A Corporate Overview of the A Corporate Overview of the Analytical Services ProgramAnalytical Services Program

George E. DetsisGeorge E. DetsisManager, Analytical Services ProgramManager, Analytical Services Program

Office of Corporate Safety Programs, HS-31Office of Corporate Safety Programs, HS-31

ASER Workshop/ASER Workshop/

Environmental Monitoring Meeting 2008Environmental Monitoring Meeting 2008Idaho Falls, Idaho Idaho Falls, Idaho

October 6-9, 2008October 6-9, 2008

OverviewOverview

• 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 Report on the Audit of DOE’s Commercial Laboratory Quality Assurance Evaluation Program Laboratory Quality Assurance Evaluation Program (June 1995)(June 1995)– Some laboratories were audited numerous Some laboratories were audited numerous

times; others were never auditedtimes; others were never audited– Evaluation methods varied significantly from Evaluation methods varied significantly from

one contractor to anotherone contractor to another– Audit results were not shared between Audit results were not shared between

contractors contractors

DOE’s response to the DOE’s response to the IG ReportIG Report

• Eliminate redundant audits between various DOE field Eliminate redundant audits between various DOE field element siteselement sites– Perform two-thirds fewer auditsPerform two-thirds fewer audits– Resulting cost savings to taxpayer – $ 2.3 millionResulting cost savings to taxpayer – $ 2.3 million

• Standardized audit methodology and proceduresStandardized audit methodology and procedures– Quality Systems for Analytical Services (QSAS)Quality Systems for Analytical Services (QSAS)– Audit checklistsAudit checklists

• Improved communicationsImproved communications– Electronic Data SystemElectronic Data System– Weekly Conference CallsWeekly Conference Calls– Annual Meeting/Annual ReportAnnual Meeting/Annual Report

DOECAP BackgroundDOECAP Background

• HSS-HQ funded/oversight/guidance/direction; DOE-ORO HSS-HQ funded/oversight/guidance/direction; DOE-ORO implementationimplementation

• Program ownership – DOE line organizations and field Program ownership – DOE line organizations and field operatorsoperators

• Not an approval or certification audit program Not an approval or certification audit program

• Volunteer auditors primarily DOE contractors/Federal TSDF Volunteer auditors primarily DOE contractors/Federal TSDF team leaders/auditorsteam leaders/auditors

DOECAP DOECAP Organizational StructureOrganizational Structure

HSS Analytical Services Program Manager

George Detsis

DOECAP ManagerCarolyne Thomas

Deputy DOECAP Manager

Richard Martin

Operations Team Leader

Nile Luedtke

Technical Operations CoordinatorJoe Pardue

Corrective Actions

CoordinatorSusan Aderholdt

Qualification CoordinatorTodd Hardt

Document Control

CoordinatorRhonda Jobe

Results of FormalizedResults of FormalizedDOE Auditing ProgramDOE Auditing Program

DOECAP reduced the Department’s risks and DOECAP reduced the Department’s risks and

liabilities through auditing analytical liabilities through auditing analytical laboratories, andlaboratories, and

verified radioactive and chemical waste verified radioactive and chemical waste dispositiondisposition

FYO8 DOECAP Auditing Activities:FYO8 DOECAP Auditing Activities:30 Analytical Environmental Laboratories30 Analytical Environmental Laboratories

1 Laboratory Surveillance1 Laboratory Surveillance

7 TSDF’s7 TSDF’s

1 Non-radiological TSDF scoping1 Non-radiological TSDF scoping

Criteria DefinitionsCriteria Definitions• Priority I Finding:Priority I Finding:

Programmatic/systematic failure Programmatic/systematic failure Imminent threat to worker safety/healthImminent threat to worker safety/health Potential for major property/facility damagePotential for major property/facility damage Repeated deficiencyRepeated 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 improvementOpportunity for improvement

What does this all mean?What does this all mean?

• DOECAP conducted 38 DOECAP conducted 38 audits in FY2008audits in FY2008

• 84% of all FY2007 audit 84% of all FY2007 audit findings were closed during findings were closed during FY2008:FY2008:– 83% of the laboratory 83% of the laboratory

findingsfindings– 86% of the TSDF findings86% of the TSDF findings

• New Findings Identified:New Findings Identified:– FY2006 = 233FY2006 = 233– FY2007 = 340FY2007 = 340– FY2008 = 218FY2008 = 218

Priority I FindingsPriority 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 ChecklistsDOECAP Audit Checklists

Laboratory ChecklistsLaboratory Checklists• Checklist 1 – QA and General Laboratory Checklist 1 – QA and General Laboratory

PracticesPractices

• Checklist 2 – Data Quality for Organic AnalysesChecklist 2 – Data Quality for Organic Analyses

• Checklist 3 – Data Quality for Inorganic Checklist 3 – Data Quality for Inorganic AnalysesAnalyses

• Checklist 4 – Data Quality for Radiochemistry Checklist 4 – Data Quality for Radiochemistry AnalysesAnalyses

• Checklist 5 - Laboratory Information Checklist 5 - Laboratory Information Management Systems/Electronic Data Management Systems/Electronic Data ManagementManagement

• Checklist 6 – Hazardous and Radioactive Checklist 6 – Hazardous and Radioactive Materials Management Materials Management

• Checklist 7 – Geotechnical MeasurementsChecklist 7 – Geotechnical Measurements

• Checklist 8 – Aquatic ToxicityChecklist 8 – Aquatic Toxicity

• Checklist 9 – Non Destructive AssayChecklist 9 – Non Destructive Assay

• Checklist 10 – Laboratory ClosuresChecklist 10 – Laboratory Closures

TSDF ChecklistsTSDF Checklists• Checklist 1 – Quality Assurance Checklist 1 – Quality Assurance

Management SystemsManagement Systems

• Checklist 2 - Sampling and Checklist 2 - Sampling and Analytical Data QualityAnalytical Data Quality

• Checklist 3 – Waste OperationsChecklist 3 – Waste Operations

• Checklist 4 – Environmental Checklist 4 – Environmental Compliance and PermittingCompliance and Permitting

• Checklist 5 – Radiological Checklist 5 – Radiological ControlControl

• Checklist 6 – Industrial & Checklist 6 – Industrial & Chemical SafetyChemical Safety

• Checklist 7 – Transportation Checklist 7 – Transportation ManagementManagement

Perspective/ContextPerspective/Context

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

Distribution FY 2008 Distribution FY 2008 Priority II Lab FindingsPriority II Lab Findings

FY00- FY08 Priority II FY00- FY08 Priority II Laboratory FindingsLaboratory Findings

0

100

200

300

400

500

600

700

QA ORG INO RAD LIMS HWM GEO

677

325410

515

214

617

2

Analytical Laboratory Analytical Laboratory Key FindingsKey Findings

• Incomplete or inconsistent SOPs/PlansIncomplete or inconsistent SOPs/Plans

- not reviewed/updated on a timely basis- not reviewed/updated on a timely basis

- adherence - SOPs do not reflect approved laboratory - adherence - SOPs do not reflect approved laboratory

practicespractices

• Inadequate training, and lack of training documentationInadequate training, and lack of training documentation

- employee training requirements not met- employee training requirements not met

- employee training documentation files incomplete- employee training documentation files incomplete

• Unacceptable performance testing resultsUnacceptable performance testing results

- ineffective corrective actions- ineffective corrective actions

- root causes not addressed resulting in reoccurrence of - root causes not addressed resulting in reoccurrence of

PT failuresPT failures

TENTATIVE FY09 TENTATIVE FY09 LAB AUDIT SCHEDULELAB AUDIT SCHEDULE

Laboratory Proposed Month Laboratory Proposed Month

S&ME, Inc October 20-21, 2008

BC Laboratories April 2009

Assaigai October 2008 GEL Laboratories April 2009

BWXT-Y12 November 2008 Xenco April 2009

GPL Alabama November 2008 EMAX May 2009

GPL Maryland December 2008 Lionville May 2009

Test America Knoxville

December 2008 Portsmouth Analytical

May 2009

Babcock & Wilcox January 2009 Shaw May 2009

Eberline Oak Ridge January 2009 Caltest June 2009

Paducah Analytical January 2009 CEBAM June 2009

Materials & Chemistry

February 2009 Davis and Floyd June 2009

UTB RMAL February 2009 Test America Richland

June 2009

Eberline Richmond February 2009 ARS July 2009

Paragon Analytics March 2009 DataChem July 2009

Southwest Research

March 2009 Shealy July 2009

Test America St. Louis

March 2009 Test America Arvada

July 2009

Distribution FY 2008 Distribution FY 2008 Priority II TSDF FindingsPriority II TSDF Findings

FY00- FY08 Priority II FY00- FY08 Priority II TSDF Findings TSDF Findings

0

20

40

60

80

100

120

140

QA DQ WO EC RC SH TR

8066

32

121

59

82

59

TSDF Key FindingsTSDF Key Findings• Quality Assurance

not following operating procedures training documentation

• Environmental Compliance

non-conformances with permit/regulatoryrequirements (e.g., aisle spacing, labeling, incompatible storage, waste identification,secondary containment, etc.)

• Transportation Management

incomplete paperworktracking and filing shipments

TENTATIVE FY09 TENTATIVE FY09 TSDF AUDIT SCHEDULETSDF AUDIT SCHEDULE

Facility Proposed MonthDiversified Scientific Services, Inc November 18-20, 2008Energy Solutions- Tennessee January 13-15, 2009Materials and Energy Corporation February 2009Perma-Fix Florida March 10-12, 2009Energy Solutions – Utah April 2009Perma-Fix Northwest May 2009Waste Control Specialist June 2009

DOECAP ChallengesDOECAP Challenges

• Increase number of Federal team leadersIncrease number of Federal team leaders

• Increase auditor poolIncrease auditor pool

- TSDFs (radiological control, and industrial and chemical safety)- TSDFs (radiological control, and industrial and chemical safety)

- Laboratories (laboratory information management systems/electronic - Laboratories (laboratory information management systems/electronic data management, hazardous and radioactive materials data management, hazardous and radioactive materials management)management)

• Improve POCs active participation -- HQ/fieldImprove POCs active participation -- HQ/field

• Improve localization/regional auditor participation to reduce travel costsImprove localization/regional auditor participation to reduce travel costs

• Considerations for External Release of DOECAP Reports/Corrective Considerations for External Release of DOECAP Reports/Corrective Action PlansAction Plans

DOECAP Challenges (Cont.)DOECAP Challenges (Cont.)

• Improve program ownership/responsibilityImprove program ownership/responsibility

• Incorporate DOECAP reference/requirement Incorporate DOECAP reference/requirement into DOE contract language into DOE contract language

• Incorporate DOECAP as a requirement in Incorporate DOECAP as a requirement in DOE OrderDOE Order

Website: Website: https://doecap.oro.doe.gov

MAPEP BackgroundMAPEP 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 - 109 domestic analytical laboratories - 17 international laboratories

Nuclear Test Ban TreatyNew Zealand (1)Brazil (1)

Cooperative MonitoringCanada (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 ConcernMAPEP – Letters of Concern

• MAPEP issues “Letters of Concern” to participants that MAPEP issues “Letters of Concern” to participants that demonstrate a performance trend that suggests there demonstrate a performance trend that suggests there is a potential quality problemis a potential quality problem

• The letters are issued to help ensure that the The letters are issued to help ensure that the laboratory and its stakeholders are aware of the laboratory and its stakeholders are aware of the potential problempotential problem

• Copies are sent to Points of Contact at DOE-HSS HQ, Copies are sent to Points of Contact at DOE-HSS HQ, DOE Field Offices, Sample Management Offices, DOE Field Offices, Sample Management Offices, DOECAP, and other stakeholdersDOECAP, and other stakeholders

MAPEP – Letters of ConcernMAPEP – Letters of ConcernNumber of Letters Issued Compared to the Number of Letters Issued Compared to the

Number of ParticipantsNumber of Participants

• 45 Letters of Concern were issued after test 45 Letters of Concern were issued after test session 18 among 124 participating laboratoriessession 18 among 124 participating laboratories

• 45/124 = 45/124 = 36.3 %36.3 % of participants received a Letter of participants received a Letter of Concernof Concern

• This indicates that it is difficult for laboratories to This indicates that it is difficult for laboratories to consistently maintain “Acceptable” performance consistently maintain “Acceptable” performance across all targeted analytes in all sample across all targeted analytes in all sample matricesmatrices

MAPEP – Letters of ConcernMAPEP – Letters of ConcernNumber of Letters Issued Compared to the Number of Letters Issued Compared to the

Number of Analyses PerformedNumber of Analyses Performed

• 8686 analytes were targeted for test session 18 analytes were targeted for test session 18

• Total analyses performed for consecutive test Total analyses performed for consecutive test sessions 17 and 18 were sessions 17 and 18 were 7030 + 6575 = 136057030 + 6575 = 13605 analysesanalyses

• 45 Letters per 13605 analyses indicates about 45 Letters per 13605 analyses indicates about 0.3 %0.3 % of the analyses performed triggered issuing of the analyses performed triggered issuing a Letter of Concerna Letter of Concern

MAPEP Program ChallengesMAPEP 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 ToolkitsSoftware Development Toolkits Background Background

Visual Sample Planning

Improves quality of environmental field/facility sampling strategies while minimizing number of samples neededto meet regulatory requirements

Software Development ToolkitsSoftware Development Toolkits Program Challenges 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: http://dqo.pnl.gov/vsp

PipelinePipeline

Assuring Environmental Data QualityHazardous WasteTreatment/Disposal Management

Ongoing Field Operations Environmental Remediation Decontamination and Decommissioning

ASP Program Contact Information

George Detsis, George Detsis, Analytical Services Program (ASP) Analytical Services Program (ASP) ManagerManager

Phone: (301) 903-1488Phone: (301) 903-1488E-mail:  E-mail:  George.Detsis@hq.doe.gov

Carolyne Thomas - Carolyne Thomas - DOECAP Manager, DOECAP Manager, DOE Oak Ridge DOE Oak Ridge Phone: (865) 576-2690Phone: (865) 576-2690E-mail:  E-mail:  thomascf@oro.doe.gov

Guy MarletteGuy Marlette, , MAPEP Coordinator, MAPEP Coordinator, Idaho National LaboratoryIdaho National LaboratoryPhone: (208) 526-2532Phone: (208) 526-2532E-mail: E-mail: marletgm@id.doe.govmarletgm@id.doe.gov

Brent PulsiferBrent Pulsifer, , VSP Coordinator, VSP Coordinator, Pacific Northwest NationalPacific Northwest NationalLaboratoryLaboratoryPhone: (509) 375-3989Phone: (509) 375-3989E-mail: E-mail: Brent.Pulsipher@pnl.govBrent.Pulsipher@pnl.gov

Questions