COMPLIANCE
When to seek derogation, and the best approach
Andrew Poplett, an Authorising Engineer (Water & Ventilation), who has over 30 years’ experience of healthcare estates management, with specific and specialist knowledge of water and critical ventilation systems, takes a look at when it may be appropriate for NHS Trusts and other health service-providers to seek derogations from official guidance and advice, the optimal approach, and how to avoid the potential pitfalls.
The question of derogations has been a complex, and, at times, highly contentious, issue for many years. It can often start with a debate over the legal status of NHS-specific guidance, and include a range of challenges. This article offers an individual opinion on the various issues, and highlights the long-term consequences and repercussions which NHS service-providers should consider when considering how to manage derogations, and, simultaneously, retain the ability to demonstrate compliance assurance to all stakeholders.
NHS standards
Over the years the NHS has developed a comprehensive range of documents to provide guidance and advice for those involved in the design, construction, and operation, of healthcare facilities. These include Health Building Notes (HBNs), Health Technical Memoranda (HTMs), Health Guidance Notes (HGNs), Health Facilities Notes (HFNs), and Fire Practice Notes (FPNs), to name just a few, with some of these standards now archived or superseded. It must also be noted that within the devolved administrations there are a number of documents which contain subtly differing guidance, although the manner in which these should be managed can be universally applied. Debate over the status of all of these documents can be highly contentious, and generally is not definitively defined. However, in my opinion, the following elements need to be considered:
Legal
Anecdotal evidence is that any failures to follow the practice or advice set out in these documents has been used in court proceedings to find against hospital Trusts. These are most likely to be in connection with Health & Safety Executive prosecutions, or possibly civil or medical malpractice cases. The various Devolved Administrations agree that the documents produced are guidance documents. They become legal requirements when they form part of a
42 Health Estate Journal September 2021
Over the years the NHS has developed a comprehensive range of documents to provide guidance and advice for those involved in the design, construction, and operation, of healthcare facilities. These include Health Building Notes, Health Technical Memoranda (shown), Health Guidance Notes, Health Facilities Notes, and Fire Practice Notes.
contract, but the guidance documents are generally considered as an Approved Code of Practice, or – at the very least – good practice.
Department of Health & Social Care guidance is relevant, and is generally taken to be authoritative by the relevant authorities and the courts, but is not conclusive. However, if the guidance isn’t followed, the Trust would be expected to justify why, and to demonstrate what measures they took to satisfy the requirement of ‘taking all reasonably practicable steps’ to protect people affected.
In addition, the Health and Social Care Act (2012), Health and Social Care Act (Regulated Activities) Regulations 2014, and the Care Quality Commission (Registration) Regulations 2009, are all used as the basis for CQC registration and certification. As such, these regulations are used as the reference by the CQC for all healthcare providers (including the NHS).
Key criteria outlined
Regulation 15 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 outlines 20 key criteria under which all healthcare providers must operate. The intention of this regulation is to make sure that the premises where care and treatment are delivered are clean, suitable for the intended purpose, maintained, and, where required, appropriately located, and that the equipment that is used to deliver care and treatment is clean, suitable for the intended purpose, maintained, stored securely, and used properly. Providers retain legal responsibility under these regulations when they delegate responsibility through contracts or legal agreements to a third party, independent suppliers, professionals, supply chains, or contractors. They must therefore make sure that they meet the regulation, as responsibility for any shortfall rests with the provider.
Regulation 15(1)(c) stipulates that healthcare promises must be ‘suitable for the purpose for which they are being used,’ i.e. that they must be fit for purpose in line with statutory requirements, and should take account of national best practice. Any alterations to the premises or the equipment that is used to deliver care and treatment must be made in line with current legislation and guidance. Where the guidance cannot be met, ‘the provider should have appropriate contingency plans and arrangements to mitigate the risks to people using the service’.
While the NHS guidance documents are not mandatory (unless specifically stated), they do, however, state that any departures / derogations – including the measures implemented – should provide a degree of safety not less than that achieved by following the guidance set out in the various documents.
Minimum standard or best practice Often the minimum standard or best practice are defined by the parties on either side of a debate around derogation. In the author’s opinion the answer is
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