A Corporate Overview of the Analytical Services Program George E. Detsis Manager, Analytical Services Program Office of Corporate Safety Programs, HS-31 ASER Workshop/ Environmental Monitoring Meeting 2008 Idaho Falls, Idaho October 6-9, 2008

Overview Analytical Services Program – 3 Component Elements - Auditing - Proficiency Testing - Data Collection Program Challenges Pipeline Program Contacts

Overview of Analytical Services Program

Finding from DOE’s Office of the Inspector General Report on the Audit of DOE’s Commercial Laboratory Quality Assurance Evaluation Program (June 1995) Report on the Audit of DOE’s Commercial Laboratory Quality Assurance Evaluation Program (June 1995) –Some laboratories were audited numerous times; others were never audited –Evaluation methods varied significantly from one contractor to another –Audit results were not shared between contractors

DOE’s response to the IG Report Eliminate redundant audits between various DOE field element sites Eliminate redundant audits between various DOE field element sites –Perform two-thirds fewer audits –Resulting cost savings to taxpayer – $ 2.3 million Standardized audit methodology and procedures Standardized audit methodology and procedures –Quality Systems for Analytical Services (QSAS) –Audit checklists Improved communications Improved communications – Electronic Data System – Weekly Conference Calls – Annual Meeting/Annual Report

DOECAP Background HSS-HQ funded/oversight/guidance/direction; DOE-ORO implementation HSS-HQ funded/oversight/guidance/direction; DOE-ORO implementation Program ownership – DOE line organizations and field operators Program ownership – DOE line organizations and field operators Not an approval or certification audit program Not an approval or certification audit program Volunteer auditors primarily DOE contractors/Federal TSDF team leaders/auditors Volunteer auditors primarily DOE contractors/Federal TSDF team leaders/auditors

DOECAP Organizational Structure HSS Analytical Services Program Manager George Detsis DOECAP Manager Carolyne Thomas Deputy DOECAP Manager Richard Martin Operations Team Leader Nile Luedtke Technical Operations Coordinator Joe Pardue Corrective Actions Coordinator Susan Aderholdt Qualification Coordinator Todd Hardt Document Control Coordinator Rhonda Jobe

Results of Formalized DOE Auditing Program DOECAP reduced the Department’s risks and liabilities through auditing analytical laboratories, and verified radioactive and chemical waste disposition FYO8 DOECAP Auditing Activities: 30 Analytical Environmental Laboratories 1 Laboratory Surveillance 1 Laboratory Surveillance 7 TSDF’s 7 TSDF’s 1 Non-radiological TSDF scoping 1 Non-radiological TSDF scoping

Criteria Definitions Priority I Finding: Priority I Finding: Programmatic/systematic failure Programmatic/systematic failure Imminent threat to worker safety/health Imminent threat to worker safety/health Potential for major property/facility damage Potential for major property/facility damage Repeated deficiency Repeated deficiency Priority II Finding: Priority II Finding: Nonconformance with internal requirements/procedures Nonconformance with internal requirements/procedures Undocumented procedures Undocumented procedures Nonconformance with DOE requirements Nonconformance with DOE requirements Observation: Observation: Isolated instance/deficiency Isolated instance/deficiency Opportunity for improvement Opportunity for improvement

What does this all mean? DOECAP conducted 38 audits in FY2008 DOECAP conducted 38 audits in FY % of all FY2007 audit findings were closed during FY2008: 84% of all FY2007 audit findings were closed during FY2008: –83% of the laboratory findings –86% of the TSDF findings New Findings Identified: New Findings Identified: –FY2006 = 233 –FY2007 = 340 –FY2008 = 218

Priority I Findings Uranium - soil (1) Uranium - soil (1) Antimony - soil (2) Antimony - soil (2) Tetryl - soil/water (1) Tetryl - soil/water (1) Organochlorine pesticides - soil (1) Organochlorine pesticides - soil (1)

DOECAP Audit Checklists Laboratory Checklists Checklist 1 – QA and General Laboratory Practices Checklist 1 – QA and General Laboratory Practices Checklist 2 – Data Quality for Organic Analyses Checklist 2 – Data Quality for Organic Analyses Checklist 3 – Data Quality for Inorganic Analyses Checklist 3 – Data Quality for Inorganic Analyses Checklist 4 – Data Quality for Radiochemistry Analyses Checklist 4 – Data Quality for Radiochemistry Analyses Checklist 5 - Laboratory Information Management Systems/Electronic Data Management Checklist 5 - Laboratory Information Management Systems/Electronic Data Management Checklist 6 – Hazardous and Radioactive Materials Management Checklist 6 – Hazardous and Radioactive Materials Management Checklist 7 – Geotechnical Measurements Checklist 7 – Geotechnical Measurements Checklist 8 – Aquatic Toxicity Checklist 8 – Aquatic Toxicity Checklist 9 – Non Destructive Assay Checklist 9 – Non Destructive Assay Checklist 10 – Laboratory Closures Checklist 10 – Laboratory Closures TSDF Checklists Checklist 1 – Quality Assurance Management Systems Checklist 1 – Quality Assurance Management Systems Checklist 2 - Sampling and Analytical Data Quality Checklist 2 - Sampling and Analytical Data Quality Checklist 3 – Waste Operations Checklist 3 – Waste Operations Checklist 4 – Environmental Compliance and Permitting Checklist 4 – Environmental Compliance and Permitting Checklist 5 – Radiological Control Checklist 5 – Radiological Control Checklist 6 – Industrial & Chemical Safety Checklist 6 – Industrial & Chemical Safety Checklist 7 – Transportation Management Checklist 7 – Transportation Management

Perspective/Context All 38 DOECAP audits conducted in FY08 were found to maintain the established management systems and operational activities necessary to meet DOE basic requirements for environmental data quality, and for the treatment and disposal of hazardous waste. However, DOECAP audits identified five Priority I findings at various analytical laboratories associated with multiple proficiency testing failures.

Distribution FY 2008 Priority II Lab Findings

FY00- FY08 Priority II Laboratory Findings

Analytical Laboratory Key Findings Incomplete or inconsistent SOPs/Plans Incomplete or inconsistent SOPs/Plans - not reviewed/updated on a timely basis - adherence - SOPs do not reflect approved laboratory practices practices Inadequate training, and lack of training documentation Inadequate training, and lack of training documentation - employee training requirements not met - employee training documentation files incomplete Unacceptable performance testing results Unacceptable performance testing results - ineffective corrective actions - root causes not addressed resulting in reoccurrence of PT failures PT failures

TENTATIVE FY09 LAB AUDIT SCHEDULE LaboratoryProposed MonthLaboratoryProposed Month S&ME, IncOctober 20-21, 2008BC LaboratoriesApril 2009 AssaigaiOctober 2008GEL LaboratoriesApril 2009 BWXT-Y12November 2008XencoApril 2009 GPL AlabamaNovember 2008EMAXMay 2009 GPL MarylandDecember 2008LionvilleMay 2009 Test America KnoxvilleDecember 2008Portsmouth AnalyticalMay 2009 Babcock & WilcoxJanuary 2009ShawMay 2009 Eberline Oak RidgeJanuary 2009CaltestJune 2009 Paducah AnalyticalJanuary 2009CEBAMJune 2009 Materials & ChemistryFebruary 2009Davis and FloydJune 2009 UTB RMALFebruary 2009Test America RichlandJune 2009 Eberline RichmondFebruary 2009ARSJuly 2009 Paragon AnalyticsMarch 2009DataChemJuly 2009 Southwest ResearchMarch 2009ShealyJuly 2009 Test America St. LouisMarch 2009Test America ArvadaJuly 2009

Distribution FY 2008 Priority II TSDF Findings

FY00- FY08 Priority II TSDF Findings

TSDF Key Findings Quality Assurance not following operating procedures training documentation Environmental Compliance non-conformances with permit/regulatory requirements (e.g., aisle spacing, labeling, incompatible storage, waste identification, secondary containment, etc.) Transportation Management incomplete paperwork tracking and filing shipments

TENTATIVE FY09 TSDF AUDIT SCHEDULE FacilityProposed Month Diversified Scientific Services, IncNovember 18-20, 2008 Energy Solutions- TennesseeJanuary 13-15, 2009 Materials and Energy Corporation February 2009 Perma-Fix FloridaMarch 10-12, 2009 Energy Solutions – UtahApril 2009 Perma-Fix NorthwestMay 2009 Waste Control SpecialistJune 2009

DOECAP Challenges Increase number of Federal team leaders Increase number of Federal team leaders Increase auditor pool Increase auditor pool - TSDFs (radiological control, and industrial and chemical safety) - Laboratories (laboratory information management systems/electronic data management, hazardous and radioactive materials management) Improve POCs active participation -- HQ/field Improve POCs active participation -- HQ/field Improve localization/regional auditor participation to reduce travel costs Improve localization/regional auditor participation to reduce travel costs Considerations for External Release of DOECAP Reports/Corrective Action Plans Considerations for External Release of DOECAP Reports/Corrective Action Plans

DOECAP Challenges (Cont.) Improve program ownership/responsibility Improve program ownership/responsibility Incorporate DOECAP reference/requirement into DOE contract language Incorporate DOECAP reference/requirement into DOE contract language Incorporate DOECAP as a requirement in DOE Order Incorporate DOECAP as a requirement in DOE Order Website:

MAPEP Background Purpose: To test and evaluate environmental samples to provide defensible data that instills confidence in DOE decision-making Program focus is radiological, stable inorganic, and organics - Media: soil, water, air filters, vegetation QSAS Section 5.9, DOE-1 - MAPEP is required for all laboratories that perform radiochemical analyses for DOE - Accredited PT program for performing radiochemical, organic, or inorganic analyses Program participation domestic analytical laboratories - 17 international laboratories Nuclear Test Ban Treaty New Zealand (1) Brazil (1) Cooperative Monitoring Canada (2) United Kingdom (2) Middle Eastern Nations Jordan (3) Iraq (1) Oman (1) Kuwait (1) Qatar (1) Turkey (1) Morocco (1) Israel (1) International Atomic Energy Agency (1)

MAPEP – Letters of Concern MAPEP issues “Letters of Concern” to participants that demonstrate a performance trend that suggests there is a potential quality problem MAPEP issues “Letters of Concern” to participants that demonstrate a performance trend that suggests there is a potential quality problem The letters are issued to help ensure that the laboratory and its stakeholders are aware of the potential problem The letters are issued to help ensure that the laboratory and its stakeholders are aware of the potential problem Copies are sent to Points of Contact at DOE-HSS HQ, DOE Field Offices, Sample Management Offices, DOECAP, and other stakeholders Copies are sent to Points of Contact at DOE-HSS HQ, DOE Field Offices, Sample Management Offices, DOECAP, and other stakeholders

MAPEP – Letters of Concern Number of Letters Issued Compared to the Number of Participants 45 Letters of Concern were issued after test session 18 among 124 participating laboratories 45 Letters of Concern were issued after test session 18 among 124 participating laboratories 45/124 = 36.3 % of participants received a Letter of Concern 45/124 = 36.3 % of participants received a Letter of Concern This indicates that it is difficult for laboratories to consistently maintain “Acceptable” performance across all targeted analytes in all sample matrices This indicates that it is difficult for laboratories to consistently maintain “Acceptable” performance across all targeted analytes in all sample matrices

MAPEP – Letters of Concern Number of Letters Issued Compared to the Number of Analyses Performed 86 analytes were targeted for test session analytes were targeted for test session 18 Total analyses performed for consecutive test sessions 17 and 18 were = analyses Total analyses performed for consecutive test sessions 17 and 18 were = analyses 45 Letters per analyses indicates about 0.3 % of the analyses performed triggered issuing a Letter of Concern 45 Letters per analyses indicates about 0.3 % of the analyses performed triggered issuing a Letter of Concern

MAPEP Program Challenges Incorporate contract language to use MAPEP as the vehicle of choice for performance evaluation and testing for laboratories directly/indirectly involved with DOE activities Improvements in PT tests results Market program – sell it and see the importance of it One shot - New remedial PT sample policy/must also pass subsequent PT test session Revise/update letters of concern Incorporate MAPEP as a DOE Order requirement

Software Development Toolkits Background Visual Sample Planning Improves quality of environmental field/facility sampling strategies while minimizing number of samples needed to meet regulatory requirements

Software Development Toolkits Program Challenges Institutionalize VSP across DOE as facilitator of defensible systemic planning and decision making Minimize sampling and analysis cost by reducing number of samples/wells required for confident decisions Ensuring most representative samples are obtained without losing hotspot detection ability (multi-increment sampling) Improve ability to visualize and communicate DQO-based decision support Website:

Pipeline Assuring Environmental Data Quality Hazardous Waste Treatment/Disposal Management Ongoing Field Operations Environmental Remediation Decontamination and Decommissioning

ASP Program Contact Information George Detsis, Analytical Services Program (ASP) Manager Phone: (301) Carolyne Thomas - DOECAP Manager, DOE Oak Ridge Phone: (865) Guy Marlette, MAPEP Coordinator, Idaho National Laboratory Phone: (208) Brent Pulsifer, VSP Coordinator, Pacific Northwest National Laboratory Phone: (509)

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