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Case Study: Continuous Improvement

Leeds Teaching Hospitals NHS Trust

Project Details

  • Customer : Leeds Teaching Hospital Trust
  • Category :Sample Management
  • Go Live :2009
  • Main Benefit : HTA Compliance
  • Customer :

The Brief

Leeds Teaching Hospitals NHS Trust (LTHT) includes St James’ University Hospital, Leeds General Infirmary and Chapel Allerton Hospital.

With diverse data and process requirements across multiple teams, the co-ordination of audits across the Trust was challenging. In 2009, LTHT chose Interactive Software’s laboratory and specimen management solution, Achiever Medical, to facilitate the auditing process whilst allowing users to carry out their daily tasks.

The solution is currently used by 39 teams across Leeds University and three hospitals to track human tissue and manage Human Tissue Act (HTA) compliance.

Following glowing reports from previous HTA audits, LTHT’s internal auditors wanted to further improve quality and maximise budgets. LTHT was looking for a solution to help them to carry out scheduled and ad-hoc internal specimen and location audits. It was envisaged that through a more pro-active auditing approach, issues could be identified and addressed earlier including amending any Standard Operating Procedures (SOPs). The solution also needed to be flexible enough to manage the differing requirements for each team involved.

The Solution

In December 2008 the trust went to tender for a system to manage tissue tracking across multiple teams, hospitals and sites and to support compliance with the Human Tissue Act.

LTHT again chose Interactive Software’s (ISL) Achiever Medical solution with its proven auditing functionality, flexible configuration tools and advanced querying capability to manage its new requirement.

LTHT has 55 active tissue collections across 39 teams and a further 44 historical archives. This extensive range of tissue holdings, containing both HTA-relevant and non-HTA relevant specimens, requires regular auditing. However, most teams work independently with different management and SOPs. The primary objective of the audit management development project was to provide flexibility when designing the solution while still providing a standard way of recording of audit logs, non-compliance recording and cross-project reporting tools. As a minimum, each audit required non-modifiable records of checks carried out, passes/fails, responsibility and remedial actions taken. All of these records had to be easily accessible by senior management and inspectors.

The remit was to implement an efficient tissue management system that covered compliance with applicable legislation (Human Tissue Act, Data Protection Act, Freedom of Information, etc.) without introducing an administrative burden on users; to maximise visibility of tissue holdings and auditing data and allow the adoption of 2D barcoding for newly collected samples.

Data migration services were also provided for a number of the teams, importing data from a variety of sources.

“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 audit to manage:

  • “Sample to Location” audits. This randomly selects specimens to check that they are where they should be.
  • “Location to Sample” audits. This randomly selects positions in storage locations to check they are populated 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 ISL worked closely together to design an enhanced audit module that would allow 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 audits. It also allows audits to be targeted by storage date to focus on when a new SOP was implemented.

The solution allows audit information to be collated and analysed per project, team or campus and the selected data can easily be exported to Microsoft Excel, which allows existing analysis tools/skills to be used. The next stage in the project is to identify graphical reporting requirements once the teams have built up a bank of solid data to analyse.

The collaborative approach between LTHT’s and ISL has allowed the design of its ideal solution through the sharing of ideas to maximise the benefits across its teams.

“The Leeds Teaching Hospital NHS Trust is happy that its database system, Achiever Medical, has the necessary robust auditing and encryption tools to both protect our donor identifiable data and also to manage it effectively.”

Main Benefits

The introduction of the new audit module is expected to provide LTHT with the following benefits:

  • Improved evidence to provide to HTA auditors of internal audit issue identification and resolution processes.
  • Improved Standard Operating Procedures (SOPs).
  • Reduced costs through coordinated auditing efforts across teams.
  • Reduced management costs via centralised maintenance of audit logs by 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.
  • Reputational benefits resulting from use of best practice backed by solid evidence.

About Interactive Software and Achiever Medical

At Interactive Software we lead the way in accessible, transformational Scientific Research solutions. We collaborate with experienced researchers to provide a refreshingly practical and integrated approach to solving real-world problems; helping our customers focus on, and exceed, their vision.

Our comprehensive sample lifecycle management solution, Achiever Medical, enhances and transforms our customers’ Standard Operating Procedures (SOPs) and provides greater transparency and insight into their data. The registration of sample details such as specimen characteristics, collection methods and conditions, storage temperatures and movement are integral to the solution. In addition to this, Achiever Medical offers extensive functionality that includes the compilation of associated donor profile, consent and demographic data, disease, diagnosis and treatment history. This combination delivers enhanced insight into specimen provenance, their availability for use and potential reliability.

Guiding customers step-by-step through our proven implementation process, we work with them to achieve tangible benefits from the point of go-live that could be within as little as 3 – 6 months.