Laboratory Ethics An Overview Part II

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Laboratory Ethics An OverviewPart II

• What You Need To Know
• What You Need To Do

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What The Data User Can Do

• Adopt Best Practices for the Detection and
  Deterrence of Laboratory Fraud
• Utilize Contractual Agreements
• Adopt QAPP, SAMP, DQO and SOP
• Consider Third-Party Experts

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• Best Practices for the Detection and Deterrence
  of Laboratory Fraud
• California Military Environmental Coordination
  Committee
• March 1997

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Data Quality Objectives

• Provide a fundamental role in data collection
  activities
• Allows decision makers to define their data
  requirements and acceptable levels of data error,
  based on intended use of data
• Specifies relevant data quality requirements
  which could potentially impact data use
  limitations
• DQO process minimizes expenditures while
  producing data of sufficient quality for its
  intended use

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QA/QC Requirements in the Laboratory Contract

• Prior to awarding a contract, the laboratory
  QA/QC requirements should be evaluated
• Provides insight into the laboratorys ability to
  comply with contract and method specific
  requirements

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Laboratory Selection and Use of Phased Audits

• Laboratory Selection more than lowest price
• ? ? ? ? ?
• Two-phase audit and check system is a method for
  oversight of laboratory operations.
• The process includes a pre-award on-site audit
  and follow-up audit

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Pre-Award On-Site Audit

• Review of program requirements (QAPP, SAMP, DQO,
  SOP)
• Review of Laboratory Procedures
• Identify laboratorys technical or managerial
  capabilities (instrumentation, technical staff,
  internal QA program)

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Audit Reports

• Must be generated following each audit
• Laboratories should respond promptly to all audit
  findings
• Critical deficiencies must be satisfactorily
  resolved prior to commencement of program.
• Copies of audit reports should be provided to all
  interested regulatory agencies

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Monitoring Laboratory Performance Using Follow-up
Audits

• Verify the adequacy and maintenance of
  instrumentation
• Continuity of personnel meeting experience
  requirements
• Acceptable performance of analytical and QC
  procedures

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Performance Evaluation Samples

• PES are used to assess routine performance levels
  of laboratories
• General QA oversight of laboratories should
  include PES program
• Use of PES sends a message to a laboratory that
  the client is serious about performance of the
  laboratory

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Types of PES Programs

• Single-blind PES concentrations are unknown to
  the laboratory
• Double-blind PES concentration and identity are
  unknown to the laboratory

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Split-Sample Analyses

• Useful tool in detecting and deterring data
  quality problems
• Measure interlaboratory performance on sample
  matrices relevant to a program (drinking water,
  waste water, etc)
• Existence of split-samples can be divulged to
  primary laboratory or not

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Laboratory Performance Histories

• Performance histories are shared among utilities,
  regulatory agencies, government project managers,
  etc
• Certain third-party consultants maintain
  performance histories of laboratories

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Data Validation

• Strategy should be established at the beginning
  of a program / project
• All data should receive some level of review by
  an independent third-party contractor
• Laboratories are typically aware that data
  reports will be reviewed by a data validator, but
  not necessary to what extent (5, 20, 100)

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Electronic Data / Tape Audits

• Useful in deterring and detecting laboratory
  fraud
• Most types of laboratory fraud involve computer
  data manipulation
• Three types of electronic audits

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Laboratory Internal Electronic Data Audits

• Electronic data handling should be well
  documented by the laboratory
• Procedures for periodic audits to ensure
  compliance
• May be performed by in-house personnel or
• Sub-contracted to third-party consultants

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Independent On-Site Audits

• Performed during pre-award and follow-up audits
• Auditor follows an established list of procedures
• Encourages development of strong internal audit
  programs throughout laboratory industry

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Independent Off-Site Audits

• By far the most rigorous form of electronic data
  audits
• Definitive tool for detecting fraud with GC,
  GC/MS, ICAP, IC, HPLC
• Most effective tool in determining laboratory
  fraud
• Useful in determining the extent of damage once
  laboratory fraud has been identified

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Quality Assurance Officer

• Involved in the initial planning stages of a
  program / project
• Review QAPPs, SAMPs, FSPs, DQOs
• Involved in laboratory selection process
• Involved in laboratory audit program
• QAO duties may be sub-contracted to third-party
  consultants

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Electronic Data Deliverables

• Use of EDDs and electronic data verification (not
  validation) promotes objectivity, reduced costs,
  and offers data exchange
• Electronic data verification allows data
  validators to focus on areas of potential
  problems

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SOW and Ethical Conduct

• Laboratories should have a company ethics policy
  read and signed by all employees
• Training should be provided to staff
• Specific SOPs for each method performed by the
  laboratory should be written and maintained
• Laboratory management must provide adequate
  resources and assign sufficient authority to
  supervisors

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Use of More Than One Laboratory

• Reduces / eliminates overload
• Split-sample opportunities
• Similar results build confidence with clients
• Helps ensure that key decisions are not based on
  a single and potentially fraudulent data source

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Contractual Agreements

• Boiler plate language is available
• QA/QC requirements
• DQO requirements
• Specify intended use of data
• Pertinent documents must be included (or
  referenced) in the agreement

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QAPP ? SAMP ? DQO ? SOP

• Prepare Project Specific Documents Tailored To
  Sampling / Analytical Requirements
• Update Documents at Least Annually
• Make Documents Available to Necessary Personnel
  (Field, Lab, etc)
• Reference Documents in Contract Agreements

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Consider Third-Party Experts

• Provide Added Value to Program
• At Additional Cost
• Independent Parties with Respect to Business
  Decisions, Laboratory, Findings, Final Report,
  etc.
• Deterrent to Potential Fraud

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Laboratory Industry Reaction to Potential
Laboratory Fraud

• NELAC
• AOAC
• ACIL
• A2LA
• ISO / IEC 17025

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What The Laboratory Can Do

• Ethics References
• Ethics Policy or Statement
• Employee Ethics Agreements
• Ethics Communication
• Ethics Program Management
• Ethics Procedures
• Zero Tolerance Policy
• Ethics Assistance and Reporting Mechanism
• Compliance Plan
• Ethics Training
• Compliance Audits

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Non-Tangible Efforts

• Ensure Capacity
• Ensure Responsibility and Authority
• Demonstrate Accountability
• Scientific Approach
• Maintain Objectivity
• Maintain Impartiality
• Measurement Traceability
• Reproducibility
• Transparency

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Other Initiatives

• ACIL
• EPA Science Policy Council
• EPA Guidance Documents

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ACIL Environmental Laboratory Data Integrity
Initiative (ELDII)

• Fifteen Principles
• Seven Elements of Technical Administrative
  Conformance
• Signatory Process
• Application
• Review and Approval
• Approx. 70 U.S. laboratories
• Reviewed with EPA, OIG, and others
• GOAL ELDII Signatory

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EPA Science Policy CouncilAssessment Factors

• Soundness
• Applicability and Utility
• Clarity and Completeness
• Uncertainty and Variability
• Evaluation and Review

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EPA Guidance and Training

• Developing an SOP for detecting and reporting
  potentially fraudulent laboratory activities
• Presenting fraud awareness workshops to all EPA
  individuals who oversee CLP laboratories or data
• Increasing scrutiny of the data by data
  reviewers/validators
• Developing a fraud hotline
• Developing a fraud profile checklist for on-site
  auditors to prompt auditors to look for
  indicators of potential fraud
• Requiring use of bound laboratory notebooks

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EPA Guidance for Developing a Training Program
for Quality Systems

• EPA QA/G-10
• Document describes a process for developing a
  training program that assists users in meeting
  the require-ments of EPA Order 5360.1 A2.

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EPA Guidance on Assessing Quality Systems

• EPA QA/G-3
• Provides guidance for assessing quality systems,
  particularly for programs conducted by or funded
  by EPA

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Potential Laboratory Fraud and the Data User

• Fraudulent activities are being performed by
  laboratories
• Protect your program(s) by planning or
  reassessing your needs
• Utilize best practices whenever possible to meet
  your analytical requirements

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Discussion
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Test
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Further Reading

• Region 9 Best Practices for the Detection and
  Deterrence of Laboratory Fraud
• EPA Guidance on Assessing Quality Systems EPA
  QA/G-3
• EPA Guidance on Developing a Training Program for
  Quality Systems EPA QA/G-10
• On Being a Scientist Responsible Conduct in
  Research 1995, National Academy of Sciences.
• A summary of General Assessment Factors for
  Evaluating the Quality of Scientific and
  Technical Information EPAs Science Policy
  Council, 2003 EPA 100B/B-03/001.

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Contact

• Patrick Garrity, Env. Scientist
• patrick.garrity_at_ky.gov
• [phone] ext. 574