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 Adopt Best Practices for the Detection and Deterrence of Laboratory Fraud Consider Third-Party Experts 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 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 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 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 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 PES are used to assess routine performance levels of laboratories General QA oversight of laboratories should include PES program 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 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; Single-blind PES = concentrations are unknown to the laboratory technicians; Double-blind PES = concentration and identity 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 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) 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 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 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 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%) 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 Laboratories should have a company ethics policy read and signed by all employees Training should be provided to staff Training should be provided to staff Specific SOPs for each method performed by the laboratory should be written and maintained 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 Laboratory management must provide adequate resources and assign sufficient authority to supervisors

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

What The Laboratory Can Do Ethics References Ethics References Ethics Policy or Statement Ethics Policy or Statement Employee Ethics Agreements Employee Ethics Agreements Ethics Communication Ethics Communication Ethics Program Management Ethics Program Management Ethics Procedures Ethics Procedures Zero Tolerance Policy Zero Tolerance Policy Ethics Assistance and Reporting Mechanism Ethics Assistance and Reporting Mechanism Compliance Plan Compliance Plan Ethics Training Ethics Training Compliance Audits Compliance Audits

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

Guidance and Training Developing an SOP for detecting and reporting potentially fraudulent laboratory activities Developing an SOP for detecting and reporting potentially fraudulent laboratory activities Presenting fraud awareness workshops to all lab supervisors who oversee laboratories or data Presenting fraud awareness workshops to all lab supervisors who oversee laboratories or data Increasing scrutiny of the data by data reviewers and validators Increasing scrutiny of the data by data reviewers and validators Requiring use of bound laboratory notebooks Requiring use of bound laboratory notebooks

Potential Laboratory Fraud and the Data User Fraudulent activities are sometimes being performed by laboratory staff Fraudulent activities are sometimes being performed by laboratory staff Utilize best practices whenever possible to meet your analytical requirements Utilize best practices whenever possible to meet your analytical requirements Establish methods to cross check the data provided by the lab staff Establish methods to cross check the data provided by the lab staff