Antenatal hepatitis b testing as a marker of quality performance of a laboratory

Abstract

Quality assurance programs (QAP) provide management with confidence in the accuracy and precision of results reported from their laboratory. Laboratory accreditation by National Association of Testing Authorities (NATA) ensures there are quality systems in place that relate to documentation of techniques and systems of checking processes as well as consistency of reporting accurate results. This overview of the last 2 years of Antenatal Hepatitis B Surface Antigen QAP identifies the common errors, both critical and less critical, while reflecting on the response of errant laboratories to improve their performance. Critical errors have an immediate impact on the patient and include false positive or negative results as well as transcriptions errors and mix-up of specimens (specimen reversal). Other errors, although they may not have an immediate impact on patient results, can still be viewed as a quality system failure and should be investigated with action taken to correct the error and avoid similar errors in future. Other common errors include incorrect cutoff values, incorrect units, expired kits and incorrect lot number information. The Antenatal Hepatitis B QAP covers screening assays for hepatitis B surface antigen, and associated supplemental and confirmatory assays. The importance of reporting these results correctly is paramount for the care of both the mother and infant and a false result, either positive or negative may result in inappropriate management of these patients.