Implementing Laboratory Information Systems in Resourcelimited Settings

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Implementing Laboratory Information Systems in
Resource-limited Settings

• PHI2008
• Friday, September 19, 2008
• Robert Martin, MPH, DrPH
• Laboratory Science Officer
• Coordinating Office for Global Health
• Centers for Disease Control and Prevention

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Topics for This Session

• Drivers for LIMS development?
• Guidance Available to Countries
• Country Experiences
• Lessons Learned

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Bridging the gap LED-based Fluorescence
Microscope

• Low cost of ultra-bright LEDs
• Affordable price existing light microscopes
• Long lifespan ( 15-20,000 hours)
• Low power consumption
• Battery operated
• No need for air conditioning or dark room
• Decreased technician workload
• Diagnostic performance standard FM especially
  in high prevalence HIV settings

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High tech in low tech settings XpertTM MTB
GeneXpert
Automated Sample Prep, Amplification and
Detection lt120 minutes

• A technology platform
• TB Rif Resistance
• Potential for HIV viral load
• Potential for

Challenges downstream Meeting the target price
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Molecular meets Microscopy TB LAMP
LAMP demonstration at microscopy center in
Dharavi slum, Mumbai, India

• A technology platform
• TB
• Malaria
• HAT
• Potential for

Challenges upstream Reaching required
sensitivity simplicity
Challenges downstream Implementation of
disruptive technology Laboratory preparedness
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International Health Regulations (2005)

IHR(2005) adopted by all Member States and
entered into force on 15 June 2007 and fully
compliant by 2012
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INTERNATIONAL HEALTH REGULATIONS (2005)MAY 2
5, 2006

• The national public health system should
  establish the laboratory capacity to identify,
  monitor and report to the health authorities on
  agents that may cause epidemics and emergencies,
  including those of international importance (see
  WHA 58.3, Annex 2), in a safe, timely and
  reliable manner

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LIMS Support of Laboratory Practice

• Business Process Improvement
• Accessioning of specimens
• Generating daily worksheets
• Electronic data capture where possible
• Quality Assurance/Quality control
• Billing
• Results reporting
• Alerting
• Management reports
• Alerting

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Opportunities
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Guidance and Technical Assistance

• WHO
• CDC (PEPFAR Global AIDS Program)
• Association of Public Health Laboratories
• International Training and Education Center
  (ITEC)
• Universities (University of Washington, Harvard,
  University of Alabama)
• Clinical Laboratory Standards Institute
• Private Sector

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APHL /PEPFAR/Global AIDS Implementation Guide
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1. Form Working Group
2. Determine functional requirements at
typical sites

• Decide standard
• or rapid methodology

4. Define scope and needed resources
5. Develop RFP using HLR template
6. Distribute RFP and select provider
7. Negotiate provider contract
8. Initiate project, LIS changes, and system
validation
9. Deploy LIS and plan for next phases of
project
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Problem-No Standard Methods to collect and
distribute data
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Result Inaccessible lab data
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Tanzania
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Two-Phase Project

• Phase I
• Formation of LIS Teams
• Overall strengthening of lab processes and
  infrastructure including paper based system.
• Creation of LIS action plan to drive project
  schedule
• Selection, purchase and installation of hardware
• Phase II
• Selection, purchase and installation of LIS at
  four pilot sites

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Phase I Progress

• LIS Management Team and LIS Working Group
  Established
• LIS Requirements defined
• Paper Based Tools collaboratively developed
• Hardware Purchased/Installation
• Basic Computer training for pilot sites
• Full training curriculum for paper based tools
  developed
• Training of in-country training facilitators
• LIS RFP distributed- 5 candidates were selected
  to present at bidders conference

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Phase II Progress

• Bidders Conference hosted
• LIS vendor/product selected
• LIS customized to meet requirements
• Infrastructure gaps identified
• Needed hardware and services to support LIS
  identified, and procured (locally)
• In-country support for network and LIS as well as
  ongoing training procured
• In-country support team trained on LIS
• Documentation of System and User docs
• Basic and Super user training completed
• LIS LIVE in four sites as of June 2008!

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TanzanianPaper based LIS

• Standardized Investigation Request Forms
• Pre-printed specimen labels
• Unique Specimen ID numbers and procedures
• Pre-printed registers with standard headings
• General Lab Management Tools (QC/QA)
• Standardized Disease Reporting Tools
• Tools distributed nationally by Ministry

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TanzanianPaper based LIS strengthening

• Overview of Toolset

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Standardized Investigation Request Forms

• Replaces multiple lab specific forms
• Standardizes data captured

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Pre-printed specimen labels

• Reduces transcription errors
• Reduces transcription steps

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Standardized Specimen ID numbers and procedures

• Preprinted labels uniquely identifies specimen
• New process to ensure that request form,
  registers and specimen get a unique number to ID
  patient samples (name or VCT/PMTCT used now)

1.
2.
3.
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Pre-printed registers with standard headings

• Standardizes data captured reported
• Improves quality consistency of columns
• Reduces effort in laboratory

13 registers were created for project
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Modified Disease Reporting

• More frequent data capture
• Monthly aggregation of data
• Quarterly MOH reporting
• Tests headings match the registers

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Training

• 20 in-country facilitators
• Battery of training docs created
• PPT slide sets (9 modules of training)
• Overview of LIS in Tanzania
• Overall vision for electronic LIS in Tanzania
• Paper Based Strengthening Implementation
• Introduction to Paper Based Strengthening Tools
• Modified Paper Based LIS
• General Investigation Request Form
• Laboratory Registers
• Quarterly Laboratory Reporting Forms
• General Laboratory Management Tools
• Facilitator guides
• User guides

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Viet Nam
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The LIS Road Less Traveled

• APHL in collaboration with CDC Viet Nam
• and the Ministry of Health have deployed
• An Open Source LIS in Hanoi and HCMC.

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Utilizing an Open Source LIS

• Employ the technical expertise and IT
  infrastructure in Viet Nam
• Collaboration between Vietnamese development
  company and public health laboratories in the US
  (MN IA)

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Viet Nam Progress to Date

• OpenElis product selected for pilot
• OpenElis customized to meet Viet Nam needs
• Translation and localization of product
• Computers, and Network Infrastructure installed
• All Lab managers and users trained
• MOH staff actively helping to support lab staff
• New features requested by lab staff being
  developed
• Minor software release, mid March
• Major software release, Mid April

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In the Near Future

• Interface all major instruments with OpenElis
  product
• Evaluate the use of the system
• Expand the use of the system

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Lessons

• Must assure that quality of testing is addressed
• Must assure capacity to integrate all laboratory
  testing
• Engage end users early and often
• Must instill a sense of ownership and
  responsibility - LIS working group/technical
  working group
• Must have consultants and staff skilled in
  clinical and public health laboratory science as
  well as information system process expertise.
• Must keep end users expectations reasonable and
  keep scope of work in check