The purpose of this years 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. 2
Slide 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 3
Slide 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 publics 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. 4
Slide 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 Integrity issued in 1999. Administrator Jackson
re-affirmed these Principles in her Scientific Integrity: Our
Compass for Environmental Protection, 5/8/2009 memo
http://www.epa.gov/Administrator/scientificmemo.htmlhttp://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
5
Slide 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. 6
Slide 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 EPAs 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. 7
Continued...
Slide 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. 8
Slide 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 anothers 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? Lets have a closer look at these issues...
9
Slide 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. 10
Slide 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 11
Slide 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) 12
Slide 13
Consequences of laboratory fraud ! In addition to the
administrative penalties mentioned previously for ethics
violations, laboratory fraud can result in criminal prosecution.
13
Slide 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. 14
Slide 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. 15
Slide 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. 16 Internal Audits Technical Systems Audits (annually)
Quality System NELAC Checklist Audit (annually) Data package
reviews (periodically) Informal internal systems audits (on-
going)
Slide 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. 17
Slide 18
In addition to assessments, OEME also uses other strategies for
continuous improvement. 18 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
Slide 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. 19
Slide 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. 20
Slide 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. 21
Slide 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. 22
Slide 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. 23
Slide 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 24
Slide 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. 25
Picture
Slide 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. 26
Slide 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. 27
Slide 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. 28
Slide 29
Chemistry Report Deliverables... 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. 29 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.
Slide 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. 30
Slide 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.
31
Slide 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. 32
Slide 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. 33
Slide 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 laboratorys quality control.
34
Slide 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 misspiked, then
corrective action must be initiated and documented. 35
Slide 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.
36
Slide 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.
37
Slide 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.
38
Slide 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. 39
Slide 40
Whats 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 Counsels
Office (617-918-1099). 40
Slide 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. 41
Slide 42
Thank you for completing the 2011 Annual Laboratory Ethics
Refresher Training. OEMEs 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. 42