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Mistake-proofing and safe systems - an unachievable goal
- Melinda N Lyons (8 February 2008)
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Safer by Design
- Dr. Maureen Baker, Professor Michael Thick, Ian Harrison, Dr. Mike Bainbridge, Kit Lewis (9 February 2008)
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CMO takeover
- David G Evans (9 February 2008)
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Melinda N Lyons, Senior Research Associate EDC, University of Cambridge
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It is with some irony that Alison Tonks recognises the contribution of human error to patient harm yet persists in suggesting the healthcare sector should aim to replicate the efforts of high-reliability industries in becoming “mistake-proof”. Mistake-proof is a misnomer that is as naïve as “satisfaction guaranteed”. Using the term “Mistake-proofing” leads to expectations of products and processes that cannot cause errors and patient harm in their use. If we could consider the humble surgeon’s scalpel, it is a tool with acknowledged risks that supports an expert in performing their work. Redesigning this to be “mistake-proof” would ensure that it could not be used in an “unsafe manner” – restricting the surgeon’s activities to only those that were predefined for the tool. Thus in an emergency, there would be no opportunity to creatively use it to achieve life-saving goals intended by the surgeon. Does this make the scalpel an inappropriate choice for “mistake-proofing”? – or does this merely beg further questions of what scope of products should fall within this requirement and what expectations we should place upon them? However, healthcare should be reassured that this concept of mistake- proofing is beyond the expectations even of high-reliability industries. For industries that focus on the contribution of human error to safety, the evaluation of a product’s safety in human hands would also include testing the potential of harm through “rule violation” - the unintentional or intentional misuse of a product. These products would be tested to the known limits of human creativity and physical abilities to identify how they would fail. With this knowledge, the weaknesses are known and not all of them will be avoided through redesign. Some will be managed through maintenance, some through procedures for use, some through training and awareness, supported by positive teamwork to prevent errors propagating through to consequences. Therefore, the resulting designs are by no means mistake-proof. Safety, like “best practice” is limited to the knowledge and capabilities of the time. Consider healthcare’s current views of those who would place a spoon in the mouth of someone having an epileptic fit or place butter on a burn. Whilst old wives’ tales would suggest these were the best practice, today’s knowledge suggests these actions, whilst well- intended, would be considered misguided. Like medicine itself, design and safety both evolve and so does best practice in these areas. High-reliability industries are not “mistake-proof” - nor do I believe they be deluded into believing they were safe through design. It is through continuous striving rather than resting on their laurels that maintains the reputation of high-reliability. Notably accidents and near- misses still occur in these industries Yet it is their awareness of their weaknesses and a willingness and capacity to learn from their mistakes that shapes public perception of them as being “safe”. It is through acknowledging the value of human creativity and using this to build resistance against the errors within the system to reduce their probability and their consequences. To achieve a “safer” system through design is an admirable goal – but healthcare should never be caught up in an illusion that a whole system can be designed as “totally safe”. Competing interests: None declared |
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Dr. Maureen Baker, National Clinical Lead for Safety NHS Connecting for Health, LS1 4HR, Professor Michael Thick, Ian Harrison, Dr. Mike Bainbridge, Kit Lewis
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Dear Ms Godlee, We were pleased to see Alison Tonk’s commentary in the 26th January issue of the British Medical Journal on designing for safety in healthcare. NHS Connecting for Health (NHS CFH) supports safer, better care for patients through systems that aim to be as safe as design and forethought will allow. We believe we are the first healthcare organisation to have implemented a comprehensive clinical safety management system for safety in health IT. This was implemented in 2005 based on the principles of IEC 61508, a generic standard for safety critical software whereby suppliers present a safety case for their products. NHS CFH has been working with the suppliers to the National Programme for IT in requesting hazard assessments, safety cases and safety closure reports from them. This documentation is formally quality assured by a dedicated Clinical Safety Group within NHS CFH comprised of Clinical Safety Officers and Safety Engineers (who work closely together); if found to be satisfactory, a Certificate of Authority to Release (CATR) is then provided by the safety team. No products can go forward to integration and deployment testing without having been granted a CATR. Such processes mirror best practice in other safety related industries. Safety professionals understand that even where safety standards are of the highest order, it is still possible that things could go wrong. Following best practice, the Clinical Safety Group have also established a structured safety incident management process: on being informed of an incident that could potentially have a clinical impact on patients, NHS CFH passes them to the Clinical Safety Group for active management. Our aim is to assess and ‘make safe’ (an engineering term that means removing the opportunity for harm) within 24 hours and ultimately to agree workarounds and permanent fixes plus disseminate any learning from such incidents across the National Programme. This process is supported by engineers and clinicians who run an on-call rota 24/7 solely for this purpose. The Clinical Safety Management System is underpinned by a programme of awareness training in the principles of safety and risk as applied to health IT. Since the beginning of 2005, several hundred clinicians and technical colleagues have completed this dedicated training programme, now entering its fourth year. We also promote patient safety by a programme of work that aims to use technology to help address known patient safety issues in the NHS. Our programme includes projects to minimise patient mis-identification, support safer handover of patients and promote safe implementation of IT within the NHS. With regard to safer prescribing, we have commissioned work on a series of potential safety features including maximising the effectiveness of alerts in prescribing decision support strategies to deal with look-alike sound-alike drugs and a focus on drug categories known to be involved in significant medication errors, with the aim of directed interventions to minimise harm. Another of NHS CFH's safety initiatives is the Common User Interface (CUI) programme, which aims to make the user interfaces of clinical software applications used in the NHS more consistent. The idea is that in the long term, this will provide our workforce with a degree of familiarity with their software sufficient for the safe and effective delivery of care, without extensive re-training. The CUI programme has already adopted many of the methods recommended in your article. It uses our Clinical Safety Management System and is led by expert designers. It follows an iterative research-design-prototype- test-refine process, in line with best practice in the software and web industries. To date, it has conducted over 300 one-on-one usability testing sessions and many hours of contextual observation in NHS care settings. By involving experts from within the NHS, especially in the area of ePrescribing, learning from previous patient safety incidents and best practice from existing implementations in the UK and abroad will be included. Yours sincerely, Dr. Maureen Baker CBE, National Clinical Lead for Safety Professor Michael Thick, Chief Clinical Officer Ian Harrison, Chief Safety Engineer Dr. Mike Bainbridge, Clinical Architect Kit Lewis, User Experience Architect Competing interests: None declared |
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David G Evans, General Medical Practitoner Llanishen Court Surgery, Cardiff, CF14 5YU
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Alison Tonks writes, "Liam Donaldson, chief medical officer for England and Wales...". Dr Tony Jewell will be most upset to hear that Liam Donaldson has taken over his job as chief medical officer for Wales! Competing interests: None declared |
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