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Division of Consolidated Laboratory Services Building a Framework for Success through Collaboration, Communication, and Commitment.

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1 Division of Consolidated Laboratory Services Building a Framework for Success through Collaboration, Communication, and Commitment

2 About DCLS The Virginia Division of Consolidated Laboratory Services (DCLS) is a Division of the Virginia Department of General Services (DGS) within the Secretary of Administration. The Virginia Division of Consolidated Laboratory Services (DCLS) is a Division of the Virginia Department of General Services (DGS) within the Secretary of Administration.Virginia Department of General ServicesVirginia Department of General Services Formed in 1972 and was the first consolidated lab in the nation. DCLS provides laboratory services for a wide variety of local, state and federal law enforcement, emergency response, health and environmental protection programs. Formed in 1972 and was the first consolidated lab in the nation. DCLS provides laboratory services for a wide variety of local, state and federal law enforcement, emergency response, health and environmental protection programs. Employs 229 full-time scientists and laboratory support staff. Employs 229 full-time scientists and laboratory support staff. Performs over 4 million tests a year to help ensure the safety and health of Virginia's citizens and the environment. Performs over 4 million tests a year to help ensure the 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.

3 About DCLS (Continued) One of 4 state public health laboratories initially selected and funded by the federal government to test human specimens for evidence of exposure to biological and chemical agents (i.e. anthrax). One of 4 state public health laboratories initially selected and funded by the federal government to test human specimens for evidence of exposure to biological and chemical agents (i.e. anthrax). First state in the nation to send Influenza test results to CDC using HL and nationally recognized data standards and vocabulary such as LOINC, SNOMED, and HL7. First state in the nation to send Influenza test results to CDC using HL and nationally recognized data standards and vocabulary such as 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 Preparedness Plan Key player in the Commonwealth’s Emergency Preparedness Plan

4 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

5 Why Focus on 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)

6 Analytical 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)

7 DCLS - Pre-9/11 Lab maintained various laboratory data in over 100 different access databases, one mainframe system, and an Oracle forms application. Lab maintained various laboratory data in over 100 different access databases, one mainframe system, and an Oracle forms application. Instrument and QC/QC data were maintained using paper log books. Instrument and QC/QC data were maintained using 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 enforced. Use of data and vocabulary standards were not enforced. Lack of system integration, both within DCLS and external to the organization. Lack of system integration, both within DCLS and external to the organization.

8 DCLS - Pre-9/11 (Continued) Inability to electronically share data across the Enterprise and/or with other public health partners. Inability to electronically share data across the Enterprise and/or with other public health partners. Wide spread use of multi-part paper-based forms for test orders and result reporting for specific test data (Over 40 forms were reviewed and consolidated into two test order formats in the new clinical LIMS). Wide spread use of multi-part paper-based forms for test orders and result reporting for specific test data (Over 40 forms were reviewed and consolidated into two test order formats in the new clinical LIMS). Significant manual data entry effort, which was labor intensive and error prone. Significant manual data entry effort, which was labor intensive and error prone. No ability to readily query data across the Enterprise. No ability to readily query data across the Enterprise.

9 Post 9/11 - Guiding Principles Align strategic plans with National IT initiatives (Public and Environmental Health and Emergency Preparedness and Response), Align strategic plans with National IT initiatives (Public and Environmental Health and Emergency Preparedness and Response), Actively engage in State and National initiatives to harmonize public health informatics, standardize electronic data exchange, improve message transport, and enhance security architectures Actively engage in State and National initiatives to harmonize public health informatics, standardize electronic data exchange, improve message transport, and enhance security architectures Develop comprehensive Laboratory Information Management systems that meet the 16 business processes as defined by Association of Public Health Laboratories (APHL). Develop comprehensive Laboratory Information Management systems that meet the 16 business processes as defined by Association of Public Health Laboratories (APHL).

10 Post 9/11 - Guiding Principles (Continued) Promote adoption of nationally recognized technologies, data standards, and coded value sets. Promote adoption of nationally recognized technologies, data standards, and coded value sets. Enhance the information supply chain through the expansion of web and e- messaging technologies. Enhance the information supply chain through the expansion of web and e- messaging technologies. Promote collaboration, interoperability and reusability of processes within DCLS and with other partner systems. Promote collaboration, interoperability and reusability of processes within DCLS and with other partner systems.

11 Overview of Major Applications At DCLS

12 LIMS Applications at DCLS LIMS Vendor = StarLims  Environmental LIMS (ENVLIMS)  Clinical/Micro LIMS (SUNRISE)  Newborn Screening LIMS (NBS)

13 Common Application Architecture Defined in the Department of General Services’ COOP plan, as mission critical applications. Defined in the Department of General Services’ COOP plan, as mission critical applications. Disaster Recovery CITRIX Farm located at DCLS, which allows lab to operate as an “island” in the event the data center is down. Disaster Recovery CITRIX Farm located at DCLS, which allows lab 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 encryption Applications 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 availability, with a no data loss configuration – migrating to 10G RAC Fall 2009 DBMS is Oracle 9i RAC – Databases are configured for high availability, with a no data loss configuration – migrating to 10G RAC Fall 2009

14 Presentation and business logic layers are stored in dictionary in the Oracle database Presentation and business logic layers are stored in dictionary in the Oracle database Application development language and tool-set is proprietary to the vendor, which is STARLIMS. Application development language and tool-set is proprietary to the vendor, which is STARLIMS. Application Security is role based with users having access to data based on business need. Application Security is role based with users having access to data based on business need. LIMS has been adopted and deployed by State public health labs in Maryland, North Carolina, West Virginia, Pennsylvania, and Tennessee, as well as, 20 other State PHL’s, including Indiana and California. Also used by the Centers for Disease Control and Prevention (CDC) as their primary LIMS system. LIMS has been adopted and deployed by State public health labs in Maryland, North Carolina, West Virginia, Pennsylvania, and Tennessee, as well as, 20 other State PHL’s, including Indiana and California. Also used by the Centers for Disease Control and Prevention (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 Architecture

15 Newborn 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.

16 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

17 Environmental LIMS (ENVLIMS) Repository for the analysis and reporting of inorganic chemicals, organic chemicals, radiation, metals, and bacterial contamination. Repository for the analysis and reporting of inorganic chemicals, organic chemicals, radiation, metals, and bacterial contamination. Performs analysis on over 800,000 samples annually, with one to many tests performed on each sample Performs analysis on over 800,000 samples annually, with one to many tests performed on each sample Heavily integrated with laboratory instrumentation and the chromatography data system. Heavily integrated with laboratory instrumentation and the chromatography data system. Total active users = 115 Total active users = 115 Adopted codes sets include: NELAC, STORET, SDWIS, UCOM, ISO, and ASTM Adopted codes sets include: NELAC, STORET, SDWIS, UCOM, ISO, and 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 and FDA Partner entities are VDH, VDACS, DEQ, law enforcement, EPA, DHS and FDA

18 Applications Used for Data Exchange

19 Data Exchange Applications Messaging Vendor = Orion Health Systems  Rhapsody  Symphonia Mapper

20 Orion 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.

21 Orion 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

22 Orion 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.

23 Messaging Requirements and/or Expectations with Various Federal Partners CDC CDC EPA EPA DHS DHS FBI FBI FDA FDA USDA USDA

24 Health IT Messaging Strategy Develop a sustainable architecture for lab data exchange for: Develop a sustainable architecture for lab data exchange for: HL7 Test Results from States to CDCHL7 Test Results from States to CDC HL7 Test Order and Test Result from State to StateHL7 Test Order and Test Result from State to State HL7 Test Order and Test Result between CDC and StatesHL7 Test Order and Test Result between CDC and States At minimum - adopt HL7 version 2.6At minimum - adopt HL7 version 2.6 HL7 Test orders and results exchange with Hospitals and RHIO’s HL7 Test orders and results exchange with Hospitals and RHIO’s Interoperability with EHR and Hospital LIS systems Interoperability with EHR and Hospital LIS systems

25 Current Messaging Capabilities Inbound – VDH (Non-HL7) Daily electronic lab orders from local health departments throughout the State Daily electronic lab orders from local health departments throughout the State Outbreak alert notifications Outbreak alert notifications HIV incident reporting HIV incident reporting Outbound – VDH (Non-HL7) Newborn Screening data Newborn Screening data TB Control information TB Control information Rabies Rabies HIV – Screening and incident reporting HIV – Screening and incident reporting Blood Lead Blood Lead Arbovirus Arbovirus Drinking Water results to Office of Water Programs Drinking Water results to Office of Water Programs Outbound – VDH (HL7) Influenza (Newly converted to HL7 2.5) Influenza (Newly converted to HL7 2.5)

26 Current Messaging Capabilities (Continued) Outbound – CDC Enterics (Non-HL7) Enterics (Non-HL7) Rabies (Non-HL7) Rabies (Non-HL7) Influenza Results (HL ) Influenza Results (HL )

27 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).

28 Challenges Lack of a sustainable funding model - Innovation, development, and deployment is still contingent upon grant sponsored partnerships with Federal and State agencies. Lack of a sustainable funding model - Innovation, development, and deployment is still contingent upon grant sponsored partnerships with Federal and State agencies. Difficult to promote interoperability when many public health partners and other State agencies maintain silo systems that do not adhere to data standards, coded value sets, nor are able to consume/generate electronic messages in an HL7 / XML format. Difficult to promote interoperability when many public health partners and other State agencies maintain silo systems that do not adhere to data standards, coded value sets, nor are able to consume/generate electronic messages in an HL7 / XML format. (i.e. influenza results to local health departments, State EPI using ELR format, CDC using ETOR format – all want something different – (HIE model and standards adoption would simplify this). 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, State EPI using ELR format, CDC using ETOR format – all want something different – (HIE model and standards adoption would simplify this).

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

30 Challenges (Continued) authentication and certificate management. - one credential authenticates to all partners. Current process is t oo cumbersome and expensive if left to each messaging partner to manage. Distributed model to facilitate message authentication and certificate management. - one credential authenticates to all partners. Current process is t oo cumbersome and expensive if left to each 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)

31 H1N1 – Storybook – May 2009 Week 1 - Lab Director in TX contacted VA State Lab and requested mutual assistance. Lab SMES’ worked with IT staff to develop an H1N1 Test specific workflow in the LIMS. Required LOINC and SNOMED codes were also added for H1N1 analysis and results reporting. Week 1 - Lab Director in TX contacted VA State Lab and requested mutual assistance. Lab SMES’ worked with IT staff to develop an H1N1 Test specific workflow in the LIMS. Required LOINC and SNOMED codes were also added for H1N1 analysis and results reporting. Week 2 –VA’s IT staff worked with TX lab to create HL7 compliant 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 generated an encrypted HL7 test result message and returned to TX through Route not Read hub in FL. Week 2 –VA’s IT staff worked with TX lab to create HL7 compliant 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 generated an encrypted HL7 test result message and returned to TX through Route not Read hub in FL. Week 3 –TX, VA and FL were ready to move forward with data exchange – Legal concerns arose because there was no State-to- State Data Exchange Agreement. (Escalated to Association of Public Health laboratories for assistance.) Week 3 –TX, VA and FL were ready to move forward with data exchange – Legal concerns arose because there was no State-to- State Data Exchange Agreement. (Escalated to Association of Public Health laboratories for assistance.) Week 4 –VA could not wait for signed data exchange agreement samples shipped from TX to VA. Samples were manually accessioned in LIMS. Results were reported to TX on paper. Week 4 –VA could not wait for signed data exchange agreement samples shipped from TX to VA. Samples were manually accessioned in LIMS. Results were reported to TX on paper. Eleven weeks later, a signed agreement was reached between TX and VA. Reality is a national/universal agreement is needed to facilitate emergency response and data exchange/sharing across jurisdictions. Eleven weeks later, a signed agreement was reached between TX and VA. Reality is a national/universal agreement is needed to facilitate emergency response and data exchange/sharing across jurisdictions.

32 Current 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)

33 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.

34 National Initiatives (Continued) - Federally-funded (HRSA) effort to develop implementation guidelines for standardized messaging (HL7 v2.3.1) for Newborn Screening sample submissions/results. National Newborn Screening and Genetics Resource Center and the Public Health Informatics Institute (PHII) Workgroup - Federally-funded (HRSA) effort to develop implementation guidelines for standardized messaging (HL7 v2.3.1) for Newborn Screening sample submissions/results.

35 Any Questions? Any Questions? Willie Andrews Willie Andrews Director Laboratory Operations Director Laboratory Operations Division of Consolidated Laboratory Services (DCLS) Division of Consolidated Laboratory Services (DCLS) Vickie Tyson Vickie Tyson IT Project Manager for DCLS IT Project Manager for DCLS DGS Information System Services DGS Information System Services


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