Leeds Teaching Hospitals takes a proactive approach to quality control by carrying out internal lab audits

The brief

Leeds Teaching Hospitals NHS Trust (LTHT) includes St James’ University Hospital, Leeds General Infirmary and Chapel Allerton Hospital. In 2009, the Trust chose Interactive Software’s laboratory and sample management software, Achiever Medical, to help streamline its tissue tracking processes for compliance. Before implementing Achiever Medical, the Trust had found it challenging to co-ordinate its audits across its multiple teams. This was because each team was using their own systems to capture data and carry out processes. The Trust chose Achiever Medical as it allowed each team to manage its data and processes according to its own requirements while providing a complete, standardised audit system for Human Tissue Act (HTA) compliance. Today, 39 teams across the Trust use Achiever Medical. Plus, the software has helped them successfully pass their recent HTA audits.

Following glowing reports from previous HTA audits, LTHT’s internal auditors wanted to further improve quality and maximise budgets. The Trust wanted to do this by carrying out their own internal lab audits. These could be scheduled and ad-hoc internal tissue sample and storage location audits. The Trust hoped that by adopting a more pro-active auditing approach, they could identify and address any issues earlier. This could include amending any Standard Operating Procedures (SOPs).  The Trust started looking for software to help them to carry out their own internal lab audits. The solution also needed to be flexible to manage the very different requirements of each team involved.

The solution

The Trust has 55 active tissue sample collections across 39 teams and a further 44 historical archives. This extensive range of tissue holdings, containing both HTA-relevant and non-HTA relevant samples, requires regular auditing. However, most teams work independently with different management and SOPs. The primary objective of this internal auditing project was to create a flexible system with a standard way of recording audit logs and tracking non-compliance. In addition, the Trust wanted to be able to analyse the internal lab audit results, so cross-project reporting tools were essential. As a minimum, each internal audit required non-modifiable records of checks carried out, passes/fails, responsibility and remedial actions taken. Also, senior management and inspectors had to be able to access these easily.

LTHT again chose Interactive Software Limited’s Achiever Medical software to help it carry out and track its internal laboratory audits. Achiever Medical’s new Auditing and Quality Assurance module provided the Trust with the functionality it needed. In addition, the Trust could take advantage of the software’s existing, proven auditing functionality, flexible configuration tools and advanced querying options to further extend and customise the functionality as required.

“We have been using Achiever to manage and segregate the data of separate teams for 9 years and this now extends to 31 teams. Achiever has now been extended to managing our internal auditing and will allow us to record consent appropriately and manage/remove data as required, to fully comply with GDPR.”

 The outcome

 LTHT had three types of internal lab audit it wanted to manage:

• “Sample to Location” audits. This randomly selects tissue samples to check that they are where they should be.
• “Location to Sample” audits. This randomly selects positions in storage locations to check users have populated these appropriately or that they are correctly empty.
• “Sample to Consent” audits. This allows auditors who are validating samples to also check informed consent to ensure that it is captured correctly, and donor preferences are being honoured.

LTHT and Interactive Software Limited worked closely together to design an enhanced audit module to manage these requirements. In addition, the solution allows candidate samples to be filtered by HTA-relevance, storage dates and even whether each sample has been audited before. All these criteria provide the flexibility the teams require to manage new “clean” audits, follow-up audits, and HTA-focussed internal lab audits. It also allows the Trust to target audits by storage date to focus on when they implemented a new SOP.

The solution allows users to collate and analyse audit information by project, team or campus. In addition, the users can easily export selected data to Microsoft Excel, which allows them to use their existing analysis tools/skills.

The next stage in the project is to identify graphical reporting requirements. The Trust will complete this once the teams have built up a bank of solid data to analyse.

Main Benefits

Through a collaborative project approach Interactive Software Limited has been able to design its internal lab audit solution to maximise benefits for the Trust. Following the introduction of the Achiever Medical’s Auditing and Quality Assurance module, LTHT is expecting to gain:

• Improved evidence to provide to HTA auditors of internal lab audit, issue identification and resolution processes.
• Improved Standard Operating Procedures (SOPs).
• Reduced costs through coordinated auditing efforts across teams.
• Reduced costs of resolving SOP issues and from optimised lab processes.
• Improved SOPs resulting from less time spent auditing and more time learning from the results.
• Reduction in loss of specimens due to lack of evidence of viability.
• Reduced management costs via centralised maintenance of internal lab audit logs by teams.
• Reputational benefits resulting from use of best practice, backed by solid evidence.