Data Integrity & Technical Ethics

ACCUTEST LABORATORIES

Data Integrity

&

Technical Ethics

January 2012

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?

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

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.

 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.

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

• 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

We Must Take Steps To

Protect Our Business

• 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.

• 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

 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

 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.

or…

Things You Should NOT Be

Doing in the Laboratory.

or…

Things You Should NOT Be

Doing in the Laboratory.

What are Improper/Fraudulent

Laboratory Practices

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

DO NOT:

Conceal a Known Problem

Inappropriately Delete Data Points

Analyze Proficiency Test Differently Than Routine Environmental Samples

• 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!!

What Can You Do About It? “ An Ounce of Prevention”

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

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

Data Integrity Investigations

- 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

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

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

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.

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.

• 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!!