Quality Control and Quality Assurance

Abstract

Upon receiving news that results of a chromosome analysis are abnormal (and even sometimes that they are normal), a patient will frequently ask, “How do I know that the lab didn’t make a mistake? How do I know that the sample they reported on was really mine? How can I be certain that this is all correct?” Most would be surprised to learn of the myriad of checks and balances that exist. Practice standards (American College of Medical Genetics [ACMG], 2003) based on the consensus of professionals and common sense are the basis for oversight by regulatory agencies, to prevent clinical and clerical errors. These comprise the area of laboratory medicine known as quality assurance and quality control (QA/QC). These are supplemented by both total quality management (TQM) and complete quality improvement (CQI) programs that seek to minimize errors where the laboratory interfaces to referring physicians and their patients.