Year 2000 and the laboratory: embedded chips, algorithms and information systems

Electronic data handling is integral to the function of the modern laboratory. Laboratory automation and laboratory information management systems (LIMS) form part of a group of safety critical systems. Analytical inaccuracy could create misleading data, which may be reported to the clinician. This may result in one of two scenarios. An abnormal result may be incorrectly reported as normal, resulting in false reassurance and lack of therapeutic action. Alternatively an abnormal result may be reported when the true value is in fact normal. This may result in a treatment being administered inappropriately or treatment, such as an insulin dose, being incorrectly adjusted. The presence of a rogue result, which is unexpected, does not result in action when the patient is obviously well. The result is at variance with the clinical state of the patient and other test results. Here, the test will generally be repeated. In the intensive care unit or acute medical ward, biochemical tests are used for monitoring and management, Abnormal values are expected in these environments. Change from an abnormal to a normal value is considered indicative of successful treatment. On the coronary care unit, treatment decisions are made in response to test results. Hence, there is the potential for life threatening scenarios. System failure, which means the laboratory is unable to provide analytical services or the inability to retrieve patient data from the LIMS may also put patients at risk. The clinician will have to make treatment decisions without the benefit of current investigations or previous laboratory results.