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Laboratory Ethics & Data Integrity

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on 22 March 2016

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Transcript of Laboratory Ethics & Data Integrity

Commonwealth Utilities Corporation Laboratory Ethics & Data Integrity Training
Objectives of Ethics Training
Ethics Definition
Why Ethical Behavior is Important
Definition Laboratory Fraud and Improper Lab Practice
What is Unethical Behavior and Penalties
Consequences of Improper Behavior
Examples of Improper Behavior
Responsibility of Laboratory and Employees
Process of Investigation

Ethics are...
A system of moral principles governing the appropriate conduct for a person or group
Doing the right thing
Being honest, straightforward; not lying or cheating
What your parents taught you!
Ethics Are Important
Personal reputation and reputation of CUC depends on it
Our decisions affect the environment and lives of others
Following CUC Lab Code of Ethics can enrich your work and home life
Laboratory Fraud
falsification of analytical and quality assurance results, where failed method and contractual requirements are made to appear acceptable
recording or reporting of incorrect information

gross deviation from method specified analytical practice, combined with intent to conceal the deviation
Unintentional mistakes, poor judgement or ignorance while not fraudulent may result in violation of law
Why Talk about Improper Practices and Fraud?
Responsibilities of Lab
Continuously monitor data on a periodic but random basis
Provide clear guidance and policies for ethical behavior - code of ethics statement signed yearly
Provide on-going training to employees
Perform confidential investigations if problem detected
Notify clients and reissue reports if data is negatively impacted
Eliminate undue pressure on analysts
Provide mechanism for confidential reporting of abuse without recriminations - whistle blower policy
Penalties for you and CUC can be Substantial
Civil and/or Criminal Prosecution can lead to Conviction.

Fines of up to $500,000 and Prison up to 5 years...

Improper Practices
Scientifically unsound or technically unjustified omission
Alteration of analytical procedures or data that bypasses required QC
Making results appear acceptable
Any alteration of data so that it is an unauthentic or untrue representation of the test performed
Improper Practices Root Causes
Personality and Attitude
Production Pressure
Misinterpretation of method requirements
Quality Systems Failure
Lack of Communication
Lack of Awareness due to lack of training
Lack of strong proactive and independent ethics policy
Types of Improper Practices
1. Fabrication of data or other info
2. Misrepresent QC Results
3. Improper Date/Time setting
4. Improper Calibration
5. Data file substitution or modification
6. Unwarranted sample dilution
7. Deleting non-compliant data
8. Improper alteration of test conditions
9. Concealment of known problem
10. Other improper practices
Create info that is not true
Create data for test not performed
Create info for sample not collected
Claiming ownership for work performed by external analysts, equipment or facility
Cutting and pasting reports and support data

subcontract PT samples, Create COC without sample possession, fill in logbook for audit, recording autoclave condition before starting

Misrepresentation of QC Results
Adding more than prescribed amount of spike
Failure to prepare blanks, spikes, PT samples or standards the same as samples
Improper Date/Time Setting
Altering the recorded time that samples were collected, extracted, or analyzed

Resetting instrument clocks to make it appear that sample was analyzed within hold time
Improper Calibration
Any Technically Unsound Deviation from Proper Calibration Techniques
Recording results for pH meter calibration not performed
Performing multiple calibration runs or QC analyses
Data File Substitution or Modification
Substituting previously generated analyses for non-compliant calibration, QC or Sample runs
Reusing historical calibration data and representing it as current
Changing sample ID in the data file
Unwarranted Sample Dilution
Diluting samples or blanks without explanation, often to a point of eliminating target analyte responses
Deletion of Non-Compliant Data
Deleting non-compliant analytical results for calibration, QC samples or blanks
Failing to record non-compliant data for these samples
Deleting lab contaminant results from method blanks
Recording in the lab notebook only tests that work
Improper Alteration of Test Conditions
Changing analytical or instrument conditions for standards or QC samples from those specified in the method or SOP
Failing to run samples and standards under sample conditions
Failing to allow instrument to reach stable conditions
Concealment of a Known Problem
Concealing a known sample problem or QC failure
Concealing an unethical or improper practice from management
Failure to discuss failures in report narrative
Failure to report and resolve equipment malfunction issues

Other Improper Practices
MDLs - Running more than 7 and selectively discarding points to achieve lower or acceptable MDL.
Running certain QC samples multiple times until one passes.
QC can be repeated once to verify that the problem is real
Running extra QC samples such as LCS and LCS Dup (not required by method)
April 28, 2011:
Blue Marsh Laboratories, Inc, PA and owner indicted for 84 counts of fraud and false statements. Allegedly prepared and submitted false and fraudulent environmental reports to Utilities. http://www.fda.gov/ICECI/CriminalInvestigations/ucm253308.htm
July 24, 2012:
Coos Bay Water Treatment supervisor pleads guilty to falsifying water test results. Fired from job, 3 years probation and 100 hours community service. http://environmentalqa.com/2012/07/28/and-environmental-lab-frauds-continue/
June 16, 2005:
Former CUC lab manager found guilty of two counts of tampering with water quality reports. http://www.saipantribune.com/newsstory.aspx?newsID=48097&cat=1

Fraud is intentional misrepresentation of lab data to hide known or potential problems
Fraud makes data look better than it really is with intent to deceive
Fraud is not a mistake
Sometimes the difference between fraud, improper practice and an honest mistake is simply the lack of proper documentation.
ZERO TOLERANCE Grounds for immediate dismissal
Responsibilities of Employee
Uphold ethics policy and practices as demonstrated in your daily conduct
Seek help when proper action is unclear or unknown to you
Remain alert and sensitive to situations that could result in actions by any employee that are improper, illegal, unethical, or a violation of the ethics policy and practices
Counsel fellow employee when it appears that they are in danger of violating ethics policy & practices
Report violations of the ethics policy to supervisor
October 2013
March 8, 2016:
Washington State wastewater operator charged with seven misdemeanor and felony charges for falsifying data reported to state. http://www.valleyrecord.com/news/370945181.html#
Full transcript