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In modern clinical laboratory, high quality and efficiency of output are highly depending on the utilization on automation and computerization Jeffrey Geoffrey, 2008. The ancillary service on electronic reporting, electronic data capturing and instant data analysis cannot be achieved without the success in implementation of electronic laboratory information system.
A laboratory information system (LIS) has been evolved from simple system which designed to generate accurate reports to complete systems that can link with other modules, such as automated analyzing systems interface, for which provide a wide scope of functionality on laboratory service. It can provide laboratory specialist to manage and review large volume of data and support the QC requirement. The QC functions in tracking and reviewing data from all workstations and performing statistical analysis to ensure that the laboratory testing accuracy and precision are maintained at acceptable levels.
The automatic functions for repeat testing on the same sample for the same test, a different test, or different instrument, following an abnormal result or specific decision criteria can reduce the unintentional error. The blocking function prevents auto release of results based on flags for abnormal results, delta check failure, panic value, improbable results, and results failing user-defined criteria so as to provide a robust reporting (Dale, 2002). All these provide a patient care orientated and error free system.
Modern LIS provides digital photography, storage, cataloging, archiving, and dissemination of pathology images at the gross and microscopic levels, thus leads a saving in storage space and time for retrieving sample. Current data management system designs have progressed from a hardware-based approach to a software-based approach that incorporates middleware and/or process control software. The web base or three- tiers architecture design is dominated and service orientated architecture (SOA) is developing.
The exporting data to electronic health record extends the laboratory data reuse by personal health record for regional or distributed health care system.
In Hong Kong hospital authority, we have a local tailor made LIS named as ECpath, for which provides different module on microbiology, clinical chemistry, haematology, virology and anatomical pathology. It was three-tier architecture, involving PowderBuilder and Sybase technology.
In our microbiology laboratory, we have BactALERTÂ® automatic blood culture system, AmplicorÂ® PCR system and VidasÂ® for EIA virology tests. These provide a robust and continuous monitoring system so as to provide a consistent and precise data with shorten detection time for better patient care.
The automation of clinical laboratory is well developed. The robust and reproducibility provide a precise and consistent testing result. The necessary in validation, verification and quality assurance of automated analyzers is a must (Albert et al.,2009). The Clinical and Laboratory Standards Institute (CLSI) provides guidance for validation, verification, calibration, quality assurance, and quality control through standardized approaches to ensure good laboratory practice with the use of internal QC, external quality assessment and calibration.
The Westguard rule base decision support system provides a statistical evidence base quality control system for most of the automatic analyzer. The system either embedded in LIS or in the propriety middleware. These minimize the labor force on the maintaining and recording of data for the quality assurance system and provide an auto blocking capability for disqualified batch results with referring to internal QC standard.
For the newly developed automatic technology, the electronic data capturing provides a strong empirical study on correlation with gold standard method or across aged and new methodology. These can succeed unless the equipment is put in service for user verification.
The function of laboratory information system covers a wide range of function on pre-analytic, analytic and post-analytic stages.
In pre-analytic stage, the availability of computer physician order entry provides a test ordering from standardized menus and includes automatic confirmation of medical necessity for performing the test. The ordered test will automatically transfer from clinical management system to laboratory information system with clear laboratory location, time, date, and priority status. The capability to embedded decision support system on drug allergy or genetic disease such as G6PD through auto-alert or reminder, all these reduce the physicianâ€™s medication error upon order entry. The utilization of 1D or 2D barcode labeling as electronic identification on the patient, specimen container and the order, provide a reliable way for correct identification.
In analytic stage, the barcode labeled specimen provide an effective way for specimen tracking through scanning and automatic specimen identification through total laboratory automation.
The diversified application in different laboratory is capable. Clinical pathology modules support specimen collection and tracking, order entry, rule-based decision making, results reporting, and automated analyzer interface. Hematology modules have extra function on allowing manual differential count to be added, deleted, or masked to automated results. Immunology modules transmit data from enzyme-linked immunosorbent assay reader to LIS. Toxicology modules provide automatic rerunning of positive results, generate complex random drug testing schedules and produce utilization reports.
Microbiology modules allow the creation of antibiogram and recording observation. Transfusion modules provide automatic transfusion service including inventory, blood distribution and emergency release capabilities. Lastly, anatomical pathology modules provide patient histories, correlation rules and image storage.
The interfacing with automatic analyzer provides data review and QC management, automatic function for repeating test, adding test or blocking function with specific decision criteria.
The support of point of care test (POCT) allows capturing of data, creating and storing of records and generating of final result.
Finally the linkage of knowledge base system provides laboratory specialist to access the knowledge bases containing clinical, genetic and molecular information.
In post-analytic stage, it provides function on result reporting in formatting and communication via fax, email or internet. It also provides linkages to populate electronic health record or linkages to pharmacy database system for selection and management of medication, such that preventing medication errors.
Apart from these, other axially system for billing system, supplies management, patient safety and error reporting and public health surveillance are possible.
Upon data handling, the greater use of genetic testing increases the need for LIS applications that support cytogenetic and molecular diagnostic testing. Examples of such applications include increased capacity for data storage, ability to detect genetic rearrangements and other abnormalities associated with malignant disease and hereditary genetic abnormalities, and ability to access patient records that contain personal gene databank and family tree information.
Decision support, specimen tracking and automation of QA and QC documentation features also must accommodate the demands of genetic testing. In order to accomplish these goals, additional software applications and more sophisticated, high-speed computer processing capabilities are required.
The capability of data interoperability across difference LIS platform or different electronic health system, such as clinical management system is necessary. The implementation of laboratory terminology standard, example Logical Observation Identifiers Names and Codes (LOINC) created by Regenstrief Institute. The standardized laboratory test provides a foundation of data interoperability. The Health Level 7 message standards for electronic data connectivity provide a standard for direct connection of new auto-analyzer to LIS without middleware interfacing and effectively reduce the financial and development time on the installation of new technology and machine.
The standardized data provides information and building knowledge base for clinical decision support system to improve patient monitoring and medication.
The point of care test provides a home care plan for chronic illness patient, through the using of standardized data in standard message provides a remote health monitoring of the patients. All these further perspective is based on the combination of automation and computerization on pathology laboratory test.
In recent year, we have a revamp on the Hong Kong hospital authority LIS system, for which there will have a technically change of the three-tiers architecture design to Java base web base system and will provide an internet form system to distribute health care electronic health report (eHR) project. The laboratory data will be standardized with LOINC terminology with HL7 message standard for data interoperability. All these provide a milestone for new millennium health care structure.