Laboratory Ethics

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Laboratory Ethics Data Integrity

• Presentation to KWWOA
• April 2, 2008
• Department for Environmental ProtectionEnvironmen
  tal Public Protection Cabinet

To Protect and Enhance Kentuckys Environment
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Science Fraud

• Of all the violations of the ethos of science,
  fraud is the gravest. As with error, fraud
  breaks the vital link between human understanding
  and the empirical world, a link that is sciences
  greatest strength. But fraud goes beyond error
  to erode the foundation of trust on which science
  is built. (Committee on the Conduct of Science,
  1989)

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Laboratory Ethics and Data Integrity

• What You Need To Know

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Laboratory Fraud

• Defined as
• the deliberate falsification of analytical and
  quality assurance results, where failed method
  and contractual requirements are made to appear
  acceptable during reporting.

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Ethical Behavior

• Defined as
• Behavior that conforms to accepted professional
  standards of conduct unethical behavior
  therefore is behavior not conforming to those
  standards.

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Bad and Fraudulent Data

• Incorrect data may either be the result of bad
  techniques, training or human error.
• Fraudulent data is the result of an individual
  purposefully misrepresenting data that does not
  conform to a given set of standards or criteria
  and making it appear as if it does.

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Unethical Conduct Being Addressed

• ACS
• NELAC / AOAC
• ISO / IEC 17025
• EPA
• DoD
• Primacy States
• Private Industry

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Producers of Laboratory Data

• Field / Sample Technicians
• Sample Custodian
• Laboratory Chemists / Technicians
• Report Generation Group
• LIMS / Information Technology
• Laboratory Managers

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Data Users

• Plant Operators
• Plant Supervisors / Managers
• Regulators
• General Public

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Data Checks and Balances

• Laboratory Chemists / Technicians
• Laboratory Quality Assurance Dept.
• Laboratory Managers
• Data Validator (Third Party)
• Auditor (In-house / Third Party)
• Regulators

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Life Cycle of a Water Sample

• Sample Collection
• Sample Analysis
• Sample Report
• Operator
• Operation / Plant Decisions
• Results Reported to State Regulator
• Public Information
• State Reports Results to EPA
• Records Retention

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Legacy of Sample Results

• Laboratory Files (hardcopy)
• Laboratory Notebooks
• Magnetic Tape (Electronic media)
• Plant Files
• State Files Database
• EPA Database

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Fraudulent Data Takes Many Forms

• Dry Labbing
• Time Traveling
• Juicing
• Improper GC/MS Tuning
• Improper Calibration / QC Analysis
• Peak Shaving
• Misrepresentation of QC Samples and Spikes
• File substitution
• Unwarranted Manipulation of Computer Software
• Improper Alteration of Analytical Conditions
• Over Dilution of Samples or Misrepresentation of
  Detection Limits
• Deletion of Non-Compliant Data
• Concealment of a Known Problem

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Why?

• Shrinking Market
• Low Prices Cutting Corners
• Insufficient Resources / Training
• Unclear Management Position
• Employee Perception
• Employee Personal Issues

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Repercussions

• Inaccurate or inappropriate changes to plant
  operating conditions
• Incorrect data reported to regulators
• May place public at risk
• Criminal implications
• Employment consequences

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Laboratory Ethics and Data Integrity

• What You Need To Do

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Certified Laboratories

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

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Ethics Data Integrity Policy

• 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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What Labs Can Do - Ethics

• Ethics Compliance Plan
• Ethics Policy or Statement
• Employee Ethics Agreements
• Ethics Training Communication
• Ethics Program Management
• Ethics Procedures (assistance and reporting
  mechanism)
• Zero Tolerance Policy
• Compliance Audits

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What Labs Can Do Non Tangible

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

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EPA Guidance and Training

• Developing an SOP for detecting and reporting
  potentially fraudulent laboratory activities
• Fraud awareness workshops
• Increasing scrutiny by data reviewers /
  validators
• EPA Fraud Hotline [phone]
• 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
• http//www.epa.gov/QUALITY/qa_docs.html

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QAPP, SAMP, DQO and 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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Quality Assurance Project Plan

• EPA Requirements for Quality Assurance Project
  Plans (QAPPs) EPA QA/R-5 March 2001
  EPA/240/B-01/003
• EPA Guidance for Quality Assurance Project Plans
  (QAPPs) EPA QA/G-5 December 2002
  EPA/240/R-02/009

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Sampling, Analysis Monitoring Plan

• Guidance on Choosing a Sampling Design for
  Environmental Data Collection (QA/G-5S) December
  2002 EPA/240/R-02/005.

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Data Quality Objectives

• EPA Guidance on Systematic Planning using the
  Data Quality Objectives Process (QA/G-4)
  February 2006EPA/240/B-06/001
• 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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Standard Operating Procedures

• EPA Guidance for Preparing Standard Operating
  Procedures (SOPs) EPA QA/G-6 April 2007
  EPA/600/B-07/001

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What PWS Can Do

• Utilize more than one laboratory
• Contractual agreements
• Consider third-party experts

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Use 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 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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Consider Third-Party Experts

• Perform on-site evaluations (audits)
• Provide added value to program
• Additional cost
• Independent parties with respect to business
  decisions, laboratory, findings, final report,
  etc.
• Deterrent to potential fraud

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Report Fraud in Kentucky

• EPPC Office of the Inspector General
• OIG Hotline [phone]

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Questions

• ?

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Contact Information

• Patrick J. Garrity
• Certification Officer Division of Water14
  Reilly Road
• Frankfort, KY 40601
• Phone [phone] ext. 574
• Fax [phone]
• Email patrick.garrity_at_ky.gov