Appendix 1. Policy on the Dissemination, Implementation and Monitoring of National Clinical Guidance

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1 Appendix 1 Policy on the Dissemination, Implementation and Monitoring of National Clinical Guidance

2 Policy Title: Executive Summary: Policy on the dissemination, implementation and monitoring of national clinical guidance This document sets out East Cheshire NHS Trust s policy and procedures for a systematic approach to the consideration, dissemination, implementation and monitoring of national clinical guidance Supersedes: Policy on the dissemination, implementation and monitoring of national clinical guidance v6 Description of Amendment(s): This policy will impact on: Trustwide systems relating to the consideration, dissemination, implementation and monitoring of national clinical guidance Financial Implications: Policy Trustwide Document ECT Area: Reference: Version V8 Effective Date: 8 th May 2017 Number: Issued By: Medical Director Review Date: 10 th April 2020 Author: F Smith Impact 2 nd May 2017 Head of Integrated Assessment Date: Governance APPROVAL RECORD Committees / Group Date Consultation: CARE Group 8 th May 2017 Approved by Clinical Audit Research & 8 th May 2017 Director: Effectiveness (CARE) Group Ratified by: Clinical Audit, Research & Effectiveness (CARE) Group 8 th May

3 Table of Contents 1.Introduction 4 2. Purpose 4 3. Roles and Responsibilities 5 4. Processes and Procedures 6 5. Monitoring Compliance with the Document 8 6. References 8 7. Communication Page 11 Page 12 Appendices Appendix 1 Types of NICE Guidance Appendix 2 - Procedure for Dissemination & Formal Response to NICE Guidance Appendix 3 Procedure for Dissemination & Formal Response to National Guidance Confidential Enquiries 3

4 1. Introduction This document sets out East Cheshire NHS Trust s policy and procedures for a systematic approach to the consideration, dissemination, implementation and monitoring of agreed best practice as defined in National Institute for Health and Care Excellence guidelines, national confidential enquiries and Higher Level Enquiries to ensure that all clinical recommendations, including those for patient safety, are taken into account in all clinical services. National clinical guidance includes guidance and reports published by the National Institute for Health and Care Excellence and National Confidential Enquiry reports 2. Purpose This policy will apply to the implementation of recommendations from all national clinical guidance (as listed below) received by the Trust. 2.1 NICE Guidance Acronym Acronym Title Acronym Acronym Title TA Technology Appraisal ES Executive Summary IPG Interventional Procedure Guidance QS Quality Standard CG Clinical Guidance DT Diagnostic Technology PHG Public Health Guidance SG Safe Staffing Guideline PSG Patient Safety Guidance SFC Support for Commissioning MT Medical Technology NG NICE Guidance MIB Medical Innovation briefing STA Single Technology Appraisal CSG Cancer Service Guideline HST Highly Specialised Technology FC Full Compliance PC Partial Compliance NC Non Compliance N/A Not Applicable TERM Terminated Appraisal NDR New Drug Request HTTA Health Technologies Adoption Programme DG Diagnostic Guidance A complete summary of each type of guidance is attached at Appendix Confidential Enquiries There are 3 types of Confidential Enquiry: National Confidential Enquiry into Patient Outcome and Death (NCEPOD), which carries out studies into aspects of care in all areas of medicine except obstetrics and mental health 4

5 MBRRACE-UK: Mothers and Babies Reducing Risk through Audits and Confidential Enquiries across the UK undertakes confidential enquiries on a nationwide basis to improve the health of mothers, babies and children National Confidential Inquiry into Suicide and Homicide by People with Mental Illness (NCISH) The aims of the Enquiries are to review clinical practice, to identify remediable factors in the care of patients, and to make recommendations for clinicians and managers to implement. The results of the Enquiries have widespread applicability because data is collected from all hospitals in England, Wales, Northern Ireland, the Isle of Man, Jersey, Guernsey, the Defence Secondary Care Agency, and from participating private hospitals. 2.3 High Level Enquiries The Care Quality Commission (CQC) is empowered by The Health and Social Care Act 2015 to conduct investigations into the provision of healthcare, by, or for, an English NHS body. When lessons are learnt from this process a wide reaching report with recommendations for all NHS organisations is published. 3. Responsibilities 3.1 Trust Board The Trust Board is responsible for ensuring that the organisation consistently follows the principles of good governance applicable to NHS organisations. This includes the development of systems and processes for governance and risk management which support this policy. 3.2 Chief Executive The Chief Executive is the Accountable Officer of the Trust and as such has overall accountability and responsibility for ensuring it meets it s statutory and legal requirements and adheres to guidance issued by the Department of Health in respect of Clinical Governance. 3.3 Medical Director The Medical Director has executive accountability for clinical effectiveness and is responsible for providing assurance to the Board on the implementation of this policy via the appropriate Board Committee. 3.4 Director of Nursing, Performance and Quality The Director of Nursing, Performance and Quality is responsible for organisational operational management of clinical services and the delivery of the Quality Strategy. The Director has executive responsibility for ensuring the Trust provides high quality care, which is supported compliance with NICE guidance within Directorates. 3.5 Director of Corporate Affairs and Governance The Director of Corporate Affairs and Governance has accountability for governance and risk management across the Trust and for working in collaboration with Medical Director to ensure the Board and relevant committees receive appropriate assurance with regard to the implementation of this policy. As Chair of the Clinical Audit Research and Effectiveness Group, will oversee the implementation of the policy together with members of the group. 5

6 3.6 Associate Medical Director for Clinical Effectiveness The Associate Medical Director is the lead clinician accountable for the implementation of this policy across the Trust, providing clinical leadership across the organisation in respect of NICE guidance. This responsibility extends to being the Vice Chair of CARE Subcommittee and working closely with members of the group and identified leads to provide assurance on compliance with NICE guidance. 3.7 Deputy Director Corporate Affairs & Governance The Deputy Director will lead and ensure mechanisms are in place to manage the governance processes related to this policy in order to achieve best practice and continued improvement; this includes having accountability for the management of the Clinical Effectiveness Team. 3.8 Head of Integrated Governance The Head of Integrated Governance will be responsible for the management and monitoring of compliance against National Clinical Guidance. 3.9 The Integrated Governance Manager The Integrated Governance Manager is responsible for the management of the Clinical Effectiveness Team Clinical Effectiveness Team The Clinical Effectiveness Team is responsible for monitoring and reporting on the Trust compliance with National Clinical Guidance, ensuring that the requirement to provide assurance on compliance / implementation of national, regional and local standards of practice is met. The team members will work with representatives of the Clinical Directorates to gain accurate assurance on compliance status against National Clinical Guidance Associate Director for Performance and Delivery The Associate Director for Performance and Delivery will lead (support) on governance performance issues throughout the Clinical Directorates Heads of Service Associate Directors are responsible for the local implementation of this policy within their respective areas and for ensuring that Audit leads and Clinical Directorate representatives on the Clinical Audit Research and Effectiveness Group fulfil their responsibilities for the dissemination, implementation and monitoring of National Clinical Guidance Clinical Audit Leads Clinical Directorate Audit Leads are responsible for the dissemination, implementation and monitoring of National Clinical Guidance within their area of responsibility, ensuring that evidence of changes in practice, where required, is available Managers Managers are responsible for the local implementation of this policy and for ensuring staff adhere to the relevant processes All clinicians and healthcare professionals All clinicians and healthcare professionals are responsible for providing clinically effective care and treatment, through awareness of National Clinical Guidance relevant to their areas. 6

7 4. Processes and Procedures 4.1 NICE guidance The Clinical Effectiveness Team is responsible for: Circulation of NICE guidance listing for horizon scanning, and listing of published guidance, to members of CARE Group. Distribution of NICE Guidance compliance gap analysis form to designated Clinical Leads for completion. Management and data entry onto the Trust s database and NICE scorecards. Reporting of progress and KPI s to CARE Group. To monitor action plans together with specified named lead and date for completion, for all recommendations made within national guidance and for which the Trust does not comply. CARE Group is responsible for: Confirmation of Lead Clinician for each relevant guidance To provide service areas with an outline of a structure to provide assurance on National Clinical Guidelines. To monitor responses from Clinical Leads through monthly reports received by CARE group and progress against action plans. CARE Group is responsible for monitoring responses and exception reporting to the SQS Committee on a quarterly basis. 4.2 Guidance other than NICE guidance The lead clinician(s) for all Confidential Enquiries (including MMBRACE and CISH) will be identified by the Local Reporters and disseminated as defined in Appendix 2. Progress will be reported through the monthly reports to the CARE Group. The lead Directorate will identify a lead clinician for each National Guidance, as appropriate, and progress will be reported to the CARE Group. Where more than one Directorate is involved in implementing guidance, a lead Directorate will be identified and their lead clinician will take overall responsibility, for developing a cohesive response. Nominated Lead Clinician is responsible for: Producing a self-assessment gap analysis, with risk assessment if required, drawing knowledge and expertise from all relevant areas, within the specified time of 3 months from publication of guidance. Consider the need to confirm level of compliance and re-audit if necessary For further clarification see flowcharts Appendix 2 and Process for ensuring that lessons learnt are acted upon throughout the organisation: An action plan and risk assessment (if applicable), with specified named lead and date for completion, will be completed for all recommendations made within National Guidance, and 7

8 for which the Trust does not comply. A final report for all guidance, other than NICE guidance, will be submitted to the Clinical Effectiveness Team for submission to the CARE Group with any exception reporting to the Trust SQS Committee. 4.4 Process when a Decision is made not to implement NCE/NICE guidance Where a clinical service does not implement/follow the recommendations from National Confidential Enquiries (NCE)/NICE Guidance, a risk assessment must be undertaken. If proposed by the Directorate as a risk, this should be escalated to the Directorate SQS Committee and CARE Sub Committee for a decision as to whether or not to go against contractual requirements to comply with NCE/NICE guidance. A statement regarding clinical risks identified with the implementation of NCE/NICE guidance and decisions made by CARE Group will be included in the quarterly report to the SQS Committee. Technological Appraisals (TA s) are mandatory and therefore are not included within this process. All TA s are monitored through the Medicines Management Group and then reported through to the CARE group and trust SQS Committee accordingly. 5. Monitoring Compliance with the Document 5.1 NICE The Clinical Effectiveness Team will monitor compliance against NICE guidance through the trust s database, onto which all departmental compliance responses, and exceptions are entered. This will include completion of self-assessments and gap analysis within 3 months of publication. An annual audit is undertaken to determine compliance with the 3 month timeframe for receipt of self-assessment and gap analysis. 5.2 NCEPOD. A separate monitoring tool is used for all NCEPOD studies, in accordance with the defined timescales from NCEPOD. 5.3 All other National Guidance These will be monitored by the Clinical Effectiveness Team with submission of reports made to CARE Group, and exception reporting to the SQS Committee on a quarterly basis. 5.4 Technology Appraisals. These are monitored by the Medical Management Group and have to be completed within 3 months. 5.5 Review This policy will be reviewed on a three yearly basis by the Head of Integrated Governance. 6. References National Institute for Health and Care Excellence. NICE into practice guide

9 Appendix 1 Types of NICE Guidance NICE Guidance - is based on a review of clinical and economic evidence. Clinical evidence measures how well the medicines or treatment works, and economic evidence is a measure of how well the medicine or treatment works in relation to how much it costs, i.e., does it represent good value for money. Clinical Guidelines - Guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS Technology Appraisals - Guidance on the clinical and cost effectiveness of specific new or existing medicines and treatments leading to recommendations on the appropriate use of the technology within the NHS. The NHS must usually make funding and resources available within 3 months of the issue of NICE technology appraisal guidance. Interventional Procedure Guidance - Recommendations about whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use. They are used for diagnosis or treatments that involve: Making a cut or hole to gain access to the inside of a patient s body, gaining access to a body cavity without cutting into the body, or using electromagnetic radiation or ultrasound. Public Health Guidance - Guidance on the promotion of good health and the prevention of ill health. Guidance may focus on a particular topic (such as smoking), a particular population (such as schoolchildren) or a particular setting (such as the workplace). Medical Technologies - Examples of products which may be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. Diagnostic Guidance - Diagnostic technologies may be used for various purposes including: diagnosis, clinical monitoring, screening, treatment triage, assessing stages of disease progression, and risk stratification. Social Care Guidance - Social care guidelines aim to improve outcomes for people who use social care support by ensuring that social care services and interventions are effective and cost-efficient. They do this by making recommendations about best practice, drawn from current evidence-based research. Medicines Practice Guidance - Medicines practice guidelines provide recommendations for good practice for those individuals and organisations involved in governing, commissioning, 9

10 prescribing and decision-making about medicines. They have a wide range of audiences across both health and social care. Highly Specialised Technologies Guidance - Contains recommendations on the use of highly specialised technologies. NICE Guidelines - NICE guidelines make evidence-based recommendations on a wide range of topics, from preventing and managing specific conditions to planning broader services and interventions to improve the health of communities. They aim to promote integrated care where appropriate. Quality Standards - are concise sets of statements, with accompanying metrics, designed to drive and measure priority quality improvements within a particular area of care. These are derived from the best available evidence, particularly NICE's own guidance and, where this does not exist, from other evidence sources accredited by NICE. Evidence Summaries - Summaries of the best available evidence to inform local NHS planning and decision-making, for selected new medicines, off-label use of licensed medicines and unlicensed medicines. Key Therapeutic Topics - 'Medicines optimisation: key therapeutic topics' summarises the evidence-base on topics identified to support medicines optimisation. Local Government Briefings Advice for local government on the public health actions that are most effective and provide best value for money. Medtech Innovation Briefings - Objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. 10

11 Appendix 2 Procedure for Dissemination & Formal Response to NICE Guidance CARE GROUP Meetings Held Monthly Forward work programme of CARE Group: Horizon scanning of NICE guidance due to be published in following 3 months to: 1. Determine if relevant to Trust 2. Identify relevant Directorate(s) /lead clinicians 3. Agree on Lead Directorate/clinician (& subsidiary) BU Rep on CARE Group to obtain identification of lead clinician for relevant Responses entered on database of NICE guidance Work programme of CARE Group on publication of guidance: 1. Confirmation of Lead Clinician for each relevant guidance 2. Monitoring of responses from Directorates/ Clinical Leads through database 3. Monitoring of process through database CE Dept forwards ECNHST compliance gap analysis form to Lead Clinician for completion for each relevant guidance. Lead clinician co-ordinates response by completing compliance gap analysis and/or risk assessment as appropriate. Decision made not to implement NCE/NICE guidance: 1. Risk assessment completed 2. Director ate to Escalate to CARE Group 3. Quarterly report to Trust SQS Within 3 months of publication Lead Clinician returns compliance gap analysis to CE Dept for entry onto NICE database, which is reported to CARE Group for review on a monthly basis. CE Dept includes NICE updates within the governance data packs for the Directorate SQS Groups Quarterly report to Trust SQS Committee Within 2-3 years Consider audit to confirm sustainability of compliance Implementation cycle completed 11

12 Appendix 3 Procedure for Dissemination & Formal Response to National Guidance Confidential Enquiries CARE GROUP Meetings Held Monthly Local Reporters identify an appropriate Lead Clinician(s) for all Confidential Enquiries (including MMBRACE and CISH), to manage gap analysis and implementation of the guidance. Database used as monitoring tool Lead Directorate representative on CARE Group to identify nominated lead for National Guidance and feedback to CARE Group Lead Clinician co-ordinates Trust-wide response, drawing on knowledge and expertise from all relevant areas Within 3 months Quarterly Report Self-assessment gap analysis, risk assessment etc.(as appropriate) to be produced by Lead Clinician within 3 months of publication and sent to CE Department for entry onto database. Progress reports provided to CARE on monthly basis for review. Within 2-3 years Trust SQS Committee Second audit sustainability of compliance Implementation cycle completed 12

13 Equality Analysis (Impact assessment) 1. What is being assessed? Policy on the Dissemination, Implementation and Monitoring of National Clinical Guidance Details of person responsible for completing the assessment: Name: Fiona Smith Position: Head of Integrated Governance Team/service: Clinical Effectiveness State main purpose or aim of the policy, procedure, proposal, strategy or service: (usually the first paragraph of what you are writing. Also include details of legislation, guidance, regulations etc which have shaped or informed the document) This document sets out East Cheshire NHS Trust s policy and procedures for a systematic approach to the consideration, dissemination, implementation and monitoring of agreed best practice as defined in NICE guidelines and national confidential enquiries, to ensure that all clinical recommendations, including those for patient safety, are taken into account in all clinical services. 2. Assessment of Impact RACE: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, racial groups differently? Yes No This policy sets out the Trust procedures for a systematic approach to the consideration, dissemination, implementation and monitoring of agreed best practice as defined in National Clinical Guidelines. If anyone has difficulty understanding the policy, translation can be arranged in accordance with the trust interpreting policy GENDER (INCLUDING TRANSGENDER): From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, different gender groups differently? Yes No This policy sets out the Trust procedures for a systematic approach to the consideration, dissemination, implementation and monitoring of agreed best practice as defined in National Clinical Guidelines. The contents do not discriminate on the grounds of gender (including transgender). DISABILITY From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, disabled people differently? Yes No This policy sets out the Trust procedures for a systematic approach to the consideration, dissemination, implementation and monitoring of agreed best practice as defined in National 13

14 Clinical Guidelines. If anyone has a visual impairment the policy could be provided in large print. AGE: From the evidence available does the policy, procedure, proposal, strategy or service, affect, or have the potential to affect, age groups differently? Yes No National Clinical Guidelines are published relevant to specific topic areas covering both adults and children, e.g. where a guideline is relevant to children a paediatric consultant would be nominated as lead for this set of guidance. LESBIAN, GAY, BISEXUAL: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, lesbian, gay or bisexual groups differently? Yes No This policy is based on agreed best practice - the contents do not discriminate on the grounds of sexuality. RELIGION/BELIEF: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, religious belief groups differently? Yes No This policy is based on agreed best practice - the contents do not discriminate on the grounds of religion/belief. CARERS: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, carers differently? Yes No This policy is based on agreed best practice - the contents do not affect or have the potential to affect carers differently. OTHER: EG Pregnant women, people in civil partnerships, human rights issues. From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect any other groups differently? Yes No This policy is based on agreed best practice - the contents do not affect or have the potential to affect any other groups differently. 3. Safeguarding Assessment - CHILDREN a. Is there a direct or indirect impact upon children? Yes No b. If yes please describe the nature and level of the impact (consideration to be given to all children; children in a specific group or area, or individual children. As well as consideration of impact now or in the future; competing / conflicting impact between different groups of children and young people: c. If no please describe why there is considered to be no impact / significant impact on children National Clinical Guidelines are published relevant to specific topic areas covering both adults and children. Where a guideline is relevant to children a lead will be nominated specific to this area e.g. paediatric consultant. 14

15 4. Relevant consultation Having identified key groups, how have you consulted with them to find out their views and made sure that the policy, procedure, proposal, strategy or service will affect them in the way that you intend? Have you spoken to staff groups, charities, national organisations etc? In-house Groups/Committees 5. Date completed: 13 th June 2017 Review Date: 10 th April Any actions identified: Have you identified any work which you will need to do in the future to ensure that the document has no adverse impact? Action Lead Date to be Achieved 7. Approval At this point, you should forward the template to the Trust Equality and Diversity Lead Approved by Trust Equality and Diversity Lead: Date:

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