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Laboratory Information Management Systems (LIMS) Good Clinical Laboratory Practice KEMRI-Wellcome Trust Research Programme Laboratory Information Management Systems (LIMS) Good Clinical Laboratory Practice KEMRI-Wellcome Trust Research Programme

What is LIMS? o Computerized information management system designed for laboratories § § Manages What is LIMS? o Computerized information management system designed for laboratories § § Manages lab data from sample log-in to reporting Interfaces with analytical instruments Sorts and organizes data into various report formats Stores data for future reference and use

Rationale for LIMS hardware, software, people, procedures and data Rationale for LIMS hardware, software, people, procedures and data

Role of LIMS o To manage n n n Data Work flow Changing business Role of LIMS o To manage n n n Data Work flow Changing business needs/processes Existing systems and improving where required Resources QA/QC

Why have a LIMS? o Improve data management in lab to increase lab potential Why have a LIMS? o Improve data management in lab to increase lab potential o Enable centralization of information o Support and enhance business processes of the lab o Take advantage of new lab information technology o Provide easy access to data

Functions of LIMS o Track specimens from receipt, processing, testing, reporting to storage o Functions of LIMS o Track specimens from receipt, processing, testing, reporting to storage o Electronically capture results from lab diagnostic equipment and store with specimen details o Protocols and algorithms for testing and final result determination

Functions of LIMS o Patient focus o Enable determination of patient outcomes o Integrate Functions of LIMS o Patient focus o Enable determination of patient outcomes o Integrate patient and specimen information o Support patient management and care/treatment

LIMS decision o Type of lab n Reference/research/public health n Clinical n Hybrid o LIMS decision o Type of lab n Reference/research/public health n Clinical n Hybrid o Volume of specimens o Types and number of tests o Size of staff/users o Existing system n Determine which areas will be affected o Requirements and expectations n Avoid ‘culture shock’

Advantages of LIMS Use o Fewer transcription errors & faster processing with direct instrument Advantages of LIMS Use o Fewer transcription errors & faster processing with direct instrument uploads o Real time control of data quality with built in QC criteria o Direct report generation meeting specific client requirements o Direct electronic reporting to clients or direct client access to data

Disadvantages/Concerns o Customization of LIMS/interfaces required for specific lab/client needs o Adequate validation to Disadvantages/Concerns o Customization of LIMS/interfaces required for specific lab/client needs o Adequate validation to ensure data quality o Data integrity and confidentiality, especially when clients have direct access to data o Limited interface between lab & field computer systems

Examples KIDMS Examples KIDMS

Reports Reports

Information available on LIMS o Project, samples, tests documentation o Sample tracking history within Information available on LIMS o Project, samples, tests documentation o Sample tracking history within the Lab o Reporting results (hardcopy, electronic file) o Financial information by test, client, dates o Information on Productivity

Benefits of LIMS o It improves the efficiency hence productivity. o Improve data quality Benefits of LIMS o It improves the efficiency hence productivity. o Improve data quality (all instrument are integrated). o Saves time because the information is obtained at the snap of the button o Improve level of data access for all stakeholders of any project. o Automated customer reports (TAT, Work Load)

Laboratory Responsibilities o Evaluate LIMS capabilities o System validation/maintenance o Interfacing capabilities o Confidentiality/data Laboratory Responsibilities o Evaluate LIMS capabilities o System validation/maintenance o Interfacing capabilities o Confidentiality/data integrity protection o Regulatory compliance/accreditation.