POLICY ON THE IMPLEMENTATION OF NICE GUID ANCE

POLICY ON THE IMPLEMENTATION OF NICE GUID ANCE Document Type Corporate Policy Unique Identifier CO-019 Document Purpose To outline the process for the implementation and compliance with NICE guidance and to set out the responsibilities of staff involved in the implementation of NICE guidance within Worcestershire Health and Care NHS Trust Document Author Renata Bozikovova (Quality & Safety Coordinator) and Sam Whitby (Audit, Research and Clinical Manager) Target Audience All staff in Worcestershire Health and Care NHS Trust. Responsible Group Quality and Safety Committee Date Ratified March 2014 Expiry Date March 2017 This validity of this policy is only assured when viewed via the Worcestershire Health and Care NHS Trust website (hacw.nhs.uk.). If this document is printed into hard copy or saved to another location, its validity must be checked against the unique identifier number on the internet version. The internet version is the definitive version. If you would like this document in other languages or formats (i.e. large print), please contact the Communications Team on 01905 760020 or email communications@hacw.nhs.uk

Version History Version Circulation Date Job Title of Person/Name of Group circulated to 01 28/02/2014 Clinical Audit and Group Quality and Safety Committee Brief Summary of Change Accessibility Worcestershire Health and Care NHS Trust has a contract with Applied Language Solutions to handle all interpreting and translation needs. This service is available to all staff in the trust via a free-phone number (0800 084 2003). Interpreters and translators are available for over 150 languages. From this number staff can arrange: Face to face interpreting Instant telephone interpreting Document translation British Sign Language interpreting Training and Development Worcestershire Health and Care NHS Trust recognises the importance of ensuring that its workforce has every opportunity to access relevant training. The Trust is committed to the provision of training and development opportunities that are in support of service needs and meet responsibilities for the provision of mandatory and statutory training. All staff employed by the Trust are required to attend the mandatory and statutory training that is relevant to their role and to ensure they meet their own continuous professional development needs. 2

Contents 1. INTRODUCTION... 4 2. PURPOSE... 4 3. SCOPE... 4 4. DEFINITIONS... 4 5. DUTIES... 5-6 6. REPORTING... 7 7. IMPLEMENTATION... 7-10 8. MONITORING IMPLEMENTATION... 11 9. QUALITY INDICATOR... 12 10. EQUALITY IMPACT ASSESSMENT... 12 11. REFERENCES... 12 APPENDIX 1 RANKING TOOL TEMPLATE... 13 APPENDIX 2 RISK ASSESSMENT TEMPLATE... 14-15 APPENDIX 3 ACTION PLAN TEMPLATE... 16 APPENDIX 4 IMPLEMENTATION PROCESS FLOWCHART... 17 3

1. Introduction This policy aims to outline the Worcestershire Health and Care NHS Trust s (WH&CT) processes for the implementation and compliance with National Institute for Health and Clinical Excellence NICE guidance, which should result in clear benefits for patients ensuring that the care provided is both clinically and cost effective. This policy also enables the Trust to comply with the standards set by the Care Quality Commission and NHS Litigation Authority. The process also supports the Trust s Quality framework and provides assurance to the Trust Board. The Trust is required to comply with all of its statutory obligations to meet the funding implications of the recommendations of all NICE Technology Appraisal Guidelines (TAG) within three months of the date of issue: unless where specifically exempted. Purpose The purpose of this policy is to ensure that the Trust has a robust mechanism in place for the dissemination, implementation, monitoring and audit of NICE guidance. This will ensure that: Patients are able to experience the most up-to-date clinically and cost effective care Patients are able to experience equity via the consistent application of the appropriate NICE guidance The trust complies with the requirements for its registration with the CQC. 2. Scope The policy outlines the process of implementation for all types of NICE guidance. Implementation of relevant guidance is to be supported by all healthcare professionals. 3. Definitions National Institute for Health and Clinical Excellence (NICE) NICE is an independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health www.nice.org.uk 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. Clinical Guidelines Clinical guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions. Interventional Procedures NICE Interventional Procedures guidance provides advice on the safety and the efficacy of new interventional procedures. These may be procedures approved for normal use, procedures which should not be used and those which may be used with certain safeguards. 4

Medical Technologies Guidance Medical technologies guidance is designed to help the NHS adopt efficient and cost effective medical devices and diagnostics more rapidly and consistently. The types of products which might 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. Public Health Guidance Public Health guidance provides guidance on the promotion of good health and prevention of ill health. Diagnostic Technologies Guidance Diagnostic Technologies Guidance is designed to help the NHS adopt efficient and cost effective medical diagnostic technologies more rapidly and consistently. Patient Safety Guidance Patient Safety Guidance provides advice on patient safety solutions. Quality Standards NICE Quality Standards are markers of Quality Care for a variety of conditions. They demonstrate to the public and to patients, as well as health and social care professionals, commissioners and service providers the standards that should be met to assure satisfactory care. NICE Evidence Service NHS Evidence https://www.evidence.nhs.uk/ is a web-based search engine which allows NHS and public health sector staff to access clinical and non-clinical evidence which has been independently accredited. It encompasses national, international and local evidence sources and incorporates all National Library for Health sources it has four distinct categories: o o o o Clinical Knowledge Summaries Journals and Databases Evidence Search Evidence Uncertainties (UK DUETs) NHS Litigation Authority (NHSLA) Part of the NHS responsible for handling negligence claims made against NHS bodies in England www.nhsla.org.uk The NHS Litigation Authority (NHSLA) requirements indicate that each trust must have an approved documented process for ensuring that agreed best practice as defined in NICE clinical guidelines, is taken into account in the context of the clinical services provided by the organisation, and that it is implemented and monitored. Care Quality Commission (CQC) The Care Quality Commission (CQC) is an independent regulator of health and social care in England www.cqc.org.uk. CQC makes it clear that the primary responsibility for implementing NICE guidance lies with the local NHS. Outcome 4 states that: Healthcare organisations should reduce the risk of people receiving unsafe or inappropriate care, treatment and support by taking account of published research and guidance. 4. Duties 5.1 Senior Management Team (Directors) has responsibility for overseeing systems and processes for Clinical Quality. The Senior Management Team and Trust Board hold responsibility for the signing off the Trust s Quality Accounts, the annual declaration to the Care 5

Quality Commission (CQC), and the provision of information to Commissioners about the quality of care provided by the trust. The Chief Executive has overall responsibility for the quality of service delivery across the Trust. 5.2 Service Delivery Unit Leads and Clinical Directors (SDU) have overall responsibility for compliance with relevant NICE guidance within their own SDU, and should ensure that there are appropriate systems in place to cascade information pertaining to NICE within their SDU. 5.3 Deputy Medical Director chairs the Clinical Audit and Group and provides expert advice on the implementation of all NICE guidance across the organisation, and ensures that where areas of non-compliance are identified, these are then performance managed by the relevant SDUs and that these are reported to the Quality and Safety Committee via the Clinical Audit & Group s bi-annual report. 5.4 Clinical Audit and Group (CAEG) is a Trust-wide multi-disciplinary group (with representatives from all SDUs) which meets on a quarterly basis and reports to the Quality and Safety Committee. The group s remit is to ensure there are systems and processes in place to provide the Board with assurance around NICE guidance implementation within the Trust. The nominated members of the group will also provide a filtering and signposting of newly published guidance function, on a monthly cycle, via an email group. 5.5 Quality/Governance Leads or equivalent individual(s) with responsibility for quality and safety governance review newly published guidance on a monthly basis. They then nominate a suitable clinical lead (referred to as the nominated Clinical Lead) for every piece of guidance applicable to their individual SDU. They work in collaboration with the nominated Clinical Lead, and provide input into the development of any action plan. They then monitor the implementation of the action plans and inform the Q&S Co-ordinator on progress, delays or any problems. 5.6 Nominated Clinical Leads** have responsibility for undertaking a NICE compliance assessment for each piece of NICE guidance that is relevant to their service/sdu, that they have been nominated to complete. The nominated Clinical Leads are also responsible for the formulation of robust action plans to address any areas of partial or non-compliance and for sharing these with their SDU Lead and all affected staff in that area. Where declarations of partial or non-compliance are made, the nominated Clinical Lead in conjunction with the Quality/Governance Lead will ensure a risk assessment is undertaken and escalated to the Clinical Director(s) and SDU Lead for their consideration of placement of relevant risks on the SDU s risk register. The nominated Clinical Lead will then report this back to the Q&S Coordinator for recording. **The nominated Clinical Lead will be the most suitably experienced professional e.g. doctor, nurse, OT, psychologist etc. 5.7 All staff involved in the assessment and care of patients are responsible for ensuring that they are cognisant with all of the latest published guidance and for ensuring that they take any recommendations contained in the guidance fully into account when deciding what services, treatments or advice to offer to patients. 5.8 Clinical Audit and Manager/ Quality and Safety Co-ordinator have responsibility for managing the processes for NICE guidance implementation. This includes the dissemination of new guidance within the Trust, circulating the NICE compliance assessments to the nominated Clinical Leads, monitoring the progress with completion of the assessments and action plans, providing advice with regard to ranking and risk assessing guidance and maintaining the Trust s compliance database, known as the NICE tracker. 6

6. Reporting 6.1 Clinical Audit and Group (CAEG) receives quarterly reports from the Quality and Safety Co-ordinator on: the progress made with regards to the implementation of relevant NICE guidance within each individual SDU the current levels of compliance and assurance across the trust any risks arising from non or only partial compliance with NICE guidance the monthly Quality Indicator figure 6.2 Quality and Safety Committee receives an overview reports containing the above from the Clinical Audit and Group on a bi-annual basis. 6.3 Finance and Performance Group receives a monthly summary report from the Quality and Safety Co-ordinator on: the progress made with regards to the implementation of relevant NICE guidance within each individual SDU the current levels of compliance and assurance across the trust any risks arising from non or only partial compliance with NICE guidance the monthly Quality Indicator figure 7. Implementation 7.1 Process for implementation of NICE guidance The Quality and Safety Co-ordinator sends out, in electronic format, all new NICE clinical guidelines (and other types of newly published guidance are also circulated for information) to the Deputy Medical Director and to the nominated representatives in each SDU (E.g. Quality or Governance Leads) to ascertain whether any of the clinical guidelines are of relevance to their services or not. The nominated representatives from each SDU then need to inform the Q&S Co-ordinator whether any of the clinical guidelines are relevant or not. If the guidance is relevant, the Q&S Co-ordinator then forwards the relevant guidance and the blank NICE compliance assessment to the nominated representative, so that they can co-ordinate the response. Within one month of receipt, the SDUs are required to rank all of the new relevant guidance for priority, using the ranking tool in the Table 1 below. It is recommended that the ranking process is undertaken by a minimum of three people to include the Quality Lead or their equivalent, clinical lead in the particular area of NICE guidance and the Q&S Co-ordinator. Table 1: Ranking tool Criteria High cost (treatment costs) High volume (amount of patients) High risk Evidence of a quality problem (incidents, complaints etc.) Not relevant (0) Limited relevance (1) Moderate relevance (2) Fully relevant (3) Score 7

Wide variation in practice Likely to improve healthcare outcomes as well as process improvements Likely to have economic and efficiency benefits Topic is a key professional or clinical interest Reliable sources of data readily available Potential for change Multidisciplinary project Interface project (Health Economy) Cost Improvement Programme Total score Table 2 lays out how scoring translates into relevance and priority for the service, and indicates the timeframe within which the base line compliance assessment should be completed, including action planning and audit. Table 2: Scoring key Score Relevance/priority Assessment timeframe 1-17 Limited relevance/ Low priority Consider not reviewing and place on Risk Register 18-34 Moderate relevance/ Medium priority within 6 months 35-51 Fully relevant/ High priority within 3 months Any guidance not ranked for prioritisation within 1 month of the SDU receiving the guidance is flagged red in the priority level column in Table 3 below, because it automatically becomes a high priority and therefore a high risk, if its importance to the service/trust is not known. It will therefore be reported with only level 1 assurance guidance circulated to Quality Leads. As mentioned above, every piece of ranked guidance needs to have a base line assessment completed in line with the timeframe associated with each priority level (see Table 2 above). For instance, a medium/moderate priority guideline would need to be assessed within 6 months and within 3 months if the guidance is rated a high priority for the service/trust. Therefore, if the guidance has been ranked as a high priority (see CGii in Table 4 below) but no baseline compliance assessment has been completed within the specified timeframe, then it will be reported with level 2 assurance only guidance has been ranked for priority, and it will be recorded as a high risk in the risk column. When there is a piece of guidance (example CGiii in Table 4 below) where the baseline compliance assessment has been completed and the level of compliance with that guidance has been established but no action plan has been agreed that would bring the service to compliance, then it will be reported with level 3 assurance compliance assessment 8

undertaken and level of compliance known. Again, Table 4 illustrates the different levels of risk associated with different priorities of guidance. As the level of scrutiny increases the level of risk reduces; the pyramid below is another way of showing this. Levels of scrutiny vs. levels of risk The gold standard to aim for is to be reporting level 5 assurance service is compliant with guidance as verified by clinical audit for all guidelines. Where guidance is ranked as a low priority for the service, it can be omitted from the baseline assessment. This is in response to the limited capacity within SDUs to review all NICE guidance. The non-assessed guidance would then be added to the relevant SDU Risk Register. This would then be monitored in light of any service changes which may result in the guidance becoming more relevant and hence a higher priority for the organisation. All low priority level guidance will be assessed by the Clinical Directors at regular intervals. Table 3: Levels of scrutiny Level of scrutiny Definition of level of scrutiny 1 Guidance circulated to Quality Leads 2 Guidance has been ranked for priority 3 Compliance assessment undertaken and level of compliance known 4 Action plan in place to deliver compliance 5 Service compliant with guidance as verified by clinical audit 9

Table 4: Reporting matrix Priority level Level of assurance Adjusted NICE Full Significant Moderate Limited No level of guidance (Level 5) (Level 4) (Level 3) (Level 2) (Level 1) risk CG i? High CG ii CG iii CG iv CG v Medium High High High Medium Medium High Medium Medium Low High Low Medium Low High Low When a newly published item of NICE guidance crosses several services and/or SDUs, it is strongly recommended that all interested parties form a small working group to address any issues arising from the NICE guidance recommendations, and to work jointly so that a unified Trust response can be given. All completed baseline compliance assessments should be reviewed and formally signed off by each SDU before they are submitted to the Q&S Co-ordinator. As best practice, it is suggested that a baseline audit of a small number of cases is undertaken to help inform the compliance assessment. Although, the individual SDU s are responsible for organising their own baseline audits, advice and support is available from the Quality and Safety Team. The Quality/Governance Lead ensures that any potential risks associated with the decision not to implement guidance have been considered and where applicable, added to the SDU risk register. The Quality Lead then notifies the Q&S Co-ordinator that this has been carried out, giving details of specific risks. The Quality/Governance Lead approves the action plans and monitors the implementation of the guidance and updates the Q&S Co-ordinator at regular intervals about the progress of implementation. The Quality/Governance Lead also informs the Q&S Co-ordinator if there are any delays or problems with the implementation of the guidance. All implementation timescales and progress are being recorded on the NICE tracker, which is managed by the Quality and Safety Team. All NICE guidance should be prioritised for clinical audit and placed on the three year rolling SDU clinical audit programme. Risk assessment framework A risk assessment template has been developed to record the risks associated with not implementing the relevant NICE recommendations. Any identified risk can then be described and a risk score attributed to it, and an agreed action added to show how that risk will be mitigated. 8. Monitoring the implementation of this policy The implementation of this policy will be monitored bi-annually through CAEG, which in return reports to QSC and the trust Board. The progress against the recommendations of all reports will be included in the Trust-wide Quality report. 10

The following matrix table illustrates how monitoring will be achieved: NHSLA Criteria Lead Monitoring Frequency Committee The sections below will contain all the requirements of the NHSLA risk management standards in relation to this policy. Who takes the lead responsibility How do we monitor that this is How often is this done? Which working groups etc. are involved The organisation has an approved, documented process for ensuring that agreed best practise as defined in NICE clinical guidelines and interventional procedures, is taken into account in the context of the clinical services provided by the organisation. As a minimum the document must include a description of the ; Trust Board Quality and Safety Committee reports Bi-annually Quality and Safety Committee Clinical Audit and Group a) Duties including leadership of the process at all stages of the process Chief Executive through the Executive Directors & Senior Managers Performance reviews Monthly Quality and Safety Committee b) Process for identifying relevant documents Audit, Research & Clinical Manager Horizon scans Quarterly Clinical Audit and Group c) Process for disseminating relevant documents Audit, Research & Clinical Manager Standing agenda item on SDUs Quality and Safety groups Monthly Clinical Audit and Group d) Process for conducting an organisational gap analysis Audit, Research & Clinical Manager & SDU Lead(s) Completed NICE Compliance Assessment For every piece of relevant guidance Clinical Audit and Group e) Process for ensuring that recommendations are acted upon throughout the organisation Clinical Audit and Group SDUs reports on progress made to Quality and Safety Committee Monthly Clinical Audit and Group d) Process for documenting any decision not to implement NICE recommendations Medical Director Decision recorded in the minutes of the Clinical Audit and For each piece of guidance NOT implemented Clinical Audit and Group Quality and 11

Group Safety Committee g) Process for monitoring compliance with all of the above Medical Director Report to Quality and Safety Committee and Trust Board Monthly and biannually Clinical Audit and Group Quality and Safety Committee 9. Quality Indicator for NICE guidance implementation Every piece of NICE guidance is scored using the ranking tool according to its level of scrutiny and assurance. The highest level of assurance Level 5 is achieved when the service is compliant with the relevant guidance as verified by clinical audit. The overall percentage will then be calculated and reported on, on a monthly basis. 10. Equality analysis This policy has undergone an equality analysis. 11. Reference National Prescribing Centre (2001). Implementing NICE Guidance: Radcliffe Medical Press NHS Litigation Authority Risk Management Standards for PCTs (May 2007) available at www.nhsla.com How to put NICE guidance into practice (2005) available at www.nice.org.uk A guide to NICE (2005) available at www.nice.org.uk The Audit Commission (2005) Managing financial implications of NICE guidance Appendix 1 Ranking tool template Prioritisation of guidance: ranking priority 12

Table 1 is a ranking tool to help rank each piece of guidance. Table 2 lays out how scoring translates into relevance and priority for the service, and indicates the timeframe within which the base line assessment should be completed, including action planning and audit. Table 1: Ranking tool Criteria High cost (treatment costs) High volume (amount of patients) High risk Evidence of a quality problem (incidents, complaints etc.) Wide variation in practice Likely to improve healthcare outcomes as well as process improvements Likely to have economic and efficiency benefits Topic is a key professional or clinical interest Reliable sources of data readily available Potential for change Not relevant (0) Limited relevance (1) Moderate relevance (2) Fully relevant (3) Score Multidisciplinary project Interface project (Health Economy) Cost Improvement Programme Total score Table 2: Scoring key Score Relevance/priority Assessment timeframe 1-17 Limited relevance/ Low priority Consider not reviewing and place on Risk Register 18-34 Moderate relevance/ Medium priority within 6 months 35-51 Fully relevant/ High priority within 3 months 13

Appendix 2 SDU: Title of the NICE guidance: NICE GUIDANCE RISK ASSESSMENT NICE Ref No. Risk Type Risk (description) Risk Score Risk Register Yes/No Planned Actions Current Status of actions (see key) Implement By Date Staff Member/Group/Team Responsible Responsible Manager Residual Risk Rating Current Status Key 1: Agreed but not yet actioned 2: Action in progress 3: Partial completion 4: Full completion 5: Action overdue 6: Not actioned (Please provide reason why) Risk Assessment Completed by: Job Title:... Date:.... Risk Assessment Completed by: Job Title:... Date:.... Risk Assessment Completed by: Job Title:... Date:.... Please send a completed copy to Renata Bozikovova, Quality and Safety Co-ordinator, Email: Renata.bozikovova@hacw.nhs.uk

Rating the risk Risk scoring = consequence x likelihood (C x L) Likelihood Likelihood score 1 2 3 4 5 Consequence score Rare Unlikely Possible Likely Almost certain 5 Catastrophic 5 10 15 20 25 4 Major 4 8 12 16 20 3 Moderate 3 6 9 12 15 2 Minor 2 4 6 8 10 1 Negligible 1 2 3 4 5 For grading risk, the scores obtained from the risk matrix are assigned grades as follows: 1-3 Low risk 4-6 Moderate risk 8-12 High risk 15-25 Extreme risk Instructions for use 1. Determine the consequence score (C) for the potential adverse outcome relevant to the risk being evaluated. 2. Determine the likelihood score (L) for the potential adverse outcome to the risk being evaluated. 3. Use table (above) to determine the likelihood score (L) for those adverse outcomes. If possible, score the likelihood by assigning a predicted frequency of occurrence of the adverse outcome. If this is not possible, assign a probability to the adverse outcome occurring within a given time frame, such as the lifetime of a project or a patient care episode. If it is not possible to determine a numerical probability then use the probability descriptions to determine the most appropriate score. 4. Calculate the risk score the risk multiplying the consequence by the likelihood: C (consequence) x L (likelihood) = R (risk score) 5. Identify the level at which the risk will be managed in the organisation, assign priorities for remedial action, and determine whether risks are to be accepted on the basis of the colour bandings and risk ratings, and the organisation s risk management system. Include the risk in the organisation risk register at the appropriate level. 15

Appendix 3 Action Plan template Service: Title of the NICE guidance: Date completed: Action plan for the implementation of NICE guidance Intended outcome Action Name of person responsible To be completed by Please return the completed action plan to Renata Bozikovova, Quality and Safety Co-ordinator, Tel: 01905681605, Email: renata.bozikovova@hacw.nhs.uk 16

Appendix 4 Procedure flowchart for the Implementation of NICE guidance Start Clinical Directors and Quality and Safety Committee review score Set out date for re-audit Compliant and added to audit forward programme set out audit date Yes Yes Ulysses Alert with newly published guidance is distributed to Quality/Governa nce Leads/Clinical Directors in each SDU by the Q&S Coordinator Quality/Govern ance Leads/Clinical Directors action the alert on Ulysses indicating whether guidance is relevant or not Quality/Governa nce Leads/Clinical Directors notify Q&S Coordinator of all applicable guidance and the name of Clinical Lead(s) for each guidance Q&S Coordinator sends the Ranking tool and the baseline compliance assessment to the Nominated Clinical Lead (NCL) Nominated Clinical Lead (NCL) completes and returns the Ranking tool Is the guidance of Low priority? No Nominated Clinical Lead (NCL) completes and returns the NICE baseline compliance assessment to Q&S Coordinator and Quality/Govern ance Lead Completed NICE baseline assessment is reviewed by the SDU and sent to Q&S Coordinator and Quality/Gove rnance Lead Is the service compliant with guidance? Timescale: within 1 week of publicaton Within 1 month of receipt Within 1 month of receipt Within 1 month of receipt 3 or 6 months or N/A if low priority guidance Service is partially or non-compliant 17

Guidance is implemented when actions are completed. Added to the audit forward programme Quality/Gov ernancelea d monitors action plans and informs Q&S Coordinator of progress and any delays NCL and/or Quality/Govern ance Lead ensure development of a SMART action plan & returns it to Q&S Coordinator Yes Will the guideline be implemented? No Assessment is reviewed by the SDU consider placing on SDU risk register and inform Q&S Co-ordinator 18