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Laboratory EDD Services
  Mid-Atlantic EQuIS Users Group
  Meeting Princeton, New Jersey
         October 12, 2012
Alpha Analytical, Inc. Overview

• Celebrating 25th Anniversary
• Established in Ashland MA in 1985
• Acquisitions (1999-2006): CDM Lab, Matrix
   Analytical, Woods Hole Lab, ENSR Air Lab
• Facilities: Westborough Lab Routine Services
  and Mansfield Lab Sediment/Tissue/Forensics
• Accreditations: NELAP (w/ NJDEP primary),
   plus Federal DOD-ELAP, plus state certs
• Serving: New England, Mid-Atlantic, Nationwide
                                          1
Laboratory Routine Services

• VOAs - Est. 4,500/month

• SVOCs - Est. 3,000/month

• Pest/PCB/Hydrocarbons - Est. 3,500/month

• Metals - Est. 4,000/month

• Wet Chem - Est. 14,000/month

• Air / TO-15 - Est. 1,000/month
                                        2
Laboratory Specialty Services

• Air / Vapor Intrusion Analytical Services
• Sediment / Tissue Analytical Services
• Forensic Hydrocarbon Services




                                              3
Laboratory IT Infrastructure

• Over 50 Servers support Company Operations
• Servers for Web Site hosting, Instrument
  operations, Sample Data Processing functions
  (EnviroQuant), Quality Assurance Tracking,
   On-Line Data Access, Accounting and Invoicing
• LIMS System on one server (SEEDPAK)
• Oracle Data Base for LIMS Data Storage
• Windows User Environment

                                          4
Client User Interfaces

• Web Site - Overview of Analytical Services,
   Webinar Notices, Events Listings, etc.
• Project Set-Up Tools - Web Portal for Bottle
  Orders, Courier Requests, Chain of Custody
  Forms, Certification Information, etc.
• ADEX - Secure Web-based Data Access for
   static file downloads
• Data Merger - Secure Web-based Interactive
   Data Tool with Regulatory Criteria

                                           5
LIMS Project Set-Up

•   Client Account (Name, Address, etc.)
•   Project Name / Location
•   Test Codes / Methods
•   Sample Matrices
•   Data Deliverables (Report type / EDD type)
•   Project Communication Form (scope details)
•   Documents (RFP, Quote, QAPP, EDD Spec,
    Project-Specific Compound List, , etc.)

                                           6
Project Sample Log-In

• Courier scans COC Form and sends web-mail to
  Lab PM and Log-In Team for pre-log-in
• Samples received and logged into LIMS
• LIMS sends Sample Receipt Confirmation and
  signed COC Form and Draft Invoice
• Sample Containers immediately Bar Coded for
   Custody Tracking thru LIMS
• Samples Stored / Refrigerated


                                       7
Sample Preparation

• Samples moved to Prep Lab (containers)
• Samples tracked in LIMS (barcodes/scanner)
• Samples grouped with QC (batches)
• Samples Extracted / Digested / Prepped
• Data entered electronically into LIMS from
  balances/instruments (some manually)
• Electronic Lab Notebook (ELN) connected to
  LIMS (Analyst types into LIMS / not on paper)

                                           8
Instrument Analysis / Data Review

• Sample Extracts loaded onto Instruments
• Analytical Data acquired from Instruments
• EnviroQuant Data files processed and
   transferred to LIMS
• Analysts conduct Data Review in LIMS
• Data 1st / 2nd / 3rd Level Reviewed for Release
  as “Approved” status in LIMS
• Data 4th Review by Reporting Group

                                            9
LIMS Data Reporting

• Data Reports created in LIMS
• Reporting Group finalizes Reports
• Reports emailed from LIMS to Client
• Reports posted from LIMS to ADEx
  (Static Downloads)
• Results posted from LIMS to Data Merger
  (Interactive Reg Criteria comparisons)

                                    10
Electronic Data Deliverables

• Laboratory Library of over 100 EDDs
• Standard and Client-Specific EDD formats
• Federal Programs (ERPIMS / SEDD / ADR)
• EPA Region 2 EDD
• NJ-HAZSITE and other state-specific EDDs
  (e.g., NY, ME, NH, MA, etc.)
• EQuIS (EZ and 4-file formats) (Est. 200/month)



                                          11
EQuIS EDD Development

•   Client sends EDD Spec / Valid Values to Lab
•   Lab Custom-Programs EDD to Client Spec
•   Lab Runs Test EDD on live Data Set
•   Client loads Test EDD into data base
•   Client provides EDD Comments to Lab
•   Lab addresses Client EDD Comments
•   EDD Development Process should occur prior
     to Sample Receipt (est. 2-3-week period)

                                          12
EQuIS EDD Generation

• Lab Approves Final Data Report (PDF file)
• Lab runs EQuIS EDD a few days after Final
   Data Report issued
• EQuIS EDDs manually validated by Lab thru
   EDP checker prior to final release to client
• Time delay results from manual validation
   process conducted by Lab prior to EDD release



                                         13
Keys to Success

•   Advance Project Planning
•   Detailed EDD Spec
•   Valid Values Files
•   Special Rules / Exceptions
•   Example Data Files
•   Lab Runs Test EDD / Client loads Test EDD
•   Plan for 2-3 week Process
•   Communication is Key

                                           14
Working with Labs

•   Client Preferred File Formats
•   Client Interpretation of Data Fields
•   Lab-specific Instrument set-ups
•   Lab-specific LIMS Data Calculations
•   Standard vs. Lab-specific Data Outputs
•   Client-Specific File Formats (EDD spec,
    reference values, etc.) vs. Default Values



                                                 15
EXAMPLE

• Client-specific interpretation of MDL Field in
   EQuIS EDD Data Results File
• Sample-Specific Aliquot entered into LIMS
• Soil % Moisture Data entered in LIMS
• Sample-Specific RL / MDL calculated by LIMS
• Pre-set basis for RL / MDL in LIMS
• “Finished” RL / MDL reported from LIMS
• MDL defined: 40 CFR Part 136, Appendix B, Rev 1.11;
   NELAC Standard 2009; DOD QSM 4.2

                                             16
EXAMPLE

• Population of “Quantitation Limit” field
• Lab default: Sample-specific, analyte-
   specific, matrix-specific value calculated
   by the LIMS
• Some clients do not use this field
• Some clients interpret and/or define this
   field differently

                                        17
In Summary
• Provide a Detailed EDD Spec to the Laboratory
• Clearly Communicate Project / Program Requirements
• Provide a Quality Assurance Project Plan (QAPP) stating
   project and program Data Quality Objectives (DQOs)
• Allow Time for EDD Development Process
• Consider Database Purpose when Writing EDD Spec:
   – Sample Tracking / Relating Data to GIS Features
   – Creating Data Tables for Data Evaluation / Reports
   – Conducting Data Validation
   – All of the Above

                                                18
Questions
       Thank you

  Alpha Analytical, Inc.
        Eileen Snyder
    Mobile: 610-585-3420
Email: esnyder@alphalab.com
      www.alphalab.com

                              19

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Alpha analytical edd_services_2012

  • 1. Laboratory EDD Services Mid-Atlantic EQuIS Users Group Meeting Princeton, New Jersey October 12, 2012
  • 2. Alpha Analytical, Inc. Overview • Celebrating 25th Anniversary • Established in Ashland MA in 1985 • Acquisitions (1999-2006): CDM Lab, Matrix Analytical, Woods Hole Lab, ENSR Air Lab • Facilities: Westborough Lab Routine Services and Mansfield Lab Sediment/Tissue/Forensics • Accreditations: NELAP (w/ NJDEP primary), plus Federal DOD-ELAP, plus state certs • Serving: New England, Mid-Atlantic, Nationwide 1
  • 3. Laboratory Routine Services • VOAs - Est. 4,500/month • SVOCs - Est. 3,000/month • Pest/PCB/Hydrocarbons - Est. 3,500/month • Metals - Est. 4,000/month • Wet Chem - Est. 14,000/month • Air / TO-15 - Est. 1,000/month 2
  • 4. Laboratory Specialty Services • Air / Vapor Intrusion Analytical Services • Sediment / Tissue Analytical Services • Forensic Hydrocarbon Services 3
  • 5. Laboratory IT Infrastructure • Over 50 Servers support Company Operations • Servers for Web Site hosting, Instrument operations, Sample Data Processing functions (EnviroQuant), Quality Assurance Tracking, On-Line Data Access, Accounting and Invoicing • LIMS System on one server (SEEDPAK) • Oracle Data Base for LIMS Data Storage • Windows User Environment 4
  • 6. Client User Interfaces • Web Site - Overview of Analytical Services, Webinar Notices, Events Listings, etc. • Project Set-Up Tools - Web Portal for Bottle Orders, Courier Requests, Chain of Custody Forms, Certification Information, etc. • ADEX - Secure Web-based Data Access for static file downloads • Data Merger - Secure Web-based Interactive Data Tool with Regulatory Criteria 5
  • 7. LIMS Project Set-Up • Client Account (Name, Address, etc.) • Project Name / Location • Test Codes / Methods • Sample Matrices • Data Deliverables (Report type / EDD type) • Project Communication Form (scope details) • Documents (RFP, Quote, QAPP, EDD Spec, Project-Specific Compound List, , etc.) 6
  • 8. Project Sample Log-In • Courier scans COC Form and sends web-mail to Lab PM and Log-In Team for pre-log-in • Samples received and logged into LIMS • LIMS sends Sample Receipt Confirmation and signed COC Form and Draft Invoice • Sample Containers immediately Bar Coded for Custody Tracking thru LIMS • Samples Stored / Refrigerated 7
  • 9. Sample Preparation • Samples moved to Prep Lab (containers) • Samples tracked in LIMS (barcodes/scanner) • Samples grouped with QC (batches) • Samples Extracted / Digested / Prepped • Data entered electronically into LIMS from balances/instruments (some manually) • Electronic Lab Notebook (ELN) connected to LIMS (Analyst types into LIMS / not on paper) 8
  • 10. Instrument Analysis / Data Review • Sample Extracts loaded onto Instruments • Analytical Data acquired from Instruments • EnviroQuant Data files processed and transferred to LIMS • Analysts conduct Data Review in LIMS • Data 1st / 2nd / 3rd Level Reviewed for Release as “Approved” status in LIMS • Data 4th Review by Reporting Group 9
  • 11. LIMS Data Reporting • Data Reports created in LIMS • Reporting Group finalizes Reports • Reports emailed from LIMS to Client • Reports posted from LIMS to ADEx (Static Downloads) • Results posted from LIMS to Data Merger (Interactive Reg Criteria comparisons) 10
  • 12. Electronic Data Deliverables • Laboratory Library of over 100 EDDs • Standard and Client-Specific EDD formats • Federal Programs (ERPIMS / SEDD / ADR) • EPA Region 2 EDD • NJ-HAZSITE and other state-specific EDDs (e.g., NY, ME, NH, MA, etc.) • EQuIS (EZ and 4-file formats) (Est. 200/month) 11
  • 13. EQuIS EDD Development • Client sends EDD Spec / Valid Values to Lab • Lab Custom-Programs EDD to Client Spec • Lab Runs Test EDD on live Data Set • Client loads Test EDD into data base • Client provides EDD Comments to Lab • Lab addresses Client EDD Comments • EDD Development Process should occur prior to Sample Receipt (est. 2-3-week period) 12
  • 14. EQuIS EDD Generation • Lab Approves Final Data Report (PDF file) • Lab runs EQuIS EDD a few days after Final Data Report issued • EQuIS EDDs manually validated by Lab thru EDP checker prior to final release to client • Time delay results from manual validation process conducted by Lab prior to EDD release 13
  • 15. Keys to Success • Advance Project Planning • Detailed EDD Spec • Valid Values Files • Special Rules / Exceptions • Example Data Files • Lab Runs Test EDD / Client loads Test EDD • Plan for 2-3 week Process • Communication is Key 14
  • 16. Working with Labs • Client Preferred File Formats • Client Interpretation of Data Fields • Lab-specific Instrument set-ups • Lab-specific LIMS Data Calculations • Standard vs. Lab-specific Data Outputs • Client-Specific File Formats (EDD spec, reference values, etc.) vs. Default Values 15
  • 17. EXAMPLE • Client-specific interpretation of MDL Field in EQuIS EDD Data Results File • Sample-Specific Aliquot entered into LIMS • Soil % Moisture Data entered in LIMS • Sample-Specific RL / MDL calculated by LIMS • Pre-set basis for RL / MDL in LIMS • “Finished” RL / MDL reported from LIMS • MDL defined: 40 CFR Part 136, Appendix B, Rev 1.11; NELAC Standard 2009; DOD QSM 4.2 16
  • 18. EXAMPLE • Population of “Quantitation Limit” field • Lab default: Sample-specific, analyte- specific, matrix-specific value calculated by the LIMS • Some clients do not use this field • Some clients interpret and/or define this field differently 17
  • 19. In Summary • Provide a Detailed EDD Spec to the Laboratory • Clearly Communicate Project / Program Requirements • Provide a Quality Assurance Project Plan (QAPP) stating project and program Data Quality Objectives (DQOs) • Allow Time for EDD Development Process • Consider Database Purpose when Writing EDD Spec: – Sample Tracking / Relating Data to GIS Features – Creating Data Tables for Data Evaluation / Reports – Conducting Data Validation – All of the Above 18
  • 20. Questions Thank you Alpha Analytical, Inc. Eileen Snyder Mobile: 610-585-3420 Email: esnyder@alphalab.com www.alphalab.com 19