Laboratory Ethic & Data Integrity

LAB-001
Revision 4, 2/27/12
Page 1 of 10

Environmental Services Division

Standard Operating Procedure

Laboratory Ethics and Data Integrity
Effective Date: 2-27-12

Approved By: __________________________

Date: _______________

Technical Manager

Approved By: __________________________

Date: _______________

QA Officer

Approved By: __________________________

Division Manager

Date: _______________

Laboratory Ethic & Data Integrity

LAB-001
Revision 4, 2/27/12
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Laboratory Ethics and Data Integrity

1

INTRODUCTION

The Sabine River Authority of Texas (SRA), Environmental Services Division (ESD) Water Quality Laboratory
will conduct business in accordance with Our Shared Values and under a code of ethics. This SOP does not
supplement, replace, or supersede the Standards of Conduct as stated in the Sabine River Authority of Texas
Employee Handbook (January 2005). This SOP interprets the SRA Standards of Conduct as related to practices
specific to the Water Quality Laboratory under NELAC.

OUR SHARED VALUES

INTEGRITY We will be honest and above board in all dealings with clients, fellow
employees, and the SRA.
QUALITY We will strive to achieve excellence in all services provided and will work
continually to show improvement in all our endeavors.
EMPLOYEE EMPOWERMENT In accordance with SRA policies, we will create and
maintain an employment environment that provides employees opportunities to grow, excel,
and achieve upward mobility. Employees will have authority that is commensurate with their
responsibilities as stated in SRA job descriptions.
CUSTOMER SATISFACTION We will meet customer expectations and needs to the best of
our abilities within the framework of our mission to SRA.
PROGRESS/INNOVATION Under the leadership of SRA, we will expend the resources
necessary to ensure that the ESD Water Quality Laboratory remains current with approved and
accepted technologies of the Texas Commission on Environmental Quality (TCEQ) and the U.
S. Environmental Protection Agency (USEPA). We will continually work to identify and
implement new ideas and ways of doing things for the betterment of the Water Quality
Laboratory.
ORGANIZATIONAL HEALTH According to SRA safety policies, we will provide a safe
and secure workplace for employees.
PROTECTION OF THE ENVIRONMENT We will maintain an awareness of
environmental issues and ensure that the Water Quality Laboratory complies with all relevant
environmental statutes and regulations.
SHARING COMMON GOALS We will work together as a team to achieve established SRA
goals. We will communicate these goals to all employees and do everything in our power to
see that those goals are met.
1.1. Under the SRA Standards of Conduct, it is the policy of the Water Quality Laboratory to
generate accurate and reliable data in accordance with project and regulatory requirements.
1.2 Data produced by the Water Quality Laboratory may have legal ramifications. Accordingly, all
activities must comply with applicable state and federal statutes and be commensurate with the
highest standards of rigor and ethics.

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1.3 To ensure that SRA ESD Water Quality Laboratory personnel understand the ethical
considerations associated with the production of data, Water Quality Laboratory employees
shall be furnished this Standard Operating Procedure (SOP) and a copy of the SRA Standards
of Conduct by the SRA ESD Quality Assurance Officer on the first workday after hiring. In
addition all SRA ESD Water Quality Laboratory employees are required to participate in
annual refresher training.
1.4 To ensure that data reported by the Water Quality Laboratory is reliable, accurate, and
defensible in a court of law, the Water Quality Laboratory Standard Operating Procedures and
project-specific requirements will be consistently followed.

2 LABORATORY PROCEDURES
2.1 It is SRA ESD Water Quality Laboratory policy that Water Quality Laboratory personnel
follow the written SOPs and the specific requirements of all projects for which sample analyses
are performed.
2.2 Deviations from project requirements (protocols) and/or SOPs must be approved in writing by
the Quality Assurance Officer or designee prior to analysis. The Quality Assurance Officer or
designee obtains approval for such deviations, either in writing or by phone (documented in a
phone log), from pertinent project authorities. Any permanent changes to SOPs and bench
sheets must be requested using the Laboratory SOP/Bench Sheet Amendment Form as
specified in the Modification of SOPS and Bench Sheet procedure, LAB-014 in the Laboratory
Practices Manual.
2.3 All laboratory errors must be fully documented in the analyst bench book and reported to the
employees immediate supervisor.

3 RESPONSIBILITIES
3.1 SRA ESD Managers and Technical Manager are responsible for communicating project
requirements to the SRA ESD Quality Assurance Officer and laboratory staff.
3.2 The Quality Assurance Officer or designee is responsible for verifying that all project
requirements and SRA ESD SOP requirements are followed.
3.3 The Quality Assurance Officer or designees perform audits to ensure that the requirements of
methods, regulations, and projects are followed.

UNETHICAL CONDUCT
4.1 Under the SRA Standards of Conduct, unethical actions include, but are not limited to the
following (also refer to the items listed in Exhibit 3):
4.2 Forging another employees name or initials.
4.3 Entering data into the Laboratory Information Management System (LIMS) under another
employees LIMS login name or network login name.
4.4 Recording or reporting results without actually analyzing the associated samples.

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4.5 Signing for review of data when such review was not completed.
4.6 Knowingly altering data entries without acceptable justification.
4.7 Any action to cover up an occurrence from which loss of data and/or revenue can occur.
4.8 Substituting previously analyzed QC samples for those issued by the Quality Assurance
Officer.
4.8.1

Spiking a little extra to improve recoveries.

4.8.2

Fabrication or falsification of records or data.

4.8.3

Any other action stated in or implied by the SRA Standards of Conduct.

4.9 Pertinent documents which describe proper laboratory practices are as follows:
Quality Assurance Project Plan
Quality Assurance Manual
ESD Safety Manual
Corrective Action
Manual Integration
Documentation Maintaining Instrument Records, Notebooks and Logbooks
Written Client Communication
SRA Employee Handbook

5 NOTIFICATION
5.1 SRA ESD Water Quality Laboratory personnel who are aware of, or reasonably suspicious of,
any unethical practice or misconduct occurring in the laboratory are asked to inform the ESD
Assistant Manager or ESD Manager immediately or use the procedure as described in Section 8
of this SOP.
5.2 No employee shall be discriminated against or disciplined for making an allegation in good
faith or for providing evidence of possible unethical behavior.
5.3 The names of all those involved in the investigation of any report of apparent unethical conduct
will be held in confidence according to the provisions of the Confidentiality paragraph (p.40)
of the SRA Employee Handbook.
5.4 Under the direction of the ESD Manager, every allegation of unethical conduct shall be
investigated.

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6 DISCIPLINARY ACTION
6.1 Any SRA ESD Water Quality Laboratory employee who participates in unethical conduct as
stated or implied by the SRA Standards of Conduct is subject to disciplinary action up to and
including termination of employment pursuant to SRA policy.
6.2 An unethical action becomes a fraudulent act when the law is violated. Knowingly faxing or
mailing false information is a violation of Title 18, United States Code, Section 1341. The
sender can be charged with wire fraud or mail fraud and could be prosecuted.

REQUIREMENTS
7.1 All new employees are required to read this SOP and the SRA Employee Handbook at the time
of hiring. Employees must sign page 71 of the Employee Handbook, Acknowledgement of
Receipt (Exhibit 1). The signed Acknowledgment of Receipt is returned to the SRA Benefits
Coordinator for filing in the employees official personnel records maintained at the Authority
General Office. Employees must also sign an acknowledgment of receipt and understanding of
this SOP (Exhibit 2). This acknowledgment form is filed for each employee in the Quality
Assurance Officers office.

REPORTING OF IMPROPER PRACTICES

8.1 A form (Exhibit 4) located in the ESD front office vault is for use by all employees for
reporting of improper laboratory practices. Information required in the form is a description of
the situation, including dates and employee(s) involved. An optional field for identification of
the user is available and appreciated.
8.2 This form can be placed in an envelope marked Confidential and left in the ESD Managers
mailbox.
8.3 The Quality Assurance Officer and a member of management staff, under the direction of the
ESD Manager, will conduct an investigation using qualified technical and management
personnel. The investigation may include interviews, data audits, and internal method audits to
determine inappropriate practices.
8.4 The investigation records are retained for the length of employment of the employee(s)
involved. If the investigation results in the termination of the employee(s), the investigation
records will be retained a minimum of five years after the closing of the investigation.
8.5 The Quality Assurance Officer will determine if the inappropriate practice has an impact on
data integrity and reported values. The Quality Assurance Officer or designee will initiate
client contact and data recall if required.
8.6 Confidentiality of unethical practices investigations will be governed by SRA policies as stated
in the SRA Employee Handbook.

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EXHIBIT I
Page Intentionally Left Blank
The Acknowledgement of Receipt can be found on page 71 in the SRA
Employee Handbook.

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EXHIBIT 2
SABINE RIVER AUTHORITY OF TEXAS
ENVIRONMENTAL SERVICES DIVISION
Water Quality Laboratory
National Environmental Laboratory Accreditation Certification
ETHICAL CONDUCT AND DATA INTEGRITY AGREEMENT

I, ________________________________________________________________________
(Print name)
have read and understand SOP LAB-001 Revision 4, 2-27-12 Laboratory Ethics and Data
Integrity. I understand that violation of the content of SOP LAB-001 is also a violation of
SRA Standards of Conduct and that disciplinary action and possible criminal penalties can be
the result of unethical behavior. I clearly understand that adherence to SRA policies regarding
ethical conduct is a requirement of continued employment.
I received/viewed a copy of the documents listed below:
Laboratory Ethics & Data Integrity SOP LAB-001, Revision 4, 2-27-12
Copy of Section 17.2 Data Integrity & Ethics from Quality Manual, current revision
Copy of Business Ethics & Conduct from the SRATX Employee Handbook dated
January 2005, pages 38-39
SRA Powerpoint presentation, Laboratory Ethics and Data Integrity
Employee
Signature____________________________________ Date___________________

ESD Manager___________________________________ Date___________________

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EXHIBIT 3
TYPICAL LABORATORY PROBLEMS AND UNACCEPTABLE AND
ACCEPTABLE SOLUTIONS
Problem
Lack of time or resources to
perform testing

Hold time near or past

Calibration or QC data not

meeting acceptance criteria

Calibration or QC data not

meeting acceptance criteria

Unacceptable Solution
Fabricating data or other information
creating data for an analysis that was not
performed or creating information that is
not true.
Improper Clock Setting (Time Traveling)
or Improper Date/Time Recording
Resetting the internal clock on an
instrument. Recording a false time of
sample collection, extraction, or analysis.
Improper Peak Integration (Peak Shaving
or Enhancing) Artificially subtracting or
adding peak area to produce an erroneous
area that forces data to meet specific QC
criteria.
Improper Calibration/QC Analysis
a) Performing multiple (more than
two) calibrations or QC runs
(including calibration
verifications, LCSs, spikes,
duplicates, and blanks) until one
analysis meets criteria. (Cherrypicking)
b) Using the incorrect (previous)
initial calibration to make
calibration verification data
appear to be acceptable.
c) Discarding points in the initial
calibration or MDLs to force the
calibration to meet acceptance
criteria.
d) Discarding points from an MDL
study to force the calculated
MDL to be higher or lower than
the actual value.

Acceptable Solution
Communicate with management to
resolve lack of time or resources
issues
Samples exceeding hold times must
be reported as such; a report narrative
will be included with the report.

Instrument peaks must be

consistently integrated and reported
according to proper techniques,
generally baseline-to-baseline.

a)

Preventive/corrective action
must be taken and
documented if calibration
and/or other QC criteria are
not met after the second
failed analysis.
b) Acceptance of calibration
verification data must be
based on the correct initial
calibration.
c) Points can be discarded at
the upper end of the curve.
See Quality Manual Section
20.3.2 for acceptable
solutions.
d) Data points for MDL can
only be rejected for
inclusion in the MDL
calculation if a known error
was made or if a statistical
evaluation indicates that a
point can be discarded.

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EXHIBIT 3
TYPICAL LABORATORY PROBLEMS AND UNACCEPTABLE AND
ACCEPTABLE SOLUTIONS
Problem
Method blanks, LCSs, or
spikes not meeting
acceptance criteria

Unacceptable Solution
Not preparing or analyzing method
blanks, LCSs, or spikes the same way
that samples are prepared or analyzed
(digestion, extraction, etc.)

Calibration or QC data not

meeting acceptance criteria

File substitution or manipulation of

computer software

Analytical conditions for

standards do not work for
samples

Using different instrument conditions or

analytical/data processing steps for
samples and QA

Sample not analyzed at

appropriate level or not
reported at correct detection
limit.

Over dilution of Samples or

Misrepresentation of Detection Limits
Intentionally diluting a sample to such
an extent that no analytes (target or nontarget) are detected without justification
as to why the high dilution was made.
Reporting a detection limit that does not
represent the sample analysis (e.g., not
including dilution factor in sample
detection limit)
Deletion of Noncompliant Data
Intentional deletion or non-recording of
noncompliant data to conceal the fact
that analyses were noncompliant

Noncompliant data

Undesirable situation with

analysis or sample;
knowledge of unethical
conduct

Concealment of a Known Problem

Concealing a known analytical or
sample problem from laboratory
management and/or client. Concealing a
known unethical behavior or actions
from laboratory or SRA management

Acceptable Solution
Method blanks, LCSs, and spikes
must be prepared and analyzed the
same way that samples are prepared
and analyzed. Any QC results outside
acceptance criteria must be reported
as such; a case narrative will be
included with the report.
Substitution of files is not permitted.
Computer manipulation is allowed
only for warranted reasons, and any
manipulation should be minimal and
traceable
All sample analyses must be performed
under the same conditions as those
used for standard analyses. Any
alteration of analytical conditions must
be allowable under the method
requirements. Any discrepancies must
be documented.
Dilutions must be made on a
reasonable basis, such as high
concentrations of target or non-target
analytes, matrix interferences, oily
samples, and other components in the
sample that could harm the instrument.
Include details concerning the reason
for the dilution in a case narrative.
Sample detection or reporting limits
must include dilution factors.
All data associated with sample
collection and analysis, including any
out-of-control events or noncompliant
data, must be documented and
retained. Preventive/corrective action
must be taken and documented for any
noncompliant data.
Any knowledge of analytical or sample
problems must be communicated to
laboratory management and the client.
Any knowledge of unethical behavior
or actions should be fully
communicated to laboratory or SRA
management.

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EXHIBIT 4
SABINE RIVER AUTHORITY OF TEXAS
ENVIRONMENTAL SERVICES DIVISION
WATER QUALITY LABORATORY
REPORTING FORM FOR IMPROPER LABORATORY PRACTICES
Date:
Issue:

Person(s) Involved:

Reported by:
(optional)
Investigation
Conducted
By:

Start
Date:
Completed
Date: