.

 

Under the new rules, which took effect in January 2016 after a 2-year educational period, labs needed to write an IQCP for every test that had been operating with EQC or perform default QC. Laboratory managers, particularly those in charge of point-of-care testing (POCT, were faced with the daunting task of conducting risk assessments and writing IQCPs for dozens or even hundreds of tests.  Read more >