Laboratory Ethics – An Overview Part II

1. Laboratory Ethics – An OverviewPart II What You Need To Know What You Need To Do

2. What the manager can do • Adopt Best Practices for the Detection and Deterrence of Laboratory Fraud • Consider Third-Party Experts

3. Best Practices for the Detection and Deterrence of Laboratory Fraud

4. 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

5. 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

6. 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

7. 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.

8. 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

9. 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%)

10. 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

11. 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

12. 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

13. Non-Tangible Efforts • Ensure Capacity • Ensure Responsibility and Authority • Demonstrate Accountability • Scientific Approach • Maintain Objectivity • Maintain Impartiality • Measurement Traceability • Reproducibility • Transparency

14. 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

15. 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