VALIDATION STANDARDS
Making the case for clinical systemvalidation
Amongst the pressures of delivering digital transformation at scale, clinical teams need more support and investment to ensure IT systems are safe to use and fit-for-purpose, says Stephen Seagreen-Bell, managing director of Transforming Healthcare Consultancy.
The moment I resigned from my NHS contract role over concerns of patient safety and undermining clinical standards is one I will never forget. Because, as many of your clinical colleagues will tell you, working in the NHS is something special, and there is no better job than helping patients get well. Our team was facing incredible pressure to get a clinical IT system live, but I strongly objected, as it had not gone through the appropriate validation process to ensure it was safe in a live environment. Nor did it have the support of the clinical leaders involved.
My fear is that this type of scenario is becoming more commonplace within the NHS. Having worked closely with NHS clinical teams to manage transformation for over 30 years, I have lost count how many times a doctor, nurse or AHP has raised concerns about an IT system not meeting their needs, or potential safety risks which have not been fully addressed. From the moment I walked away from that clinical IT system project, I have become increasingly concerned about the lack of validation and compliance within the digitisation of our health service.
Why is validation important?
Anyone who has worked on a digital project will know what clinical system validation (CSV) is. In short, regulators, such as the MHRA and CQC, set the standards that any new or upgraded clinical software or hardware have to meet to ensure systems
NHS Trusts that run a Blood Transfusion Service should be ‘inspection-ready’ to avoid closure by the MHRA according to Seagreen-Bell.
can demonstrate they are fit-for-purpose, safe for use and without risk of patient harm. This follows what we call the Good Manufacturing Practice Guideline (GaMP).
They require a quality-controlled process of requirements gathering; system design, build and configuration; testing that the build meets the requirements; testing that the intended use causes no risk to patients; and testing that the use matches the operating practices within the specialist area of work.
How compliant is the NHS?
An essential part of CSV for each IT system is having a User Requirement Specification (URS) in place. Again, most clinicians will
Regulators, such as the MHRA and CQC, set the standards that any new or upgraded clinical software or hardware have to meet to ensure systems can demonstrate they are fit-for-purpose, safe for use and without risk of patient harm.
AUGUST 2019
know what this is: a URS is the starting block to gather evidence that an IT system software is able to provide the necessary functionality to meet the clinical need and to be fit-for-purpose for the services it serves and the healthcare professionals that use it. NHS providers that do not have a URS run the risk of adding to the current workflow and increasing workload of busy clinical teams. URSs ultimately support Health Secretary Matt Hancock’s recent reaffirmation that the NHS needs technology and innovations that meet users’ needs1
to
drive forward better patient outcomes. We undertook some recent research that revealed that 25% of NHS acute Trusts’ laboratory information management systems (LIMS) either do not have a URS in place or that it has not been reviewed since the last software upgrade.2
LIMS represents a small proportion of all NHS acute IT systems but is heavily regulated due to its ability to cause direct harm to patients through blood transfusion services. My strong suspicion is that URSs are even less commonly used across the other tens of thousands of clinical systems that are live across the NHS.
Why are validation standards not being met?
Digital transformation is happening faster than ever. The speed at which it is happening is unprecedented. Technologies are developing quickly in modern times, plus there is a real sense of energy across the digital health sector after years of steady, arguably frustrating progress for the NHS. Policy makers are clearly engaged, and Matt Hancock is a man on a mission. ‘Change has been slow’ read the NHSX launch publicity. He’s right and I agree. Our tech-enthused Health Secretary wants to make sure we do not delay any further in getting vital digital tools in the hands of NHS staff to help improve outcomes and experiences for patients. NHS IT leaders are
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