Transcript The Electronic Laboratory Notebook: Why Hasn't It Been

LIMS Selection In A Forensic Toxicology Laboratory
Robert D. Walla, Larry A. Hacker, Ph.D.
Astrix Technology Group
1090 King Georges Post Rd
Edison, NJ 08837
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




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
o
Medical Examiners Database
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
Requirements Analysis
Onsite Requirements Meetings
 Include All Stakeholder Groups
 User Focus Groups
 Story Boarding

Requirements Analysis



Collect Detailed User Requirements
Iterative Process
Segment and Prioritize
o
o
o

Priority 1 – Critical To Work Process
Priority 2 – Improves Work Process
Priority 3 – Nice To Have
Decompose To Level 2-3
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
Vendor Evaluation and Selection Process










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
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


Company Profile
o
Response To Solicitation
o
Industry Experience
o
References
o
Support Services
Cost Analysis
Compatibility
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 08837
732.661.0400
www.astrixsoftware.com