The foundation of any laboratory’s reputation is built on confidence in the laboratory’s ability to provide correct and reliable data. Data integrity is critical to the success of any laboratory.
How can your laboratory effectively provide confidence in its competence, impartiality, judgment, or operational integrity of its operations? This can be assured through the use of detailed policies, procedures, and a program that specifically address these topics.
Laboratories often state within their quality documentation that they ensure the integrity of operations but provide limited details for how this is assured. There may also be some kind of a confidentially / ethics agreement in place that personnel have signed once upon hire. Is this enough to assure that all employees fully understand and retain the importance of this topic and assure compliance?
Laboratory Policy on Ethics / Integrity
The laboratory should have a policy in place addressing the laboratory’s exact position on Ethics, Integrity, and Code of Conduct. From this policy, procedures should be in place that defines exactly how the Policy will be implemented and assured.
The laboratory’s policy may include its organizational mission and its relationship to the critical need for 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.
Laboratory Ethics / Integrity Program
An Ethics / Integrity program may 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 are 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.
Ethics / Integrity Program Should:
- Define improper and unethical, or 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 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 the instrument software, all electronic tracking and audit functions must be enabled;
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;
- a. Creating data for a test that was not performed
- b. Creating information for a sample that was not collected
- c. Using external analysts, equipment, and/or laboratories to perform analyses when not allowed by contract
- Improper clock setting (time traveling) or improper date/time recording;
- a. Resetting the internal clock on an instrument to make it appear that a sample was analyzed within holding time when in fact it was not
- b. Changing the actual time or recording a false time to make it appear that specified times were met
- c. Changing the times for steps to make it appear that specifications were met
- Unwarranted manipulation of samples, software, or test conditions;
- a. Unwarranted manipulation of computer software
- b. Turning off, or otherwise disabling, electronic instrument audit/tracking functions
Implementation of Ethics / Integrity Policy
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 assure effective implementation of the laboratory’s Ethics / Integrity policy and program, Top Management must acknowledge their 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 very serious consequences including immediate termination, debarment or civil/criminal prosecution.
Training / Effectiveness
A laboratory should provide Ethics / Integrity training as a formal part of new employee orientation and should also be provided 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 have participated and understand their obligations related to Ethics / Integrity program.
Data integrity training should require emphasis on the importance of proper written narration on the part of laboratory personnel with respect to those cases where data may be useful and provide specific examples of breaches of ethical behavior.
