robert d. walla, larry a. hacker, ph.d. astrix technology group 1090 king georges post rd edison, nj...

Robert D. Walla, Larry A. Hacker, Ph.D.Astrix Technology Group

1090 King Georges Post RdEdison, NJ 08837

LIMS Selection In A Forensic Toxicology Laboratory

AbstractAbstractCommercial Laboratory Information Management Systems (LIMS) have proven themselves as valuable information technology tools to the Analytical Laboratory Manager. There are over a hundred LIMS products commercially available. Many of these systems are capable of serving in a wide variety of laboratory environments while others are focused on a specific market such as forensic laboratories. The selection and implementation of the correct LIMS product is a crucial decision in order to obtain the quality and efficiency gains offered by implementing this technology.

 Unfortunately, the selection of a LIMS product is not always based on laboratory requirements but rather sales demonstrations or a cursory review of its functionality. This results in organization selecting the wrong LIMS that then requires extensive effort and resources to customize and implement. LIMS projects of this nature result in cost and schedule overruns or even cancellation of the project.

AbstractAbstractUndertaking a Laboratory Information Management System (LIMS) upgrade takes considerable resources that are often underestimated by the client. In addition to the obvious license and support costs, most commercial off the shelf (COTS) products will require customization and/or configuration to meet a client’s specific requirements and work flows. If these are not documented and compared to the base functionality of the COTS LIMS prior to the installation, it is unlikely that adequate resources will be allocated and the project will fall short of its objectives.

Forensic LIMS UpgradeForensic LIMS Upgrade Project ObjectivesProject Objectives

Purchase Of a COTS LIMS Support Both The Law Enforcement Division and Post

Mortem Division Integration Of Analytical Instruments Interface With Existing Data Systems

o Medical Examiners Databaseo Billing System

Stakeholder GroupsStakeholder Groups

Laboratory Stakeholderso Sample Receiving

o Sample Preparation

o HPLC Lab

o Mass Spectrometry

o Color Testing Laboratory

o Headspace Laboratory

o Screening

Stakeholder GroupsStakeholder Groups

Non-Laboratory Stakeholderso Quality Assurance

o Information Technology

o Lab Management

o Data Group

o Law Enforcement

o Medical Examiners

o Finance

“Implementing An Information Management System In A Laboratory Is Like Changing The Tires On A Car Traveling 100 mph”

— Author Unknown

LIMS Risk ComponentsLIMS Risk Components

60% of IT Projects Are Cancelled Prior To Implementation Many Systems Never Get Implemented Due To Functional,

Time and Budget Constraints Customization And Integration Requirements Underestimated Unrealistic Schedule And Budget Estimates Risk Management Plan Not Well Established No Formal Process In Place to Select and Implement LIMS

Astrix Technology Process ApproachAstrix Technology Process Approach

Business Case Preparation Collect and Organize User Requirements Development of Functional Specification Request For Proposal Evaluation of Vendor Responses (GAP Analysis) Configuration/Customization/Integration Validation And Testing Life Cycle Planning and Maintenance

Onsite Requirements Meetings Include All Stakeholder Groups User Focus Groups Story Boarding

Requirements AnalysisRequirements Analysis

Collect Detailed User Requirements Iterative Process Segment and Prioritize

o Priority 1 – Critical To Work Processo Priority 2 – Improves Work Processo Priority 3 – Nice To Have

Decompose To Level 2-3

Requirements AnalysisRequirements Analysis

Requirement Types

Functional Requirements Technical Requirements Security Requirements Regulatory Requirements Business Requirements

System Specifications

Description Of Processes and Procedures System Requirements Process Flow Diagrams Suggested Workflow Changes (if applicable)

Interface Design Report Design System Architecture System Topology Security Model

Standards and Tools

LIMS Selection Protocol

“Roadmap” Of the Selection and Evaluation Process Description Of Each Phase Define Roles and Responsibilities Evaluation Criteria Project Plan

Generate Request For Proposal (RFP) Distribution To Pre-Qualified Vendors Analysis of Vendor Responses Shortlist Vendors Vendor Demonstrations Demonstration Evaluation GAP Analysis Identify GAP’s That Are Showstoppers GAP Option Analysis Cost Analysis and Purchase

Vendor Evaluation and Selection Vendor Evaluation and Selection ProcessProcess

Request For Proposal

Developed From System Specifications Sent To Pre-Qualified Vendors Provide Information on Company, Product and

Services Develop Vendor Shortlist

Request For ProposalComponents

Business Overview Organizational Structure Work Process Descriptions Process Flow Diagrams Requirements Matrix Vendor Response Forms

Proposal Evaluation

Requirement Priority/Response Matrix Evaluation Conformance To Current Workflow Architecture/Topology Compatibility Company Profile

o Response To Solicitation

o Industry Experience

o References

o Support Services

Cost Analysis

Product Demonstration

Demonstrate How System Conforms To Requirements and Workflows Not A Sales Demonstration Standardize Demonstration Using Demonstration Scripts

o Outline Tasks To Be Performed

o Standard Demonstration Data

Demonstration Evaluation

Conformance To Test Scripts Scoring Criteria

Conforms Workaround Available

Non-Conformance

GAP Analysis

Evaluate GAPS Prioritize GAP Options Analysis

o Specifications

o Cost Analysis

Vendor Recommendation

Results Of Product Demonstration GAP Analysis Results Cost Analysis

LIMS Purchase

Contract Negotiations Payment Schedule Source Code Escrow Agreement Maintenance Agreement Warrantee

Benefits Of A Systematic ApproachBenefits Of A Systematic Approach

Capture All User RequirementsCapture All User Requirements Assures that the LIMS is selected based on Assures that the LIMS is selected based on

Requirements not featuresRequirements not features Consistent evaluation criteria applied to all Consistent evaluation criteria applied to all

productsproducts Reduces the risk associated with the purchase of a Reduces the risk associated with the purchase of a

LIMSLIMS

For More Information, contact:

Astrix Technology Group

1090 King Georges Post RdSuite 604Edison, NJ 08837732.661.0400www.astrixsoftware.com