Safety first for NHS IT systems

Healthcare is a safety critical business. When something goes wrong in healthcare, patients can be harmed and could suffer serious consequences.
The notion that safety science can be applied within a clinical context is relatively new in healthcare. However, clinicians and managers are now learning that taking a structured approach to safety, in a similar way to other safety critical industries (aviation; construction; oil and gas) can lead to safer, better care for patients.
Modern healthcare is increasingly using IT as an essential part of the infrastructure for care. If things go wrong with health IT systems, given the nature of our business, there could potentially be adverse consequences for patients. In recognition of this, NHS Connecting for Health (NHS CFH) has developed a structured safety management approach with the aim that the systems delivered through the National Programme for IT in the NHS will be as safe as design and forethought will allow, and will support clinicians to practise safely.

In 2004, when we were developing our Clinical Safety Management System (CSMS) for NHS CFH, there were no specific safety standards that could be applied to healthcare IT. However, we identified a generic standard for safety critical software – IEC 61508 – and applied the principles underpinning this standard to systems being developed for the NHS as part of the national programme. We took the view that it is the responsibility of suppliers to deliver safe systems, but that we had a responsibility to carry out an assurance process that would demonstrate that systems were safe, in so far as is reasonably practicable.
In essence, the CSMS requires three pieces of documentation to be approved:

  • Hazard Assessment – this is a structured process to identify what might go wrong with a product in the context in which it will be used, and what impact this could have on patient care
  • Safety Case – building on the hazard assessment, this details the risks and any necessary mitigations of risks thus making the case that the product will be safe in use
  • Safety Closure Report – this is the documentation that sets out the evidence that risks have been mitigated as set out in the safety case.

This documentation is presented to the Clinical Safety Group (comprised of clinical safety officers and safety engineers) and, if accepted, results in the award of a document, ‘Clinical Authority to Release’ (CATR). The CSMS was implemented in 2005 and no system has since been implemented in the absence of a CATR. Although relatively ‘light touch’, the CSMS has proved to be an effective and robust method of ensuring that systems provided through NHS CFH have undergone a safety assurance process.

Safety standards
In the time since we developed our CSMS for NHS CFH, there has been considerable progress in establishing an international standard for the safety of healthcare IT products. The European Standards body, CEN, has commissioned the development of a standard, which has progressed to the stage where it is expected to be issued by the end of 2008. As CEN has a mirror panel with ISO, the global standards body, then this is expected to become the generally applied standard in healthcare IT worldwide. As NHS CFH is the first organisation in the healthcare sector to apply a safety management approach across the entire sector, and at a national level, we have had considerable input to this standard, which largely reflects our approach and is also predicated on the development of a safety case for healthcare IT products.
Along with the standard for manufacturers/ suppliers, an accompanying standard for safe implementation of healthcare IT is also being developed. This standard is intended to provide guidance for users of these products (generally NHS Trusts in our context) such that products are introduced in a structured manner having been appropriately risk assessed.

Accredited clinician training
A fundamental aspect of the CSMS is the involvement of clinicians in developing and agreeing safety documentation. We firmly believe that if products are to be safe in use in the healthcare sector then clinicians must work - together with those who have technical expertise - in the design, build and test phases of the software lifecycle.
In order to ensure that clinical colleagues had the appropriate skills for this work, we commissioned a training programme to convey awareness of the principles of safety and risk as applied to healthcare IT. This programme has now been running for more than three years and we have trained hundreds of clinicians, together with other colleagues, in these principles. On completion of the training programme, clinicians can apply to become ‘accredited clinicians’ if they also meet the following criteria:

  • They are registered with an appropriate regulatory body (eg General Medical Council; Nursing and Midwifery Council)
  • They have a minimum of five years NHS experience
  • They have a legitimate relationship with NHS CFH or one of its suppliers.

All of our safety documentation needs to be signed off by an accredited clinician. In signing they demonstrate that they believe that due process has gone through and that they are not aware of any outstanding concerns other than those addressed within the documentation.

Detecting incidents
In operating a reliable safety management approach, safe organisations recognise that even though considerable effort is expended proactively in developing safe products, it is still possible - indeed likely - that systems will go wrong in some way. So as well as taking a proactive approach, as described above, there also needs to be a process for detecting incidents when things go wrong and for rapidly responding to these. Our Safety Incident Management Process (SIMP) is therefore a critical component of the safety approach within NHS CFH.
If notified of a problem with any of our systems that could potentially cause harm to patients, we arrange for the incident to be assessed by both a safety engineer and a clinical safety officer (who will be an accredited clinician). The first priority is to ensure the incident is ‘made safe’ (an engineering term meaning that the potential for harm is removed) without introducing new risks. Our safety team runs a 24/7 duty rota and we aim to achieve ‘made safe’ status within 24 hours of incidents being reported to us.

Technology for safety
In line with our aim of supporting clinicians to practise safely, we are also looking to support the introduction of technology that will help to address known patient safety problems. Our work in this field falls into three main categories:

  • Right patient right care – In line with the National Patient Safety Agency programme of this name, we are exploring ways in which technology can ensure that patients are correctly matched with artefacts of care (eg case notes; medications; blood products; procedures). We are presently interested in ‘matching technologies’ such as bar coding and radio-frequency identification, but in the future biometric technologies like finger printing and iris recognition might also be considered.
  • Safer prescribing – Medication errors are one of the major causes of patient safety incidents in all healthcare systems. We are taking forward programmes of work looking at prescribing decision support; use of properly designed prompts and alerts; and the introduction of processes such as ‘tall man lettering’ to reduce the incidence of errors from look-alike, sound-alike drugs.
  • Safer handover – Interfaces of care are potentially dangerous places for patients and many patient safety incidents are caused by lack of timely access to information. Work on handover datasets and datasets for patient wristbands is progressing with the aim of supporting safe handover.

Clinical Safety Team
To deliver the programme of work as described here, NHS CFH has invested in a dedicated safety team involving accredited clinicians from a number of healthcare disciplines, together with safety engineers and project managers. Additionally, a number of the major programmes have a clinical safety lead (an accredited clinician) and many of the project managers and technicians involved in NHS CFH activity have participated in the safety training programme. NHS CFH is building a safety culture across the organisation and patient safety is its first priority.

Support from IT
A major benefit from investment in NHS IT should be in supporting clinicians in delivering safer, better care to patients. Given the safety critical nature of healthcare, it is imperative that new IT products support safe practice whilst minimising the opportunities of introducing new risks. We believe that we in NHS CFH are taking a robust approach to safety, based on best practice in other industries, resulting in safer systems for a safer NHS.

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