External quality assurance (EQA) provides ongoing evaluation to verify that laboratory medicine results conform to quality standards expected for patient care. While attention has focused predominantly on test accuracy, the diagnostic phases, consisting of pre- and post-laboratory phases of testing, have thus far lagged in the development of an appropriate diagnostic-phase EQA program. One of the challenges faced by Australian EQA has been a lack of standardisation or "harmonisation" resulting from variations in reporting between different laboratory medicine providers. This may introduce interpretation errors and misunderstanding of results by clinicians, resulting in a threat to patient safety. While initiatives such as the Australian Pathology Information, Terminology and Units Standardisation (PITUS) program have produced Standards for Pathology Informatics in Australia (SPIA), conformity to these requires regular monitoring to maintain integrity of data between sending (laboratory medicine providers) and receiving (physicians, MyHealth Record, registries) organisations' systems. The PITUS 16 Informatics EQA (IEQA) Project together with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) has created a system to perform quality assurance on the electronic laboratory message when the laboratory sends a result back to the EQA provider. The purpose of this study was to perform a small scale pilot implementation of an IEQA protocol, which was performed to test the suitability of the system to check compliance of existing Health Level-7 (HL7 v2.4) reporting standards localised and constrained by the RCPA SPIA. Here, we present key milestones from the implementation, including: (1) software development, (2) installation, and verification of the system and communication services, (3) implementation of the IEQA program and compliance testing of the received HL7 v2.4 report messages, (4) compilation of a draft Informatics Program Survey Report for each laboratory and (5) review consisting of presentation of a report showing the compliance checking tool to each participating laboratory.
Available for download on Wednesday, September 11, 2019