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

3. What is LIMS?  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

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

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

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

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

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

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

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

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

12. Examples KIDMS

16. Reports

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

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

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