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NHS AMBULANCE SERVICE Compliance & Quality Assurance National Provisions for Interoperable Capabilities January 2018 Version 1.0

NHS AMBULANCE SERVICE NARU DOCUMENT INFORMATION TABLE Full Title Version Security Marking Document Type NHS / NARU Ref CMT Approval Date Publication Date Implementation Date Review Date Aligned to JESIP Principles Impact on Contract Standards? Superseded Documents Related Documents or Cross References Circulation Action Required Lead NARU Contact Document Protection Summary of Amendments Compliance and Quality Assurance National Provisions for Interoperable Capabilities 1.0 Not Protectively Marked Guidance N1217-01 07/12/17 01/01/18 Not Applicable January 2020 Yes No Not Applicable First Edition. Cabinet Office: National Risk Register of Civil Emergencies 2017 NHS England: EPRR Core Standards NARU Annual Business Plan 2016/17 NARU Annual Work Plan 2016/17 NHS England EPRR Teams Lead Commissioners of NHS Ambulance Service Providers NHS Ambulance Service Providers in England Stakeholders: As determined by NARU For information. Head of Compliance This is a controlled document. Whilst this document may be printed, the electronic version published on the NARU website (or held securely on the NARU server if protectively marked) remains the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should be accessed from the internet whenever possible. In the event that NARU also publishes hard / paper copies of the document, the controlled or live document remains the online version which may be subject to change or amendment. Check the online status of the document via the NARU website at regular intervals. All documents containing the official NARU badge are protected through standard English copyright law provisions and in accordance with the terms of the NHS England NARU Contract. Not Applicable First Edition. 2 www.naru.org.uk

CONTENTS Contents SECTION 1 Compliance & Quality Assurance at a Glance 4 SECTION 2 Introduction 5 SECTION 3 Interoperable Capabilities Extending NHS Care Into High Risk Environments 7 SECTION 4 Compliance Developing & Monitoring Standards 13 SECTION 5 Quality Assurance Reviewing & Improving Standards 25 SECTION 6 Internal Compliance NARU s Governance Arrangements 38 3

NHS AMBULANCE SERVICE Compliance & Quality Assurance at a Glance 1 COMPLIANCE & QUALITY ASSURANCE AT A GLANCE NATIONAL MANDATE Department of Health requires interoperable capabilities to contribute to the UK s Resilience Strategies. NHS MANDATE NARU NHS England mandates interoperable capabilities through the EPRR Core Standards and Standard Ambulance Contract. Coordinates and maintains capabilities at the national level. NARU CQA PROVISIONS THE INTEROPERABLE CAPABILITIES COMPLIANCE: Developing and monitoring standards. QUALITY ASSURANCE: Reviewing and improving standards SAFETY CRITICAL SYSTEM OF WORK SUBJECT MATTER EXPERTISE Interoperable capabilities can be combined to provide a scalable national response. Hazardous materials MTFA (Terrorist attacks involving firearms) Chemical / Biological / Radiological / Nuclear / Explosives Safe Working at Height Confined Space Unstable Terrain Water Rescue and Flooding Support to Security Operations Patient Decontamination Command & Control UTILISING THE CAPABILITIES 12,689 utilisations of the capabilities. Use of these capabilities at incidents is increasing year on year. INCREASED SURVIVAL RATES + IMPROVED CLINICAL OUTCOMES + ENHANCED RESPONDER SAFETY 4 www.naru.org.uk

INTRODUCTION The United Kingdom s Risk Register for Civil Emergencies details a range of threats to society. These include accidental, environmental and malicious hazards. The NHS is obligated to provide care to those caught inside the inner cordon of high risk emergencies. Ambulance personnel cannot rely on other responding agencies to provide clinical care and extrication from these environments so a series of special capabilities have been introduced nationally to extend the reach of the NHS. This is essential to save life and improve clinical outcomes for our patients. Introduction In extending its reach, the NHS has also extended its legal duty of care, both to employees and to those critically in need of its services. It has simultaneously increased its exposure to risk. The capabilities that facilitate this care must, therefore, be subject to clear standards and a consistent safe system of work. NARU facilitates this through its Compliance and Quality Assurance activities. Our Compliance activities involve developing and monitoring national standards. Our Quality Assurance activities involve reviewing and improving those standards. We do both with the aim of keeping specialist responders safe whilst taking calculated risks to improve the clinical outcomes of patients caught within dangerous environments. NARU works closely with a range of stakeholders to develop these standards, including; Regulators, NHS Commissioners and various responding agencies. We also work closely with our parent organisation, NHS England, and the Department of Health to develop policy which is consistent with that balance of risk. As always, it is essential that we undertake this work in a manner that achieves the greatest efficiency from the public funds we are allocated. Over the last two years we have managed to achieve more for less. This publication sets out the national provisions maintained by NARU to support the Ambulance Service s interoperable capabilities. It focuses on Compliance and Quality Assurance (CQA) to brief our stakeholders on these specific aspects of our work. However, it should be read in the context of wider NARU activities, particularly Education and Capabilities, both of which are essential to maintaining these specialist services. We are also extremely grateful to the operational personnel that use these capabilities to deliver care to patients. Their skill and dedication is the most significant component of all. 2 Keith Prior MSc MCPara National Director Christian Cooper JP MSc PGDipLaw SIRM Head of Compliance 5

19,602 responses 12,689 utilisations per annum* The interoperable capabilities (inc. HART & CBRN) are utilised at the scene of 12,689 incidents per year to commit NHS Paramedics into the inner cordon and provide patient care. That number is increasing every year. * Figures for 2016/17 A Paramedic trained in Swift Water Rescue and Urban Flooding begins a tethered swim to reach a trapped patient.

INTEROPERABLE CAPABILITIES Extending NHS care into high-risk environments The Clinical Requirement An engineer servicing a wind turbine 120 meters above the ground develops central crushing chest pain. A gas explosion in a hotel causes the building to partially collapse. Several residents suffer serious burns and become trapped under the rubble. A female dialysis patient is cut off by rising flood waters. Several factory workers are unconscious after being exposed to caustic agents during a container breach at a chemical works. Shoppers are shot and critically injured by terrorist gunmen at a retail outlet. These examples are linked to foreseeable risks contained in the UK s National Risk Register of Civil Emergencies. They each involve patients with unstable medical conditions trapped within high-risk environments. Only emergency personnel that are trained and equipped to operate in those environments can access them. If these patients do not receive medical interventions within minutes they are likely to suffer long term health problems. If they do not receive advanced clinical care within the first 60 minutes of being trapped at the scene, their chance of survival is significantly reduced. Further to this, their extraction from the incident must be supervised by NHS clinicians to avoid the risk of further injury and ensure a smooth transition into wider NHS care. Rapid medical interventions inside the hazardous area are therefore essential to improve clinical outcomes and save life, but it puts our responders at foreseeable risk. Interoperable Capabilities 3 The Mandate There are several Cross-Government strategies to ensure the United Kingdom has an effective response to national emergencies. They include the National Capabilities Programme and the Counter Terrorism Strategy. The Department of Health ensures that the NHS and Public Health England provide the required health contribution to these essential strategies. The contribution of NHS Providers, including the Ambulance Service, are defined by NHS England in the EPRR 1 Core Standards. NHS Ambulance Trusts in England are required to maintain these standards as part of their commissioned Ambulance contract (Standard Condition 30). Each Trust Board must make an annual declaration that their organisation remains compliant with these standards. Regulators and Commissioners use these 1 Emergency Preparedness Resilience and Response 7

NHS AMBULANCE SERVICE contract standards to confirm and challenge the level of preparedness for national emergencies through various assurance activities. The interoperable capabilities described in this document form part of those contract obligations. The National Ambulance Resilience Unit (NARU) works under contract for NHS England. Part of NARU s remit is to develop and maintain National Standards for each of the interoperable capabilities. These standards are then approved by NHS England and incorporated into the wider EPRR Core Standards. NARU also supports Regulators and Commissioners in their assurance activities by providing subject matter expertise to audits, inspections and reviews. Interoperable Capabilities 3 NATIONAL PROVISIONS For defining the interoperable capabilities National Standards for HART National Standards for MTFA National Standards for CBRN National Standards for Command & Control National Standards for Mass Casualty Incidents Interoperability Interoperability is the way we maintain a consistent level of service throughout England. This approach has four key advantages: 1. Scalability Standardisation and consistency means the capability in each Ambulance Trust can be combined to increase the amount of resource available for a protracted national incident. For example, an industrial explosion causes several structures to collapse trapping large numbers of people inside. The Safe Working at Height, Confined Space and Unstable Terrain capabilities are all interoperable so teams of specialist Paramedics from around the country can combine using the same equipment, training and operating procedures to provide a unified response to the national emergency. The specialist response from the Ambulance Service can therefore be scaled up or down depending on the scale of the incident itself. 8 www.naru.org.uk

2. Value for Money The ability to combine multiple resources from several different regions reduces the need to have larger concentrations of resource in every locality. The interoperable approach represents the most cost effective way of maintaining these specialist service lines. Consistent equipment and training also allow NARU to establish national buying frameworks and central training programmes. Both yield significant savings compared to an autonomous localised approach. 3. Resilience Processes and resources are consistent across the country which allows assets to be shared or pooled. A single failure in any part of the system can therefore be absorbed by the collective until the issue is rectified. Where intelligence provides advance notice of a threat, resources can be moved across traditional Ambulance and Commissioning boundaries to concentrate capabilities in any given location. Several interoperable capabilities maintain a 30-minute notice to move anywhere in the country. Learning from local mistakes and untoward incidents helps to continually improve the national systems and processes. Experience is shared nationally and consistently so improvements occur at an accelerated pace. Without interoperability, local variance within the capabilities would make it much harder to identify and act on safety risks. Reduced local variance means reduced liability to individual Trusts. Local Operations Interoperable capabilities can operate at both the national and local level. Each Ambulance Service Region contains several Local Resilience Forums. These LRFs each maintain community risk registers which identify the potential for complex or major emergencies specific to their area. This will include high-risk industrial sites, transportation accidents and specialist infrastructure (the Channel Tunnel is a good example). The interoperable capabilities also form part of the local emergency response plans to deal with these local risks. Despite their national characteristics, the capabilities respond locally to over 200 complex emergencies every week using their specialist skills and equipment to improve patient outcomes and save life. Interoperable Capabilities 3 4. Safety The capabilities are highly specialised and can expose staff to significant risk. The interoperable approach means that safe systems of work can be developed by subject matter experts at the national level with access to relevant authorities and regulators. A single approach to these developments avoids duplication and additional cost across each Ambulance Trust. It also reduces the burden on local Ambulance Trust s which may not have the internal subject matter expertise to develop such systems. 9

Rapid medical interventions inside the hazardous area are essential to improve clinical outcomes and save life, but it puts our responders at foreseeable risk. Dr. Eddie Tunn NARU Medical Advisor A patient exposed to a caustic agent is extracted from the hot zone to the warm zone where a CBRN / SORT Responder prepares them for decontamination. The Ambulance Service is the lead agency for patient decontamination.

INTEROPERABLE CAPABILITIES Core Capability Tactical Options Commissioning HART Hazardous Area Response Teams Hazardous Materials Working inside the inner cordon Industrial accidents High risk infectious diseases Complex transportation accidents Reference costs are set out in the National Standards produced by NARU. CBRN(e) Chemical Biological Radiological Nuclear Explosives MTFA Marauding Terrorist Firearms Attack Safe Working at Height (SWaH) Specialist, inner cordon response to CBRN(e) / also a component part of the CBRN(e) capability Specialist support to the wider MTFA response / component part of the MTFA capability Man-made structures Natural environment Then commissioned locally via the Ambulance Service baseline funding mechanism. Interoperable Capabilities 3 Confined Space Substantially enclosed spaces Building collapses Compromised atmospheres Entrapments Unstable Terrain Active rubble piles Rural access / difficult terrain Water Operations Swift water rescue Urban and rural flooding Boat operations Support to Security Operations Support to security operations Support to police operations Illicit drug laboratories VIP close protection support 11

NHS AMBULANCE SERVICE Core Capability Tactical Options Commissioning MTFA Marauding Terrorist Firearms Attack Working inside a ballistically unsafe area (warm zone) Siege / stronghold Funded directly by NARU via pass through funds to Trusts annually. CBRN(e) Chemical, Biological, Radiological, Nuclear, Explosives Initial Operational Response (IOR) Specialist Operational Response (SOR provided by HART) Interim decontamination of casualties affected by CBRNe Full wet decontamination of casualties affected by CBRNe Funded directly by NARU via pass through funds to Trusts annually. Interoperable Capabilities 3 C2 Command and Control Strategic command of major and critical incidents Tactical command of major and critical incidents Operational command of major and critical incidents National Interagency Liaison Officers (NILOs) Strategic and Tactical Advisors Medical Advisors Core business capability commissioned locally via the Ambulance Service baseline funding mechanism. Mass Casualties Initial provision to treat; x100 P1 and x250 P2/P3 patients. Scalable nationally to; x2400 P1 and x6000 P2/P3 patients. Support to a large casualty clearing station. Funded directly by NARU via pass through funds to Trusts annually. 12 www.naru.org.uk

COMPLIANCE Developing and Monitoring Standards NARU advises NHS England on appropriate standards to maintain the interoperable capabilities. The standards are then set in contract obligations for NHS Ambulance Trusts. NARU follows a comprehensive process for developing and recommending these standards. Contract Obligations The first step in developing standards is to confirm the mandate for the capability. This can come from direct Ministerial or Executive mandates, commitments agreed in Joint Doctrine or requirements defined by the NHS England EPRR Core Standards. NARU then translates the commitment into a set of national standards using the following approaches: Legal / Regulatory Obligations The standards arising from these approaches are confirmed and recommended to NHS England. They are then incorporated into the Standard NHS Contract for Ambulance Services via the EPRR Core Standards. For new capabilities or significant changes to existing capabilities, the National Standards may be preceded by a business case setting out predicted costs, resource implications and training requirements. Capability Matrices Standard Operating Procedures Consultation Compliance Monitoring Innovation 4 13

NHS AMBULANCE SERVICE Legal / Regulatory Obligations Compliance 3 Providing emergency care to patients in high-risk environments creates several legal obligations and potential liabilities. The main legal areas considered by NARU during the process of developing standards are: Health and safety obligations Duty of care (tort of negligence) obligations Contract and procurement obligations The Health and Safety at Work Act 1974 and associated regulatory provisions require employers to take reasonably practicable steps to keep their employees safe. Several specific regulations apply directly to some of the interoperable capabilities. Examples include; the Work at Height Regulations 2005 and the Confined Space Regulations 1997. There are also numerous Approved Codes of Practice (ACoP) and regulatory guidance that directly apply to the various capabilities. NARU researches these requirements and develops a compliant safe system of work for each capability with the support of external experts such as the Health and Safety Executive. We then develop an appropriate set of minimum controls for each high risk activity. The duty to keep employee s safe must be balanced against the duty of care owed by the Ambulance Service to its patients. This is an established common law duty to provide a reasonable standard of care without unreasonable delay. The reasonable standard of care has been defined in cases such as Bolam v Friern Hospital Management Committee [1957] 2 All ER 118 and the avoidance of unreasonable delay has been confirmed in the case of Kent v Griffiths [2001] QB 36. Kent v Griffith was a landmark case for the Ambulance Service. It distinguished the duty of care owed by the Ambulance Service from that of other responding agencies such as the Police and Fire & Rescue Service. Police and Fire Services owe a duty to members of the public but the duty to individual casualties already injured at the scene is, for the most part, discretionary. In contrast, the Ambulance Service is under a positive duty from the point at which it accepts a 999 call to each and every patient affected by the incident. From the point of accepting the call, the Ambulance Service would need to provide appropriate justification for any delay in getting to the patient and any care falling below the expected professional standard (i.e. that of a Paramedic or Medical Technician). Not trained and not equipped has been a strong defence for the Ambulance Service in the past. If employees are not trained or equipped to work in a hazardous area, their employer has solid legal grounds not to commit them under its health and safety obligations. This has been accepted by the Courts as justification for a delay in care. Staff performing the interoperable capabilities are now highly trained and well equipped, with a safe system of work for them to deploy forward into the higher risk areas of an incident. The justification for any delay in providing patient care is now a key factor for on-scene Commanders. Safety of Ambulance responders still provides an appropriate justification but only where the features of an incident prevent a safe system of work being put in place. The default position now is that hazardous area medical responders should be committed without unreasonable delay. This is a key consideration for the blue light responding agencies applying Joint Emergency Services Interoperability Programme (JESIP) principles at the scene. These duties are carefully considered by NARU and feed into national policy developments. They provide the foundation upon which the Standard Operating Procedures for our interoperable capabilities are constructed. 14 www.naru.org.uk

The Ambulance Service is part of the health service and has a special relationship with the patient. The NHS Ambulance Service owes a legal duty of care to individual patients at the scene of an incident that is not shared by the other emergency services. Christian Cooper NARU s Head of Compliance Describing the principle set out in Kent v Griffiths [2001] QB 36 MTFA responders stabilise and extricate an injured patient from a hazardous area whilst the Police attempt to contain armed terrorists during Exercise Blue Guardian.

NHS AMBULANCE SERVICE Duty of Care Summary Extract from an aide memoire contained within the HART Standard Operating Procedures: Duty of Care to Staff Take all reasonable and practical steps to keep employees safe. Use the activities and controls specified in the SOPs. Ensure staff are competent to undertake activity (core competencies in the TIS). Statutory duties under the Health and Safety at Work Act 1974 and subsequent regulatory provisions. Ensure the equipment mandated by the SOP is available. Duty of Care to the Patient Provide a reasonable standard of care without any unreasonable delay. Undertake the risk assessment and determine the action as quickly as possible. Continually review the position and deliver care as soon as possible. Established duty at common law. It is a positive duty on the Ambulance Service to provide a reasonable standard of care without unreasonable delay. This duty is unique to the Ambulance Service. Police and Fire have duties to the public at large but their duty to individual patients is discretionary (Kent v Griffith [2001] QB 36). Compliance 4 Article 2 Right to Life Risk Assess the Activity Take steps to protect people from harm which may lead to loss of life. Assess the risks for both staff and patients. Balance the two duties set out above. Undertake a dynamic risk assessment at the scene based on hazards and the available controls. Regularly review the risk assessment. This is a qualified right. If the correct balance is achieved (duty of care to staff and duty of care to patients) the duty will be discharged. If the rescue is too dangerous for the responders, Art. 2 positive duties can be avoided. If the activity is likely to result in death or serious injury to a member of staff despite the controls, do not commit. The statutory health and safety obligations on the employer provides justification for the delay in care. Multi- Agency Joint Doctrine Contribute to the joint risk assessment as part of JESIP and ensure a common understanding of the risks. Joint risk assessment (multiagency) using the JESIP tools. If the risk of death or serious injury to staff can be mitigated by the safe system of work (making the likelihood low) you must avoid delay in committing staff to provide care or the Ambulance Service may face liability (Kent v Griffith [2001] QB 36). 16 www.naru.org.uk

The National Safe System of Work The Compliance and Quality Assurance Team within NARU is responsible for maintaining the National Safe System of Work for interoperable capabilities. The Safe System of Work is made up of the following key components: NATIONAL STANDARDS CAPABILITY MATRIX Breaks core capabilities down into activities or tactical options. Maps the minimum competence and equipment requirements. SOPs GRPs GORAs TISs EDSs SOPs Standard Operating Procedures Controls GRPs Generic Rescue Plans Emergency procedures GORAs Generic Operational Risk Assessments Hazard mitigation TISs Training Information Sheets Core competences Compliance EDSs Equipment Data Sheets Equipment specifications Note: The safe system of work is part of a wider quality management system described later in this document. 4 17

NHS AMBULANCE SERVICE Capability Matrices The requirement for the capabilities and the legal obligations are then aligned to operational practice through Capability Matrices and Standard Operating Procedures. Each capability has its own matrix. To create the matrix a list of operational activities or tactical options are scoped. For example, the requirement to provide Paramedic care during flooding might include the activity of working in or around boats. The matrix breaks down each capability into a set of activities or tactical options. NATIONAL PROVISIONS For developing and monitoring standards Compliance Capability Matrices Standard Operating Procedures National User Interface (the SOP App) Generic Rescue Plans Training Information Sheets Equipment Data Sheets Proclus Dashboard Resource Monitor Reports from NARU Audits & Capability Reviews NHS England EPRR Assurance Support Policy support to NHS England and DH Support to Commissioners Joint Working Agreements (Multi-Agency) 4 Standard Operating Procedures Once a draft capability matrix has been produced, NARU can move on to developing a full set of Standard Operating Procedures (SOPs) for a specific capability. The NARU Compliance Advisor coordinates this activity. Not every capability requires a suite of SOPs. The Mass Casualty Capability is principally about making large volumes of clinical equipment available for local use at an incident. Thus, this capability has a National Standards publication but does not require national SOPs. However, the HART capability requires extensive SOPs to cover its full range of operational activities. NARU revised the format of its SOPs in 2017 following a research and development project. This project included consultation 18 www.naru.org.uk

with external lawyers and the Health & Safety Executive to ensure the SOP s became an integral part of a legally compliant safe system of work. The revised format is based around activity lists and controls. The activities are taken from the capability matrix and a series of minimum controls are developed to create a safe system of work. This process requires extensive research and expert consultation. NARU invites operational practitioners to form drafting groups for each SOP. Their drafts are shared with external subject matter experts and refined until a final draft can be approved by the National Operations Group. SOPs also include the following supportive elements: Rescue Plans Each SOP has a corresponding Generic Rescue Plan (GRP). This contains a list of potential emergencies which could be encountered while executing the activity. If the standard controls fail, there will be a corresponding set of emergency procedures which can be followed to protect or rescue deployed staff. Risk Assessments Each SOP has a corresponding Generic Operational Risk Assessment (GORA). This lists potential hazards and risks associated with the SOP activities. It assesses the risk exposure and applies several generic controls to mitigate them. The GORA s provide Team Leaders and Operatives with a generic assessment of risk upon which they can add their dynamic risk assessment at the scene. This makes the process of risk assessment on the incident ground much more efficient. Core Competencies Once an activity list and set of controls have been defined in an SOP, a minimum set of competencies can be developed. These are core elements or skill sets which every Operative will need to be proficient in to undertake the activity safely. The Core Competencies are set out in Training Information Sheets (TIS s) which are cross referenced in the SOPs. The NARU Education Centre and local Ambulance Service Training Managers then take the core competencies and develop sub-competencies and training packages to facilitate a consistent standard of training. All training for the interoperable capabilities should be aligned to a relevant Training Information Sheet. This ensures the effective integration of training within the safe system of work. Each Training Information Sheet has its own corresponding risk assessment to cover the training activity. Equipment Specifications Each SOP defines the minimum level of equipment needed to undertake the activity, including Personal Protective Equipment (PPE). Supplementary or optional equipment is also listed. Every item of equipment listed in the SOPs must have a corresponding Equipment Data Sheet (EDS). The EDS defines and specifies the equipment including conformity standards, regulatory requirements, procurement arrangements etc. Each Equipment Data Sheet has its own corresponding risk assessment specific to the use of that equipment. Several equipment components for the interoperable capabilities are deemed to be safety critical and are subject to strict maintenance and inspection schedules. Compliance 4 19

NHS AMBULANCE SERVICE Consultation NARU consults a wide range of stakeholders as part of its Compliance and Quality Assurance activities. Draft National Standards are initially reviewed by sub-groups of the NARU Central Management Team (CMT) comprising operational practitioners. They are then passed to the following specific groups before the final draft is produced: The National Directors of Operations Group (NDOG) The Emergency Preparedness Resilience & Response Group (EPRRG) Human Resource Directors National Ambulance Service Medical Directors Group (NASMeD) A final draft of the National Standards is then produced and sent to NHS England for ratification. At this point NARU works with NHS England to integrate the standards into the wider NHS EPRR Core Standards. The CMT sub-groups then provide the following contributions: National Operations Group: Confirms the activities and controls. National Trainers Forum: Confirms the core competencies. National Clinical Reference Group: Reviews the clinical provisions. National Equipment Group: Confirms the logistical requirements. The final drafts are then uploaded to an online testing portal so the draft provisions can be viewed via a user interface. At this point, all operational practitioners can review and test the provisions and the controls. NARU also invites representatives from other responding agencies to review the procedures and comment. Compliance 4 Production of the Matrices and Standard Operating Procedures requires consultation on many levels: The first stage involves Operational Practitioners and Instructors (Ambulance) who produce the first drafts. These are then reviewed by internal and external subject matter experts with specific knowledge of the subject area. Existing (external) best practice is also considered. During the drafting phase, the Head of Compliance may refer the provisions for further review by external lawyers and regulators. 20 www.naru.org.uk

Safety critical systems have been developed for our interoperable capabilities in conjunction with the relevant Regulators. They must be maintained without compromise or lives may be put at unnecessary risk. Christian Cooper NARU s Head of Compliance A HART Entry Control Officer monitors the safety of Paramedics committed inside the hot zone. Ambulance Commanders must carefully balance the safety of the deployed team and controlling the risks so that NHS care can be provided to those that need it.

NHS AMBULANCE SERVICE Monitoring Once the standards have been set, NARU is required by NHS England to support a range of assurance activities. This principally involves providing subject matter expertise to Commissioners or Regulators during their various reviews and assessments. Members of the NARU Central Management Team are regularly asked to support the EPRR assurance process by accompanying Commissioners and NHS England Regional Representatives during inspections of Ambulance Services. NARU is also commissioned by NHS England to undertake deep dive reviews or audits following concerns raised by Regulators or Independent Reviews. To facilitate these activities, the Compliance and Quality Assurance Team includes qualified Chartered Quality Institute (CQI) Auditors. NARU representatives regularly attend exercises to observe the performance of the interoperable capabilities. The Compliance and Quality Assurance Advisors undertake regular visits to Ambulance Trusts that host interoperable capabilities to meet with staff and provide advice. Levels of resource (personnel and equipment) to support the delivery of the interoperable capabilities are monitored daily by NARU. Each Ambulance Trust hosting interoperable capabilities is required to update an online dashboard twice daily which shows the number of trained personnel on duty along with the availability of key logistics. Reports are compiled for commissioners and NHS England on compliance against the minimum resource standards. NARU also conducts no-notice spot checks on resource availability and response time standards. Compliance 4 Innovation NARU is continually seeking to innovate through these approaches. Our national position allows us to review the latest operational techniques to support the interoperable capabilities. For example, a unique user interface has been designed by NARU to facilitate access to the Standard Operating Procedures and associated safety critical information. Operational practitioners can access a secure online application (an App) via internet enabled devices. This facilitates a graphical interface which presents critical information to the user relevant to the activity they are undertaking on the incident ground. The same interface is used to manage changes which may affect the safety critical systems ensuring that all operational staff remain fully informed of new procedures, equipment and training provisions. 22 www.naru.org.uk

The Compliance and Quality Assurance Process This process diagram summarises how the safe system of work fits into our wider quality process. COMPLIANCE QUALITY ASSURANCE Developing & Monitoring Standards Reviewing & Improving Standards NHS Contract Standards NATIONAL STANDARDS Capability Matrices Ongoing Maintenance National Operations Group National Trainers Forum National Equipment Group National Clinical Group National Standard Operating Procedures Annual Whole System Review Equipment Controls Activities Risk Assessment Competence National Standards Capability Matrices Standard Operating Procedures Resilience & Capability Survey Review of legal and regulatory provisions Procedures Rescue Plans Operational Risk Assessments Equipment Data Sheets Training Information Sheets Monitoring Safety Notification System Change Management Process SOP Amendment Process Compliance Audit / Reviews Assurance Support to NHS England Commissioning Support Support to Regulators Resource Level Monitoring Root Cause Analysis Investigations Learning Lessons Process Support to National Policy Development National Assurance Courses & Exercises 4 Physical & Psychological Evaluation Process 23

When specialist Ambulance responders from around the country combine in response to a national emergency it is critical that they can work safely and effectively together. Our staff are the most valuable asset we have. Keith Prior Director of NARU HART Paramedics use specially designed Incident Ground Technology (IGT) to support their high-risk deployments. The national provisions, including safe system controls and risk management tools, are available to HART, MTFA and CBRN responders on the incident ground via a secure user interface.

QUALITY ASSURANCE Reviewing and Improving Standards Our quality assurance programme aims to continually review and improve the provisions created by our compliance activities. All NARU Departments support the quality assurance process. Quality assurance is a critical part of maintaining the national safe system of work. It keeps safety critical processes under continual review and includes a structured approach to change management. We also have processes for identifying and rectifying risks to the system which are managed through the National Operations Group. Our approach to quality assurance has allowed NARU to realise significant savings over recent years through organisational learning, increased efficiency and better use of technology. For example; funding for the HART service line has remained fixed for over seven years with no inflationary uplift. During that time, HART has been required to develop additional capabilities and the operating costs have increased. Despite this, NARU has been able to increase efficiency within the service line to absorb the impact without compromise to the safe system of work. In effect, more is being done for less. Ongoing Maintenance The interoperable capabilities have many components. Highly technical equipment, complex training requirements and comprehensive procedures combine to maintain a safe system of work. Many of these components require careful ongoing maintenance. That is the principle function of four national sub-groups reporting into the NARU Central Management Team. Each sub-group comprises; national subject matter experts, local practitioners and capability managers. They examine particular aspects of the national provisions to ensure they remain fit for purpose. The sub-groups also allow representatives from every Ambulance Trust to share in the ownership of the capabilities at a national level. NATIONAL OPERATIONS GROUP Quality Assurance NATIONAL EQUIPMENT GROUP NATIONAL CLINICAL GROUP NATIONAL TRAINERS FORUM 5 25

NHS AMBULANCE SERVICE The National Operations Group (N.O.G.) The NOG membership includes local managers of the interoperable capabilities from each of the English Ambulance Services and the Devolved Administrations (Scotland, Wales and Northern Ireland). It also includes several NARU Officers, national subject matter experts and national representation for Ambulance Service finance, human resources and procurement. The group is always Chaired by a member of the NARU Central Management Team. A key responsibility of NOG is to review and approve the national Standard Operating Procedures. The group also provides the NARU Central Management Team with subject matter expertise on any issues passed to it for consideration. It is a principle consultation group for National Standards and capability enhancement proposals. The membership of NOG makes it ideally placed to act as a filter between the other sub-groups and the Central Management Team. It therefore acts as a revising body for papers and recommendations arising from the other groups. The group also plays a central role in maintaining the National Change Management Process. specified equipment are first considered by this group before progressing through the National Change Management Process. This group is also responsible for reviewing and maintaining the Equipment Data Sheets. The National Trainers Forum (N.T.F.) The NTF membership includes local Training Managers from each of the Ambulance Trusts and Instructors from the NARU Education Faculty. The group is Chaired by the NARU Head of Education. The main role of the NTF to review the ongoing training provisions for the interoperable capabilities and maintain the competence of practitioners in a consistent manner. Any requests to change, update or modify nationally specified training activity are first considered by this group before progressing through the National Change Management Process. This group is also responsible for reviewing and maintaining the Training Information Sheets. Quality Assurance 5 The National Equipment Group (N.E.G.) The NEG membership includes Equipment Leads from each of the Ambulance Trusts and selected NARU Officers. It also has a national procurement lead. The main role of the NEG is to review the equipment provisions for the national interoperable capabilities. This includes safety critical equipment and personal protective equipment (PPE). Any requests to change, update or modify nationally The National Clinical Group (N.C.G.) The NCG membership is considerably smaller than the other sub-groups. It comprises; a small selection of clinical leads from Trusts, NARU s Head of Compliance, NARU s Training Manager and a representative from both the NHS England Clinical Reference Group (CRG) and the National Ambulance Service Medical Directors Group (NASMeD). The group is Chaired by NARU s Medical Advisor. 26 www.naru.org.uk

The main role of the NCG is to review clinical aspects specific to the interoperable capabilities and corresponding clinical standards. Its primary focus is on the standard of clinical care provided to patients caught within the high-risk areas of incidents (i.e. those requiring the interoperable capabilities). Any requests to change, update or modify the medical or clinical activities conducted as part of the interoperable capabilities are referred to this group. The group then determines whether it can make approvals in its own right or whether matters need to be laid before NHS England s CRG or NASMeD (or both) for further consideration. Annual Whole System Review In addition to the ongoing maintenance facilitated by the National Sub-Groups, NARU also conducts an annual whole system review. This activity is coordinated by the Quality Assurance Advisor and involves a systematic inspection of all components (i.e. SOPs, GORAs, TISs, EDSs etc). Any component that has not been reviewed or modified in the previous 12 months is identified and forwarded to an appropriate body for review. This process also consolidates all change requests, safety notices and national lessons (identified by NARU via the national lessons systems) to produce a cross check list of any outstanding actions. Any remaining issues or actions which impact on the safe system of work are then referred to the relevant sub-group for follow up. The review also assesses the efficiency and effectiveness of the system as a whole. The subgroups and stakeholders are consulted on their experiences of operating the system and recommendations are made to the Head of Compliance on how the system could be improved. Safety Notification System NARU maintains an online system which allows any Trust or individual practitioner to report a safety issue affecting the interoperable capabilities. An online form is completed which triggers a formal notification to a member of the NARU Compliance and Quality Assurance Team. If urgent, the notification is sent direct to the NARU On-Call Duty Officer. The notification is then reviewed and the impact on the interoperable capabilities is assessed. Depending on the outcome of that review, a national safety notification can then be issued by NARU to all Trusts operating the interoperable capabilities. Quality Assurance 5 27

NHS AMBULANCE SERVICE The notification may include advisories, warnings or immediate actions to be taken. In the most serious of cases, the system can be used to implement an immediate suspension of operations for a particular capability or prevent the use of a particular item of equipment. Whenever a national notice is issued, warnings simultaneously appear on the national Standard Operating Procedures system so responders will see an alert prior to applying a procedure in the operational setting. All safety notices that are disseminated nationally trigger a review of the relevant national provisions in the safe system of work. Change Management Process The capabilities must remain interoperable. Therefore, any change or modification to existing provisions must be put through a formal change management process. This is a contract obligation on Trusts that maintain interoperable capabilities. The online system has been designed to be user friendly and it manages each approval stage, automatically referring actions to people or groups for completion. The system also allows practitioners and managers to track the progress of any change in the system. Quality Assurance NARU has implemented an on-line system to allow any operator to make an initial change request. That request then passes through a series of formal stages to assess its validity and the potential impact on the capabilities. National subject matter experts provide various assessments and the request is formally considered by each of the sub-groups. This includes a formal assessment from the Compliance and Quality Assurance (CQA) team on what impact the change will have in relation to the safe system of work. Where appropriate, the change management process includes NHS tendering and full field evaluations. The system collates all the inputs to create a final report for consideration at the National Operations Group. If the group endorses the change it sends a recommendation to the NARU Central Management Team for final approval. If approval is granted, the CQA team make the necessary updates and amendments to the safe system of work and contract standards. 5 28 www.naru.org.uk

NARU prides itself on the delivery of effective and relevant courses for front line staff and commanders. National standards are essential to maintaining quality, competency based education modules. Such modules are reviewed as part of a continuous process to ensure that content matches both national standards and delegate needs. Dave Bull QAM NARU s Head of Education HART Paramedics working inside the hot zone stabilise a simulated patient after a chemical release until they can be extricated to a safe area for further treatment.

NHS AMBULANCE SERVICE Summary of the Change Management Process STAGE 1: Change Request Request to change or modify national provisions are submitted via an online form. STAGE 2: Initial Assessment The request is reviewed by a lead sub-group. Standard enquiries are answered and submitted back to the system. STAGE 3: Impact Assessment Part 1: Each Sub-Group (NOG/NEG/NTF) formally consider the impacts of the change based on their expertise and remit. Each group submits their findings via a standard form back to the system. Part 2: NARU appointed Subject Matter Experts (SMEs) provide responses to standard enquiries and submit them back to the system. STAGE 4: Evaluation Based on responses so far, the Lead Sub-Group selects what further evaluation is required (e.g. market assessment, ethics approval, tender / procurement, field evaluation etc). The group can also decide that no further evaluation is required and move forward to the next stage. Appointed individuals will lead on the different aspects of the evaluation and upload their reports to the system. STAGE 5: Recommendation The system then compiles an interim report for consideration by the National Operations Group (NOG). NOG completes some final standard enquiries (including; cost / benefit analysis, risk appraisal, outstanding concerns etc). These enquires and the recommendation of the group are submitted back to the system. Quality Assurance STAGE 6: Implementation The system complies the final report for NARU CMT. CMT then approve or reject the change for national implementation. The system produces a Dissemination Report and a file for archiving. 5 30 www.naru.org.uk

SOP Amendment Process The initial development process for each Standard Operating Procedure (SOP) is explained in the Compliance section above. The SOP s include the controls needed to create a safety critical system of work. As a result there is a strict approval process for any subsequent amendments. The Change Management Process will often necessitate amendments to the SOPs but specific changes can also be made under a streamlined process as a result of the following activities: Safety notifications Lessons identified / post incident debriefs The following NARU Officers have the required authority to make approved amendments to the online system (i.e. editing rights): National Director Head of Compliance Head of Capabilities Compliance Advisor Quality Assurance Advisor Once an amendment is made to an SOP, an immediate update goes live across the system and an online log highlights the change to all system users. As part of the annual quality assurance process (the annual review) Recommendations from the National Operations Group Directive from the NARU Central Management Team Amendments are proposed in a paper which must be endorsed by the National Operations Group (NOG). The paper must include an impact assessment by at least one subject matter expert, usually a qualified instructor for the relevant capability. The endorsement by the NOG must then be authorised by the Head of Compliance on behalf of the NARU Central Management Team before an amendment is uploaded into the system. The Head of Compliance may request further research or drafting work prior to approving such an amendment. In the absence of the Head of Compliance, only the National Director can authorise the change. Quality Assurance 5 31

HART Paramedics prepare to stabilise a fallen Fire Fighter and administer intravenous pain relief prior to extrication from a cliff face.

NHS AMBULANCE SERVICE Learning Lessons Process Under the EPRR Core Standards each Trust delivering the interoperable capabilities is required to maintain a robust system for identifying and learning lessons from both incidents and training exercises. This is also a statutory duty under the Civil Contingencies Act 2004 and its provisions for sharing information with other Category One responders. NARU has a national process in place for monitoring lessons identified at the local and national level. National debrief reports are reviewed by either the Head of Capabilities or the Head of Education (depending on whether the report was generated following an incident or a training exercise). They then identify any relevant lessons for the interoperable capabilities and provide a corresponding paper to the Central Management Team (CMT). Issues may then be referred by CMT to one of its sub-groups for action and implementation. NARU has also developed a national on-line register to collate and share lessons that arise from local operations or training involving the interoperable capabilities. The Lessons Identified Database (LID) allows other Trusts to review key learning which originates in another part of the country. Further to this, local Ambulance Providers and NARU can both submit lessons on the JESIP 2 Joint Organisational Learning system (based on the LID system developed by NARU). This allows lessons to be shared with multi-agency partners and is particularly important where the interoperable capabilities are interdependent on safe systems provided by other agencies. The NARU Quality Assurance Advisor monitors these three mechanisms (CMT, LID and JOL) to assess whether any lessons directly affect the safe system of work. The Quality Assurance Advisor can then propose amendments to the Standard Operating Procedures (or associated provisions) based on practitioner s experiences. This process is in addition to the safety notification system. The lessons process identifies less urgent and more qualitative learning as part of continual improvement. Support to National Policy Development Quality Assurance 5 2 Joint Emergency Services Interoperability Programme The Department of Health and NHS England develop policy to support the aims of Central Government. This includes supporting UK strategies to deal with civil emergencies and the Ambulance Service interoperable capabilities provide a vital contribution. NARU Departments provide advice based on their respective areas of business. Compliance and Quality Assurance supports national policy development through the following contributions: National standards Contract standards Business cases for capability enhancement The duty of care and legal obligations of the Ambulance Service Safe systems of work and balancing risk Audit and assurance 34 www.naru.org.uk

The Compliance and Quality Assurance Team (CQA) undertake extensive assurance activities to ensure the capabilities are being maintained to the required standards. This includes working closely with Commissioners and Regulators. Members of the CQA Team are also qualified Auditors. The findings from various assurance activities are then fed back into national policy development, principally through the annual revision of the National Standards. Assurance Through Training In addition to providing some of the initial training for interoperable capabilities, the NARU Education Faculty also provides a wide range of assurance activities. These take the form of assurance courses or specific activities designed to evaluate levels of competence among staff delivering the interoperable capabilities. This provides an important contribution to our Quality Assurance programme. Performance on the national assurance courses or specific activities is evaluated by the National Trainers Forum and reported back to the National Operations Group to allow targeted improvement activities. The NARU Quality Assurance Advisor then works closely with the respective sub-groups to incorporate findings into the wider system. Physical & Psychological Evaluation Process Ambulance staff delivering the interoperable capabilities face a unique set of physical and psychological demands. These responders are operating in high-risk situations, they are required to deploy in a complex ensemble of personal protective equipment, they are often deployed for protracted periods and witness horrific events within the inner cordon of incidents. In short, they are trained and equipped to be sent into harm s way and it is essential that they are appropriately prepared both physically and mentally. HART and MTFA responders are required to undertake physical competency assessments to ensure they are physically fit enough to undertake the role. The psychological effects of the role are also monitored through an annual Resilience & Capability Survey, the results of which are analysed by trained psychologists. Further to this, the Capabilities team keep the physical and psychological standards under regular review. This represents a key component in the quality assurance system. During 2017/18, NARU led an evaluation project to develop a Selection and Recruitment Manual for the interoperable capabilities. Specialist scientists in conjunction with the University of Chichester and Zeal Solutions were commissioned to conduct a root and Quality Assurance 5 35

NHS AMBULANCE SERVICE branch review of the physical and psychological demands created by the interoperable capabilities. This has led to a revised set of physical and psychological standards covering operational and training activities for each capability. This feeds into the National Standards as part of our continual review process. NATIONAL PROVISIONS For developing and monitoring standards Safety notification system Change management process SOP amendment process Physiological & psychological evaluation programme Resilience & capability survey Annual review of National Standards Annual review of matrices Annual whole system review The National Operations Group The National Equipment Group The National Trainers Forum National buying frameworks Lessons process Awareness films Assurance training courses Quality Assurance 5 36 www.naru.org.uk

We need to understand the precise physical and psychological demands placed upon our specialist responders so we are able to put appropriate support and welfare measures in place. Gerry Byrne NARU s Head of Capabilities A scientist conducts respiratory function tests on NHS MTFA personnel as part of the NARU Physical and Physiological Evaluation Programme.

NHS AMBULANCE SERVICE Internal Compliance INTERNAL COMPLIANCE NARU s Governance Provisions 6 The National Ambulance Resilience Unit (NARU) works with Ambulance Trusts to coordinate the delivery of Ambulance Emergency Preparedness, Resilience and Response (EPRR). Constitutionally, NARU operates as an emanation of NHS England under a formal contract arrangement. West Midlands Ambulance Service NHS Foundation Trust are the current contract hosts extending its corporate functions and services to cover the work undertaken. Each meeting of this group has a particular focus on NARU activities which rotates equally through Capabilities, Education and Compliance. Central Management Team (CMT) NHS England approves a NARU Work Plan on an annual basis. This provides NARU with a commissioned set of deliverables under its contract. Coordinating and maintaining the interoperable capabilities is a key feature of that work plan. Each NARU contract term lasts between three and five years. CMT is the main management body of NARU. It is a monthly meeting of the NARU Heads of Service and principle advisors. Chaired by the National Director it oversees the delivery of all NARU services and acts as the accountable body for its sub-groups. Several management groups are responsible for ensuring good corporate governance and the effective management of NARU functions. The Steering Group This is the accountable body for the NARU contract. It meets to approve the contract itself or review its overall delivery. The group is owned by NHS England and Chaired by its Director of Operations. Delivery Board This meeting is owned by West Midlands Ambulance Service (WMASFT) as the current hosts of the NARU contract. The NARU Director also Chairs this group but in their capacity as an Assistant Chief of WMASFT. This group provides WMASFT with assurance that the contract, and particularly its financial provisions, are being appropriately maintained inline with WMASFT policies. The Contract Management Group This group meets regularly throughout the year to approve the NARU Work Plan and monitor delivery of its component serials. The group is owned by NHS England and Chaired by its National Head of EPRR. 38 www.naru.org.uk

NARU Contract Governance Internal Compliance STEERING GROUP Owner: NHS England Chair: NHS England Director of Operations WMAS-FT CEO WMAS-FT Trust Board 6 CONTRACT MANAGEMENT GROUP Owner: NHS England Chair: NHS England Head of EPRR CENTRAL MANAGEMENT TEAM (CMT) Owner: NARU Chair: Director of NARU DELIVERY BOARD Owner: WMAS-FT Chair: Director of NARU NATIONAL OPERATIONS GROUP NATIONAL EQUIPMENT GROUP NATIONAL CLINICAL GROUP NATIONAL TRAINERS FORUM 39

NHS AMBULANCE SERVICE Internal Compliance NARU s Organisational Structure 6 Director NARU CMT Members Medical Advisor Head of Education Coordinator Head of Capabilities Head of Compliance Training Manager Ambulance Advisors Compliance Advisor Command Trainers Admin Support Quality Assurance Advisor Instructors Support Service Mgr. Admin Support Logistics Support Logistics Support NATIONAL PROVISIONS For NARU s internal governance The NARU Contract NARU s Annual Business Plan NARU s Work Plan Contract Steering Group Contract Management Group NARU Central Management Team Delivery Board (WMAS-FT) Production & Classification of NARU Documents Procedure 40 www.naru.org.uk

The NHS is immensely proud of our specialist responders. They are a dedicated group of highly trained staff. HART, MTFA and CBRN personnel are at the sharp end of the Government s Emergency Preparedness and Counter Terrorism Strategies. They put themselves in harm s way to provide care and save lives. Stephen Groves OBE National Head of EPRR* NHS England * Emergency Preparedness, Resilience & Response The NARU Quality Assurance Advisor reviewing SWaH (Safe Working at Height) standards at a local Ambulance base. Each interoperable capability is defined through service specifications developed by NARU and ratified by NHS England. The specifications are then incorporated into the NHS England EPRR Core Standards.

NHS AMBULANCE SERVICE Internal Compliance 6 The National Compliance & Quality Assurance Team Christian Cooper JP MSc PGDipLaw SIRM Head of Compliance Christian has extensive strategic management experience in the NHS, holding dual qualifications in clinical and legal practice. He has led the health response to several major incidents and served as a special advisor to Central Government during national emergencies. Christian is NARU s Head of Service for Compliance and Quality Assurance. He oversees all associated activities on behalf of the Central Management Team. Email Christian at: christian.cooper@nhs.net Jenna Davies CertEd MCPara Quality Assurance Advisor Jenna has an operational and training background routed in the interoperable capabilities. As well as being a residential Instructor at the National CBRN Centre, Jenna has also been the Training Manager for HART Units serving London and the South West. Jenna is now the NARU lead for Quality Assurance providing advice to Ambulance Trusts and maintaining the national quality management system. Email Jenna at: jenna.davies@wmas.nhs.uk Nick Spence Compliance Advisor Nick is an experienced operational manager. He has commanded several major incidents in the UK and responded to eight disasters overseas as part of technical rescue or disaster relief teams. More recently Nick managed Air Operations in the South West where he was responsible for six aircraft and critical care teams. Nick is now the NARU lead for Compliance, maintaining the national standard operating procedures and advising Trusts on their delivery. Email Nick at: Nicholas.spence@wmas.nhs.uk 42 www.naru.org.uk

Further Information Internal Compliance The suite of documents that make up the National Provisions are available from the Compliance And Quality Assurance section of the NARU website unless they are protectively marked / restricted circulation. 6 To request access to protectively marked documents, contact the Compliance Advisor at Nicholas.spence@wmas.nhs.uk The latest Compliance and Quality Assurance information is posted on the CQA section of the NRU website at: www.naru.org.uk 43

NHS AMBULANCE SERVICE Compliance & Quality Assurance National Provisions for Interoperable Capabilities For further information please contact: National Ambulance Resilience Unit (NARU) Website: www.naru.org.uk January 2018 Version 1.0