The foundation of any laboratory’s reputation is built on confidence in its ability to provide correct and reliable data. ISO/IEC 17025, subclause 4.1.5 d, requires that your management system “have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment, or operational integrity.”
How can your laboratory effectively provide “confidence in its competence, impartiality, judgment or operational integrity?” This can be ensured through the use of detailed policies, procedures, and a program that specifically addresses these topics.
Laboratories often state within their quality manuals that they ensure the integrity of their operations but provide limited details for how this is ensured. There may also be some kind of a confidentially or ethics agreement in place that personnel signed when hired. Is this enough to ensure that all employees fully understand and retain the importance of this topic and will comply?
The laboratory should have a policy in place addressing the lab’s exact position on ethics, integrity, and code of conduct. Based on this policy, procedures should be put in place that define exactly how the policy will be implemented and ensured.
The lab’s policy may include its organizational mission and commitment to honesty and full disclosure in all aspects of laboratory operations, including reporting of data. Detecting and deterring improper, unethical, or illegal actions begins with a zero-tolerance philosophy established by management.
An ethics/integrity program might also include written ethics agreements, examples of improper practices, examples of improper data manipulations, requirements for external ethics program training, and any external resources available to employees.
Improper actions include intentional or unintentional deviations from contract-specified or method-specified analytical practices that have not been authorized. Unethical or illegal actions are the deliberate falsification of analytical or quality control results, where failed method or contractual requirements are made to appear acceptable.
An ethics/integrity program should:
• Define improper, unethical, and illegal actions
• Outline elements of detection/deterrence programs for improper, unethical, or illegal actions
• Provide examples of improper laboratory practices
• Require the ethics policy to be read and signed by all personnel
• Have in place a “no-fault” reporting policy that encourages laboratory personnel to report suspected improper, unethical, or illegal activities without fear of retribution
• Have in place a designated data-integrity officer to whom personnel may confidentially report suspected instances of improper, unethical, or illegal activities
• Require initial and annual ethics training
• Be included as part of the internal audit program
• Require an explanation and sign-off on all manual changes to data
• Where available in instrument software, all electronic tracking and audit functions must be enabled
An ethics/integrity program should prohibit:
• Concealing a known problem
• Concealing a known improper or unethical behavior or action
• Failing to report the occurrence of a prohibited practice or known improper or unethical act to the appropriate laboratory or contract representative
• Misrepresenting or misreporting equipment quality control or verification data
• Fabrication, falsification, or misrepresentation of data, including
• Improper clock setting (e.g., time traveling) or improper date/time recording, including
• Unwarranted manipulation of samples, software, or test conditions, including
Detecting and deterring improper, unethical, or illegal actions begins with a zero-tolerance philosophy established by management. Improper, unethical, or illegal actions are detected through the implementation of surveillance protocols.
To ensure effective implementation of the laboratories ethics, policy, and program, top management must acknowledge its support by upholding the spirit and intent of the organization’s ethics and integrity procedures and effectively implementing the specific requirements.
Employees must understand that any infractions of the laboratory data integrity procedures will result in a detailed investigation that could lead to serious consequences including immediate termination, debarment, or civil/criminal prosecution.
A laboratory should provide ethics/integrity training as a formal part of new employee orientation as well as on an annual basis for all current employees. Topics covered should be documented in writing and provided to all trainees.
Training should include discussion regarding all ethics/integrity procedures and documentation. The initial ethics/integrity training and annual refresher training should have a signature attendance sheet or other form of documentation that demonstrates all staff has participated and understand the obligations related to the ethics program.
Data integrity training should require emphasis on the importance of proper written narration on the part of lab personnel with respect to those cases where data may be useful and provide specific examples of breaches of ethical behavior.
Source reference, in part, regarding citations: U.S. Department of Defense (DoD) Quality Systems Manual v. 4.1