Clinical Excellence (NICE) Guidance VELINDRE NHS TRUST Trust Procedure Black 21 PROCEDURE FOR THE IMPLEMENTATION OF NATIONAL INSTITUTE OF HEALTH & CLINICAL EXCELLENCE (NICE) GUIDANCE Lead: Lisa Heydon-Mann Quality & Safety Manager Ref: Black 21 Page 1 of 14
Clinical Excellence (NICE) Guidance EXECUTIVE SUMMARY Overview: Trust Procedure for the Dissemination of NICE Guidance This Procedure ensures the Trust has a robust system for recording receipt, distribution and implementation of National Institute of Health & Clinical Excellence (NICE) Guidance. Who is the policy intended for: Key Messages included within the policy: Velindre NHS Trust and hosted organisations NICE guidance is developed using the expertise of the NHS and the wider healthcare community including NHS staff, healthcare professionals, patients and carers, industry and the academic world. NICE produces guidance on public health, health technologies and clinical practice. For the purposes of this Procedure Guidance incorporates: Technology Appraisals. Clinical Guidelines Interventional Procedures Public Health Intervention Guidance All Wales Medicines Strategy Group As part of this procedure it is also necessary to ensure that there is a process in place for assessing any associated costs of the Guidance. Implementation plans will need to be developed by the Service Divisions. PLEASE NOTE THIS IS ONLY A SUMMARY OF THE PROCEDURE AND SHOULD BE READ IN CONJUNCTION WITH THE FULL DOCUMENT. Ref: Black 21 Page 2 of 14
Clinical Excellence (NICE) Guidance Contents 1. Introduction Page 3 2. Background Page 3 3. Scope Page 5 4. Duties Page 5 5. Dissemination Page 7 6. Appendices Page 9 Appendix 1 - NICE Guidance Dissemination Flow Chart Appendix 2 - Circulation of NICE Guidance Form Medical Director Appendix 3 - Circulation of NICE Guidance Form Divisional Director Page 10 Page 11 Page 12 Appendix 4 Implementation of NICE Guidance Page 13 Ref: Black 21 Page 3 of 14
1. Introduction The National Institute for Health and Clinical Excellence (NICE) was originally established in April 1999 to promote clinical excellence and the effective use of resources in the health service in England and Wales. Following the Arms Length Bodies Review undertaken by the Department of Health in 2004, NICE merged with the former English Health Development Agency to become the National Institute for Health and Clinical Excellence (also to be known as NICE), and was re-established on 1 April 2005 as an England only Special Health Authority. The Welsh Government has an agreement in place with NICE covering the Institute's technology appraisals, clinical guidelines and interventional procedure guidance, which all continue to apply in Wales. Guidance being developed, and published by NICE can be found by accessing NICE work programme The All Wales Medicines Strategy Group (AWMSG) was formed using powers in section 2 of and Schedule 14 to the National Health Service (Wales) Act 2006. The aim of the Strategy group is to provide advice in an effective, efficient and transparent manner to the Assembly on strategic medicines management and prescribing. 2. Background NICE procedures guidance in three areas of health: 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. Health Technologies guidance on the use of new and existing medicines, treatments and procedures within the NHS. Clinical Practice guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Doing Well, Doing Better: Standards for Health Services in Wales, the health standards for Wales, set out the Welsh Government's common framework of standards to support the NHS and partner organisations in providing effective, timely and quality services across all healthcare settings. Ref: Black 21 Page 4 of 14
Standard 7 requires organisations and services to ensure that patients and service users are provided with safe, effective treatment and care that is based on agreed best practice and guidelines, including those defined in NICE guidance. For the purposes of this Procedure Guidance incorporate: 2.1 Definitions Technology Appraisals Clinical Guidelines Interventional Procedures Public Health Intervention Guidance All Wales Medicines Strategy Group Guidance Technology Appraisal Guidance Technology Appraisal guidance issued by NICE is subject to a funding direction issued by the Welsh Government s Minister for Health and Social Services. This places a statutory obligation on Local Health Boards and NHS Trusts in Wales to make available health technologies recommended by NICE within three months of the date of publication, unless otherwise instructed by the Welsh Government. Clinical Guidelines Although clinical guidelines issued by the Institute are not subject to the Assembly's three months funding Direction, the Welsh Government expects NHS bodies in Wales to take full account of the recommendations made by the Institute when commissioning and delivering services Clinical Guidelines and Public Health Guidelines should be implemented within Trust s current resources as no additional funding is made available. No specific timescale for implementation is set, since they often involve changes that may take a number of years to implement. Once NICE publishes clinical guidance, health professionals and the organisations that employ them are expected to take it fully into account when deciding what treatments to give people. However, NICE guidance does not replace the knowledge and skills of individual health professionals who treat service users; it is still up to them to make decisions about a particular service in consultation with the service user and/or their guardian or carer as appropriate. Interventional Procedures These contain recommendations about whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use. Ref: Black 21 Page 5 of 14
NICE defines interventional procedures as: Making a cut or hole to gain access to the inside of a patient s body for example, when carrying out an operation or inserting a tube into a blood vessel. Gaining access to a body cavity (such as the digestive system. Lungs, womb or bladder) without cutting into the body for example examining or carrying out treatment on the inside of the stomach using an instrument inserted via the mouth. Using electromagnetic radiation (which includes X-rays, lasers, gamma rays and ultraviolet light) for example, using a laser to treat eye problems. Public Health Guidance Public Health Guidance deals with broader activities for promoting good health and preventing ill health. This guidance may focus on a topic, particular population or a particular setting. All Wales Medicines Strategy Group Guidance As part of their remit, the Group is responsible for developing timely, independent and authoritative advice on new drugs and on the cost implications of making these drugs routinely available on the NHS. (This would include making interim recommendations on the place in treatment of drugs awaiting appraisal by the National Institute for Clinical Excellence (NICE). 3. Scope This policy details the responsibility of staff within Velindre NHS Trust and a hosted organisation confers responsibilities on individual clinicians and managers. 4. Duties Trust Board (and delegated responsibility to Quality & Safety Committee) The Board has accountability for ensuring Trust compliance with NICE guidance; including considering and approving any decision NOT to implement NICE guidance. The Quality & Safety Committee has delegated responsibility for providing assurance to the Board via the Trust Executive Leads on the Trusts arrangements for effectively managing NICE compliance. Director of Nursing and Medical Director The Director of Nursing and Medical Director are the Executive Leads for the management of NICE Guidance. The Medical Director is also responsible for assessing applicability of the guidance. Ref: Black 21 Page 6 of 14
Quality & Safety Manager The Trust Quality & Safety Manager through the Quality & Safety department will facilitate the process for monitoring the implementation of NICE guidance including the disseminating new guidance, tracking baseline assessments, reporting compliance by:- Disseminating guidance across the Trust. Preparing quarterly assurance reports for the Quality & Safety Committee. Maintaining and updating a database of applicable NICE guidance. Linking with the Divisional Coordinators/Leads. Quality & Safety Committee The Quality & Safety Committee has the responsibility to ensure the NICE Implementation Procedure is fully implemented through: Receiving and reviewing summary information and key performance indicators reports on a quarterly basis. Monitoring the Trust compliance with NICE guidance and risk status. Ensuring the overall effectiveness of the process for managing NICE guidance are robust and effective. Service Directors (Trust and Hosted organisations) The Service Director will ensure the implementation of a robust process for NICE guidance. This includes notifying the Trust Quality & Safety Committee of any implementation risks identified as part of the quarterly reporting mechanism to the Trust Quality & Safety Committee. A lead clinician will be identified to support the Service Director in performing this function. The Service Division will Evaluate the current situation against the Guidance Consider completed baseline assessments for their area of responsibility. Ensure an impact assessment is completed identifying any risks involved in implementing/ not implementing the guidance. Impact assessments should be undertaken with the appropriate staff and consider all areas of the workplace and activities likely to be affected by the guidance. (Refer to Velindre Policy on Prescribing Unlicensed Medicines for a suggested toolkit). Ensure that the Finance Department is aware of the Guidance and is involved in assessing costs, if any, associated with the Guidance and any other financial implications there will be. Additionally, to confirm any costs already identified as part of the forward planning process Hold responsibility for developing business cases if a resources implication is identified and escalating to the Quality &Safety Committee if appropriate. Develop an action plan required to achieve the standard set out in the Guidance. Ref: Black 21 Page 7 of 14
Retains overall responsibilities for compliance with NICE guidance for their service area Consult appropriately with all key stakeholders and partner organisations. Director of Finance Ensure resource implications of NICE implementation are factored into the Trusts annual business planning procedures and taken into account in negotiations. Head of Pharmacy Participate in NICE assessments, during business planning and implementation stages and also has a responsibility for notifying Drugs & Therapeutics Committee of required formulary additions. All Clinicians Individual Clinicians are responsible for ensuring that they: Are aware of guidance which is relevant to their area of work Read and comply with disseminated NICE Guidance including supporting the review, implementation and monitoring phases of the policy. Address any training needs identified with the education and Workforce Development department. Raise any queries about implementation with the lead clinician and/or nominated Guidance lead. Once NICE guidance is published, health professional are expected to take it fully into account when exercising their clinical judgement. However, NICE guidance neither does nor overrides the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian/carer. (http://www.nice.org.uk/page.aspx?o=206924) 5. Process for Disseminating and Implementing NICE Guidance Receipt of Guidance Guidance is received from NICE/AWMSG via the Chief Executive and circulated to the Quality & Safety Manager. The Guidance is then disseminated by Quality & Safety department to the Medical Director who will assess its relevance to the Trust (see Appendix 1 flow chart of dissemination). The Medical Director will complete the form at Appendix 2 and return it to the Q&S department for action and filing within 5 working days of receipt. The Q&S department will disseminate the Guidance to the relevant Divisional Director for action. The Divisional Director will complete part 1 and 2 of the form at Ref: Black 21 Page 8 of 14
Appendix 3 and forward it to the identified Site Specific/Service Lead within the organisation. Assessment The Lead Clinician and Service Directors are responsible for ensuring that the service reviews its compliance with NICE guidance and submits a statement (Appendix 3) reflecting the initial understanding of local compliance to the Quality &Safety Department within 8 weeks of receipt of guidance. The Drugs and Therapeutic Committee will support the implementation of NICE Technology Appraisals for medicines and NICE guidelines where medicines are a significant feature. Implementation The service will then undertake a gap analysis of the recommendations against current practice and complete an action plan which should be submitted to the relevant Service groups within 3 months of receipt of guidance. Where the service is not compliant with NICE guidance the service should assess the risk using the Trust standard scoring risk matrix and consider it for inclusion in departmental and/or service risk registers. The action plan should include as a minimum: Actions required to implement the recommendations Any additional resources required for all affected departments Names of people responsible for implementing the action plan. Date by which the action plan will be implemented. Any barriers to implementation that cannot be resolved by the speciality. The nominated speciality lead will send a copy of the completed action plan to an identified local Coordinator. Gap Analysis Service Divisions will have a robust process in place to consider baseline assessments and recommendations either not to implement or action required to ensure compliance with the guidance. The Service Division will produce an action plan of work that is required to fully meet the requirements of the guidance issued. Where resource implications are identified, or decisions not to implement are made, the Service Director will be responsible for escalating issues of guidance to the Quality & Safety Committee for consideration and approval. Monitoring Reports will be provided on a quarterly basis to the Quality & Safety Committee providing assurance of compliance to the guidance. Ref: Black 21 Page 9 of 14
The Service Division will monitor local implementation, compliance and effectiveness of the process to manage NICE guidance. 6. Appendices Appendix 1 NICE Guidance Dissemination Flow Chart Appendix 2 Circulation of NICE Guidance Form Medical Director Appendix 3 Circulation of NICE Guidance Form Divisional Director Appendix 4 Implementation of NICE Guidance Ref: Black 21 Page 10 of 14
Appendix 1 NICE Guidance Dissemination Flow Chart NICE Guidance Chief Executive Quality & Safety Department Medical Director Quality & Safety Department Director Velindre Cancer Services Director Hosted Organisation Director Welsh Blood Service Divisional Lead/Clinical Site Specialist Divisional Lead Ref: Black 21 Page 11 of 14
Appendix 2 Circulation of NICE Guidance Form Medical Director Title of Nice Guidance/Guidelines/ Appraisals/ Interventions/AWMS Guidance: Date Received: Medical Director to complete this section and return within 5 working days Trust Implications: Yes No Please provide reasons for your assessment: Divisional Director Responsible: Medical Director Signature: Date: Form to be returned to: Quality & Safety Department Chief Executive Offices Trust Headquarters 2 Charnwood Court Parc Nantgarw Cardiff CF15 7QZ Ref: Black 21 Page 12 of 14
Appendix Three Circulation of NICE Guidance Form Divisional Director Title of Guidance: Date Received: Director to complete this section and forward to Service Lead Responsibility for co-ordinating and reporting on implementation (name): Director Signature & Date: Site Specific/Service Lead to complete this section and forward to Divisional Director (and Clinical Change Facilitator for VCC cases) Please provide overview of implementation: Date of Discussion: Relevant Group/Staff: Outcome of discussion: Resource implication identified and notified: Proposed audit details: (continue overleaf) Form to be returned to: (1) Divisional Director (2) Clinical Audit Facilitator (VCC only) (3) Clinical Change Facilitator (VCC only) Ref: Black 21 Page 13 of 14
Implementation of NICE Guidance Appendix 4 Title of Guidance: Date Received: Responsibility for co-ordinating and reporting on implementation (name): Division: Please provide overview of implementation: Audit details: Ref: Black 21 Page 14 of 14