&EPA United States Environmental Protection Agency Office of Superfund Remediation & Technology Innovation Fact Sheet Electronic Data Exchange & Evaluation System (EXES) EXES is a web-based data assessment and management tool that efficiently evaluates analytical laboratory data regardless of the format (PDF, XML, CSV, Excel, etc.). EXES provides users with advanced customization capabilities to add, edit, and review evaluation parameters, tests, Method Quality Objectives (MQOs) and Quality Assurance Project Plan (QAPP) requirements Its flexibility and scalability allows it to support any large monitoring program that involves laboratory analysis of samples - environmental, clinical, food, agricultural, or forensic. It supports federal, state, and commercial laboratory data assessment needs. Key Features Data Assessment EXES provides the ability to evaluate a virtually unlimited number of analytical methodologies, technologies, and data exchange formats. • Fully customizable automated completeness and compliance checks are executed in accordance with client specified criteria. • Modular approach to test design and creation dramatically reduces time and cost associated with supporting dynamic requirements. • Self-Inspection feature allows for preliminary review and correction of data deficiencies prior to official data submission. Report Generation EXES generates a variety of routine reports including Data Summary, Data Compliance, and Data Validation reports within minutes of a compliant electronic data deliverable submission. • Merges analytical and field data into a standardized spreadsheet that can be further customized to suit each client's unique data validation and reporting process. • Notifies authorized users when reports and deliverables are available for viewing and retrieval in the web-based EXES Data Manager (EDM). • EDM provides users with the ability to customize, edit, and regenerate spreadsheet reports containing data validation results. Sara Goehl, Analytical Services Branch OSWER/OSRTI " Phone: (703) 603-9097 Email: goehl.sara@epa.gov CONTACT INFORMATION Data Storage The EXES Data Manager application (EDM) provides a centralized data repository to view and retrieve generated reports, spreadsheets, and other data deliverables as defined by the client. • Data deliverables are available for web-based viewing and retrieval to authorized users 24 hours a day. • User management controls restrict what data can be accessed, and by whom, according to client specifications. • Historical data is routinely archived to optimize system performance and retained for future retrieval. Document Version 2.0- August 1, 2014 Nazy Abousaeedi, CSC Phone: (703) 818-4233 Email: fabousaeedi@fedcsc.com ------- EXES Data Management Process The Electronic Data Exchange & Evaluation System (EXES) was developed to assist with the rapid processing, assessment, and distribution of analytical data submitted to EPA's Contract Laboratory Program (CLP). EXES provides a centralized system that enables data submissions, electronically assesses data to customizable specifications, and provides users with EXES generated reports for use in down-stream external processes and systems. Client Client Site Laboratory Program Management Record Archives I Sample Analysis Data Benefits and Highlights • Robust Evaluation Capabilities: Each electronic data deliverable (EDD) is subjected to more than 3,500 Quality Assurance (QA) and Quality Control (QC) checks to ensure contractual and technical completeness and compliance. The EXES design allows for extensive client customization to meet different needs and assess data delivered in a variety of formats. • Proven Performance: Since June 2006, CSC has processed more than 1,000,000 analyses including more than 309,000 modified analyses. EXES continues to provide highly comprehensive electronic reports to EPA Regions within 24 to 48 hours at a 99.9% accuracy level. • Flexible Design: Modular approach to system design allows for scalability in response to evolving requirements and new processes. User interfaces allow for dynamic test rule creation, management, and implementation without the need for extensive IT system upgrades or modifications. • Cost Savings: EXES has saved EPA over $60M associated to data assessment and delivery activities and has produced documented savings of 80% over manual data validation. Sara Goehi, Analytical Services Branch OSWER/OSRTi Phone: (703) 603-9097 Email: goehl.sara@epa.gov CONTACT INFORMATION Document Version 2.0- August 1, 2014 Nazy Abousaeedi, CSC Phone: (703) 818-4233 Email: fabousaeedi@fedcsc.com ------- New Shared Data Assessment and Management Services U.S. Environmental Protection Agency ------- No Note: The sample can be an environmental sample collected from a Superfund site or a sample collected in support of FDA, NIH, DOD, etc. U.S. Environmental Protection Agency ------- Electronic Data Review Data Assessment Process ^ • Method Compliance Assessment: - Self-inspection - performed by a laboratory prior to delivery - Performed by a third party to assess compliance with the requested method and data reporting procedures - Used by an organization to assess the compliance of their data (State and Regional labs, ORD, etc.) - Litigation /OIG • Data Usability Assessment: - Used by a third party to assess and establish a data usability determination - Used by the organization (State and Regional labs, ORD, etc.) - Make educated decision (confidence) on the site or a sampling event (OSCs, RPMs, Health or other agencies) U.S. Environmental Protection Agency ------- What Challenges Data Users Are Currently Facing — Q PRO}. Reduction of available funding to continuously develop, update and maintain an electronic/automated review tool Program and Project Mangers are required to answer the same pressing questions with shrinking resources and funding pools Environmental and human health decisions must be made based on credible data The wrong review tool is used - Does not allow users the ability to define project quality objectives upfront; forcing them to use set requirements - Can only process a specific Electronic Data Deliverable (EDD) - Only set up for limited methods Incorrect implementation of automated review processes - No planning - No training for laboratory and data user U.S. Environmental Protection Agency ------- Electronic I Automated Data Review Tools —— Automated/electronic data review tools currently on the market: - Accept a limited set of EDD formats (one or two) - Perform data review based on only existing methods and/or specifications - can only pick one of the listed methods - The tests/checks performed are hardcoded/set -making changes costly and time consuming - Limited scalability - If any of the above requirements change, the tool will need major updates or a complete redo What is missing/needed: - Format neutral data review tool - Provide data users with the ability to modify review spec based on their needs - User friendly web User Interfaces (Ul) to set up requirements and customize on an as-needed basis - real time - no development delay - Ability to recalculate/verify results - Scalable and configurable ------- What Sets Enhanced EXES Apart Other Tools on the Market • Efficiently evaluates analytical data regardless of the format of the data deliverable that is submitted. • Provides users with advanced customization capabilities to review, edit, and add evaluation parameters, tests. Method Quality Objectives (MQOs). and Quality Assurance Project Plan (QAPP) requirements. • The Enhanced EXES is comprised of a dynamic test creation core working in tandem with an expandable reference data set that is not limited to specific analytical processes and procedures. U.S. Environmental Protection Agency ------- • Applies to any large monitoring program that involves laboratory analysis of samples — food, clinical, environmental, agricultural, or forensic • Scalable processes for managing sample or specimen collection and laboratory analysis through a centralized system • Leverage technology to reduce costs and improve quality • Minimizes cost while simultaneously maximizing data quality and ensuring legal defensibility - Better data: ASB's Electronic Data exchange and Evaluation System (EXES) provides independent assessment and validation of laboratory data - Lower costs: During the past 15 years, EXES has saved EPA $60 million through automation U.S. Environmental Protection Agency ------- • A Web-based data assessment/validation and management tool that can evaluate analytical data. It uses: - Format neutral domain and data model - Re-usable Process Flow Libraries (PFL) - Method Evaluation Libraries (MELs) - Method Evaluation Procedures (MEPs) - Ul for custom test creation • It is capable of supporting federal, state and commercial laboratory data assessment needs. U.S. Environmental Protection Agency ------- Self-inspection 12/2012 Full Method Compliance 03/2014 Data Validation 09/2014 v Self-inspection: Allowing labs and vendors to check EDDs for compliance to a method. Full Method Compliance: Full method compliance including calculation of all reported results with the ability to post lab deliverables and compliance reports to EXES Data Manager (EDM) for retrieval. Data Validation: Generation of data validation reports and spreadsheets with the ability to post to EDM for retrieval. U.S. Environmental Protection Agency ------- Samples £ Commercial Laboratory XML • ^ • % * A Federal Laboratory EXCEL Y State Laboratory CSV * NRAS Laboratory SEDD2a CLP Laboratory 1 1 1 1 4 I > f 1 4 SEDD3 T T Standard Deliverable ------- EXES Benefits/New Features - You Are in Control — O Flexible - user interfaces that enable you to create test rules, data review criteria and reports dynamically; select and create your desired level of assessments. Reusable - features allow users the ability to create new libraries or search and modify existing libraries; saving time and effort, and resulting in cost savings. Consistent - reproducible and independent electronic review improves overall project transparency. Customizable - tailored deliverable process flow to meet your specific analytical evaluation needs. Capability to support multiple programs with different program needs. U.S. Environmental Protection Agency ------- Modern and Simple to Use - Allows users to specify desired data assessment outputs in terms of reports and assessment results that can be standardized or customized according to the user's needs. Easily Extendable Component - Data driven and modular approach allows for rapid expansion in response to new program/client needs with minimum to no development effort and cost. Format Neutral - Accepts all types of EDDs - XML, EXCEL, CSV, etc.) Data Manager- The only automated data review tool with a data management component serving as a Web-based secure data & report repository - completely paperless U.S. Environmental Protection Agency ------- EDM provides a Web-based/centralized data management tool: - Stores all laboratory deliverables - Data assessment/validation reports available within minutes of data upload - Spreadsheets and outputs include both field and analytical data ready for upload to databases and mapping tools - Provides results based on data user's assessment criteria - Allows users to edit and regenerate all dynamic reports - Provides an audit tracking log of all changes made by user name and date/time - Who can have access to what portion of data or reports in EDM can be set based on data user's request U.S. Environmental Protection Agency ------- Contact Information EPA - Sara Goehl, Analytical Services Branch OSWER/OSRTI - Phone: (703)603-9097 - email: Goehl.Sara@epa.gov CSC - Nazy Abousaeedi, Sr. Manager, Science & Engineering Line of Service - Phone: (703)818-4233 - email: nazv@fedcsc.com U.S. Environmental Protection Agency 14 ------- |