Characteristics of Adequate Audit Trails in Sample Management Systems

An audit trail ensures that each interaction with a sample is tracked and recorded properly.
In lab settings, it’s important to know which samples have been handled by whom and when. Not only are such trackers crucial to ensure sample integrity, but audit trails are a critical component to ensuring patient safety and regulatory requirements.

Lab sample management in the age of automation can expedite lab processes and ensure speedy reporting for lab personnel or regulators.

Lab sample management audit trails defined
In terms of lab sample management, an audit trail can be defined as the creation, documentation and management of records used to identify actions. The audit trail measures the precise sequence of events and provides evidence that justifies and/or explains what actions have occurred. The documentation identifies, for each sample, the source, transfer of ownership, work completed and transportation.

Put another way, an audit trail keeps track of samples, who has accessed them and what actions were taken with each.

There are three essential reasons that having a robust audit trail is critical.

Security
An audit trail ensures that you know what has happened to each and every sample, when it was handled, and what happened to it at each step in the lab. In the unfortunate event that something happens with a sample, the audit trail can quickly identify who had access and what actions were completed. In automated lab systems, where human interaction is minimal, the audit trail ensures safety and accountability.

Patient Confidentiality
Personal health information needs to remain confidential in a lab setting. For that reason, your audit system has to maintain patient privacy in many circumstances. Failure to protect personal health information can result in regulatory scrutiny, loss of trust, and damage to individual patients regarding medical conditions.

Regulatory Compliance
Tracking sample usage and management is essential for compliance with a number of local, state, and federal authorizing agencies. While many regulatory requirements may be common among different agencies, there can be variations. Your audit management software needs to allow for multiple agency reporting requirements.

Audit trails help ensure patient safety and compliance with various regulatory requirements.
With such essential needs for sample management, there are a number of critical components to evaluate when purchasing lab sample management software packages. Here are a few factors to consider closely:

Fundamental Functionality
At a minimum, the following characteristics of adequate audit trails in sample management should be present:
  • What sample data was changed
  • The names and user names of employees who changed the information
  • The date and time when the sample was changed
  • What was used or done to the sample
  • Both the original and changed values of the data
  • Why the sample was changed
Automation
Automated audit trails significantly reduce the risk of human error.

Usability
The audit trail should be searchable, reportable, customizable, and its data un-editable. Lab software should not need to be modified to fit system constraints; the selected software should allow for a lab to translate and apply functions and procedures.

When you want automated lab management system software that provides you with confidence, accuracy, and the proper audit functionalities, turn to Freezerworks. Our products and services allow for proper tracking of lab samples, improved efficiency, and flexibility to create a solution that works for every lab. Request a demo to learn about Freezerworks’ ability to transform your lab while ensuring the right audit systems.

To learn more about how Freezerworks can assist in meeting your regulatory requirements, see our Quality Assurance section.