NHS England Data Sharing Remote Audit: Liverpool University Hospitals NHS Foundation Trust

Purpose

This report records the key findings of a remote data sharing audit of Liverpool University Hospitals NHS Foundation Trust (LUHFT) and the Liverpool Clinical Trials Centre (LCTC) at the University of Liverpool (UoL) where the interviews were conducted between 13 and 21 March 2023. It provides an evaluation of how the LUHFT and the LCTC conform to the requirements of:

• the data sharing framework contracts (DSFC)
  • CON-313262-W1P4R-v2.01 - LUHFT
  • CON-312559-T8H2T-v2.01 - UoL
• the data sharing agreement (DSA) DARS-NIC-161422-Q0K1M-v4.3

This DSA covers the provision of the following datasets:

The joint Controllers are the LUHFT and the UoL. 

The LUHFT and the UoL require the data for use in a study titled “A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneurysms: The UK COMPlex AneurySm Study (UK-COMPASS)”.

Abdominal aortic aneurysm (AAA) is a common condition where the aorta, the largest artery, begins to bulge abnormally. Usually this expands over years and can eventually burst, causing fatal internal bleeding. When an emergency life-saving operation is possible, they have a high failure rate. A planned AAA repair operation prevents a burst aneurysm. The aim of the study is to answer the question: “What are the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA?”.

This report also considers whether the LUHFT and the LCTC conform to their own policies, processes and procedures.

The interviews during the audit were conducted through video conferencing.

This is an exception report based on the criteria expressed in the NHS England Data Sharing Remote Audit Guide version 1.

Audit type and scope

Data recipient’s acceptance statement

The LUHFT and the LCTC have reviewed this report and confirmed that it is accurate.

Data recipient’s action plan

The LUHFT and the LCTC will establish a corrective action plan to address each finding shown in the findings tables below. The Audit Team will validate this plan and the resultant actions at a post audit review with the LUHFT and the LCTC to confirm the findings have been satisfactorily addressed. The post audit review will also consider the outstanding evidence at which point the Audit Team may raise further findings.

The following tables identify the 4 agreement nonconformities, 1 observation, 5 opportunities for improvement and 4 points for follow-up raised as part of the audit. 

In addressing a finding, the data recipient must take account of any referenced supplementary notes.

Supplementary notes

The following note refers to the tables above and provides additional commentary on the linked finding.

Note 1.   One option to progress this finding, is for a risk assessment to be completed. The risk assessment shall assess the threats to and the vulnerabilities of the un-encrypted connection and identify the mitigating controls in place. This assessment shall be signed off by the organisation’s Senior Information Risk Officer (or equivalent). If the risk is considered acceptable and all aspects of the connection are inside the area of direct control by the Auditee, then the link need not be encrypted. NHS England reserves the right to review this assessment.

Use of data

The LUHFT and the LCTC confirmed that the datasets were only being processed and used for the purposes defined in the DSA and were only being linked with those datasets explicitly allowed in the DSA.

Data location

The LUHFT and the LCTC confirmed that processing and storage locations, including disaster recovery and backups, of the datasets were limited to the location shown in the following table.  These locations conform with the territory of use defined in section 2c of the DSA.

Backup retention

The duration for which data may be retained on backup media is:

Good Practice

During the audit, the Audit Team noted the following area of good practice:

• the planned work clearly indicated that the research using the data would benefit health and social care.
   

The audit was based upon a sample of the data recipient’s activities, as observed by the Audit Team. The findings detailed in this audit report may not include all possible nonconformities which may exist. In addition, as the audit interviews were conducted through a video conference platform, certain controls that would normally be assessed whilst onsite could not be witnessed

NHS England has prepared this audit report for its own purposes. As a result, NHS England does not assume any liability to any person or organisation for any loss or damage suffered or costs incurred by it arising out of, or in connection with, this report, however such loss or damage is caused. NHS England does not assume liability for any loss occasioned to any person or organisation acting or refraining from acting as a result of any information contained in this report.