Division of Consolidated Laboratory Division of Consolidated Laboratory Services Services

Building a Framework for Success through Collaboration, Building a Framework for Success through Collaboration, Communication, and CommitmentCommunication, and Commitment

About DCLSAbout DCLS The Virginia Division of Consolidated Laboratory Services The Virginia Division of Consolidated Laboratory Services

(DCLS) is a Division of the (DCLS) is a Division of the Virginia Department of General ServicesVirginia Department of General Services (DGS) within the (DGS) within the Secretary of Administration. Secretary of Administration.

Formed in 1972 and was the first consolidated lab in the Formed in 1972 and was the first consolidated lab in the nation. DCLS provides laboratory services for a wide variety nation. DCLS provides laboratory services for a wide variety of local, state and federal law enforcement, emergency of local, state and federal law enforcement, emergency

response, health and environmental protection programs.response, health and environmental protection programs. Employs 229 full-time scientists and laboratory support Employs 229 full-time scientists and laboratory support

staff. staff.

Performs over 4 million tests a year to help ensure the Performs over 4 million tests a year to help ensure the safety and health of Virginia's citizens and the environment.safety and health of Virginia's citizens and the environment.

Accredits environmental laboratories (over 900 facilities) throughout the Commonwealth to ensure compliance with Virginia Regulations 1 VAC 30, Chapters 45 and 46 and VA Safe Drinking Water act.

About DCLS (Continued)About DCLS (Continued) One of 4 state public health laboratories initially One of 4 state public health laboratories initially

selected and funded by the federal government to selected and funded by the federal government to test human specimens for evidence of exposure to test human specimens for evidence of exposure to biological and chemical agents (i.e. anthrax).biological and chemical agents (i.e. anthrax).

First state in the nation to send Influenza test First state in the nation to send Influenza test results to CDC using HL7 2.3.1 and nationally results to CDC using HL7 2.3.1 and nationally recognized data standards and vocabulary such as recognized data standards and vocabulary such as LOINC, SNOMED, and HL7.LOINC, SNOMED, and HL7.

Performs testing on every infant born within the Commonwealth for twenty-eight metabolic and genetic disorders. (Approximately 120,000 infant samples per year)

Key player in the Commonwealth’s Emergency Key player in the Commonwealth’s Emergency Preparedness PlanPreparedness Plan

As the State Public Health Laboratory

Unique Functions• Uses systems that are specimen,

and not patient centric

• All Hazards testing and response

• Performs testing to detect emerging public health threats

• Provides State-to-State Mutual Assistance

• Performs Newborn screening testing

• Performs environmental analysis

Health Impacts• Population Health Management

• Commonwealth’s Emergency preparedness

• Surveillance, outbreak management, and treatment

• Surge and Pandemic Response

• Reduce infant mortality/ improve child health

• Safe drinking water, air….

Provides data for decision making

Why Focus on Why Focus on Laboratory Data?Laboratory Data?

Lab results are a factor in:

85% of clinical decisions

100% of disease detection, surveillance, and outbreak management and containment, and

100% of the action plans invoked in response to all-hazard events (BT, CT, and natural disasters)

Analytical Services Performed at DCLSAnalytical Services Performed at DCLS Newborn screening (PKU, Sickle Cell, CAH, MSUD,

MCAD…) Microbial Reference (TB, Pertussis, Bacti Reference) Immunology and Virology (H1N1, HIV, WNV, Rabies)

Enteric and Parisitology (e-Coli, Salmonella) Air, soil, and water Metals and Radiation Non-metal inorganic Commodities, motor fuels, organics, pesticides, lottery tickets Food, Feed, and Fertilizer All Hazards (Chemical, Biological, Natural Disaster)

DCLS - Pre-9/11DCLS - Pre-9/11 Lab maintained various laboratory data in over 100 Lab maintained various laboratory data in over 100

different access databases, one mainframe system, different access databases, one mainframe system, and an Oracle forms application.and an Oracle forms application.

Instrument and QC/QC data were maintained using Instrument and QC/QC data were maintained using paper log books.paper log books.

Used silo systems that did not share data.Used silo systems that did not share data.

Use of data and vocabulary standards were not Use of data and vocabulary standards were not enforced.enforced.

Lack of system integration, both within DCLS and Lack of system integration, both within DCLS and external to the organization.external to the organization.

DCLS - Pre-9/11 (Continued)DCLS - Pre-9/11 (Continued) Inability to electronically share data across the Inability to electronically share data across the

Enterprise and/or with other public health partners.Enterprise and/or with other public health partners.

Wide spread use of multi-part paper-based forms Wide spread use of multi-part paper-based forms for test orders and result reporting for specific test for test orders and result reporting for specific test data (Over 40 forms were reviewed and data (Over 40 forms were reviewed and consolidated into two test order formats in the new consolidated into two test order formats in the new clinical LIMS). clinical LIMS).

Significant manual data entry effort, which was Significant manual data entry effort, which was labor intensive and error prone.labor intensive and error prone.

No ability to readily query data across the No ability to readily query data across the Enterprise.Enterprise.

Post 9/11 - Guiding PrinciplesPost 9/11 - Guiding Principles Align strategic plans with National IT initiatives (Public and Align strategic plans with National IT initiatives (Public and

Environmental Health and Emergency Preparedness and Environmental Health and Emergency Preparedness and Response),Response),

Actively engage in State and National initiatives to Actively engage in State and National initiatives to harmonize public health informatics, standardize electronic harmonize public health informatics, standardize electronic data exchange, improve message transport, and enhance data exchange, improve message transport, and enhance security architectures security architectures

Develop comprehensive Laboratory Information Develop comprehensive Laboratory Information Management systems that meet the 16 business processes Management systems that meet the 16 business processes as defined by Association of Public Health Laboratories as defined by Association of Public Health Laboratories (APHL).(APHL).

Post 9/11 - Guiding Principles (Continued)Post 9/11 - Guiding Principles (Continued)

Promote adoption of nationally recognized Promote adoption of nationally recognized technologies, data standards, and coded technologies, data standards, and coded value sets.value sets.

Enhance the information supply chain Enhance the information supply chain through the expansion of web and e-through the expansion of web and e-messaging technologies.messaging technologies.

Promote collaboration, interoperability and Promote collaboration, interoperability and reusability of processes within DCLS and reusability of processes within DCLS and with other partner systems. with other partner systems.

Overview of Major Applications At DCLS

LIMS Applications at DCLSLIMS Applications at DCLS

LIMS Vendor = StarLims LIMS Vendor = StarLims

Environmental LIMS (ENVLIMS)Environmental LIMS (ENVLIMS) Clinical/Micro LIMS (SUNRISE)Clinical/Micro LIMS (SUNRISE) Newborn Screening LIMS (NBS)Newborn Screening LIMS (NBS)

Common Application ArchitectureCommon Application Architecture Defined in the Department of General Services’ COOP plan, as Defined in the Department of General Services’ COOP plan, as

mission critical applicationsmission critical applications. .

Disaster Recovery CITRIX Farm located at DCLS, which allows lab Disaster Recovery CITRIX Farm located at DCLS, which allows lab to operate as an “island” in the event the data center is down.to operate as an “island” in the event the data center is down.

Architecture is Client/Server (Three-Tier Technology) Architecture is Client/Server (Three-Tier Technology)

Applications are accessed through CITRIX using 128 bit encryptionApplications are accessed through CITRIX using 128 bit encryption

O/S is Windows Server 2003 O/S is Windows Server 2003

DBMS is Oracle 9i RAC – Databases are configured for high DBMS is Oracle 9i RAC – Databases are configured for high availability, with a no data loss configuration – availability, with a no data loss configuration – migrating to 10G migrating to 10G RAC Fall 2009RAC Fall 2009

Presentation and business logic layers are stored in dictionary in the Presentation and business logic layers are stored in dictionary in the Oracle databaseOracle database

Application development language and tool-set is proprietary to the Application development language and tool-set is proprietary to the vendor, which is STARLIMS.vendor, which is STARLIMS.

Application Security is role based with users having access to data Application Security is role based with users having access to data based on business need.based on business need.

LIMS has been adopted and deployed by State public health labs in LIMS has been adopted and deployed by State public health labs in Maryland, North Carolina, West Virginia, Pennsylvania, and Maryland, North Carolina, West Virginia, Pennsylvania, and TennesseeTennessee, as well as, 20 other State PHL’s, including , as well as, 20 other State PHL’s, including Indiana and Indiana and California. Also used by the Centers for Disease Control and California. Also used by the Centers for Disease Control and Prevention (CDC) as their primary LIMS systemPrevention (CDC) as their primary LIMS system..

Business Objects (Crystal) is used for paper-based reporting.Business Objects (Crystal) is used for paper-based reporting.

Common Application ArchitectureCommon Application Architecture

Newborn Screening SystemNewborn Screening System

Processes 120,000 infant samples annually, screening each for 28 different genetic or metabolic disorders.

Heavily integrated with laboratory instrumentation

LIMS is also used by the Virginia Department of Health (VDH), to monitor and record follow-up treatment for babies that have been diagnosed with a disorder. Data from the LIMS is exported to VDH’s VA Infant Screening and Infant Tracking System (VISITS).

Test results, along with treatment recommendations, are communicated daily to VDH Follow-up group, pediatricians, hospitals throughout Virginia, and various military bases around the world.

Total active users = 40.

Three State PHL’s use this LIMS to test newborn babies, including North Carolina and Maryland

Adopted codes sets include: UCOM, ISO, and ASTM - Will be implementing LOINC, Enzyme codes, and ICD-9.

Clinical and Micro LIMS (Sunrise) Used for managing, processing, and reporting analytical result data for public

health samples including, clinical, micro, food, biological, chemical, and animal samples.

Processes up to 500,000 samples annually, on which 1 million tests are performed.

Results reported daily to VDH, hospitals, physician offices, various state agencies, Office of the Chief Medical Examiner, and various law enforcement agencies.

Information used for outbreak management, disease detection and surveillance, pandemic response, emergency response preparation, and response to legal and forensics issues.

Heavily integrated with laboratory instrumentation.

Total active users = 100

Adopted codes sets include: LOINC, SNOMED, PHIN_VADS, HL7, UCOM, ISO, and ASTM

Messaging formats include HL7 v2.3.1 and HL7 v 2.5

Environmental LIMS (ENVLIMS)

Repository for the analysis and reporting of inorganic chemicals, Repository for the analysis and reporting of inorganic chemicals, organic chemicals, radiation, metals, and bacterial contamination. organic chemicals, radiation, metals, and bacterial contamination.

Performs analysis on over 800,000 samples annually, with one to Performs analysis on over 800,000 samples annually, with one to many tests performed on each samplemany tests performed on each sample

Heavily integrated with laboratory instrumentation and the Heavily integrated with laboratory instrumentation and the chromatography data system.chromatography data system.

Total active users = 115Total active users = 115

Adopted codes sets include: NELAC, STORET, SDWIS, UCOM, ISO, and Adopted codes sets include: NELAC, STORET, SDWIS, UCOM, ISO, and ASTM ASTM

Use standard messaging formats (i.e. EPA’s SDWIS XML schema 2.0)Use standard messaging formats (i.e. EPA’s SDWIS XML schema 2.0)

Partner entities are VDH, VDACS, DEQ, law enforcement, EPA, DHS Partner entities are VDH, VDACS, DEQ, law enforcement, EPA, DHS and FDAand FDA

Applications Used for Data ExchangeApplications Used for Data Exchange

Data Exchange ApplicationsData Exchange Applications

Messaging Vendor = Orion Health SystemsMessaging Vendor = Orion Health Systems

Rhapsody Rhapsody Symphonia MapperSymphonia Mapper

Orion RhapsodyOrion Rhapsody

Orion Rhapsody serves as the data integration engine and message broker. Although primarily used by hospital systems for HL7 messaging, it has a strong presence in public health agencies including the CDC.

Adopted and used by 2,500 Hospitals to message Biosense data with CDC and 45 State PHL’s and Health Depts. to report test results and notifiable disease data to CDC. Also used to deploy HL7 v3 messaging initiatives in Canada and the UK.

Modular and powerful: deploys OSGi framework; allows for customization through Java plug-ins and JavaScript filters; a handful of hospital systems routinely process over one million messages a day on a single Rhapsody server.

Orion RhapsodyOrion Rhapsody

Highly secure: supports SSL and TLS over HTTP, TCP, FTP, and other transmission protocols; supports XML encryption and signing; allows for structural and content validation of incoming messages.

Built-in functions include message validation for HL7 2.x, X.12, HIPAA, and XML messages; ability to map between messages; database connectivity for lookups and data manipulation; ability to generate PDF documents; can serve as a web service client and server

Orion SymphoniaOrion Symphonia

Orion’s Symphonia software is the mapping tool. Built-in libraries for HL7 2.x, X.12, and HIPAA provide for rapid development of message definitions. It also has an XSD generator to build definitions from XML documents.

Messaging Requirements and/or Messaging Requirements and/or Expectations with Various Expectations with Various

Federal PartnersFederal Partners

CDCCDC EPAEPA DHSDHS

FBI FBI FDAFDA USDAUSDA

Health IT Messaging StrategyHealth IT Messaging Strategy

Develop a sustainable architecture for lab Develop a sustainable architecture for lab data exchange for:data exchange for:• HL7 Test Results from States to CDC HL7 Test Results from States to CDC • HL7 Test Order and Test Result from State HL7 Test Order and Test Result from State

to State to State • HL7 Test Order and Test Result between HL7 Test Order and Test Result between

CDC and States CDC and States • At minimum - adopt HL7 version 2.6 At minimum - adopt HL7 version 2.6

HL7 Test orders and results exchange with HL7 Test orders and results exchange with Hospitals and RHIO’sHospitals and RHIO’s

Interoperability with EHR and Hospital LIS Interoperability with EHR and Hospital LIS systemssystems

Current Messaging CapabilitiesCurrent Messaging CapabilitiesInbound – VDH (Non-HL7)Inbound – VDH (Non-HL7) Daily electronic lab orders from local health Daily electronic lab orders from local health

departments throughout the Statedepartments throughout the State

Outbreak alert notifications Outbreak alert notifications

HIV incident reporting HIV incident reporting

Outbound – VDH (Non-HL7)Outbound – VDH (Non-HL7) Newborn Screening dataNewborn Screening data TB Control informationTB Control information RabiesRabies HIV – Screening and incident reportingHIV – Screening and incident reporting Blood LeadBlood Lead ArbovirusArbovirus Drinking Water results to Office of Water Drinking Water results to Office of Water

ProgramsPrograms

Outbound – VDH (HL7)Outbound – VDH (HL7) Influenza (Newly converted to HL7 2.5)Influenza (Newly converted to HL7 2.5)

Current Messaging Capabilities (Continued)Current Messaging Capabilities (Continued)

Outbound – CDCOutbound – CDC Enterics (Non-HL7)Enterics (Non-HL7) Rabies (Non-HL7)Rabies (Non-HL7) Influenza Results (HL7 2.3.1)Influenza Results (HL7 2.3.1)

In Progress….In Progress….Inbound Electronic test orders and results (HL7 2.6) – State-to-

State and State-to-CDC - In support of surge, pandemic, and emergency response. Pilot includes: H1N1, Salmonella, and B Anthracis data exchanges

Outbound Electronic Lab Reporting (HL7) to VDH NEDSS (National

Electronic Disease Surveillance System)– VDH interface with CDC will be in HL7. Pilot includes: Influenza, TB, and Enteric results reporting

Newborn Screening results (HL7)- Partnering with Augusta Regional and INOVA hospitals to pilot HL7 result reporting

Electronic Test Results to VDH for Lab orders placed by local health departments using WebVision (Non-HL7).

ChallengesChallenges Lack of a sustainable funding modelLack of a sustainable funding model - Innovation, - Innovation,

development, and deployment is still contingent upon grant development, and deployment is still contingent upon grant sponsored partnerships with Federal and State agencies.sponsored partnerships with Federal and State agencies.

Difficult to promote interoperability when many public health Difficult to promote interoperability when many public health partners and other State agencies maintain silo systemspartners and other State agencies maintain silo systems that that do not adhere to data standards, coded value sets, nor are do not adhere to data standards, coded value sets, nor are able to consume/generate electronic messages in an HL7 / able to consume/generate electronic messages in an HL7 / XML format.XML format.

Need to harmonize messaging formats – Issues with exchanging the same data to the same or multiple messaging partners, using different HL7 versions or in different file formats (i.e. influenza results to local health departments, (i.e. influenza results to local health departments, State EPI using ELR format, CDC using ETOR format – all State EPI using ELR format, CDC using ETOR format – all want something different – (HIE model and standards want something different – (HIE model and standards adoption would simplify this).adoption would simplify this).

Challenges (Continued)Challenges (Continued)

Lack of “trained / skilled” public health informatics workforce. Need to develop degree level programs with emphasis on the sciences, public health administration, and technology.

Operating in a fully transformed environment supported by VITA/NG partnership. (Lack of understanding of business needs and role of State PHL in Commonwealth’s Preparedness response and population health management)

Governance model to provide oversight and Governance model to provide oversight and enforceability enforceability of “approved” messaging formats (HL7, of “approved” messaging formats (HL7, XML, or CDA), data standards, and coded value sets for XML, or CDA), data standards, and coded value sets for electronic data exchange. Need vocabulary registry.electronic data exchange. Need vocabulary registry.

Challenges (Continued)Challenges (Continued)

Distributed model to facilitate message authentication and certificate authentication and certificate managementmanagement.. - one credential authenticates to all partners. - one credential authenticates to all partners. Current process is tCurrent process is too cumbersome and expensive if left to each oo cumbersome and expensive if left to each messaging partner to manage.messaging partner to manage.

Need for universal “Business Associate” agreements that facilitate data exchange across jurisdictions, states, and territorial borders. Too many variations in local, state, and national security and privacy regulations which hinder data exchange capabilities which are needed for national pandemic response.

(Example on next slide)

H1N1 – Storybook – May 2009H1N1 – Storybook – May 2009

Week 1 -Week 1 - Lab Director in TX contacted VA State Lab and requested Lab Director in TX contacted VA State Lab and requested mutual assistance. Lab SMES’ worked with IT staff to develop an mutual assistance. Lab SMES’ worked with IT staff to develop an H1N1 Test specific workflow in the LIMS. Required LOINC and H1N1 Test specific workflow in the LIMS. Required LOINC and SNOMED codes were also added for H1N1 analysis and results SNOMED codes were also added for H1N1 analysis and results reporting.reporting.

Week 2Week 2 –VA’s –VA’s IT staff worked with TX lab to create HL7 compliant IT staff worked with TX lab to create HL7 compliant test order/result messages. An encrypted HL7 test order message test order/result messages. An encrypted HL7 test order message was sent from TX to VA using the Route not Read Hub in FL. VA was sent from TX to VA using the Route not Read Hub in FL. VA generated an encrypted HL7 test result message and returned to TX generated an encrypted HL7 test result message and returned to TX through Route not Read hub in FL.through Route not Read hub in FL.

Week 3Week 3 –TX, VA and FL –TX, VA and FL were ready to move forward with data were ready to move forward with data exchange – Legal concerns arose because there was no State-to-State exchange – Legal concerns arose because there was no State-to-State Data Exchange Agreement. (Escalated to Association of Public Health Data Exchange Agreement. (Escalated to Association of Public Health laboratories for assistance.)laboratories for assistance.)

Week 4Week 4 –VA –VA could not wait for signed data exchange agreement - could not wait for signed data exchange agreement - 500 samples shipped from TX to VA. Samples were manually 500 samples shipped from TX to VA. Samples were manually accessioned in LIMS. Results were reported to TX on paper.accessioned in LIMS. Results were reported to TX on paper.

Eleven weeks later, a signed agreement was reached between TX and Eleven weeks later, a signed agreement was reached between TX and VA.VA. Reality is a national/universal agreement is needed to facilitate Reality is a national/universal agreement is needed to facilitate emergency response and data exchange/sharing across jurisdictions.emergency response and data exchange/sharing across jurisdictions.

Current National InitiativesCurrent National Initiatives Public Health Lab Interoperability Project (PHLIP) w/ CDC

and 6 partner states; focus is on Influenza data exchange; VA also acts as mentor state for new states enrolling in program

Electronic Test Orders and Results Workgroup (ETOR) – Tasked with developing message and encoding guidelines for PHL’s to exchange nationally notifiable disease data (State-to-State and State-to-CDC).

LIMSi Workgroup – Message exchange project with CDC for LRN-B and LRN-C. Pilot results for BT/CT samples.

Route not Read (RNR) – Partnered with Texas and Florida – Project sponsored by APHL - Building national/redundant gateways for public health message exchange (State-to-State and State-to-CDC)

National Initiatives (Continued)National Initiatives (Continued) APHL Informatics Committee – Willie Andrews, Director Lab

Operations, serves as Chairperson. Oversees technology and data standards used across LIMS systems (Labware, Open LIS, StarLims)

NEDSS Messaging User Group (NMUG) –Tasked with developing messaging and data standards for reporting notifiable disease and surveillance data to CDC.

StarLims User Group – Member State and Willie Andrews, Director Lab Operations, serves as Chairperson.

Rhapsody User group – Member State

Lab Community of Practice – (CoP) Members of core workgroup which partners with CDC and other public health labs to adopt standards for data exchange, and promote interoperability.

National Initiatives (Continued)National Initiatives (Continued)

National Newborn Screening and Genetics Resource Center and the Public Health Informatics Institute (PHII)

Workgroup - - Federally-funded (HRSA) effort to develop Federally-funded (HRSA) effort to develop implementation guidelines for standardized messaging implementation guidelines for standardized messaging (HL7 v2.3.1) for Newborn Screening sample (HL7 v2.3.1) for Newborn Screening sample submissions/results.submissions/results.

Any Questions?Any Questions?

Willie AndrewsWillie Andrews Willie.Andrews@dgs.Virginia.Gov Willie.Andrews@dgs.Virginia.Gov

Director Laboratory OperationsDirector Laboratory Operations

Division of Consolidated Laboratory Services (DCLS)Division of Consolidated Laboratory Services (DCLS)

Vickie TysonVickie Tyson Vickie.Tyson@dgs.Virginia.gov Vickie.Tyson@dgs.Virginia.gov

IT Project Manager for DCLSIT Project Manager for DCLS

DGS Information System ServicesDGS Information System Services