Laboratory Data Management and Reportingand …

1 Laboratory data Management and reporting Mid Atl ti EQuIS. Mid-Atlantic EQ IS Users U Group G Meeting M ti August 2011. Company Information Founded F d d 1986. Employee-owned since 1997. Laboratories Six Service Centers Two Total Staff 450. Annual Revenue $45M. In the Top 5 Labs Nationwide Columbia Analytical Network Columbia Analytical Services Routine Full Service Analysis Low-Level Trace Analysis Sed Sediment e t / Tissue ssue Programs og a s Porewater /Elutriate Testing Drinking Water Testing HR/MS - Dioxins/Furans, Dioxins/Furans PCB congeners Columbia Analytical Services Mining / Treatability Testing Emergent E t Contaminants C t i t Endocrine Disruptors Pharmaceutical and Personal Care Product Residues (PPCPs).

2 Columbia Analytical Services Fuels / Product Testing Passive Passi e Sampling Devices De ices Import/Export Permits Boiler MACT Testing Air Quality Testing Programs Air Quality Services AIHA and NELAP accredited Ambient Air Testing St ti Stationary S. Source T. Testing ti Indoor Air Quality S Vapor Testing Soil Vapor Intrusion Testing Industrial Hygiene Consulting Landfill Gas Testing New Odor Scan TM Testing Sulfur Speciation Testing Certifications / Accreditations NELAP Accredited Network Certified in 40 States AF C. N CE. E NT. ER F LLE. OR EN E XCE.

3 VIR M ENTAL. ON. DOD-ELAP Accredited U S Air Force /AFCEE. Navy / NFESC. Army / ASCE. American Industrial Hygiene Association (AIHA). Technical Expertise Industrial Process Testing Import / Export testing Pharmaceutical and Life Sciences Testing (FDA / R&D). Creative C i P Problem bl S. Solving l i Technical Expertise Method Research and Development Emergent g Chemicals Unregulated Compounds Analytical Consulting Forensics F i and d Liti Litigation ti S Supportt Electronic data Management data Management and reporting How do we manage all these data ?

4 Network data Management Project data Tracking Electronic data reporting Work Flow Process Hardware + Software Infrastructure What is a LIMS? LIMS. Database Laboratory Information Management System (LIMS) = Network-wide System +. Modules for data reporting reporting , etc 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 System Platform Columbia C l bi A Analytical l ti l uses S. Server / L. Locall A. Area network (LAN) configuration Columbia Analytical standardized on Microsoft (MS) Windows applications (i ( , e Word Word, Outlook Outlook, Excel, Access, MS Exchange).)

5 Columbia Analytical Oracle database LIMS. data Management Tools Virtually every piece of information in the Laboratory network is managed electronically in LIMS. D. data t are generated t d and d stored t d electronically l t i 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 data Management Work Flow P j t Set-up Project S t / Sample S l RReceipt i t data Analysis / Acquisition / Review Report Generation / Production Sample Disposal / Archiving Project Setup Create Project in LIMS.

6 Sample/Matrix/Tests/ Container Analytes Project Holding Times Request w/. Requirements reporting Limits LIMS. Barcode data Quality Database Objectives data Flagging Rules Table Specifications data Specifications Field Maps EDD Customized data Entry R. Requirements i t I t f i Interfacing data reporting Levels Tier Tier Tier Tier I II III IV. Transmittal Letter . Case Narrative * . Method Blank Results . Surrogate Recovery Results . Chain-of-Custody Documentation . Matrix Spike Results * . Duplicate Results * . Laboratory Control Sample (LCS & Dup).

7 Results CLP data Forms . Raw data . * Client Specific Only Basic EDD Specifications Sample Receipt and Log-In Document cooler temp. Verify sample preservation Sample Note discrepancies Cooler LIMS. Receipt Scan cooler receipt and Receipt and Database Chain of Custody Form COC Forms Match COC to LIMS. Project Set-up Enter or upload field data Sample Add demographics Login Print and label samples, p , LIMS Request, service request, etc. Store samples and initiate Database Labels, internal chain of custody Confirmation Log Samples into LIMS. Project bar code report facilitates matching samples to SDG in LIMS.

8 Log L sample l iinformation, f ti fifield ld d data , t and d demographics to LIMS. Sample Receipt Confirmation Sample acknowledgement report EQuIS EDGE sample receipt EDD as confirmation. f . Analytical Testing / Validation Create test groups in LIMS. Add QC Samples to test Test Batch Analytical groups LIMS data data Technical Review of test data Database Upload or input data into LIMS. Verify batch QC results Verify method QC results data Validate against Project Certified Validation DQOs against Client Flag g data LIMS Reports Requirements Draft Case Narrative Database Print reports Instrument data Acquisition Metals (MARRS).

9 Organics (Stealth). Instrument data Acquisition, data Reduction data Verification Reduction, Verification, data Validation, data reporting Systems Function as LIMS Modules Instrument data Acquisition Example data Validation to Project DQOS. Validation routine compares test data , data batch QC, Initial and Continuing C lib ti Calibrations (ICAL / CCV). CCV), etc. t 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. data Superset . Superset File data Superset.

10 Superset file has 105 fields including: project information, sample d demographics, hi matrix, t i ttest, t analyte, l t chemical abstract number, analytical results, result demographics, QC. results, QC criteria, data qualifiers, and raw data records . Large L d data t sett allows ll flflexibility ibilit tto meet most client EDD requirements EDD Generation and Delivery Generate CAS. Superset . Transfer Superset to EDD. GENERATE EDD Generator LIMS Module Run EDD. EDD Output EDD Database Ch Check k EDD. against Client . DELIVER specification EDD Run EDD in client test file format EDD.