COMPLIANCE
actually that both need to be met; the guidance sets safe minimum standards which should not be relaxed where they impact on patient safety or operational resilience, including lifespan. However, there isn’t an alternative guidance document which could be described as best practice or ‘compliance plus’ standards, as the NHS guidance is generally considered by many as ‘world- leading’. It is thus not unreasonable to describe it as best practice, or even as an Approved Code of Practice, at least in some circumstances.
Definition of a derogation In the simplest of forms (the dictionary definition), a derogation is an exemption from, or relaxation of, a rule or law or standard. As it applies to NHS guidance, this exemption must be appropriately recorded, with all implications understood and accepted by all parties, and approved at a suitable level, and, where appropriate, alternative and equivalent mitigation must be agreed for the risks or implications of the derogation.
The need to demonstrate a robust process for agreeing any derogation from technical guidance is a core component of the assurance process, and, as such, must provide a clear, auditable trail.
Derogations to guidance will potentially increase risks to the organisation, and potentially clinical activity or patient safety – and should thus only be considered in exceptional circumstances. A schedule of derogations will be required for any project. This schedule is not a simple list of derogations which can be stored in a project file and forgotten about; it needs to be comprehensive, stored where it can be easily referenced by all stakeholders, and kept under regular review and monitored to ensure that it remains safe and appropriate. To this end it is understood that the Devolved Administrations are considering a formalised derogations process, which it is hoped will be issued in the near future.
Risk assessment
While it is recognised that derogation is required in some cases, this must be risk- assessed, agreed, and documented, in order that it may be considered within the appraisal and approval process. Derogations must be properly authorised by the project’s senior responsible owner, and informed and supported by appropriate technical, Infection Prevention & Control (IPC), and clinical advice (irrespective of a project’s internal or external approval processes).
Reasons or drivers to consider derogating Typically there are many reasons cited to derogate from elements of, or even entire, HTMs or HBNs, including, but not limited to:
Table 1: The minimum information needed for a full and detailed schedule for all proposed derogations or clarifications considered during a project or scheme.
Reference Number of Standard For example, HBN / HTM reference Specific Clause reference Derogation/Clarification
Details of what is being proposed for derogation, including a detailed reason/ explanation of why, the extent/impact, and details of any proposed alternative design solutions.
Derogation proposed by Date
Comments by Project team lead
Date
Comments by Authorised Person (AP)
Date
Working Safety Group (if applicable) comments/ risk assessment
Date
Comments by Authorising Engineer (AE)
Date
Executive Board Level Designated Person
assessment Date Status
Sign-off by the DP or similar level Board member to accept or reject derogation.
Approved or rejected (including a time limit if appropriate).
n Refurbishment of existing buildings, facilities, or services (including the limitations associated with existing footprints etc).
n Room allocation and sizes. n Cost or budget allowance, (however, cost should never be the sole consideration, as the budget should be set to reflect full compliance).
n The scope of the project. n The omission of a compliance issue at business case/design/construction stage, or
n ‘We haven’t done it before, or had it agreed on a previous scheme’.
Considering the full implications At times a derogation is a sensible and safe option to consider; however, the full implications of any such consideration must be carefully balanced, and a full and detailed record made of the impact, risks, cost consequences, practical limitations of a scheme or site, and a formal review and approval process. This process may also identify other forms of mitigation or control measures, and should also include
a post-project ‘in use’ assessment to ensure that the decision was justified with the benefit of operational hindsight.
What cannot be derogated In HTMs and HBNs, modal verbs such as ‘must’, ‘should’, and ‘may’, are used to convey notions of obligation, recommendation, or permission. The choice of modal verb will reflect the level of obligation needed to be compliant. The following describes the implications and use of these modal verbs in HTMs/HBNs: n ‘Must’ is used when indicating compliance with the law. These cannot be the subject of derogation.
n ‘Should’ is used to indicate a recommendation (not mandatory/ obligatory), i.e. among several possibilities or methods, one is recommended as being particularly suitable – without excluding other possibilities or methods. These are elements which, in extreme or specific circumstances, could be considered for an area of derogation. However, the
September 2021 Health Estate Journal 43 Name of individual with details/commentary to
evidence any recommendation to approve or reject the proposed derogation.
Details/commentary to evidence any recommendation to approve or reject the proposed derogation.
Name of individual with details/commentary to
evidence any recommendation to approve or reject proposed derogation.
Name of individual with details/commentary to
evidence initial design review, and a recommendation to approve or reject the proposed derogation.
Name of individual or company proposing/ requesting the derogation.
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