A System to deliver HTA Compliance across multiple Teams, Hospitals and Sites

A System to deliver HTA Compliance across multiple Teams, Hospitals and Sites

THE ORGANISATION

Leeds Teaching Hospital NHS Trust (LTHT) includes Leeds University and six NHS hospitals – Chapel Allerton Hospital, Leeds Dental Institute, Leeds General Infirmary, St James’s University Hospital, Seacroft Hospital and Wharfedale Hospital. Achiever Medical is currently used at four of those hospitals and right across the University.

THE CHALLENGE

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

The main challenge for the Trust was to provide tissue tracking facilities across 27 separate locations with a consistent system/processes, where previously each team in each location had local solutions such as separate databases or spreadsheets and locally-designed procedures. Each team also had different team-specific data requirements. HTA compliance management was, therefore, very difficult.

ISL and their Achiever Medical solution was awarded. 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.

Reorganising and Standardising Data

ISL managed all data migration for a number of the teams, importing data from a variety of sources. It was an ideal opportunity for the teams to carry out a data cleansing and standardisation exercise on their data. This often involved the merging of storage data from one data source with clinical and sample data from another data source.

There are now 92 separate tissue collections being managed by Achiever Medical across LTHT. These projects contain 275,000 sample records linked to more than 33,000 donors. There is also a large number of separate storage locations being managed, linked to the collections that are allowed to use them.

ISL provided standard templates from which data could be imported into Achiever Medical and offered guidance on data formatting and processing. Imports were then scheduled and carried out by ISL after each team had cleansed its data in anticipation. Teams were trained in suitably sized groups as close to go-live as logistically possible to maintain the learning and best prepare the users.

Small team-specific configuration elements were important to support user buy-in as each team was used to having autonomy in its data handling, so careful application of customisation allowed the standard institute-wide compliance and tracking benefits to be rolled out smoothly across some very disparate working environments.

Chris Chambers, IT Systems Officer, said; “The University of Leeds chose to implement Achiever Medical in order to facilitate the safe and secure storage and management of human tissues used for research. It is in use on the main University campus and within the Leeds Teaching Hospitals Trust. We passed our HTA inspection in 2013 and it was commented in the final report that the system enables good practice for tissue tracking. It has enabled multiple teams to move away from excel based record keeping to a robust database system, which in turn reduces potential for human error and loss of data. Removing manual audit tasks and the automation of repetitive data entry has created time for both clinicians and laboratory workers. This allows for more research and less concern about legislative compliance.

In addition to the security filters segregating teams’ data, the identity of sample donors was a very important issue. Roughly half the user teams were based on the NHS N3 network, no patient identifiable data was allowed to be stored in Achiever Medical as it was hosted on the University’s “Janet Network”. This meant that the donor ID and other profiling data was very important for identification.

Teams operating on the University’s Janet Network could benefit from Achiever Medical’s encryption capabilities that encrypts all sensitive data as it is saved in the database, as credit card details are encrypted in online shopping systems. This protects the identity of donors from research staff and even the database administrators. Donor names are typically only visible to the clinicians treating the patient, the nurses who take the tissue samples in clinic, and perhaps the head of the research team – although even this last role may not have visibility.

Improving Data Quality, reducing Costs and increasing Value

Donor clinical profile information is also held in the database linked to the donated samples, which allows researchers to search for tissue samples from specific cohorts of donors, further filtering by the level of consent given by the donors. This level of search capability allows the teams to service very specialist research requests, increasing the value of each team’s tissue holdings as a whole.

The quality of the donor, consent, storage and tissue viability data greatly increases the value of the tissues to researchers. Once cleansed, the storage management capabilities help to increase levels of utilisation, reducing overhead costs per sample.

Integration

As there was an established in-house developed computer system for logging informed consent taken at the hospitals it made sense to continue to use this system and integrate it with Achiever Medical in a way that best supported the nurses taking consent.

The existing system, known as Patient Registration System (PRS) was modified to send consent and donor information outwards across the N3/Janet Network bridge and into the Achiever Medical database.

Achiever then automatically created the corresponding donor, participant and informed consent records and then passed back to PRS a link that would allow the clinic nurse to open the corresponding participant record in Achiever Medical and immediately add the sample records for the tissues just consented.

This link is audited on a monthly basis and to date has not had a single error. The integration reduces the clinic nurses’ workloads, avoids duplication of data entry and maximises data quality while working within the IT and legislative constraints imposed by the disparate working environments of the users.

Chris Chambers, IT Systems Officer, commented; “The customer service we receive from ISL is very good. Support tickets are actioned in a timely manner, communications are clear and we have a good working relationship with many staff members at ISL. Our users are always looking to enhance the use and effectiveness of the system through changes requests and have previously benefited from many time saving features that have been added into the system.