Maine HETL Lessons Learned with Environmental/Chemical LIMS Implementation and Data Exchange

1. Maine HETL Lessons Learned with Environmental/Chemical LIMSImplementation and Data Exchange Jack Krueger, Chief, Maine Health and Environmental Testing Laboratory (HETL) Division of Public Health Systems Maine CDC & P Maine HETL

2. This Session Will Provide An Overview Of Data Exchange Associated With Environmental/Chemical Laboratory Homeland Security Information. Also, Provide Some Examples of the Technology and Terminology Used by Lab Managers to Integrate Their Lab Into the National Laboratory Response Networks for ALL-Hazards Maine HETL

3. Laboratory Data Component of Homeland Security Goal: To develop and implement an electronic data flow directly from laboratories to multiple homeland security agencies Maine HETL

4. Components of this Goal • Connectivity for a national network of laboratories, including public and private laboratories at the federal, state, and local levels • Establish a laboratory network to meet testing needs for threats to public safety • Support response to threats by conducting analyses and providing high quality, timely results. Maine HETL

5. Why Laboratory Data Exchange? • The exchange of Laboratory Data within the state, to other states, and to federal entities provides critical surveillance data • There are many data exchanges, few are interoperable to multiple federal agencies • As an example: An interoperable data exchange aligns with HSPD 9 Maine HETL

6. HSPD 9 • Homeland Security Presidential Directive 9 (HSPD 9) directs EPA to: • “develop robust, comprehensive, and fully coordinated surveillance and monitoring systems . . . for . . . water quality that provide early detection and awareness of disease, pest, or poisonous agents” • “develop nationwide laboratory networks for . . . water quality that integrate existing Federal and State laboratory resources, are interconnected, and utilize standardized diagnostic protocols and procedures” Maine HETL

7. There are many Networks: As an example, for a Food Related Event here is a Potential Concern: • If it’s the Ketchup, Mayo, Bun send the data to FDA • If it’s the Hamburger or Lettuce send the data to USDA • Did someone eat it? Test it at the Public Health Lab and report to CDC/State EPI • Was the Food Contaminated due to Environmental Concerns: Send the Data to the EPA Maine HETL

8. Networks/Messages • LRN (Laboratory Response Network –BT and CT), FERN (Food Emergency Response Network), NAHLN (National Animal Health Lab Network), eLRN (Environmental Lab Response Network), NPDN (National Plant Diagnostic Network) • Messages-HL-7, CDX (eDWR/SEDD), eLEXnet Maine HETL

9. Example: EPA’s Exchange Network An Internet and standards-based method for exchanging environmental information between partners. • Data standards • Partners agree on exchange data type, frequency, and method • Trading Partner Agreements • Registered XML schema • Partners exchange data over a secure network via each partner’s data transfer point, or “Node” • Facilitated with NAAS- National Authentication and Authorization Service Maine HETL

10. ICLN:Integrated Collaboration of Laboratory Networks Maine HETL

11. Before A Lab Can Create An Electronic Message To Be Sent To a Data Exchange Network, A LIMS Is NecessaryToday I Wish to Focus On The Environmental/Chemical Laboratory LIMS and Data Exchange.Many in Public Health Have LIMS Developed for Infectious DiseaseSome Discussion About the Comparison of the Infectious Disease LIMS and the Environmental/Chemical LIMS Is Useful Maine HETL

12. Infectious Disease Data & Env/Chemical Data LIMS And Data Exchange For These Two Types Of Analysis Have Much In Common: • Both Addressed in Public Health Informatics LIMS Requirements and Business Processes • Both track samples/specimens/QC Data, Results, and provide business management functions • Each have Data Standards For Analytical Results • Customers typically request the data in different formats- • Vocabulary Definitions • Packaging Of Data Into A Data Message • The Need For A Node Or Portal To Send Data Securely [A Node is a Web server (hardware with appropriate software) that provides a point for exchanging information over the Internet. ] Maine HETL

13. Infectious Disease Data Exchange for CDC • Think of it this way. HL7 is the letter, ebXML is the envelope (with the address, return address, container for the letter, etc), and PhinMS is the postal carrier (requires envelopes to look just so in order to deliver them). • PhinMS uses a certain kind of message wrapper and protocol, called ebXML in order to deliver messages.ebXML is payload agnostic, in that it can carry any kind of message. We just happen to be using HL7. Maine HETL

14. The Security LayerHypertext Transfer Protocol (HTTP)/Secure Socket Layer (SSL) or Public Key Infrastructure (PKI) • The Transport LayerThe standard transport mechanism for Web service messages is HTTP • The Messaging Envelope Simple Object Access Protocol (SOAP) as the envelope layer for Web service messaging. The SOAP envelope is further broken down into two compartments: The SOAP Header and Body. The Header contains information regarding the sender of the message. The SOAP Body contains the payload, or document (generally an XML instance document/schema). This can also contain attachments, generally in DIME or SWA formats Looked at in another way: Maine HETL

15. Major Differences in the Infectious Disease and Environmental/Chemical LIMS Environmental/Chemical LIMS: • Results are numerical with significant statistical QC data included with the analytical result • Data tends to be site centric vs. patient centric • Environmental data is subject to significant regulatory requirements • Results are typically methods based rather than performance based and results require links to multiple method references • Very Rigorous Certification/Accreditation Standards • Significant instrument interfaces are utilized • Results have units, MDL’s, RL’s, Qualifiers, and sometimes ranges of values • Results typically include multiple analytes (often over 50 on a single sample) with different criteria for each analyte Maine HETL

16. Maine’s LIMS Experience • Maine has an early version of Starlims Sunrise Version 9. • One year to build, and live for 2 Years, NELAP Accredited, used for DW, Waste, Chemical Terrorism, Radiation, Env Micro, Forensics • Except for “Raw” data, all information associated with analytical reside in the DB, analytical data is imported electronically from instruments, the LIMS “manages” which data meets reporting criteria and Quality Assurance Objectives • Analytical Data can be exported internally or remotely in an XML message and this message can be securely transported to other Trading Partners/networks. Maine HETL

17. Data Exchange Requires Partnering One Example is EPA’s Regional Laboratory Response Plan The purpose of the RLRP is to establish a comprehensive, regional, all-hazards approach to drinking water laboratory response across a spectrum of activities including preparedness, response, remediation, and recovery Maine HETL

18. Laboratories that participate in regional response networks need to be able to communicate analytical results in a standardized, interoperable and secure mechanism. This communication is particularly important during times of emergency. A highly desirable goal for the Northeast state laboratories is the use of a standardized electronic message to communicate between an analytical service requester (ASR), a primary response laboratory (PRL), and mutual support laboratory (MSL). Maine HETL

19. Further, the acceptance of a single nationally standardized lab reporting format will greatly serve the community of developers of Laboratory Information Management Systems (LIMS). Currently, the existence of multiple data formats has compromised commercial production of tools to produce electronic messaging. Maine HETL

20. The New England State Lab Directors at a Recent RLRP Meeting Have Recommended Key Components of Standardized Lab Reporting Maine HETL

21. Accept the ESAR data standard (Environmental Sampling and Analytical Results, developed through the Environmental Data Standards Council) and agree on the minimum data set (a subset of all elements) for analytical and metadata. A multi-media data standard is recommended, so that different formats are not required for different matrixes or programs. • Focus on a module of information provided by Laboratories intended to be reused by any schema requiring Sampling Analysis and Results Maine HETL

22. A schema in this case can be a description of the data represented within a database. The format of the description varies but includes a table layout for a relational database or an entity-relationship diagram. Maine HETL

23. A future electronic format should include quality control data, but this inclusion can be delayed (using the minimal data set of key elements) until universally implemented. Certification/accreditation of laboratories can serve as the intermediate function for assessing quality. Maine HETL

24. The initial technical implementation of the data standard should be the XML schemas: • eDWR (electronic Drinking Water Results) and/or • SEDD (Staged Electronic Data Deliverables) stage 1. • Both of these technical implementations exist and have unique advantages. Maine HETL

25. Note: Extensible Markup Language (XML) is a flexible language for creating common information formats and sharing both the format and content of data over the Internet and elsewhere. XML is a formatting language recommended by the World Wide Web Consortium (W3C). An XML schema defines the structure of an XML document. An XML schema defines things such as which data elements and attributes can appear in a document; how the data elements relate to one another; whether an element is empty or can include text; which types of data are allowed for specific data elements and attributes; and what the default and fixed values are for elements and attributes. Maine HETL

26. TWO EPA Adopted SCHEMA’s— SEDD is Staged Electronic Data Deliverable. Its origins are in the Superfund program, with strengths in capturing data quality information and more complete metadata. eDWR – Electronic Drinking Water Reporting. This was primarily focused on drinking water, is linked to SDWIS, but does include a “matrix” tag Maine HETL

27. Both of the implementations [eDWR and SEDD] share the same minimum data set of key elements. For emergency and many applications, their use can be interchangeable. A conversion tool from one to the other would be very helpful. This conversion tool will provide a crosswalk between the two technical implementations. Maine HETL

28. Interoperability and security must be addressed. For this reason: • The data must feed to the SDWIS-state application (EPA-OW); and, • Comply with data exchange Network Design Rules (AQS (Air Quality Subsystem, FRS (Facility Registry System), TRI (toxic release inventory), SDWIS Safe Drinking Water Information System, etc). • The Data Exchange Network is an Internet-based system used by state, tribal, and territorial partners to securely share environmental and health information with one another and EPA Maine HETL

29. Use of the existing Environmental Information Exchange Network may be an efficient use of resources. 48 states have EPA Nodes that can be used as to exchange data between labs and data consumers Maine HETL

30. So here is a challenge to you all………………. Maine HETL

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32. Questions and Credits ? ? ? ? ? Jack Krueger 207-287-2727 john.a.krueger@maine.gov EPA Homeland Security Challenge Grant enfoTech & Consulting Lawrenceville, NJ Maine HETL