Improving quality of transcutaneous bilirubin measurements: Value of in-house developed quality control

OBJECTIVES: Quality assurance (QA) plays an integral role in Point of Care Testing (POCT) programs. Quality control (QC) is an important QA program component to ensure high quality results and enhanced patient care. The measurement of transcutaneous bilirubin (TcB) in the POCT setting is an essential part of newborn care in Alberta, Canada. However, there is currently no available commercial QC material for TcB meters. An in-house developed QC material has been in use within a single TcB POCT program within Alberta. The objective of this study was to determine the performance of this QC material by other POCT staff and clinical end-users to assess whether its use could be expanded. DESIGN AND METHODS: Two levels of QC material were measured by POCT staff and clinical end-users across 12 different sites using the Dräger Jaundice Meter JM-103® and JM-105® meters. RESULTS: The performance of the QC material was acceptable when tested by POCT staff, was stable and reliable over time, and had an acceptable CV (≤8%). However, the data does not support use of the QC material by clinical end-users. CONCLUSIONS: The use of the QC material could be expanded into other TcB settings for use by POCT staff. Additional training and experience with the QC material by end-users is needed to facilitate QC use in the clinical setting.