A quarter of NHS acute trusts are not compliant with standards that ensure that Laboratory Information Management Systems (LIMS) are fit for purpose and user friendly.
A total of 120 NHS acute trusts responded to a survey by Transforming Healthcare Consultancy (THC) in March and April this year, with 30 stating that they either do not have a User Requirement Specification (URS) in place or that it has not been reviewed since the last software upgrade.
A URS is a fundamental piece of evidence that enables an IT system’s software to be tested.
It demonstrates that the pathology laboratory using the system has proved to reduce, as far as possible, any risk of potential harm to patients, and can be shown to be fit for purpose for the services it provides and the healthcare professionals that use it.
And URS ultimately supports Health Secretary, Matt Hancock’s, recent reaffirmation that the NHS needs technology and innovations that meet user needs to drive forward better patient outcomes.
Former NHS Pathology Transformation Programme director, Stephen Seagreen-Bell, said: “The move to consolidate pathology services for greater efficiencies and improved patient safety relies heavily on technology that can be trusted by laboratory staff and clinicians to make the right, accurate test available at the right time.”
NHS trusts that do not have a URS for their LIMS run the risk of increasing workload of busy laboratory staff.
This level of compliance is absolutely necessary to ensure that patient safety is not compromised by delayed results or incorrect results being published.
And it is an area of increasing focus for regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA).
In particular, NHS trusts that run a blood transfusion service and are found not to have the sufficient URS documentation in place risk the closure of hospital services.
THC’s research also revealed that the shortest MHRA inspection notice that NHS trusts had experienced was just two days, and yet 53% of the NHS trusts surveyed believed themselves to be ready for LIMS validation.
Seagreen-Bell, who is now managing director of THC, said: “The results demonstrate that nearly half of trusts are not fully aware of the risks of not validating LIMS, or do not have the skills, experience, or resources to become compliant.
“All too often a URS is generated at the start of a system implementation and not updated as part of an upgrade or if changes are made to the software.
“To maintain quality and safe IT systems means you need to continuously update the URS especially when, for example, changes to legislation or clinical practice affect how the system is used.”
NHS trusts that pro-actively validate LIMS will ensure they have a patient-safe solution and prevent their hospitals from a ‘cease and desist’ order that would severely disrupt patient services, and unnecessary wasted time and cost.
As part of a pro-active strategy, NHS trusts should be working to a ‘Validation Master Plan’, which provides the framework to a risk-based approach to validation.
This includes a Requirements Traceability Matrix (RTM), an essential audit trail tool to ensure all requirements included within a URS are verified and tested.
From the NHS trusts surveyed, 33% said that they did not have an RTM in place.
“At a time when pathology services are going through major upheaval by moving to regional networks, it is essential for trusts to be pro-active with compliance to ensure they are inspection-ready at all times.
“I have seen so much unnecessary pressure placed on busy pathology staff, trying to prove to regulators that their systems are safe to use.
“At the end of the day, being compliant is about protecting patients from avoidable harm”, said Seagreen-Bell.
LIMS aim to reduce human errors while increasing efficiencies by automating the management of test results, and its adoption was accelerated by the 2008 Carter Review into NHS Pathology Services in England which recommended ‘that IT connectivity be put in place for NHS pathology services as a matter of priority’.
