Compliance to specifications in an external quality assurance program: did new biological variation estimates of the European Federation of Laboratory Medicine (EFLM) affect the quality of laboratory results?

The results of external quality assurance schemes are evaluated against specifications generally based on biological variation (BV) data. This study was carried out to determine whether new BV values affected the level of compliance to specifications. Our secondary objective was to identify the conditions that would be compromised as a result of poor analytical performance in disease associated markers.