Documentation Control IMPLEMENTATION OF NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE) GUIDANCE POLICY Reference CL/CGP/002 Approving Body Trust Board Date Approved 30 Implementation Date 30 Version 8 Summary of Changes from Previous Version Policy updated to reflect latest practice Supersedes NUH version 7 (October 204) Medical Director Director of Finance Consultation Undertaken Divisional Directors Clinical Effectiveness Committee Senior Management Team (SMT) Chief Pharmacist Drugs and Therapeutics Committee Date of Completion of Equality Impact Assessment September 204 (Reviewed January 207) Date of Completion of We Are Here for You Assessment September 204 (Reviewed January 207) Date of Environmental Impact Assessment (if applicable) September 204 (Reviewed January 207) Legal and/or Accreditation Implications NICE, CQC, NHS LA. Target Audience Divisional Management Teams, all Clinical Staff Review Date February 2020 Lead Executive Author/Lead Manager Further Guidance/Information Medical Director Owen Bennett, Head of Patient Safety Extension 7604 Andrew Carden, Clinical Audit & Effectiveness Coordinator Extension 54057
CONTENTS Paragraph Title Page. Introduction 3 2. Executive Summary 4 3. Policy Statement 4 4. Definitions (including Glossary as needed) 4 5. Roles and Responsibilities 5 6. Policy and/or Procedural Requirements 7 7. Training, Implementation and Resources 7 8. Impact Assessments 9 9. Monitoring Matrix 0 0. Relevant Legislation, National Guidance and Associated NUH Documents Appendix Process for the identification, dissemination and performance management of NICE Clinical 2 Guidance at NUH Appendix 2 Implementation of NICE Guideline, Quality Standard or Diagnostic Guidance 3 Appendix 3 Equality Impact Assessment 5 Appendix 4 Environmental Impact Assessment 7 Appendix 5 Here For You Assessment 9 Appendix 6 Certification Of Employee Awareness 2 2
.0 Introduction. NICE produces guidance in a number of areas (see definitions, section 4): Guidelines on the use of new and existing medicines, treatments (Technology Appraisals) and procedures (Interventional Procedures and technologies guidance) within the NHS. Clinical practice guidance, including Quality Standards on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Public Health guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector. For Technology Appraisals, it is a statutory duty for all Trusts to implement the recommendations within three months of issue. The Care Quality Commission (CQC) makes it clear that the primary responsibility for implementing NICE guidance lies with the local NHS; Healthcare organisations should take into account nationally agreed guidance when planning and delivering treatment and care ; this will enable trusts to meet core standards defined by the CQC (Acute Trusts). 2 NICE consider that there is no single model for effective implementation. NICE suggest principles of implementation and require that the organisation s approach to meeting these principles should be stated in an implementation policy. NICE (2005) How to put NICE guidance into practice 2 Care Quality Commission (2009) Core Standards for Acute Trusts 3
2.0 Executive Summary 2. The Trust must be assured that practitioners are competent in the activities that they undertake. As part of this requirement, there is a responsibility to ensure that all clinical practices are safe and effective. In particular they must be in line with published NICE Guidelines, unless a clear rationale (to provide assurance) exists that an alternative guideline is safe and effective. The Trust requires confirmation of the compliance level (defined through a risk based assessment) from each Specialty/Division for all applicable published guidelines. The Specialty/Division has a responsibility to inform the Trust by submission of an Implementation Plan (Appendix 2) of their level of risk based compliance with a published guideline. 3.0 Policy Statement 3. This policy sets out the structures and procedures at Nottingham University Hospitals NHS Trust to ensure NICE guidance is reviewed and where indicated implemented. This includes the identification of associated risk where guidance cannot be fully implemented. 4.0 Definitions 4. Technology Appraisals Technology Appraisals are recommendations on the use of new and existing health technologies. The Secretary of State has directed that the NHS should normally provide funding and resources for medicines and treatments that have been recommended by NICE Technology Appraisals within 3 months of the date of publication. The CQC criteria for assessing core standard (C5a) states that healthcare organisations must ensure that they conform to NICE Technology Appraisals and where it is available, take into account nationally agreed guidance when planning and delivering treatment 4
and care. 4.2 Clinical Guidelines Clinical Guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions. Implementation of Clinical Guidelines forms part of the CQC core standards (C5a) where patients should receive effective treatment and care that conforms to nationally agreed best- practice, particularly as defined by NICE guidance. 4.3 Public Health Guidance Public Health guidance provides guidance on the promotion of good health and prevention of ill health. Implementation of public health guidance will help the organisation demonstrate that it meets core CQC standards (C5a). 4.4 Diagnostic Guidance Diagnostics includes all types of measurements and tests that are used to evaluate a patient's condition, such as physiological measurements, laboratory tests and pathology tests, imaging and endoscopy. 4.5 Quality Standards Quality Standards are markers of Quality Care for various conditions. They demonstrate to the public and patients, health and social care professionals, Commissioners and service providers the standards that should be met to assure satisfactory care. 5.0 Roles and Responsibilities 5. 5.. Committees Clinical Effectiveness Committee (CEC) Reviews the list of Guidelines where NICE has produced guidance for the previous quarter. Escalates risks above 20 to the SMT. 5
5..2 NUH Drugs and Therapeutics Committee Tables medicine related NICE Technology Appraisal Guidelines and Clinical Guidelines for discussion. Highlights NUH issues relating to drugs that are within the NICE recommendations taking into consideration formulary status and position in local Clinical Guidelines, liaising with prescribers and specialists as appropriate. Liaises with the Nottingham Area Prescribing Committee when appropriate regarding the implementation of NICE recommendations affecting both primary and secondary care. Advises Divisional Directors, Directors of Finance and Planning and Commissioners on medicines expenditure trends and the financial implication of anticipated development, including those resulting from NICE guidance, in order to aid planning and prioritisation. 5.2 5.2. Individual Officers Medical Director Has delegated accountability for ensuring implementation of all NICE guidance across the Trust Reports to the Quality Assurance Committee (QuAC). The Medical Director ensures QuAC on a bimonthly basis receives a copy of the CEC minutes outlining any relevant areas of compliance with regard to NICE Guidance. 5.2.2 Divisional Director Responsible for the implementation of relevant NICE guidance at Divisional level. Identifies an appropriate clinician(s) against NICE guidance to be contacted by the NICE coordinator. This is to ensure that a gap analysis is undertaken. Monitors level of compliance against NICE guidance at relevant Governance Groups. Ensures all identified risks are added onto the Divisional Risk Register. 6
5.2.3 Lead Clinician(s) against Guidance (Speciality level) Provides a gap analysis in the form of a risk based compliance assessment against NICE guidance (appendix 2). Where clinical risk is identified as high ( 5), a full Risk Assessment must be completed. Ensures where indicated audit/quality Improvement (QI) activity is registered with the Divisional Clinical Audit Officer. 5.2.4 Head of Clinical Effectiveness Ensures bi-monthly reports of risks associated with NICE guidance are produced by the NICE Coordinator for the CEC. Escalates non registration of Audit to Divisional Directors and to the CEC. Ensures any risks 5 related to NICE guidance are reviewed at CEC and escalated via the Chair of CEC to the SMT. Attends Trust CEC meetings. 5.2.5 NICE Coordinator Identifies new NICE guidance via the NICE website on a monthly basis. Ensures NICE guidance is disseminated to relevant Clinical Divisions via the Divisional Director(s) once a month. Alerts the Head of Clinical Effectiveness to any risks 5. Ensures the relevant Clinical Audit Officers are made aware where an audit against NICE guidance is indicated. Published a monthly summary of NICE Guidance for Speciality and Divisional review (on the intranet). 6.0 Policy and/or Procedural Requirements 6. The structures and process for implementation of NICE guidance at Nottingham University Hospitals is presented as a flowchart in Appendices and 2. 7.0 Training and Implementation 7
7. Training No additional training is required. 7.2 7.2. 7.2.2 7.2.3 7.2.4 7.2.5 Implementation The NICE Co-ordinator will facilitate cross speciality working where the guidance covers more than one speciality. The NICE Co-ordinator will disseminate the NICE Guidance to the relevant Divisions (s) on publication and request an assessment of the current level of compliance / gap analysis (appendix 2). Where a decision is made not to implement NICE guidance this will be documented along with the reason(s) why and a risk assessment completed, (appendix 2). This information will be captured on the Trust NICE portal (NUH Matrix) and reviewed at the CEC. Where full compliance is not achieved the Speciality is responsible for the development of an implementation plan, (using the guidance specific implementation tools available from the NICE website where applicable). This will be submitted to the Specialty Governance Group who will oversee implementation. If non-compliance against guidance cannot be resolved by the Division and the CEC then this will be escalated to the SMT and where necessary the Trust Board (see appendix 2 for the escalation process). The CEC will monitor the implementation and effectiveness of this policy through: Review of progress reports from the NICE portal (NUH Matrix) (via the NICE Coordinator). These will be informed by action plans received from Divisions. Reviewing relevant Patient Safety incidents. Reviewing Clinical Audit results. Reviewing the Trust Risk Register. 8
7.2.6 The Medical Director is responsible for presenting an annual NICE report to QuAC regarding Clinical Effectiveness. This will include performance against the implementation of NICE guidance. 7.2.7 Implementation of Interventional Procedures Guidance Medical Technologies Guidance and 7.2.8 The assessment of compliance with NICE Interventional Procedure Guidance and Medical Technologies Guidance is described within the separate Ensuring Competence for Clinical Procedures Policy (CL/CGP/009). 7.3 Resources No additional resources are required. 8.0 Trust Impact Assessments 8. Equality Impact Assessment An equality impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.2 Environmental Impact Assessment An environmental impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.3 Here For You Assessment A Here For You assessment has been undertaken on this document and has not indicated that any additional considerations are necessary. 9
9.0 Policy / Procedure Monitoring Matrix Minimum requirement to be monitored Responsible individual/ group/ committee Process for monitoring e.g. audit Frequency of monitoring Responsible individual/ group/ committee for review of results Responsible individual/ group/ committee for development of action plan Responsible individual/ group/ committee for monitoring of action plan NICE-Ensuring compliance with NICE guidelines to Clinical Procedures and Medical Technologies Procedure Lead for Clinical Effectiveness (Clinical Quality, Risk and Safety Manager) Reports to CEC Formal bimonthly review Monitoring bimonthly via CEC Various Divisional Governance Forums / CEC bimonthly/nice group 0
0.0 Relevant Legislation, National Guidance and Associated NUH Documents 0. Care Quality Commission (2009) Core Standards for Acute Trusts. Available online at http://www.cqc.org.uk NICE (2005) How to put NICE guidance into practice. Available online at http://www.nice.org.uk/usingguidance
Appendix : Process for the identification, dissemination and performance management of NICE Clinical Guidance at NUH NICE Coordinator identifies new guidance via NICE web site on the first Wednesday in the month If relevant to NUH: NICE Coordinator emails Divisional Director (DD) DD makes request to a Lead Clinician to review compliance against guidance NICE Coordinator Contacts Lead Clinician by email requesting assessment of compliance using standard template (appendix 2), giving 3 month deadline ASSESSMENT OF COMPLIANCE (GAP ANALYSIS) MADE BY LEAD CLINICIAN LOW RISK 9 MEDIUM RISK (0-4) HIGH RISK ( 5) NO REPLY FROM LEAD CLINICIAN NOT APPLICABLE NICE Coordinator updates NUH Matrix Risk Assessment, reviewed at Divisional Level Risk reviewed / confirmed at Divisional Governance Fora No reply after month - follow up email to lead clinician If guidance is not applicable, record maintained on NUH Matrix Risk ( 5) reviewed at CEC ( 20 escalated to SMT) No reply after 2 months - follow up email copied into: Head of Effectiveness DD for action Clinical Effectiveness Committee Receives written compliance report from Clinical Effectiveness Unit. Where implementation of guidance has not been responded to or remains medium or high risk after intervention from the chair of CEC (MD) the chair escalates to SMT. Any risk scores 20 or above escalated to SMT automatically. No reply after 3 months Report to CEC 2
Appendix 2: Implementation of NICE Guideline, Quality Standard or Diagnostic Guidance 3
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Appendix 3: Equality Impact Assessment (EQIA) Form Q. Date of Assessment: Q2. For the policy and its implementation answer the questions a c below against each characteristic (if relevant consider breaking the policy or implementation down into areas) Protected Characteristic a) Using data and supporting information, what issues, needs or barriers could the protected characteristic groups experience? i.e. are there any known health inequality or access issues to consider? The area of policy or its implementation being assessed: b) What is already in place in the policy or its implementation to address any inequalities or barriers to access including under representation at clinics, screening c) Please state any barriers that still need to be addressed and any proposed actions to eliminate inequality Race and N/A N/A N/A Ethnicity Gender N/A N/A N/A Age N/A N/A N/A Religion N/A N/A N/A Disability N/A N/A N/A Sexuality N/A N/A N/A Pregnancy and Maternity N/A N/A N/A 5
Gender N/A N/A N/A Reassignment Marriage and N/A N/A N/A Civil Partnership Socio-Economic N/A N/A N/A Factors (i.e. living in a poorer neighbour hood / social deprivation) Area of service/strategy/function Q3. What consultation with protected characteristic groups inc. patient groups have you carried out? Q4. What data or information did you use in support of this EQIA? Q.5 As far as you are aware are there any Human Rights issues be taken into account such as arising from surveys, questionnaires, comments, concerns, complaints or compliments? Q.6 What future actions needed to be undertaken to meet the needs and overcome barriers of the groups identified or to create confidence that the policy and its implementation is not discriminating against any groups What By Whom By When Resources required Q7. Review date 6
Appendix 4: Environmental Impact Assessment The purpose of an environmental impact assessment is to identify the environmental impact of policies, assess the significance of the consequences and, if required, reduce and mitigate the effect by either, a) amend the policy b) implement mitigating actions. Area of impact Waste and materials Soil/Land Water Air Environmental Risk/Impacts to consider Is the policy encouraging using more materials/supplies? Is the policy likely to increase the waste produced? Does the policy fail to utilise opportunities for introduction/replacement of materials that can be recycled? Is the policy likely to promote the use of substances dangerous to the land if released (e.g. lubricants, liquid chemicals) Does the policy fail to consider the need to provide adequate containment for these substances? (e.g. bunded containers, etc.) Is the policy likely to result in an increase of water usage? (estimate quantities) Is the policy likely to result in water being polluted? (e.g. dangerous chemicals being introduced in the water) Does the policy fail to include a mitigating procedure? (e.g. modify procedure to prevent water from being polluted; polluted water containment for adequate disposal) Is the policy likely to result in the introduction of procedures and equipment with resulting emissions to air? (e.g. use of a furnaces; combustion of fuels, emission or particles to the atmosphere, etc.) Does the policy fail to include a procedure to mitigate the effects? Does the policy fail to require compliance with the limits of emission imposed by the relevant regulations? Action Taken (where necessary) N/A No No No 7
Energy Nuisances Does the policy result in an increase in energy consumption levels in the Trust? (estimate quantities) Would the policy result in the creation of nuisances such as noise or odour (for staff, patients, visitors, neighbours and other relevant stakeholders)? No No 8
Appendix 5: We Are Here For You Policy and Trust-wide Procedure Compliance Toolkit The We Are Here For You service standards have been developed together with more than,000 staff and patients. They can help us to be more consistent in what we do and say to help people to feel cared for, safe and confident in their treatment. The standards apply to how we behave not only with patients and visitors, but with all of our colleagues too. They apply to all of us, every day, in everything that we do. Therefore, their inclusion in Policies and Trust-wide Procedures is essential to embed them in our organisation. Please rate each value from - 3 ( being not at all, 2 being affected and 3 being very affected) Value Score (-3). Polite and Respectful Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people s individuality, privacy and dignity. 2. Communicate and Listen We take the time to listen, asking open questions, to hear what people say; and keep people informed of what s happening; providing smooth handovers. 3. Helpful and Kind All of us keep our eyes open for (and don t avoid ) people who need help; we take ownership of delivering the help and can be relied on. 4. Vigilant (patients are safe) Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates attention to detail for a clean and tidy environment everywhere. 5. On Stage (patients feel safe) We imagine anywhere that patients could see or hear us as a stage. Whenever we are on stage we look and behave professionally, acting as an ambassador for the Trust, so patients, families and 9
carers feel safe, and are never unduly worried. 6. Speak Up (patients stay safe) We are confident to speak up if colleagues don t meet these standards, we are appreciative when they do, and are open to positive challenge by colleagues 7. Informative We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues. 8. Timely We appreciate that other people s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital. 9. Compassionate We understand the important role that patients and family s feelings play in helping them feel better. We are considerate of patients pain, and compassionate, gentle and reassuring with patients and colleagues. 0. Accountable Take responsibility for our own actions and results. Best Use of Time and Resources Simplify processes and eliminate waste, while improving quality 2. Improve Our best gets better. Working in teams to innovate and to solve patient frustrations TOTAL 2 20
Appendix 6: CERTIFICATION OF EMPLOYEE AWARENESS Document Title Implementation of National Institute for Health and Clinical Excellence (NICE) Guidance Policy Version (number) 8 Version (date) 30 I hereby certify that I have: Identified (by reference to the document control sheet of the above policy/ procedure) the staff groups within my area of responsibility to whom this policy / procedure applies. Made arrangements to ensure that such members of staff have the opportunity to be aware of the existence of this document and have the means to access, read and understand it. Signature Print name Date Division / Directorate The manager completing this certification should retain it for audit and/or other purposes for a period of six years (even if subsequent versions of the document are implemented). The suggested level of certification is; Clinical Divisions Divisional General Manager or nominated deputy Corporate Directorates - Deputy Director or equivalent. The manager may, at their discretion, also require that subordinate levels of their Division / department utilise this form in a similar way, but this would always be an additional (not replacement) action. 2