Data Integrity & Technical Ethics
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1 ACCUTEST LABORATORIES Data Integrity & Technical Ethics January 2012
2 What is Data Integrity? Data that has been produced to the ethical standards of the industry, which is traceable and defensible. What is a Data Integrity Program? A system which combines technical and ethics training with active procedures designed to prevent unethical laboratory practices.
3 The Purpose of the Program To Develop a Proactive Program for the Prevention and Detection of Improper, Unethical or Illegal Actions. To Increase Your Awareness of Laboratory Ethics Related Issues. To Ensure That You Know the Rules 3
4 Accutest Data Integrity Policy A comprehensive, systematic approach for assuring that data produced by the laboratory accurately reflects the outcome of the tests performed on field samples and has been produced in a bias free environment by ethical professionals. 4
5 The Accutest Code Of Ethics Perform chemical and microbiological analysis using accepted scientific practices and principles. Perform tasks in an honest, principled and incorruptible manner inspiring peers & subordinates. Maintain professional integrity as an individual. Provide services in a confidential, honest, and forthright manner. Produce results that are accurate and defensible. Report data without any considerations of self-interest. Comply with all pertinent laws and regulations associated with assigned tasks and responsibilities.
6 Accutest Data Integrity Program Data Integrity Elements Data Integrity Training In-Depth, Periodic Monitoring of Data Integrity Data Integrity & Ethical Conduct Attestation Confidential Data Integrity Reporting Data Integrity Investigations Correction, Notification, Discipline 6
7 Why Do We Need A Data Integrity Program? DATA FRAUD CAN BE A PROBLEM IN THE LAB: Ethics Issues Have Tainted Our Industry, Causing Distrust by Our Clients. Fraud Incidents Have Cost Government Agencies Millions of Dollars and Reversed Remedial Progress By As Much As Ten Years. Criminal Fraud Indictments Have Ruined Careers and Resulted In Fines and Incarceration Upon Conviction. Fraud Implications Have Destroyed Businesses Regulatory Agency Accreditation Requirement
8 We Must Take Steps To Protect Our Business and Our Livelihood!
9 Technical Ethics & Data Production Accutest Produces Data for Regulatory Purposes Our Data Provides the Foundation for Determining the Risk Presented by a Chemical Pollutant to Human Health and the Environment. Our Industry Is Dependent Upon the Accurate Portrayal of Environmental Chemistry Data. This Process Is Reliant Upon a High Level of Scientific and Personal Ethics and Data Integrity.
10 Technical Ethics & Data Production It Is Essential That Each Employee Understands the Company s Commitment to Data Integrity and the Ethical and Quality Standards Required to Work in This Industry. Each Employee Must Adhere to the Ethical Code of Conduct Adopted by the Company
11 Why Unethical Behavior Occurs Real or Perceived Pressure Lack of Ethics Education and Awareness Lack of Understanding of the Impact of Unethical Behavior Lack of Knowledge or Confidence in Appropriate Ways to Solve Problems Ineffective Oversight by Management Focus on Production over Quality Unrealistic Expectations Lack of Fortitude or Personnel Standards
12 Laboratory Fraud or Scientific Misconduct Lab Fraud is a legal term with legal consequences for the individual and the organization Scientific Misconduct is a violation of ethical rules of conduct which may have the potential to damage the organization or affect our ability to do business NEITHER IS AN ACCIDENT NOR A MISTAKE and is intended to make data look better with the intent to deceive.
13 What are Improper/Fraudulent Laboratory Practices or Things You Should NOT Be Doing in the Laboratory.
14 DO NOT: Fabricate Information Misrepresent QC Results Manipulate GC/MS Tuning Data Improperly Alter Operating Conditions Use Improper Calibrations or Verifications Perform Improper Manual Peak Integrations Alter Samples Prior to Analysis Perform Unwarranted Software Manipulations Delete Non-Compliant Data Time Travel
15 DO NOT: Conceal a Known Problem Inappropriately Delete Data Points Analyze Proficiency Test Differently Than Routine Environmental Samples THOUSANDS OF OTHER EXAMPLES!
16 What Can You Do About It? An Ounce of Prevention DOCUMENT, DOCUMENT, DOCUMENT If You Think It Is Wrong CHECK IT OUT!! What Does The SOP Say? What Does The Method Say? Talk With Your Manager or Supervisor Be Conservative, If You Think You Messed Up Just Start Over Follow The SOP As Written!!
17 Data Integrity Monitoring Documented Data Integrity Procedures Established Objective: Isolate, Identify, Correct Data Integrity Issues Monitoring Performed for Three Key Processes - Routine Data Review: Supervisors DI Indicators - Manual Chromatographic Peak Integration: Supervisors - GALP Audit Trail Monitoring: QA Comprehensive * Logbook Review * Electronic Data GALP File: Instrument * Signatures, dates, Attendance * Raw Data Review Manual Edit Traceability * GALP Audit LIMS Findings Referred for Further Investigation
18 Confidential Data Integrity Reporting Procedure Discuss Data Integrity Concerns with Supervisor if Possible Employ Confidential Reporting Method When Necessary Contact Corporate HR to Discuss Concerns HR Arranges Closed Door Meeting With QA QA Evaluates Concerns and Takes Appropriate Action - Clarify Legitimate Practices for Employee Benefit - Initiate Data Integrity Investigation for Items of Concern Investigations Take Place Without Mentioning or Involving the Concerned Employee.
19 Data Integrity Investigations Formal Procedure Performed by Senior Staff - Employee Report Response - Data Integrity Monitoring Finding Investigation Conducted in Privately & Confidentially Information Gathered, Interviews Conducted Formal Report Conclusion Based on Findings - No Action: Data Integrity Issue Not Verified - Further Action: Corrective Action Report to President for Final Action Report Archived for Five Years
20 Corrective Action, Client Notification, Disciplinary Action Corrective Action Required for Investigation Findings Process Changes to Prevent Reoccurrence Client Notification for Negatively Impacted Data - Data Recall May be Necessary Disciplinary Action Consistent with Severity - No Action - Retraining - Warning - Dismissal
21 Data Integrity Training Acknowledgement & Ethical Conduct Agreement I understand the high ethical standards required of me with regard to the duties I perform and the data I report in connection with my employment at Accutest Laboratories. I have received formal instruction on the code of ethics that has been adapted by Accutest Laboratories and agree to comply with these requirements. I have received formal instruction on the elements of Accutest Laboratories Data Integrity Policy and have been informed of the following specific procedures: - Formal procedures for the confidential reporting of data integrity issues are available, which can be used by any employee
22 Data Integrity Training Acknowledgement & Ethical Conduct Agreement - A data integrity investigation is conducted when data issues are identified that may negatively impact data integrity. - Routine data integrity monitoring is conducted on sample data, which may include an evaluation of the data I produce, I am aware that data fraud is a punishable crime that may include fines and/or imprisonment upon conviction. I also agree to the following: - I shall not intentionally report data values, which are not the actual values observed or measured. - I shall not intentionally modify data values unless the modification can be technically justified through a measurable analytical process.
23 Data Integrity Training Acknowledgement & Ethical Conduct Agreement - I shall not intentionally report dates and times of data analysis that are not the true and actual times the data analysis was conducted. - I shall not condone any accidental or intentional reporting of inauthentic data by other employees and immediately report it s occurrence to my superiors. - I shall immediately report any accidental reporting of inauthentic data by myself to my superiors.
24 Important Final Points and Summary It Is Really OK To Make A Mistake. They Do Not Lead To Fraud Unless You Try To Hide Them. Short Term Gains ARE NOT Worth Long Consequences. TRACEABILITY Is The Operative Word. Everything You Do Must Be Able To Be Traced Back From Beginning To End And Can Be Re- Created. Report Inappropriate Behavior, Unethical or Illegal Practices to Management. BE VIGILENT AND TAKE PRIDE IN WHAT YOU DO!!
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