The Features and Functions included with the LIS must be designed specifically to support the physician office laboratory, providing sufficient functionality to support all laboratory data management from the least (e.g. a small number of CLIA-waived tests) to the most (multiple physicians and locations using a single POL, with multiple instruments and moderate complexity testing), but without being overly complex and difficult to use, since user qualifications tend to be less than those for reference, clinical trials, research and other lab-centric businesses. Therefore, scalability is important if it is to be a system that is useful over time as practices grow. Equally, it should not be limited in its support of types of testing.

It is important that the POL LIS helps the practice meet CLIA and other compliance standards, so that it may concentrate on its main mission of patient care rather than having to worry about the additional regulations involved in running a lab.

The LIS features and functions user requirement specifications here, transcluded from, represent those concerns, and map to relevant compliance standards. They are presented by general areas of functionality.


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