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Laboratory Information Management Systems (LIMS)

Good Clinical Laboratory Practice

KEMRI-Wellcome Trust Research Programme

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

Rationale for LIMS

hardware, software, people, procedures

and data

Role of LIMS

To manage Data Work flow Changing business needs/processes Existing systems and improving where

required Resources QA/QC

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

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

Functions of LIMS

Patient focus Enable determination of patient

outcomes Integrate patient and specimen

information Support patient management and

care/treatment

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’

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

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

Examples

KIDMS

Reports

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

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)

Laboratory Responsibilities

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