Any form of derogation from guidance is perceived by some as incorrect. This article discusses the role of derogations, but perhaps more importantly how guidance should be perceived and utilised in ensuring the safe design, construction, and commissioning, of healthcare facilities. NHS England has recently published a process for managing derogations.1 This is most welcome to help ensure that derogations are not used as ‘a back door’ for inappropriate decisions, and such a format should provide the necessary transparency. Annex A of the new publication lists derogations in the context of the business case process referred to in the HBNs and HTMs, which are seen as best practice guidance (Table 1).1
To some, any form of derogation is regarded as inappropriate. This likely stems from the HTM and HBNs being promoted as ‘best practice’. The latter terminology is not only incorrect, but just as derogations for the wrong reason can result in patient harm and increase costs, failure to derogate will also result in avoidable patient harm, in addition to being a wasteful use of health service funds. Derogations which can be evidenced as providing a higher standard should not only be encouraged, but are fundamentally necessary to ensuring patient safety
All guidance has limitations, including:
It is only as good as the information available at the time of publication. Unless these are ‘live’ documents which are regularly updated in the light of new information, innovations, or incidents (which could affect patient safety), the contents will be outdated. Some HBNs are a decade old – e.g. HBN 00-09. Infection control in the built environment.
Guidance does not replace the requirement for training – it cannot turn individuals into experts. Thus, architects and design teams need access to expertise to aid them in their decisions.
Quality of guidance is reflected by the choice of individuals invited to participate in its production, as well as the dynamics of the group.
Ambiguity – it is open to different interpretation by different groups and individuals.
It cannot cover every hazard, hazardous event, or risk; therefore it cannot be relied upon alone to ensure patient safety.
Risk of ‘stifling innovation’
Perceived incorrectly (as ‘best practice’), guidance is also likely to stifle innovation. For example, several augmented care units have been forced to move to ‘water-free patient’, to prevent the spread of water/ wastewater-borne infections which were otherwise intractable. The implementation of water-free patient units, which have been shown to be effective in protecting patients, would be prevented by a culture which sees the HTM and HBN as best practice, and does not allow for change.2
Guidance, combined with compliance, have formed the backbone of construction (including healthcare) and numerous other industries, despite a long history of failing to deliver safe buildings. Compliance is seductive, and for many becomes their target, perhaps based on the philosophy that if followed, then no fault can be attributed to ensuing work. It is not only a lazy, but also a dangerous, approach, incorrectly perceived as removing the need for thought and recognition of risk to patients.
The Hackitt report, Building a safer future, has called for a cultural change within the industry. We believe this cultural change should begin with how guidance is perceived and utilised. A compliant building does not equate to a safe building. For example, in a recently opened new hospital (which is both HBN and HTM-compliant), clinical handwash stations are having to be removed, as the water and drains pose an unacceptable risk to patient care. The risk is not trivial. Grenfell rightly attracted media attention and drove change. In contrast, the number of patients contracting avoidable infections – including fatalities from water/ wastewater systems – significantly exceeds the number of lives lost at Grenfell, yet due to limitations in surveillance, these cases are not traced back to water/wastewater systems. Unless patient safety is placed right at the front and centre of everything we do, such needless folly will continue.
Given the slow pace of change and learning around risks associated with water and wastewater systems, combined with further delays in translating into guidance, valid concerns should arise if a new healthcare facility has no derogations from current guidance. Many of the current transmission events leading to infections or dispersal of antimicrobial resistance are preventable
Guidance is a necessity; this is not in question. However, understanding its purpose, limitations, and the absolute requirement to establish the correct framework (culture and training) across the stakeholders involved for it to be used correctly, is essential to ensure that safe healthcare design, construction, and commissioning, are delivered
We believe a risk-based approach is the key to the necessary cultural change being sought by the industry. An environment of ‘informed governance’ is created, whereby everyone should understand the consequences of their actions on patient safety. This new focus moves away from cost, and whether or not the building will be delivered on time to the patient. By shifting focus, this does not mean that buildings will not be within in budget or on time. In fact, the converse is true. Through early identification of the risks, mitigations can be put in place, removing unsafe surprises further down the line, which are costly, delay completion, and harm patients
So, how is this accomplished? The following example may shed some light. Members of the Design team at an external contractor were invited to the New Hospital Programme project Water Safety Group. A discussion ensued about the risks emanating from wastewater systems. There was a degree of scepticism among some members of the Design team, so a training session was held to describe how wastewater systems in healthcare facilities were a major route of dispersal of organisms and antimicrobial resistance. Once aware of the issues, the Design team was able to utilise its expertise and skills to put forward solutions. Up until then the team was unaware of the problems experienced once a healthcare facility was occupied. Such information is rarely found in guidance. Thus, by front-loading a project by bringing the necessary expertise (established by gap analysis) to work alongside design teams and architects, the culture can be changed to focus on risk and developing mitigations.
A once-in-a-lifetime opportunity
For most individuals in a healthcare facility, a new hospital build is a once-in-a-lifetime opportunity. The majority will not have been trained for such an event. For a Trust Chief Executive getting a new hospital might be perceived in the same terms as purchasing a new car. This is far from the case. Trusts need to move away from merely facilitating the new-build process, to understanding that they have to take control of, and responsibility for, the project if they are to stand any chance of acquiring a safe building. When the Health & Safety Executive investigates incidents, the three most common underlying causes identified are poor management, poor communication, and inadequate training. These are all elements of governance. What is required to be delivered is informed governance – whoever you are and whatever you do, you should have had sufficient training, i.e. be competent and understand the consequences of your actions on patient safety.
Training is a word used very loosely nowadays – ranging from an awareness session through to competency-based training. It is the latter that should be striven for. This brings us back to guidance. Not only have architects and design teams in the main not received training in the healthcare built environment, but the same is largely true of infection control personnel. No one disputes that Infection Control need to be involved in the process. However, with rare exceptions, their involvement in a newbuild project is usually based upon job title, rather than whether they have the requisite expertise/training/competence in the built environment. Thus they bring no added value to the table. This is not the fault of infection control specialists. HTM 04-01, issued following the death of neonatal patients due to waterborne infections with Pseudomonas aeruginosa, quite rightly laid responsibility for water safety within a multidisciplinary team which included Infection Control. With Legionella, which is mostly about engineering controls (not exclusively), the private sector was able to step in and deliver risk assessments and training
With P. aeruginosa and allied organisms this is more about how a range of staff interface and risk assess water/wastewater services. This is ideally the province of Infection Control personnel, who provide cascade training to other staff groups. The private sector was unable to support the training requirements, and thus a significant knowledge gap has been allowed to develop. A key message when issuing guidance is that if it is to be successful, there needs to be accompanying training, and staff need to be competent
Important caveats
In summary, guidance (all guidance relating to design, construction, commissioning, not just the HBN and HTMs) is a necessary component, but should come with important caveats on how it is used. Through better understanding of its purpose and limitations users must realise that chasing compliance with guidance as the end-goal when handing over a newbuild has not, and will not, deliver safe and cost-effective buildings. A change of culture is required whereby a risk-based approach is taken, supported by evolving guidance.
Without the accompanying essential change in culture to a risk-based approach, it would be wrong to consider guidance even as a minimum standard. If there were need for proof, the evidence is abundant. It is not just the number of projects which make the headlines, but the many others which lead to patient harm (often unrecognised) and significant financial loss. Every stakeholder in a new project needs to understand that being compliant with guidance alone is insufficient to the delivery of key objectives, including – most importantly – patient safety
George McCracken
George McCracken joined the NHS in 1993 as a hospital engineer in Down Lisburn Trust, before this working in industry – in cable manufacture and foundry works. In 2002 he moved to the Royal Group of Hospitals, Belfast as a senior engineer, before in 2007 being appointed head of Estates Risk and Environment in the new Belfast Health and Social Care Trust, one of the UK’s largest NHS Trusts. He holds a First Class Honours Degree in Construction Engineering & Management, is a Chartered Member of the Institute of Building, and a member of IHEEM. He currently leads a Risk Team that ‘continues to provide an innovative approach to the management of risk within a healthcare estates environment’.
Susanne Lee
Dr Susanne Surman-Lee, Hon. FRSPH, FRSB, CBIOL, FIHEEM, FWMSoc, FPWTAG, is a Consultant Clinical Scientist specialising in public health microbiology, and a Director of Leegionella Ltd, an independent public health consultancy specialising in the detection and prevention of waterborne disease. A member of the Healthcare Infection Society, the Infection Prevention Society, and the Central Sterilising Club, she is also a Liveryman of the Worshipful Company of Plumbers, and a member of the WCOP Educational and Technical Committee member.
Dr Michael Weinbren
Dr Michael Weinbren is a Consultant Medical Microbiologist, a Specialist advisor for microbiology to the New Hospital Programme, and Chair of the Healthcare Infection Society Working Party on water/wastewater.
Jimmy Walker
Jimmy Walker PhD, BSc, is a microbiologist with over 30 years’ experience in water microbiology and decontamination. He previously worked for Public Health England, managing a range of projects on biofilms and pathogens such as Legionella spp., Pseudomonas aeruginosa, and Mycobacteria spp. He has worked with the Department of Health and the Health and Safety Executive in writing and developing national and international guidance on the microbiology of water and decontamination in healthcare. On leaving PHE he established his independent consultancy, Walker on Water. He is currently the Chair of the Central Sterilising Club. Jimmy and colleagues have recently published their new book entitled ‘Safe Water in Healthcare – a practical guide for the non-expert’, with illustrations and photos.
Dr Manjula Meda
Dr Manjula Meda is a Consultant Clinical Microbiologist and the Infection Control Doctor at Frimley Health NHS Foundation Trust. She is also the current Honorary Secretary to the Healthcare Infection Society. A collaborator on many projects with the University of Surrey and the UKHSA, she is actively involved in supporting clinical research in the Trust’s hospitals. She has a special interest in infection prevention and control in the built environment, and has been involved in leading the management of major infection prevention incidents and outbreaks in healthcare.
Dr Teresa Inkster
Dr Teresa Inkster is Consultant Medical Microbiologist at NHS Greater Glasgow and Clyde, with an interest in the built environment
References
1 Processes for managing and reporting derogations from estates technical standards and guidance. NHS England. 6 July 2023. https://tinyurl.com/3edrhbtr
2 Hopman J, Tostmann A, Wertheim H, Bos M, Kolwijck E, Akkermans R et al. Reduced rate of intensive care unit acquired gramnegative bacilli after removal of sinks and introduction of ‘water-free’ patient care. Antimicrob Resist Infect Control 2017; 6:59.
3 Health Technical Memorandum 04-01: Safe water in healthcare premises. Part C: Pseudomonas aeruginosa – advice for augmented care units. https://tinyurl. com/52ewbcy6