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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: [email protected]
Carolyne Thomas - Carolyne Thomas - DOECAP Manager, DOECAP Manager, DOE Oak Ridge DOE Oak Ridge Phone: (865) 576-2690Phone: (865) 576-2690E-mail: E-mail: [email protected]
Guy MarletteGuy Marlette, , MAPEP Coordinator, MAPEP Coordinator, Idaho National LaboratoryIdaho National LaboratoryPhone: (208) 526-2532Phone: (208) 526-2532E-mail: E-mail: [email protected]@id.doe.gov
Brent PulsiferBrent Pulsifer, , VSP Coordinator, VSP Coordinator, Pacific Northwest NationalPacific Northwest NationalLaboratoryLaboratoryPhone: (509) 375-3989Phone: (509) 375-3989E-mail: E-mail: [email protected]@pnl.gov
Questions