Benefits of Developing an Individualized Quality Control Plan.

Abstract

A clinical laboratory can benefit from developing an individualized QC plan (IQCP)2 in many ways. This editorial will explore some of the lessons we learned from developing our IQCPs and the advantages of interacting with clinical staff through the IQCP process. The Centers for Medicaid and Medicare Services adopted changes to the Clinical Laboratory Improvements Amendments (CLIA) interpretive guidelines on January 1, 2016, that give clinical laboratories the option to perform a minimum of two concentrations of QC each day or develop an IQCP (1, 2). An IQCP allows the laboratory to reduce the frequency of QC to the minimum recommended by the manufacturer provided the laboratory has conducted a thorough risk assessment. IQCPs apply to CLIA non-waived tests. Sites conducting CLIA waived testing only need to follow manufacturer instructions and pay a biennial fee for renewal of their CLIA certificate. The Clinical and Laboratory Standards Institute approved the EP23-A guideline to help laboratories develop an IQCP (3). Many newer laboratory and point-of-care testing (POCT) instruments have built-in and manufacturer-engineered control processes, some conducted with each test, that can monitor the quality of the sample, the instrument, and the chemistry of the reactions, making external QC redundant. An IQCP allows a laboratory to balance external QC with the quality …