Quality in point-of-care testing.

Point-of-care testing (POCT) is an increasingly popular means of providing laboratory testing at or near to the site of patient care. POCT provides rapid results and has the potential to improve patient outcome from earlier treatment. However, a faster result is not necessarily an equivalent result to traditional, core laboratory testing. Preanalytic, analytic and postanalytic factors can influence the quality of POCT and lead to misinterpretation. Concerns over the quality of POCT have resulted in a hierarchy of laboratory regulations in the USA and POCT guidelines are appearing in a number of countries worldwide. Quality POCT must control every aspect of the test and testing process that can affect the ultimate result. Laboratory quality regulations are very similar to industrial quality requirements and POCT can be viewed like any manufacturing business where the product being produced is the test result. Use of industrial management techniques, such as failure mode and effects analysis, can be applied to POCT to isolate and reduce the sources of testing error. Data management is fundamental to quality. Analyzing POCT data can show quality trends before they affect the result. Newer POCT devices have computerized data capture and storage functions that can collect the key information at the time the test is performed and later transmit that data to a POCT data manager or hospital information system. Recent standards, such as the National Committee for Clinical Laboratory Standards POCT1-A, provide a connectivity standard to allow different POCT devices to share a common interface and data manager system, reducing the cost of implementing and maintaining POCT. Guaranteeing POCT quality is resource-intensive and as healthcare budgets get tighter and staffing shortages grow, patient outcome must be weighed against available resources to determine optimum testing strategies. Use of the POCT literature can help establish an evidence-based justification to support POCT.