March 2012

1. Training based on the 2011 EPA New England Laboratory AnnualEthics and Data Integrity Refresher TrainingMoira Lataille, Quality Assurance UnitAgnes Van Langenhove, Chemistry Laboratory QAODave McDonald, Biology Laboratory QAO March 2012

2. The purpose of this year’s annual training is to: • Review the OEME Laboratory Ethics Policy. • Provide refresher training on data integrity as required under the 2003 NELAC Standard, Chapter 5 Quality Systems, Section 5.5.2.7. • Underscore the importance of continuous improvement.

3. OEME has a documented Laboratory Ethics Policy. Where can you find our Laboratory Ethics Policy? The Ethics Policy is documented in both OEME Laboratory QA Plans: • Chemistry Laboratory • Laboratory QA Plan • Biology Laboratory • Laboratory QA Plan OEME Laboratory QA Plans are maintained in the “Lab SOPs” database under plans and policies

4. Why does OEME need an Ethics Policy? The mission of EPA New England is to protect human health and the environment. In order to fulfill its mission and ensure the public’s trust, this region relies on the generation of credible data. To that end, data must be accurate, objective, and legally and scientifically defensible. In addition, the data must be “transparent” -- in other words all data must be supported by a detailed trail of records and documentation. Our Ethics Policy sets forth a set of shared standards of conduct for field personnel, biologists, chemists, and other personnel involved in data collection within our organization. It lays the groundwork for proper performance and ensures data integrity. By that we mean the data we collect and generate are true representations of sampling plans and of the experiments and tests performed.

5. Administrator Jackson re-affirmed scientific integrity as the cornerstone for Agency decision-making. By adopting a proactive Ethics program and clear Ethics Policy that are strongly supported by senior management, our region adheres to the Principles of Scientific Integrityissued in 1999. Administrator Jackson re-affirmed these Principles in her Scientific Integrity: Our Compass for Environmental Protection, 5/8/2009 memohttp://www.epa.gov/Administrator/scientificmemo.html Deputy Administrator Perciasepe confirmed an earlier memorandum from President Obama that articulated the need for sound science, memo 2/16/2012. In his e-mail, Mr. Perciasepe announced the enactment of a new Scientific Integrity Policy. http://www.epa.gov/osa/pdfs/epa_scientific_integrity_policy_20120115.pdf

6. What does the OEME Ethics Policy mean to you? As scientists and data generators, you directly support Agency decisions that affect public health and the environment. Your data links you with Superfund clean-up decisions, enforcement actions, drinking water protection, risk assessments and many other environmental activities that directly impact the health of your fellow New Englanders. Our Ethics Policy allows you to perform your work knowing that management is fully committed to supporting your integrity as an EPA scientist. It also allows you to operate in an atmosphere of trust knowing that your co-workers are similarly trained and committed to following shared standards of professional integrity.

7. Our Laboratory Ethics Policy states the following: “It shall be the policy of the EPA New England Region 1 Laboratory to conduct all business with integrity and in an ethical manner. It is a basic and expected responsibility of each staff member and each manager to hold to the highest ethical standard of professional conduct in the performance of all duties and to adhere to EPA’s Principles of Scientific Integrity, dated November 24, 1999. Failure to adhere to this policy will result in corrective discipline in accordance with EPA Order 3120.1B Conduct and Discipline Manual. Continued . . .

8. Laboratory Ethics Policy (cont.) Section 45 of EPA Order 3120.1B describes Scientific Misconduct and the following specific offenses: • Fabrication or knowing falsification of data, research procedures, or data analysis. • Plagiarism or other misrepresentation, in proposing, conducting, reporting, or reviewing research or other scientific activities. • Ordering, advising, or suggesting a subordinate engage in scientific misconduct. Penalties for violations range from oral admonishment to removal. The specific penalty will be dependent upon a range of factors including those outlined in EPA Order 3120.1B.”

9. Is data integrity a problem at “our” laboratory? No, but you might be interested to know that in a recent National Institute of Health (NIH) survey of over 3000 scientists, 1/3 of the respondents admitted to carrying out at least one of the top ten unethical behaviors as defined by NIH, including: • Using another’s ideas without credit • Not presenting data that contradicts earlier data • Dropping data points from an analysis based on a gut feeling • Keeping inadequate records Did these scientists just have a momentary lapse of ethical behavior? Make an isolated mistake? Or follow an improper laboratory practice? Or did these scientists commit laboratory fraud? Let’s have a closer look at these issues . . .

10. Laboratory Fraud: A special case. . . The OIG defines laboratory fraud as “The deliberate falsification of analytical data or quality control results, where failed methods and contractual requirements are made to appear acceptable.” Typically, laboratory fraud is committed to hide problems and to make data look better than they really are. Note that the determination of fraud can only be made through the formal legal process.

11. Some potentially fraudulent activities occur when an employee intentionally. . . • Destroys Agency records • Falsifies chain-of-custody records • Mislabels sample containers (e.g., misrepresents sampling date, location, parameter information) • Misrepresents the sampling process by filling out logbooks/field sheets with erroneous information

12. Also, potentially fraudulent activities occur when an analyst intentionally. . . • Manipulates data so that it no longer represents true measurements (e.g., changing sample weights, peak area shaving or enhancing) • Inappropriately adjusts instrument time clocks • Fabricates data (a.k.a. drylabbing) • Modifies samples to alter their characteristics • Deviates from standard analytical or calibration procedures so that data do not accurately represent samples (e.g., not performing all sample preparation steps, inappropriately dropping calibration points, changing concentrations of standards) • Falsifies QC samples and spikes (e.g., fortifies spikes)

13. Consequences of laboratory fraud! In addition to the administrative penalties mentioned previously for ethics violations, laboratory fraud can result in criminal prosecution.

14. Non-fraudulent improper laboratory practices . . . Unlike fraud, an improper laboratory practice is not a deliberate act – it may be the result of lack of training, carelessness or inattention to detail. An improper laboratory practice is defined as “a scientifically unsound or unjustified omission, manipulation, or alteration that bypasses the required QC parameters, making the results appear acceptable.” Improper practices can result in the alteration of data such that the data are not true representations of the experiment or test performed. Similar to laboratory fraud, improper laboratory practices can also result in data that are not true and lack integrity. Laboratories are required under NELAC to establish systems and procedures to ensure that proper laboratory practices are followed.

15. OEME ensures proper laboratory practices and data integrity by . . . • Requiring all OEME personnel to follow written technical and QA/QC policies and procedures when performing sample collection, data generation, review, reporting and record-keeping tasks. • Implementing proactive ethics and quality assurance programs that promote and support proper laboratory practices and ethical behavior. These programs provide scientists with technical training and mandatory annual ethics refresher training. In addition, personnel electronically attest that they have read and understand the most recent version of the Laboratory QA Plan, Ethics policy and SOPs. • Ensuring all OEME products undergo Section-specific standardized internal review processes prior to release to clients. • Performing routine internal and external audits to identify and correct improper activities and systematic errors.

16. On-site OEME laboratory assessments are conducted routinely . . . External Audits • On-site NELAC assessments are conducted every 2 years. • On-site OEI Quality System assessments conducted every 3 years. • Internal Audits • Technical Systems Audits (annually) • Quality System NELAC Checklist Audit (annually) • Data package reviews (periodically) • Informal internal systems audits (on-going)

17. Laboratory assessments are important tools that . . . • Check for improper lab practices and non-conformances, • Spot systematic trends in measurement bias, • Isolate sources of inadvertent mistakes or “blunders,” • Identify areas needing corrective action, and • Provide the basis for continuous improvement.

18. In addition to assessments, OEME also uses other strategies for continuous improvement. • These strategies are part of our on-going effort to stay current with emerging science and technologies and include: • Attending technical seminars to learn new ways of doing things • Routine review and update of standard procedures and practices • Maintaining customer contacts to identify needs and preferences

19. Examples of recent system improvements . . . • Laboratory record-keeping processes were streamlined by taking advantage of new software and hardware technologies, examples include: • instrument data are automatically uploaded into LIMS; thus reducing transcription errors • providing customers with on-line reports and EDDs • Mercury calibration thermometers were recycled and replaced with NIST certified thermistors. • Project planning and documentation were simplified by using generic plans.

20. OEME describes specific policies and procedures to prevent improper laboratory practices. These policies and procedures are described in the OEME Laboratory QA Plans and in written Standard Operating Procedures (SOPs). All OEME SOPs, including analytical and field sampling SOPs, are maintained electronically in the Lab SOPs Lotus Notes database in accordance with the “OEME Document Control Standard Operating Procedure.” By following these policies and procedures you will avoid improper practices and help to ensure the integrity of the data you generate.

21. Field sampling requirements . . . • COC forms, field notebooks, field data sheets and sample container labels must be cross-referenced to ensure that the sample information is consistent, complete and accurate. • Any known issues that may compromise the data must be recorded in the field notebooks, field data sheets (including any electronic field data sheets) and COC forms. • Sampling equipment must be decontaminated in accordance with OEME SOPs.

22. Data reporting requirements . . . • Measurement results for all field samples and QC samples, including PE samples, must represent the actual outcomes of testing performed by Regional scientists in accordance with specified laboratory SOPs. • An appropriate written narrative must be provided when reporting data to describe method modifications, analytical problems encountered, and any data deficiencies that may potentially impact data usability. • Contracted and subcontracted analyses must be identified as such to the client; results from contractors/subcontractors may not be presented to the client as work done in-house at the EPA NE laboratory.

23. Laboratory data confidentiality policy states that . . . • Sample results, including electronic deliverables and preliminary data, may only be released to the client who requested the sample analyses. • Data may not be released to others without the permission of the customer unless legally required.

24. Data confidentiality policies . . . • Ensure consistent and timely release of data to our clients. • Are integral to the Incident Command System and conform to regional Information Quality Guidelines Pre-dissemination Review procedures. • Prevent miscommunication. • And underscore our personal role in maintaining data security

25. Laboratory records requirements. . . • Sample results and associated activities (e.g., sample preparation, QC information) must be documented in Laboratory Bench Sheets (hardcopy or electronic), bound Notebooks or Logbooks. • Deviations from SOPs must be recorded and reported with sample results. • Mistakes and transcription errors must never be erased, deleted, or written over; corrections are crossed out using a single line and signed or initialed and dated by the analyst or reviewer. The reasons for corrections that are due to other than transcription errors must be documented. • All data must be kept; no data may be discarded. • All corrective actions must also be documented and retained. Picture

26. Laboratory Logbook and Notebook requirements . . . • Each laboratory notebook must clearly state the beginning and ending date of its use. • Laboratory notebooks are stored on-site in their respective laboratory areas for a minimum specified period of time. • Chemistry records are maintained on-site for a minimum of three years. • Biology records are maintained on-site for a minimum of five years. After that time they may be archived to the Federal Records Center in accordance with Records Retention Schedules.

27. Chemistry Laboratory Electronic Instrument Data . . . • Data are stored on instrument-specific storage devices (usually a computer hard drive) or on a network server. • CDs and DVDs are the preferred media for long term storage of electronic instrument data and are maintained in their respective analytical areas for a minimum of five years. • Data remain on the server indefinitely. The servers are backed up on a daily basis: incremental back-ups throughout the week, and a full back-up on Fridays. Back-up tapes are retained for 30 days.

28. Chemistry Project Files . . . • Hardcopies of all raw generated data (instrument or manual) pertaining to a particular analysis (e.g., cyanide, VOCs) are filed in a color-coded Project File, by LIMSCODE and Project Number. • Results for each analysis are entered into the LIMS. A hardcopy of each analyte-specific (e.g., cyanide, VOCs) final report is also filed in the color-coded Project File. • Project Files must be maintained on site for a specified period of time in accordance with the Laboratory QA Plan and/or SOP and then archived to the Federal Records Center.

29. Chemistry Report Deliverables . . . • A .pdf file of the analysis-specific Final Report (by LIMSCODE) is posted to an EPA intranet “Report Website”. A notification is sent to the client that a Final Report has been posted. • When all analyses for a project have been reported to the Website, an Excel sheet (EDD) is generated and also posted on the “Report Website.” The EDD represents a "convenience copy" for the client and is not an official record that requires retention.

30. Measurement condition requirements . . . • Testing of environmental samples must be performed under the same measurement conditions as those used for standards analyses. • All modifications to measurement conditions must be allowable under OEME Standard Operating Procedures.

31. Traceability of Reagents, Standards, and Reference Materials requirements . . . • Records must be maintained that certify the traceability, purity, and document expiration dates of standards, reference material, media, and reagents. Prepared reagents must be labeled with the preparation date. • All reagents, chemicals, and media are tracked and controlled in accordance with the “Chemical Inventory and MSDS Management Standard Operating Procedure.” • Standards and reference materials are tracked and controlled by the requestor in “Standard Logbooks.” Records indicate traceability to source materials. Manufacturers’ expiration dates for standards and reference materials are carried forward to prepared dilutions.

32. Calibration requirements . . . • When calibrations and calibration checks do not meet acceptance criteria, corrective action (as specified in the SOP or Laboratory QA Plan) must be taken and documented. • Continuing calibrations must be compared against the correct initial calibration. • Instruments and equipment must be calibrated in accordance with the appropriate SOP prior to the analysis of samples. Deviations from required calibration procedures must be documented in the project file for the reported data. • Records of all calibration runs must be kept. Discarding calibration points without documented technical justification is not permitted.

33. QC Samples requirements. . . • QC samples (field and laboratory replicates, spiked field samples, method blanks, performance evaluation samples, control samples, etc.) must be prepared, analyzed, and reported according to appropriate SOPs and in the same manner as field samples. • Corrective action must be taken and documented when QC acceptance criteria are not met.

34. Example of Field QC Sample requirements . . . All field QC sample requirements in the SAP or QAPP must be followed. These many involve trip blanks, equipment blanks, field duplicates and the collection of extra samples for the laboratory’s quality control.

35. Examples of Chemistry QC Sample requirements . . . • For organic analyses, surrogate spike compounds must be added before extraction of the sample or as specified in the SOP. • For inorganic analyses, when samples are spiked after digestion the results must be reported as “post-digested analyses.” • If required “spiking” concentrations are modified to adjust for sample dilutions (or other technical reason), the analyst must record the adjusted spiking levels. • If a sample is accidentally “mis”spiked, then corrective action must be initiated and documented.

36. Examples of Biology QC Sample requirements . . . • Laboratory control samples must be included in toxicity laboratory studies and must meet test-acceptability criteria (TAC) in order for the test to be determined acceptable. • Laboratory control samples and/or blanks are also required in microbiology laboratory studies as well as laboratory duplicates. • Reference toxicant control charts must be generated for all test species; both chronic and acute control charts are maintained electronically in the G:\\allshare directory.

37. Date and Time recording requirements . . . • The recorded date and time of sample collection, preparation, analysis, and data entry must match the actual date and time that the activity was performed. • Corrections and revisions to documents and reports must be accurately and clearly dated and signed (or initialed). • Instrument time clocks must not be reset inappropriately. • Sample preparation or analyses that exceed holding times must be identified as such and reported as laboratory qualified data.

38. Data review requirements . . . • Before reporting data to the client, all data must be reviewed in accordance with QC procedures described in the OEME Laboratory QA Plans. • The client is then responsible for ensuring the usability of the data prior to release to the public in accordance with regional Information Quality Guidelines Pre-dissemination review procedures. • Procedures for addressing complaints and for correcting sampling or laboratory errors must be followed to ensure the accuracy of reported data. • Revisions of issued reports must be clearly identified as revisions, and both original and revised documents are maintained.

39. OEME conducts data integrity monitoring. Procedures for reporting, documenting, and tracking errors, deficiencies, and “out-of-control” situations are described in the OEME Laboratory QA Plans and SOPs. In addition, as part of the internal laboratory auditing program, evidence of inappropriate actions or vulnerabilities related to data integrity is reviewed. All investigations that result in the finding of inappropriate and deliberate activity will be documented and will result in disciplinary actions, corrective actions, and appropriate notifications to clients. These records will be maintained and archived in accordance with regional procedures.

40. What’s your responsibility if you observe an unethical or improper laboratory practice? The Principles of Scientific Integrity states: “Accept the affirmative responsibility to report any breach of these principles” So you have a responsibility to raise potential data integrity issues to management. Remember that OEME management ensures confidentiality when staff identify the occurrence of an improper laboratory practice or violation of the OEME ethics policy. You can also call the Fraud hotline (1-800-546-8740) or contact Tim Williamson of the Regional Counsel’s Office (617-918-1099).

41. Take home message . . . • Adhere to standardized technical and quality-related policies and procedures. • Understand your personal role in maintaining data confidentiality. • Be aware of situations that may involve borderline improper practices and alert management.

42. Thank you for completing the 2011 Annual Laboratory Ethics Refresher Training. OEME’s management recognizes that training is only one factor in maintaining an effective Ethics program. Your active participation is the key component! Ongoing and open discussion and analysis of real and hypothetical situations is also important to understanding and responding to ethical issues that may arise. Therefore, open discussions will be held periodically during Unit meetings to consider hypothetical examples of potentially unethical behavior and improper laboratory practices. Any suggestions that you may have for discussion topics should be provided to the QA Officers for ECA and EIA. • Please attest to completing this course by checking the attest button.