Robert D. Walla, Larry A. Hacker, Ph.D. Astrix Technology Group 1090 King Georges Post Rd Edison, NJ LIMS Selection In A Forensic Toxicology Laboratory

Abstract Commercial 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.

Abstract Undertaking 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 Upgrade Project Objectives Project 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 Database o Billing System

Stakeholder Groups  Laboratory Stakeholders o Sample Receiving o Sample Preparation o HPLC Lab o Mass Spectrometry o Color Testing Laboratory o Headspace Laboratory o Screening

Stakeholder Groups  Non-Laboratory Stakeholders o 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 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 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 Analysis

 Collect Detailed User Requirements  Iterative Process  Segment and Prioritize o Priority 1 – Critical To Work Process o Priority 2 – Improves Work Process o Priority 3 – Nice To Have  Decompose To Level 2-3 Requirements 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 Process

Request For Proposal  Developed From System Specifications  Sent To Pre-Qualified Vendors  Provide Information on Company, Product and Services  Develop Vendor Shortlist

Request For Proposal Components  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 Approach  Capture All User Requirements  Assures that the LIMS is selected based on Requirements not features  Consistent evaluation criteria applied to all products  Reduces the risk associated with the purchase of a LIMS

For More Information, contact: Astrix Technology Group 1090 King Georges Post Rd Suite 604 Edison, NJ