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Laboratory Ethics – An Overview Part II. What You Need To Know What You Need To Do. What the manager can do. Adopt Best Practices for the Detection and Deterrence of Laboratory Fraud Consider Third-Party Experts. Best Practices for the Detection and Deterrence of Laboratory Fraud.
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Laboratory Ethics – An OverviewPart II What You Need To Know What You Need To Do
What the manager can do • Adopt Best Practices for the Detection and Deterrence of Laboratory Fraud • Consider Third-Party Experts
Best Practices for the Detection and Deterrence of Laboratory Fraud
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
Data Quality Objectives • 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
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 laboratory staff that the client/ lab manager are serious about performance of the laboratory
Types of PES Programs • Single-blind PES = concentrations are unknown to the laboratory technicians; • Double-blind PES = concentration and identity are unknown to the laboratory technicians.
Split-Sample Analyses • Useful tool in detecting and deterring data quality problems • Measure inter-laboratory performance on sample matrices relevant to a program (drinking and irrigation water, waste water, soil and plant samples) • Existence of split-samples can be divulged to primary laboratory or not
Data Validation • Strategy should be established at the beginning of a program / project • All data should receive some level of review by lab manager and/or independent third-party contractor • Laboratory technicians should be aware that data reports will be reviewed by a data validator/ lab manager, but not necessary to what extent (5%, 20%, 100%)
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
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
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
Non-Tangible Efforts • Ensure Capacity • Ensure Responsibility and Authority • Demonstrate Accountability • Scientific Approach • Maintain Objectivity • Maintain Impartiality • Measurement Traceability • Reproducibility • Transparency
Guidance and Training • Developing an SOP for detecting and reporting potentially fraudulent laboratory activities • Presenting fraud awareness workshops to all lab supervisors who oversee laboratories or data • Increasing scrutiny of the data by data reviewers and validators • Requiring use of bound laboratory notebooks
Potential Laboratory Fraud and the Data User • Fraudulent activities are sometimes being performed by laboratory staff • Utilize best practices whenever possible to meet your analytical requirements • Establish methods to cross check the data provided by the lab staff