Laboratory Data Management. August 2011
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1 Laboratory Data Management and Reporting Mid-Atlantic ti EQuIS Users Group Meeting August 2011
2 Company Information Founded d 1986 Employee-owned since 1997 Laboratories Six Service Centers Two Total Staff 450 Annual Revenue $45M In the Top 5 Labs Nationwide
3 Columbia Analytical Network
4 Columbia Analytical Services Routine Full Service Analysis Low-Level Trace Analysis Sediment e / Tissue Programs Porewater /Elutriate Testing Drinking Water Testing HR/MS - Dioxins/Furans, PCB congeners
5 Columbia Analytical Services Mining / Treatability Testing Emergent Contaminants t Endocrine Disruptors Pharmaceutical and Personal Care Product Residues (PPCPs)
6 Columbia Analytical Services Fuels / Product Testing Passive Sampling Devices Import/Export Permits Boiler MACT Testing Air Quality Testing Programs
7 Air Quality Services AIHA and NELAP accredited Ambient Air Testing Stationary ti Source Testing Indoor Air Quality Soil Vapor Testing Vapor Intrusion Testing Industrial Hygiene Consulting Landfill Gas Testing New Odor Scan TM Testing Sulfur Speciation Testing
8 A F Certifications / Accreditations NELAP Accredited Network Certified in 40 States DOD-ELAP Accredited U.S. Air Force /AFCEE U.S. Navy / NFESC U.S. Army / ASCE American Industrial Hygiene American Industrial Hygiene Association (AIHA) CE NTER FOR ENV I R O N ME E NTAL EXCE LLENC
9 Technical Expertise Industrial Process Testing Import / Export testing Pharmaceutical and Life Sciences Testing (FDA / R&D) Creative Problem Solving
10 Technical Expertise Method Research and Development Emergent Chemicals Unregulated Compounds Analytical Consulting Forensics and Litigation Support Electronic Data Management
11 Data Management and Reporting How do we manage all these data? Network Data Management Project Data Tracking Electronic Data Reporting Work Flow Process Hardware + Software Infrastructure
12 What is a LIMS? Laboratory Information Management System (LIMS) = Network-wide System + Modules for Data Reporting, etc. Sample ID, Matrix, Test, Analyte, DQOs Analyte-specific Data for each Sample Tracks all data review /rework / release / data reporting / report revisions Queries / Management Reports LIMS Database
13 System Platform Columbia Analytical l uses Server / Local larea network (LAN) configuration Columbia Analytical standardized on Microsoft (MS) Windows applications (i.e., Word, Outlook, Excel, Access, MS Exchange) Columbia Analytical Oracle database LIMS
14 Data Management Tools Virtually every piece of information in the laboratory network is managed electronically in LIMS Data are generated and stored electronically ll on a single network-wide LIMS Data move from department to department electronically via the LIMS Data reports generated electronically from LIMS Data uploads via LIMS to client / agency database
15 Data Management Work Flow Project Set-up /S Sample Receipt Data Analysis / Acquisition / Review Report Generation / Production Sample Disposal / Archiving
16 Project Setup Project Requirements Create Project in LIMS Sample/Matrix/Tests/ Analytes Holding Times Reporting Limits Data Quality Objectives Data Flagging Rules LIMS Database Container Request w/ Barcode Table Specifications Data Specifications Field Maps Customized Data Entry I t f i EDD Requirements Interfacing
17 Data Reporting Levels Transmittal Letter Case Narrative * Method Blank Results Surrogate Recovery Results Chain-of-Custody Documentation Matrix Spike Results * Duplicate Results * Laboratory Control Sample (LCS & Dup) Results CLP Data Forms Tier I Tier II Tier III Tier IV Raw Data * Client Specific Only
18 Basic EDD Specifications
19 Sample Receipt and Log-In Document cooler temp. Verify sample preservation LIMS Database Sample Note discrepancies Cooler LIMS Receipt Scan cooler receipt and Chain of Custody Form Receipt and COC Forms Sample Login Match COC to LIMS Project Set-up Enter or upload field data Add demographics Print and label samples, service request, etc. Store samples and initiate internal chain of custody LIMS Database Request, Labels, Confirmation
20 Log Samples into LIMS Project bar code report facilitates matching samples to SDG in LIMS Log sample information, field data, and demographics to LIMS
21 Sample Receipt Confirmation Sample acknowledgement report EQuIS EDGE sample receipt EDD as confirmation.
22 Analytical Testing / Validation Analytical Data Create test groups in LIMS Add QC Samples to test groups Technical Review of test data Upload or input data into LIMS LIMS Database Test Batch Data Data Validation against Client Requirements Verify batch QC results Verify method QC results Validate against Project DQOs Flag data Draft Case Narrative Print reports LIMS Database Certified Reports
23 Instrument Data Acquisition Metals (MARRS) Organics (Stealth) Instrument Data Acquisition, Data Reduction, Data Verification, Data Validation, Data Reporting Systems Function as LIMS Modules
24 Instrument Data Acquisition Example
25 Data Validation to Project DQOS Validation routine compares test data, batch QC, Initial and Continuing Calibrations (ICAL / CCV), etc. against project requirements System returns a set of validation reports to the analyst for review Validated data is ready for reporting Data Superset generated for EDD
26 Data Superset File Data Superset file has 105 fields including: project information, sample demographics, matrix, test, t analyte, chemical abstract number, analytical results, result demographics, QC results, QC criteria, data qualifiers, and raw data records Large data set allows flexibility to meet most client EDD requirements
27 EDD Generation and Delivery GENERATE EDD Generate CAS Superset Transfer Superset to EDD Generator Run EDD Output EDD LIMS Database EDD Module DELIVER EDD Check EDD against specification Run EDD in client test file format Client EDD
28 EDD Module for Data Reporting EDD Module can be part of a LIMS or custom software developed by a Lab Three primary functions: Translate laboratory data to client-specified format (e.g., naming conventions, field order, field formats, etc.) Organize laboratory data into custom client-specific EDD format Standardize process to produce EDDs
29 Data Reduction / Reporting Data Super Set is created Proprietary program Electronic Data Deliverable Generator (EDDGE) EDDGE program normalizes data and translates necessary Columbia Analytical internal valid values into Client-specific valid values EDDs created from EDDGE System
30 Project Specifications / DQOs QAPPs Data Quality Objectives Project Limits Tables Data Reporting detail EDD Specs Project specifications stored in LIMS
31 Project DQOs / QAPPs / Specs Project-specific data quality objectives are used to build project-specific table of data validation criteria i Project-specific criteria are used to verify data is generated / reported compliant with project data quality objectives
32 Example DQO Table in LIMS
33 Example DQO Table in LIMS
34 EDD Development Process Client Project Manager CAS Project Manager Error-Free EDD Generation becomes Routine Client Data Manager CAS IT (EDD Specialist) CAS Report Production Specialist
35 Client EDD Spec is Important EQuIS EDD spec is extremely detailed Laboratories address a wide variety EDD requests and formats All client project specifications may not captured in basic EQuIS EDD spec
36 EDD Checker Routines EQuIS EDD checker routines State-Specific (NJDEP, NYSDEC, etc.) USEPA Region-specific EDD checkers USEPA SEDD online checker Laboratory Data Consultants (Adapt) Alaska Corps of Engineers (COELT and SEDD Savvy) CA Dept of Water Resources GEOTRACKER U.S. Air Force ERPTOOLS X
37 Electronic Data Deliverable Formats EQuIS EZ and 4-file formats (with checker) ADR/ADAPT, GIS\Key, Locus EIM, EnviroData EDF for GeoTracker (COELT 1.2i w/edcc) State-specific formats (NJ, NY, AZ, CA, TX, etc.) Federal Programs formats (ERRIS, etc) USEPA formats (SEDD, etc) Client-Custom EDD formats
38 EDD Formats Supported CAS supports more than 500 EDD formats ADR/Adapt - Laboratory Data Consultants GISKey - GIS/Solutions ArcInfo - ESRI GIS + Mapping Software Product EQuIS/EDP Earthsoft Environmental Quality Information System SEDD - USEPA Staged Electronic Data Deliverable, Level 2a COELT - Corps of Engineers Loading Tool EPA Region 3 Format EPA Region 4 Format EPA Region 5 Format Geotracker /EDF - Cal EPA State Water Resources Control Board ERPIMS/ERPTOOLS - Environmental Resources Program Information Management System Navy CLEAN - US Navy Comprehensive Long Term Environmental Action Navy AZDEQ - Arizona Department of Environmental Qualifier NJPEP / Hazsite EDS - New Jersey Department of Environmental Protection RIBS - New York Department of Environmental Conservation TRRP - Texas Commission on Environmental Quality Risk Reduction Program
39 Electronic Data Transfer / Delivery Data electronic transfer options from LIMS: FTP Web Site file attachment Diskette or CD-ROM Hard Copy File Uploads
40 Eileen Snyder Technical Sales Consultant MidAtlantic Region cell:
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