Ethics & Data Integrity Training Level 1

1. Ethics & Data Integrity TrainingLevel 1Small labs, Admnistrative staff and Field Technicians Rev. 00: 12/2014 Prepared for PAAAEL

2. Training Goal • To describe Laboratory’s Data integrity and Ethics Policy • To develop a culture of ethics and integrity in the workplace based on company policies and procedures • To obtain commitment from the lab staff to the principle that all laboratory operations shall meet ethical standards

3. Training Goal • Discuss why this training is necessary. • Define Ethics, Data Integrity and Fraud. • Discuss Improper Laboratory Practices • Provide examples and answer questions.

4. What’s Ethics? Webster’s online dictionary defines ethics as: • -the discipline dealing with what is good and bad and with moral duty and obligation • -a set of moral principles • -a theory or system of moral values • -the principles of conduct governing an individual or a group • -a guiding philosophy • -a consciousness of moral importance

5. Why Act Ethically? • Your personal reputation and the reputation of your business depends upon it. • Acting ethically can enrich your work life as well as your personal life. • The legal consequences including penalties for misconduct for you and your organization can be substantial. • Our actions affect the lives of other people

6. Examples of Good Ethics • “Helping” someone who is not following a procedure correctly. • Documenting and reporting mistakes. • Follow the “MOM rule”: Would mom approve of your action(s)?

7. Being ‘Ethical’: What Does It mean To You? Honest, decent, fair, principled, just, correct, noble Honesty in following procedures Honesty in documenting Honesty in reporting

8. Data Integrity-Definition -Data of known and documented quality -Data that is reproducible and legally defensible. -Data that is accurate, complete and traceable -Data that is useable for its intended purpose

9. Our Quality Policy • ABC Labs is committed and dedicated to providing only the highest quality analytical data possible to its clients. • Data produced, managed and reported must meet the requirements of its clients, and comply with the letter and spirit of the various municipal, state and federal regulations and guidelines, TNI 2009 Standard, and ISO 17025:2005 requirements where applicable.

10. Quality Policy (continued) ABC Labs will only offer analyses for which it can consistently demonstrate compliance with high quality, traceable and legally defensible performance standards. All the ABC staff including the laboratory management are committed to good professional practice and to the quality of its environmental testing with complete honesty in the production and reporting of data.

11. What is “Fraud?” • The intentional misrepresentation of lab data to hide known or potential problems • An intentional gross deviation from method specified analytical practices, combined with an intent to conceal the deviation.

12. Laboratory Fraud • Scientifically or technically unjustified manipulation, omission or alteration to make the data appear acceptable. • Deliberate falsification of analytical and quality control data. • Deliberate falsification of general data including purchasing, billing, staff qualifications etc.

13. Improper Practices in the Laboratory

14. Types of Improper Laboratory Practices • Unintentional actions, through ignorance or lack of communication. (Example: Not reporting Blank contamination) • Intentional actions, but with minor impact on public health or environment (Example: Not reporting LCS recovery of 102% which was outside QC limits) • Intentional actions, which jeopardizes public health (Example: Mercury result just below permit limit, but CCV and LCS recoveries below QC limits)

15. Lab Areas And Associated Problems • Overall Laboratory Appearance • Testing and Non-Testing Areas • Field Sampling equipment and Sample Receiving • Sample Analysis and Data- Generation • Quality Control • Data Reporting

16. This is a REALLY bad sign! A “suspect” laboratory!

17. Cleanliness and Safety Broadcast Pride in a Lab’s Work • Keep the Lab Area Clean! • Organize and properly label all Reagents and Equipment! • Use Proper Safety Equipment! • Keep Required Documentation

18. Sample Receiving IssuesThoroughly mixing the samples (all matrices) before use is critical.

19. Good Sample Receiving Practices • Samples collected/received in proper containers! • Chain of Custody is correct and complete • Sample preservation (temperature, pH, chlorine, etc.) documented • Samples stored at proper temperature in safe custody where there is no room for tampering. • Client notified immediately if there is a problem. DOCUMENT IT!

20. Problems in Sample Receiving • No/incomplete sample paperwork • Use of Thermometers w/expired calibration • Samples not checked for proper preservation. • Improper transport/storage temperature. • Out of date preservation reagents. • Cross-contamination

21. When It Might Be Fraud • Recording different temperatures than read on the thermometer. • Fabricating a Chain of Custody. • “Faking” a client’s signature. • Recording False Receipt Dates/Times • Recording Samples as “preserved” when they are not. • Filling in sampling times for the sampler.

22. Laboratory Analysis Issues Good Laboratory Practices • If you do it, write it down. • If you make a mistake, admit and report it. • If there is a problem with an analysis, flag it and report it. • If the SOP is incorrect, fix it. • Date and initial everything you do.

23. Possible Lab Fraud • No Instrument Available for the Analysis. • Instrument isn’t in Operating Condition. • No Bench Sheets or Log Books. • Staff not qualified or available • Missing Standards or Reagents for Analyses

24. Good Indicators of Bad Data (Data that is not legally defensible) • Results don’t match the Final Report. • Sample prep info not recorded • Not saving the work file on the computer. • Not initialing or signing work. • Skipping critical steps in the prep or analysis steps • Skipping sample prep/digestion to save time.

25. Responsible Recordkeeping • Records must include identity of personnel • Date and time properly recorded at the time of event. Example: COC • Proper corrections of errors (single-line cross out with the initials, the date of correction and an explanation of the error. NO OBLITERATING, WHITE-OUT OR SCRIBBLES. • Use of permanent ink only

26. Error Corrections

27. Potential Consequences for Breaching Data Integrity • Results are too low or too high, Public may be at risk • End user of data is making decisions based on faulty data • Unnecessary and expensive remediation • health effects on many people -A discussion with employee and notation in their record • Fines and/or imprisonment • Termination of employment.

28. Regulations or Statutes that may be used for Fraud Prosecution: All of these may get you up to 5 years in prison and/or $500,000 fine • False Claims – 18 U.S.C. 287 • False Statements – 18 U.S.C. 1001 • Mail Fraud – 18 U.S.C. 1341 • Wire Fraud – 18 U.S.C. 1343 • Conspiracy – 18 U.S.C. 371 • Misprision (Concealment) of Felony –18 U.S.C. 4 • Obstruction of Justice – 18 U.S.C. 1505

29. Data Integrity Management Commitment Senior Management is responsible for upholding the spirit and intent of the data integrity procedures. Senior management support for this program is acknowledged through its approval of this training program.

30. Do it Right, the First time • It is OK to make a mistake. It is not OK to hide mistakes. • It is OK to have QC out of limits. It is not OK to hide QC that is out of limits. • There are potentially severe consequences for scientific misconduct that can affect the entire facility. • Good communication (and documentation!) can be the key to prevention of many problems!

31. If You Suspect a Mistake.. • Alert your Supervisor • Initiate proper corrective and preventive action procedures. (Document it.) • Determine “Root Cause”. • Get proper training • Continue analysis only after the analytical system meets criteria. • Reanalyze sample(s) where necessary • Notify clients if required • Contact the Data Integrity Advisor (QA Director), and Lab Director or President for confidential reporting.

32. Lab Fraud and Criminal Cases • In 1995, Eureka Laboratories, Inc. was fined $1.8 million and two chemists who worked at Eureka were convicted of federal fraud charges related to the manipulation of lab results for federal contracts. • CompuChem Labs Settled civil suit for $ 200,000 in 2006, in NC for bypassing QC standards and improper GC/MS calibrations • Ed Kellogg, President and QC Officer of Johnson Lab, PA sentenced to 16 months in prison, and was fined for fraudulent reporting. Volatile samples were analyzed by EPA 624, but reported by EPA 601/602, with his knowledge, even though he didn’t have the necessary instrument in working condition to run 601/602. http://www.epa.gov/oig/reports/results_oi.htm

33. Part 2: Pop Quiz, Case Studies

34. Case Study # 1 • A sampler calibrates her pH meter using standards pH 4 and pH 10. pH 4 reading was outside acceptance range. Therefore she uses pH 7 and pH10, both of which passes. She takes a grab sample for pH, analyzes the sample and gets a reading of pH 6.0. She realized that the result was outside calibration range, yet reported the results.

35. What do you think? • IS THIS ETHICAL? • IS THE DATA ACCEPABLE? • IS IT FRAUD? • JAIL TIME?

36. Case #1 Answers • Is it Ethical? No, it is not. She did not take proper corrective action of getting a new Ph standard, or new Ph meter. She did not notify her Manager about the problem.) • Is the Data reliable? Nope. The sample result was outside calibration range; the results may be biased. The results should have been qualified. • Is it Fraud? Yup. Any time you intentionally change or ignore a situation that influences results, it is technically, fraud. • Jail Time? Probably not, if it was an isolated incident. However, since she reported fraudulent data, there could be loss of job, fines, or other legal penalties.

37. Case Study # 2 • A field sampler pulled a grab to check for residual chlorine. He was new and used a cell meant for 0-3 mg/L slide comparator instead a cell meant for 0-10 mg/L comparator. He got a reading of 8 mg/L, and reported it as is.

38. Case Study #2 Answers • Is it Ethical? Yes. The new guy didn’t know he was doing anything wrong. • Is the Data reliable? No. The reported chlorine level was biased high. The client probably reduced the level of chlorine, which caused bacterial growth, and health hazard. • Is it Fraud? No. He didn’t intentionally report incorrect data. • Jail Time? No. However, the fines will be heavy. Unfortunately he will be blamed. Retraining will be required. But who is really to blame? His boss for bad training.

39. Summary • Use Approved/certified Methods • Follow the Method/SOP • Perform the Required Quality Control. • Report results with proper units and analytical methods • Record and report any QC issues associated with the test results.

40. References • “Ethics and Improper Laboratory Practices” Ray Terhune, US EPA Region 4 QA Section • “EPA Lab Fraud” presented by Michael Daggett, Director Lab Fraud Investigations, USEPA • “Laboratory Fraud: Investigation and Prosecution” by Stacy Mitchell, USDOJ • “Manual Integration & Ethical Issues” by Richard McMillin, USEPA Region VI • “Ethics and Data Integrity”, PAAAEL presentation by Becky Roztocil, Summer 2011