ISO compliant laboratory quality systems and incident monitoring improve the implementation of laboratory information systems

Abstract

Quality systems can provide a means of measuring the rate of occurrence of defined incidents and non-conformities. We have studied the application of laboratory quality systems to monitoring the implementation of laboratory information systems (LIS) in two similar size tertiary hospital pathology laboratories in Australia. At one site, one department implemented a quality system accredited to ISO 9001–1987 and ISO 9001–1994 while the rest of the organisation did not have a formal quality system; this site implemented the Cerner PathNet LIS. At the other site, the organisation was in the process of implementing ISO/IEC Guide 25–1990 and ISO/IEC 17025–1999; this site implemented the PJACC AUSLAB LIS. The rate of quality system incidents and non-conformities was used to track the progress of implementation of the LIS. We found that different quality systems appeared equally useful in monitoring the rate of occurrence of incidents. However, the presence of a formal quality system greatly improved the proportion of incidents that could be investigated and resolved at root cause level. Incident monitoring, as part of a formal quality system, proved to be a useful tool in monitoring and managing the implementation of these LIS.