Laboratory Information Management Systems

Laboratory Information

• The sole product of any laboratory, serving any purpose, in any industry, is information

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Laboratory Informatics Defined

• The specialized application of information technology to optimize and extend laboratory operations

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Data Flow in the Laboratory

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Lab Automation& Robotics

EquipmentInterfacing

LaboratoryInstruments

ChromatographyData Systems

Laboratory InformationManagement

Systems (LIMS)

DataAnalysis

DataMining

DataWarehousing

ElectronicLaboratoryNotebooks

Data Acquisition Information Processing Knowledge Management

Functional Hierarchyin Laboratory Informatics

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rules

rules

context

people

LIMS

Basic Concept of LIMS• Laboratory Information Management System• Definition: A collection of computerized methods

to acquire, analyze, store, and report laboratory data

• No “standard” LIMS– Developed– Customized– Configured

• LIMS are various because client labs are highly diverse– Analytical– Clinical– Environmental– Production

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Origin of LIMS

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SampleLabeling Job

Assignment ProgressTracking

ResultsEntryResults

VerificationReporting

IN

OUT

Facilitation of Routine Laboratory Operations

SampleLabeling Job

Assignment ProgressTracking

ResultsEntryResults

VerificationReporting

Modern Lab Workflow

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New ProjectPage

New StudyPage

Project/Study Maintenance

Basis of study may be multspecies:

PatientBloodTissue

Cellular BasedCell type

Sample BasedSample Type

AddSamples

Add tests

AssignTests/work

Project Manager/Owner

AssignWorkMgmt

AssignWorkMgmt

Sample Handling Manager/Owner

Activate/AssignTests/Work

Test DataEntry

Test ResultsPreview

Gel Makeand Load Pass

Sample Management

Samples may be:

SubmissionsCustomerInternal

Librariestypically internal

Requestsspecific samp type

AddSamples

ReceiveSamples

FindSamples

RequestSamples

UpdateStatus

SampleType

Tissue

Blood

Synth

Serum

OtherSoluble

ProteinProduction

Gel ImagePreview

Pass

Protein Sample Manager/Owner

ReadySamples

SamplePrep/Dilute

SelectTreatment

Fractionate

PerformTreatment

Make andLoad 1D

Gel

Select 2DGels type

and transfer

Run 1D andTreatmentSelection

Run 2D gelsand set

notification

Image Analysis Manager/Owner

Acquire GelImages inProgeneraGel Staining

AcquireGlobal Spot

List

SapphireSync

AcquireDifferentialSpot List

MS Prep Manager/Owner

Spot List toPAA

New SpotPlate

Created

SpotDigestion

Maldi SpotLoad

Run Maldi

MS and PID Search Manager/Owner

Get MS filefor each

SpotSearch MS

Ident peptidesand protein(s)

Store SpotPlate

View MS

IN

OU

T

Universal Need for LIMS

• Regardless of focus, all labs need:– Quality assurance and control– Error reduction– Fast sample turnaround– Management of information

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Increasing Need for LIMS:Information Management

• Advances in instrument automation– Robotics for sample processing– Microarray technology

http://www.dnalc.org/resources/3d/26-microarray.html

• Increased government regulations• Demands of enterprise resource planning

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Increasing Need for LIMS:Quality Assurance & Control

• Quality assurance (QA)• Quality control (QC)• Statistical process control (SPC)• ISO 9000

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Increasing Need for LIMS:Error Reduction

• Data entry restriction– Acceptable parameters– Drop-down lists

• Range checking– Customer specifications– Internal controls

• Sample log-in– Bar code reader

• Automatic calculations12

Increasing Need for LIMS:Sample Turnaround

• Automated data entry• Automatic calculations• Rapid data retrieval• Automatic reporting• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2282400/

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Types of DataUsed in LIMS

• Alphanumeric• Descriptive• Limits• Numeric

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Types of LaboratoriesUsing LIMS

• Research & Development labs• Analytical labs• Manufacturing labs

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Research & Development Laboratories

• Objective– Support pure or applied research

• Characteristics– Small, autonomous– Diverse, non-routine tests– Low sample volume– Flexible operations– High internal security– Low, circumscribed data flow

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LIMS requirements forResearch & Development Labs

• Flexibility– Sample types, tests, methods, reports

• Traceability– Audit trails, on-the-fly notation

• Security– Very limited access, but with lateral authorization

• Time– Usually not an issue

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Analytical Laboratories

• Objective– Provide a service (information)

• Characteristics– Large, organization-dependent– Routine tests– High sample volume– Client-driven operations– High, narrow data flow

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LIMS Requirements for Analytical Labs

• Tracking– Samples, orders, reports

• Scheduling– Tests, equipment maintenance

• Quality assurance– Validation

• Data access and sharing– Instrument interfacing– Client-centered reporting

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Manufacturing Laboratories

• Objective– Assure product specifications– Statistical process control

• Characteristics– Ongoing testing: raw materials, process, final

product, stability– Dynamic, demanding environment– High, wide data flow– Fast turnaround

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LIMS Requirements for Manufacturing Labs

• Rapid sample turnaround– Automation, bar-code entry

• Connectivity– Manufacturing resource planning (MRP)– Enterprise resource planning (ERP)– Customer relationship management (CRM)

• Statistical analysis– Statistical process control

• Flexible reporting– Diverse information demands

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Functional Model of LIMS

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CB

data capturesyste

ms mgt

A

data

ana

lysi

slab m

gtreporting

DBMS

Data Capture

• Sample identification– Log-In, reading, labeling

• Work scheduling– Test initiation, test assignment

• Data acquisition– Interfacing, instrument control

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Data Analysis

• Data transfer– Buffer tapping, file transfer

• Data processing– Conversion, reduction, specification review,

statistical analysis

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Reporting

• Client-centered reports• User-defined reports• Automated batch reports• Tabular and graphical formats• Ad hoc queries• Event triggers• Exportation to external IS

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Lab Management

• Work scheduling• Sample tracking• Job tracking• Standard Operating Protocols (SOP)• Pricing and invoicing• Cost analysis

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Systems Management

• Security– External: unauthorized access– Internal: data sabotage

• Data archiving– Mirroring– Off-loading

• Data warehousing– Long-term storage– Far-off retrieval

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Enterprise-ScaleInformation Management

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Research &Development

Manufacturing

QualityControl

ProductSupport

RegulatoryAffairs

RawMaterials

CustomerService

QualityAssurance

Laboratory

LIMS Functionality

Examples using Labware™ LIMS

Configuring for Each User

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Labeling Samples

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Maintaining Instruments

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Configuring Test Components

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Assigning Tests for Samples

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Scheduling Tests

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Acquiring Data

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Capturing Data

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Setting Result Responses

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Reviewing Sample Status

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Reviewing Results

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Performing Quality Control

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Using Statistical Process Control

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Analyzing Laboratory Operations

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Submitting Reports

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