‘Audit’. The mere mention of the word can strike fear into the heart of the most experienced and organised laboratory managers. Hours can be spent preparing for an external audit such as those conducted by the Human Tissue Authority (HTA). Researchers spend precious time collating information and formatting documents. Whilst Principal Investigators (PI) and lab managers prepare to handle any questions that may arise. With all this trepidation surrounding audits it is easy to forget their purpose – to ensure lab and biological sample quality.
Sample tracking software or laboratory information management system (LIMS) can ease the administrative burdens of data management for audit compliance. These systems help to instil quality and traceability into your daily processes.
What if you were to go one step further and carry out your own internal audits?
Whatever the frequency, actively conducting your own internal quality checks on biospecimens and storage locations can help eliminate the traditional ‘audit rush/panic’.
Regular internal audits and quality checks allow you to confirm that the procedures and processes you have implemented are working effectively. This approach also allows for earlier identification of improvements and any necessary corrective actions.
They can help ease the tension that can be experienced around external audits. You and your team will be more confident demonstrating the quality processes and procedures you have in place and importantly, evidence their use.
In addition, your team will be well prepared and practised in the art of being audited and understand the significance of quality.
When deciding which areas to audit, it is important to ensure the critical information that will help you monitor and manage quality and be realistic. Some ideas of things to include in an internal audit to ensure lab and biological sample quality are:
- Randomly selecting of biological samples collected over a defined period to confirm storage locations.
- Choosing a selection of specimens collected over a defined period to check their use is within agreed consent restrictions.
- Identifying donors that have withdrawn consent to confirm all biological samples have been destroyed and are no longer in your biorepository. This is in accordance with your Standard Operating Procedures (SOPs).
- Recording any compliance issues or required corrective action.
Tracking Outcomes and Progress
Integrated, interactive dashboards and reports can be used to monitor audit progress and outcome. Dashboards can include audits completed, results (pass/fail), outcome comparisons (versus last year or last quarter), trends and averages. This information can be evidenced in any external compliance audits such as those conducted by the Human Tissue Authority (HTA). In addition, it can be made available for your management reporting. Thereby allowing you to monitor and measure biospecimen viability, track Return on Investment (ROI) and increase the value of your biological samples.
Integrated Approach to Promoting Lab and Biological Sample Quality
The benefit of this integrated approach means your system is set up for internal audits as and when you wish to perform them. The intuitive dashboard enables data to be continually organised in such a way that the auditing process becomes simply a reporting exercise. Your information will be easily and readily available. Thereby enabling you and your team to become more proactive.