1. Laboratory Information Management System Project Certification Request November 2007

2. Agenda Overview Of SLD Operations Modernization Of SLD
LIMS Definition And Project History
Current System
Proposed System
Benefits Of A Laboratory Information Management System (LIMS)
Security/System Architecture
Budget
Archive

3. SLD Overview
The Scientific Laboratory Division (SLD) is a component of the Department of Health. SLD provides primary and reference laboratory services to federal, state and local government agencies and to private entities.

4. SLD Performs 700,000 Tests Per Year
SLD Services
SLD Performs 700,000 Tests Per Year
Biology Bureau – Disease Testing For Humans, Animals And Food
Chemistry Bureau – Environmental Testing Of Air, Water, And Other Materials
Toxicology Bureau – Forensic Testing For Alcohol And Drugs

5. SLD Partners -- SLD has A Broad Impact Across The State
New Mexico Department Of Agriculture
NM Office Of The Medical Examiner
New Mexico Environment Department
Tribes Across New Mexico
Hospitals, Physicians And Private Labs
The Dairy Industry
Food and Drug Administration (FDA), Center For Disease Control (CDC), Environmental Protection Agency (EPA)
Federal, State and Local Law Enforcement
Governor’s DWI Initiative
-- SLD has A Broad Impact Across The State

6. Modernization of SLD SLD Will Break Ground In 2008 On A New Building:
- The Most Complex Building Ever Built By The State of New Mexico
- Total Budget of $90 Million
- 180,000 Thousand Square Feet
-- The LIMS Project Is The Workflow Process Component Of This Modernization

8. LIMS Definition
A Laboratory Information Management System (LIMS) Is A Workflow Data System That:
- Tracks Samples Across Entire Facility
- Case Management Tool For Every Section
- Generates Reports
- Collects And Stores QC data
- Improves Archiving And Security

9. Current Lab Information Systems
Mission Critical
A Collection Of Systems Relying On A Variety Of Technologies Including:
MS SQL
MS Excel
MS Access
-- Stand Alone Systems In Each Section

10. Issues With Current System
No Single View Of Lab Wide Workflow And Processes
Compliance With Federal Regulations Including HIPAA, & FDA
Compliance With Certifying Agencies Including ABFT, CLIA, EPA, SA, & AAVLD
Effort To Maintain Disparate Systems
Does Not Produce Needed QA Data
Lack Of Desired Business And Management Features
Inability To Transmit Results Electronically
Manual Process With Redundant Key Strokes

11. Benefits of New System
Maintaining Laboratory Certifications And Accreditations
Improved Data Quality
The Ability To Analyze Data Across All Areas Of The Lab
The Ability to Transmit Results Electronically
Greater Control Of Inventory And Customer Accounts
Faster More Secure, Transmittal Of Results To Customers

12. Project Timeline
Careful note to disparage Social Services Architecture Delay as it is expected that DoIT folks at table were part of that effort

13. Completed in FY06 Received $1M C2 Funding
Initial Phase Certification In December 2005
Launched Project
Planning And Creation Of Teams And Committees
IV&V Vendor On Board
Research
Spoke With 5 Other States Regarding LIMS Projects:
Requirements Definition Critical
As Is and To Be Workflow Diagrams Critical

14. Completed in FY07 & FY08 Creation of RFP Issued RFP
Detailed Requirements Created By Industry Expert
‘As Is’ And ‘To Be’ Workflow Diagrams
Issued RFP
Vendor Demonstrations And Selection Of Vendor
Price and Contract Negotiations
Project Management Documents Completed
IV&V Contractor On Board

15. Implementation Approach

16. Mid Level Architecture
The selected LIMS product can be deployed as a client/server or Citrix Metaframe application. The project chose the Citrix solution. Network latency is very important for adequate system response. Citrix solution helps mitigate this.
Minimum client workstation requirements are Windows 2000 Pro or Windows XP with 1.5 GHz processor, 256 MB RAM, 200 MB free hard drive space.
Internal clients will access the LIMS behind the DOH firewall. Clients will utilize the nFuse web client (Active X download for IE) to connect to the Citrix installation.
External clients will access the LIMS through an SSL VPN.
All LIMS traffic is encrypted using SSL over HTTP or HTTPS.

17. Security Diagram
LIMS accesses an LDAP server for two different reasons: to authenticate LIMS users to the application and to validate role assignment. You can choose to have authentication done through an LDAP server, either via a normal connection or one encrypted with SSL.
All of the LIMS information is kept in a database. The application server connects to the database server via ODBC.
There are two LIMS functions which involve or may involve security certificates.
The SSL connection between users' browsers and the LIMS web server involves a server certificate that must be trusted by the browsers.
LIMS may be configured to perform authentication to an LDAP server through an SSL connection, in which case LIMS must trust the LDAP server's certificate.

18. Business Continuity and Disaster Recovery Diagram
A hot site has not been determined yet for the redundant LIMS instance.
In the event of a production failure a manual switch can be enabled to connect users to the hot site with the redundant LIMS instance.
Log shipping and file replication will be evaluated to ensure that the redundant instance is in sync with the production instance of LIMS. This will be based upon SLD requirements.

19. Funding

20. Certifications Phases Amount Requested Major Deliverables Due Dates
Initiation:
$155,000
Detailed Product Requirements Document, Project Charter
9/05 - 6/06
Planning:
$253,925
RFP developed by LIMS Implementation Specialist, IV&V Reviews, As Is Workflow Diagrams, To Be Workflow Diagrams
7/06 - 3/07
Implementation
$591,075
RFP Issuance, Vendor Selection, Contract Negotiations, IV&V Periodic Reports
4/07 – 1/08
$879,986
Execute contract, System Implementation and User Acceptance, LIMS Implementation testing, IV&V Periodic Reports
2/08 – 7/09
Closeout:
DoIT Project Closure Report, Project Materials Archive, Closed Contract File
8/09

21. Budget By Category

22. Questions