1. U.S. Department of Energy’s Consolidated Laboratory Auditing and Proficiency Testing Programs George E. Detsis Manager, Analytical Services Program Office of Corporate Safety Analysis, HS-30 Presented before the 2009 Department of Defense Environmental Monitoring and Data Quality Workshop March 30 – April 3, 2009 San Antonio, Texas

2. Presentation Outline Mission Statement Mission Statement Auditing Background Auditing Background Audit Checklists Audit Checklists Laboratory Audit Findings Laboratory Audit Findings Laboratory Audit Schedule FY09 Laboratory Audit Schedule FY09 Proficiency Testing Background Proficiency Testing Background Proficiency Testing Accomplishments Proficiency Testing Accomplishments

3. Program Mission To foster development of quality environmental data of known and documented value; thereby, improving the confidence level of decision- makers, enhancing public trust, and reducing inherit agency liabilities. To foster development of quality environmental data of known and documented value; thereby, improving the confidence level of decision- makers, enhancing public trust, and reducing inherit agency liabilities.

4. DOECAP Background Program Purpose: Elimination of audit redundancies Elimination of audit redundancies Standardization of audit methodology, policies and procedures Standardization of audit methodology, policies and procedures Communication of Lessons Learned Communication of Lessons Learned Reduction of overall Department risks and liabilities Reduction of overall Department risks and liabilities Program Implementation: Administrative funding by DOE-HSS Headquarters through the Analytical Services Program Administrative funding by DOE-HSS Headquarters through the Analytical Services Program Linked to Site and Contractor laboratory contractual agreements Linked to Site and Contractor laboratory contractual agreements Involves participation by all DOE line and field organizations Involves participation by all DOE line and field organizations Auditors are primarily DOE contractors Auditors are primarily DOE contractors Auditors are trained and qualified Auditors are trained and qualified Federal DOE staff supplement laboratory audit staff Federal DOE staff supplement laboratory audit staff

5. Audit Findings Priority I Finding: Key programmatic/systematic failure Key programmatic/systematic failure Imminent threat to worker or public safety/health Imminent threat to worker or public safety/health Documented unlawful or unethical practices Documented unlawful or unethical practices Significant data quality failures Significant data quality failures Failure to implement corrective actions/repeat deficiencies Failure to implement corrective actions/repeat deficiencies Priority II Finding: Nonconformance with internal requirements/procedures Nonconformance with internal requirements/procedures Undocumented procedures or processes Undocumented procedures or processes Nonconformance with DOE requirements Nonconformance with DOE requirementsObservation: Isolated instance or minor deficiency Isolated instance or minor deficiency Opportunity for improvement Opportunity for improvement

6. Audit Checklists DOECAP Laboratory Checklists Module 1 -Quality Assurance Management Systems and General Laboratory Practices Module 2 -Data Quality for Organic Analyses Module 3 - Data Quality for Inorganic and Wet Chemistry Analyses Module 4 - Data Quality for Radiochemistry Analyses Module 5 - Laboratory Information Management Systems and Electronic Data Management Module 6 - Hazardous and Radioactive Materials Management

7. Laboratory Findings by Audit Discipline

8. Findings and Observations/ Laboratory Over Past Nine Fiscal Years

9. Laboratory and Commercial Waste Vendor Contractual Agreements Projected FY09 DOECAP Audited Facilities Utilized by Each DOE Site

10. Common Labora tor y Findings QA Management Systems and General Laboratory Practices A lack of SOPs or inadequate SOP content, particularly in sub-sampling and support equipment maintenance. A lack of SOPs or inadequate SOP content, particularly in sub-sampling and support equipment maintenance. QAP deficiencies including a lack of direction for internal assessments, certification documentation, major equipment documentation, etc. QAP deficiencies including a lack of direction for internal assessments, certification documentation, major equipment documentation, etc. Inadequate or untimely closure of corrective actions. Inadequate or untimely closure of corrective actions. A lack of logbook review, with incomplete or inconsistent implementation of corrections. A lack of logbook review, with incomplete or inconsistent implementation of corrections. Lack of back-up systems to prevent catastrophic loss of samples (i.e., monitoring refrigerators on a calendar day basis). Lack of back-up systems to prevent catastrophic loss of samples (i.e., monitoring refrigerators on a calendar day basis). Inadequate control of log books, notebooks, or operational aids. Inadequate control of log books, notebooks, or operational aids. Failure to notify clients of accreditation loss or Performance Testing failures. Failure to notify clients of accreditation loss or Performance Testing failures.

11. Common Labora tor y Findings Data Quality for Organic Analyses All target analytes are not included in matrix spikes or laboratory control samples over a two year period. All target analytes are not included in matrix spikes or laboratory control samples over a two year period. Calibration deficiencies. Calibration deficiencies. Data Quality for Inorganic and Wet Chemistry Analyses SOPs do not reflect actual practices being implemented in the lab. SOPs do not reflect actual practices being implemented in the lab. Failure to utilize a solid matrix for laboratory control samples during analysis of soil and other solid matrices. Failure to utilize a solid matrix for laboratory control samples during analysis of soil and other solid matrices. Consecutive Performance Test failures in soil matrices. Consecutive Performance Test failures in soil matrices.

12. Common Labora tor y Findings Data Quality for Radiochemistry Analyses Consecutive Performance Test failures in soil matrices. Consecutive Performance Test failures in soil matrices. Inadequate documentation and references for gamma and alpha spectroscopy instrument libraries. Inadequate documentation and references for gamma and alpha spectroscopy instrument libraries. Methods and/or practices do not include all required Programmatic QC elements. Methods and/or practices do not include all required Programmatic QC elements. Laboratory Information Management Systems and Electronic Data Management Lack of computer hardware/software security measures (e.g., controlled server access, unprotected spreadsheet formulas for calculating data). Lack of computer hardware/software security measures (e.g., controlled server access, unprotected spreadsheet formulas for calculating data). Inadequate inspections and testing of software and electronic data. Inadequate inspections and testing of software and electronic data. An absence of SOPs and system documentation. An absence of SOPs and system documentation.

13. Common Labora tor y Findings Hazardous and Radioactive Materials Management Deficiencies in sample receipt of potentially radiological materials. Deficiencies in sample receipt of potentially radiological materials. Inadequate tracking and documentation of unused sample portions to disposal or return to client. Inadequate tracking and documentation of unused sample portions to disposal or return to client.

14. FY09 Laboratory Audit Schedule Laboratory Proposed MonthLaboratory Proposed Month S&ME, Inc October 2008 Paragon March 2009 Assaigai October 2008 SwRI April 2009 Test America, Knoxville November 2008 GEL April 2009 GPL, Maryland December 2008 EMAX April 2009 USEC Paducah December 2008 BC Laboratories May 2009 ORISE, Oak Ridge January 2009 USEC Portsmouth May 2009 Eberline Oak Ridge January 2009 Shaw May 2009 BWXT Lynchburg February 2009 Test America, Richland June 2009 UTB RMAL February 2009 Davis and Floyd June 2009 Eberline Richmond February 2009 Caltest June 2009 Xenco February 2009 CEBAM June 2009 MCL March 2009 Test America, Arvada July 2009 Lionville March 2009 Shealy Environmental July 2009 GPL, Alabama March 2009 DataChem SLC July 2009 Test America, St. Louis March 2009 ARS July 2009 * Highlighted Laboratories are both DOE/DOD Audited Laboratories

15. MAPEP Background Program Purpose: To test and evaluate environmental analytical laboratory performance. To test and evaluate environmental analytical laboratory performance. To provide defensible data that instills confidence in DOE decision- making. To provide defensible data that instills confidence in DOE decision- making. Program Focus: ISO 17025 Accredited PT Provider with traceability to NIST ISO 17025 Accredited PT Provider with traceability to NIST Radiological, stable inorganic, and organic analyses. Radiological, stable inorganic, and organic analyses. Soil, water, air filter, and vegetation media. Soil, water, air filter, and vegetation media. Interaction with DOECAP and QSAS. Interaction with DOECAP and QSAS. - MAPEP required for all laboratories performing analysis for DOE

16. MAPEP Laboratories MAPEP Laboratory Participants: 109Domestic Laboratories 109Domestic Laboratories 17 International Laboratories 17 International Laboratories - Nuclear Test Ban Treaty Laboratories New Zealand (1); Brazil (1) - Cooperative Monitoring Canada (2); United Kingdom (2) - Middle Eastern Nations Jordan (3); Irag (1); Oman (1); Kuwait (1); Qatar (1); Turkey(1); Morocco (1); Israel (1) - International Atomic Energy Agency (1)

17. MAPEP Accomplishments DOE’s - Radiological and Environmental Sciences Laboratory (RESL) on the Idaho National Laboratory, Idaho Falls, Idaho ISO 17025 Accredited Proficiency Test Provider (American Association for Laboratory Accreditation (A2LA) approval on a 2 year cycle) ISO 17025 Accredited Proficiency Test Provider (American Association for Laboratory Accreditation (A2LA) approval on a 2 year cycle) RESL won A-76 Study competition for outsourcing RESL won A-76 Study competition for outsourcing Letter of Obligation – formalizes work commitments Letter of Obligation – formalizes work commitments (3 yrs./2 option years) MOU – NE/HSS/RESL defines roles/responsibilities MOU – NE/HSS/RESL defines roles/responsibilities

18. MAPEP Initiatives Test session 20 distribution (March 2009)Test session 20 distribution (March 2009) Test session 21 distribution (September 2009)Test session 21 distribution (September 2009) 60 day timeframe for laboratory reporting test results to RESL60 day timeframe for laboratory reporting test results to RESL New remedial PT sample policy – one remedial attempt, then must also pass subsequent routine PT sessionNew remedial PT sample policy – one remedial attempt, then must also pass subsequent routine PT session HSS Letters of Concern for consecutive PT failuresHSS Letters of Concern for consecutive PT failures Track and trend reasons for Letters of ConcernTrack and trend reasons for Letters of Concern

19. Proficiency Testing Analyses Fiscal YearSeries Number of MAPEP Samples # of Analyses by Laboratories FY0715 & 16109813628 FY0817 & 18113613605 FY0919 & 20120014000 MAPEP Matrix Series 19Matrix Id.Total SamplesForeign Labs Mixed-Analyte SoilMaS11316 Mixed-Analyte WaterMaW13317 Semi-volatile Organic WaterOrW380 Radiological VegetationRdV7015 Radiological Air FiltersRdF8713 Gross alpha/beta WaterGrW7211 Gross alpha/beta FilterGrF758 Samples Distributed to Participating Laboratories, MAPEP Series 19 (2008) Increase in Samples Distributed and Analyses by Laboratories

20. Laboratory Auditing and Proficiency Test Preparation

21. Radiological Analysis Liquid Scintillation Counting

22. 2009 ASP Workshop Date:September 13-17, 2009 Location:Snow King Lodge Jackson Hole, Wyoming Jackson Hole, Wyoming

23. ASP Program Contact Information George E. Detsis, Analytical Services Program (ASP) Manager Phone: (301) 903-1488 E-mail: George.Detsis@hq.doe.gov George.Detsis@hq.doe.gov Jorge Ferrer - DOECAP Manager, DOE Oak Ridge Phone: (865) 576-6638 E-mail: ferrerja@oro.doe.gov @oro.doe.gov@oro.doe.gov Guy Marlette, MAPEP Coordinator, Idaho National Laboratory Phone: (208) 526-2532 E-mail: marletgm@id.doe.gov Brent Pulsifer, VSP Coordinator, Pacific Northwest National Laboratory Phone: (509) 375-3989 E-mail: Brent.Pulsipher@pnl.gov