There are several pieces of core functionality associated with the laboratory processing phases that tend to appear in most LIS or LIMS. A lab worker matches blood samples to documents. With an LIS, this sort of sample management is made more efficient.
Sample Function
The core function of LIMS or LIS has traditionally been the management of samples. This typically is initiated when a sample is received in the laboratory, at which point the sample will be registered in the LIS. Some LIS will allow the customer to place an “order” for a sample directly to the LIS at which point the sample is generated in an “unreceived” state.
Sample Processing
The processing could include a step where the sample container is registered and sent to the customer for the sample to be taken and then returned to the lab. The registration process may involve accessioning the sample and producing barcodes to affix to the sample container.
Various Parameters
Various other parameters such as clinical or phenotypic information corresponding with the sample are also often recorded. The LIS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of the shelf, rack, box, row, and column. Another event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may be required.
Expansive Capabilities
Modern LIS have implemented extensive reconfigurability, as each laboratory’s needs for tracking additional data points can vary widely. LIS vendors cannot typically make assumptions about what these data tracking needs are, and therefore, vendors must create LIS that are adaptable to individual environments.
LIS Compliance
LIS users may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP, and FDA specifications, affecting certain aspects of sample management in an LIS solution. One key to compliance with many of these standards is audit logging of all changes to LIS data, and in some cases, a full electronic signature system is required for rigorous tracking of field-level changes to LIS data.
Application Integration
Modern LIS offer an increasing amount of integration with laboratory instruments and applications. An LIS may create control files that are “fed” into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The LIS may then import instrument results files to extract data for quality control assessment of the operation of the sample.
