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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
Presentation Outline
• Mission Statement
• Auditing Background
• Audit Checklists
• Laboratory Audit Findings
• Laboratory Audit Schedule FY09
• Proficiency Testing Background
• Proficiency Testing Accomplishments
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.
DOECAP Background
Program Purpose:
• Elimination of audit redundancies
• Standardization of audit methodology, policies and procedures
• Communication of Lessons Learned
• Reduction of overall Department risks and liabilities
Program Implementation:
• Administrative funding by DOE-HSS Headquarters through the
Analytical Services Program
• Linked to Site and Contractor laboratory contractual agreements
• Involves participation by all DOE line and field organizations
• Auditors are primarily DOE contractors
• Auditors are trained and qualified
• Federal DOE staff supplement laboratory audit staff
Audit Findings
Priority I Finding:
• Key programmatic/systematic failure
• Imminent threat to worker or public safety/health
• Documented unlawful or unethical practices
• Significant data quality failures
• Failure to implement corrective actions/repeat deficiencies
Priority II Finding:
• Nonconformance with internal requirements/procedures
• Undocumented procedures or processes
• Nonconformance with DOE requirements
Observation:
• Isolated instance or minor deficiency
• Opportunity for improvement
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
Laboratory Findings by
Audit Discipline
Percent Distribution of DOECAP Laboratory Priority ll Findings per Audit Area
Hazardous &
Radioactive Materials
Management
18%
Quality Assurance
34%
LIMS
4%
Radiochemistry
14%
Organic
12%
Inorganic
18%
FY08
Findings and Observations/ Laboratory
Over Past Nine Fiscal Years
60
Findings & Observations / Laboratory
50
Findings
40
Observations
30 Totals
20
10
0
2000 2001 2002 2003 2004 2005 2006 2007 2008
Fiscal Year Audit Cycle
Laboratory Audit Performance Statistics
Laboratory and Commercial Waste
Vendor Contractual Agreements
Projected FY09 DOECAP Audited Facilities Utilized by Each DOE Site
Savannah River Office
Sandia Nat'l Lab
Pantex Operations
Paducah Operations
Nevada Office
Legacy Management
Lawrence Livermore Nat'l Lab
# Audited Labs Used
Lawrence Berkley Nat'l Lab
Los Alamos Nat'l Lab # Audited TSDFs Used
Idaho Office
Richland Office
Oak Ridge Office
0
5
10
15
20
25
Common Laboratory Findings
QA Management Systems and General Laboratory Practices
• 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.
• Inadequate or untimely closure of corrective actions.
• 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).
• Inadequate control of log books, notebooks, or operational aids.
• Failure to notify clients of accreditation loss or Performance Testing failures.
Common Laboratory Findings
Data Quality for Organic Analyses
• All target analytes are not included in matrix spikes or laboratory control
samples over a two year period.
• Calibration deficiencies.
Data Quality for Inorganic and Wet Chemistry Analyses
• 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.
• Consecutive Performance Test failures in soil matrices.
Common Laboratory Findings
Data Quality for Radiochemistry Analyses
• Consecutive Performance Test failures in soil matrices.
• Inadequate documentation and references for gamma and alpha spectroscopy
instrument libraries.
• 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).
• Inadequate inspections and testing of software and electronic data.
• An absence of SOPs and system documentation.
Common Laboratory Findings
Hazardous and Radioactive Materials Management
• Deficiencies in sample receipt of potentially radiological materials.
• Inadequate tracking and documentation of unused sample portions to disposal
or return to client.
FY09 Laboratory Audit Schedule
Laboratory Proposed Month Laboratory 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
MAPEP Background
Program Purpose:
• To test and evaluate environmental analytical laboratory
performance.
• To provide defensible data that instills confidence in DOE decision-
making.
Program Focus:
• ISO 17025 Accredited PT Provider with traceability to NIST
• Radiological, stable inorganic, and organic analyses.
• Soil, water, air filter, and vegetation media.
• Interaction with DOECAP and QSAS.
- MAPEP required for all laboratories performing analysis for DOE
MAPEP Laboratories
MAPEP Laboratory Participants:
• 109 Domestic 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)
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)
• RESL won A-76 Study competition for outsourcing
• Letter of Obligation – formalizes work commitments
(3 yrs./2 option years)
• MOU – NE/HSS/RESL defines roles/responsibilities
MAPEP Initiatives
• Test session 20 distribution (March 2009)
• Test session 21 distribution (September 2009)
• 60 day timeframe for laboratory reporting test results to RESL
• New remedial PT sample policy – one remedial attempt, then
must also pass subsequent routine PT session
• HSS Letters of Concern for consecutive PT failures
• Track and trend reasons for Letters of Concern
Proficiency Testing Analyses
Samples Distributed to Participating Laboratories, MAPEP Series 19 (2008)
MAPEP Matrix Series 19 Matrix Id. Total Samples Foreign Labs
Mixed-Analyte Soil MaS 113 16
Mixed-Analyte Water MaW 133 17
Semi-volatile Organic Water OrW 38 0
Radiological Vegetation RdV 70 15
Radiological Air Filters RdF 87 13
Gross alpha/beta Water GrW 72 11
Gross alpha/beta Filter GrF 75 8
Increase in Samples Distributed and Analyses by Laboratories
Number of # of Analyses by
Fiscal Year Series
MAPEP Samples Laboratories
FY07 15 & 16 1098 13628
FY08 17 & 18 1136 13605
FY09 19 & 20 1200 14000
Laboratory Auditing and
Proficiency Test Preparation
Radiological Analysis
Liquid Scintillation Counting
2009 ASP Workshop
Date: September 13-17, 2009
Location: Snow King Lodge
Jackson Hole, Wyoming
ASP Program Contact Information
George E. Detsis, Analytical Services Program (ASP) Manager
Phone: (301) 903-1488
E-mail: George.Detsis@hq.doe.gov
Jorge Ferrer - DOECAP Manager, DOE Oak Ridge
Phone: (865) 576-6638
E-mail: ferrerja@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
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