Laboratory Ethics – An OverviewLaboratory Ethics – An OverviewPart IIPart II

What You Need To KnowWhat You Need To Know

What You Need To DoWhat You Need To Do

What the manager can doWhat the manager can do

Adopt Best Practices for the Detection Adopt Best Practices for the Detection and Deterrence of Laboratory Fraudand Deterrence of Laboratory Fraud

Consider Third-Party ExpertsConsider Third-Party Experts

Best Practices for the Detection and Best Practices for the Detection and Deterrence of Laboratory FraudDeterrence of Laboratory Fraud

Data Quality ObjectivesData Quality Objectives

Provide a fundamental role in data Provide a fundamental role in data collection activitiescollection activities

Allows decision makers to define Allows decision makers to define their data requirements and their data requirements and acceptable levels of data error, acceptable levels of data error, based on intended use of databased on intended use of data

Data Quality ObjectivesData Quality Objectives

Specifies relevant data quality Specifies relevant data quality requirements which could requirements which could potentially impact data use potentially impact data use limitationslimitations

DQO process minimizes DQO process minimizes expenditures while producing expenditures while producing data of sufficient quality for its’ data of sufficient quality for its’ intended useintended use

Performance Evaluation SamplesPerformance Evaluation Samples

PES are used to assess routine PES are used to assess routine performance levels of laboratoriesperformance levels of laboratories

General QA oversight of laboratories General QA oversight of laboratories should include PES programshould include PES program

Use of PES sends a message to Use of PES sends a message to laboratory staff that the client/ lab laboratory staff that the client/ lab manager are serious about manager are serious about performance of the laboratoryperformance of the laboratory

Types of PES ProgramsTypes of PES Programs

Single-blind PES = concentrations Single-blind PES = concentrations are unknown to the laboratory are unknown to the laboratory technicians;technicians;

Double-blind PES = concentration Double-blind PES = concentration and identity are unknown to the and identity are unknown to the laboratory technicians.laboratory technicians.

Split-Sample AnalysesSplit-Sample Analyses

Useful tool in detecting and deterring Useful tool in detecting and deterring data quality problemsdata quality problems

Measure inter-laboratory performance Measure inter-laboratory performance on sample matrices relevant to a on sample matrices relevant to a program (drinking and irrigation program (drinking and irrigation water, waste water, soil and plant water, waste water, soil and plant samples)samples)

Existence of split-samples can be Existence of split-samples can be divulged to primary laboratory or notdivulged to primary laboratory or not

Data ValidationData Validation

Strategy should be established at the Strategy should be established at the beginning of a program / projectbeginning of a program / project

All data should receive some level of All data should receive some level of review by lab manager and/or review by lab manager and/or independent third-party contractorindependent third-party contractor

Laboratory technicians should be Laboratory technicians should be aware that data reports will be aware that data reports will be reviewed by a data validator/ lab reviewed by a data validator/ lab manager, but not necessary to what manager, but not necessary to what extent (5%, 20%, 100%)extent (5%, 20%, 100%)

SOW and Ethical ConductSOW and Ethical Conduct

Laboratories should have a company Laboratories should have a company ethics policy read and signed by all ethics policy read and signed by all employeesemployees

Training should be provided to staffTraining should be provided to staff Specific SOPs for each method performed Specific SOPs for each method performed

by the laboratory should be written and by the laboratory should be written and maintainedmaintained

Laboratory management must provide Laboratory management must provide adequate resources and assign sufficient adequate resources and assign sufficient authority to supervisorsauthority to supervisors

Use of More Than One LaboratoryUse of More Than One Laboratory

Reduces / eliminates overloadReduces / eliminates overload Split-sample opportunitiesSplit-sample opportunities Similar results build confidence with Similar results build confidence with

clientsclients Helps ensure that key decisions are Helps ensure that key decisions are

not based on a single and potentially not based on a single and potentially fraudulent data sourcefraudulent data source

What The Laboratory Can DoWhat The Laboratory Can Do Ethics ReferencesEthics References Ethics Policy or StatementEthics Policy or Statement Employee Ethics AgreementsEmployee Ethics Agreements Ethics CommunicationEthics Communication Ethics Program ManagementEthics Program Management Ethics ProceduresEthics Procedures Zero Tolerance PolicyZero Tolerance Policy Ethics Assistance and Reporting MechanismEthics Assistance and Reporting Mechanism Compliance PlanCompliance Plan Ethics TrainingEthics Training Compliance AuditsCompliance Audits

Non-Tangible EffortsNon-Tangible Efforts

Ensure CapacityEnsure Capacity Ensure Responsibility and AuthorityEnsure Responsibility and Authority Demonstrate AccountabilityDemonstrate Accountability Scientific ApproachScientific Approach Maintain ObjectivityMaintain Objectivity Maintain ImpartialityMaintain Impartiality Measurement TraceabilityMeasurement Traceability ReproducibilityReproducibility TransparencyTransparency

Guidance and TrainingGuidance and Training

Developing an SOP for detecting and reporting Developing an SOP for detecting and reporting potentially fraudulent laboratory activitiespotentially fraudulent laboratory activities

Presenting fraud awareness workshops to all lab Presenting fraud awareness workshops to all lab supervisors who oversee laboratories or datasupervisors who oversee laboratories or data

Increasing scrutiny of the data by data reviewers Increasing scrutiny of the data by data reviewers and validatorsand validators

Requiring use of bound laboratory notebooksRequiring use of bound laboratory notebooks

Potential Laboratory Fraud and Potential Laboratory Fraud and the Data Userthe Data User

Fraudulent activities are sometimes Fraudulent activities are sometimes being performed by laboratory staffbeing performed by laboratory staff

Utilize best practices whenever Utilize best practices whenever possible to meet your analytical possible to meet your analytical requirementsrequirements

Establish methods to cross check the Establish methods to cross check the data provided by the lab staffdata provided by the lab staff